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Domperidone restricted to a POM

9th September 2014

As of the 4th September 2014, domperidone is available only as a Prescription Only Medicine (POM) in the UK. All unexpired stock of products previously designated as Pharmacy medicines (P) have been recalled by the MHRA. This follows the Europe-wide review of the safety and efficacy of domperidone (see our news item 30th April 2014) which has resulted in the conclusion by the UK Commission on Human Medicines (CHM) that products containing domperidone no longer meet the requirements for supply with legal status ‘P’.

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Liverpool Care pathway replaced by five Priorities for Care

9th September 2014

The Leadership Alliance for the Care of Dying People (LACDP) has published a new approach to caring for people in the last few days and hours of life. This approach, based on five new priorities for care, is outlined in the new document ‘One Chance to Get it Right’ and follows the recommendation made by the independent Neuberger review of the Liverpool Care Pathway (LCP) that the LCP be phased out by 14 July 2014.

The Five new Priorities for Care are:

  • the possibility that a person may die within the coming days and hours is recognised and communicated clearly, decisions about care are made in accordance with the person’s needs and wishes, and these are reviewed and revised regularly
  • sensitive communication takes place between staff and the person who is dying and those important to them
  • the dying person, and those identified as important to them, are involved in decisions about treatment and care
  • the people important to the dying person are listened to and their needs are respected
  • care is tailored to the individual and delivered with compassion, with an individual care plan in place.

The full document can be downloaded from the Department of Health website, here.

Full details are available on the LACDP section of NHS England website, here.

CQC annual report: safer management of controlled drugs

29th August 2014

The UK Care Quality Commission (CQC) has published their 2013 annual report on the safer management of controlled drugs. They have made the following recommendations to support the work of NHS England controlled drug accountable officers (CDAOs):

  • CDAOs must be adequately resourced to carry out their roles and responsibilities with regard to controlled drugs
  • CDAOs must be clear about their responsibilities for controlled drug governance arrangements and strengthen their relationships with clinical commissioning groups (CCGs) and commissioning support units (CSUs) so that these organisations are clear as to how they can support them
  • CDAOs should consider organising learning events for controlled drug accountable officer colleagues and controlled drug leads, to enable them to share learning and best practice
  • CDAOs should consider extending membership of the controlled drug local intelligence network to other relevant local organisations (such as social enterprise organisations or community interest companies) either on a permanent or ‘as required’ basis
  • a formal process should be put in place by CDAOs to ensure controlled drug concerns and good practice are shared nationally where appropriate
  • healthcare providers must determine whether they are required to appoint a CDAO or whether they meet the criteria for an exemption
  • CQC should summarise the key messages from the Controlled Drugs National Group meetings and circulate them to CDAOs to pass on to members of their controlled drug local intelligence networks.

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Sativex approved in Wales to treat MS symptoms on NHS

29th August 2014

The cannabinoid Sativex (delta-9-tetrahydrocannabinol/cannabidiol) can now be prescribed on the NHS in Wales to treat symptoms of multiple sclerosis.

The decision taken by the All Wales Medicines Strategy Group was given ministerial approval and supersedes the recommendation made earlier this year, in draft guidance by the National Institute for Health and Care Excellence (NICE), that the drug should not be made available in England and Wales because it is not cost effective.

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Ketamine rescheduling consultation

28th August 2014

Ketamine was classified as a Class B drug under the Misuse of Drugs Act on 10 June 2014 in the UK (see our news item 6 June 2014). The promised consultation document, seeking views on the impact of the proposed change of ketamine to a Schedule 2 CD from a Schedule 4 (part 1) CD as recommended by the Advisory Council on the Misuse of Drugs, is now available. The consultation is open until 3 November 2014 and responses can be made on-line, via e-mail or via post.

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Levobupivacaine 250mg/200mL epidural infusion bags supply problem

28th August 2014

There is a manufacturer’s supply problem with levobupivacaine 250mg/200mL (Chirocaine® 1.25mg/mL; AbbVie) epidural infusion.  It is unclear when normal supplies will resume but it is expected to be the end of September 2014. There is no authorized alternative available, however we are aware of an unauthorized levobupivacaine 250mg/200mL epidural infusion from a specials manufacturing unit (ITH Pharma; 020 8838 8260).

Dexamfetamine sulfate oral solution now authorized

14th August 2014

Dexamfetamine sulfate 1mg/mL oral solution is now an authorized product in the UK (previously a special order product). It is available from Martindale pharmaceuticals, NHS list price of 500mL is £109.

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Cochrane review: Levetiracetam for neuropathic pain in adults

14th August 2014

A Cochrane review on Levetiracetam for neuropathic pain in adults (CD010943) has been published in full on-line.

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Cochrane review: Topical lidocaine for neuropathic pain in adults

14th August 2014

A Cochrane review on topical lidocaine for neuropathic pain in adults (CD010958) has been published in full on-line.

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PCF4+ 2013 e-book now half price!

11th August 2014

The PCF4+ 2013 e-book version of the Palliative Care Formulary  is now available for a special half price offer of £15 via our website store! 

Please note that it is anticipated that PCF5 print edition and PCF5 e-book, will be available in Autumn 2014. The online formulary will still be continually updated, providing the most up to date version of the Palliative Care Formulary. For further details of publication plans during 2014 see our news article (9 January 2014).

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Class 2 Medicines Recall: Buccolam (midazolam) oromucosal solutions

10th August 2014

The UK MHRA has issued a class 2 medicines recall (action within 48h) for specific batches of Buccolam (midazolam) oromucosal solution 2.5mg, 5mg, 7.5mg and 10mg (ViroPharma SPRL). This is following a routine inspection of the company’s contract manufacturing site in the UK. The inspection identified the possibility for chemical contamination. No evidence of contamination has been identified within Buccolam oromucosal solution on the market.

Replacement stocks of Buccolam are available.

Full information, including affected batch numbers, can be obtained from the link below.

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Cochrane review: Oxycodone for neuropathic pain and fibromyalgia in adults

22nd July 2014

A Cochrane review on oxycodone for neuropathic pain and fibromyalgia in adults (CD010692) has been published in full on-line.

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BNF changes to haloperidol maximum dose

22nd July 2014

In May 2014, the BNF changed the PO dosing schedule of haloperidol for the treatment of schizophrenia, mania and psychoses, and reduced the maximum recommended PO dose to 20mg/day in divided doses. This was in line with changes in the Haldol SPC (Janssen) that were made in line with recent studies that used lower doses of antipyschotics due to the known risk of QT prolongation and other adverse effects.

At the time, the maximum dose of the IM formulation was not updated. In addition, the situation was complicated by the discontinuation of the Haldol brand of haloperidol tablets and injection (note generic versions of all formulations remain).

Following queries, the BNF has now also reduced the maximum IM dose from 20mg/day to 12mg/day in divided doses, based on the fact that the bioavailability of PO haloperidol is generally accepted to be approximately 60% of IM haloperidol.

The BNF notes that some of the generic SPCs for both the oral and IM formulations have not yet been amended and have highlighted this inconsistency to the MHRA. In the meantime, they have noted that BNF doses may differ from the product literature. 

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A new fentanyl sublingual tablet launched in UK

21st July 2014

Another fentanyl sublingual tablet (Recivit; Grunenthal) has been launched in the UK for the treatment of breakthrough pain in adults who are already receiving maintenance opioid therapy for chronic cancer pain. The sublingual tablets are available as 133, 267, 400, 533 and 800microgram and as with other forms of transmucosal fentanyl, must be individually titrated for each patient. The formulations are not bio-equivalent with other fentanyl products. Each sublingual tablet costs £4.50.

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Tapentadol oral solution launched in UK

21st July 2014

Tapentadol oral solution 20mg/mL (Palexia: Grunenthal) has been launched in the UK for the treatment of moderate to severe acute pain in adults which can be managed only with opioid analgesics. It is available in 100mL and 200mL packs and the cost of a 50mg (2.5mL) dose = £0.45, which is equivalent to the tablet formulation. The dose can be taken undiluted or diluted in water or any non-alcoholic cold drink, and is also suitable for administration via enteral feeding tubes.

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A new oxycodone m/r tablet launched in UK

21st July 2014

Another oxycodone 12hourly m/r tablet (Dolocodon® PR: Zentiva) has been launched in the UK for the treatment of severe pain which can be adequately managed only with opioid analgesics. The m/r tablets are available in 5, 10, 20 and 40mg and the cost of 28 days @ 10mg, 20mg, and 40mg b.d. = £25, £50, and £100 respectively.

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A new oxycodone immediate-release generic capsule launched in UK

21st July 2014

Another oxycodone immediate-release capsule (Lynlor: Actavis) has been launched in the UK for the treatment of severe pain which can be adequately managed only with opioid analgesics. The immediate-release generic oxycodone capsules are available in 5, 10, and 20mg.

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Cochrane review: Heparin for perioperative thromboprophylaxis in patients with cancer

21st July 2014

A Cochrane review on low molecular weight heparin versus unfractionated heparin for perioperative thromboprophylaxis in patients with cancer (CD009227) has been published in full on-line.

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Class 2 Medicines Recall: Midazolam buccal liquid 10mg/mL (unauthorized product)

17th July 2014

The UK MHRA has issued a class 2 medicines recall (action within 48h) for specific batches of Midazolam buccal liquid 10mg/mL, 5mL (unauthorized product manufactured under a Specials Licence by Penn Pharma, distributed in Quantum Pharmaceutical livery). The screw caps on some units have not been correctly placed during manufacture, which may result in evaporation of the aqueous component of the product and a therefore an increase in the concentration of midazolam. More information including batch numbers can be obtained from the link below.

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New drug driving offence - Department for Transport guidance

9th July 2014

The UK Government Department for Transport has produced guidance for health professionals on the new drug driving offence; driving in excess of specified levels of certain controlled drugs in the body. This offence, which is in addition to the existing rules on drug impaired driving and fitness to drive, is expected to come into force on 2 March 2015 (see our previous news items 07-01-2014 and 08-08-2013).

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Reminder of risk of life-threatening harm from accidental exposure to fentanyl patches

30th June 2014

The MHRA have sent out a reminder of the potential risk of life-threatening harm from accidental exposure to transdermal fentanyl patches. Cases of accidental exposure continue to be reported and many involve children. To reduce this risk, they advise informing patients and care-givers:

  • to choose the patch application site carefully (see the patient information leaflet)
  • to check the adhesion of the patch once applied, especially the edges
  • to fold the used patch as soon as it is removed so that the adhesive side of the patch sticks firmly to itself and dispose of the folded patch safely
  • if a patch is transferred to another person, remove it immediately and seek medical advice
  • if a patch is swallowed, seek medical help immediately.

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Cochrane review on the undesirable effects of opioids in cancer pain

26th June 2014

A Cochrane review on the use of morphine, fentanyl, oxycodone or codeine on patient consciousness, appetite and thirst when used to treat cancer pain (CD011056) has been published in full on-line.

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Cochrane review: imipramine for neuropathic pain in adults

26th June 2014

A Cochrane review on the use of imipramine for neuropathic pain in adults (CD010769) has been published in full on-line.

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Ketamine update on regulation and availability

6th June 2014

Ketamine will be classified as a Class B drug under the Misuse of drugs Act from 10 June 2014 in the UK. A consultation is still due to take place to assess the impact of the proposed change from a Schedule 4 (part 1) controlled drug to a Schedule 2 controlled drug as recommended by the Advisory Council on the Misuse of Drugs (see our news item 25 February 2014).

There are problems with the availability of ketamine injection in the UK (see our news item 16 May 2014), which are not expected to be resolved until March 2015.

In the absence of suitable authorized alternatives, we are aware of the following products which may be imported if necessary, although there may be a time delay:

  • Ketamine 10mg/mL, 5mL and 20mL vials (European-sourced)
  • Ketamine 100mg/mL, 2mL vials (from Australia)
  • S-ketamine 5mg/mL, 5mL amps; note the ketamine used in the UK is a racemic mixture of two enantiomers. S-ketamine is about twice as potent as the racemic mixture and thus doses of this product should be halved, see PCF Ketamine monograph. 

Great care must be taken to avoid potential patient safety issues associated with the different strengths, pack sizes and type of product.

24 Jun 2014 An in use product safety assessment report for ketamine hydrochloride and esketamine hydrochloride injections produced by UK Medicines Information (UKMI) is available to download from the link below.

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Benzodiazepines therapeutic review

5th June 2014

A therapeutic review on benzodiazepines has been published in the Journal of Pain and Symptom Management (JPSM): 

Howard P. et al (2014) Therapeutic Reviews: Benzodiazepines. Journal of Pain and Symptom Management. 47: 955−964. 

This article in the series; is based on the latest Benzodiazepines monograph (updated June 2014) featured in the on-line Palliative Care Formulary.

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NICE Evidence Update: Opioids in palliative care

28th May 2014

The UK National Institute for Health and Care Excellence has produced a summary of the selected new evidence relevant to the use of opioids in palliative care since the NICE clinical guideline: Opioids in palliative care (CG140) was published in 2012. The new evidence identified in this Evidence Update (58) is not expected to have any potential impact on the existing guidance.

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Tramadol to become Schedule 3 Controlled Drug

21st May 2014

Tramadol, currently a Prescription Only Medicine (POM) will become a Schedule 3 Controlled Drug as from 10 June 2014 in England, Wales and Scotland. Controlled Drug prescription requirements will apply, but it will be exempt from safe custody requirements. This follows a consultation by the Advisory Council on the Misuse of Drugs (see our news article 14 March 2014).

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Zopiclone and zaleplon to become Schedule 4 (Part 1) Controlled Drugs

21st May 2014

Zopiclone and zaleplon currently both Prescription Only Medicines (POM) will become Schedule 4 (Part 1) Controlled Drugs as from 10 June 2014 in England, Wales and Scotland. This brings them under the same category as zolpidem and the benzodiazepines (except temazepam and midazolam).

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Ranitidine injection supply problems

21st May 2014

There is a short-term manufacturer’s supply problem with ranitidine injection 50mg/2mL. We understand it is likely to last until the end of May 2014.

Ketamine injection supply problems

16th May 2014

Pfizer UK has confirmed that it is currently out of stock of ketamine (Ketalar) 10mg/mL and 100mg/mL injection and that the 50mg/mL injection is very low.

There have been supply problems with ketamine injection since November 2012 (see our news article 21-09-2012).

The ketamine 10mg/mL and 100mg/mL are not expected to be back in stock until March 2015. There are currently no further details on the 50mg/mL injection.

For enquiries please contact Pfizer customer services (01304 616161).

EMA restricts domperidone dose and duration of use

30th April 2014

The European Medicines Agency (EMA) has recommended changes to the indications, dose and duration of use of domperidone in adults and children following a review. This follows concerns highlighted in 2012 that domperidone is associated with a small increased risk of serious cardiac undesirable effects. Domperidone is now:

  • indicated for nausea and vomiting only, all other uses are unauthorized
  • contra-indicated in patients:
    • where cardiac conduction is, or could be, impaired
    • with underlying cardiac disease, e.g. CHF
    • with severe hepatic impairment
    • concurrently receiving drugs known to be CYP3A4 inhibitors and/or cause QT prolongation.

In addition domperidone:

  • should be used at the lowest effective dose, for the shortest possible time (generally ≤1 week)
  • should be limited to a maximum dose of 10mg t.d.s. (for adults and children >12 years and >35kg) or 0.25mg/kg t.d.s (for children <12 years and <35kg).

Patients should be advised to seek prompt medical attention should symptoms such as syncope or cardiac arrhythmias occur.

The restrictions also apply to OTC domperidone products, with a maximum duration of use of 48h.

The full EMA report and MHRA health professionals letter can be found from the links below.

EMA domperidone report

MHRA health professionals letter

Note: palliativedrugs.com has contacted the EMA for clarification surrounding the use of domperidone in palliative care.

Free access to the on-line Palliative Care Formulary renewed for NHS Scotland

25th April 2014

We are delighted to report that NHS Education for Scotland has subscribed to the on-line Palliative Care Formulary (PCF) for a second year. The on-line PCF is hosted on the Palliative Care portal of the Knowledge Network website and is available free of charge to those with an NHS Education Scotland ATHENS user name and password. The content is continually updated and represents the most current version.

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NICE guideline on managing pressure ulcers

23rd April 2014

The UK National Institute for Health and Care Excellence (NICE) has published a clinical guideline on managing pressure ulcers (CK179).

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Dexamethasone 4mg/mL injection supply problem

11th April 2014

There is a UK manufacturer’s supply problem with the MSD (Organon livery) dexamethasone base 4mg/mL injection. It is unclear when normal supply will resume.

The alternative Hospira brand of dexamethasone injection available (dexamethasone phosphate 4mg/mL) contains dexamethasone base 3.3mg/mL. There is scope for confusion when switching to this preparation or when switching from PO to SC route.

For more details clarifying dexamethasone prescribing see the www.palliativedrugs.com factsheet below, produced in 2010 when the labeling and prescribing of dexamethasone injection was standardized to dexamethasone base by the MHRA.

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NICE guideline on managing medicines in care homes

31st March 2014

The UK National Institute for Health and Care Excellence (NICE) has published guidelines on managing medicines in care homes (SC1).

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New buprenorphine patch launched in UK

31st March 2014

A new brand of buprenorphine transdermal patch (Hapoctasin; Actavis) has been launched in the UK. The patches are authorized for moderate to severe chronic cancer pain and severe pain unresponsive to non-opioid analgesics in adults. The patches are available as 35, 52.5 and 70micrograms/h for 72h (i.e. changed every 3 days).

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Die Ausgabe 01/2014 des APM-Newsletter ist erschienen

25th March 2014

Issue 01/2014 of the APM Newsletter for German-speaking users of palliativedrugs.com is available.

Die Ausgabe 01/2014 des APM-Newsletter ist erschienen. Über die aktuelle Ausgaben des Newsletters wird Sie das Bulletin Board informieren.

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Tramadol to be a Schedule 3 CD and temazepam exemptions to be removed

14th March 2014

The UK government has decided that tramadol will become a Schedule 3 controlled drug (CD) later this year, but will have exemption from the safe custody requirement. It also plans to remove the prescription writing exemptions for temazepam to be in-line with other schedule 3 CDs, subject to further advice from the Advisory Council on the Misuse of Drugs. This follows a consultation between July and October 2013 (see our news item 30 July 2013).

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PCF4 print version now only £25!

4th March 2014

The print version of the Palliative Care Formulary 4th edition (PCF4) is now available for a special half price offer of £25 via our website store. 

Please note that it is anticipated that PCF5 print edition, will be available in Autumn 2014. The online formulary will still be continually updated, providing the most up to date version of the Palliative Care Formulary. For further details of publication plans during 2014 see our news article (9 January 2014).

NICE evidence summary of oral ketamine for chronic pain

27th February 2014

The National Institute for Health and Care Excellence (NICE) has published its evidence summary (ESUOM27) for the unauthorized (unlicensed)/off-label use of oral ketamine for chronic pain.

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First ever Global Atlas identifies unmet need for palliative care

25th February 2014

A new publication mapping the provision of palliative care around the world has been published jointly by the World Health Organization (WHO) and the Worldwide Palliative Care Alliance (WPCA). The Global Atlas identifies that only 1 in 10 people who need palliative care are receiving it, and calls on all countries to include palliative care as an essential component to every modern healthcare system. The importance of palliative care is also being emphasized by the WHO Global Action Plan for the Prevention and Control of Noncommunicable Diseases 2013–2020 and the most recent WHO essential medicines list which includes a specific section on medicines for palliative care (see our news item 18 July 2013). The documents can be downloaded from the links below.

Global Atlas

Global Action Plan for the Prevention and Control of NCDs 2013-2020

ACMD recommends reclassifying ketamine

25th February 2014

The UK Advisory Council on the Misuse of Drugs (ACMD) has recommended that ketamine be controlled under the Misuse of Drugs Act 1971 as a Class B substance (currently Class C) and that there should be a consultation on reclassifying ketamine as Schedule II of the Misuse of Drugs Regulations 2001 (currently Schedule 4 part 1). This is based on the evidence of chronic bladder and urinary tract toxicity. The government minister for crime prevention has accepted these recommendations.

ACMD report on ketamine

Government response  

Phosphate enema new contra-indication

25th February 2014

The UK SPC for Fleet Ready-to-use Enema (phosphate enema) has been updated to include a new contra-indication in patients with clinically significant renal impairment (not defined). In addition, precautions added include; conditions predisposing to dehydration, or drugs that may decrease GFR, affect electrolyte levels, prolong QT interval, affect renal perfusion or function, or hydration status.

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Opioid antagonists therapeutic review

11th February 2014

A therapeutic review on opioid antagonists has been published in the Journal of Pain and Symptom Management (JPSM):

Barnett V. et al (2014) Therapeutic Reviews: Opioid Antagonists. Journal of Pain and Symptom Management. 47:341 −352. 

This is the 16th article in the series; all are based on monographs featured in the Palliative Care Formulary.

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NICE consultation on enhancing the BNF with other prescribing resources: an opportunity to lobby for the Palliative Care Formulary

7th February 2014

NICE has opened a consultation on the future format of the British National Formulary (BNF) and how it can enhance the information it provides by linking to other authoritative sources of prescribing information.

This provides an opportunity for UK members of www.palliativedrugs.com to highlight to NICE the value of the Palliative Care Formulary (PCF).

We encourage members to respond to the consultation and suggest that linking to the on-line PCF would enhance the BNF. This can only help in our endeavours to secure a national subscription and provide, once more, free-access for UK health professionals.

The feedback form takes 5–10min to complete and comprises a tick box question on how you currently access the BNF followed by three short questions.

The consultation closes at 9am 31 March 2014.

BNF consultation document (4 pages)

On-line response link

SIGN guidance on lung cancer updated

6th February 2014

The Scottish Intercollegiate Guidelines Network (SIGN) have updated their guideline on the management of lung cancer (SIGN 137). This supersedes SIGN 80.

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Interim statement as LCP is phased out

21st January 2014

The leadership Alliance for Care of Dying People (LACDP) has published an interim statement on its work following the publication of the independent report on the Liverpool Care Pathway in July 2013. 

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News about palliativedrugs.com publications in 2014

9th January 2014

We anticipate that the PCF5 print and e-book editions will be available in autumn 2014. 

Apart from updated monographs, PCF5 will also contain additional selected information from Symptom Management in Advanced Cancer; this will be discontinued in 2014 after existing stock has been sold. 

We would like to thank our members for their support over 2013, particularly to those who have subscribed to the website. By way of thanks:

  • the price of PCF5 print edition will be unchanged at £50 (including p&p in theUK), although bigger and thus more costly to produce and post
  • the cost of the PCF5 e-book will be reduced to £25. 

In anticipation of these updated editions, we will also be discounting PCF4 print edition from 1st March 2014 to half price (£25) and, from 1st August 2014, the PCF4+ 2013 e-book to £15. 

The online formulary will still be continually updated, providing the most up to date version of the Palliative Care Formulary. If more members subscribe in 2014, we will review the cost of subscription to see if this can be reduced in 2015. 

We hope that the above information will help guide decisions on your purchases in 2014. 

If you require bulk purchases of any format please contact hq@palliativedrugs.com to discuss your requirements.

New drug driving offence changes to SPCs and product labelling

7th January 2014

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued information about changes that will be made to UK SPCs, PILs and product packaging for all medicines controlled by the Misuse of Drugs Act. This is in anticipation of the new drug driving offence that is due to be debated in parliament and come into effect later in 2014.

The main target for this offence is dangerous drivers who are impaired after recreational use of drugs, including illicit as well as controlled drugs such as morphine, amphetamine and some benzodiazepines (see our news item 08-08-2013). A statutory defence has been included in the draft legislation for patients who have been prescribed the drugs for medical or dental purposes and are taking them in accordance with the prescriber’s directions and information given by the manufacturer. The information given by the manufacturer in section 4.7 of the SPC is now to include the following text:

“This medicine can impair cognitive function and can affect a patient’s ability to drive safely. This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988. When prescribing this medicine, patients should be told:

  • The medicine is likely to affect your ability to drive
  • Do not drive until you know how the medicine affects you
  • It is an offence to drive while under the influence of this medicine
  • However, you would not be committing an offence (called ‘statutory defence’) if:
    • The medicine has been prescribed to treat a medical or dental problem and
    • You have taken it according to the instructions given by the prescriber and in the information provided with the medicine and
    • It was not affecting your ability to drive safely”.

Similar wording is to be added to the PIL and product packaging.

In addition to this a further consultation on the amphetamine limit for drug driving was opened on 19th December 2013, closing on 30th January 2014.

MHRA information on changes

Drug driving proposed regulations

Consultation on amphetamine limit

Follow @palliativedrugs on twitter

30th December 2013

www.palliativedrugs.com is now on twitter! Follow us @palliativedrugs or via the twitter icon on our home page for news on drugs in palliative care and updates to the on-line Palliative Care Formulary and website. Please retweet us!

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NICE to distribute BNF annually

27th December 2013

The British National Formulary (BNF) is produced in print twice a year in March and September. However, the UK National Institute for Health and Care Excellence (NICE) is to change to distributing the print version once a year in September (still free of charge to eligible prescribers), in addition to the availability via its website and app. NICE will not be purchasing the March 2014 edition for nationwide distribution to NHS health professionals in England. Copies can be purchased through the Pharmaceutical press website.

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Class 4 drug alert: Matrifen 100microgram/h TD patches

17th December 2013

The UK Medicines and Healthcare products Regulatory Agency (MHRA) have issued a Class 4 drug alert (caution in use) for the Matrifen brand of fentanyl 100microgram/h transdermal patches (Takeda UK, Teva livery 01628 537900 ).

There is an error in the text on the pouch for batches of patches distributed since 25 May 2013. The strength is expressed correctly in the heading but in the smaller body text underneath, it is expressed incorrectly, as 75microgram/h. The size of the patch is also stated incorrectly. It is given as 25.2cm², whereas it is actually 33.6cm². The text on the carton, the patch label and in the patient information leaflet is all correct.

To avoid disruption of supply, distribution of affected stock will continue for the next few weeks. Corrected stock is expected to be available during February 2014, when distribution of affected stock will cease.

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Strong opioids and the relief of cancer pain: Information for patients, families and friends

17th December 2013

We are proud to announce the publication of a new booklet Strong opioids and the relief of cancer pain: Information for patients, families and friends published by the editorial team of the Palliative Care Formulary. Based on the booklet Oral Morphine and the Relief of Cancer Pain: Information for patients, families and friends by Dr Robert Twycross and Dr Sylvia Lack (Beaconsfield publishers 1987), it has been fully revised to include all strong opioids. 

Written in question and answer form, Strong Opioids and the Relief of Cancer Pain deals with the many concerns which patients, and their family and friends, may have when a strong opioid is first prescribed. It is not meant to be read straight through from beginning to end; it is more for dipping into. Easy to understand language is used throughout which has been approved by the Plain English Campaign and carries the prestigious Crystal Mark for clarity. Some example questions answered include:

  • Will I become addicted?
  • How soon will I become pain-free?
  • What should I do if I forget to take a dose?
  • What can I do if the pain comes back between regular doses?
  • What about unwanted effects with skin patches?
  • Do strong opioids have many unwanted effects?
  • What is 'spinal' morphine? 

It is available via our store priced £5.99 including p&p, (discounts available for purchases of 10 or more) or from amazon.

Cochrane overview of antiepileptic drugs for neuropathic pain and fibromyalgia

12th December 2013

An overview of Cochrane reviews on antiepileptic drugs for neuropathic pain and fibromyalgia (CD010567.pub2) has been published.

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NG tube placement checks reminder

12th December 2013

An alert has been issued by NHS England reminding health professionals that NPSA advice on initial checks to confirm correct nasogastric (NG) tube placement i.e. pH or x-ray testing after initial insertion, should be followed for all NG tubes including those with placement devices. This follows 2 fatal incidents where enteral nutrition was unintentionally given into the respiratory tract through a misplaced NG tube inserted with the aid of a placement device.

The NPSA Alert Reducing the harm caused by misplaced nasogastric tubes in adults, children and infants (2011) stated that a pH of 1 to 5.5 or an x-ray are the only acceptable methods for confirming initial placement of a nasogastric tube. This Alert and a later Rapid Response Report (2012) also emphasised the importance of ensuring all possible steps are taken to reduce the likelihood of human error, including competency-based training for staff interpreting x-rays or testing the pH of aspirate, using CE marked pH paper intended for gastric secretions, and never inserting any substance down the tube (including lubricant to aid guide wire removal) prior to confirming initial placement. This advice still stands, even when placement devices are used.

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SIGN guideline management of chronic pain

12th December 2013

The Scottish Intercollegiate Guidelines network (SIGN) has published its guideline on the management of chronic pain (SIGN 136).

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Pain e-learning package

5th December 2013

A new multidisciplinary e-learning package designed to improve the early diagnosis and management of pain has been launched by the Faculty of Pain Medicine of the Royal College of Anaesthetists and the British Pain Society. The first two 30minute modules on Basic Pain Management and Basic Science are now available. A further 7 will be released in 2014, several of these have been written by specialist pharmacists in pain and palliative care.

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Die September/Oktober Ausgabe des APM Newsletter ist fertig

26th November 2013

The September/October issue of the APM Newsletter for German-speaking users of www.palliativedrugs.com is available.

Die September/Oktober Ausgabe des APM-Newsletter Jahrgang ist erschienen. Über die aktuelle Ausgaben des Newsletters wird Sie das Bulletin Board informieren.

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Neuropathic pain guidelines published

26th November 2013

The UK National Institute for Health and Care Excellence (NICE) has published its guidelines on the pharmacological management of neuropathic pain in adults in a non-specialist setting (CG173). This supersedes the previous guideline 96.

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MHRA guidance on switching between different manufacturers products of anti-epileptic drugs

14th November 2013

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued guidance on switching between different manufacturer’s products of anti-epileptic drugs. The anti-epileptics are split into the 3 groups below to help prescribers decide whether it is necessary to maintain continuity of supply of a specific manufacturer’s product. This advice relates to the treatment of epilepsy and is not intended for other indications e.g. mood stabilisation or neuropathic pain.

Group 1 Ensure the patient is maintained on a specific manufacturer’s product. Prescribe either by specifying a brand name or by using the generic drug name and name of the manufacturer (marketing authorisation holder):

  • carbamazepine, phenobarbital, phenytoin, primidone.

Group 2 Base the need for continuity of supply of a specific manufacturer’s product on clinical judgement, patient consultation, seizure frequency and treatment history:

  • clobazam, clonazepam, eslicarbazepine, lamotrigine, oxcarbazepine, perampanel, retigabine, rufinamide, topiramate valproate, zonisamide.

Group 3 Usually unnecessary to maintain a patient on a specific manufacturer’s product unless there are specific concerns such as patient anxiety, confusion or risk of dosing errors:

  • ethosuximide, gabapentin, lacosamide, levetiracetam, pregabalin, tiagabine, vigabatrin. 

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Fentanyl buccal film launched in UK

14th November 2013

A fentanyl buccal film (Breakyl; Meda Pharmaceuticals) has been launched in the UK for the treatment of breakthrough pain in adults with cancer who are already receiving maintenance opioid therapy for chronic cancer pain. The film is currently available in 200, 400 and 800microgram dosage forms and as with other forms of transmucosal fentanyl must be individually titrated for each patient. The formulations are not bio-equivalent with other fentanyl products. Each buccal film costs £5.

As this product has been available in the US, information on its use is already included in the recently updated on-line PCF fentanyl (transmucosal) monograph.

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Oral ketoconazole tablets discontinued in UK

14th November 2013

Janssen Pharmaceuticals has discontinued ketoconazole 200mg tablets (Nizoral). This follows the EU-wide review of the risk of hepatotoxicity with oral ketoconazole and the MHRA statement that oral ketoconazole-containing products should no longer be prescribed for fungal infections as the risk of liver injury outweighs the benefits (see our news article 06-08-2013).

Topical ketoconazole formulations (creams, ointments, and shampoos) have very low systemic absorption and continue to be available for use as indicated. 

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SMC accepts orodispersible ondansetron

13th November 2013

The Scottish Medicines Consortium (SMC) has accepted ondansetron orodispersible films (Setofilm; Norgine) for restricted NHS use for its authorized indications in patients with an enhanced risk of aspiration or who have difficulty swallowing. 

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Strong Opioid Identification Booklet now available!

7th November 2013

Palliativedrugs.com Ltd. have produced a Strong Opioid Identification Booklet. This new resource is designed to be used in two ways:

• as a quick reference guide for the range of strong opioids and their formulations and doses available in the UK. Palliative Care Formulary (PCF) encourages safe and rational prescribing which extends to considering size, shape and taste of tablets and solutions, and avoiding doses which force patients to take more tablets, and/or open more containers than necessary. We hope this resource helps health professionals to address these issues

• to aid the identification of strong opioid formulations available in the UK. Where available and appropriate, photographic images of branded products are included. These are not to scale but can be used by health professionals in consultations with patients to help establish or confirm which drug is being used, along with the dose or particular brand. 

The booklet is only available to UK health institutions and is provided free of charge as a service to medicine by Qdem Pharmaceuticals Ltd. 

Booklets will be distributed free of charge on a first-come, first-served basis and are subject to availability. Generally, they will be shipped within 7-10 days of an order being placed. Each order is limited to a maximum of 5 booklets.

To order your free copy, login and click on the link on our home page. The booklet is being distributed by an external company. Please note, when given the choice please select the ‘order without registering’ option.

Diamorphine nasal spray launched in UK

7th November 2013

A diamorphine nasal spray (Ayendi; Wockhardt) indicated for the treatment of acute severe nociceptive pain in children and adolescents 2-15years old in a hospital setting, is now available as an authorized (licensed) product.

The nasal spray is available as 720microgram/metered spray and 1600microgram/metered spray and is provided with 0.5% saline for reconstitution and 9 disposable nasal tips to allow multiple patients to use the product within its 14day expiry.

The NHS list price is currently £112.50 and £123.75 for the 720microgram and 1600microgram bottle (containing 160metered dose sprays), however we understand that significant discount is available until a smaller pack size is launched later in the year.

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FDA approves first hydrocodone m/r capsule

7th November 2013

The U.S. Food and Drug Administration (FDA) has approved a hydrocodone m/r capsule (Zohydro ER; Zogenix Inc) for the management of pain severe enough to require daily, around-the-clock, long-term treatment and for which alternative treatment options are inadequate.

Zohydro ER is a schedule II controlled drug and is the first FDA-approved single-entity (not combined with another analgesic) and modified-release hydrocodone product. It is available as 10mg, 15mg, 20mg, 30mg, 40mg and 50mg m/r capsules.

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Consultation on end of life care guidance

5th November 2013

The Leadership Alliance for the Care of Dying People (LACDP) set up in response to the recommendations from the independent report into the Liverpool Care Pathway (see news item 30-08-2013) has published a consultation document about care in the last days of life. The document can be downloaded from the NHS England website link and feedback can be given via the on-line survey on the website until 6 January 2014.

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EMA confirms metoclopramide restrictions

28th October 2013

The European Medicines Agency (EMA) has re-examined the recommended changes for metoclopramide in adults and children that it made in July 2013, following a request from one of the marketing authorization holders. It has concluded that the original advice for the use of medicines containing metoclopramide should be maintained. The following changes apply:

  • metoclopramide is now only licensed for short-term use (up to 5 days). It is not licensed for use in chronic conditions such as gastroparesis, dyspepsia and gastro-oesophageal reflux disease, nor as an adjunct in surgical and radiological procedures
  • in adults, metoclopramide remains licensed for prevention of post-operative nausea and vomiting (PONV), radiotherapy-induced nausea and vomiting and delayed (but not acute) chemotherapy-induced nausea and vomiting, and for symptomatic treatment of nausea and vomiting including that associated with acute migraine (where it may also be used to improve absorption of oral analgesics)
  • in children, metoclopramide is only licensed as a second-line option for prevention of delayed chemotherapy-induced nausea and vomiting and treatment of established PONV. Use is contra-indicated in children under 1 year of age
  • for adults and children the maximum dose is 0.5mg/kg/24h. In adults, the usual dose for all routes is 10mg up to 3 times daily. In children the recommended dose is 0.1 to 0.15mg/kg up to three times daily
  • the following licensed products will be withdrawn from those countries where they are available; oral liquids containing more than 1mg/mL, intravenous formulations with concentrations above 5mg/mL and suppositories containing 20mg
  • intravenous doses should be administered as a slow bolus over at least 3 minutes to reduce the risk of adverse effects
  • special care should be taken in populations likely to be at increased risk of cardiovascular undesirable effects, including the elderly, patients with cardiac conduction disturbances, uncorrected electrolyte imbalance or bradycardia, and those taking other drugs known to prolong QT interval.

Patients who are currently taking regular metoclopramide should have their treatment reviewed at a routine medical appointment.

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Oxybutynin elixir re-introduced to UK

25th October 2013

Oxybutynin elixir 2.5mg/5mL (Ditropan; Sanofi) has been re-introduced to the UK as a licensed product. The NHS cost of 150mL bottle = £6.88, which is approximately the same price as before it was discontinued.

Note: oxybutynin oral solution 5mg/5mL (unlicensed product) will no longer be reimbursed under part VIIIb of the specials tariff unless the prescription specifically states “unlicensed special”.

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Paracetamol (acetaminophen) therapeutic review

25th October 2013

A therapeutic review on paracetamol (acetaminophen) has been published in the Journal of Pain and Symptom Management (JPSM): 

Twycross R. et al (2013) Therapeutic Reviews: Acetaminophen (paracetamol). Journal of Pain and Symptom Management. 46:747 -755. 

This is the 15th article in the series; all are based on monographs featured in the Palliative Care Formulary.

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CQC: Safer use of controlled drugs guidance

24th October 2013

The Care Quality Commission (CQC) has developed guidance in association with NHS England for health professionals handling controlled drugs. The guidance is published on the CQC website and is intended as supporting information to be read alongside the 2012 annual report on the safer management of controlled drugs which was published in August 2013 (see our news item 13-08-2013).

There are three sections; safer use of fentanyl and buprenorphine transdermal patches, safer use of oral oxycodone medicines and safer use of MS syringe drivers. All contain information on patient safety incidents reported and a checklist for safe use.

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FDA approves a new oral diclofenac formulation

24th October 2013

The US Food and Drug Administration (FDA) has approved a new oral diclofenac formulation (Zorvolex; Irko Pharmaceuticals) with altered absorption properties that allows patients to be treated with dosages 20% lower than currently available diclofenac. The capsules are 18mg or 35mg and are recommended up to three times a day. They are not interchangeable with other formulations of diclofenac. Full prescribing information can be found on the FDA website.

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Update to the supply of clonazepam injection in the UK

24th October 2013

Following the discontinuation of clonazepam 1mg/mL injection (Rivotril) in the UK (see news item 10-10-2013), we can confirm that discontinuation is just in the UK. The French and Swiss Rivotril will be available via IDIS as an unauthorised (unlicensed) UK product in the next couple of weeks. However, the price for a pack of 6 (6 x 1mL ampoule of solution and 6 x 1mL ampoule of solvent) = £34.55, which is approximately 10 times the cost of the original UK product.

MHRA strengthened contra-indications for apixaban, and rivaroxaban

20th October 2013

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has strengthened contra-indications for the new oral anticoagulants apixaban (Eliquis) and rivaroxaban (Xarelto) in line with those for dabigatran (Pradaxa) that were introduced in July 2012. All three new oral anticoagulants are now contra-indicated in patients with a lesion or condition that is considered a significant risk factor for major bleeding. Examples include; current or recent gastrointestinal ulceration, malignant neoplasm at high risk of bleeding, recent brain or spinal injury or surgery, recent ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformation, vascular aneurysms, or major intraspinal or intracerebral vascular abnormalities. They are also contra-indicated in combination with any other anticoagulants except when switching therapy or when unfractionated heparin is given at doses to maintain an open central arterial/venous catheter. Full details are available in the MHRA October 2013 Drug Safety Update.

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Die Juli/August Ausgabe des APM Newsletter ist fertig

16th October 2013

The July/August issue of the APM Newsletter for German-speaking users of www.palliativedrugs.com is available.

Die Juli/August Ausgabe des APM-Newsletter Jahrgang ist erschienen. Über die aktuelle Ausgaben des Newsletters wird Sie das Bulletin Board informieren.

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New suppository for chronic constipation launched in UK

15th October 2013

A new type of laxative for chronic constipation has been launched in suppository form in the UK for adults and children. Lecicarbon A suppository (Aspire Pharma) contains (3-sn-Phosphatidyl)cholin = soybean oil, lecithines, as phosphatides. Small bubbles of carbon dioxide are formed when the suppository comes into contact with moisture in the rectum. Reflex bowel evacuation from the physical stimulation of the carbon dioxide produced occurs approximately 15-30min after insertion. The suppositories can also be used for bowel evacuation prior to surgical or diagnostic procedures. Use is contra-indicated in patients allergic to peanuts or soya. The NHS cost of a pack of 10 Lecicarbon A suppositories = £8.20.

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TD fentanyl Cochrane review

15th October 2013

A Cochrane review on the use of transdermal fentanyl for cancer pain (CD010270.pub2), has been published.

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Buprenorphine 15microgram/h TD patch launched in US

12th October 2013

A buprenorphine 15microgram/h transdermal patch (BuTrans, Purdue Pharma) is now available in the US. It is indicated for management of moderate to severe chronic pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. The transdermal patch is applied every 7 days and is an addition to the product range of 5, 10 and 20microgram/h transdermal patches already available.

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Clonazepam injection discontinued in UK

10th October 2013

Roche has discontinued clonazepam 1mg/mL injection (Rivotril) in the UK, due to on-going supply chain difficulties and low product demand, with immediate effect. Limited emergency stock may still be available via wholesalers. There are currently no other suppliers of clonazepam injection in the UK that we are aware of. Roche medical information (0800 3281629). 

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World Hospice and Palliative Care Day 12 October 2013

10th October 2013

The theme for 2013 is 'Achieving universal coverage of palliative care: dispelling the myths'.  For more information and to register your event visit the World Hospice and Palliative Care Day website.

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PCF4+ 2013 PDF now available, special launch price of £24.99

8th October 2013

The September 2013 e-book PDF version of the Palliative Care Formulary (PCF4+) is now available to purchase at the special launch price of £24.99 until the end of 2013 (usual price £29.99).

PCF4+ 2013 contains over 50 sections and monographs which have been updated since the publication of the PCF4 book in 2011 (ISBN 978-01-9552547-5-8) and is thus denoted PCF4+.

We anticipate publishing a PDF version annually, with the fifth edition of the book (PCF5) in 2014. 

To purchase a licensed copy, and help support palliativedrugs.com, please go to the e-book section of our store.

MHRA strengthened recommendations for IV iron

26th September 2013

The UK Medicines and Healthcare products Regulatory Agency (MHRA) have strengthened recommendations for the administration of IV iron in order to further manage and minimise the known risks of serious hypersensitivity reactions.

A Europe wide review has shown that serious hypersensitivity reactions can occur irrespective of whether a patient has received a test dose or previous treatment with the product. Therefore test doses are no longer recommended, due to the fact that they may confer false reassurance and will be removed from the product literature. Otherwise the product should be administered strictly as per the specific SPC (advice varies between products). In addition, caution is required with every dose of IV iron, with patients being monitored closely for signs of hypersensitivity during and for 30minutes after every dose. Resuscitation facilities and staff trained to use them must be available for every dose. Full details are available in the MHRA August 2013 Drug Safety Update (updated 9th September 2013).

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MHRA class 2 drug alert for Buprenorphine (Natzon) sublingual tablets

26th September 2013

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has  issued a class 2 medicine alert (action within 48h) for Natzon (buprenorphine) 0.4mg sublingual tablets (Morningside healthcare).

This is due to the inadvertent packaging of a small number of blister packs containing buprenorphine 8mg sublingual tablets into cartons labelled Natzon 0.4mg sublingual tablets.

Any Natzon 0.4mg sublingual tablet cartons with the batch numbers 13D22 and 13D24 (pack size 1 x 7; expiry April 2016) should be returned to the original supplier.

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EMA to re-examine metoclopramide restrictions

24th September 2013

The European Medicines Agency (EMA) is to re-examine the recommended changes for metoclopramide in adults and children that it made in July 2013 (see our article 8th August 2013), following a request from one of the marketing authorization holders, and will then issue a final opinion.

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FDA restrictions on m/r opioids

24th September 2013

The US Food and Drug Administration has announced proposed class-wide changes to the indications for all modified-release (m/r) opioids. Previously the products were indicated for ‘moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time’. The new indication will be, ‘for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate’.

New warnings on the risk of neonatal opioid withdrawal syndrome will be also added. Manufacturers will, in addition, be required to perform more studies and clinical trials to further assess the known risks of misuse, abuse, hyperalgesia, addiction, overdose, and death.

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NICE guidance urinary incontinence in women

24th September 2013

The UK National Institute for Health and Care Excellence (NICE) has published Clinical Guideline 171 Urinary incontinence in women. This supersedes the previous guideline CG40.

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NICE quality standards for lower urinary tract symptoms in men

24th September 2013

The UK National Institute for Health and Care Excellence (NICE) has published Quality Standard 45 Lower urinary tract symptoms in men.

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SIGN pain booklet for consultation

23rd September 2013

The Scottish Intercollegiate Guidelines Network (SIGN) has published a consultation draft of a book ‘Management of chronic pain: a booklet for patients and carers’.

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FDA request ink colour change for fentanyl transdermal patches

23rd September 2013

The US Food and Drug Administration (FDA) is requesting manufacturers of fentanyl transdermal patches print the name and strength of the drug on the patch in long-lasting ink, in a colour that is clearly visible. The current ink colour varies by strength and is not always easy to see. This is part of a safety use initiative and reminder of the dangers of accidental exposure.

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Lorazepam injection 4mg/mL now available

19th September 2013

Following extensive supply issues since 2010, lorazepam solution for injection 4mg/mL (Ativan; Pfizer) is now available again without restriction.

BNF accreditation decision by NICE for consultation

17th September 2013

The National Institute for Health and Care Excellence (NICE) has opened a consultation on its draft decision not to give NICE accreditation to the processes used to produce the British National Formulary (BNF) and British National Formulary for Children (BNFc).

An independent advisory committee found that certain standard criteria, against which the BNF and BNFc were assessed, were not fully met. The full details of these can be found in appendix A of the full draft accreditation decision (see link below).

The consultation closes on the 4th October. Following a final decision, if accreditation is not granted, the BNF and BNFc will still be available on the NICE Evidence site but will not be identified by the accreditation mark graphic.

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BNF online pricing updated

11th September 2013

The prices in the on-line BNF and BNFc have now been updated and are consistent with the new print edition of the BNF66 (September 2013), which is now available.

BNF prices had been unchanged since BNF 62 (2011-2012) due to an overhaul of the system, which has now been completed.

Pricing data is obtained from the NHSBSA (formerly the PPD) and will be updated with each print edition (i.e. 6monthly).

Tapentadol SPC updated

11th September 2013

The UK SPC for tapentadol has been updated to include palpitations and hypersensitivity, including angioedema as uncommon (≥1/1,000 to <1/100) undesirable effects.

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Anexate (flumazenil) discontinued

11th September 2013

Roche has discontinued flumazenil injection 100microgram/mL, 5mL ampoules (Anexate) due to low demand. However, there is an equivalent generic version available.

Japanese translation of PCF over 3,000 copies sold since May 2013!

4th September 2013

We are delighted to report that following the launch of the Japanese translation of the Palliative Care Formulary (PCF) in May 2013 (see our new item 2013-05-21), over 3,000 copies have been sold and the book is already in its 3rd reprint!

It has been published by Igaku-Shoin and is available to purchase from the link below.

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National alliance formed to respond the LCP review

30th August 2013

A new Leadership Alliance for the Care of the Dying has been formed by NHS England in response to the independent review of the Liverpool Care Pathway (LCP). It will be chaired by Dr Bee Wee, National Clinical Director for End of Life Care at NHS England, and many key organizations have already joined; Care Quality Commission, Department of Health, General Medical Council, Health Education England, NHS Improving Quality, Nursing and Midwifery Council and the National Institute for Health and Care Excellence.

The alliance will take forward the information from the LCP review and respond at a strategic and system-wide level to:

  • support everyone involved in the care of people who are dying to respond to the findings of the review
  • be the focal point for the system’s response to the findings and recommendations of the LCP review
  • provide guidance on what needs to occur in place of the LCP
  • consider how best health and social sector can address the recommendations in the review about the accountability and responsibility of individual clinicians, out of hours decisions, nutrition and hydration and communication with the patient and their relatives or carers
  • map existing guidance, training and development, as a prelude to considering how these impact on the care of dying people and the circumstantial factors that might affect the adoption of good practice.

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Physiotherapists and podiatrists able to become independent prescribers

28th August 2013

New legislation has been introduced in the UK to allow physiotherapists and podiatrists to become independent prescribers following successful completion of their prescribing course.

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Nitrofurantoin reminder of precautions for use in renal impairment

22nd August 2013

The UK Medicines and Healthcare products Regulatory Agency (MHRA) is reminding health professionals that nitrofurantoin should not be used in patients with a renal creatinine clearance of <60mL/min, as treatment failure may occur due to insufficient drug being secreted into the urinary tract. The renal status of patients, particularly the elderly, should be checked before treatment.

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Alfentanil SPC updated

22nd August 2013

The UK SPC for alfentanil 500micgram/mL solution for injection has been updated to include information for use in paediatrics, following the outcome of an EU paediatric work-sharing procedure for alfentanil that was published earlier this year.

Alfentanil 500microgram/mL injection SPC

EU work-sharing procedure for alfentanil

Oral morphine Cochrane review

20th August 2013

An updated version of the Cochrane review on oral morphine for cancer pain (CD003868.pub3), first published in 2003, is now available.

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Granisetron patches launched in UK

20th August 2013

Granisetron transdermal patches 3.1mg/24h (Sancuso; ProStrakan) have been launched in the UK. They are indicated for adults for the prevention of nausea and vomiting associated with moderately or highly emetogenic chemotherapy, for a planned duration of 3 to 5 consecutive days, where oral anti-emetic administration is complicated by factors making swallowing difficult. A single transdermal patch should be applied 24–48h before chemotherapy and removed a minimum of 24h after completion. The patch can be worn for up to 7 days depending on the duration of the chemotherapy regimen.

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Risperidone SPC updated

15th August 2013

The SPC for risperidone has been updated to include the warning of the risk of leukopenia, neutropenia and agranulocytosis which has been classified as occurring very rarely (<1/10,000 patients) following post-marketing surveillance. For more information see the SPC below.

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CQC annual report: safer management of controlled drugs

13th August 2013

The UK Care Quality Commission (CQC) has published their 2012 annual report on the safer management of controlled drugs.

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Driving under the influence of controlled drugs government consultation

8th August 2013

The UK department for transport has issued a consultation seeking views on proposals for threshold drug driving limits to be specified in the new regulations regarding the offence of driving with a controlled drug in the body. 

Views are sought on the government’s preferred policy option of making it an offence to drive if any of 16 controlled drugs are found in the blood over a specified limit. They propose a zero tolerance approach to the threshold limits that are given for 8 drugs most associated with illegal use; cannabis and cannabinol, cocaine, ketamine, benzoylecgonine, Lysergic Acid Diethylamide (LSD), MDMA (Ecstasy), methamphetamine, 6-monoacetylmorphine (6-MAM; Heroin/diamorphine). A road safety risk approach to the threshold limits is proposed for a further 8 drugs most associated with medical uses; clonazepam, diazepam, flunitrazepam, lorazepam, methadone, morphine, oxazepam and temazepam. A limit for amphetamine will be subject to a further consultation. Two other policy options are also considered.

This consultation follows the report ‘Driving under the influence of drugs’ from the expert panel on drug driving which was published in March 2013. The report states that there was not enough evidence to set threshold limits for other opioids e.g. codeine, dihydrocodeine, oxycodone, hydrocodone, tramadol. However recommendations regarding the role of the health professionals in informing patients about the risks of driving under the influence of drugs are made. 

The consultation which closes on 17 September 2013 and the full report from the expert panel which advised the department for transport can be downloaded below.

Drug driving consultation

Drug driving expert panel report 

 

EMA restricts metoclopramide dose and duration of use

8th August 2013

The European Medicines Agency (EMA) has recommended changes to the dose and duration of use of metoclopramide in adults and children following a review. They recommend several changes to the authorized indications including restricting metoclopramide to short-term use (up to 5 days) with a maximum dose in adults of 10mg t.d.s. and significant restrictions for use in children. The full list of recommendations can be found from the link below.

There has been discussion on our bulletin board about the impact of this decision on palliative care patients including a posting of a statement from the EMA regarding use in palliative care situations.

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MHRA consultation on diclofenac as a Pharmacy medicine

8th August 2013

The UK Medicines and Healthcare products Regulatory Agency is consulting on the continued availability of diclofenac as a Pharmacy (P) medicine, as a result of the EU review on the cardiovascular risks of NSAIDs. The consultation closes on 28th October 2013.

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Etamsylate tablets discontinued in UK

6th August 2013

Etamsylate 500mg tablets (Dicynene; Sanofi-Aventis) have been discontinued in the UK for commercial reasons, there is no alternative available.

Etamyslate 500mg tablets are available via IDIS 01932 824000 (Dicynone; a French product) as an unathorized UK product. They are considerably more expensive than the original UK tablets i.e. pack of 20 tablets = £23 approximately compared with the previous price of 100 tablets for £8.44.

The supply section of the on-line PCF Etamsylate monograph has been updated to reflect this.

 

Oral ketoconazole contra-indicated for fungal infections

6th August 2013

The UK MHRA has stated that oral ketoconazole-containing products should no longer be prescribed for fungal infections as the risk of liver injury outweighs the benefits. This follows reported cases of hepatitis, cirrhosis and liver failure at the recommended daily dose of 200mg occurring sometimes less than 1month after starting treatment.

Topical ketoconazole formulations (creams, ointments, and shampoos) have very low systemic absorption and may continue to be used as currently approved.

The European Commission is considering suspending all licenses for oral ketoconazole, however, arrangements are being put in place to ensure patients with Cushing’s syndrome using oral ketoconazole off-label continue to have access to this product.

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FDA risk of rare but serious skin reactions with paracetamol (acetaminophen)

6th August 2013

The FDA has warned health professionals to be aware of the rare but serious risk of severe skin reactions, e.g. Stevens Johnson Syndrome, toxic epidermal necrolysis and acute generalised exanthematous pustulosis, with paracetamol (acetaminophen) following a review of the FDA adverse event reporting system database and medical literature. Warnings are to be added to the product labels of both prescription and over the counter drugs.

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Consultation on Controlled Drug Scheduling for tramadol

30th July 2013

The UK government has issued a consultation document proposing that tramadol becomes controlled via Schedule 3 of the Misuse of Drugs Regulations 2001, following control under the Misuse of Drugs Act 1971 as a Class C drug.

The consultation also seeks views on the continued application of current exemptions for prescriptions for the Schedule 3 drug temazepam.

The consultation closes on 11 October 2013.

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Updated IV Ondansetron dosing for CINV

25th July 2013

The UK MHRA has given new guidance for the administration of IV ondansetron based on further information on the risk of dose-dependent QT interval prolongation, (first reported in August 2012). The new advice is:

  • for Chemotherapy Induced Nausea and Vomiting (CINV) in patients aged 65 years or older, all IV doses should be diluted in 50–100mL saline or other compatible fluid and infused over at least 15 minutes. The maximum single IV dose of ondansetron may be up to 16mg (maximum 8mg in patients aged 75 years or older).
  • repeat IV doses of ondansetron should be given a minimum of 4 hours apart.

There are no changes to the recommended dosing or administration details for PO or PR ondansetron for CINV (including elderly patients), for IV or PO use in Postoperative Nausea and Vomiting (including elderly patients) or for IV or PO use in either indication in children (age >6 months and adolescents).

MHRA remind health professionals that ondansetron should be avoided in patients with congenital long QT syndrome, hypokalaemia and hypomagnesaemia should be corrected before ondansetron administration, and caution used in patients with risk factors for QT interval prolongation or cardiac arrhythmias.

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Fentanyl updated SPC

25th July 2013

The UK SPCs for fentanyl injection (Sublimaze; Janssen-Cilag) and fentanyl transdermal patches (Durogesic; Janssen-Cilag) have been updated to include a warning that if fentanyl is used in combination with other serotinergic drugs e.g. Selective Serotonin Re-uptake Inhibitors (SSRIs), Serotonin Norepinephrine Re-update Inhibitors (SNRIs) and Monoamine Oxidase Re-uptake Inhibitors (MAOIs) there is a possibility of serotonin syndrome occurring. This update comes following a review by Janssen- Cilag.

Fentanils have always been included in PCF as drugs with clinically relevant serotinergic potency (see Antidepressants, serotonin toxicity, Box 4.F) with a risk of serotonin toxicity in combination with MAOIs in particular (see Drug interactions in both the Fentanyl and Fentanyl (transmucosal) monographs). In addition, SPCs of some other fentanyl products have always stated that fentanyl should not be used within 14 days of discontinuation of an MAOI.

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Cannabinoids therapeutic review

24th July 2013

A therapeutic review on cannabinoids  has been published in the Journal of Pain and Symptom Management (JPSM): 

Howard P. et al (2013) Therapeutic Reviews: Cannabinoids. Journal of Pain and Symptom Management. 46:142 -149 (subscription required).

This is the 14th article in the series; all are based on monographs featured in the Palliative Care Formulary.

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LCP independent report published

19th July 2013

The independent report reviewing the Liverpool Care Pathway (LCP) for dying patients has been published. The recommendations include:

  • phasing out the LCP and replacing it with an individual end of life care plan
  • a general principle that a patient should only be placed on the LCP or a similar approach by a senior responsible clinician in consultation with the healthcare team
  • unless there is a very good reason, a decision to withdraw or not to start a life-prolonging treatment should not be taken during any ‘out of hours’ period
  • an urgent call for the Nursing and Midwifery Council to issue guidance on end of life care
  • an end to incentive payments for use of the LCP and similar approaches
  • a new system-wide approach to improving the quality of care for the dying.

The full report, evidence, and press release can be found from the link below.

NHS England has published interim guidance to assist health professionals caring for people in the last days of life in light of the recommendations. A similar document is available from the Scottish Government, and the Palliative Care Implementation Board for Wales has issued a response document.

LCP report

NHS England guidance

Scottish governmnet guidance

Palliative Care Implementation Board for Wales guidance 

 

WHO publishes a model list of essential medicines for palliative care

18th July 2013

The World Health Organization (WHO) has published the new editions of the WHO Model List of Essential Medicines for Adults and for Children. The new editions of the model lists now include a list of medications used to treat the most common symptoms occurring in palliative care, and are located in a new separate section (section 2) called Medicines for Pain and Palliative Care. The new section includes three subsections; non opioids and Non-Steroidal Anti-Inflammatory Medicines (NSAIMs), opioid analgesics, and medicines for other symptoms common in palliative care.

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Die Mai/Juni Ausgabe des APM Newsletter ist fertig

16th July 2013

The May/June issue of the APM Newsletter for German-speaking users of www.palliativedrugs.com is available.

Die Mai/Juni Ausgabe des APM-Newsletter Jahrgang ist erschienen. Über die aktuelle Ausgaben des Newsletters wird Sie das Bulletin Board informieren.

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NICE evidence summary of oral glycopyrronium bromide for hyperhidrosis

14th July 2013

The National Institute for Health and Care Excellence (NICE) has published its evidence summary (ESUOM16) for the unauthorized (unlicensed)/off-label use of oral glycopyrronium bromide for hyperhidrosis.

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NICE evidence summary of oral glycopyrronium bromide for hypersalivation

11th July 2013

The National Institute for Health and Care Excellence (NICE) has published its evidence summary (ESUOM15) for the unauthorized (unlicensed)/off-label use of oral glycopyrronium bromide for hypersalivation.

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Cochrane review: pharmacological interventions for pruritus in adult palliative care patients

2nd July 2013

A recent Cochrane review on the pharmacological interventions for pruritus in adult palliative care patients (CD008320) has been published.

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Neuropathic pain consultation

28th June 2013

NICE has published for consultation, its guideline on the pharmacological management of neuropathic pain in adults in a non-specialist setting. Registered stakeholders are able to comment until the deadline of 17 July 2013.

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Diclofenac new contra-indications and warnings

28th June 2013

All formulations of diclofenac, except topical formulations, are now contra-indicated in patients with established:

  • ischaemic heart disease
  • peripheral arterial disease
  • cerebrovascular disease
  • congestive heart failure (New York Heart Association [NYHA] classification II–IV).

This follows the findings of a European review, which showed that the cardiovascular risk of diclofenac is equivalent to that of COX-2 inhibitors. Patients with these conditions already taking diclofenac should be switched to an alternative at their next routine appointment. The existing guidance that naproxen and low-dose ibuprofen are considered to have the most favorable thrombotic cardiovascular safety profiles of all non-selective NSAIDs still applies.

MHRA also recommend caution for patients with significant risk factors for cardiovascular events (eg, hypertension, hyperlipidaemia, diabetes mellitus, smoking).

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Abstral SPC updated

28th June 2013

The UK SPC for Abstral (fentanyl citrate) sublingual tablets has been updated. Section 4.2 now states that during titration or the maintenance period, patients should wait at least 2 hours before treating another episode of break through pain with Abstral.

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Lenalidomide authorized for a new indication

27th June 2013

Lenalidomide (Revlimid; Celgene) has been authorized for a new indication in the UK. The updated license now includes treatment of patients with transfusion-dependent anaemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.

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Hydroxyethyl starch intravenous infusion suspended

27th June 2013

The UK MHRA has suspended all licenses for hydroxyethyl starch (HES) following trial results reporting an increased risk of renal dysfunction and death in critically ill patients compared with crystalloids. All remaining stock of HES products has been recalled.

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Codeine restricted use in children

26th June 2013

The MHRA have restricted the use of codeine in children following the results of a European safety review (see our news item 16-10-2012). Codeine is now contraindicated in:

  • all children age 0–18 years who undergo tonsillectomy or adenoidectomy (or both) for obstructive sleep apnoea
  • all patients of any age known to be CYP2D6 ultra-rapid metabolisers.

In addition:

  • codeine should only be used to relieve acute moderate pain in children older than 12 years and only if it cannot be relieved by other painkillers such as paracetamol or ibuprofen alone. The maximum daily dose should not exceed 240mg taken in divided doses up to four times a day at intervals of no less than 6 hours. It should be used at the lowest effective dose for the shortest period and for a maximum of 3 days
  • codeine is not recommended for use in children whose breathing might be compromised, including those with: neuromuscular disorders; severe cardiac or respiratory conditions; upper respiratory or lung infections; multiple trauma; or extensive surgical procedures. Morphine toxicity may be increased in these settings
  • codeine should not be used by breastfeeding mothers because of potential harm to the baby via the breast milk.

The regulatory authorities in the USA and Canada have issued similar restrictions and warnings.

MHRA advice

FDA advice

Health Canada advice 

 

 

Ketorolac 10mg tablets discontinued in UK

25th June 2013

Ketorolac 10mg tablets (Toradol; Roche) have been discontinued in the UK due to low demand. There are now no oral formulations of ketorolac available.

Ondansetron injection SPC updated

25th June 2013

The UK SPC for ondansetron injection (Zofran; GlaxoSmithKline) has been updated. Section 4.2 now states that repeat dosing should be a minimum of 4 hours apart. A new maximum single dose of 8mg has been specified for patients aged above 75 years, which should be given over 15min diluted in 50-100mL of compatible infusion fluid.

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FDA approves denosumab for giant cell tumour of the bone

18th June 2013

The US Food and Drug Administration has approved denosumab (Xgeva; Amgen, California) for giant cell tumour of the bone in adults and adolescents, whose bones have matured, where the tumour is unresectable or likely to result in severe morbidity.

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MHRA infusion device warning with 50mL syringes

28th May 2013

The UK Medicines and Healthcare products Regulatory Agency (MHRA) have issued two separate warnings of the risk of false occlusion alarms occurring when using certain 50mL syringes.

50mL Luer Lok Plastipak syringes made by BD Medical (MDA/2013/024):

A change in the design of the syringe plunger in April 2012 may require syringe pump occlusion alarm settings to be adjusted by biomedical engineering departments to avoid false occlusion alarms with the new type of syringes. In addition, BD is now recalling syringes of the old design to avoid the risk of a delay to the occlusion alarm being triggered from older design syringes in pumps that have been adjusted. For further details, including pictures of the two types of syringes and the batch numbers being recalled click here.

50mL Luer Lok syringes made by Terumo (MDA/2013/030):

Three batches of syringes have been recalled as they have been found to require a greater force than usual to push the plunger. This can lead to false occlusion alarms being triggered when they are used in syringe pumps. For further details including the batch numbers being recalled click here.

Thalidomide: increased risk of haematological second primary malignancies

28th May 2013

The UK Medicines and Healthcare products Regulatory Agency (MHRA) have highlighted the risk of haematological second primary malignancies (acute myeloid leukaemia and myelodysplastic syndromes) when treating patients with thalidomide. The data was from an ongoing study of patients with newly diagnosed multiple myeloma who were receiving melphalan, prednisolone and thalidomide compared with lenalidomide plus dexamethasone.

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Tolvaptan: risk of liver injury

28th May 2013

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has highlighted a risk of drug-induced liver injury in patients being treated with tolvaptan. The data was from a clinical trial investigating long term use in patients with autosomal dominant polycystic kidney disease, and at doses double the maximum approved for the treatment of hyponatraemia secondary to inappropriate antidiuretic hormone secretion (SIADH). MHRA recommend liver-function tests should be done in all patients taking tolvaptan who report signs or symptoms that suggest liver injury and tolvaptan suspended during investigations.

The US Food and Drug Administration (FDA) has limited tolvaptan use to a maximum of 30 days based on the data it has for trials in hyponatraemia and has stated that it should not be used in patients with underlying liver disease.

MHRA guidance

FDA guidance

MHRA caution in use alert: lorazepam injection 4mg/mL

28th May 2013

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued a caution in use alert for specific batches of lorazepam injection 4mg/mL, 1mL ampoules (Ativan; Pfizer). Although no specific problems have been reported with these batches, glass particles have been identified in a small number of ampoules of subsequent batches (which have not been released). As a precautionary measure and to keep supply of lorazepam injection within circulation, the following procedures should be followed prior to administration:

  • all ampoules should be individually checked for particulate matter and not used if found to contain any
  • draw up the injection into the syringe via a 5 micron filter needle or filter straw
  • replace the filter needle or filter straw with a new sterile needle before administration.

For more information, including the batches affected, see below.

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Cochrane review: levomepromazine for nausea and vomiting in palliative care

28th May 2013

A recent Cochrane review (CD009420) has reported that there are no randomised controlled trials for the use of levomepromazine for nausea and vomiting in palliative care and that further studies of levomepromazine and other antiemetic agents are needed.

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Cyclizine 50mg/mL injection resolved supply problem

23rd May 2013

Cyclizine injection 50mg/mL (Valoid; Amdipharm) is now available through the usual wholesalers in unrestricted quantities. The UK supply problem with cyclizine 50mg/mL injection reported in April 2013 (see our news item 16-04-13) has been resolved.

Sativex reclassified as schedule 4 part 1 Controlled Drug

23rd May 2013

Sativex (Cannabis sativa extract oromucosal spray; Bayer Heathcare and GW Pharmaceuticals) has been reclassified in England, Wales and Scotland as a Schedule 4 part 1 Controlled Drug (CD), with specific recording requirements applicable to possession and destruction. This has the following implications from the 10th April 2013:

  • prescription writing requirements (as for schedule 2 and 3 CD) do not apply to Sativex
  • safe custody requirements (as for schedule 2 and 3 CD) do not apply to Sativex
  • the destruction of expired stocks of Sativex and patient returns by healthcare professionals does not need to be witnessed by an authorized witness
  • standardized private prescription forms i.e. FP10PCD, PPCD(1), WP10PCD and their requirements are not required when Sativex is prescribed privately
  • a Home Office licence “for reseach or other special purpose” for Sativex is no longer required.

Although record keeping requirements are not required for schedule 4 part1 CDs, records must be kept for 2 years for cannabis-based medicines (1961 UN Convention on Narcotic Drugs). This includes the amounts of Sativex possessed or destroyed by those authorized to do so (patients and their representatives are exempt). The Home Office strongly recommends the use of the CD register to do this.

A guide to the legislative changes has been produced by the Royal Pharmaceutical Society (access via pharmacist members). Further information can be found on the UK Government website.

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Japanese translation of PCF now available!

21st May 2013

We are delighted to announce that a Japanese translation of the Palliative Care Formulary (PCF) is now available! It has been published by Igaku-Shoin and is available to purchase from the link below.

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Die Mrz/April Ausgabe des APM Newsletter ist fertig

21st May 2013

The March/April issue of the APM Newsletter for German-speaking users of www.palliativedrugs.com is available.

Der neue APM-Newsletter, Ausgabe März/April ist erschienen. Über die aktuelle Ausgaben des Newsletters wird Sie das Bulletin Board informieren.

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Buprenorphine therapeutic review

7th May 2013

A therapeutic review on buprenorphine has been published in the Journal of Pain and Symptom Management (JPSM): 

Foster B. et al (2013) Therapeutic Reviews: Buprenorphine. Journal of Pain and Symptom Management. 45: 939-949. 

This is the 13th article in the series; all are based on monographs featured in the Palliative Care Formulary.

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Cyclizine 50mg/mL injection supply problem in UK

16th April 2013

There is a national shortage of cyclizine 50mg/mL injection (Valoid; Amdipharm) which is expected to last into May 2013. There is no other authorized (licensed) cyclizine injection in the UK and the company does not have any stock for emergency supply.

Note there is not a supply problem with the cyclizine tablets – only the injection is affected.

SIGN lung cancer guideline for consultation

16th April 2013

The Scottish Intercollegiate Guidelines Network (SIGN) has published a draft review of the management of lung cancer guidelines for consultation. Comments should be submitted by 13th May 2013.

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NICE evidence summary of oral desmopressin

9th April 2013

The National Institute for Health and Care Excellence (NICE) has published its evidence summary (ESUOM10) for the  unauthorized / off-label use of oral desmopressin for nocturia and nocturnal polyuria in men with lower urinary tract symptoms.

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Free access to the on-line Palliative Care Formulary in Scotland

9th April 2013

From April 2013, NHS Education for Scotland has subscribed to the on-line Palliative Care Formulary (PCF4+). The content is continually updated and represents the most current version. It is hosted on the Palliative Care Portal of the Knowledge Network website: http://www.knowledge.scot.nhs.uk/home/portals-and-topics/palliative-care.aspx

It is available free of charge to those with an NHS Education Scotland ATHENS username and password.

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NICE changes its name

4th April 2013

The National Institute for Health and Clinical Excellence, has changed its name and is now known as the National Institute for Health and Care Excellence, still retaining the acronym NICE. This is to reflect recent changes to its role which include the integration of the National Prescribing Centre (NPC) and National Electronic Library for Medicines (NeLM) to form a joint new Medicines and Prescribing Centre.

Information previously on the NeLM has been incorporated in the NHS Evidence services section which is now provided by NICE.

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Asilone discontinued in UK

28th March 2013

Asilone® oral suspension (Thornton & Ross) an antacid containing simeticone 135mg, aluminium hydroxide 420mg and magnesium oxide 70mg/5mL has been discontinued in the UK. Alternative simeticone-containing antacid preparations are:

Maalox Plus® (Sanofi Aventis)
Oral suspension (sugar-free) simeticone 25mg, dried aluminium hydroxide 220mg, magnesium hydroxide 195mg/5mL, 28days @ 5mL q.d.s = £3; low Na+.

Altacite plus®(Peckforton)

Oral suspension (sugar-free) co-simalcite 125/500 (simeticone 125mg, hydrotalcite 500mg)/5mL 28days @ 10mL q.d.s = £7.50; low Na+.

See PCF Simeticone monograph.

 

GMC publishes Good practice in prescribing and managing medicines and devices

28th March 2013

The General Medical Council has published it Good practice in prescribing and managing medicines and devices (2013), which came into effect on the 25 February 2013. It replaces Good practice in prescribing medicines (2008) and incorporates Remote prescribing via telephone, video-link or online (2012). It is available to view or download from the GMC website.

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Aqueous cream may cause skin irritation

27th March 2013

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has warned that aqueous cream may cause skin irritation particularly in children with atopic eczema. The reactions may be due to the presence of sodium lauryl sulfate or other ingredients. If irritation occurs, treatment should be discontinued and an emollient that does not contain sodium lauryl sulfate should be tried.

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Die Januar/Februar Ausgabe des APM Newsletter ist fertig

26th March 2013

The January/February issue of the APM Newsletter for German-speaking users of www.palliativedrugs.com is available.
Der neue APM-Newsletter Jahrgang ist in der Ausgabe Januar/Februar erschienen. Über die aktuelle Ausgaben des Newsletters wird Sie das Bulletin Board informieren.

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Updated Controlled Drugs Regulations from 1st April 2013

28th February 2013

Controlled Drugs (Supervision of Management and Use) Regulations 2013 (SI2103/373) for England and Scotland will come into force on 1st April 2013. These deal with governance arrangements, in particular the role and functions of Controlled Drugs Accountable Officers (CDAO), and also reflect the new architecture for the NHS in England from April 2013. 

These regulations supersede the Controlled Drugs (Supervision of Management and Use) Regulations 2006 (“the 2006 Regulations”) which came into force in 2007, and follow a consultation process by the Department of Health (DH) in September 2012 (see our article 28-09-2012). 

The DH has published information about the 2013 Regulations which can be downloaded below, along with the official Regulations and the summary of responses to the consultation.

Information about the controlled drugs regulations 2013 

Controlled Drugs (Supervision of Management and Use) Regulations 2013 

Consultation responses

Dexamfetamine sulphate 5mg caution in use alert

27th February 2013

The MHRA have issued a caution in use alert for Dexamfetamine sulphate 5mg (Auden McKenzie; pack size x 28, batch number 12123/A) first distributed on 10-01-2013. A very small number of packs from the above batch may contain three blister strips instead of two. Pharmacists are asked to check the contents of packs from this batch and contact Auden McKenzie (01895 627420) if extra blister strips are found.

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NPA resources on controlled drugs

26th February 2013

The UK National Pharmacy Association (NPA) has produced resources for controlled drugs including Standard Operating Procedures (SOPs) and guidance sheets for its members.

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Two strengths of insulin now available in UK

21st February 2013

Insulin degludec (Tresiba; Novo Nordisk) has been launched in two strengths in the UK as 100units/mL and 200units/mL. This 200units/mL is higher than any other strength in the UK. Both strengths are available as pre-filled pen devices with distinct labeling to differentiate between the two strengths.

The pre-filled pen devices both have a dose counter window and deliver the dose in units, regardless of the strength, therefore dose conversion is not required if swapping patients from one strength to another.

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Denosumab rare cases of atypical femoral fracture with long-term use

21st February 2013

The Medicines and Healthcare products Regulatory Agency (MHRA) have reported on rare cases of atypical femoral fracture in patients receiving denosumab 60mg (Prolia®) for post-menopausal osteoporosis for more than 2.5 years.

They advise:

  • During denosumab treatment, patients should report new or unusual thigh, hip, or groin pain which should be evaluated for an incomplete femoral fracture
  • Atypical femoral fractures may occur with little or no trauma in the subtrochanteric and diaphyseal regions of the femur
  • The contralateral femur should be examined in denosumab-treated patients who have sustained a femoral shaft fracture, as atypical femoral fractures are often bilateral
  • Consider discontinuing denosumab treatment if an atypical femur fracture is suspected, while the patient is evaluated. An individual assessment of the benefits and risks should be performed.

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Routine hepatic monitoring recommended for lenalidomide

14th February 2013

The latest Medicines and Healthcare products Regulatory Agency (MHRA) Drug Safety Update recommends routine monitoring of hepatic function at baseline, every week for the first 8 weeks and then monthly, for patients being treated with lenalidomide (Revlimid). This follows reports of elevations of hepatic enzymes occurring in 1−10 patients out of every 100 treated with lenalidomide for multiple myeloma in clinical trials; the majority of these were non-serious. Serious (potentially fatal) hepatic injuries such as acute hepatic failure, toxic hepatitis, hepatocellular hepatitis, and cholestatic hepatitis have been reported overall in

MHRA advise that impaired hepatic function generally resolves when lenalidomide is stopped and that once abnormal hepatic parameters return to baseline, treatment with lenalidomide at a lower dose can be considered.

Lenalidomide is excreted predominantly renally. The dose of lenalidomide should be adjusted in patients with renal impairment to avoid high plasma levels which may increase the risk of severe hepatotoxicity, as well as haematological undesirable effects.

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Oxymorphone new crush resistant strengths in US

12th February 2013

Oxymorphone modified release, crush resistant tablets (Opana ER; Endo pharmaceuticals, US) are now available in 7.5mg and 15mg strengths joining the rest of the strength range (5mg, 10mg, 20mg, 30mg, and 40mg).

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SMC accepts palonosetron capsules

11th February 2013

The Scottish Medicines Consortium (SMC) has accepted palonosetron 500microgram soft capsules (Aloxi®) for use within NHS Scotland for the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy in adults.

At recommended authorized doses the soft capsule formulation has been shown to be clinically non-inferior to the intravenous formulation and is cost neutral. SMC has previously accepted palonosetron intravenous injection for the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.

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NICE evidence summary of oral magnesium glycerophosphate use

31st January 2013

The National Institute for Health and Clinical Excellence (NICE) has published its evidence summary for the use of unauthorized (unlicensed) oral magnesium glycerophosphate for preventing recurrent hypomagnesaemia.

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Guide on advance decisions to refuse treatment

31st January 2013

The National Council for Palliative Care and the NHS National End of Life Care Programme have produced a guide for health professionals on advance decisions to refuse treatment (ADRT). This guide supersedes the 2008 version. 

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Die November/Dezember Ausgabe des APM Newsletter ist fertig

22nd January 2013

The November/December issue of the APM Newsletter for German-speaking users of www.palliativedrugs.com is available.
Die November/Dezember Ausgabe des APM Newsletter ist fertig. Über die aktuelle Ausgaben des Newsletters wird Sie das Bulletin Board informieren.

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Glycopyrronium bromide inhaler launched in UK

15th January 2013

A glycopyrronium bromide hard capsule powder inhaler (Seebri Breezhaler, Novartis) has been launched in the UK and is authorized for maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). The recommended dose is the inhalation of one 50microgram hard capsule once daily, this delivers a dose of 44micrograms of glycopyrronium. The NHS cost of an inhaler plus 30 capsules = £28.

The Scottish Medicines Consortium (SMC) has accepted Seebri Breezhaler for use within NHS Scotland for the authorized indication.

The National Institute for Health and Clinical Effectiveness (NICE) has produced a new medicine evidence summary for this product which can be accessed from the link below.

SPC for glycopyrronium hard capsule powder inhaler

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Carbamazepine, oxcarbazepine and eslicarbazepine risk of serious skin reactions

10th January 2013

The December MHRA Drug Safety Update has highlighted the risk of serious skin reactions, including Stevens-Johnson syndrome, with carbamazepine, oxcarbazepine and eslicarbazepine in patients with European descent or Japanese origin who have the HLA-A*3101 genetic marker.

The risk of serious skin reactions with these drugs is known to be associated with patients of Asian origin who have the genetic marker HLA-B*1502, and screening is recommended for patients of Han Chinese or Thai origin before treatment with these drugs.

There are currently insufficient data to support screening for the HLA-A*3101 genetic marker before treatment. Current advice is that patients of European descent or Japanese origin who are known to have the genetic marker HLA-A*3101 should only receive carbamazepine, oxcarbazepine or eslicarbazepine after careful consideration of the benefits and risks.

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Magnesium therapeutic review

8th January 2013

A therapeutic review on magnesium has been published in the Journal of Pain and Symptom Management (JPSM):

Crosby V. et al (2013) Therapeutic Reviews: Magnesium. Journal of Pain and Symptom Management. 45: 137-144.

This is the 12th article in the series; previous ones include Octreotide (July 2010), Propofol (September 2010), Psychostimulants (November 2010), Thalidomide (January 2011), Ketamine (March 2011), Antipsychotics (May 2011), Loperamide (August 2011), Anti-epileptics (November 2011), Stimulant laxatives (February 2012), Fentanyl; transmucosal (July 2012) and Antidepressant drugs (November 2012). All are based on monographs featured in the Palliative Care Formulary.

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BNF palliative care section updated

18th December 2012

The online BNF(December 2012) Palliative care section has been reorganised and now includes new tables for opioid conversions. The new pain management with opioids section has been organised to provide guidance on specific routes for pain management. The Equivalent doses of opioid analgesics table has been expanded to include more drugs and routes; also included is a new buprenorphine table and updated fentanyl patch conversion table.

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Alfentanil 5mg/mL supply problem

13th December 2012

There is a supply problem with high strength alfentanil 5mg/mL injection (Rapifen Intensive Care; Janssen-Cilag), due to a manufacturing issue. It is hopeful that the stock situation will resume by February 2013. Janssen-Cilag have an extremely limited supply available for emergency use. The prescriber must complete an emergency order form and discuss their requirements with the Janssen-Cilag medical team. For more details contact customer services (0800 7315550).

The generic manufacturer Hamelyn has limited alfentanil 5mg/mL stock available which is restricted to NHS hospitals only.

Haloperidol for psychosis-induced aggression or agitation

13th December 2012

A Cochrane review has been published on the use of haloperidol for rapid tranquilisation of psychosis-induced aggression or agitation.

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DTB Sativex in multiple sclerosis

13th December 2012

The latest Drug and Therapeutics Bulletin (DTB) examines the place of the cannabinoid product, Sativex (GW Pharma, UK) in multiple sclerosis.

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LCP independent review

4th December 2012

Following a round table discussion, Norman Lamb (Minister for Care and Support) is to appoint an independent chair to understand what lies behind the reports of poor quality care associated with the implementation of the Liverpool Care Pathway (LCP) in the media and oversee and validate the review work initiated by the National End of Life Care Programme, the Association for Palliative Medicine and Dying Matters. The results of the independent review will be reported next year.

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Pecfent in-use expiry extended to 60 days

22nd November 2012

The UK SPC for Pecfent (fentanyl citrate) nasal spray 100microgram/spray and 400microgram/spray has been updated. The in-use expiry of the product has been extended from 14 days to 60 days i.e. the SPC now reads:

“If the product has not been used for 5 days, re-prime by spraying once. Discard bottle 60 days after first opening.”

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Antidepressant drugs therapeutic review

15th November 2012

A therapeutic review on antidepressant drugs has been published in the Journal of Pain and Symptom Management (JPSM): 

Howard P. et al (2012) Therapeutic Reviews: Antidepressant drugs. Journal of Pain and Symptom Management. 44: 763-783. 

This is the 11th article in the series; previous ones include Octreotide (July 2010), Propofol (September 2010), Psychostimulants (November 2010), Thalidomide (January 2011), Ketamine (March 2011), Antipsychotics (May 2011), Loperamide (August 2011), Anti-epileptics (November 2011), Stimulant laxatives (February 2012) and Fentanyl; transmucosal (July 2012). All are based on monographs featured in the Palliative Care Formulary.

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Denosumab; fatal cases of severe symptomatic hypocalcaemia

15th November 2012

The UK Medicines and Healthcare products Regulatory Agency (MHRA) have highlighted cases of severe symptomatic hypocalcaemia that have occurred in patients receiving denosumab 120mg (Xgeva®; authorized for use prevention of skeletal related events in adults with bone metastases from solid tumours) or 60mg (Prolia®; authorized for use in osteoporosis).

Hypocalcaemia is a known risk with denosumab use, especially in patients with severe renal impairment (creatinine clearance <30 mL/min) or receiving dialysis. Severe symptomatic hypocalcaemia, including three fatal cases, has been reported in patients receiving denosumab 120mg. Although hypocalcaemia with denosumab most commonly occurs within the first 6 months of dosing, it can occur at any time during treatment.

Pre-existing hypocalcaemia must be corrected prior to initiating denosumab, and supplementation of calcium and vitamin D is required in all patients receiving the 120mg dose unless hypercalcaemia is present. Periodic monitoring of calcium levels (at the discretion of the prescriber) is recommended after use of denosumab in patients predisposed to hypocalcaemia, including those with severe renal impairment.

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Die September/Oktober Ausgabe des APM Newsletter ist fertig

13th November 2012

The September/October issue of APM Newsletter for German-speaking users of www.palliativedrugs.com is available.

Die September/Oktober Ausgabe des APM Newsletters ist fertig. Über die aktuelle Ausgaben des Newsletters wird Sie das Bulletin Board informieren.

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EMA review of cardiovascular safety of NSAIDs

13th November 2012

The European Medicines Agency (EMA) has finalised a review of recently published information on the cardiovascular safety of non-steroidal anti-inflammatory drugs (NSAIDs). The review confirms the findings from previous reviews, conducted in 2005 and 2006, which concluded that the overall benefit-risk balance of NSAIDs remained positive, but that a small increased cardiovascular risk could not be excluded.

Most of the data related to diclofenac, ibuprofen and naproxen. The latest evidence appears to further highlight a consistent but small increase in the risk of cardiovascular undesirable effects for diclofenac compared with other non-selective NSAIDs, similar to the risks of COX-2 inhibitors. This information, particularly with long-term use of high doses and in patients who are already at high risk, is well recognised and warnings have been included in the SPC for some years. However, the EMA will now assess all available data on diclofenac (both published and unpublished) to consider the need for updated treatment advice. In relation to naproxen and ibuprofen, the current treatment advice adequately reflects the knowledge regarding the safety and efficacy of these medicines.

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MHRA Medicines Device Alert for Inadine dressings

12th November 2012

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued a Medicines Device Alert for Inadine® PVP-I non adherent dressing (9.5cm x 9.5 cm) manufactured by Systagenix Wound Management (Product code: P0149; Lot numbers: 1227/1228/1229). There is a possible risk of infection due to compromised sterility, and the affected batches should not be used. For further information see the full alert below.

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Suboxone SL tablets replaced by SL film in US

8th November 2012

Sublingual (SL) combination tablets containing buprenorphine and naloxone (Suboxone; Reckitt Benckiser, Warren, NJ, USA), are being replaced by a sublingual film in the US. The tablet formulation, authorized for maintenance treatment in opioid dependence, is now off-patent and available as a generic product. The manufacturer states that the sublingual film has a faster dissolving rate, a more favourable taste and improved child-safety packaging.

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MHRA alert: chlorhexidine risk of anaphylaxis

25th October 2012

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued an alert for products or medical devices containing chlorhexidine following reports of anaphylaxis. Examples of products which contain chlorhexidine are: antiseptic creams, wipes, cleansers and skin preparations; antiseptic mouthwashes, toothpastes and dental implants; eye drops and contact lens solutions; antiseptic lozenges and throat sprays; urinary catheters; central venous catheters; and antimicrobial dressings.

The following advice has been given:

• be aware of the potential for an anaphylactic reaction to chlorhexidine

• ensure that known allergies are recorded in patient notes

• check the labels and instructions for use to establish if products contain chlorhexidine prior to use on patients with a known allergy

• if a patient experiences an unexplained reaction, check whether chlorhexidine was used or was impregnated in a medical device that was used

• report allergic reactions to products containing chlorhexidine to the MHRA.

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NICE issues denosumab costing template

24th October 2012

The National Institute for Health and Clinical Excellence (NICE) has published a costing template to accompany its guidance on denosumab for preventing skeletal-related events in adults with bone metastases from solid tumours (TA 256).

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Liverpool Care Pathway consensus statement

18th October 2012

Over 20 organisations have signed a consensus statement in support of the Liverpool Care Pathway for the dying patient, including professional bodies, third sector organisations, disease specific charities and organisations representing care homes, hospices, social services and palliative care specialists.

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Metolazone discontinued

18th October 2012

Metolazone tablets (Sanofi Aventis) have been discontinued by the manufacturer in the UK and supplies are almost exhausted. There is currently no other supplier of metolazone tablets in the UK. The British Society for Heart Failure (BSH) has advised switching patients from metolazone to bendroflumethiazide when a patient's supplies run out, at a dose of 2.5 mg, increasing to 5mg, if indicated.

It is thought that generic manufacturers may step into the breach, and metolazone may become available again in the UK in the future.

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DTB antidepressant treatment of neuropathic pain

18th October 2012

The latest Drug and Therapeutics Bulletin features part 1 of two articles on the treatment of neuropathic pain and features the use of antidepressants.

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NICE evidence summary of tranexamic acid off-label use

17th October 2012

The National Institute for Health and Clinical Excellence (NICE) has published its first evidence summary for the off-label use of products (see our article 04-10-2011). It is for the use of tranexamic acid for significant haemorrhage following trauma.

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Change of supplier for Epanutin (phenytoin) capsules

16th October 2012

Flynn Pharma has taken over the manufacture and distribution of Epanutin (phenytoin) capsules in the UK, with the product now marketed as Phenytoin sodium Flynn hard capsules (a generic). Phenytoin sodium Flynn hard capsules are bioequivalent to Epanutin and the capsules have markings and colourings exactly like Epanutin capsules, including still having the marking ‘Epanutin’.

Prescribers are advised to specify the Flynn Pharma product when ordering as pharmacies cannot give the Flynn Pharma product against a prescription for Epanutin and will need to get the prescription amended. 

Concern has been raised in the media regarding the significant cost increase from £0.66 for a pack of 28 x 25mg capsules to £15.74.

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EMA to review safety of codeine for post-operative pain relief in children

16th October 2012

The European Medicines Agency (EMA) has started its first safety review of a medicine under the new EU rules on pharmacovigilance. It will consider the safety of codeine-containing medicines when used for post-operative pain relief in children. This has been initiated at the request of the UK MHRA on the basis of recent concerns over an increased risk of morphine toxicity when codeine is given in this setting. In particular, a very small number of cases of rare but fatal or life-threatening respiratory depression have been reported in children who are CYP2D6 ultra-rapid metabolisers and were given codeine after surgical removal of the tonsils or adenoids in the treatment of obstructive sleep apnoea.

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WHO scoping document available for persistent pain in adults

15th October 2012

A scoping document for guidelines for the pharmacological treatment of persistent pain in adults has been published by the World Health Organization (WHO). Subject to the availability of funding, it is anticipated that these guidelines will be ready by Spring 2015.

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Hydromorphone ER 32mg launched in US

12th October 2012

A once daily modified-release hydromorphone 32mg tablet (Exalgo; Mallinckrodt, Hazelwood, MO) has been added to the existing product range of 8mg, 12mg and 16mg modified-release tablets for opioid-tolerant adult patients with moderate to severe chronic pain in the US.

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BNF now updated monthly on-line

11th October 2012

BNF 64 (September 2012) is now available. In addition, both the BNF and BNF for Children will now be updated online every month via bnf.org, MedicinesComplete, NHS Evidence and the NICE BNF apps. Print editions of BNF will continue to be published every six months, and BNF for Children annually.

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Paediatric morphine doses

11th October 2012

Following the publication of the WHO Guidelines on the Pharmacological Treatment of Pain in Children with Medical Illness (see our article 8-03-2012), WHO have highlighted that the new dosage guidelines for morphine have a more cautious approach and replace the dosage recommendations in the WHO Model Formulary for Children (2010). For specific details see the WHO newsletter and the full guidelines.

Topical capsaicin cream, Cochrane review

10th October 2012

A Cochrane review on the use of low concentration topical capsaicin cream for neuropathic pain has been published.

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FDA warn of skin injury with OTC rubefacients

9th October 2012

Rare cases of serious burns on the skin have been reported to the US Food and Drug Administration (FDA) where over-the-counter (OTC) topical muscle and joint pain relievers were applied. The products contained the active ingredients menthol, methyl salicylate, or capsaicin.

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Epistatus product description change

3rd October 2012

There has been a change made to the product description of the unauthorized (unlicensed) midazolam product Epistatus (Special Products Limited; 01932 690325) as follows:

Midazolam (Epistatus) 10mg in 1mL Buccal Liquid x 5mL

has been replaced with

Midazolam (Epistatus) 10mg in 1mL Oromucosal Solution x 5mL.

DH Consultation: Governance arrangements for controlled drugs

28th September 2012

The Department of Health (DH) is consulting on proposed changes to the governance arrangements for controlled drugs in England and Scotland, including the role and functions of Controlled Drugs Accountable Officers (CDAOs). 

The significant structural changes introduced by the Health and Social Care Act 2012 will have an impact on the overall governance of controlled drugs and the role and functions of primary care trust CDAOs. Consequently, the Controlled Drugs (Supervision of Management and Use) Regulations 2006 require revision. 

The consultation and supporting documentation can be downloaded from the website link below. The consultation ends on 15 November 2012.

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Paracetamol overdose: new guidance on treatment

26th September 2012

New simplified guidance on the treatment of acute paracetamol overdose with acetylcysteine is now in place following an evidence-based review by the Commission on Human Medicines (CHM). Full details can be found in the MHRA September 2012 Drug Safety Update.

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BNFC now available as a free app

25th September 2012

Health professionals can now access the British National Formulary for children (BNFC) from a smartphone or tablet via a new application (app) from the National Institute for Health and Clinical Excellence (NICE). This follows the recent launch of the BNF app. The apps require an NHS Athens username and password and can be run without an internet connection once they have been downloaded.

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Batch recall of Lyrica 50mg capsules (Kosei Pharma)

25th September 2012

A company-led recall of a batch of Lyrica (pregabalin) hard capsules 50mg (parallel distributed in the UK by Kosei Pharma Limited) has been issued, as the label applied by the parallel distributor states the strength as 25mg instead of 50mg. It is understood that a very small number of units have been distributed. The affected batch number is 0605032P/2 (first distributed 7th September 2012; expiry date February 2015). For further information contact Kosei Pharma UK Customer Services (01753 569528).

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Ketamine injection supply problems

21st September 2012

Pfizer UK has confirmed that there is a supply problem with ketamine (Ketalar) 10mg/mL and 100mg/mL injection. All orders for these products are now being re-directed to a Pfizer central ordering point (0845 608866), to allow close monitoring of the stock situation. It is anticipated that the 100mg/mL injection will run out completely in the next week and will not be available until November 2014. Pfizer has stated that this situation has occurred due to a transfer of manufacturing site beyond their control. More ketamine 10mg/mL injection are being manufactured as an interim measure. The stock situation of ketamine 50mg/mL is currently sufficient but is being monitored. For further details please contact Pfizer customer services (01304 606161).

Oxycodone m/r generic launched in UK

21st September 2012

Oxycodone m/r generic launched in UK

Qdem Pharmaceuticals (Cambridge, UK) have launched generic oxycodone m/r (Longtec prolonged release) 5mg, 10mg, 20mg, 40mg and 80mg tablets. Supplies will come from Bard Pharmaceuticals, the production and supply chain business of Napp, and will be available through the usual wholesalers. The NHS cost and product range comparison with Oxycontin m/r (Napp) is: 

Longtec (Qdem)
Tablets m/r 5mg, 10mg, 20mg, 40mg and 80mg, 28 days @ 1 tablet b.d.= £21, £21, £42, £85, and £170 respectively. 

Oxycontin (Napp)
Tablets m/r 5mg, 10mg, 15mg, 20mg, 30mg, 40mg, 60mg, 80mg and 120mg, 28 days @ 1 tablet b.d. = £25, £25, £37, £50, £75, £100, £150, £200 and £300 respectively. 

Note: The remains of the m/r tablet may appear in the patient’s faeces (‘ghost tablets’), as can also occur with Oxycontin and Targinact (oxycodone/naloxone combined m/r tablet). These are inert residues, and do not affect the efficacy of the products.

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Dexamethasone 4mg/mL injection supply

6th September 2012

There has been a temporary UK manufacturer’s supply problem with the MSD (Organon livery) dexamethasone base 4mg/mL injection. However the manufacturers have confirmed today (06-09-2012) that supplies are now available and no further shortages are anticipated.

Note: The alternative Hospira brand of dexamethasone injection available (dexamethasone phosphate 4mg/mL) contains dexamethasone base 3.3mg/mL. There is scope for confusion when switching to this preparation or when switching from PO to SC route.

For more details clarifying dexamethasone prescribing see the www.palliativedrugs.com factsheet below, produced in 2010 when the labeling and prescribing of dexamethasone injection was standardized to dexamethasone base by the MHRA.

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Fentanyl (transmucosal) therapeutic review

6th September 2012

A therapeutic review on transmucosal fentanyl has been published in the Journal of Pain and Symptom Management (JPSM):

Twycross R. et al (2012) Therapeutic Reviews: Fentanyl (transmucosal). Journal of Pain and Symptom Management. 44: 131-149.

This is the 10th article in the series; previous ones include Octreotide (July 2010), Propofol (September 2010), Psychostimulants (November 2010), Thalidomide (January 2011), Ketamine (March 2011), Antipsychotics (May 2011), Loperamide (August 2011), Anti-epileptics (November 2011) and Stimulant laxatives (February 2012). All are based on monographs featured in the Palliative Care Formulary. 

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Die Juli/August Ausgabe des APM Newsletter ist fertig

31st August 2012

The July/August issue of APM Newsletter for German-speaking users of www.palliativedrugs.com is available.

Die Juli/August Ausgabe des APM Newsletter ist fertig. Über die aktuelle Ausgaben des Newsletters wird Sie das Bulletin Board informieren.

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FDA authorize tapentadol m/r for neuropathic pain

30th August 2012

US Food and Drug Administration (FDA) have authorized tapentadol m/r tablets (Nucynta ER; Janssen Pharmaceuticals) for the management of neuropathic pain associated with diabetic peripheral neuropathy in adults when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.

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NPSA Insulin Passport deadline

30th August 2012

NHS organisations should ensure that by 31 August 2012 the following actions outlined in the National Patient Safety Agency (NPSA) alert ‘The adult patient’s passport for safer use of insulin’ (NPSA/2011/PSA003) have been implemented:

  • adult patients on insulin therapy receive a patient information booklet and an Insulin Passport to help provide accurate identification of their current insulin products and provide essential information across healthcare sectors
  • health professionals and patients are informed how the Insulin Passport and associated patient information can be used to improve safety
  • when prescriptions of insulin are prescribed, dispensed or administered, health professionals cross-reference available information to confirm the correct identity of insulin products
  • systems are in place to enable hospital inpatients to self-administer insulin where feasible and safe.

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NICE final draft guidance for denosumab

21st August 2012

The UK National Institute for Health and Clinical Excellence (NICE) has published final draft guidance on the use of denosumab for the treatment of bone metastases from solid tumours and multiple myeloma. It makes the following recommendations:

  • denosumab is recommended as an option for preventing skeletal-related events in adults with bone metastases from breast cancer and from solid tumours (other than breast and prostate) if bisphosphonates would otherwise be prescribed and the manufacturer provides denosumab with the discount agreed in the patient access scheme
  • denosumab is not recommended for preventing skeletal-related events in adults with bone metastases from prostate cancer.

 

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Ondansetron new maximum IV single dose

9th August 2012

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has restricted the maximum single IV dose of ondansetron for the management of chemotherapy-induced nausea and vomiting in adults to 16mg (infused over at least 15min). This is in response to the results of a recent study which demonstrated a dose-dependent prolongation of the QT interval. There are no changes to the dosing for post-operative nausea and vomiting or for any indication in children or for any indication via the oral or rectal route. Ondansetron should be avoided in patients with congenital long QT syndrome and caution taken in patients with risk factors for QT interval prolongation or arrhythmias. Electrolyte disturbances should be corrected before drug administration. The FDA has also implemented the same restrictions.

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Roche discontinue midazolam 10mg/5mL injection

31st July 2012

Roche have discontinued Midazolam hydrochloride (Hypnovel) 2mg/mL (5mL ampoule) solution for injection in the UK for commercial reasons. A generic midazolam 2mg/mL (5mL ampoule) injection formulation is available. The high strength Hypnovel formulation midazolam 5mg/mL (2mL ampoule) injection is still available.

CQC annual report: safer management of controlled drugs

27th July 2012

The UK Care Quality Commission (CQC) has published their 2011 annual report on the safer management of controlled drugs. This fifth report makes a number of recommendations for accountable officers. Other key recommendations include:

• accountable officers must ensure the safe and effective use of transdermal fentanyl patches through establishing a suitable system and educating staff involved in prescribing, dispensing, administering and disposing of them

• methylphenidate and dexamfetamine should be monitored carefully to ensure that they are prescribed appropriately in all sectors.

• the use of a standard Controlled Drug Requisition Form (FP10 CDF) should be encouraged more actively.

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Cyclizine (Valoid) 50mg tablets license transferred to generic

18th July 2012

The UK marketing authorization (license) for cyclizine 50mg tablets (Valoid, Amdipharm) has been transferred to its sister company Waymade Healthcare. The Valoid brand of tablets is no longer available in the UK, however generic cyclizine 50mg tablets (100 pack) are now available through Waymade’s Sovereign livery (01268 535230). The generic cyclizine 50mg tablets can be obtained via the usual wholesalers and there are no known supply issues.

It is thought that the marketing authorization for cyclizine 50mg tablets (Valoid) in Ireland, New Zealand and Australia is to remain with Amdipharm.

MHRA launches new website section for medicines information

12th July 2012

A new section has been added to the UK Medicines and Healthcare products Regulatory Agency (MHRA) website, bringing together the different types of information related to medicines. The following sources of information are linked to from this page (see below):

  • Summary of Product Characteristics (SPCs) and Patient Information Leaflets (PILs)
  • Drug Analysis Prints
  • Drug Safety Updates
  • Public Assessment Reports
  • Summaries of risk management plans
  • Yellow card site.

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Olanzapine injection to be discontinued in UK

10th July 2012

Olanzapine injection, powder for reconstitution 5mg/mL, 10mg vial (Zyprexa; Lilly) is to be withdrawn in the UK on 31/8/12, for sales volume reasons and not for any safety reason. There is no generic or alternative rapid-acting olanzapine injectable formulation available in the UK. It will still be available in other Countries outside the UK.

Note: the depot injection, olanzapine embonate (ZypAdhera; Lilly) will still remain available in the UK.

FDA approve REMS for m/r opioids

10th July 2012

US Food and Drug administration (FDA) has approved a Risk Evaluation and Mitigation Strategy (REMS) program for all modified-release (m/r) opioids. Key components include prescriber training, updated patient information guides and counselling documents and manufacturer assessment/auditing requirements.

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FDA approve pregabalin for neuropathic pain associated with spinal cord injury

9th July 2012

US Food and Drug Administration (FDA) have approved pregabalin capsules and oral solution (Lyrica capsules or oral solution CV, Pfizer) for the treatment of neuropathic pain associated with spinal cord injury.

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Die Mai/Juni Ausgabe des APM Newsletter ist fertig.

3rd July 2012

The May/June issue of APM Newsletter for German-speaking users of www.palliativedrugs.com is available.

Die Mai/Juni Ausgabe des APM Newsletter ist fertig. Über die aktuelle Ausgaben des Newsletters wird Sie das Bulletin Board informieren.

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Paediatric Palliative Formulary 2nd edition published

28th June 2012

The Association for Paediatric Palliative Medicine has published the second edition of its formulary. It has been updated to reflect the recently published World Health Organization guidelines on treating pain in children as well as changes in the use of certain medicines since the publication of the first edition of the formulary in 2011. It can be downloaded from the Together for short lives website link below, or from our document library under the topic of books (paediatric), with grateful thanks to Dr Susie Lapwood (Helen and Douglas House Hospices for children and young adults and Honorary Clinical Fellow, Oxford University Hospitals NHS Trust).

 

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Summary of NICE guidance of opioids in palliative care

22nd June 2012

The North West Medicines Information Centre have produced a summary of the key prescribing points from the NICE guidance (CG140) on opioids in palliative care in their monthly bulletin, NICE Bites. 

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AWMSG recommendations for Buccolam

20th June 2012

The All Wales Medicines Strategy Group (AWMSG) has approved midazolam oromucosal solution 5mg/mL (Buccolam, ViroPharma) as an option for use within NHS Wales for the treatment of prolonged, acute, convulsive seizures in infants, toddlers, children and adolescents (from 3 months to <18 years). For infants between 3–6 months of age treatment should be in a hospital setting where monitoring is possible and resuscitation equipment is available. AWMSG state Buccolam should be prescribed by brand name to reduce the risk of medication errors.

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BNF now available as a free smartphone app

19th June 2012

Health professionals can now access the British National Formulary (BNF) from a smartphone via a new application (app) from the National Institute for Health and Clinical Excellence (NICE). The app requires an NHS Athens username and password and can be run without an internet connection once it has been downloaded.

 

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RPS report on the transfer of information about medicines

19th June 2012

A report published by the Royal Pharmaceutical Society (RPS) calls for improvements to the transfer of information about medicines when patients move between care settings and includes several recommendations. The report, Keeping Patients Safe When They Transfer Between Care Providers: Getting the Medicines Right, outlines the results of a 6month project involving over 30 healthcare organisations which volunteered to implement RPS guidance on transfer of medicines information.

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NICE consultation on denosumab

14th June 2012

The National Institute for Health and Clinical Excellence (NICE) has issued a second appraisal consultation document on the use of denosumab as a treatment to delay or prevent skeletal-related events in people with bone metastases from solid tumours. This follows the committee’s reconsideration of evidence in light of information received during the first consultation. The latest draft guidance makes the following preliminary recommendations:

• denosumab is recommended as an option for preventing skeletal-related events in adults with bone metastases from breast cancer, if the manufacturer provides denosumab with the discount agreed in the patient access scheme

• denosumab is not recommended for preventing skeletal-related events in adults with bone metastases from prostate cancer

• denosumab is recommended as an option for preventing skeletal-related events in adults with bone metastases from solid tumours other than breast and prostate if zoledronic acid or disodium pamidronate would otherwise be prescribed for these patients and the manufacturer provides denosumab with the discount agreed in the patient access scheme

• adults with bone metastases from solid tumours currently receiving denosumab for the prevention of skeletal-related events that is not recommended according to the above, should be able to continue treatment until they and their clinician consider it appropriate to stop.

The consultation period runs until 2 July 2012 and document can be accessed from the link below.

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Pregabalin oral solution launched in UK

14th June 2012

Pregabalin oral solution 20mg/mL (Lyrica; Pfizer, Sandwich, Kent, UK) has been launched in the UK and is licensed in adults for:

  • peripheral and central neuropathic pain
  • epilepsy as adjunctive therapy in adults with partial seizures with or without secondary generalisation
  • general anxiety disorders.

The NHS cost of a 473mL bottle = £99; 28 days @75mg, 150mg, or 300mg b.d. = £44, £88 and £177 respectively, whereas the oral capsules cost £64 for 28 days treatment at the above doses for all 3 strengths. Pregabalin oral solution has been shown to be bioequivalent to pregabalin capsules.

The Scottish Medicines Consortium (SMC) has accepted pregabalin oral solution for restricted use within NHS Scotland for the following indications in patients who find it difficult to or are unable to swallow tablets:

  • patients with peripheral neuropathic pain who have not achieved adequate pain relief from, or have not tolerated, conventional first and second line treatments for peripheral neuropathic pain. Treatment should be stopped if the patient has not shown sufficient benefit within 8 weeks of reaching the maximally tolerated therapeutic dose
  • adjunctive therapy in adults with partial seizures with or without secondary generalisation. It should be initiated only by physicians who have appropriate experience in the treatment of epilepsy and should be used principally in patients who have not benefited from treatment with an older anti-convulsant drug such as carbamazepine or sodium valproate, or for whom these drugs are unsuitable because of contra-indications, interaction or poor tolerance.

Pregabalin is not recommended for use in the treatment of generalised anxiety disorder in adults as the company have not made a submission to SMC for use in this indication. For more information see the link below.

SMC product report for pregabalin oral solution

SPC for pregabalin oral solution

Cyclizine injection from Martindale recalled

31st May 2012

Martindale Pharmaceuticals Ltd UK is recalling all remaining unexpired ampoules of cyclizine lactate injection 50mg/mL ampoules, which has been discontinued, as a precautionary measure. The recall is due to a Good Manufacturing Practice (GMP) concern at a third-party supplier and their own site. It is likely that very little stock remains but the company wishes to minimize any potential patient risk.Recipients are requested to return any remaining stock to their normal supplier for credit.

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Biotene Oralbalance gel supply problem

31st May 2012

There is a UK supply problem with Biotene Oralbalance saliva replacement gel (GSK), this is due to a manufacturing problem at one of the companies owned by GSK. The product is out of stock and currently there is no information on when this is likely to be resolved. An alternative similar product is BioXtra salivia replacement gel (RIS Products). The Biotene Oralbalance mouth moisturizing liquid has previously been discontinued.

GMC postpones plans for unlicensed drug prescribing

30th May 2012

The UK General Medical Council (GMC) has postponed plans, which were put out for consultation last year, which would allow doctors to prescribe cheaper off-label or unlicensed alternatives to licensed medicines.

The Medicines and Healthcare products Regulatory Agency (MHRA) and the Association of the British Pharmaceutical Industry (ABPI) opposed the proposals. Legal advice, on the European Union (EU) directive on medicinal products for human use, confirmed that unlicensed medicines could be prescribed only where there was a special need, and that this could not be taken to encompass unlicensed medicines for patients with rare conditions if there were a licensed alternative or circumstances in which commissioning bodies did not support the funding of a licensed alternative. As a result, the GMC has agreed to revert to their existing guidance on prescribing unlicensed medicines, although they are still exploring the issue as the EU directive does not specifically address prescribing drugs outside the terms of their licence.

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NICE issues clinical guideline on prescribing opioids in palliative care

25th May 2012

The National Institute for Health and Clinical Excellence (NICE) has issued a clinical guideline (CG140) on the safe and effective prescribing of strong opioids for pain in palliative care of adults. The guideline is for first-line treatment with strong opioids for patients who have been assessed as requiring pain relief at the third level of the WHO pain ladder, and is primarily aimed at non-specialist healthcare professionals.

A costing report on the impact of implementing the guideline and a template for assessing local impact have also been issued. The report states that there are unlikely to be any significant costs in implementing this guidance as an increase in prescribing of strong opioids is not expected. In addition, the following potential savings and benefits are expected:

• Saving in prescribing costs for strong opioids

• Improved patient comfort

• Reduction in patient misinterpretations and misunderstanding in relation to opioids

• Consistent advice on the prescribing of strong opioids.

Stimulant laxatives therapeutic review

24th May 2012

A therapeutic review on Stimulant laxatives and opioid-induced constipation has been published in the Journal of Pain and Symptom Management (JPSM):

Twycross R. et al (2012) Therapeutic Reviews: Stimulant laxatives and opioid-induced constipation. Journal of Pain and Symptom Management. 43: 306-313.

This is the 9th article in the series; previous ones include Octreotide (July 2010), Propofol (September 2010), Psychostimulants (November 2010), Thalidomide (January 2011), Ketamine (March 2011), Antipsychotics (May 2011), Loperamide (August 2011) and Anti-epileptics (November 2011). All are based on monographs featured in the Palliative Care Formulary.

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US shared REMS for TIRF website now available

22nd May 2012

The access website for the shared Risk Evaluation and Mitigation Strategy (REMS) program for prescribing, dispensing and distribution of all Transmucosal Immediate Release Fentanyl (TIRF) formulations in the US is now available (see our news item 20-02-2012).

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NHS Evidence update on depression

11th May 2012

NHS Evidence has issued a summary of selected new evidence relevant to the National Institute of Health and Clinical Excellence (NICE) clinical guideline 90 (published 2009) on the treatment and management of depression in adults. The update identifies new evidence that might reinforce or generate future change to the practice laid out in the NICE guideline.

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Study published on the impact of co-proxamol withdrawal

9th May 2012

A time series study on the impact of co-proxamol withdrawal on prescribing and deaths in the UK has been published. The study concludes that during the 6 years following the withdrawal of co-proxamol in the UK, there was a major reduction in poisoning deaths involving this drug, without apparent significant increase in deaths involving other analgesics.

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Die zweite Ausgabe des APM Newsletter ist fertig.

8th May 2012

The second issue of APM Newsletter for German-speaking users of www.palliativedrugs.com is available.

Die zweite Ausgabe des APM Newsletter ist fertig. Über die aktuelle Ausgaben des Newsletters wird Sie das Bulletin Board informieren.

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Prescribing and mixing controlled drugs - changes

24th April 2012

The following awaited changes to the prescribing and use of controlled drugs came into force on the 23rd April 2012:

  • Pharmacist Independent Prescribers (PIPs) and Nurse Independent Prescribers (NIPs) are now able to prescribe, administer and give directions for all schedule 2, 3, 4 and 5 drugs within their competence. This extends to diamorphine, dipipanone or cocaine for treating organic disease or injury but not for treating addiction.
  • All prescribers who are authorised to prescribe controlled drugs (e.g. doctors, dentists, supplementary prescribers, PIPs and NIPs) are able to write a direction to enable compounding (mixing) of schedule 2, 3, 4 or 5 controlled drugs.
  • All registered pharmacists and nurses are able to supply diamorphine or morphine under a patient group direction (PGD) for the immediate, necessary treatment of sick or injured persons.

Guidance for pharmacists is available on the Royal Pharmaceutical Society website (member’s only area) and general guidance is available from the National Prescribing Centre. The explanatory memorandum for the legislative changes is available here.

Tolvaptan: over-rapid increase in serum sodium and risk of serious neurological events

23rd April 2012

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has warned that treatment with tolvaptan (Samsca, Otsuka) can result in over-rapid correction of hyponatraemia, which can lead to serious neurological events. They give specific advice for healthcare professionals on monitoring of serum sodium and the acceptable rate of rise of serum sodium during treatment and highlight that co-administration of other drugs or fluids with a high sodium content (e.g. normal or hypertonic saline) is not recommended. They also warn that tolvaptan may reduce the effect of vasopressin analogues (e.g. desmopressin) used to control or prevent bleeding.

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Risks of hypomagnesaemia and increased risk of fracture with long-term PPI use

23rd April 2012

The UK Medicines and Healthcare products Regulatory Agency (MHRA) have alerted healthcare professionals of the possible risks of hypomagnesaemia and also increased fracture risk with long-term Proton Pump Inhibitor (PPI) use (generally >1year) in their latest Drug Safety Update publication.

 

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NICE updated infection control guidelines

29th March 2012

An updated guideline on the prevention and control of healthcare-associated infections in primary and community care has been published by the UK National Institute for Health and Clinical Excellence (NICE). The updated guideline takes into account new evidence that has been published since NICE's original guideline in 2003.

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MHRA alert for co-codamol 8/500 tablets

28th March 2012

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued a patient level recall for a batch of co-codamol 8/500 tablets (Wockhardt UK Ltd; batch code LL11701; expiry September 2014; first distributed December 2011). Rogue higher strength co-codamol 30/500 tablets have been found in this batch.

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NPSA RRR: Harm from flushing of nasogastric tubes before confirmation of placement

27th March 2012

The UK National Patient Safety Agency (NPSA) has issued a Rapid Response Repost (RRR) following two patient deaths since 10 March 2011 where staff had flushed nasogastric tubes with water before initial placement had been confirmed. 

Misplaced nasogastric tubes leading to death or severe harm are ‘never events’. The patient safety alert Reducing the harm caused by misplaced nasogastric feeding tubes in adults, children and infants was issued by the NPSA on 10 March 2011 with an action complete date of 12 September 2011. Alongside other actions, the alert requires all organisations to ensure that ‘Nasogastric tubes are not flushed, nor any liquid/feed introduced through the tube following initial placement, until the tube tip is confirmed by pH testing or x-ray to be in the stomach.’ 

Confusion appears to have arisen over nasogastric tubes with water-activated lubricants. The above guidance is applicable for all nasogastric tubes including those with water-activated lubricants. The lubricant is not needed for placement, only to aid removal of the guidewire/ stylet from the tube after gastric placement has been confirmed

All organisations in the NHS and independent sector where nasogastric feeding tubes are placed and used for feeding patients should ensure that the following implemented by 21-09-2012:

1.     Assign a named clinical lead to coordinate implementation of the actions in this RRR with any actions outstanding from the earlier Alert 

2.     Remind all staff responsible for checking initial placement of nasogastric tubes (including staff who support parents/carers who check initial placement of nasogastric tubes):

a.    NOTHING should be introduced down the tube before gastric placement has been confirmed

b.    DO NOT FLUSH the tube before gastric placement has been confirmed

c.     Internal guidewires/ stylets should NOT be lubricated before gastric placement has been confirmed

3.    This reminder should be given through:

a.    Distributing this RRR to all relevant staff

b.    Providing warning notices and/ or overwraps with warning labels on all current and future stock of nasogastric tubes, until these are provided as standard by manufacturers

c.     Reviewing and, if necessary, amending all local policy, protocol and training materials.

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Capsaicin patch license extension application withdrawn

21st March 2012

Astellas Pharma has withdrawn its application to the European Medicines Agency (EMA) for a license extension for Qutenza® (capsaicin 8% transdermal patch). The application was to extend the marketing authorization for Qutenza® to all adult patients with exclusion of patients with pain caused by diabetes. 

The withdrawal was based on the Committee for Medicinal Products for Human Use (CHMP)'s view that the data provided would not allow the committee to conclude on a positive benefit-risk balance.

Qutenza® continues to be authorized for the treatment of peripheral neuropathic pain (PNP) in non-diabetic adults either alone or in combination with other medicinal products for pain.

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Wir freuen uns, Ihnen den ersten APM Newsletter vorstellen zu drfen

20th March 2012

We are happy to present the first APM Newsletter for German-speaking users of www.palliativedrugs.com!
Wir freuen uns, Ihnen den ersten APM Newsletter vorstellen zu dürfen. Der Newsletter wird alle zwei Monate erscheinen und soll Sie über aktuelle Themen im Bereich der palliativmedizinischen Arzneimitteltherapie informieren. Er ist Teil des Angebotes, das Ihnen kostenfrei unter www.arzneimittel-palliativ.de zur Verfügung steht. Sie können den aktuellen Newsletter auf der Website palliativedrugs.com im Bereich "News" herunterladen. Über aktuelle Ausgaben des Newsletters wird Sie das Bulletin Board informieren. Alternativ können Sie sich unter newsletter@arzneimittel-palliativ.de kostenfrei für den Newsletter registrieren.

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Alert update on Prednisolone e/c recalled from Teva

20th March 2012

Following the Medicines and Healthcare products Regulatory Agency (MHRA) recall of prednisolone enteric coated (e/c) blister packs from Teva UK (see our news item 16-12-2011), the recall has been extended to certain batches of prednisolone 2.5mg and 5mg e/c tablets packed in pots. Again, this is due to elevated levels of related substances being detected during stability studies.

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MHRA launches opioid learning module

16th March 2012

A self-directed learning package outlining the key risks and undesirable effects of opioids has been launched by the Medicines and Healthcare products Regulatory Agency (MHRA) for doctors, pharmacists and nurses.

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Tapentadol DTB review

15th March 2012

The Drug and Therapeutics Bulletin (DTB) has featured a review on the evidence for tapentadol (Palexia®; Grünenthal) for moderate to severe acute pain.

The bulletin highlights some of the limitations of the available evidence as follows (taken directly from source): 

• This evidence base for the treatment of acute pain is limited to comparisons between tapentadol and oxycodone or placebo; other than a single-dose phase II trial, there are no published studies comparing tapentadol with other drugs that might be more relevant in clinical practice, and with which clinicians will be more familiar (e.g. codeine, morphine).

• Non-opioid analgesics were not given before moving on to, or in combination with, the trial drugs (which might be tried in practice).

The review concludes that tapentadol has been shown to have similar efficacy compared to oxycodone although evidence to suggest that it has fewer gastrointestinal undesirable effects compared to oxycodone is limited. "Further studies are required comparing tapentadol in the management of acute pain with morphine or alternative opioids other than oxycodone before it can be recommended for routine use. In view of the trial limitations and lack of comparison with other analgesics, it is difficult to see a place in therapy for tapentadol in the management of moderate to severe acute pain at present."

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Loron (clodronate disodium 520mg tablets) change of licence holder

13th March 2012

Roche Products Ltd has issued a notification of divestment and related new distribution arrangements for Loron (clodronate disodium 520mg tablets).This product is being divested to Riemser Arzneimittel AG and the supplier of Loron to the UK will change to Intrapharm Laboratories from 2nd April 2012. Loron will be available from all mainline wholesalers and Intrapharm’s distributor Movianto UK Ltd. Intrapharm will continue to sell stock in Roche livery until new stock make-up is available. All orders received up until Friday 30th March will be delivered. For more information contact Movianto order processing and customer Service: 01234 248 632, orders.uk@movianto.com, or Roche customer care: 0800 731 5711.

SMC accepts Bufyl

13th March 2012

The Scottish Medicines Consortium (SMC) has accepted bupivacaine HCL 1mg/mL and 1.25mg/mL plus fentanyl (as citrate) 2microgram/mL solution for infusion (Bufyl®; Goldshield, Croydon, Surrey) for use within NHS Scotland as epidural analgesia, to relieve pain during labour and to control post-operative pain. It states that for patients in whom the combination of bupivacaine and fentanyl is an appropriate choice of therapy, Bufyl® provides two fixed-dose, pre-mixed preparations.

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AWMSG issues final appraisal for capsaicin 8% patch

9th March 2012

The All Wales Medicines Strategy Group (AWMSG) does not recommended Capsaicin 8% patch (Qutenza® Astellas Pharma, Staines, Middlesex, UK) as an option, within NHS Wales, for use on its own for the treatment of peripheral neuropathic pain (PNP) in non-diabetic adults.

The Group does recommend capsaicin patch as an option for restricted use within NHS Wales for the treatment of PNP in non-diabetic adults in combination with other medicinal products for pain and in patients who have not received adequate benefit from, or are intolerant to, alternative conventional treatments. Patches should be administered by specialists.

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WHO guidelines for treating persistent pain in children

8th March 2012

The World Health Organization (WHO) has published a package on the pharmacological treatment of persisting pain in children with medical illnesses, which replaces the previous guidelines 'Cancer pain relief and palliative care in children'. The package contains information for:

  • physicians and nurses 
  • pharmacists 
  • policy-makers and medicines regulatory authorities, hospital managers and health insurance managers,

a dosing card, pain scales and a wall chart.

Changes to the guidelines include recommending using analgesic treatments in two steps according to the child’s level of pain severity. Paracetamol and ibuprofen are the medicines of choice in the first step: the treatment of mild pain. In the second step, the treatment of moderate to severe pain, morphine is the medicine of choice. WHO recommends that codeine and tramadol no longer be used for children. Finally, the initial dosages of strong opioids recommended by WHO are lower than those recommended elsewhere.

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DH guidance on clostridium difficile infections

8th March 2012

The UK Department of Health (DH) has issued revised guidance on how to test, report and manage clostridium difficile infections.

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New combined bupivacaine and fentanyl epidural infusion

7th March 2012

A combined bupivacaine and fentanyl solution for epidural infusion has been launched in the UK (Bufyl®,Goldshield). It is indicated for maintaining analgesia post-operatively and during labour and comes in two strengths bupivacaine 1mg/mL (0.1%) combined with fentanyl 2microgram/mL  and bupivacaine 1.25mg/mL (0.125%) combined with fentanyl 2microgram/mL. The NHS cost of a 250mL or 500mL infusion bag of either strength is approximately £9.

SPC Bufyl 1mg/mL and 2microgram/mL infusion

SPC Bufyl 1.25mg/mL and 2microgram/mL infusion

NPSA signal on prevention of harm with buccal midazolam

7th March 2012

The UK National Patient Safety Agency (NPSA) has highlighted the potential for errors to occur when administering buccal midazolam, in a signal report.  Signals are notifications of key risks emerging from review of serious incidents reported to the National Reporting and Learning System (NRLS) and shared by the NPSA. Between April 2008 and August 2011, 132 medication incidents were reported; three were associated with severe harm, five with moderate harm and the remainder with no or low harm. NPSA highlight the risk of a dosing error caused by transferring from unlicensed buccal midazolam 10mg/mL to licensed buccal midazolam 5mg/mL (Buccolam®), which has also been addressed by the MHRA (see our news item 13-10-2011) and the risk of a product with a ‘Luer’ connector being inadvertently administered via the IV route. One manufacturer of an unlicensed buccal midazolam 10mg/mL preparation (Epistatus®, Special Products) is currently changing their syringes to non-luer tips (see our news item 14-02-2012). NPSA recommend minimizing these risks by:

• using licensed medicines where possible
• developing a Trust policy to cover the use of unlicensed medicines, including midazolam
• developing a written protocol for the use of buccal midazolam, which includes essential information on clinical indication, dose and administration method, and ensuring that this is available in all clinical areas using this medicine
• ensuring that the dose is always prescribed in mg and mL
• ensuring that buccal midazolam is only administered using oral syringes that are not compatible with intravenous or other parenteral devices.

An additional risk with Epistatus® (Special Products) was highlighted recently due to a change in syringe size supplied with the product and the risk of wrong dose errors (see our news item 14-02-2012). 

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CHMP recommends a marketing authorisation for granisetron patch

6th March 2012

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending the granting of a marketing authorisation for granisetron 3.1mg/24h transdermal patch (Sancuso) intended for the prevention of nausea and vomiting associated with moderately or highly emetogenic chemotherapy.

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CHMP recommends a marketing authorisation for generic zoledronic acid

6th March 2012

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending the granting of a marketing authorisation for generic zoledronic acid 4mg/5mL concentrate for solution for infusion intended for the prevention of skeletal related events in adult patients with advanced malignancies involving bone, and the treatment of tumour-induced hypercalcaemia.

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New generic buprenorphine sublingual tablets

23rd February 2012

A branded generic of buprenorphine 200microgram and 400microgram sublingual tablets (Tephine, Sandoz) has been launched in the UK. They are indicated as a strong analgesic for the relief of severe pain and are bioequivalent to Temgesic (RB Pharmaceuticals). The NHS cost of 50 tablets is £5 and £10 for the 200microgram and 400microgram strengths respectively.

Generic buprenorphine 400microgram, 2mg and 8mg sublingual tablets are already available but are indicated for substitution treatment for opioid dependence. Sandoz have also launched a branded generic in these strengths (Prefibin, Sandoz).

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FDA approve a shared REMS for all transmucosal fentanyl products

20th February 2012

The US Food and Drug Administration (FDA) have approved a shared Risk Evaluation and Mitigation Strategy (REMS) for all Transmucosal Immediate Release Fentanyl (TIRF) products. This shared program has been designed to streamline the REMS process and will allow prescribers and pharmacists to enrol in one shared REMS system for all TIRF products. The branded fentanyl products currently included are; Abstral (sublingual tablet), Actiq (lozenge), Fentora (buccal tablet), Lazanda (nasal spray), Onsolis (buccal soluble film) and Subsys (sublingual spray), the website will be available in March 2012.

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FDA approve a fentanyl sublingual spray

20th February 2012

The US Food and Drug Administration have approved a novel fentanyl single-dose sublingual spray (Subsys, Insys therapeutics, Phoenix, Arizona), indicated for treatment of breakthrough cancer pain in adult patients who are already receiving opioids for persistent cancer pain. The product is due to be launched shortly and will be available in individual, disposable spray units of 100microgram, 200microgram, 400microgram, 600microgram, and 800microgram strengths.

This product will come under the newly approved shared Risk Evaluation and Mitigation Strategy (REMS) for Transmucosal Immediate Release Fentanyl (TIRF) products (see our news item 20-02-12).

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SMC accepts midazolam 5mg/mL oromucosal solution

16th February 2012

The Scottish Medicines Consortium (SMC) has accepted midazolam 5mg/mL oromucosal solution (Buccolam®, Viropharma) for use within NHS Scotland for the treatment of prolonged, acute, convulsive seizures in children (3months to <18years).

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NPC reports on safe management of controlled drugs

16th February 2012

The UK National Prescribing Centre (NPC) has published three final reports regarding the safe management and use of controlled drugs in England; in prison, in the ambulance and paramedic services and private prescribing and requisitioning.

Safe management and use of controlled drugs in prison health in England

Safe management and use of controlled drugs in the ambulance and paramedic services in England

Safe management and use of controlled drugs review of private prescribing and requisitioning in England

Epistatus liquid - temporary change to syringe size

14th February 2012

The oral syringe supplied with the unlicensed midazolam buccal liquid 10mg/mL, 5mL bottle (Epistatus) has temporarily changed in size from 1mL to 1.5mL. This modification was made in order to allow measurement of an adult dose of midazolam up to 15mg. However, in response to customer feedback the manufacturer (Special Products Ltd) has reverted back to the 1mL syringe size.

The new 1mL syringes will have a non-luer tip, in order to ensure full compliance with the National Patient Safety Agency (NPSA) 2007 guidelines "Promoting safer measurement and administration of liquid medicines via oral and other enteral routes".

Extra care should be taken when measuring and patients should be made aware that the syringe size supplied may vary.

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Morphine manifesto

10th February 2012

Leading organisations in the UK and around the world are supporting the morphine manifesto, which calls for an end to the unethical practice of promoting access to expensive opioid analgesics without also making low cost immediate release oral morphine available. The manifesto is appealing to governments, healthcare institutions, and the pharmaceutical industry to assure the accessibility of immediate release morphine to patients in need at a cost that the individual and community can afford. For more information and to sign the manifesto see below.

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EAPC guidelines on the use of opioid analgesics for cancer pain

9th February 2012

An updated version of the guidelines of the European Association for Palliative Care (EAPC) on the use of opioids for the treatment of cancer pain has been published. The update was undertaken by the European Palliative Care Research Collaborative (EPCRC). The new guidelines were published in Lancet Oncology this month. The supporting evidence for the updated opioid guidelines consists of 17 systematic reviews that were published in a special issue of Palliative Medicine in July 2011. A patient friendly summary of the guidelines can be downloaded from the EPCRC website.

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FDA safety communication on PPIs and clostridium difficile diarrhoea

9th February 2012

The US Food and Drug Administration has issued a safety communication stating that proton pump inhibitors (PPIs) may be associated with an increased risk of clostridium difficile associated diarrhoea.

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Clonazepam oral solution - new licensed product

8th February 2012

Rosemont Pharmaceuticals (0800 919312) has launched Clonazepam 0.5mg/5mL and 2mg/5mL oral solutions in the UK. They are licensed for all clinical forms of epileptic disease and seizures in adults. The formulations are not indicated for paediatric use due to the presence of ethanol and should not be mixed with water. The NHS cost of 150mL bottle of 0.5mg/5mL and 2mg/5mL is £40 and £48 respectively.

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MHRA consult on loperamide classification from P to GSL

7th February 2012

The UK Medicines and Healthcare products Regulation Agency (MHRA) are consulting on the reclassification of Imodium Instants (loperamide orodispersible tablets 2mg) 12 tablet pack from Pharmacy (P) to General Sales List (GSL) classification. Consultation closes 5 March 2012.

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Revised patient guide on advance care planning

2nd February 2012

An updated version of the guide "Planning your future care" has been published by the National End of Life Care Programme, the University of Nottingham and the Dying Matters Coalition. This guide aims to explain advance care planning and the different options available to people when planning for their end of life care.

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MHRA warns against Butterbur herbal remedies

26th January 2012

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has warned people not to take Butterbur (Petasites hybridus) herbal remedies due to the risk of hepatic toxicity. Products containing butterbur are being marketed in the UK, most commonly for the treatment of migraine and hayfever. However, none of these are licensed under the Traditional Herbal Registration Scheme.

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FDA approve generic morphine sulphate m/r capsules

19th January 2012

The US Food and Drug Administration (FDA) have approved a generic morphine sulphate m/r capsule (equivalent to Kadian®). Morphine sulfate ER (Watson Laboratories, Corona, California) is available as 20mg, 30mg, 50mg, 60mg, 80mg and 100mg extended release capsules.

Discontinuation of granisetron (Kytril) infusion 1mg/mL

19th January 2012

Roche has discontinued granisetron (Kytril®) infusion 1mg/mL (1mL and 3mL ampoules), with immediate effect in the UK, due to low demand. A generic granisetron 1mg/mL solution for infusion or injection (1mL and 3mL ampoules) remains available from Hameln Pharmaceuticals.

SMC accepts fentanyl single dose nasal spray

17th January 2012

The Scottish Medicines Consortium (SMC) has accepted fentanyl single dose nasal spray (Instanyl®, Nycomed) for use within NHS Scotland for the management of breakthrough pain in adults already receiving maintenance opioid therapy for chronic cancer pain.  Its use is restricted to patients who are unsuitable for other short-acting oral opioids (e.g. oral morphine) as an alternative to other buccal and sublingual fentanyl preparations. 

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Crush resistant formulation of oxymorphone approved in US

17th January 2012

The US Food and Drug Administration (FDA) have approved a crush resistant formulation of oxymorphone which is aimed at reducing abuse potential. The company (Endo Pharmaceuticals, Chadds Ford, Pennsylvannia, USA) plans to retain the name Opana ER and replace the 7 dosage strengths of the current formulation of Opana ER with the new crush resistant product during 2012.

NICE end of life care commissioning guide

12th January 2012

NICE has published a guide for commissioners of end-of-life care services. The guide aims to support local implementation of the Department of Health (2008) End of Life Care Strategy and the NICE (2011) Quality Standard for end of life care for adults, and is aligned with the NHS Outcomes Framework and supports commissioning for Quality, Innovation, Productivity and Prevention (QIPP).

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AWMSG approve tapentadol m/r for restricted use

12th January 2012

The All Wales Medicines Strategy Group (AWMSG) has recommended tapentadol modified release (m/r) (Palexia® SR, Grunenthal, Buckinghamshire) as an option, within NHS Wales, for restricted use for patients with severe chronic pain in whom morphine sulphate m/r has failed to provide adequate pain control or is not tolerated.

The Group does not recommend tapentadol m/r for the management of severe chronic pain in adults, which can be adequately managed only with opioid analgesics, outside of the subpopulation described above.

The Group also recommends that tapentadol m/r should initially be prescribed by a specialist.

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NPSA Rapid Response Report on spinal connectors

29th December 2011

The UK National Patient Safety Agency (NPSA) have issued a Rapid Response Report on minimising risks of mismatching spinal, epidural and regional devices with incompatible connectors (NPSA/2011/RRR03).  NPSA have quoted a recent patient safety incident, where a spinal needle with a neuraxial connector was supplied and used in error when a device with a Luer connector was required. The labelling and packaging of the two devices with Luer and neuraxial connectors, from the same manufacturer, looked very similar in their appearance. 

 

Spinal, epidural and regional devices, with non-Luer compatible neuraxial connectors, that will not connect with intravenous equipment, are being placed on the market by industry in response to the NPSA Patient Safety Alert issued in 2009 (NPSA/2009/PSA004A) and updated in January 2011 (NPSA/2011/PSA001). Although the use of these devices will reduce the risks of wrong route errors, it is essential that effective controls are in place to minimise the risk of mis-selection and supply of devices with incompatible connectors that could cause delay in clinical procedures and harm patients.

 

The RRR provides additional guidance to the original patient safety alert, on minimising the risk of mis-selecting incompatible connectors, with a deadline for action complete of 31 March 2012.

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Update: anti-epileptics monograph

29th December 2011

The anti-epileptics monograph has been updated and published in the Journal of Pain and Symptom Management (JPSM) as a therapeutic review. 

Howard P et al (2011) Therapeutic Reviews: Anti-epileptic drugs. Journal of Pain and Symptom Management. 42: 788-804.

This is the 8th therapeutic review in a series in the JPSM. Previous featured monographs include octreotide (July 2010), propofol (September 2010), psychostimulants (November 2010), thalidomide (January 2011), ketamine (March 2011), antipsychotics (May 2011) and loperamide (August 2011). All of these articles are based on those featured in PCF4.

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NPC review m/r oxycodone/naloxone

22nd December 2011

The NHS National Prescribing Centre (NPC) has published a MeReC rapid review of modified release oxycodone/naloxone in cancer pain discussing the results of a published 4 week clinical trial.

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Prednisolone e/c blister packs recalled from Teva

16th December 2011

MHRA has issued a drug recall for all remaining stock in hospitals, clinics, pharmacies and wholesalers of prednisolone 2.5mg and 5mg e/c tablets in blister packs of the batches listed below from Teva UK.

Elevated levels of related substances have been detected early in the shelf-life during routine stability testing. Only blister packs are affected;

Prednisolone 2.5mg Batch 69894 Expiry Dec 2013.

Prednisolone 5mg Batch 80077 Expiry Jan 2014.

Prednisolone 5mg Batch 80057 Expiry Jan 2014.

Prednisolone 5mg Batch 69896 Expiry Feb 2014.

 

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Citalopram and escitalopram maximum daily doses restricted

15th December 2011

Restrictions on the maximum daily doses of citalopram and escitalopram have been made following the evaluation of a QT study by the UK Medicines and Healthcare products Regulatory Agency (MHRA). The study showed dose-dependent QT interval prolongation with citalopram and escitalopram, and post-marketing reports of prolonged QT interval have also been received. A similar decision was taken by the US Food and Drug Administration last year (see our news item 25-08-11).

Citalopram

The maximum daily dose of citalopram should be restricted to 40mg (20mg in the elderly or those with hepatic impairment).

Escitalopram

The maximum daily dose of escitalopram for adults <65 years remains 20mg daily, however in adults >65 years, the dose has been reduced to 10mg daily.

Citalopram and escitalopram are contra-indicated in patients with known QT interval prolongation or congenital long QT syndrome and in conjunction with other products known to prolong the QT interval. These include;

  • class IA and III antiarrhythmics (eg, amiodarone, dronedarone, quinidine)
  • antipsychotics (eg, fentiazine derviatives, pimozide, haloperidol)
  • tricyclic antidepressants
  • some antimicrobial agents (eg, sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, antimalaria treatment - particularly halofantrine)
  • some antihistamines (astemizole, mizolastine)
  • some antiretrovirals (eg, ritonavir, saquinavir, lopinavir).

Caution is advised in patients with underlying heart conditions and those who are predisposed to low serum levels of potassium and magnesium.

Doses of citalopram and escitalopram may also need to be reduced if used in conjunction with drugs that increase their plasma levels e.g. some antiretrovirals, omeprazole and cimetidine.

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Extemporaneous thalidomide oral suspension stability study

15th December 2011

A stability study of thalidomide oral suspension 20mg/mL, using the contents of oral thalidomide capsules and a 1:1 mixture of Ora-Plus and Ora-Sweet, has been published. The HPLC method demonstrated stability for at least 35days when stored in amber plastic bottles under refrigeration.

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Reminder about fentanyl patches and heat sources

12th December 2011

The Royal Pharmaceutical Society has issued a reminder about counselling patients regarding avoiding heat sources when using fentanyl patches. This follows reports in the press about the dangers of using them in the bath, with one reported fatality.

Patients using fentanyl patches should avoid heat sources such as hot water bottles, heat patches, electric blankets, heat lamps, hot whirlpool spa baths and prolonged hot baths, as an increase in temperature could increase the release-rate of fentanyl from the patch. This information is contained in the patient information leaflet.

This advice is echoed in our Quick Practice Guide: Use of transdermal fentanyl patches. PCF further advises that patients may shower but should not soak in a hot bath.

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NICE consults on draft recommendations on the use of opioids in palliative care

8th December 2011

The UK National Institute for health and Clinical Excellence (NICE) is consulting on draft recommendations for the use of opioids in palliative care. Comments should be made using the standard proforma via registered stakeholders. The consultation period closes on 06-01-12. Full details, including the consultation document and a list of stakeholders are available below.

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Draft specialist palliative care measures consultation

8th December 2011

A draft version of the specialist palliative care measures for inclusion in the Manual for Cancer Services has been issued by the UK Department of Health for a 12 week consultation period. It is aimed at interested stakeholders only and ends 27 February 2012.

 

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Staggered paracetamol overdose

28th November 2011

There has been a large media interest following the publication of a study in the British Journal of Clinical Pharmacology surrounding the repeated ingestion of slightly greater than recommended doses of paracetamol and the associated increased risk of fatality. See below for further information.

British Journal of Clinical Pharmacology (link to free access full article)
British Journal of Clinical Pharmacology (link to press release)

Update: anti-epileptics monographs

24th November 2011

The anti-epileptics monograph has been updated and published in the Journal of Pain and Symptom Management (JPSM) as a therapeutic review.

Howard P et al (2011) Therapeutic Reviews: Anti-epileptic drugs. Journal of Pain and Symptom Management. 42: 788-804.

This is the 8th therapeutic review in a series in the JPSM. Previous featured monographs include octreotide (July 2010), propofol (September 2010), psychostimulants (November 2010), thalidomide (January 2011), ketamine (March 2011), antipsychotics (May 2011) and loperamide (August 2011). All of these articles are based on those featured in PCF4.

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MHRA update: lenalidomide

18th November 2011

The November 2011 issue of Drug Safety Update from the MHRA features an update about the risk of a second primary malignancy associated with the use of lenalidomide (see our news item 31-05-2011). Clinical trials investigating use of lenalidomide in patients with newly diagnosed multiple myeloma have shown a four-fold increased risk of second primary malignancy (including: haematological malignancies such as acute myeloid leukaemia, Hodgkin’s disease, and B-cell lymphocytic leukaemias; myelodysplastic syndrome; solid tumours; and melanomas). There seems to be a smaller increased risk of second primary malignancy in patients treated with lenalidomide for relapsed or refractory myeloma; the authorised indication.

The MHRA advice continues to be: 

• Use of lenalidomide in unlicensed indications is not recommended unless it takes place as part of a clinical trial

• Patients should be carefully evaluated before and during treatment with lenalidomide using routine cancer screening for occurrence of second primary malignancy and treatment should be instituted as indicated

• Healthcare professionals should report all suspected adverse reactions, including second primary malignancy promptly to us via the Yellow Card Scheme.

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Positive benefit-risk balance of pholcodine-containing cough medicines

18th November 2011

The European Medicines Agency (EMA) has confirmed that the benefits of pholcodine-containing cough medicines outweigh their risks and that these medicines should remain available for the treatment of non-productive (dry) cough in children and adults

A review was initiated following concerns that its use may put people at risk of developing anaphylactic reactions to neuromuscular blocking agents used during surgery. However the EMA Committee for Medicinal Products for Human Use (CHMP) found no firm evidence to substantiate the hypothesis and it also noted that pholcodine-containing medicines have been available for the treatment of non-productive cough in the EU for decades and existing data confirm a positive benefit-risk balance of these medicines.

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Palonosetron capsules launched in UK

18th November 2011

Palonosetron capsules (Aloxi, IS Pharmaceuticals) have been launched in the UK for the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy in adults. The dose is 500microgram administered approximately one hour before the start of chemotherapy. The cost of a 500microgram capsule is £56.

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EMA reject appeal for new indication for duloxetine

18th November 2011

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has confirmed its previous negative opinion on the application for a new indication for duloxetine (Cymbalta) for the treatment of moderate to severe chronic somatic pain in patients not taking NSAIDs regularly.

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A review of nabilone for chronic pain management

15th November 2011

The Canadian Agency for Drugs and Technologies in Health (CADTH) has published a review of clinical effectiveness, safety and guidelines for the use of nabilone for chronic pain management. It includes a review of studies for neuropathic pain, cancer pain, non-cancer pain, spasticity-related pain resulting from MS and spinal pain.

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PSNC resource for specials

11th November 2011

The Pharmaceutical Services Negotiating Committee (PSNC) guidance on unlicensed specials and imports has been updated to clarify some common queries based on the new arrangements for reimbursing and endorsing prescriptions for unlicensed specials and imports.

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SMC rejects aprepitant

8th November 2011

Following a resubmission, the Scottish Medicines Consortium (SMC) does not recommend the use of aprepitant (Emend) within NHS Scotland as part of combination therapy, for prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy. The SMC concluded that the clinical and economic analyses submitted by the company were not sufficiently robust to gain its acceptance.

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Single dose fentanyl nasal spray launched in UK

2nd November 2011

NycoMed has launched Instanyl (fentanyl) single-dose nasal spray for the management of breakthrough pain in adults already receiving maintenance opioid therapy for chronic cancer pain.  Instanyl single-dose nasal spray is available as a pack of 6 individual child-resistant blisters in 50, 100 and 200microgram strength all costing £35.70 i.e. £5.95 per dose (NHS list price). The single dose blisters do not need priming before use.

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EMA to review cardiovascular safety of NSAIDs

21st October 2011

The European Medicines Agency (EMA) is to review the latest available data on the cardiovascular safety of non-selective non-steroidal anti-inflammatory drugs (NSAIDs) and update its opinion which was published in 2006.

 

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DH "Never Events"

20th October 2011

The UK Department of Health (DH) published it’s list of "Never Events" for 2011-2012 earlier this year, which has expanded to 25 from the original 8 published in previous years. "Never events" are very serious, largely preventable patient safety incidents that should not occur if the relevant preventative measures have been put in place.

  1. Wrong site surgery (existing)
  2. Wrong implant/prosthesis (new)
  3. Retained foreign object post-operation (existing)
  4. Wrongly prepared high-risk injectable medication (new)
  5. Maladministration of potassium-containing solutions (modified)
  6. Wrong route administration of chemotherapy (existing)
  7. Wrong route administration of oral/enteral treatment (new)
  8. Intravenous administration of epidural medication (new)
  9. Maladministration of Insulin (new)
  10. Overdose of midazolam during conscious sedation (new)
  11. Opioid overdose of an opioid-naïve patient (new)
  12. Inappropriate administration of daily oral methotrexate (new)
  13. Suicide using non-collapsible rails (existing)
  14. Escape of a transferred prisoner (existing)
  15. Falls from unrestricted windows (new)
  16. Entrapment in bedrails (new)
  17. Transfusion of ABO-incompatible blood components (new)
  18. Transplantation of ABO or HLA-incompatible Organs (new)
  19. Misplaced naso- or oro-gastric tubes (modified)
  20. Wrong gas administered (new)
  21. Failure to monitor and respond to oxygen saturation (new)
  22. Air embolism (new)
  23. Misidentification of patients (new)
  24. Severe scalding of patients (new)
  25. Maternal death due to post partum haemorrhage after elective Caesarean  section (modified)

For more information see below

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NETAG does not recommend capsaicin cutaneous patch for neuropathic pain

14th October 2011

The NHS North East Treatment Advisory Group (NETAG) does not recommend the use of capsaicin cutaneous patch (Qutenza) for neuropathic pain, the group were concerned about the clinical efficacy of the treatment and considered that it did not represent a cost-effective treatment option.

NETAG capsaicin patch outcome
NETAG capsaicin patch appraisal

NETAG does not recommend tolvaptan for hyponatraemia due to SIADH

14th October 2011

The NHS North East Treatment Advisory Group (NETAG) does not recommend, following an appeal, the use of tolvaptan (Samsca) for hyponatraemia due to syndrome of inappropriate anti-diuretic hormone secretion (SIADH). The group concluded that tolvaptan is unlikely to be cost-effective compared with existing treatment options and was concerned about the potential for unrestricted long-term treatment. The group recognised that long-term treatment could be appropriate in certain circumstances according to a local protocol, see below for more details.

NETAG tolvaptan outcome
NETAG long term treatment protocol

Monitoring unwanted effects of antipsychotics

13th October 2011

A recent article in the Drug and Therapeutics Bulletin (DTB) discusses monitoring for unwanted effects of antipsychotics in adults, with a particular focus on second-generation antipsychotics. For more information see link below (subscription required for full text).

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MHRA: Avoid use of aqueous calamine cream before X-ray

13th October 2011

The UK Medicines and Healthcare Regulatory agency (MHRA) has issued a reminder that aqueous calamine cream should not be applied to the skin before an X-ray examination because it may affect the outcome of the radiograph. This preparation contains zinc oxide 3.0% w/w, and if used on the skin before an X-ray, the zinc oxide may mimic intramammary calcifications, which can be an important indicator of early breast cancer. The product label and leaflet have been updated to reflect this new advice.

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MHRA: Transferring patients to the new licensed buccal midazolam preparation

13th October 2011

The UK Medicines and Healthcare Regulatory Agency (MHRA) have highlighted that care is needed on transferring patients from unlicensed buccal midazolam preparations to the new licensed buccal midazolam preparation (Buccolam, ViroPharma).

Buccolam is oral midazolam 5mg/mL provided in age-specific, individual doses of 2.5mg, 5mg, 7.5mg or 10mg, in pre-filled syringes for buccal delivery (see our news item 14-09-2011). The NHS list price of 4 dose units is £82, £85.50, £89 and £91.50 respectively. It is licensed for patients diagnosed with epilepsy from age 3months to <18years.

Buccolam is half the strength of some of the unlicensed preparations that have been used and is also a different salt; it contains the hydrochloride salt, whereas some other preparations contain the maleate salt of midazolam. MHRA state that although there is some suggestion that the maleate salt may be better absorbed in the buccal cavity, there are adequate studies with midazolam hydrochloride to support the dosing schedule authorized for Buccolam in the SPC. It also references a publication of the experience of a hospital paediatric unit transferring its patients to licensed Buccolam.

MHRA safety update for Buccolam
SPC for Buccolam 2.5mg dose

World Hospice and Palliative Care Day - 8 October 2011

6th October 2011

The theme for 2011 is 'many diseases, many lives, many voices – palliative care for non-communicable conditions' and will focus on how people living with conditions which are not infectious (cardiovascular diseases, cancers, chronic respiratory conditions and diabetes) can benefit from palliative care. For more information and to register your event visit the new World Hospice and Palliative Care website www.worldday.org.

Evidence for unlicensed and off-label medicines

4th October 2011

The UK Department of Health (DH) has announced that it will commission expert assessments of the evidence on the use of unlicensed or 'off-label' medicines, including in rare conditions. These assessments will be designed to inform doctors' decision-making and patients' choices, not to provide a yes or no recommendation. The work will be delivered by the National Institute for Health and Clinical Excellence (NICE), through its NHS Evidence arm, beginning in spring 2012.

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US FDA approve tapentadol extended-release

30th September 2011

The US. Food and Drug Administration (FDA) has approved tapentadol extended-release formulation, (Nucynta ER, Janssen Pharmaceuticals). The drug is available in 50mg, 100mg, 150mg, 200mg, and 250mg tablet strengths and is designed to be taken twice daily for the management of moderate to severe chronic pain in adult patients who need continuous, around-the-clock pain relief for an extended period of time. Janssen’s immediate-release formulation of tapentadol was approved by the FDA in 2008. Tapentadol, a centrally-acting synthetic analgesic, is a Schedule II controlled drug, For complete administration and safety recommendations, see the Prescribing Information and Medication Guide and the Nucynta ER REMS Program documentation.

MHRA communication on NSAIDs and risk of heart problems

29th September 2011

The UK Medicines and Healthcare products Regulatory Agency (MHRA) have commented on the recent international review that reports that the use of NSAIDs can increase the risk of heart attack or stroke by one-third. MHRA state that the findings are not new; an increase risk of heart attack or stroke with some NSAIDs has been well recognised for some years, particularly with long-term use of high doses and in patients who are already at high risk. However, for most patients the risks of side effects are outweighed by the benefits of treatment. MHRA state that to minimise risk, its advice remains that all NSAIDs should be used for the shortest time and at the lowest dose necessary to control symptoms.

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End of Life Care strategy annual report

29th September 2011

The UK Department of Health (DH) has published the third annual report of the End of Life Care strategy.

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Consultations on independent prescribing for physiotherapists and podiatrists

22nd September 2011

The UK Department of Health and Medicines and Healthcare products Regulatory Agency (MHRA) have jointly launched two public consultations concerning proposals for independent prescribing for physiotherapists and podiatrists. Both consultations close 8 December 2011.

Consultation for physiotherapists
Consultation for podiatrists

Lorazepam injection - UK supply discussed

22nd September 2011

The British Medical Journal (BMJ) has printed a letter and a reply from Pfizer discussing the current lack of supply of lorazepam injection in the UK.

Supply has been a problem since the middle of 2010 and was expected to resume to normal in late 2011. However in June 2011 the sterile manufacturing activities of Recipharm, who was producing lorazepam for Pfizer, closed. Pfizer states that it is working to ensure the long term resupply of lorazepam injection to UK customers and stocks are expected in the second quarter of 2013. It is also exploring short term resupply alternatives for customers and patients, and will continue to update the UK regulatory authorities on progress.

Lorazepam injection is available in the US, although it is not manufactured or supplied by Pfizer. It can be imported as an unlicensed medicine on a named patient basis.

BMJ Pfizer reply (subscription required)

US FDA approve denosumab

20th September 2011

The US Food and Drug Administration (FDA) has approved denosumab (Prolia, Amgen) for the following indications:

• to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer

• to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for non-metastatic prostate cancer.

NICE consults on changes to recommendations for neuropathic pain

15th September 2011

The UK National Institute for health and Clinical Excellence (NICE) is consulting on proposed changes to some of the recommendations made in its clinical guideline on the pharmacological management of neuropathic pain in adults in non-specialist settings (CG 96; March 2010). This action follows concerns about the associated costs that pregabalin may bring to the NHS as one of the first line treatment options for adults with neuropathic pain, and considers new evidence regarding the first-line treatment options. 

The main recommendations regarding first-line drug therapy are:

• Oral amitriptyline or gabapentin should be offered as first-line treatment, except for those with painful diabetic neuropathy, who should be offered duloxetine (amitriptyline if this is contra-indicated)

• Consider imipramine or nortriptyline as alternatives if amitriptyline is effective but not tolerated

• Consider pregabalin if gabapentin is effective but the patient has difficulty adhering to the dosage schedule or cannot tolerate the adverse effects. 

Comments on the draft amended guideline must be via registered stakeholders. The consultation closes at 9am on 10th October 2011. The current clinical guideline should be used until any further announcement is made. Further details including the list of stakeholders can be found on the website link below.

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FDA approve more REMS

14th September 2011

The US Food and Drug Administration (FDA) has approved the Risk Evaluation Mitigation Strategy (REMS) for Actiq (oral transmucosal fentanyl citrate), Fentora (fentanyl buccal tablet) and Nucynta ER (tapentadol m/r tablets).

A full downloadable list of all approved REMS (which also includes other fentanyl, buprenorphine, hydromorphone morphine, oxycodone and thalidomide preparations) is available.

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Tramadol oral drops solution launched in UK

14th September 2011

 

Tramadol oral drops 100mg/mL solution (Goldshield, 08700 703033) has been launched in the UK for the treatment of moderate to severe pain. The oral solution is not intended as a fast action relief for breakthrough pain, the SPC states, "In case tramadol drops is used for acute pain, it should be stressed that its activity is somewhat delayed in comparison to that of other analgesics." Also, it has not been licensed for children under 12 years. The dosage is expressed as drops (50mg = 20drops) and the 10mL bottle contains an integral dropper. The drops should be diluted with a glass of water before administration. The cost of a 10mL bottle (approx 20 doses of 50mg) = £3.50.

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Midazolam oromucosal solution granted first paediatric European marketing authorisation

14th September 2011

The European Commission has granted the first ever new Paediatric Use Marketing Authorisation (PUMA) for Buccolam (midazolam, oromucosal solution), for the treatment of prolonged, acute, convulsive seizures in infants, toddlers, children and adolescents, from 3 months to less than 18 years of age.

Buccolam is oral midazolam provided in an age-specific, ready to use, pre-filled syringe containing an individual dose for buccal delivery. It is expected that the product will be available in the UK from October 2011.

A PUMA is a new type of centralised marketing authorisation designed to encourage the development of older medicines, no longer covered by a patent, specifically for use in children.

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AWMSG support the use of PecFent

14th September 2011

The All Wales Medicines Strategy Group (AWMSG) has supported the use of fentanyl nasal spray (PecFent, Archimedes) within NHS Wales for the management of breakthrough pain in adults who are already receiving maintenance opioid therapy for chronic cancer pain. It should be considered as an option when immediate release opioids (e.g. morphine, oxycodone) are inadequate or unsuitable. It should be initiated by, and remain under the supervision of, a specialist physician experienced in the management of opioid therapy in cancer patients and be prescribed by brand name to avoid automatic substitution. PecFent may be suitable for shared care within NHS Wales for the above indication. 

PecFent has also been accepted for use in NHS Scotland by the Scottish Medicines Consortium (SMC) last year, but was not recommended by the North East Treatment Advisory group (NETAG). Currently NETAG does not recommend the novel fentanyl analgesics (Abstral, Effentora, Instanyl or PecFent) for breakthrough pain associated with cancer.

AWMSG report
SMC report
NETAG report

MHRA warns against Beline herbal supplement

14th September 2011

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued a warning advising people not to take the illegal herbal supplement Beline capsules. Analysis of samples of Beline have revealed that the product, which claimed to be herbal, actually contained chlorphenamine, oxetacaine, piroxicam, and betamethasone. There have been several reports of adverse reactions to Beline.

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FDA approves fentanyl nasal spray

8th September 2011

The US Food and Drug Administration (FDA) has approved the first fentanyl nasal spray (Lazanda, Archimedes) for breakthrough pain in adults patients with cancer. It is due to be available late 2011. The product is already available in five European Countries,including the UK, (known as PecFent). Prescribing information and REMS documentation are available.

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NPC guide to prescribing specials

1st September 2011

The UK National Prescribing Centre (NPC) has produced a good practice guide to prescribing specials which includes a quick practical checklist for prescribers (appendix 2).

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EMEA approves denosumab for prevention of skeletal related events

30th August 2011

The European Medicines Agency (EMEA) has granted a marketing authorisation for denosumab (Xgeva, Amgen) for the prevention of skeletal related events in adults with bone metastases from solid tumours.

Xgeva is given once every four weeks as a single 120mg subcutaneous injection in the thigh, abdomen or upper arm.

Patients should take also take calcium 500mg and vitamin D 400 unit supplements.

Xgeva 120mg/1.7mL, 1 vial = £309.86 (reimbursement/discount arrangements available for certain hospitals).

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Extra Strength Tylenol maximum daily dosage reduced in US

30th August 2011

The maximum daily dosage of Extra Strength Tylenol (McNeil Consumer Health, US) which contains acetaminophen (paracetamol) 500mg/tablet, has been reduced to 3,000mg/day (6 tablets/day in divided doses). The product has not changed, the reduction has come in response to concerns about drug-induced liver injury.

The company plans to reduce the maximum daily dosage of regular strength Tylenol and other products containing acetaminophen (paracetamol) in 2012. It is unclear whether other US manufacturers of acetaminophen (paracetamol) will follow this same route of dosage reduction.

MHRA patient level recall for all Nurofen Plus tablets

29th August 2011

MHRA have issued a Class 1 Patient Level Recall for all remaining unexpired stock of Nurofen Plus tablets in any pack size and any batch (Reckitt Benckiser 0500 455456). This follows the discovery of rogue blister strips of Seroquel XL 50mg tablets (AstraZeneca 0800 783 0033) and Neurontin 100mg capsules (Pfizer 01304 616161) within the Nurofen Plus cartons.

 

A Patient Level Recall means that wherever possible patients should be contacted and asked to return any Nurofen Plus tablets from where they were purchased or dispensed for a refund. More information and a copy of the MHRA alert are available from the link below.

 

Update 30-09-11

 Reckitt Benckiser has resumed production of Nurofen Plus, new packs can now be ordered from wholesalers.

The new packs (pack size 12, 16, 24, and 32) are individually wrapped in clear cellophane and have batch codes starting with 2 letters (NS) followed by 3 digits, e.g. NS123, so they can be easily distinguished from recalled stock.

The Class 1 Drug Alert recalling Nurofen Plus tablets containing rogue Seroquel XL 50mg tablets and Neurontin 100mg capsules issued on 26 August 2011  (see below) is still in place, and all remaining stock of unexpired Nurofen Plus should still be returned. Patients should be advised to bring back any old packs to the pharmacy.

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Consultation on the UK Misuse of Drugs Regulations

29th August 2011

The Home Office has issued a consultation document seeking views to consolidate and review specific provisions regarding controlled drugs under the Misuse of Drugs Regulations 2001. The suggested amendments are: 

  • exempt designated bodies – hospices – and prisons from the requisition requirements under regulation 14
  • include paramedics and operating department practitioners in the list of professions required to present a requisition in order to obtain controlled drugs under regulation 14(4)
  • provide registered midwife ward managers with similar authorities to those currently applicable to senior registered nurses in charge of a ward
  • make it mandatory for veterinary practitioners to include their Royal College of Veterinary Surgeon number on prescriptions for schedules 2 and 3 controlled drugs except temazepam
  • remove the reference to the National Health Service (Scotland) Act 1978 from regulation 14(5)(b)
  • clarify that regulation 15(3) – which enables a prescription for schedules 2 and 3 controlled drugs for the treatment of a patient in a hospital or care home to be written on the patient’s bed card – is not applicable to prisons
  • extend the authorities currently applicable to senior registered nurses in charge of wards to senior registered nurses in charge of prison health centres.
  • include prisons in the 2001 Regulations
  • make midwife supply orders specific to a patient
  • provide authority to enable ambulance trusts to possess and supply controlled drugs
  • enable pharmacists to supply phenobarbital or phenobarbital sodium for the emergency treatment of epilepsy.

In addition:

  • it is not proposed to introduce a legislative amendment making the use of a standardised requisition form by individual healthcare professionals mandatory at this time
  • it is proposed not to make running balances for controlled drug registers a mandatory requirement at this time but to review the position in the light of further information.

The proposed changes to the Misuse of Drugs Regulations 2001 would have effect in England, Wales and Scotland. Northern Ireland has its own misuse of drugs regulations.

The closing date for responses is 28th October 2011. Full details of the proposals and information about responding are available from the link below.

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FDA restrict citalopram maximum daily dose to 40mg

25th August 2011

The FDA has stated that the maximum daily dose of citalopram should be restricted to 40mg. This follows post-marketing reports of prolonged QT interval and an FDA evaluation of a QT study. The study showed dose-dependent QT interval prolongation with citalopram.

Patients with underlying heart conditions and those who are predisposed to low serum levels of potassium and magnesium are also at particular risk of QT interval prolongation. The FDA adds that studies have not shown a benefit in the treatment of depression at doses higher than 40mg per day, although the US drug label had stated that certain patients may require a dose of 60mg per day. In the UK the maximum daily dose is 60mg.

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FDA approves botulinum toxin A for urinary incontinence

25th August 2011

The FDA has approved botulinum toxin A injection (Botox) to treat urinary incontinence in people with neurological conditions such as spinal cord injury and multiple sclerosis who have an overactive bladder.

Botox is currently not approved for this indication in the UK.

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CQC annual report on safer management of controlled drugs

25th August 2011

The UK Care Quality Commission (CQC) has published its latest annual report into the safer management of controlled drugs, which includes recommendations on how chief executives and accountable officers could better aid the safer management of controlled drugs.

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NICE scope for opioids in palliative care published

25th August 2011

The UK National Institute for health and Clinical Excellence (NICE) has published the scope for the guideline it is to develop on the safe and effective prescribing of strong opioids for pain in palliative care of adults. The consultation process is due in early 2012, with guidance publication due May 2012.

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Guidance for pharmacists - safe custody of controlled drugs

22nd August 2011

The UK Royal Pharmaceutical Society has produced guidance on the safe custody of controlled drugs (CDs) aimed at pharmacists working in registered pharmacy premises. It explains which CDs require safe custody, exemptions when CDs do not require safe custody, structural requirements of safes, cabinets and rooms used for storing CDs, and guidance on key responsibilities, including a key log. To access the guidance click the link below. (RPS membership required).

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Nystatin oral suspension - anticipated stock shortage

18th August 2011

Bristol-Myers Squibb has advised on an anticipated shortage of Nystan Oral Suspension 100,000 units/mL (nystatin) in the UK. It is likely that supply will be limited and intermittent from July 2011 until December 2011. The issue is related to the supply of pipettes used to administer the product.

Generic equivalents are available. Please see link below for further information.

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DTB reviews prucalopride in constipation

10th August 2011

The August 2011 issue of the Drug and Therapeutics Bulletin (DTB), reviews the evidence for prucalopride (Resolor, Shire pharmaceuticals) and considers its place in the treatment of chronic constipation.

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FDA approve a tamper-resistant oxycodone formulation

1st August 2011

A novel formulation of oxycodone immediate-release tablets (Oxecta, Pfizer and Acura Pharmaceuticals) using a drug delivery system designed to reduce the incidence of abuse and tampering, has been approved by the FDA. The new technology discourages abuse by causing the active ingredient to gel or to irritate nasal passages, thereby hindering injection or inhalation.

Due to the nature of the new technology, the tablets cannot be crushed, chewed or dissolved and must not be administered by enteral feeding tubes as they will cause obstruction.

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Guidance on the transfer of information about medicines

27th July 2011

The Royal Pharmaceutical Society has produced new best practice guidance on keeping patients safe when they transfer between care providers – getting the medicines right.

The guidance, endorsed by the Academy of Medical Royal Colleges, the Royal College of GPs, the Royal College of Nursing and the Royal College of Physicians, contains:

  • good practice principles for all healthcare professionals involved in the sending and receiving of information about medicines
  • recommended core information about medicines that should move with the patient in order to ensure safe transfer
  • suggestions for provider and commissioner organisations to help with the implementation of the good practice principles.

The guidance for both health care professionals and organisations can be downloaded from the links below. More information about the campaign is available on the Royal Pharmaceutical Society website http://www.rpharms.com/medicines-safety/getting-the-medicines-right.asp

Professional guidance
Organisational guidance

Thalidomide increases risk of arterial thrombosis

27th July 2011

The MHRA have highlighted the following in their July Drug Safety Update:

Patients treated with thalidomide have an increased risk of arterial thromboembolism, including myocardial infarction and cerebrovascular events, in addition to the established risk of venous thromboembolism. Healthcare professionals should consider venous and arterial thrombotic risk and administer antithrombotic prophylaxis for at least the first five months in patients commencing thalidomide.

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Paracetamol - new dosing guidelines for children

27th July 2011

New dosage instructions for paediatric oral liquid paracetamol will be on products entering the UK market by the end of 2011. The dosing for children has been revised and is based on narrower age bands with a single dosing option per band to ensure that children receive the optimum and safe dose for their age.

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Reports on addiction to prescribed and over-the-counter medicines published

27th July 2011

The MHRA July Drug Safety Update has highlighted the publication of two reports commissioned by the Department of Health on addiction to prescribed and over-the-counter medicine. They feature benzodiazepines and codeine containing medicines.  

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Risk of accidental overdose with IV paracetamol

27th July 2011

Letters have been sent out by the MHRA to healthcare professionals highlighting the risk of accidental overdose with confusion over the strength of paracetamol 10mg/mL intravenous infusion, particularly in children. There have been several fatalities worldwide where 10 times the dose has been given in error. Special care and attention should be given to prescribing and administering the dose. In addition the 100mL infusion bags (containing 1g paracetamol) should only be used in patients weighing >33kg.

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NICE End of Life consultation

7th July 2011

The draft National Institute for Health and Clinical Excellence (NICE) quality standard for end of life care is now available for consultation. The draft quality standard contains 20 statements for the care of adults (18 years and older) with advanced, progressive, or life-limiting conditions who are approaching the end of their life, and for adults who die suddenly or after a very brief illness, in settings where care is provided by health and social care staff. It also covers support for the families and carers of people in these groups.

The consultation period will end at 5pm on 22nd July 2011.

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Glycopyrronium oral suspension stability study

7th July 2011

A stability study for extemporaneously prepared glycopyrronium oral suspension 0.5mg/mL in a 1:1 mixture of Ora-Plus/Ora-Sweet or Ora-Plus/Ora-Sweet SF, for 90days at room temperature, has been published. 

Cober M et al. (2011) Stability of extemporaneously prepared glycopyrrolate oral suspensions. American Journal of Health-System Pharmacy. 68: 843-845.

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Tapentadol launched in the UK

7th July 2011

Tapentadol (Palexia, Grunenthal, 0870 3518960) has been launched in the UK for the treatment of adults with severe chronic pain, which can only be adequately managed with opioid analgesics. Tapentadol is a Schedule 2 controlled drug with two mechanisms of action, μ-opioid receptor agonism and noradrenaline reuptake inhibition (MOR-NRI).

It is available as 50mg and 75mg immediate-release tablets, costing £24.91 and £37.37 respectively for a box of 56 tablets, and 50mg, 100mg, 150mg, 200mg, 250mg modified-release tablets (Palexia SR) costing £24.91, £49.82, £74.73, £99.64 and £124.55 respectively for a box of 56 tablets.

 

For more information see the SPC below.

 

Following a resubmission, the Scottish Medicines Consortium (SMC) has accepted tapentadol modified-release (Palexia SR) for restricted use within NHS Scotland for the management of severe chronic pain in adults, which can be adequately managed only with opioid analgesics. Its use is restricted to patients in whom morphine sulphate modified-release has failed to provide adequate pain control or is not tolerated. The SMC has not yet received a submission for tapentadol immediate-release tablets and theses are therefore currently not recommended for use in NHS Scotland.

Palexia SPC
Palexia SR SPC
SMC advice

Thalidomide SPC updated

7th July 2011

The SPC for Thalidomide Celgene 50mg hard capsules has been updated as follows:

Section 4.4 includes further information regarding MI and VTE. Additions have also been made to the section regarding patients with renal and hepatic impairment.

Section 4.5 states that non-enzymatic hydrolysis suggests the potential for drug-drug interactions with thalidomide is low.

Section 4.8 includes hypersensitiviy, hearing impairment or deafness, renal failure, myocardial infarction and worsening of Parkinson's disease symptoms and pancytopenia to adverse reactions experienced in post marketing surveillance.

See below for link to SPC.

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Clonidine 300microgram tablets to be discontinued

21st June 2011

Clonidine 300microgram tablets (Catapres, Boehringer Ingelheim 01344 742579) are to be discontinued in October 2011 in the UK. The 100microgram tablets (Catapres, Boehringer Ingelheim) and the 25microgram tablets (Dixarit, Boehringer Ingelheim) will remain available.

Bisphosphonates and atypical femoral fractures

14th June 2011

The European Medicines Agency (EMEA) Committee for Medicinal Products for Human use (CHMP) has concluded that rare atypical femoral fractures are a class effect of bisphosphonates.

Atypical femoral fractures have been reported rarely and mainly in patients receiving long-term treatment for osteoporosis. The overall benefits of bisphosphonates in their licensed indications continues to outweigh their risks. Patients on bisphosphonates should be advised to report any hip, thigh or groin pain.

For further information on the key findings of the EMEA review and guidance to healthcare professionals, see the links below.

MHRA Drug Safety Update June 2011
EMEA press release

Risk assessment tool to support NPSA RRR on loading doses

14th June 2011

Following the NPSA Rapid Response Report (RRR) on loading doses (see our news item 11-01-2011), the UK Medicines Information network (UKMi) has produced a tool to support organisations implement the risk assessment and prevent duplication of effort. The tool identifies the majority of medicines in routine clinical practice for which a loading dose is given, rates the severity of the consequence if that medicine was omitted or continued inadvertently, and provides a framework for assessment and response. The deadline for implementation of the RRR is 25-11-2011.

click here to view

PCF Update: antipsychotics monograph

14th June 2011

The antipsychotics monograph has been fully updated and has been published in the Journal of Pain and Symptom Management (JPSM) as a therapeutic review. This version supersedes the PCF3 (first print, 2007) and the website version (dated June, 2008).

 

Howard P et al (2011) Therapeutic Reviews: Antipsychotics. Journal of Pain and Symptom Management. 41: 956-965.

 

This is the 5th therapeutic review in a series in the JPSM. Previous updated monographs include octreotide (July 2010), propofol (September 2010), psychostimulants (November 2010) and thalidomide (February 2011). The updated octreotide monograph was the top article downloaded from the JPSM website in 2010.

Look out for more updated monographs in the therapeutic reviews section in the coming months e.g. ketamine.

click here to view

BMJ Group launches new international supportive and palliative care journal

9th June 2011

The British Medical Journal (BMJ) group has sent us the following press release:

 

Launched by BMJ Group in April 2011, BMJ Supportive & Palliative Care aims to promote a global exchange of research-based evidence and innovative practice across many disciplines and specialties.

The journal will publish articles that are relevant to clinical practice and clinical service development; including transitional research, clinical trials, epidemiology, behavioural sciences, health service research, ethics, reviews, and comment. Content is published continuously online (quarterly in print) and there is a regularly updated blog including content from palliativedrugs.com as well as news, research highlights from other journals and events.

We welcome submissions from all areas of supportive and palliative care and can offer rapid peer review and immediate online publication of accepted articles. Your work will receive wide international exposure as the website will be free in 2011 to subscribers to any BMJ Journal including the BMJ itself. You can find author guidance online. You should also sign up for our content alerts so you don’t miss anything.

 

The Association for Palliative Medicine of Great Britain and Northern Ireland and the Australia & New Zealand Society of Palliative Medicine have officially adopted the title.

If you have any questions feel free to contact us info.spcare@bmjgroup.com.

 

Risks of opioid prescribing, analysis of US practice and harm

9th June 2011

A recent issue of the Journal of American Medical Association (JAMA, issue 305) has featured several articles on opioid prescribing in the US and makes recommendations aimed at reducing fatal overdoses and diversion for illicit use:

 

  • Bohnert A et al. Association between opioid prescribing patterns and opioid overdose related deaths
  • Volkow N et al. Characteristics of opioid prescriptions in 2009
  • Volkow N et al. Curtailing diversion and abuse of opioid analgesics without jeopardising pain treatment

click here to view

Lenalidomide investigation of risk of second primary malignancies in myeloma

31st May 2011

Data from three large controlled clinical trials investigating use of lenalidomide in patients with newly diagnosed multiple myeloma have recently shown a signal of an apparent excess of second primary malignancies. On the basis of this observation, a review of the balance of benefits and risks of lenalidomide in its authorised indication is being undertaken in the EU. The UK MHRA have stated that the use of lenalidomide in newly diagnosed multiple myeloma or other unlicensed indications is not recommended and that healthcare professionals should be vigilant for the occurrence of second primary malignancies, and should report such events promptly. For further information see the May 2011 edition of the MHRA Drug Safety Update.

click here to view

Oxycodone m/r 15mg, 30mg, 60mg and 120mg launched

26th May 2011

New strengths of oxycodone m/r (Oxycontin, Napp Pharmaceuticals 01223 424444) have been launched for the treatment of moderate to severe pain in patients with cancer or post operative pain and severe pain requiring the use of a strong opioid. The cost of a box of 56 tablets is £37.41, £74.81, £149.66, £299.31 for the 15mg, 30mg, 60mg and 120mg respectively. This is in line with the cost of the other preparations already available.

click here to view

BTS/SIGN asthma guideline 2011 revision

26th May 2011

The 2011 revision of the British Thoracic Society (BTS) and Scottish Intercollegiate Guidelines Network (SIGN) management of asthma guideline is now available. There are updates to monitoring patients with asthma (section 2.6) and its pharmacological management (section 4), and a new section on asthma in adolescents (section 7).

The full guideline, a quick reference guide and further information can be downloaded from the BTS or SIGN website.

BTS website
SIGN website

Cochrane review: interventions for improving palliative care for older people living in nursing care homes

26th May 2011

A Cochrane review has been published where the primary objective was to determine effectiveness of multi-component palliative care service delivery interventions for residents of care homes for older people. The secondary objective was to describe the range and quality of outcome measures.

click here to view

Guidance for staff responsible for care after death

26th May 2011

The NHS National End of Life Care Programme has published guidance for staff responsible for care after death.

click here to view

Guidance for withdrawing treatment in children's palliative care

26th May 2011

The UK children’s palliative care charity, ACT, has launched two new resources:

  • a care pathway to support extubation within a children’s palliative care framework
  • a parent’s guide – making critical care choices for your child.

click here to view

NPC handbook for controlled drugs for accountable officers

26th May 2011

The National Prescribing Centre (NPC) has produced a handbook for controlled drugs for accountable officers in England, intended to supplement the guidance from the Department of Health.

click here to view

Guide to needs based palliative care commissioning for children, young people and their families

10th May 2011

This guide was commissioned by the South West Development Centre. It has been developed jointly with the Association for Children's Palliative Care (ACT), in consultation with a number of parents and professionals across the country. It is designed to assist commissioners in identifying the types of services they should consider when commissioning provision for children and young people with life-limiting and/or life-threatening conditions.

 

click here to view

WHO policy guidelines for controlled substances

10th May 2011

The World Health Organisation (WHO) Access to Controlled Medicines Team has now published "Ensuring Balance in National Policies on Controlled Substances: Guidance for availability and accessibility for controlled medicines."

click here to view

Recall of McKinley T34 extension sets

28th April 2011

The MHRA have issued a recall of all T34 syringe pump extension sets manufactured by CME (McKinley Medical UK). before 1 January 2011. This is due to the potential for leakage at the female luer syringe connector.

 

The product codes affected are: 100-172S, 100-170S, 100-172SLL, 100-172SB, 100-172SC.

 

Returns and replacement stock can be obtained by contacting Paul Fletcher (McKinley Medical UK, 01253 894646, email: pfletcher@cme-mckinley.co.uk). The manufacturer states that other syringe sets can be used in the interim (ensuring local guidelines and practice are adhered to),

click here to view

FDA announces REMS for m/r opioids

27th April 2011

The US Food and Drug Administration (FDA) has published its Risk Evaluation and Mitigation Strategy (REMS) for all modified-release opioid drugs which focuses on reducing the misprescribing, misuse, and abuse of opioids. The REMS requires manufacturers to develop an educational program for prescribers and patients. For more information see the FDA Question and Answer document below.

click here to view

NPSA - Safer spinal (intrathecal), epidural and regional devices

1st March 2011

The UK National Patient Safety Agency (NPSA) has issued a two-part patient safety alert update which supersedes NPSA/2009/PSA004A issued in November 2009 (see our news item 25-11-2009).

Part A of the alert extends the original implementation date from 1st April 2011 to the 1st April 2012, to allow organisations time to review and evaluate the range of new devices available and introduce them into clinical practice. Part B of the alert remains unchanged.

In summary:

Part A requires that by 1st April 2012 all spinal (intrathecal) bolus doses and lumbar puncture samples are performed using syringes, needles and other devices with connectors that cannot also connect with intravenous equipment.

Part B requires that by 1st April 2013 all epidural, spinal (intrathecal) and regional anaesthesia infusions and bolus doses should be performed with devices with connectors that will not also connect with intravenous equipment.

For more information see the link below.

click here to view

Lenalidomide MHRA safety warning and SPC updated

15th February 2011

Lenalidomide (Revlimid, Celgene) is authorised in combination with dexamethasone for treatment of multiple myeloma in patients who have received at least one previous treatment. Section 4.2 of the UK SPC for lenalidomide has been updated to include the sentence "Prescribing physicians should carefully evaluate which dose of dexamethasone to use, taking into account the condition and disease status of the patient."

Evidence from clinical trials and case reports suggest that lenalidomide may further increase the elevated risk of both venous and arterial thromboembolic reactions, including myocardial infarction and cerebrovascular accident, in patients with myeloma. Additional information has been added to section 4.4 under cardiovascular disorders, regarding this and section 4.8 has been amended to include adverse reactions from post marketing data.

For more details see the MHRA drug safety update and the SPC from the links below.

Revlimid SPC
MHRA drug safety update

NPSA publishes risk assessment guide for venous thromboembolism

15th February 2011

The UK National Patient Safety Agency (NPSA) has published a ‘How to’ guide to support NHS organisations in the implementation of venous thromboembolism risk assessment for all patients admitted to hospital. It builds on existing resources already available on this topic and can be used to support the implementation of NICE Quality Standards Programme, CQUIN requirements and NICE Guideline 92.

NPSA How to guide
NICE clinical guideline CG92

Update: thalidomide monograph

9th February 2011

The thalidomide monograph has been fully updated and has been published in the Journal of Pain and Symptom Management (JPSM) as a therapeutic review. This version supersedes the PCF3 (first print, 2007) and the website version (dated June, 2008).

Prommer E et al (2011) Therapeutic Reviews: Thalidomide. Journal of Pain and Symptom Management. 41: 140-145.

This is the 4th therapeutic review in a series in the JPSM. Previous updated monographs include octreotide (July 2010), propofol (September 2010) and psychostimulants (November 2010). The updated octreotide monograph was the top article downloaded from the JPSM website in 2010.

Look out for more updated monographs in the therapeutic reviews section in the coming months e.g. ketamine.

click here to view

Chronic heart failure: draft quality standard for consultation

28th January 2011

The UK National Institute for Health and Clinical Excellence (NICE) draft quality standard for chronic heart failure is now available for consultation. The document can be downloaded from the link below, further details on how to submit comments can be obtained from the website link. The closing date for comments is February 16th 2011.

Chronic heart failure, draft quality standard
NICE website

Cardiovascular safety of NSAIDs: network meta-analysis

28th January 2011

The British Medical Journal has published a network meta-analysis of the available evidence for the cardiovascular safety of non-steroidal anti-inflammatory drugs.

Trelle S et al. (2011) Cardiovascular safety of non-steroidal anti-inflammatory drugs: network meta-analysis. British Medical Journal 342:7086.

BMJ article (full text, open access)

FDA limits the amount of acetaminophen (paracetamol) to 325mg per dosage unit for prescription products

18th January 2011

The US Food and Drug Admnistration (FDA) has asked manufacturers to reformulate prescription products containing acetaminophen (paracetamol) so that a single dosage unit contains a maximum of 325mg acetaminophen. This includes combination products of acetaminophen and opioids.

Additional boxed warnings highlighting the potential for sever liver injury and allergic reactions are also to be added to the product packaging.

Dosage recommendations will not be changed as a result of the lower amount of acetaminophen. The maximum daily dose of 4g/day is to remain in place.

click here to view

DH templates to monitor expenditure on end of life and specialist palliative care

18th January 2011

The UK Department of Health (DH) has issued templates to Strategic Health Authorities and PCT Directors of Finance to monitor how the additional money provided to help implement the End of Life Care Strategy has been invested in 2010/11, and expenditure on specialist palliative care in 2010/11.

click here to view

The commission on assisted dying: call for evidence

18th January 2011

The commission on assisted dying was launched in the UK on 30-11-2010 with a speech from the Chair, Lord Falconer. The aim of the commission is to:

 

  • Investigate the circumstances under which it should be possible for people to be assisted to die
  • Recommend what system, if any, should exist to allow people to be assisted to die
  • Identify who should be entitled to be assisted to die
  • Determine what safeguards should be put in place to ensure that vulnerable people are neither abused nor pressured to choose an assisted death
  • Recommend what changes in the law, if any, should be introduced

 

There is a general public call for evidence on the commission on assisted dying website, with structured questions seeking opinions and a space for comments or personal experience. Submissions can be completed on-line or via a specific document that can be downloaded. The commission on assisted dying will run for 12months and will culminate in the publication of an independent report based on the evidence it has collected before the end of 2011.

click here to view

Diclofenac SPC updated

17th January 2011

The drug interaction section of the SPC for all Voltarol preparations (diclofenac, Novartis Pharmaceuticals) has been updated. Two new paragraphs have been inserted as follows:

Potent CYP2C9 inhibitors-caution is recommended when co-prescribing diclofenac with potent CYP2C9 inhibitors (such as sulfinpyrazone and voriconazole), which could result in a significant increase in peak plasma concentrations and exposure to diclofenac due to inhibition of diclofenac metabolism.

Phenytoin-when using phenytoin concomitantly with diclofenac, monitoring of phenytoin plasma concentrations is recommended due to an expected increase in exposure to phenytoin.

For further information, see the SPC which can be downloaded from the link below.

click here to view

Licensed warfarin oral suspension now available in UK

11th January 2011

A licensed warfarin sodium oral suspension 1mg/1mL is now available in the UK (Rosemont Pharmaceuticals, 0113 2441400) costing £55 plus VAT for 150mL.

click here to view

NPSA Rapid Response Report on loading doses

11th January 2011

The UK National Patient Safety Agency (NPSA) has issued a Rapid Response Report on preventing fatalities from medication loading doses, aimed at reducing the risk of incorrect use of loading doses or subsequent maintenance regimens that may lead to severe harm or death.

All organisations in the NHS and in the independent sector should ensure that (taken directly from source):

1. All medicines used by the organisation that are likely to cause harm if loading doses and subsequent maintenance doses are not prescribed and administered correctly are risk assessed and used to produce a list of critical medicines (which may contain speciality subsections). This must include warfarin, amiodarone, digoxin, phenytoin and any other medicines identified locally.

2. There is effective communication regarding loading dose and subsequent maintenance dose regimens when prescribing, dispensing or administering critical medicines. This should include handover of patients between healthcare organisations. Tools such as loading dose work sheets, loading dose prescription charts, handover and clinical protocols, and patient-held information should be considered.

3. Clinical checks are performed by medical, nursing and pharmacy staff (when available) so that loading and maintenance doses are correct. Appropriate information should be available to support these checks.

4. Healthcare professionals in the community know when to challenge abnormal doses of the identified critical medicines.

The deadline for action complete is 25th November 2011.

click here to view

EMEA review of potential for interaction between alcohol and opioid modified-release mechanisms

11th January 2011

The European Medicines Agency has completed a review of the safety and effectiveness of modified-release oral opioid medicines when taken with alcohol. This was undertaken following reports of the risk of alcohol dissolving the modified release coating and releasing the whole dose in one go i.e. ‘dose dumping’.

They found that this risk is minor for the majority of modified release products and have concluded that the benefits of most of these medicines continue to outweigh their risks. However, the SPCs and PILs should be updated and warnings made consistent across the class that the concomitant use of alcohol with opioids may enhance the pharmacodynamic effect and should be avoided.

However, for modified-release medicines that contain a ‘polymethacrylate-triethylcitrate controlled release system’, the committee concluded that the marketing authorisations should be suspended until the companies that make these medicines have reformulated them so that they are more stable in alcohol. Currently the product that appears to be affected is Ethirfin (morphine sulphate, prolonged-release capsules, 20, 60, 120 and 200mg) previously available in Denmark.

click here to view

FDA approves denosumab for prevention of skeletal-related events in patients with metastatic cancer

11th January 2011

The US Food and Drug Administration (FDA) has approved denosumab (Xgeva) for the prevention of skeletal-related events in patients with metastatic cancer. Denosumab is a monoclonal antibody that targets the protein human RANKL involved in cancer-related bone destruction.

Currently in the UK, denosumab is licensed for the treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures and for the treatment of osteoporosis in postmenopausal women at increased risk of fractures.

click here to view

NPC e-learning resources for mixing of medicines

11th January 2011

The UK National Prescribing Centre (NPC) has produced an e-learning resource to support those involved in the mixing of medicines. This follows the Department of Health guidance points and NPC implementation resource that was published in last year (see our news item 2010-06-09). There are two workshops, one for prescribers and one for those mixing medicines, there is also a quiz and podcast.

click here to view

SMAC 4th edition receives a glowing review in JPSM

6th January 2011

A recent review of Symptom Management in Advanced Cancer (SMAC) 4th edition in the Journal of Pain and Symptom Management (JPSM) states that the book is:

"...a great resource for all clinicians..."

"...a well-organized, concise and clinician-orientated text…"

"...a very user-friendly guide, especially for the busy clinician…"

"...a great addition to the libraries of all palliative medicine specialists."

It also positively highlights the additional new chapter on Last days which incorporates information on advance planning, artificial nutrition and hydration, cardiopulmonary resuscitation, withholding and withdrawing life-prolonging treatment, symptom relief, palliative sedation, diagnosing imminent death and dying at home.

The full review can be accessed on-line from the link below (registration required).

Lesage P and Zange A (2010) A clinician’s guide to symptom management: Symptom management in advanced cancer 4th edition. Journal of Pain and Symptom Management. 40:626-627.

The book is published by www.palliativedrugs.com and edited by Robert Twycross, Andrew Wilcock and Claire Stark Toller. It can be purchased directly from the website for £40 and the proceeds are used to help keep www.palliativedrugs.com a free access resource.

 

JPSM review
Purchase SMAC 4th edition

Update: psychostimulants monograph

4th January 2011

The psychostimulants monograph has been fully updated and has been published in the Journal of Pain and Symptom Management (JPSM) as a therapeutic review. This version supersedes the PCF3 (first print, 2007) and the website version (dated June, 2008).

Howard P et al (2010) Therapeutic Reviews: Psychostimulants. Journal of Pain and Symptom Management. 40: 789-795.

This is the 3rd therapeutic review in a series in the JPSM. Previous updated monographs include octreotide (July 2010) and propofol (September 2010). The updated octreotide monograph was the top article downloaded from the JPSM website in 2010.

Look out for more updated monographs in the therapeutic reviews section in the coming months, including thalidomide and ketamine.

click here to view

Itraconazole SPCs updated

4th January 2011

The SPCs for all Sporanox (itraconazole, Janssen-Cilag) formulations have been updated. Several changes have been made to sections 4.3–4.8. Changes of note include:

Section 4.3 – contraindications: addition of atorvastatin. Also, women of child-bearing potential should use contraceptive precautions.

Section 4.4 – special warnings: addition of the following wording

Itraconazole should not be used within 2 weeks after discontinuation of treatment with CYP 3A4 inducing agents (rifampicin, rifabutin, phenobarbital, phenytoin, carbamazepine, Hypericum perforatum (St. John's wort)). The use of itraconazole with these drugs may lead to subtherapeutic plasma levels of itraconazole and thus treatment failure.

The current SPCs for the oral preparations can be accessed from the links below. A history of the changes can also be obtained.

SPC Sporonox 10mg/mL oral solution
SPC Sporonox 100mg capsules

Lorazepam 4mg/mL injection UK national shortage

28th December 2010

There is a national shortage of lorazepam injection 4mg/mL (Ativan, Pfizer) in the UK. This is due to an unexpected manufacturing issue, and is not expected to be resolved until late in 2011.

Full details of the manufacturing problem and phone numbers for supply queries and medical queries can be obtained from the letter sent to the Department of Health from Pfizer, which can be downloaded from the link below.

click here to view

NPSA Rapid Response Report on syringe drivers

22nd December 2010

The UK National Patient Safety Agency (NPSA) has issued a Rapid Response Report (RRR) on the safer use of ambulatory syringe drivers. The report warns of the risk of errors using older types of ambulatory syringe drivers that have rate settings in millimetres (mm) of syringe plunger travel rather than in millilitres (mL) and other issues that have led to eight deaths (four in 2009) and 167 non-fatal error reports between 2005 and 2010.

 

The NPSA recommend a coordinated approach and timescale to change over to ambulatory syringe drivers with additional safety features to minimise the additional risks of introducing the safer equipment. All organisations in the NHS and independent sector should (taken directly from source):

1. Develop a purchasing for safety initiative that considers the following safety features before ambulatory syringe drivers are purchased:
a) rate settings in millilitres (mL) per hour;
b) mechanisms to stop infusion if the syringe is not properly and securely fitted;
c) alarms that activate if the syringe is removed before the infusion is stopped;
d) lock-box covers and/or lock out controlled by password;
e) provision of internal log memory to record all pump events.

2. Agree an end date to complete the transition between existing ambulatory syringe drivers and ambulatory syringe drivers with additional safety features (as soon as locally feasible, and within five years of this RRR).

3. Take steps to reduce the risks of rate errors while older designs of ambulatory syringe drivers remain in use, based on a locally developed risk reduction plan which may include: raising awareness, providing information to support users with rate setting, and using lock-boxes.

4. Take steps to reduce the risks during any transition period when both types of design are in use, including:
a) reviewing and updating policies and protocols to include the safe operation of all designs of ambulatory syringe driver in local use;
b) revising user training programmes to include the safe operation of all designs of ambulatory syringe driver in local use.

The deadline for the above actions to be completed is 16 December 2011. The RRR and further information can be downloaded from the links below.

Rapid Response Report RRR019
RRR019 supporting information
NPSA website

MHRA batch recall: Gabapentin 300mg capsules (Teva)

22nd December 2010

Teva UK Ltd are recalling all remaining stock of the following batches of gabapentin 300mg capsules due to the discovery of a small number of capsules with low fill weights. The affected batches are: 003784, 003795, 003796, 003798, (pack size 100, first distributed in August 2010, expiry June 2012). All remaining stock should be quarantined and returned to the supplier for credit. For enquiries relating to stock returns call Teva UK Ltd (0800 590502). For further information see the MHRA recall notice which can be downloaded from below.

click here to view

Annual evidence update on complementary and alternative medicine for lower back pain

16th December 2010

The UK NHS Evidence complementary and alternative medicine website (formerly a specialist section of National Library for Health) has produced the 4th annual update of the evidence on complementary and alternative medicine for lower back pain.

click here to view

Annual evidence update on chronic lung disease

16th December 2010

The UK NHS Evidence supportive and palliative care section (formerly National Library for Health) has produced an annual update of the evidence in chronic lung disease focusing on the treatment of cough and dyspnoea.

click here to view

Clarifying dexamethasone prescribing

1st December 2010

The new BNF (60) now recommends prescribing of dexamethasone injection as dexamethasone base. This follows recent changes to the labelling of both UK dexamethasone injection products (Organon product, 2003 and Hospira product June 2010) in line with guidance from the UK MHRA and NPSA.

In order to clarify the label changes and highlight the potential for confusion when swapping between products, we have put together a palliativedrugs.com fact sheet which can be downloaded from the link below.

click here to view

Propoxyphene to be withdrawn from US market

23rd November 2010

The US Food and Drug Administration (FDA) has requested that companies voluntarily withdraw propoxyphene products from the US market. They have recommended that healthcare professionals in the US stop prescribing and dispensing medicines containing propoxyphene, on the basis of a review of evidence suggesting that it has significant cardiac toxicity, even at therapeutic doses.

The European Medicines Agency (EMA) recommended that the marketing authorisations for dextropropoxyphene be withdrawn across the European Union in June 2009.

click here to view

DH care planning information sheets

22nd November 2010

The UK Department of Health (DH) has published a series of information sheets for health care professionals supporting individuals with long term conditions. The information sheets cover a range of topics including care planning, care co-ordination, managing need and assessment of risk, motivating people to self care, goal setting and action planning and end of life care.

click here to view

Annual evidence update on end of life care

22nd November 2010

The UK NHS Evidence health information resources website (formerly a specialist section of National Library for Health) has produced the first annual update of the evidence on end of life care.

click here to view

Annual evidence update on head and neck cancer

9th November 2010

The UK NHS Evidence health information resources website (formerly a specialist section of National Library for Health) has produced the first annual update of the evidence in head and neck cancer.

click here to view

FDA approves duloxetine for chronic pain

9th November 2010

The US Food and Drug Administration (FDA) has approved duloxetine to treat chronic musculoskeletal pain, including discomfort from osteoarthritis and chronic lower back pain.

click here to view

Oramorph SPC updated

8th November 2010

The UK SPC for Oramorph oral solution 10mg/5mL (morphine sulphate, Boehringer Ingelheim 01344 424600) has been updated to include a specific section for paediatric patients and new information for children aged 13-18years old.

Specific information has also been added on excipients methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) and the amount of ethanol (alcohol) The SPC now states that Oramorph oral solution contains 10vol% ethanol (alcohol). Each dose contains up to 0.81g of alcohol which is equivalent to 20mL beer or 8.3mL wine. The latest SPC can be accessed from the link below.

click here to view

Actiq SPC updated

5th November 2010

Section 4.2 of the SPC for Actiq (Oromucosal fentanyl lozenge , Flynn Pharma 01462 458 974) has been amended to include additional information on measures to prevent a potential overdose and to further clarify the dosage during titration, maintenance therapy and dose readjustment.

Actiq SPC

OTC codeine cough liquid preparations should not be used in children

3rd November 2010

The UK Medicines and Healthcare products Regulatory Agency (MHRA) have advised that cough liquid preparations containing codeine should not be available for over the counter purchase (OTC) for use in children and young people under 18years. This follows an evaluation of the benefits and risks of OTC oral codeine liquids for the treatment of cough in children. Further information is contained in the MHRA October 2010 Drug Safety Update which can be accessed from the link below.

click here to view

NPSA multiple Signal notifications

2nd November 2010

The UK National Patient Safety Association (NPSA) has issued several Signals. Signals are notifications of key risks emerging from reviews of serious incidents reported to the National Reporting and Learning System (NRLS). Signals issued in October include:

Delay in diagnosis and treatment of spinal cord compression

Accurate patient weight

Wrong site nerve block

Haemorrhage following removal of femoral catheters

Non-invasive ventilation

Risk of harm to bariatric patients from delays in treatment

Anticoaguated patients and head injury

Overdose of IV paracetamol in infants and children.

The full details of these notifications can be found on the NPSA Signal website link below.

click here to view

Generic ibandronic acid

2nd November 2010

The European Medicines Agency (EMA) has recently granted a marketing authorization for generic ibandronic acid (Ibandronic acid Teva) for the prevention of skeletal events in patients with breast cancer and bone metastases (50mg tablets) and for the treatment of osteoporosis in post-menopausal women at risk of developing fractures (150mg tablets).

The Committee for Medicinal Products for Human Use (CHMP) of the EMA has also adopted a positive opinion recommending the granting of a marketing authorization for generic ibandronic acid (Iasibon) for the prevention of skeletal events in patients with breast cancer and bone metastases (tablets and infusion), and for the treatment of tumour-induced hypercalcaemia with or without metastases (infusion).

EMA authorisation Ibandronic acid Teva
CHMP opinion on Iasibon

GlucaGen 1mg Hypokit drug alert

1st November 2010

A class 4 medicines defect drug alert has been issued by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for GlucaGen 1mg Hypokit (glucagon 1mg powder and solvent for injection, Novo Nordisk A/S).

It has been found that in an extremely small number of cases, the glass of the powder vial is cracked close to the base so that when the solvent is added, the vial leaks.

Recipients of the affected batches (YW60411 and YW60452, expiry 31/12/2012, first distributed 01/09/2010 and 07/09/2010 respectively) are asked to check their stock for signs of this defect, which is very obvious, and to discard any affected vials. Patients who may have received these batches should also be contacted. Replacement stock from alternative batches is available. For further details see the MHRA website link below.

click here to view

King's Fund publication on End of Life Care Strategy

1st November 2010

The King's Fund has published "Implementing the End of Life Care Strategy: Lessons from good practice". It is available as a download from the website link below.

click here to view

Rosiglitazone no longer available in UK

19th October 2010

Further to our news item on the 7th October on the suspension of the licence for rosiglitazone, the two preparations containing rosiglitazone (Avandia and Avandamet, GSK) will no longer be available after the 21st October. GSK is now in the process of recalling stocks. For further information see the GSK website link below.

click here to view

Annual evidence update on GI symptoms

10th October 2010

The UK NHS Evidence supportive and palliative care section (formerly National Library for Health) has produced its third annual update on the evidence for treating gastrointestinal symptoms, specifically anorexia and cachexia.

click here to view

Update: propofol monograph

8th October 2010

The propofol monograph has been fully updated and has been published in the Journal of Pain and Symptom Management as a therapeutic review. This version supersedes the PCF3 (first print, 2007) and the website version (dated June, 2008).

Wilcock A and Twycross R (2010) Therapeutic Reviews: Propofol. Journal of Pain and Symptom Management. 40: 466—470.

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Booklet of copmpatibility charts now available

8th October 2010

We are pleased to announce that a ring bound booklet containing all the palliativedrugs.com compatibility charts is now available!

All 14 charts from the website plus some additional compatibility data for oxycodone 50mg/mL have been reproduced in a ring bound booklet on waterproof specialist paper and are a handy size for the clinic room or to put in a syringe driver out of hours box. Napp Pharmaceuticals Ltd UK have sponsored the production of these and they are available free of charge from your local Napp representative (01223 424444).

We hope you find them useful, we would be grateful for any feedback on improvements or suggestions to hq@palliativedrugs.com. The on line version of the charts can be found from the link below.

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Rosiglitazone licence suspended

7th October 2010

Rosiglitazone will cease to be available for patients in the UK and Europe within the next few months. This follows the conclusions of the Europe-wide review saying that the scientific evidence shows that rosiglitazone is associated with an increased risk of cardiovascular disorders and that the benefits of treatment no longer outweigh the risks. The products affected are Avandia (rosiglitazone) and Avandamet (rosiglitazone and metformin combination). Patients should have their treatment reviewed at the earliest opportunity and should be swapped to an alternative preparation if appropriate. Further information including a letter and advice for healthcare professionals, question and answer document for patients and updated NICE guidance is available from the MHRA website link below.

 

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World Hospice and Palliative Care Day - 9 October 2010

5th October 2010

The theme for 2010 is 'Sharing the care', highlighting how good working partnerships between service providers, governments, hospitals, people living with the illness, carers and community members are vital to the provision of quality care.

World day website

End of Life Care strategy annual report

2nd September 2010

The Uk Department of Health (DH) has published the second annual report of the End of Life Care strategy.

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Safer management of controlled drugs annual report

26th August 2010

The Care Quality Commission has published the 2009 annual report of the safer management of controlled drugs.

 

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Risk of photosensitivity reactions with topical keptoprofen

10th August 2010

Letters have been sent to healthcare professionals from the manufacturers of topical ketoprofen preparations (Oruvail gel, Sanofi-Aventis and Powergel, Menarini) summarising the results of the European Medicines Agency (EMA) review. The Committee for Medicinal Products for Human Use (CHMP) concluded that photosensitivity reactions of topical ketoprofen containing medicines are important undesirable effects but that the benefit/risk profile remains favourable. Several recommendations for safer use are listed including; not exposing treated areas to sunlight during treatment (even if cloudy) and for two weeks afterwards, not using topical ketoprofen under occlusive bandaging and washing hands thoroughly. These medicines should be available only under prescription. For more information see below.

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Update: octreotide monograph

3rd August 2010

The octreotide monograph has been fully updated and has been published in the Journal of Pain and Symptom Management as a therapeutic review (subscription required). This version supersedes the PCF3 (first print, 2007) and the website version (dated June, 2008).

Wilcock A and Twycross R (2010) Therapeutic Reviews: Octreotide. Journal of Pain and Symptom Management 40: 142—148.

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NICE statement on neuropathic pain guidelines

22nd July 2010

The UK National Institute for Health and Clinical Excellence (NICE) has posted a statement on it's website with reference to the concerns on the recommendation of the use of pregabalin (taken directly from source):
"NICE is aware that there have been concerns about the associated costs that pregabalin may bring to the NHS as one of the first line treatment options for adults with neuropathic pain. NICE, in collaboration with the Health Technology Assessment group are reviewing the economic modeling. Until a further announcement is made, the guideline continues to represent best practice for the NHS."

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MHRA and FDA warnings against quinine for leg cramps

15th July 2010

The June issue of the MHRA drug safety update reminds health professionals about the risks of serious undesirable effects with the use of quinine. It states that quinine should not be a routine treatment for nocturnal leg cramps. It should only be considered when cramps cause regular disruption of sleep, when cramps are very painful or frequent, when other treatable causes of cramp have been ruled out and when non-pharmacological measures have not worked (e.g. passive stretching exercises). After an initial trial of 4 weeks, treatment should be stopped if there is no benefit.
In the US, the FDA has approved a risk management plan (REMS) to warn against the off-label use of quinine sulphate (Qualaquin) for night time leg cramps following continued reports of serious side effects. The FDA states that quinine should not be used for night time leg cramps and requires that patients be given a medication guide explaining what the drug is and is not approved for, as well as the potential side effects. In addition, the REMS requires that the manufacturer issue a Dear Health Care Provider letter warning of the risk of serious and life-threatening haematological reactions.
Further advice and information can be obtained from the links below.

MHRA Drug Safety update June
FDA alert for quinine

NPSA updated guidance for medical safety incidents

15th July 2010

The UK National Patient Safety Agency (NPSA) has issued updated guidance on the steps junior doctors should follow in the event of a medical safety incident. This supersedes the version first published in 2005.

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NPSA rapid response report on insulin safety

8th July 2010

The UK National Patient Safety Agency (NPSA) has issued a rapid response report aimed at reducing the number of wrong dose incidents involving insulin.
All organisations in the NHS and independent sector should ensure that (taken directly from source):
• All regular and single insulin (bolus) doses are measured and administered using an insulin syringe or commercial insulin pen device Intravenous syringes must never be used for insulin administration.
• The term 'units' is used in all contexts. Abbreviations, such as 'U' or 'IU', are never used.
• All clinical areas and community staff treating patients with insulin have adequate supplies of insulin syringes and subcutaneous needles, which staff can obtain at all times.
• An insulin syringe must always be used to measure and prepare insulin for an intravenous infusion. Insulin infusions are administered in 50mL intravenous syringes or larger infusion bags. Consideration should be given to the supply and use of ready to administer infusion products e.g. prefilled syringes of fast acting insulin 50units in 50mL sodium chloride 0.9%.
• A training programme should be put in place for all healthcare staff (including medical staff) expected to prescribe, prepare and administer insulin. An e-learning programme is available from: www.diabetes.nhs.uk/safe_use_of_insulin
• Policies and procedures for the preparation and administration of insulin and insulin infusions in clinical areas are reviewed to ensure compliance with the above.
Insulin safety forms part of the NPSA's 10 for 2010 improvement programme. The deadline for the above actions to be completed is 16 December 2010.

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GMC guidance for end of life care

8th July 2010

New guidance, "Treatment and care towards the end of life: good practice in decision making", from the UK General Medical Council (GMC) came into effect on 1st July 2010 and replaces the booklet "Withholding and withdrawing life-prolonging treatments" (2002) and expands on the guidance in "Consent, patients and doctors making decisions together".

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MHRA drug safety update: zoledronic acid

8th July 2010

The April issue of the MHRA drug safety update reminds health professionals about the use of intravenous zoledronic acid and adverse effects on renal function. Zoledronic acid is associated with reports of renal impairment and renal failure, especially in patients with pre-existing renal dysfunction or other risk factors. Renal function should be measured before each dose, and patients should be adequately hydrated before treatment. Renal function monitoring is recommended after use of zoledronic acid in at-risk patients and those with pre-existing renal impairment. Use in patients with severe renal impairment is generally not recommended, but may be considered for tumour-induced hypercalcaemia, if the benefits outweigh the risks.
For further information see the original article and the PCF monograph for zoledronic acid.

MHRA drug safety update April
PCF zoledronic acid monograph

MHRA alert acetylcysteine injection

30th June 2010

Black particles have been found in a very small number of ampoules of acetlcysteine injection 200mg/mL (Aurum pharmaceuticals, Martindale livery, batch numbers 80455 and 90114).
The particles are carbonised material which forms if droplets of solution are present during sealing of the ampoules. Particles may be suspended in the solution, or may adhere to the inner wall of the ampoule neck.
In order to avoid stock shortages, these batches are not being recalled. The ampoules should be inspected as per normal parenteral practices and any affected ampoules should be discarded.

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DTB questions NICE neuropathic pain guidance for pregabalin

17th June 2010

The editorial in the latest Drug and Therapeutics Bulletin (DTB) questions the recommendation in the recent guideline on neuropathic pain from the UK National Institute for health and Clinical Excellence (NICE) that clinicians should offer oral amitriptyline or pregabalin as first-line treatment (see our news 2010-04-20).

DTB extract (full text requires subscription)
NICE neuropathic pain guidance

FDA approves ketorolac nasal spray

17th June 2010

U.S. Food and Drug Administration (FDA) has approved ketorolac tromethamine nasal spray (Sprix, Roxro Pharma), for the short-term (up to 5days) management of acute moderate to moderately severe pain that requires analgesia at the opioid level.

Sprix PI

Diclofenac gel availability OTC

16th June 2010

The maximum pack size of diclofenac ethylammonium 1.16% gel available over the counter (OTC) in the UK for the local symptomatic relief of pain and inflammation has been increased from 50G to 100G and the maximum treatment period (without medical advice) has been extended from 7days to 14days.

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Annual evidence update on homeopathy

15th June 2010

The UK NHS Evidence complementary and alternative medicine website (formerly a specialist section of National Library for Health) has produced the 2010 annual update of the evidence for homeopathy.

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DH guidance and NPC resource on mixing of medicines

9th June 2010

The UK Department of Health (DH) has published guidance on mixing of medicines prior to administration. This follows the changes in legislation in December 2009 to enable doctors and other prescribers to mix medicines themselves and to direct others to mix (see our news item 2010-01-07). The National Prescribing Centre (NPC) has published supporting guidance to help with practical questions, both documents can be downloaded from the links below.
Legislation changes to the Misuse of Drugs Regulations are still needed for mixing with controlled drugs. However, the guidance states that the original MHRA statement advising that it "would not consider taking enforcement action against those prescribing and administering mixtures of licensed medicines in clinical practice, unless it is in the public interest to do so," includes controlled drugs and that existing good practice arrangements on mixing before administration, which includes a controlled drug, should continue .

DH guidance on mixing of medicines
NPC supporting guidance

MHRA recall: Gabapentin PIL missing text

8th June 2010

All unused stock of a specific batch of Gabapentin 100mg capsules (Ranbaxy, batch number 2037862, pack size 100) are being recalled because the following text is missing from the patient information leaflet (PIL):
'A small number of people being treated with anti-epileptics such as Gabapentin have had thoughts of harming and killing themselves. If at any time you have these thoughts, immediately contact your doctor.'
Subsequent batches have been updated. Further information can be found from the link below and from Ranbaxy (UK) limited (02087425299).

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Instanyl recommendations within NHS Wales

8th June 2010

The All Wales Medicines Strategy Group (AWMSG) has made recommendations for the use of Fentanyl intranasal spray (Instanyl) within NHS Wales.
Fentanyl intranasal spray (Instanyl) is recommended as an option for use within NHS Wales for the management of breakthrough pain in adults already receiving maintenance opioid therapy for chronic cancer pain.
Fentanyl intranasal spray (Instanyl) should only be considered as an option for the management of breakthrough cancer pain when immediate release oral opioids (e.g. morphine, oxycodone) are either inadequate or unsuitable.
Fentanyl intranasal spray (Instanyl) may be suitable for shared care but should be initiated by, and remain under the supervision of a physician experienced in the management of opioid therapy in cancer patients.
Full details can be found in the AWMSG final appraisal report Fentanyl (Instanyl) - April 2010 which can be accessed from the link below.

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MHRA alert - diclofenac injection recall

27th May 2010

Dyloject vials (diclofenac 75mg/2mL) have been recalled in the UK due to possible contamination with small amounts of white particles. The particles are not readily visible and work is ongoing to determine the nature, size and risk posed by this contamination. More information including a full list of batch numbers can be found on the MHRA website (see link below).

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Prucalopride launched in UK for chronic constipation in women

4th May 2010

Prucalopride (Resolor, Movetis) has been launched in the UK for the symptomatic treatment of chronic constipation in women in whom laxatives fail to provide adequate relief. The drug is a novel enterokinetic agent acting via selective high affinity 5-HT4 receptor antagonism. The National Institute for Health and Clinical Effectiveness (NICE) are expected to issue guidance on this product in December 2010.
The recommended dose is 2mg daily (1mg in severe renal or hepatic impairment), elderly patients should start on 1mg daily, increasing to 2mg daily, if needed.
The cost of 28 days @ 1mg or 2mg daily = £38.69 and £59.52 respectively.

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FDA launches initiative to reduce infusion pump risks

4th May 2010

The US Food and Drug Administration have announced a new initiative to address safety problems associated with external infusion pumps and is moving to establish additional premarket requirements for infusion pumps. There is also a new webpage devoted to infusion pump safety including strategies for risk reduction.

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Nabilone now a controlled drug

22nd April 2010

Further to a change in UK legislation, nabilone is now classified as a Schedule 2 controlled drug under the Misuse of Drugs Regulations 2001.

Annual evidence update on pain

22nd April 2010

The UK NHS Evidence supportive and palliative care section (formerly National Library for Health) has produced the 4th annual update of the evidence on pain in supportive and palliative care.

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Guidance on implementing end of life pathway

22nd April 2010

The NHS National End of Life Care programme, in conjunction with My Home Life, has published a series of fact sheets entitled "route to success resources" to support the implementation of the end of life pathway. They can be downloaded from the website link below.

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NICE guideline for neuropathic pain

20th April 2010

The UK National Institute for Health and Clinical Excellence (NICE) has published a clinical guideline on the pharmacological management of neuropathic pain in adults in non-specialist settings (CG96). This updates and replaces recommendations on the drug treatment of painful diabetic neuropathy in previous NICE clinical guidelines (CG15 and CG87).

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Guidance on care planning and decisions made in advance

20th April 2010

The NHS National End of Life Care programme has published a guide providing information on the difference between care planning and decisions made in advance. It sets out the key aspects of general care planning, advance care planning/advance statements, Advance Decisions to Refuse Treatment (ADRT) and Do Not Attempt Cardiopulmonary Resuscitation (DNACPR) decisions and can be downloaded from the link below.
The End of Life Care programme has also published a holistic common assessment guide of supportive and palliative care needs for adults requiring end of life care, which can also be downloaded from the link below.

Care planning and advance decisions
Holistic common assessment guide

Personal resuscitation plans for children

20th April 2010

The Association for Children's palliative care (ACT) has produced model resuscitation plans for children and young people in palliative care. They can be downloaded from the link below.

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EAPC white paper

20th April 2010

The European Association for Palliative Care (EAPC) has published a White paper on standards and norms for hospice and palliative care. The paper covers definitions and terminology of palliative and hospice care, common values and philosophy of palliative care, levels of care, patient groups, needs assessment and requirements for different types of services and settings.

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BNF significant changes

2nd April 2010

The new BNF 59 is now available online and contains significant changes as below:
• Appendices 2–5 removed
The information in the previous appendices on renal impairment, hepatic impairment, pregnancy and breastfeeding has been removed. The general information on these topics is now located in the guidance on prescribing section, with the specific information on dosing now located in the individual drug monographs.
• Renal impairment
The BNF is now using estimated Glomerular Filtration Rate (eGFR) Modification of Diet in Renal Disease (MDRD) formula to define renal function, instead of using creatinine clearance as a surrogate for glomerular filtration rate (GFR). This change was made in BNF58, however, in terms of dosage adjustment most individual drug monographs now contain information based on the eGFR rather than creatinine clearance.
The BNF recommends that although the two measures of renal function are not interchangeable, in practice, for most drugs and for most patients (over 18 years) of average build and height, eGFR (MDRD formula) can be used to determine dosage adjustments in place of creatinine clearance.
However, for patients at extremes of weight e.g. BMI <18.5Kg/m² (which may include some palliative care patients) either absolute GFR (which can be calculated from eGFR using body surface area) or creatinine clearance (using ideal body weight) should be used as the measure of renal function on which to adjust doses for drugs in renal failure. Creatinine clearance should also still be used for adjusting doses for toxic drugs.
For more information see the principles of dose adjustment in renal impairment found within the guidance on prescribing section in the BNF and also the guidance on presribing in renal impairment section in PCF3 (see below).
• Equivalent doses of morphine sulphate and diamorphine hydrochloride table
The table showing equivalent doses of morphine sulphate and diamorphine hydrochloride in the prescribing in palliative care section has been revised to improve clarity. The updated version now shows equivalent doses of morphine sulphate and diamorphine hydrochloride over 24h.

BNF changes section (registration required to access BNF content)
PCF3 guidance on prescribing in renal impairment in palliative care patients

National VTE risk assessment tool

30th March 2010

The UK Department of Health (DH) has revised the national venous thromboembolism (VTE) risk assessment tool as part of the national VTE prevention programme for the NHS in England.
From the 1st June 2010 all patients should be risk assessed on admission to hospital, using the criteria in the document, as outlined in a letter to all medical directors in England on the 24th March 2010.
The revised risk assessment tool is fully aligned to the new clinical guideline published by the National Institute for Clinical Effectiveness (NICE) earlier this year.
There are additioanl resources available to support the NHS in implementing VTE prevention on the DH website (see links below).

DH letter mandatory VTE risk assement
DH revised VTE risk assessment
NICE guideline CG92
DH VTE additional resources

HPCFusa flyer available for download

23rd March 2010

Please help support palliativedrugs.com by telling your colleagues about HPCFusa (2nd edition). We have created a pdf flyer suitable for e-mailing or printing to help you to do this which can be accessed from the link below or from the review section of HPCFusa in the new testimonials section on the website. Sample chapters are also available to download from this section.

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Palliativedrugs.com receives glowing review

23rd March 2010

Palliativedrugs.com website has received a glowing 6 page review in the Journal of Pain and Palliative Care Pharmacotherapy.
The author states that the website provides "the perfect forum for expert knowledge and is a 'must see' resource. It's existing content is voluminous reliable, filtered and reviewed by renowned clinicans and educators in the field".
The article positively appraises each section of the website in detail and concludes that "palliativedrugs.com is an invaluable resource for all practitioners who deal with end-of-life issues and symptom management", recommending it "wholeheartedly and without reservation".
The article can be accessed on-line from the link below (registration required).
Gavrin J. (2009) Expert Knowledge in Palliative Care on the World Wide Web: Palliativedrugs.org. Journal of Pain and Palliative Care Pharmacotherapy 23: 374–379.

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Happy 10th birthday palliativedrugs.com

22nd March 2010

Palliativedrugs.com is 10years old this year (2010) and to highlight it's success and associated achievements we have added a testimonials section featuring your comments on the website and reviews of PCF3, HPCFusa (2nd edition) and SMAC (4th edition). The testimonials section can be found on the main horizontal menu tab bar on the top of each website page (also see link below).
We would like to thank members for the support given in helping to make this a valuable resource for professionals and thus patients and families around the world. We are always grateful to receive your feedback and suggestions please email us hq@palliativedrugs.com.
Our aim is to keep the website free-access, but finances have been exhausted on more than one occassion, and it would have been impossible to continue without the personal financial support of one of the directors. We have constantly explored ways of securing core funding, and will continue to do so. Please support the site financially by:
1. Purchasing books via our website bookshop http://www.palliativebooks.com/
• Palliative Care Formulary (3e) UK edition
• Symptom Management in Advanced Cancer (4e)
• Hospice and Palliative Care Formulary USA (2e)
A Canadian version will also be available very shortly.
2. Completing a market research survey when invited to do so.
We are very grateful to those members who have done this, it really is a big help.
3. Making a donation or voluntary subscription.
We have never sought direct donations before, but if members or their organisations were so inclined to support our work, it would be most welcome. This could be in the form of a voluntary subscription. Please contact hq@palliativedrugs.com.
With your support, we know that the website will continue to grow and go from strength to strength.

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DH guidance for planning discharge

21st March 2010

The UK Department of Health (DH) has published a resource to support improvements in managing the discharge of individuals and transfer of care between settings for the elderly.

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NPSA rapid response report on omitted and delayed medicines in hospital

3rd March 2010

The UK National Patient Safety Agency (NPSA) has issued a rapid response report and supporting guidance (see below) on reducing harm from omitted and delayed medicines in hospital.
This report focuses on specific critical medicines. Immediate action is required by all NHS and independent organisations who admit patients for in-patient treatment and must be completed by 24th February 2011. Further work on reducing risks over a longer term is also planned.

NPSA Rapid Response Report
NPSA supporting information

Ibandronic acid revised dosing schedule in moderate renal impairment

3rd March 2010

The dosing schedule for ibandronic acid solution for infusion and tablets (Bondronat, Roche) for patients with moderate renal impairment (creatinine clearance ≥30 and <50 mL/min) being treated for the prevention of skeletal events in patients with breast cancer and metastatic bone disease has been updated.

The new SPC for IV infusion now reads as follows:
For patients being treated for the prevention of skeletal events in patients with breast cancer and metastatic bone disease
• mild renal impairment (CLcr ≥50 and <80 mL/min) no dosage adjustment is necessary i.e. dose 6mg over 15min diluted in 100mL 0.9% saline or 5% glucose
• moderate renal impairment (CLcr ≥30 and <50 mL/min) dose 4mg over 1h diluted in 500mL 0.9% saline or 5% glucose
• severe renal impairment (CLcr <30 mL/min) dose 2mg over 1h diluted in 500mL 0.9% saline or 5% glucose

The new SPC for tablets now reads as follows:
For patients being treated for the prevention of skeletal events in patients with breast cancer and metastatic bone disease
• mild renal impairment (CLcr ≥50 and <80 mL/min) no dosage adjustment is necessary i.e. dose 50mg daily
• moderate renal impairment (CLcr ≥30 and <50 mL/min) a dosage adjustment to 50mg every second day
• severe renal impairment (CLcr <30 mL/min) a dosage adjustment to 50mg once weekly.

SPC for ibandronic acid infusion
SPC for ibandronic acid 50mg tablets

COPD consultation in England

3rd March 2010

The Department of Health has launched a consultation on a strategy for chronic obstructive pulmonary disease (COPD) services in England. The strategy sets out a number of recommendations to improve outcomes for patients and help to reduce the cost of COPD to the NHS including: identifying the disease earlier, improving diagnosis of COPD and asthma, helping people to manage their condition better through structured education and exercise, reducing admissions and re-admissions to hospital, improving access to end of life care, and working to prevent COPD. The consultation runs until 5th April 2010, the documentation can be accessed from the link below.

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Templates for SHAs and PCTs for monitoring use of money to implement End of Life Care Strategy

3rd March 2010

The Department of Health has issued Strategic Health Authority (SHA) and Primary Care Trust (PCT) directors of finance with templates to monitor how the additional money provided to help implement the End of Life Care Strategy in 2009/10 is being invested. See below for access to the templates.

Link to SHA templates
Link to PCT templates

NHS evidence: second annual evidence update on patient and carer involvement in chronic disease

3rd March 2010

The NHS evidence palliative and supportive care specialist library (formerly part of the National Library for Health) has produced the second annual evidence update on patient and carer involvement in chronic disease.

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ACT prompts for care in the last days of a child's life

10th February 2010

The association for children's palliative care (ACT) has launched a good practice tool to help professionals prepare when they are caring for a child in the last hours and days of their life. The prompts cover the management of pain and other symptoms, treatment reviews and the provision of psychological, social, spiritual and practical support for the child, siblings and family. It can be downloaded from the link below.

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FDA approves morphine sulfate oral solution 20mg/mL

4th February 2010

The US Food and Drug Administration (FDA) has approved morphine sulfate oral solution 20mg/mL (Roxane Laboratories) for the relief of moderate to severe, acute and chronic pain in opioid-tolerant patients.
This is the only FDA approved morphine sulfate oral solution available at this concentration. Although the use of this medicine to manage pain has been common practice for many years, this form and concentration of morphine was not FDA approved until now (see our news item 2009-04-21).

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King's Fund summit report on End of life Care Strategy

4th February 2010

The King's Fund summit report "Delivering better care at end of life: the next steps" has been published. It includes papers given at the summit, in November 2009, covering issues such as commissioning, hospice and hospital care, quality markers, and challenges for providers. It identifies 10 critical actions to help the successful implementation of the government's End of Life Care strategy.

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End of Life Assistance (Scotland) bill published

4th February 2010

The End of Life Assistance (Scotland) bill has been published. The members bill was introduced to the Scottish Parliament by Margo MacDonald MSP on 20 January 2010. The purpose of the bill is to enable persons whose life has become intolerable and who meet the conditions prescribed in the bill to legally access assistance to end their life.

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Redesigned NebuChamber now available in UK

4th February 2010

Further to the recall of the NebuChamber spacer device in April 2009 (see our news item 2009-04-07), a redesigned NebuChamber mouthpiece and facemask (AstraZeneca) is now available. The new mouthpiece cannot now be fitted to the spacer incorrectly. The facemask has been redesigned to accommodate the new mouthpiece.

Warfarin safety information clarified

2nd February 2010

The UK Medicines and Healthcare Regulatory Agency (MHRA) has recently reviewed the safety information for warfarin. There are no new safety concerns, however the SPC will shortly be amended to give clearer advice, in particular in the following areas;
• timing of warfarin after a stroke
• management of a patient before dental or surgical procedure
• patients at particular risk of haemorrhage
• interactions with herbal products, foods and food supplements
• management of a patient with a significantly raised INR/haemorrhage.
The new core information that will be added to the SPC is available in the MHRA assessment report which can be downloaded from the link below.

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Oxycodone import consultation and diamorphine supply

22nd January 2010

A consultation exercise from the UK Home Office is underway which examines four options around the importation of oxycodone.
In February 2008 the Home Office made changes to allow the importation of oxycodone from outside the European Economic Area (EEA). These changes were considered to have led to a number of undesirable consequences, including threatening the economic viability of Macfarlan Smith Limited (MSL), the sole producer of diamorphine, whom are reliant on sales of oxycodone.
The decision to allow these imports of oxycodone was therefore rescinded in February 2009, based on a number of factors, including that the Department of Health considered it essential that the supply of diamorphine was maintained for the NHS.
The Government's current preference is to restrict imports of oxycodone from outside the EEA and preserve the supply of diamorphine to the NHS. The consultation document can be downloaded from the link below and closes on 15th February 2010.
We are currently running a survey to see if you view diamorphine as an essential opioid. If you are a UK practitioner, we would be grateful if you would spend a few moments giving us your opinion. Please access the survey from our homepage.

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Changes to medicines legislation to enable mixing of medicines prior to administration

7th January 2010

The Medicines and Healthcare products Regulatory Agency (MHRA) has now put in place changes to medicines regulations to enable mixing of medicines prior to administration in clinical practice, effective from 21 December 2009 (see previous news item 2009-11-05).
These changes enable:
• Doctors and dentists, who can already mix medicines themselves, to direct others to mix
• Nurse and pharmacist independent prescribers to mix medicines themselves and to direct others to mix
• Supplementary prescribers to mix medicines themselves and to direct others to mix, but only where that preparation forms part of the clinical management plan for an individual patient
• Nurse and pharmacist independent prescribers to prescribe unlicensed medicines for their patients, on the same basis as doctors and dentists (and supplementary prescribers if part of a clinical management plan).
The legal changes also define mixing as "the combination of two or more medicinal products together for the purposes of administering them to meet the needs of a particular patient".
These changes apply not only to palliative care, but to all clinical areas where the mixing of medicines prior to administration is accepted practice and supported by the employer's policies for the delivery of healthcare.
No changes are intended to the existing legal requirements for Patient Group Directions (PGD) for medicines resulting from the mixing of medicines, so a PGD cannot be used for this purpose.
The MHRA has also approached the Home Office and the Advisory Council for the Misuse of Drugs (ACMD) that corresponding amendments for controlled drugs are made to the Misuse of Drugs Regulations. In the meantime, existing good practice arrangements on mixing before administration which includes a controlled drug should continue.

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MHRA ondansetron IV drug alert

5th January 2010

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class 4 drug alert for ondansetron IV injection (Teva UK, all supplied in the Pliva livery). The SPC and PIL are missing certain information. To avoid stock shortages, existing stock is not being recalled. The SPC missing information relates to warnings about rare ECG changes with use and a statement about the unlikely need for dose changes due to drug interactions. The PIL missing information is about what to do in overdose. Full information can be found in the drug alert below.

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Guide to management of controlled drugs in primary care (England) 3rd edition

15th December 2009

The third edition of the guide to good practice in the management of controlled drugs in primary care (England) is now available and takes into account the significant legislative changes, introduced by the government, to strengthen the governance arrangements for controlled drugs. The guide, which can be downloaded from the link below, is primarily aimed at developing good practice for the management of controlled drugs in primary care in England, but also encompasses issues raised at the interfaces between primary, secondary and social care.

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MHRA recalls metatone tonic

15th December 2009

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has recalled metatone tonic 300mL (Chefaro UK, batch number 112) due to low level contamination with petrol. This product is available on the General Sales List (GSL) i.e. it can be purchased in the community.

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Thank you for your support

9th December 2009

A big thank you to all of the 60 members who completed a recent survey when invited to do so. They are helping to keep palliativedrugs.com a free access resource. In appreciation of their help, 5 members selected at random to receive a free copy of Symptom Management in Advanced Cancer 4e were Dr Georgina Parker, Dr Alexa Clark, Dr Humaira Jamal, Dr Jill Stewart, all from the UK, and Dr Drew Rosielle from the USA. In addition, as first selected, Dr Parker will also be able to donate £120 to a registered charity of her choice.
Without the help of these members we would have to charge a subscription fee. Please can all members consider supporting us in this way if invited to complete a survey.

EAPC framework for sedation in palliative care

3rd December 2009

The European Association for Palliative Care (EAPC) has produced a recommended framework for the development of institutional guidelines on the use of sedation in palliative care. The framework provides guidance on how to prepare, organize, initiate, titrate, monitor and evaluate the sedation procedure.

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Annual evidence update on chronic lung disease

26th November 2009

The UK NHS Evidence supportive and palliative care section (formerly National Library for Health) has produced an annual update of the evidence in chronic lung disease focusing on the treatment of cough and dyspnoea.

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NPSA alert: safer use of spinal (intrathecal), epidural and regional devices

25th November 2009

The UK National Patient Safety Agency (NPSA) has produced guidance building on previous safe practice to minimise the risk of wrong route errors. All NHS healthcare organisations are asked to ensure that:
• from 1 April 2011 all spinal (intrathecal) bolus doses and lumbar puncture samples are performed using syringes, needles and other devices with connectors that will not also connect with intravenous Luer connectors (Part A)
• from 1 April 2013 all epidural, spinal (intrathecal) and regional infusions and boluses are performed with devices that use safer connectors that will not connect with intravenous Luer connectors or intravenous infusion spikes (Part B).
NHS organisations will need to review and update their purchasing policies, procedures and clinical protocols to include the use of devices with safer connectors. These devices with safer connectors are not currently available. By issuing this Alert the NPSA is expecting that the medical device and pharmaceutical industry will work collaboratively with the NHS to develop devices with safer connectors.
For further information see the link to the NPSA website below.

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Palliativedrugs.com exceeds 10,000 members

19th November 2009

We are delighted to announce that www.palliativedrugs.com has exceeded 10,000 members since the relaunch of our website in August 2008.
There are 110 countries represented. Over half the members are from the UK with 851, 792, 553, 346 and 305 members from Australia, USA, Canada, Ireland and New Zealand respectively. Members consist mainly of doctors, nurses and pharmacists from palliative care, general medicine, oncology, general practice, medicines information and pain teams.
We would like to take this opportunity to thank you all for your support. We are particularly grateful for your contributions to the bulletin board, SDSD, surveys and donations of guidelines, protocols and patient/carer information leaflets. As always we encourage feedback please send your comments or suggestions to hq@palliativedrugs.com.

MHRA recalls multiple antacids

19th November 2009

The UK Medicines and Healthcare products Regulatory Agency (MHRA) have recently recalled the following products due to low level bacterial contamination detected in the products. The products affected are 500mL bottles of the following:
Gaviscon Advance Peppermint Flavour (Reckitt Benckiser); batch numbers 924471 and 925071
Boots Heartburn Relief Peppermint Flavour, batch number 41808
Peptac Peppermint Liquid (Ivax Pharmaceuticals UK), batch numbers 41808 and 41957
Peptac Liquid Aniseed Flavour (Ivax Pharmaceuticals UK), batch number 41757.
The recall is precautionary, the contamination could cause the medicine to spoil and change the smell from peppermint/aniseed to antiseptic. The microbial contamination is not likely to be harmful to normally healthy consumers. However, if these products are being used by patients with suppressed immune systems, the risk of infection and other adverse reactions cannot be ruled out.
For further details see the MHRA recall notices below.

MHRA recall notice for Reckitt Benckiser product
MHRA recall notice for Boots and Ivax products

FDA approves capsaicin patch

19th November 2009

The US Food and Drug Administration (FDA) has approved capsaicin 8% patch (Qutenza, NeurogesX Inc's), a medicated skin patch that relieves the pain of post-herpetic neuralgia (PHN). The dosage is a single application of up to 4 patches for a 60min period repeated no more frequently than every 3months. Pre-treatment with topical anaesthetic is required. See the product information below for further details.

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FDA approves tranexamic acid tablets

19th November 2009

Tranexamic acid tablets are now available in the US. The Food and Drug Administration (FDA) has approved tranexamic acid tablets (Lysteda, Xanodyne pharmaceuticals) to treat menorrhagia.

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Reducing the risk of errors when ePrescribing opioids

19th November 2009

The UK organisation NHS Connecting for Health has produced a document on reducing the risk of mis-selecting opioid preparations in electronic systems. It is likely to be of interest to individuals involved in the design and implementation of ePrescribing systems, and those who use them.
The document can be downloaded from below.

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NICE consultation on delirium

19th November 2009

NICE is developing a clinical practice guideline on delirium. A draft version has been issued for consultation; registered stakeholders have until 6th January to comment on the provisional recommendations made. Please see the link below for details

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RCGP launch end of life care strategy

19th November 2009

The UK Royal College of General Practitioners (RCGP) has published an end of life care strategy. Development of the strategy was led by Professor Keri Thomas. The aim of the strategy is to help develop good practice and promote excellence and identifies 10 recommended areas for further work.

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Consensus guidelines for oral bowel cleansing agents

19th November 2009

The British Society of Gastroenterology, the British Society of Gastrointestinal and Abdominal Radiology, the Renal Association, the Royal College of Radiologists, and the Royal College of Surgeons have issued consensus guidelines for the prescription and administration of oral bowel-cleansing agents. These guidelines address the issue of clinical assessment and potential risks of harm through inappropriate use raised in the National Patient Safety Agency (NPSA) alert in February 2009 (see our news item 2009-03-24). Please see the link below for the full guidelines.

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FAQ on non-medical prescribing

19th November 2009

The UK National Prescribing Centre (NPC) has put together a collection of Frequently Asked Questions (FAQs) on non-medical prescribing which have been developed as a result of queries received by the NPC. The answers have been reviewed by the NPC and the Department of Health. Please see link to the NPC website below.

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FDA warnings of severe tissue injury with promethazine

19th November 2009

The US Food and Drug Administration has recently notified healthcare professionals that a boxed warning is being added to the prescribing information for promethazine hydrochloride products describing the risks of severe tissue injury, including gangrene requiring amputation, following intravenous administration of promethazine. The boxed warning will remind practitioners that due to the risks of intravenous injection, the preferred route of administration is deep intramuscular injection and that subcutaneous injection is contraindicated. For further information and guidance for healthcare professionals on the use of promethazine, see the FDA link below.

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Intranasal fentanyl launched in the UK

17th November 2009

Intranasal Fentanyl (Instanyl, Nycomed 0800 633 5797) has been launched in the UK for the management of breakthrough pain in adults already receiving maintenance opioid therapy for chronic cancer pain. It is contra-indicated for opioid naive patients.
Breakthrough pain (BTP) is described as a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain.
Maintenance opioid therapy is described as those who are taking at least 60mg of oral morphine daily, 25microgram of transdermal Fentanyl/h, 30mg of oral oxycodone daily, 8mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.
The dose of Instanyl is independent of the daily opioid maintenance dose and must be individually titrated starting from 50microgram. The maximum daily dose is the treatment of four BTP episodes/day, each with no more than two doses separated by at least 10min, with at least 4h before treating another BTP episode.
See the SPC below for further details.
The nasal spray is available as 50microgram/dose, 100microgram/dose and 200microgram/dose of fentanyl and costs £59.50 per 1.8mL bottle (10 doses) or £119 per 2.9mL bottle (20 doses). The product has recently been approved by the Scottish medicines Consortium (SMC).

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MHRA drug safety advice on mixing medicines in clinical practice

5th November 2009

The latest publication of Drug Safety Update from the UK Medicines and Healthcare products Regulatory Agency (MHRA) contains an update on mixing medicines in clinical practice.
The MHRA plan to implement the necessary legislative amendments that are needed to support the recommendations agreed with ministers earlier this year (see our article 2009-07-07) in November 2009.
The agreed recommendations were;
• Doctors and dentists (who can already mix medicines themselves) should be able to direct others to mix
• Non-medical prescribers should be able to mix medicines and be able to direct others to mix
• Nurse and pharmacist independent prescribers should be allowed to prescribe unlicensed medicines for their patients
• The MHRA should approach the Home Office and the Advisory Council for the Misuse of Drugs (ACMD) with CHM's recommendations that corresponding amendments are made to the Misuse of Drugs Regulations for controlled drugs
• Guidance should be developed for those involved in the mixing of medicines
• Research should be commissioned to develop authoritative national advice on mixing of medicines.
The full article can be downloaded from the MHRA website link below.

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EMEA confirms previous recommendation of withdrawal of oral dextropropoxyphene medicines

5th November 2009

The European Medicines Agency has confirmed its previous recommendation to withdraw the marketing authorization for all non-parenteral formulations of dextropropoxyphene containing medicines because their risks, particularly the risk of potentially fatal overdose, are greater than their benefits. However, for the parenteral formulation, the committee concluded that the marketing authorizations should not be withdrawn but suspended until further clinical data are available which may support the re-introduction of this formulation onto the market. Further information is available from a Q&A link below.

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NPSA rapid response report for oxygen safety

5th November 2009

The UK National Patient Safety Agency (NPSA) has produced a rapid response report for NHS organisations across England and Wales to minimise the risks of oxygen therapy in hospitals. Deadline for action complete is 2010-03-29.

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MHRA drug safety advice on bisphosphonates and osteonecrosis of the jaw

4th November 2009

The latest publication of Drug Safety Update from the UK Medicines and Healthcare products Regulatory Agency (MHRA) contains information and guidance for healthcare professionals on bisphosphonates and osteonecrosis of the jaw.
They summarize that the risk of osteonecrosis of the jaw is greater for patients receiving intravenous bisphosphonates for cancer than for patients receiving oral bisphosphonates for osteoporosis or Paget's disease. All patients with cancer should have a dental check-up before bisphosphonate treatment. During treatment patients should be encouraged to maintain good oral hygiene, receive routine dental check-ups and report any oral symptoms.
The full article can be downloaded from the MHRA website link below.

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NICE consultation on neuropathic pain

20th October 2009

The UK National Institute for Health and Clinical Excellence (NICE) has issued draft guidance on the pharmacological management of neuropathic pain. The closing date is 11 November 2009. The document and further details can be found on the NICE website (see below).

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Manual for cancer services - complementary therapy and psychological support measures

20th October 2009

The final version of complementary therapy safeguarding practice measures has been issued as part of the revised manual for cancer services which is part of the NHS Cancer Reform.
A draft version of the psychological support measures has been issued for consultation, which will run until 8 January 2010.

Complementary therapy safeguarding practice measures
Draft pyschological support measures guidance

FDA guidance on safe disposal of opioids

20th October 2009

The US Food and Drug Administration (FDA) has issued guidance for consumers on disposal of certain medicines including high potency opioids and some controlled drugs. There is a list of medicines which should be disposed of by flushing to prevent danger to people and pets in the home.

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New strength oxycodone/naloxone tablets available in UK

16th September 2009

Two new strengths of oxycodone/naloxone prolonged release tablets (Targinact, Napp 01223 424444) have been launched. Oxycodone/naloxone 5mg/2.5mg and 40mg/20mg strengths have been added to the existing range of prolonged release tablets which are currently available in 10 mg/5 mg and 20 mg/10 mg tablet strengths (see our news item 2009-01-27). The maximum daily dose of Targinact is 80mg oxycodone hydrochloride and 40mg naloxone hydrochloride (i.e. twice daily administration of Targinact 40mg/20mg prolonged release tablets).
A pack of 28 tablets of Targinact 5mg/2.5mg costs £17.56.
A pack of 56 tablets of Targinact 10mg/5mg, 20mg/10mg and 40mg/20mg costs £35.11, £70.11 and £140.44 respectively.
A pack of 28 tablets of Oxycontin 5mg costs £13.23.
A pack of 56 tablets of Oxycontin 10 mg, 20mg and 40mg costs £26.45, £52.89 and £105.80 respectively.

Targinact SPC

Lorazepam injection updated SPC

15th September 2009

The UK SPC for lorazepam injection (Ativan, Wyeth 0845 367 0098) has been updated in section 4.5 (interactions). The following information has been added:
• Concurrent administration of lorazepam with valproate may result in increased plasma concentrations and reduced clearance of lorazepam. Lorazepam dosage should be reduced to approximately 50% when co-administered with valproate.
• Concurrent administration of lorazepam with probenecid may result in a more rapid onset or prolonged effect of lorazepam due to increased halflife and decreased total clearance. Lorazepam dosage needs to be reduced by approximately 50% when co-administered with probenecid.
• Concomitant use of clozapine and lorazepam may produce marked sedation, excessive salivation and ataxia.
• Administration of theophylline or aminophylline may reduce the sedative effects of benzodiazepines including lorazepam.
There have been reports of apnoea, coma, bradycardia, heart arrest and death with the concomitant use of lorazepam injection solution and haloperidol.

Ativan injection SPC

CMO letter on best practice when administering parenteral opioids

15th September 2009

A letter has been sent from the UK Chief Medical Officer (CMO) on the safe administration of parenteral opioids. The letter highlights the well known risk of respiratory depression with parenteral opioids, the need for monitoring of patients and makes the following recommendations:
• All hospitals should have in place guidelines and protocols for monitoring patients on parenteral opioids, and systems for confirming that high levels of compliance with guidance are being consistently achieved.
• All clinicians should routinely follow this guidance and institutions engaged in the training of clinicians should ensure this area is adequately covered in their undergraduate and postgraduate curricula.
• It should be routine practice to ask patients about their pain and document a pain score in the clinical record.
Editors note: the reference in the letter relates to neuroaxial administration rather than parenteral administration. We would be grateful if members would share any guidelines they have or explain their usual approach to monitoring opioid naive patients who are given parenteral opioids.

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MHRA restrict OTC codeine and dihydrocodeine

10th September 2009

New warnings and tighter controls on the sales of non-prescription i.e. over the counter (OTC) medicines containing codeine or dihydrocodeine are being introduced by the UK Medicines and Healthcare products Regulatory Agency (MHRA) to minimise the risk of overuse and addiction. All OTC medicines containing codeine or dihydrocodeine
• are now only indicated for the short term treatment of acute, moderate pain which is not relieved by paracetamol, ibuprofen or aspirin alone (all indications related to colds, flu, coughs and sore throats, and references to minor painful conditions will be removed)
• will contain information and label warnings stating not to take for more than three days to avoid the risk of addiction and overuse headache
• will have a maximum pack size of 32 tablets.

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Annual evidence update on GI symptoms

10th September 2009

The UK NHS Evidence supportive and palliative care section (formerly National Library for Health) has produced its second annual update on the evidence for treating gastrointestinal symptoms, specifically mouthcare, PEG feeding and diarrhoea.

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Care Quality Commission annual report on the safer management of controlled drugs

10th September 2009

The UK Care Quality Commission has published its second annual report on the regulation of controlled drugs, covering the year ended 31st December 2008. Key recommendations are:
• healthcare organisations should ensure they have accountable officers in place and mechanisms to replace them immediately when they leave
• a robust workable procedure should be devised to ensure that fentanyl 72h patches are applied at appropriate intervals to ensure that patients are not left in pain (due to too long an interval) or patches are wasted (due to too short an interval)
• PCT officers should collaborate more effectively to ensure that suitable numbers of authorised witnesses are available for destroying obsolete drugs
• local intelligence networks should ensure their designated bodies are kept up to date with the formation, working arrangements and leadership of the network.

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Metrotop 0.8% gel discontinued

10th September 2009

Metroptop (metronidazole) 0.8% gel (Medlock 0161 6212100) has been discontinued and all stock is exhausted.
An alternative product of similar cost is metronidazole 0.75% gel e.g. Anabact (CHS) 15g = £4.47, 30g = £7.89.

Dexamethasone 500microgram tablets recalled

31st August 2009

The UK Medicines and Healthcare products Regulatory Agency (MHRA) have issued a class 2 drug alert recalling the following batches of dexamethasone 500microgram tablets due to concerns with the results of stability tests.
Dexamethasone 500microgram (Essential Generics livery, Chemidex pharma) batch numbers 9334 and 9336, first distributed on 2009-03-05 and 2009-06-12 respectively.
All unused stock of the above batches should be quarantined and returned for credit. For stock return enquiries contact Movianto Customer Care (01234 248632). For medical information enquiries contact Chemidex Pharma (01784 477167).
We understand dexamethasone 500microgram tablets can be imported via Durbin PLC (020 8869 6555).
Update [2009-09-08]
Dexamethasone tablets 500microgram (PMS, Canada) can be obtained via Durbin PLC (020 8869 6555), 100tablets = £16.82 (based on exchange rate) + VAT + delivery charge (£5.95 + VAT per order), although currently awaiting stock delivery.
NB the product licence holder does not provide a certificate of analysis/conformity.

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EMEA approves fentanyl citrate nasal spray

31st August 2009

The European Medicines Agency (EMEA) has granted a marketing authorisation for fentanyl citrate (Instanyl) nasal spray solution for the management of breakthrough pain in adults already receiving maintenance opioid therapy for chronic cancer pain. Nycomed plans to launch the product later this year.
The product details for the lowest strength preparation 500microgram/mL (50microgram/dose), can be downloaded from the link below.

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MHRA information on herbal products

24th August 2009

The latest UK Medicines and Healthcare products Regulatory Agency (MHRA) drug safety update contains information on herbal products and Traditional Herbal Registration (THR). A product with a THR number will have been assessed by the MHRA for safety, quality and patient information. The permitted minor indications are based on traditional use and not proven efficacy. The SPCs and PiLs for these products are contained within the public assessment reports for each THR product and can be found on the MHRA website (see below).

MHRA August 2009 drug safety update
MHRA list of THR products (public assessment reports)
MHRA herbal products website information for consumers

DH consultation on regulation of alternative medicine practitioners

24th August 2009

A joint consultation has been launched from the UK Department of Health (DH) seeking views on whether, and if so how, to regulate acupuncturists, herbal medicine practitioners and traditional Chinese medicine (TCM) practitioners. The closing date is 2nd November 2009. The consultation document and on-line response system can be accessed from the link below.

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Interaction between PPIs and clopidogrel

24th August 2009

The UK Medicines and Healthcare products Regulatory Agency (MHRA) have highlighted a clinically significant interaction between Proton Pump Inhibitors (PPIs) and clopidogrel. Several studies have found that the use of PPIs lowered the clinical effectiveness of clopidogrel in preventing the recurrence of atherothrombotic events in patients who have previously had a serious heart condition. Clopidogrel can cause GI side effects and is therefore frequently prescribed together with a PPI.
Current advice to healthcare professionals is:
• review the need for PPI therapy in patients who are also taking clopidogrel at the next appointment. Use of these medicines together should be avoided unless considered essential
• check whether patients who are taking clopidogrel are using over-the-counter PPI omeprazole and consider whether another gastrointestinal therapy would be more suitable
• PPIs should be prescribed in line with their licensed indications where possible.
Further information can be obtained from the MHRA website link below.

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NICE supplementary advice for end of life treatments

24th August 2009

The supplementary advice to be given to the UK National Institute for Clinical Excellence (NICE) appraisal committees when they are appraising treatments which may extend life, at the end of life, is now available from the NICE website (see below). This follows the consultation in December 2008. The consultation responses and summary to responses are also available.

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RPSGB calls for equality in CD prescribing for pharmacists

24th August 2009

The UK Royal Pharmaceutical Society of Great Britain (RPSGB) has called for equality between nurses and pharmacists in the prescribing of controlled drugs (CD). Independent nurse prescribers are allowed to prescribe CDs in certain conditions. Currently pharmacist independent prescribers cannott prescribe CDs, even when the medicine in question is a CD which they can sell as ingredients in over the counter medicines.

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FDA takes action against unapproved topical ibuprofen products

24th August 2009

The US Food and Drug Administration (FDA) has informed consumers and healthcare professionals of its intent to take action against eight companies that market unlawful over-the-counter (OTC) topical drug products containing ibuprofen. The names of the products and manufacturers that received warning letters are:
Emuprofen (Progressive Emu, Inc.)
BioEntopic 15% Ibuprofen Creme (BioCentric Laboratories, Inc.)
Ibunex Topical Ibuprofen (Core Products International, Inc.)
LoPain AF 15% Ibuprofen Creme (Geromatrix Health Products)
IB-RELIEF (MEKT LLC)
Profen HP (Ridge Medical Products)
IbuPRO-10 Plus (Meditrend, Inc. dba Progena Professional Formulations)
IBU-RELIEF 12 (Wonder Laboratories)
There are currently no approved applications for topical ibuprofen products in the US.

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FDA approves buccal fentanyl with REMS plan

6th August 2009

The US Food and Drug Administration (FDA) has approved a fentanyl buccal soluble film preparation (Onsolis) for breakthrough pain in cancer, in patients who already use opioid pain medication around the clock and are considered opioid tolerant. The preparation delivers the drug via an absorbable film that adheres to the inside of the cheek. The absorption profile is substantially different to other transmucosal fentanyl products and doses are not equivalent.
Onsolis was approved with a Risk Evaluation and Mitigation Strategy (REMS) plan and will only be available through a restricted distribution program called the FOCUS program. Under this program, only registered prescribers, pharmacies and patients will be able to prescribe, dispense, and receive Onsolis. The program will provide training and educational materials to prescribers and pharmacy personnel, and a counselling call will be placed to patients prior to dispensing to ensure they have been adequately educated about the appropriate use of the drug. Prescription orders will be filled only by participating pharmacies that send the product directly to the patients' homes.
For further details see the FDA website question and answer document link below.

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Consultation on a new benchmark on pain

23rd July 2009

The UK Department of Health (DH) has issued a consultation on a new benchmark in pain in their "Essence of care" system of benchmarking. The closing date for responses is 2009-10-12. The consultation document and the questionnaire can be downloaded from the DH website link below.

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Updated SIGN/BTS guidance on the management of asthma

23rd July 2009

The British guideline on the management of asthma published by the Scottish Intercollegiate Guidelines Network (SIGN) and the British Thoracic Society (BTS) has been updated. The updated guideline can be downloaded from the link below. It contains updates in the following sections: pharmacological management (section 4), management of acute asthma (section 6), and asthma in pregnancy (section 7.3).

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NICE guidance on lenalidomide for multiple myeloma

23rd July 2009

The UK National Institute for Health and Clinical Excellence (NICE) has published guidance on the treatment of multiple myeloma in patients who have received at least one prior therapy. NICE have also issued a costing template. Both documents can be downloaded from the links below.
NICE has recommended that lenalidomide in combination with dexamethasone is used, within its licensed indication, as an option for the treatment of multiple myeloma only in people who have received two or more prior therapies, with the condition that the drug cost of lenalidomide (excluding any related costs) for people who remain on treatment for more than 26 cycles (each of 28 days; normally a period of 2 years) will be met by the manufacturer. People currently on lenalidomide for this condition, who have not received two or more prior therapies, should have the option to continue therapy until they and their clinicians consider it appropriate to stop.

NICE guidance on lenalidomide for multiple myeloma
NICE costing template for lenalidomide

Oxycodone injection 50mg/mL now available in UK

16th July 2009

Oxycodone 50mg/mL solution for injection or infusion (OxyNorm, Napp 01223 424444) has been launched in the UK. It should be diluted and used for SC or IV injection or infusion for moderate to severe pain in patients with cancer and post-operative pain. The SPC contains information regarding mixing oxycodone 50mg/mL with the following drugs; hyoscine butylbromide, hyoscine hydrobromide, dexamethasone sodium phosphate, haloperidol, midazolam, metoclopramide, levomepromazine, glycopyrronium and ketamine. We understand that this is extra compatibility data generated specifically for the 50mg/mL product and is awaiting publication. There is also additional information on mixing with cyclizine at concentrations >3mg/mL. The cost of a pack of 5 ampoules is £70.10.

SPC OxyNorm injection 50mg/mL

End of Life Care strategy annual report

15th July 2009

The Uk Department of Health (DH) has published the first annual report of the End of Life Care strategy.

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MLX 356: MHRA allows mixing of medicines

7th July 2009

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has confirmed that the outcome of the MLX 356 consultation about amendments to medicines legislation to allow mixing in palliative care has now been published and will shortly be available on the MHRA website.

"We have published the outcome of the consultation on proposals to regularise the position of those involved in the mixing of medicines, including in palliative care. We have also included a summary of the Commission on Human Medicines' (CHM) consideration of the proposals and recommendations since they extend to other clinical areas where mixing of medicines is undertaken and is established practice. The Chief Nursing Officer and Chief Pharmaceutical Officer for England endorse the CHM's recommendations, which will help to support clinical care. Ministers have accepted these recommendations and agreed to amend medicines legislation accordingly. We plan to implement the changes later this year."

In summary the MHRA and CHM have agreed the following, which covers all areas of clinical practice where mixing is currently undertaken including palliative care:
• Doctors and dentists (who can already mix medicines themselves) should be able to direct others to mix
• Non-medical prescribers should be able to mix medicines themselves and should be able to direct others to mix
• Nurse and Pharmacist Independent Prescribers are to be allowed to prescribe unlicensed medicines for their patients on the same basis as doctors and supplementary prescribers
• The MHRA should approach the Home Office and the Advisory Council for the Misuse of Drugs (ACMD) with CHM's recommendations that corresponding amendments are made to the Misuse of Drugs Regulations for controlled drugs.
Until the medicines legislation has been changed, the MHRA has issued a revised statement on mixing of medicines in clinical practice to allow current practice to continue in all clinical areas where the mixing of medicines is accepted practice.
The full outcome of consultation and the revised statement on mixing of medicines in clinical practice can be downloaded below.

MHRA outcome of consultation MLX356:
MHRA revised statement on mixing of medicines in clinical practice

Symptom Management in Advanced Cancer 4th edition

2nd July 2009

We are delighted to announce that the new edition will be available in 2 months time. Buy now to take advantage of the special prepublication price of £30 (normal price £40). Purchasing this book will help to keep palliativedrugs.com a free access resource.
It will be available only from our website bookshop www.palliativebooks.com which can be accessed via the www.palliativedrugs.com home page).
Symptom Management in Advanced Cancer is an established text which provides a framework of knowledge to enable clinicians to develop a systematic and scientific approach to treatment. It offers practical information and advice on the wide range of symptoms encountered in patients with advanced cancer. This edition has been extensively revised and expanded, and has a new chapter on Last days.

FROM REVIEWS OF PREVIOUS EDITIONS
A masterly work: clear, concise and practical: Age and Ageing

A masterpiece...an essential book: Geriatric Medicine

Without doubt the best of the numerous offerings on this subject. It is up to date, the information flows logically and the reader acquires concrete information in a few minutes. I have no reservations about recommending it: Oncology in Practice

Should be within reach of all clinicians involved in the management of patients with advanced cancer: Palliative Medicine

Every general practitioner, hospital doctor (medical and surgical) and especially oncologist and palliative care physicians should have this book on their shelf: British Journal of Hospital Medicine.

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MHRA multiple drug recalls

2nd July 2009

The UK Medicines and Healthcare products Regulatory Agency has recalled several products, all of which are distributed by Karib Kemi Pharm, due to serious Good Manufacturing Practice (GMP) deficiencies found during an inspection of their contract manufacturer. Three separate alerts have been issued. The products involved are co-amilozide tablets, doxazosin tablets, fluoxetine capsules, metformin tablets and naproxen tablets. Full details of the batch numbers concerned are in the alerts below.

2009-07-02 pm An additional fourth alert from Sandoz has been issued regarding baclofen tablets, fluoxetine capsules and metformin tablets.

MHRA alert fluoxetine
MHRA alert doxazosin and fluoxetine
MHRA alert co-amilozide, metformin and naproxen
MHRA alert baclofen, fluoxetine and metformin

End of life care strategy: quality markers and measures publication

2nd July 2009

The end of life care strategy, published in July 2008, included a commitment to publish quality markers for end of life care. This has now been published and is available on the UK Department of Health (DH) website (see below).

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Guide on core competences for end of life care published

2nd July 2009

The national end of life care programme has published a document on common core competences and principles for health and social care workers working with adults at the end of life. It can be downloaded from the link below.

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FDA approves injectable ibuprofen

16th June 2009

The US Food and Drug Administration (FDA) has approved Caldolor (Cumberland Pharmaceuticals), the first injectable formulation of ibuprofen, for the treatment of acute pain and fever. It will be available for hospital use only and is licensed for administration over 30min, in doses of 400-800mg every 6h for acute pain, and 400mg initially followed by 400mg every 4-6h or 100-200mg every 4h as necessary for fever.

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Disodium clodronate injection discontinued in UK

16th June 2009

Disodium clodronate injection 60mg/ml (Bonefos concentrate, Bayer 01635 563000) has been discontinued in the UK. There is no alternative injectable disodium clodronate product available and no residual stock. The company has confirmed that the tablets and capsules continue to remain available.

MHRA recall oxybutynin 5mg tablets

15th June 2009

Oxybutynin 5mg tablets from Niche Generics and Actavis UK Ltd from the batches listed below are being recalled due to the possible inclusion of undispersed active ingredient which has the potential to result in patient overdose. It is not yet clear whether the undispersed active ingredient, found during the early stages of production, has reached the finished tablet, however all stock from the following batches is being recalled as a precautionary measure.
Niche Generics affected batches 09D02 and 09D04, first distributed 16/04/09.
Actavis UK affected batches 146401 and 146402, first distributed 05/05/09 and 22/05/09 respectively.
Both companies have requested that patients should be contacted and supplied with replacement stock from unaffected batches.
Medical information (for both companies) can be obtained from the Niche Medical Information Department (Dr Vineet Kacker, 07753 606357).
Further information can be accessed from the MHRA website link below.

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Antipsychotics: risk of venous thromboembolic events

9th June 2009

The UK Medicines and Healthcare products Regulatory Agency (MHRA) drug safety update has advised that there may be an increased risk of venous thromboembolic events associated with antipyschotics. There is insufficient data to determine any difference between conventional or atypical antipyschotics or between individual drugs. Healthcare professionals are advised to identify all possible risk factors for venous thromboembolism before and during antipyschotic use and take preventative measures.

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FDA website links have changed

9th June 2009

The US Food and Drug Administration (FDA) has changed it's website this week. Unfortunately many of the articles referenced on our site and in the Palliative Care Formulary (PCF3 and HPCFusa2) have been moved. We are in the process of updating links on the site and will ensure that all links are corrected in future publications.

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NICE publishes final scope for neuropathic pain guidance

26th May 2009

The UK National Institute for health and Clinical Excellence (NICE) has published the final scope for the guidance for pharmacological management of neuropathic pain in adults in non-specialist settings. The expected publication date of the guidance is March 2010, full details of the process can be found on the NICE website via the links below.

NICE final scope for neuropathic pain
NICE website

Nystan products discontinued

21st May 2009

Bristol Myers Sqibb (01895 523000) has discontinued Nystatin (Nystan) pessaries, vaginal cream, pastilles, oral tablets, cream and ointment in the UK.
We have confirmed that nystatin (Nystan) 100 000units/mL suspension 30mL remains available.

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Change in blood glucose reporting

21st May 2009

From the 1 June 2009 laboratories in the UK will be changing the way in which HbA1c results are reported for people with diabetes. The new measurement will be in mmol/mol instead of %. The equivalent of the current target of 6.5% will be a target of 48mmol/mol. Dual reporting will take place until 31 May 2011 to allow people to become familiar with the new system. Further details for healthcare professionals, laboratory professionals and patients can be downloaded from the links below.

Healthcare professionals leaflet
Laboratory professionals leaflet
Patient information leaflet

MHRA recall seretide 250 evohalers

14th May 2009

The UK Medicines and Healthcare products Regulatory Agency (MHRA) have recalled batch 1183R of seretide 250 evohalers (25microgram of salmeterol xinafoate and 250microgram of fluticasone propionate per actuation) due to the possible presence of counterfeit inhalers in the legitimate supply chain.
Analytical testing of counterfeits, with this batch number, has indicated that some parts of the counterfeit product are genuine. Performance tests have demonstrated that there could be a reduced patient dose if patients have obtained and used a counterfeit inhaler.

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FDA Oxycodone tablet shortage in US

14th May 2009

The US Food and Drug Administration have reported that there is a shortage of Oxycodone immediate release tablets (5mg, 15mg and 30mg) due to increased demand following earlier product recalls by other manufacturers.

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New UK product droperidol injection

12th May 2009

Droperidol injection is now available again in the UK. Droperidol 2.5mg/ml (Xomolix, ProStrakan 01896 664000) has recently been licensed in the UK for:
• the prevention of nausea and vomiting induced by morphine derivates during post-operative patient controlled analgesia (PCA) in adults and
• prevention and treatment of post-operative nausea and vomiting in adults and, as second line, in children and adolescents.
The SPC is now available from the link below. NHS Cost is £39.40 for 10 x 1ml ampoules.
All formulations of droperidol (Droleptan, Janssen-Cilag) were voluntarily discontinued in the UK in March 2001 due to concerns about use in chronic conditions and it's potential effect on the cardiac QT interval (see MHRA safety warning below). The company also stated that continuation of the injectable form would not be viable.

Droperidol SPC
MHRA safety warning droperidol (Droleptan)

MHRA alert doxepin 50mg capsules

7th May 2009

Packs of doxepin 50mg capsules (Sinepin, Marlborough Pharmaceuticals 01672 514187) from batch 0901001 have an error in the Braille print on the front of the carton. The Braille embossed on the carton states 'Sinepin 25mg'. This is incorrect and it should state 'Sinepin 50mg'.
All other batches are unaffected. The company has re-worked stocks of batch 0901001 which had not yet entered the supply chain. This stock will be distributed as batch number 0901001A and the Braille is corrected.
Pharmacists are asked to contact any visually impaired customers who may have received the affected batch to make them aware of this issue and should not dispense this batch of product to anyone who relies on Braille for the identification of the product.

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MHRA advice: oral salicylate gels in under 16s

7th May 2009

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued new precautionary advice recommending that topical oral pain relief gels containing salicylate salts are not used in those under 16years old.
This is a precautionary measure only and there are no new safety concerns. The advice is being introduced due to a theoretical risk these products could increase the possibility of a child developing Reye's syndrome. The main products affected are Bonjela and Bonjela Cool Mint Gel.

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FDA explains proposed opioid prescribing changes

7th May 2009

The US Food and Drug Administration (FDA) is planning a Risk Evaluation and Mitigation Strategy (REMS) that will affect opioid prescribing. This initiative is being introduced to reduce the misuse, abuse, addiction and overdose deaths associated with opioids whilst maintaining access for legitimate patients.
The FDA has produced a series of webinar (audio-with slide) programs to inform healthcare professionals about the issues related to REMS for opioid analgesics. The webinars can be accessed from the FDA link below or the slides alone can be downloaded. Input from stakeholders is requested and a public meeting is being held on 27th and 28th May for broader public interest and participation (see below for more infomation).

FDA opioid REMS webinar and slides
FDA notification of proposed opioid REMS
FDA notice of public meeting

EMEA positive opinion for fentanyl citrate nasal spray

7th May 2009

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has adopted a positive opinion, recommending the granting of a marketing authorisation for fentanyl citrate nasal spray solution (Instanyl) 0.5 mg/mL, 1mg/mL, 2mg/mL, intended for the management of breakthrough pain in adults already receiving maintenance opioid therapy for chronic cancer pain.

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EMEA negative opinion for extension of pregabalin indication

7th May 2009

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has adopted a negative opinion recommending the refusal of an extension of the indication to the treatment of fibromyalgia in adults experiencing moderate to severe pain, for Lyrica (pregabalin). Lyrica is currently authorised for the treatment of neuropathic pain, epilepsy and generalised anxiety disorder in adults.

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Withdrawal of marketing authorisation for epoetin delta

7th May 2009

Shire Pharmaceuticals have voluntarily withdrawn the marketing authorisation for Dynepo (epoetin delta) for commercial reasons.

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Flu pandemic planning

5th May 2009

The UK Department of Health (DH) has published the following guidance "Pandemic flu: managing demand and capacity in health care organisations (surge)" which can be accessed from the DH website link below.
The document "Flu pandemic planning: advice for hospices" from Help the Hospices has been updated and can also be downloaded from below.

DH website
Flu pandemic planning: advice for hospices

FDA botulinum toxin safety update

5th May 2009

As the result of an ongoing safety review, the US Food and Drug Administration (FDA) has notified the manufacturers of licensed botulinum toxin products to strengthen warnings in product labelling, and add a boxed warning, about the risk of adverse events when the effects of the toxin spread beyond the site of injection. A Risk Evaluation and Mitigation Strategy (REMS) should also be developed to ensure that the benefits of the product outweigh the risks to the patient. The REMS would include a communication plan and medication guide to provide more information on the risk for distant spread of botulinum toxin effects after local injection, as well as information to explain that botulinum toxin products cannot be interchanged.
The FDA is also requiring manufacturers to submit safety data of use in children and adults with spasticity to assess the signal of serious risk regarding distant spread of toxin effects.

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Itraconazole updated SPC

5th May 2009

The UK SPC for itraconazole (Sporanox, Janssen Cilag 0800 7318450) has been updated as follows:
Section 4.4 has been updated with "Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine".

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CKS topic review: palliative cancer care pain

30th April 2009

This topic review from Clinical Knowledge Summaries (CKS; formerly PRODIGY) covers the assessment and management of adults with cancer who are in pain.

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MHRA reminder: effects of MRI on implantable drug pumps

28th April 2009

The UK Medicines and Healthcare products Regulatory Agency (MHRA) issued a recent reminder about the effects of MRI scanning in patients with Medtronic Synchromed implantable drug pumps. These implantable pumps, which are often used to provide baclofen or morpine infusions, have been reported not to behave as expected when exposed to the magnetic field of an MRI scan.
The pump rotor is known to stop temporarily by MRI scanning, thus suspending the drug infusion, but should resume once the patient is removed from the MRI field. However, a medical device alert in December 2008 highlighted a risk of delay of the drug infusion restarting, following incident reports, and a delay in the logging of motor stall events.
Healthcare professionals should ensure departmental procedures are in place for MRI scanning of patients with implantable Medtronic Synchromed drug pumps and where discussion with pump management staff has not been possible, consider alternative imaging techniques or more regular observations of the patient to confirm the pump has restarted.
Full details of the effect of magnetic field on the pumps, the problem and action to be taken can be found in the MHRA medical device alert below.

MHRA drug safety update
MHRA medical device alert December 2008

MHRA safety advice: off-label use or unlicensed medicines

28th April 2009

The UK Medicines and Healthcare products Regulatory Agency (MHRA) recent drug safety update advises prescribers of their responsibilities and best practice when prescribing off-label or unlicensed medicines.

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MHRA safety advice: antipsychotics in elderly people with dementia

28th April 2009

The UK Medicines and Healthcare products Regulatory Agency (MHRA) issued a recent drug safety update reminding health professionals there is an increased risk of stroke and small increased risk of death when antipsychotics (typical or atypical) are used in elderly patients with dementia.
It also discusses the balance of risks and benefits of the use of risperidone to treat behavioural disturbances in dementia and its licensed indication for short term use for persistant aggression in alzheimers type dementia (black triangle status).

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MHRA safety advice: antiepileptics and adverse effects on bone

28th April 2009

The UK Medicines and Healthcare products Regulatory Agency (MHRA) recent drug safety update advises on the adverse effects of long term use of antiepileptics on bone.

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FDA allows interim production and distribution of unapproved morphine sulfate oral solution 20 mg/mL

21st April 2009

The US Food and Drug Administration (FDA) have agreed to allow the continued production and distribution of morphine sulfate oral solution 20mg/mL, currently an unapproved product, on an interim basis.
This announcement follows the FDA statement on 30th March 2009 warning manufacturers to stop the production and distribution of certain unapproved prescription opioids (see below) as part of the initiative against illegally marketed unapproved drugs. According to the FDA "Doctors and patients are often unaware that not all drugs on the market are backed by FDA approval. It is a high priority for the FDA to remove these products from the market because they may be unsafe, ineffective, inappropriately labelled, or of poor quality".
For the majority of drugs on the list, other approved formulations are available, however, there is not an approved formulation of high concentrate morphine sulfate oral solution 20mg/mL.
In light of concerns raised by patients and health professionals in the palliative care community, the FDA will now allow companies that are currently manufacturing and distributing unapproved morphine sulfate oral solution 20mg/ml to continue to do so on an interim basis until an FDA approved version of this product or another acceptable alternative therapy becomes available.
The FDA statement of the 30th March 2009 still stands for the other products listed which include unapproved formulations of immediate release morphine sulfate, hydromorphone and oxycodone tablets.

FDA announcement on morphine sulfate oral solution 20mg/ml
FDA statement 30th March
FDA question and answers on unapproved opioids

NLH annual evidence update on acupuncture

21st April 2009

The National Library of Health (NLH) complementary and alternative medicine library has produced an annual update on the evidence for acupuncture.

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RCP guidelines on botulinum toxin for spasticity

14th April 2009

The UK Royal College of Physicians (RCP) has published guidelines on the management of spasticity in adults with botulinum toxin. They can be downloaded from the RCP website link below.

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RCP guidelines on treating anaphylaxis

14th April 2009

The UK Royal College of Physicians (RCP) has published guidelines on the treatment of anaphylaxis. A copy of the guidelines can be obtained by contacting the RCP communications officer on 020 7935 1174 x354, e-mail zoe.horwich@rcplondon.ac.uk.

Thalidomide updated SPC

14th April 2009

The UK SPC for thalidomide pharmion 50mg hard capsules (Celgene 08448 010045) has been updated as follows:
Section 4.2 peripheral neuropathy guidelines have been amended.

Thalidomide Pharmion SPC

Lenalidomide updated SPC

14th April 2009

The UK SPC for Lenalidomide (Revlimid, Celegene 08448 010045) has been updated as follows:
Section 4.2 has been updated with new dosing guidelines for patients with impaired renal function.

Lenalidomide (Revlimid) SPC

GMC consultation on end of life treatment and care

7th April 2009

The UK General Medical Council (GMC) is consulting on new draft guidance, "End of life treatment and care: Good practice in decision-making". This updates and builds on the existing guidance "Withholding and withdrawing life-prolonging treatments" but also provides advice on end of life care more generally, including issues such as advance care planning, palliative care, bereavement issues and discussions about organ donation.
The consultation runs until 13 July 2009.

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NebuChamber (inhalation aid) recalled in UK

7th April 2009

All NebuChambers, an inhalation aid intended to be used with Pulmicort pressurised metered dose inhaler (AstraZeneca 01582 836836), have been recalled in the UK.
NebuChamber contains a one-way valve and it is essential that the mouthpiece is attached to the spacer in the correct direction. The product is normally manufactured to achieve this. AstraZeneca has received reports that the mouthpiece can sometimes be attached in the incorrect direction which is clinically significant.
AstraZeneca is requesting healthcare professionals contact known patients who have received a NebuChamber device and arrange for a device other than NebuChamber to be provided or switch the patient to an alternative medication. If an alternative device or treatment is not available or suitable, healthcare professionals are asked to emphasise the importance of correct assembly i.e. the frosted end of the mouthpiece must be attached to the spacer.

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MHRA drug alert: heparin sodium

7th April 2009

A very low level (0.6%) of over sulphated chondroitin sulphate (OSCS) has recently been identified in the active raw material used in the manufacture of 31 batches of CP Pharmaceuticals and Wockhardt UK heparin sodium injections distributed in the UK. This was identified using a more sensitive test method than was previously available. Wockhardt UK have provided details of affected presentations and batch numbers. Batches are in both CP (branded Monoparin and Multiparin) and Wockhardt (unbranded) livery.
Due to a potential out-of-stock situation which would have adverse clinical consequences, these products are NOT being recalled.
There is no evidence that this very low level of OSCS is associated with the anaphylactoid reactions reported following use of heparin with OSCS levels of 17 to 21% after i.v. administration, which were observed outside of the UK during 2007/8. Nonetheless healthcare professionals are advised to exercise particular caution when using the affected batches. Current evidence suggests that the risk of adverse reactions (ADRs) may be reduced by s.c. administration. Patients should be carefully monitored for signs of anaphylactoid or hypotensive reactions both during and after treatment, and standard therapies (ie vasopressor treatment and steroids) should be available as a precaution. Any suspected ADRs observed should be reported to the MHRA and Wockhardt UK in the usual way. As an extra precaution, it is suggested that batch details are recorded routinely in the patient's notes when using any heparin product.

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New National Clinical Guideline Centre

1st April 2009

A new National Clinical Guideline Centre (NCGC), formed from the merger of four National Collaborating Centres (NCCs) has been officially launched today in the UK.
Funded by the National Institute for Health and Clinical Excellence (NICE) and hosted by the Royal College of Physicians (RCP), the NCGC will replace the NCCs for acute conditions (based at the Royal College of Surgeons), chronic conditions (based at the RCP), nursing and supportive care (based at the Royal College of Nursing), and primary care (based at the Royal College of General Practitioners). All four established Royal Colleges will contribute to the governance of the new centre.

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NLH annual evidence update on pain

1st April 2009

The UK National Library of Health (NLH) supportive and palliative care specialist library has produced an annual evidence update on the following aspects of pain in supportive and palliative care:
. cannabinoids for pain management
. pain management in dementia
. pain and cancer survivorship

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MHRA consultation on reclassification of domperidone 10mg tablets

1st April 2009

The UK Medicines and Healthcare products Regulatory Agency (MHRA) is consulting on the reclassification of domperidone 10mg tablets (Motilium 10) from POM to P for the additional indication of nausea and vomiting of less than 48 hours duration. Domperidone can already be sold to the public for the relief of postprandial symptoms of excessive fullness, nausea, epigastric bloating and belching accompanied by epigastric discomfort and heartburn. Comments should be submitted to the MHRA by 7th May 2009.

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Celecoxib researcher admits fabricating data in 21 articles

31st March 2009

A leading researcher, Dr Scott Reuben, who supported the use of celecoxib, has admitted fabricating data in 21 of his 72 articles indexed by PubMed. A list of these articles, which have now been retracted, can be downloaded from the link below. A full report can be found in the British Medical Journal:
Lenzer J (2009) Prominent celecoxib researcher admits fabricating data in 21 articles. British Medical Journal 338: 618-619.
We have checked though the PCF3 and HPCF USA monographs. We currently have only one reference by this author, which is NOT on the retracted list. The reference appears in the general NSAIDs monograph in chapter 5 and refers to a statement on NSAIDs and bone healing. However, because the original data on which it was based cannot be guaranteed accurate, we are currently investigating alternative supporting evidence for the claims made by this reference and will amend the monograph.

Retraction notice
BMJ reference (registration required)

NICE guideline on diagnosis and treatment of breast cancer

31st March 2009

The UK National Institute for Health and Clinical Excellence (NICE) has issued a new guideline on best practice for the diagnosis and treatment of advanced breast cancer.

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Advance Care Planning national UK guidelines

26th March 2009

National guidelines have been published on advance care planning (ACP) in clinical practice in the UK. The guidelines have been jointly prepared by the British Geriatrics Society, Royal College of Physicians, Royal College of Nursing, Royal College of Psychiatrists, Royal College of General Practitioners, British Society of Rehabilitation Medicine, Alzheimer's Society, Help the Aged and the National Council for Palliative Care and can be downloaded from the Royal College of Physicians website (see link below).

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Dexamethasone 500microgram tablets available in UK

25th March 2009

Dexamethasone 500microgram tablets are now available again as a licensed product in the UK from Chemidex Pharma Ltd (01784 477167, info@chemidex.co.uk ). The tablets can be ordered direct from Movianto Healthcare (code DEX500T) or via mainline wholesalers (pip code 114-6091). The NHS list price is £29.50 per 28 tablets (no minimum order requirement).

Capsaicin patch (Qutenza) for peripheral neuropathic pain

24th March 2009

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has recommended the granting of a marketing authorisation for capsaicin 179mg cutaneous patch (Qutenza) for the treatment of peripheral neuropathic pain in non-diabetic adults, either alone or in combination with other medicinal products for pain.

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New BNF 57 available

24th March 2009

The latest edition of the British National Formulary (number 57, March 2009) is now available in print and on-line.

BNF website
What's new in BNF57

NPSA rapid response report: Reducing harm from oral bowel cleansing solutions

24th March 2009

The UK National Patient Safety Agency (NPSA) has issued a rapid response report on reducing the risk of harm from oral bowel cleansing solutions. Death and harm from electrolyte abnormalities, dehydration and serious gastro-intestinal problems have been reported following the inappropriate use of oral bowel cleansing solutions (Picolax, Citrafleet , Fleet Phospho-Soda, Klean Prep, Moviprep) prior to surgery and/or investigative procedures.
Harm from these medicines has resulted from lack of clarity in relation to who is authorising the use of these products (and is clinically responsible) and who is authorised to supply these products. The alert sets out action for all organisations in the NHS and independent sector where bowel cleansing solutions are used. Deadline for completed action is 7 September 2009.

Rapid response report on oral bowel cleansing solutions
Supporting information on oral bowel cleansing solutions
NPSA website

ICS statement on unlicensed and off-label prescribing

18th March 2009

The Intensive Care Society (ICS) has issued a consensus statement regarding the use of unlicensed medicines or licensed medicines for unlicensed uses in critically ill patients.

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SMC rejects oxycodone/naloxone prolonged release tablets (Targinact)

18th March 2009

The Scottish Medicines Consortium (SMC) has not accepted, within NHS Scotland, oxycodone/naloxone prolonged release tablets (Targinact) for the treatment of severe pain which can be adequately managed only with opioid analgesics. The SMC stated that "the addition of naloxone to oxycodone did not impair analgesia and improved bowel function when patients were not receiving regular laxative therapy. However the clinical benefit in patients receiving regular laxative therapy is uncertain and the manufacturer did not present a sufficiently robust economic analysis to gain acceptance by SMC".

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ACPA Guide 2009 - Pain Medications & Treatments

12th March 2009

The American Chronic Pain Association (ACPA) has published it's annually updated pain management reference. The 2009 update features expanded coverage of non-drug interventions and complementary therapies.

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Carbamazepine and genetic testing updated SPC

12th March 2009

The UK SPC for all Tegretol preparations (carbamazepine, Novartis Pharmaceuticals) have been updated with the following statement:
'Before deciding to initiate treatment, patients of Han Chinese and Thai origin should whenever possible be screened for HLA-B*1502 as this allele strongly predicts the risk of severe carbamazepine-associated Stevens-Johnson syndrome'.
This follows information from the MHRA in April 2008 (see below).
According to the SPC, if these individuals test positive for HLA-B*1502, carbamazepine should not be started unless there is no other therapeutic option. Patients who test negative, have a low risk of Stevens-Johnson syndrome, although the reactions may still very rarely occur. It is not known whether all individuals of south east-Asian ancestry are at risk due to lack of data. The allele HLA-B*1502 has been shown not to be associated to Stevens-Johnson syndrome in the Caucasian population.

Tegretol Retard SPC
MHRA report

Buprenorphine transdermal patch (BuTrans) updated SPC

10th March 2009

The following sections of the UK SPC for BuTrans 5, 10 and 20microgram/h (buprenorphine transdermal patch, Napp 01223 424912) have been updated as follows:
Section 4.1 The indication has changed from severe pain to moderate pain and now reads "BuTrans is indicated for the treatment of non-malignant pain of moderate intensity when an opioid is necessary for obtaining adequate analgesia. BuTrans is not suitable for the treatment of acute pain."
Section 4.6 A warning that BuTrans should not be used during pregnancy or in women of childbearing potential not using effective contraception has been added.

BuTrans SPC

Adcortyl in Orabase 10g discontinued in UK

10th March 2009

Bristol-Myers Squibb Pharmaceuticals has discontinued Adcortyl in Orabase (triamcinolone acetonide 0.1% in oral paste) 10g tubes as of 31st March 2009 or when current stock is exhausted.
A 5g tube of Adcortyl in Orabase obtainable as a Pharmacy medicine (P) for mouth ulcers will remain available on sale to the public. For further information, contact their Medical Information department on 0800 7311736.

Syringe driver survey - help needed please

12th February 2009

Calling all members! We are running the next palliativedrugs.com syringe driver survey throughout March/April 2009 and need as many people as possible to collect data on Continuous Subcutaneous Infusions (CSCI) prescribed in their units for 4 weeks during this time.
We feel it is particularly important to collate as much compatibility data as possible whilst the MHRA are reviewing the practice of mixing medicines, to demonstrate the extent to which this method of administration is used and the wealth of knowledge and practice available.
We have run the survey twice before with the help of www.palliativedrugs.com members from all over the world and this led to the setting up of our syringe driver survey database (SDSD) and also updating the compatibility charts for PCF3 and this website.
Please help us gather compatibility data which will benefit all members searching the SDSD and add to the body of clinical experience that the MHRA may draw upon.
If you would be prepared to be involved in the 4 week data collection survey please contact hq@palliativedrugs.com for further details. A copy of the form that will be used to record each CSCI is available to download from the link below, if possible we also ask that the data is added to the SDSD before sending us the completed forms, so that we can cross-check the entries.
If you are unable to help with the survey, please remember we welcome the addition of any drug combinations to the SDSD at any time, particularly those for which we have little or no data.

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SIGN booklet on cancer pain for patients and carers

10th February 2009

The Scottish Intercollegiate Guidelines Network (SIGN) has published a booklet for patients and carers on cancer pain. The booklet accompanies the SIGN guideline on this topic published in November 2008 (see news item 2008-11-14), both can be downloaded from the SIGN website link below.

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NLH: new section on GI symptoms

9th February 2009

The National Library for Health (NLH) palliative and supportive care specialist library has produced the first annual evidence update on 'gastrointestinal symptoms in supportive and palliative care'. It collects together evidence on nausea and vomiting, constipation and bowel obstruction.

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Fentanyl sublingual tablets (Abstral) launched in UK

5th February 2009

Fentanyl (as citrate) sublingual tablets (Abstral, Prostrakan 01896 664000) have been launched in the UK and are licensed for the management of breakthrough pain in adult patients using opioid therapy for chronic cancer pain.
The SPC describes maintenance opioid therapy as those who are taking at least 60mg of oral morphine daily, at least 25microgram of transdermal fentanyl per hour, or an equianalgesic dose of another opioid, for a week or longer.
The initial dose of Abstral should be 100microgram, titrating upwards as necessary through the range of available tablet strengths (100, 200, 300, 400, 600, 800microgram) to an effective dose (see the SPC below for full details of the method of titration). The SPC states that switching from other fentanyl containing products to Abstral must not occur at a 1:1 ratio because of different absorption profiles. If patients are switched from another fentanyl containing product, a new dose titration with Abstral is required.
Abstral sublingual tablets come in packs of 10 (100, 200, 300, 400microgram) and 30 (all strengths). The cost of 1 tablet (regardless of strength) is £4.99.
Another fentanyl tablet for breakthrough pain was also recently launched (see news item 2009-01-22).

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Piroxicam injection discontinued in UK

5th February 2009

Piroxicam (Feldene, Pfizer 01304 616161) intramuscular injection 20mg/ml will no longer be available from March 31st 2009 due to commercial reasons. Other presentations of piroxicam (capsules and melt tablets) will still be available.

Docusate sodium micro-enema updated SPC

5th February 2009

The UK SPC for docusate sodium micro-enema (Norgalax, Norgine 01895 826600) has been updated. The use of docustae sodium micro-enema is now contraindicated in: haemorrhoids, anal fissures, rectocolitis, anal bleeding, abdominal pain, intestinal obstruction, nausea, vomiting, inflammatory bowel disease, ileus and known hypersensitivity to any of the ingredients.

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Oxycodone/Naloxone product launched in UK

27th January 2009

Oxycodone hydrochloride/naloxone hydrochloride 10mg/5mg and 20mg/10mg prolonged-release (Targinact, Napp 01223 424444) have been launched in the UK and are licensed for the treatment of severe pain, which can be adequately managed only with opioid analgesics. The opioid antagonist naloxone is added to counteract opioid-induced constipation by blocking the action of oxycodone at opioid receptors locally in the gut.
The analgesic efficacy of Targinact is equivalent to oxycodone prolonged-release formulations. The maximum daily dose of Targinact is limited to 40 mg/20 mg (e.g. twice daily administration of Targinact 20 mg/10 mg prolonged-release tablets). Patients requiring higher doses should be administered supplemental prolonged-release oxycodone at the same time intervals. In the case of supplemental oxycodone dosing, the beneficial effect of naloxone on bowel function may be impaired.
A pack of 56 tablets of Targinact 10mg/5mg and 20mg/10mg costs £35.11 and £70.11 respectively.
A pack of 56 tablets of Oxycontin 10 mg and 20mg costs £26.45 and £52.89 respectively.

Targinact SPC

NCPC launches Mental Capacity Act summary guidance

27th January 2009

The UK National Council for Palliative Care (NCPC) has published Good Decision-making: the Mental Capacity Act and End of Life Care guide. This guide, written in straightforward language, is for patients, relatives, carers, residents in care homes and for health and social care staff and provides information about the Mental Capacity Act (MCA) and its impact on end of life care. It explains how people can use this legislation to express and protect their choices about their future care should they lose the capacity to make decisions for themselves. It contains checklists and references to more detailed information.
For more information and to order a copy of the guide see the NCPC website www.ncpc.org.uk (see link below).

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Fentanyl patch (Matrifen) updated SPC

27th January 2009

The UK SPC for Matrifen fentanyl patch (Nycomed 0800 633 5797) has been updated to include paediatric specific information and indications for use in opioid-tolerant patients aged 2-16 years of age.

Matrifen SPC

Nifedipine capsules updated SPC

27th January 2009

The UK SPC for nifedipine 5mg and 10mg immediate release capsules (Adalat, Bayer 01635 563393) has been updated in section 4.1 as follows:
- restriction of the indication from "hypertension" to "essential hypertension"
- restriction of use in patients with essential hypertension or chronic stable angina pectoris to use only when no other treatment is appropriate (due to demonstrable dose-dependant increase in cardiovascular complications and mortality in this population, when treated with fast-release forms of nifedipine).

Adalat SPC

Thank you for your support

22nd January 2009

A big thank you to 46 members who recently completed a survey when invited to do so. They are helping to keep palliativedrugs.com a free access resource. In appreciation of their help, 5 members selected at random to receive a free copy of PCF3 were Dr Boyland (UK), Dr von Hofacker (Norway), Dr Ponten (Sweden), Dr Montanari (Italy) and Dr Soderberg (Sweden). In addition, as first selected, Dr Boyland will also be able to donate £100 to a charity of her choice.
Without the help of these members we would have to charge a subscription fee. Please can all members consider supporting us in this way if invited to complete a survey.

Fentanyl buccal tablets (Effentora) launched in UK

22nd January 2009

Fentanyl buccal tablets (Effentora, Cephalon 0800 7834869) have been launched in the UK and are licensed for the treatment of breakthrough pain in adults with cancer who are already receiving maintenance opioid therapy for chronic cancer pain.
The SPC describes maintenance opioid therapy as 'those who are taking at least 60mg of oral morphine daily, at least 25microgram of transdermal fentanyl per hour, at least 30mg of oxycodone daily, at least 8mg of oral hydromorphone daily or an equianalgesic dose of another opioid, for a week or longer'.
In clinical studies, the effective dose of Effentora for breakthrough pain was not predictable from the daily maintenance dose of opioid. The initial dose of Effentora should be 100microgram, titrating upwards as necessary through the range of available tablet strengths (100, 200, 400, 600, 800microgram) to an effective dose (see the SPC below for full details of the method of titration). The bioavailability of Effentora differs significantly to other oral fentanyl products and independent dose titration with Effentora is required.
The tablets effervesce on contact with moisture and the SPC gives specific details of handling and administration to prevent premature disintegration of the tablets and ensure optimum drug absorption.
A box of 4 tablets Effentora (regardless of strength) costs £20.56.
Another fentanyl tablet for breakthrough pain has also been recently launched (see news item 2009-02-05).

click here to view

NLH: new section on self care in chronic disease

22nd January 2009

The National Library for Health (NLH) palliative and supportive care specialist library has produced the first annual evidence update on 'patient and carer involvement in chronic disease'. It collects together the best current knowledge on self care in a small sample of chronic conditions (kidney disease, lymphoedema and end-of-life care).

click here to view

Free prescriptions for cancer patients from April 2009 in UK

21st January 2009

The Department of Health has announced that people undergoing treatment for cancer, the effects of cancer, or the effects of cancer treatment will be eligible for free prescriptions from 1st April 2009. This includes palliative care cancer patients (see guidance below).
All cancer patients can apply for a 5year medical exemption certificate, which will entitle them to free NHS prescriptions for all medicines, not just those relating to cancer.
Application forms are now available from GP surgeries and oncology clinics and must be countersigned by the patient's GP, or hospital doctor. The form will then be sent to the NHS Business Services Authority, who will issue an exemption certificate. Applications received by 24th March will be processed in time to be used for 1st April.

DH press release
Guidance for doctors on exempt medical conditions

NICE supplementary advice document for end of life treatments

15th January 2009

The National Institute for Health and Clinical Excellence (NICE) has made available the supplementary advice document for appraising treatments which may extend life, at the end of life. The supplementary advice will be given to the institute's appraisal committees when they are evaluating end of life treatments. The changes follow a public consultation in November 2008 which ended on the 10th December 2008 (see news items 2008-11-27). The supplementary advice document, consultation responses and summary response to consultation can be accessed from the link below.

click here to view

FDA alert : US recall of Hydromorphone 2mg tablets (Ethex)

30th December 2008

A single lot of hydromorphone hydrochloride 2mg tablets (ETHEX Corporation, Lot 90219, Expiry 03/2010, NDC 58177-0620-04) have been recalled due to the potential for oversized tablets. The parent company of ETHEX Corporation, KV Pharmaceutical has advised the FDA that it is also voluntarily suspending shipments of all FDA-approved drug products in tablet form. This action is being taken as a precautionary measure, to allow KV to address manufacturing issues that have come to management's attention. Among the list of tablets affected are dextroamphetamine sulfate tablets, morphine sulfate extended release tablets, ondansetron orally disintegrating tablets, oxycodone hydrochloride tablets. The company is unable to determine when redistribution will resume. See the links below for more information.

FDA hydromorphone recall notice
FDA suspended shipments notice
FDA list of tablets affected

NPSA rapid response report: Reducing the risk of overdose with midazolam injection

11th December 2008

The NPSA has issued a rapid response report following 498 midazolam patient safety incidents between November 2004 and November 2008 where the dose prescribed or administered to the patient was inappropriate. Three of these incidents resulted in death.
The Report makes the following recommendations:
- storage and use of high strength midazolam (5mg/ml in 2ml and 10 ml ampoules; or 2mg/ml in 5ml ampoules) should be restricted to general anaesthesia, intensive care, palliative medicine and clinical areas/situations where its use has been formally risk assessed, for example, where syringe drivers are used
- in other clinical areas, storage and use of high strength midazolam should be replaced with low strength midazolam (1mg/ml in 2ml or 5ml ampoules)
- review therapeutic protocols to ensure that guidance on use of midazolam is clear and that the risks, particularly for the elderly or frail, are fully assessed
- ensure all healthcare practitioners involved directly or participating in sedation techniques have the necessary knowledge, skills and competences required
- ensure stocks of flumazenil are available where midazolam is used and the use of flumazenil is regularly audited as a marker of excessive dosing of midazolam
- ensure sedation is covered by organisational policy and that overall responsibility is assigned to a senior clinician which, in most cases, will be an anaesthetist.
The date for completion of actions is 09/06/09.

NPSA report on midazolam
NPSA report on midazolam, supporting evidence
NPSA website

MHRA consultation on mixing medicines in palliative care MLX 356

9th December 2008

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued a document (MLX 356) seeking views on its proposals to regularise the legal position of practitioners mixing and administering medicines in palliative care. This follows a position statement from the MHRA in September 2008 (see our news section 02-09-08).
The MHRA has reiterated it's previous guidance, both in the document and on it's website, stating that "whilst we secure a permanent legal basis for this long-standing practice, the Agency has issued a statement which makes clear that we would not consider enforcement action for breaches of medicines legislation by doctors, Nurse Independent Prescribers and Pharmacist Independent Prescribers prescribing and administering (and instructing others to administer) a mixture of licensed medication unless it would be in the public interest to do so. This also applies to those mixing in accordance with the directions of the prescriber."
The Royal Pharmaceutical Society of Great Britain (RPSGB) has issued a Law and Ethics Bulletin which takes the same view on this issue.
The MHRA have produced this document in conjuction with the Home Office as the practice of mixing medicines in palliative care involving controlled drugs is covered by both the Medicines Act 1968 and the Misuse of Drugs Regulations 2001.
We would encourage as many of you as possible to respond to this consultation, either on-line (via the link below) or in writing (address and details in the document). The deadline for response is 27 February 2009.

MHRA website link to MLX 356
MLX 356 document
RPSGB Law and Ethics Bulletin

Gabapentin (Neurontin) updated SPC

9th December 2008

The UK SPC for gabapentin (Neurontin, Pfizer 01304 616161) has been updated with a warning regarding suicidal ideation and behaviour in patients treated with antiepileptic medication. Also see our news report on MHRA advice on antiepileptics and suicidal thoughts 2008-08-04.

Neurontin SPC

Hospice and Palliative Care Formulary USA 2nd edition (HPCF2) now available

4th December 2008

HPCF2 is a comprehensive compendium which brings together a wealth of essential therapeutic information about drugs commonly used in hospice and palliative care, including drugs given for off-label indications or routes. Developed specifically for the USA, with the help of American pharmacists and an Editorial Advisory Panel.
HPCF2 costs $75 and can be ordered from Atlas books, or for members of the American Academy of Hospice and Palliative Medicine at the special price of $65. To claim this discount, go to the AAHPM website, log on and visit the Publisher Discount part of the members' only section.

Atlas books click here
AAHPM website click here

FDA questions and answers on erythropoiesis-stimulating agents medication guides

4th December 2008

The US Food and Drug Administration (FDA) has published a question and answer document regarding their patient medication guides on erythropoiesis-stimulating agents eg epoetin alfa (Procrit, Epogen) and darbepoetin alfa (Aranesp).

click here to view

EMEA review of conventional (typical) antipyschotics in elderly patients with dementia

4th December 2008

The European Medicines Agency (EMEA) has completed a review of the evidence on the safety of conventional (typical) antipyschotics in elderly patients with dementia and concluded that there is some evidence that these medicines can increase the risk of death in these patients.
The EMEA was unable to confirm whether the risk differs between individual conventional (typical) antipyschotics or whether the risk is greater with conventional (typical) antipyschotics than with atypical antipyschotics as suggested by some studies. The underlying mechanism is also unknown.
The EMEA has recommended that the product information (SPC) for all conventional (typical) antipyschotics be updated to include the increased risk of death in elderly patients with dementia in line with those for atypical antipyschotics.

EMEA review
EMEA Question and Answers

Oramorph oral solution 10mg/5ml recall

27th November 2008

The remaining stock of several batches of Oramorph oral solution 10mg/5ml have been recalled due to several complaints regarding deviation in taste and some non-serious adverse events.
The affected batch numbers are: 833206A, 833207A, 833208A, 833209A, 833210A, 833214A, 833215A, 833216A, 833217A, 832873B.
All unused stock of the above batches should be quarantined and returned for credit via the original supplier. Please contact Boehringer Ingelheim Ltd. for returns and credit enquiries (01344 741191) or for medical information (01344 741286).
Full details of the recall can be obtained from the MHRA website link below.

click here to view

NICE announces measures on end of life medicines

27th November 2008

The National Institute for Health and Clinical Excellence (NICE) has announced proposals regarding recommendations on the use of end of life medicines for rare illnesses. The proposed changes to its technology appraisal process will mean that NICE will be able to provide its independent advisory bodies with additional information on the use of medicines that can extend life in some patients with rarer terminal illnesses. The proposals will be subject to a consultation, which closes on the 10th December 2008.

Press release
NICE consultation

Consultation on the Manual for Cancer Services 2008: Draft Children's Measures

27th November 2008

The UK Department of Health (DH) has released a consultation document on the new children's cancer measures to be added to the revised Manual for Cancer Services 2008 (due to be published later this year). The closing date for the consultation is 30 January 2009. A copy of the document and a response proforma can be downloaded from the DH website link below.

click here to view

National Audit Office report: End of life care

26th November 2008

The UK National Audit Office has published a report examining the current provision of end of life care. The report highlights areas for improvement and the issues that will need to be addressed in the implementation of the Department of Health's End of Life Care Strategy (see news items 2008-11-10 and 2008-08-04).

click here to view

NICE guidance on metastatic spinal cord compression

26th November 2008

The UK National Institute for Health and Clinical Excellence (NICE) has published guidance on metastatic spinal cord compression in adults. The guidance covers adults who have, or are at risk of developing, metastatic spinal cord compression. A summary and commentary of the guidance has been published in the British Medical Journal (BMJ).

NICE guidance
BMJ summary (full text requires athens registration)
BMJ commentary (full text requires athens registration)

NCEPOD report on systemic anti-cancer therapy

26th November 2008

The National Confidential Enquiry into Patient Outcome and Death (NCEPOD) has released the report, Systemic anti-cancer therapy: For Better, for Worse? The report highlights the process of care of patients who died within 30 days of receiving systemic anti-cancer therapy and takes a critical look at areas where the care of patients might have been improved. A copy can be obtained via the link below.

click here to view

FDA alert for skin reactions with phenytoin

25th November 2008

The US Food and Drug Administration (FDA) is investigating new preliminary data regarding a potential increased risk of serious skin reactions including Stevens Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) from phenytoin therapy in Asian patients positive for a particular human leukocyte antigen (HLA) allele, HLA-B*1502. Because fosphenytoin is a prodrug and is converted to phenytoin after administration, any concern regarding this association is also applicable to fosphenytoin. The FDA and MHRA have previously issued advice regarding this allele and an increased risk of SJS/TEN with carbamazepine. As with carbamazepine, the risk for serious skin reactions with phenytoin appears to be greatest in the first few months of therapy. Prescribers are advised to consider avoiding phenytoin and fosphenytoin as alternatives for carbamazepine in patients who test positive for HLA-B*1502.

FDA alert for phenytoin
FDA alert for carbamazepine
MHRA report on carbamazepine

Formoterol turbohaler updated SPC

25th November 2008

The UK SPC for formoterol 6 and 12 inhalation powder (Oxis turbohaler) has been updated with the following information:
Product contains lactose, which contains small amounts of milk proteins; these may cause allergic reactions.

Oxis turbohaler SPC

EMEA suspension of fentanyl iontophoretic transdermal system

25th November 2008

The European Medicines Agency (EMEA) has recommended the suspension of the marketing authorisation of Ionsys (fentanyl iontophoretic transdermal system) because of a defect with the delivery system that could lead to patients being overdosed. All batches were recalled in the EU in September 2008 as a precautionary measure (see news item 2008-09-30), however the company has been unable to resolve the problems and prevent this defect occurring. The EMEA has therefore concluded that the benefits of Ionsys no longer outweigh its risks and has recommended the suspension of the marketing authorisation until the company can robustly demonstrate the quality of the product.

EMEA press release

Consultation document on palliative care bill for Scotland

25th November 2008

A consultation document on a bill which calls for access to needs-based, high-quality palliative care for everyone in Scotland has been published. It aims to place a statutory duty on health boards in Scotland to provide palliative care to those who need it. Responses must be submitted by 28 February 2009.

click here to view

MHRA warn defibrillators may fail

25th November 2008

The UK Medicines and Healthcare products Regulatory Agency (MHRA) have issued a warning about Medtronic Physio-Control LIFEPAK CR Plus automatic external defibrillators (AED). If you have these available in your unit, please read the information from the link below about concerns that the defibrillator could fail to turn on and work due to a faulty internal cable.

click here to view

SIGN 106 Control of pain in adults with cancer published

14th November 2008

The Scottish Intercollegiate Network (SIGN) has published guideline 106: Control of pain in adults with cancer, on-line and in print. The full guide, quick reference guide and British Medical Journal (BMJ) summary can be downloaded from the links below. The guidelines have also been added to our document library under the topic of Pain (general).

SIGN 106 full guide
SIGN 106 quick reference guide
BMJ article (full text requires athens registration)

CRD summary of oxygen for relief of dyspnoea

14th November 2008

The NHS Centre for Reviews and Dissemination (CRD) has commented on the systematic review and meta-analysis of oxygen for the relief of dyspnoea in mildly or non-hypoxaemic patients with cancer, published in the British Journal of Cancer in January, and added it to their Database of Abstracts of Reviews of Effects (DARE). The review of five small studies found no symptomatic benefit from oxygen therapy in patients with refractory dyspnoea. The CRD summary states that these findings are likely to be reliable, but should be interpreted with some degree of caution given the possibility of language and publication bias. The database entry and original full text paper can be accessed from the links below.

DARE entry
BJC article

DH consultation on End of Life Care Quality Markers

10th November 2008

The UK Department of Health (DH) has launched a consultation on Quality Markers for End of Life Care, as promised in the End of Life Care Strategy published in July (see our news 04/08/08). The document is aimed at commissioners, performance managers and providers of end of life care services, from the NHS, voluntary and independent sectors. The consultation period closes on 6th February 2009.

click here to view

Dexamethasone 500microgram tablets discontinued in UK

4th November 2008

Organon (01223 432700) has discontinued manufacturing dexamethasone 500microgram tablets in the UK for commercial reasons. Supplies are expected to be exhausted by the end of 2008, but a small emergency stock of the tablets will be reserved. Dexamethasone 2mg tablets will remain available. Dexamethasone oral solution 2mg/5ml (Dexsol, Rosemont 0113 2441999) is an alternative product for dexamethasone doses less than 2mg.

Dexsol SPC

Lidocaine 5% plaster revised SPC

4th November 2008

The UK SPC for lidocaine 5% medicated plaster (Versatis, Grunenthal Ltd 0870 351 8960) has been revised. The main changes are summarised below. Section 4.1: Indications updated - Versatis is indicated for the symptomatic relief of neuropathic pain associated with previous herpes zoster infection. Section 4.2: Clarification and further advice on application and duration of use of the plaster.
Section 4.3: Addition of - The plaster must not be applied to inflamed or injured skin, such as active herpes zoster lesions, atopic dermatitis or wounds.
Section 4.4: Updates to warnings including addition of information on lidocaine metabolites and information on long term use.

click here to view

Ketoconazole tablets updated SPC

4th November 2008

The UK SPC for ketoconazole tablets (Nizoral, Janssen-Cilag 0800 7318450) has been updated as follows.
Update to section 4.8 - Undesirable effects: addition of photosensitivity as an adverse effect.

click here to view

IASP Global Year Against Cancer Pain

4th November 2008

The International Association for the Study of Pain (IASP) has launched the 2008-2009 Global Year Against Cancer Pain to focus attention on the pain and suffering faced by people with cancer and seek to raise awareness, grow support and improve treatment.
Throughout the year, there will be various programs and events designed to highlight the issues associated with cancer pain.
Further information, including fact sheets on cancer pain topics are available from the IASP website link below.

click here to view

NHS advice on mixing two licensed products under PGD

13th October 2008

The UK NHS Patient Group Directions (PGD) website has published a frequently asked question entitled "Can two licensed medicinal products be mixed together prior to administration under a PGD?". The information was written in collaboration with the MHRA with some examples to help organisations and practitioners make an informed decision as to whether their practice creates an unlicensed product and therefore cannot be supplied or administered under a PGD. The information does not directly relate to palliative care, however, the MHRA has already confirmed that the mixing of medicines prior to administration by a syringe driver constitutes the creation of an unlicensed product and therefore cannot be supplied or administered under a PGD.
For information on non-medical (independent nurse or pharmacist) prescribing in palliative care, the MHRA recently produced a statement specifically addressing concerns about the mixing of drugs prior to administration via a syringe driver (see link below).

NHS PGD website
MHRA statement on mixing medications in palliative care

GI bleeding due to interaction between SSRIs and NSAIDs

7th October 2008

A meta-analysis has concluded that the combined use of a selective serotonin reuptake inhibitor (SSRI) and a non-steroidal anti-inflammatory drug (NSAID) may increase the relative risk of an upper gastro-intestinal (GI) bleed six times. It also found that the risk of having an upper (GI) bleed more than doubled in patients taking SSRIs alone, and tripled in those taking NSAIDs alone, compared with controls who were not.
The article can be accessed from the link below.
The NHS National Prescribing Centre (NPC) has produced an iblog discussing this article which can be accessed from the second link below.

click here to view
NPCi blog

Granisetron patches approved in the USA

7th October 2008

The US Food and Drug Administration (FDA) has approved granisetron transdermal patches (Sancuso, Prostrakan International) for the management of nausea in patients receiving chemotherapy. The manufacturer is also seeking approval from the European Medicines Agency.
Prescribing information can be downloaded from the link below.

click here to view

Zoledronic acid - SPC change

7th October 2008

The SPC for zoledronic acid (Zometa, Novartis 01276 698370) has been changed to state that it must not be mixed with calcium or other divalent cation-containing infusion solutions such as lactated Ringer's solution. To avoid potential incompatibilities, Zometa concentrate should be diluted with 0.9% saline or 5% glucose solution and should be administered as a single intravenous solution in a separate infusion line. Full details can be found in the SPC below.

click here to view

BTS publishes guidelines on emergency oxygen use in adults

7th October 2008

The British Thoracic Society (BTS) guidelines on emergency oxygen use in adult patients, has been published in the October 2008 issue of Thorax and an executive summary is available from the BTS website link below. There is no specific section in the guidelines on palliative care.

click here to view

GMC updated good prescribing practice guidelines

3rd October 2008

The UK General Medical Council (GMC) have updated their guidance on "good practice in prescribing medicines". The guidance includes prescribing unlicensed medicines, off-label medicines, patient group directions and remote prescribing.

click here to view

Tropisetron (Navoban) to be discontinued in UK

3rd October 2008

Novartis Pharmaceuticals UK Ltd (01276 698370) will be discontinuing all Navoban (tropisetron) presentations as a result of a commercial decision, with effect from 31st October 2008.

Prescribing information highlighted for methylnaltrexone bromide

3rd October 2008

Wyeth UK (0845 3670098) has highlighted two important features concerning the prescribing of methylnaltrexone bromide (relistor) at the request of the UK MHRA.
1. It should only be used when response to usual laxative treatment has not been sufficient in adults with advanced illness who have opioid-related constipation.
2. To avoid risk of overdose, patients and carers should be made aware that one vial does not always contain the appropriate single dose.
The letter sent to healthcare professionals can be downloaded from the link below.

click here to view

Fentanyl iontophoretic transdermal system withdrawal

30th September 2008

Janssen-Cilag Ltd are recalling all Ionsys iontophoretic transdermal system (fentanyl 40 microgram per dose) stock, irrespective of batch number in the UK. Some units of one batch of the transdermal system have been found to self-activate which has the potential to cause overdose. The device should be removed from patients immediately, alternative analgesia provided and patients monitored.
No other fentanyl products from Janssen-Cilag are affected. Medical information can be obtained from Janssen-Cilag Ltd (0800 0323013), returns and credit enquiries (01494 567400). The full MHRA withdrawal notice can be downloaded from the link below.

click here to view

New BNF 56 available

17th September 2008

The latest edition of the British National Formulary (number 56, September 2008) is now available in print and on-line.

BNF website
What's new in BNF56

PCF3 receives 5 star review

9th September 2008

We are delighted to report that PCF3 has received a 5 star review in the September 2008 issue of Palliative Medicine.
The review is available on-line from the link below (subscription required).

click here to view

MHRA warning on fentanyl patches

3rd September 2008

The MHRA have highlighted the risks of serious and fatal opioid overdose from erroneous prescribing, incorrect application and use of fentanyl patches in their latest drug safety update. The recommendations are similar to those issued by the US FDA in 2005 which have been encompassed in the PCF3 fentanyl monograph and guidelines on the use of transdermal fentanyl patches and can be found in the formulary section on this website.

click here to view

MHRA statement on mixing drugs in syringe drivers

2nd September 2008

The MHRA have issued a statement on non-medical prescribing and mixing medicines in palliative care. This follows concern from palliative care health professionals on previous MHRA advice stating that the mixing of two or more medicines prior to administration constitutes the manufacture of an unlicensed product and the implications this has for non-medical prescribing. The statement can be downloaded from the link below.
In summary, the MHRA stand by their original statement. However, having met with palliative care representatives, they recognise that palliative care requires special consideration and would not wish to obstruct the provision of effective pain relief to patients. This may lead to a change in medicines legislation. In the meantime the MHRA would not consider enforcement action for breaches of medicines legislation by a nurse or pharmacist independent prescriber engaging in the long standing accepted practice of prescribing and administering (and providing directions to others to administer) a mixture of licensed medication via a single injection or a syringe driver unless it would be in the public interest to do so. This also applies to those mixing and administering medicines in accordance with the directions of the prescriber.

click here to view

PCF3 Highly Commended in BMA book competition

28th August 2008

We are delighted to report that the PCF3 has been Highly Commended in the medicine category of the British Medical Associaton 2008 book competition and would like to thank all those involved who have contributed to this success.

click here to view

Epoetin Zeta (Retacrit) launched in UK

28th August 2008

Epoetin zeta (Retacrit, Hospira UK, 01926 821 010) has been launched in the UK. Full information on indications and use can be found in the SPC -

click here to view

NPSA warning on vinca alkaloid administration

28th August 2008

The UK National Patient Safety Agency (NPSA) has stated that vinca alkaloids, e.g. vincristine for adults and adolescents, should be prepared and administered in intravenous 50mL minibags not syringes, to reduce the risk of fatal wrong route error. All bags should contain the warning "For intravenous use only - fatal if administered by other routes" along with other recommendations to differentiate the minbags from other infusions.

click here to view

Updated DH guidance on intrathecal chemotherapy administration

28th August 2008

The Department of Health (DH) has produced updated national guidance for England on the safe administration of intrathecal chemotherapy. This has been produced alongside the guidance from the NPSA on the safe administration of vinca alkaloids (see other news item 28-08) to prevent fatal intrathecal administration. The DH guidance sets out a competency based system where only staff who have been trained, checked and entered on a register of designated personnel will be able to administer intrathecal chemotherapy.

click here to view

MHRA guidance on use of Epoetins in cancer

5th August 2008

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has summarised the recent published data and reports relating to the use of recombinant human erythropoietins (r-HuEPOs) for treatment of anaemia in cancer:
- available evidence suggests use is associated with reduced overall survival and a negative effect on progression free survival
- data do not allow definitive conclusion that the risk outweighs the benefit in their authorised indication in patients with cancer
- data suggests that blood transfusion should be the preferred option for the management of anaemia in patients with cancer, particularly those receiving adjuvant chemotherapy or who are being treated with curative intent and may be preferable in patients with advanced metastatic cancer who have a good survival prognosis
- the decision to administer r-HuEPOs should be based on an informed risk-benefit assessment with patient participation taking into account tumour type and stage, degree of anaemia, life expectancy, environmental factors and patient preference.

click here to view

MHRA review on safety of thalidomide and lenalidomide

5th August 2008

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has produced a review of the safety implications surrounding the use of lenalidomide and thalidomide now that both are licensed for the treatment of multiple myeloma in the EU.

click here to view

Thalidomide licensed and commercially available in UK

5th August 2008

Thalidomide was recently licensed in the EU for use in untreated multiple myeloma in those aged 65 years and over or ineligible for high dose chemotherapy in combination with Melphalan and Prednisone. Thalidomide is now commercially available as Thalidomide Pharmion (Celgene 08448 010045), and must be prescribed and dispensed in accordance with the Thalidomide Pharmion Pregnancy Prevention Programme. Only pharmacies that have registered will be able to obtain a supply of the product. Those pharmacies currently supplying patients with unlicensed Thalidomide Pharmion must now register with the Thalidomide Pharmion Pregnancy Prevention Programme to ensure continuity of supply of thalidomide for their patients.

click here to view

DH End of Life Care strategy published

4th August 2008

The UK Department of Health (DH) has published the End of Life Care strategy which promotes high quality care for all adults at the end of life. Its aim is to provide people with more choice about where they would like to live and die and encompasses all adults with advanced, progressive illness and care given in all settings.

click here to view

MHRA advice on antiepileptics and suicidal thoughts

4th August 2008

A Europe wide review has concluded that any antiepileptic drug may rarely be associated with a small increased risk of suicidal thoughts and behaviour. The review took into account antiepileptic drugs indicated for epilepsy, psychiatric disorders and other disorders including neuropathic pain. The UK Medicines and Healthcare products Regulatory Agency (MHRA) has advised that the risk of suicidal thoughts and behaviour may be seen as early as 1 week after starting treatment. Patients should be advised of the risk, to seek medical advice if they develop symptoms and should be referred for treatment if necessary. The available evidence does not define whether this risk differs between antiepileptics.

click here to view