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Buccolam pre-filled syringes: medicines defect information

7th December 2017

MHRA have highlighted reports that the translucent tip-cap of Buccolam (midazolam) oromucosal syringes (all strengths) sometimes remains on the syringe tip when the red outer cap is pulled off. The company are highlighting that the translucent tip cap must be removed manually to enable the administration of Buccolam, and prevent it falling into the patient’s mouth upon application of extreme pressure. Health professionals, patients and carers should be advised to check that the tip cap has been removed before attempting administration.

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Items which should not be routinely prescribed in primary care

7th December 2017

NHS England and NHS Clinical Commissioners have now published guidance for Clinical Commissioning Groups (CCGs) on items which should not be routinely prescribed in primary care. This follows a recent consultation (see our news item).

The list includes items which may be relevant to palliative care. Since the consultation, slight changes to the guidance for fentanyl immediate-release products and lidocaine patches have been made (see below).

In summary, it is now recommended that prescribers in primary care should not initiate the following products for any new patient and that CCGs should support the deprescribing of these products:

  • immediate-release fentanyl products; unless for palliative care and in line with NICE guidance and in conjunction with specialist recommendation
  • lidocaine plasters – unless for post herpetic neuralgia in line with NICE guidance
  • oxycodone and naloxone combination products
  • rubefacients (excluding topical NSAIDs)
  • tramadol and paracetamol combination products.

Note. If, in exceptional circumstances there is a clinical need for immediate-release fentanyl, lidocaine plasters or oxycodone/naloxone combination products to be prescribed in primary care, this should be undertaken in a co-operation arrangement with a multi-disciplinary team and/or other health professional.

Other products covered in the guidance are: coproxamol, dosulepin, doxazosin modified-release, glucosamine and chondroitin, herbal treatments, homeopathy, liothyronine, lutein and antioxidants, omega-3 fatty acid compounds, perindopril arginine, tadalafil (once daily), travel vaccines, trimipramine.

A further consultation on the prescribing of over-the-counter products is expected.

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SIGN guidelines on the management of diabetes

29th November 2017

SIGN 116 guideline: management of diabetes has been updated. In addition, a new guideline, SIGN 154: pharmacological management of glycaemic control in people with type 2 diabetes, has been published. 

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Cochrane review: ketamine as an adjuvant to opioids for cancer pain

29th November 2017

This update (last updated in 2012) has been published in full on-line. The authors conclude that there is still insufficient evidence to assess the benefits and harms of ketamine as an adjuvant to opioids for the relief of refractory cancer pain. The evidence is very low quality. Rapid dose escalation of ketamine to high-dose (500mg) does not appear to have clinical benefit and may be associated with serious undesirable effects. More randomised controlled trials regarding specific low-dose ketamine clinical regimens in current use are needed.

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Calcichew-D3 500mg/400 IU caplets (Takeda) batch recall

28th November 2017

Takeda UK are recalling a specific batch of calcichew-D3 500mg/400 IU caplets due to traces of a non-approved excipient (not thought to pose a significant risk to health). The details are as follows:

Batch number: 11372123

Expiry date: May 2019

Distribution since: 15 November 2017.

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Submit your levetiracetam combinations to the SDSD

23rd November 2017

We have added levetiracetam to the drug selection list on our syringe driver survey database (SDSD). We are now able to accept and display anecdotal compatibility information on the combination of levetiracetam with other drugs. For more information on the use of levetiracetam via CSCI, see the PCF6 levetiracetam monograph.

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PCF6 book now available

21st November 2017

We are delighted to announce that the Palliative Care Formulary 6th edition, PCF6, is now available in print to purchase from our website store for £55 (including p&p in the UK). It contains the latest content of the on-line Palliative Care Formulary as of September 2017. Over these next two weeks, we will be giving priority to processing and dispatching copies to those members who pre-ordered PCF6 during September and October.

Since the publication of PCF5 in 2014, the content has been reviewed and extensively updated. PCF6 has 35 chapters and appendices, an increase of three from PCF5. In Part 1, some drug monographs have been merged and new ones added. Part 2 has been divided into Parts 2 and 3. The new chapters are all in Part 2: Prescribing in children, Renal impairment and Hepatic impairment. Part 3 covers Routes of Administration.

Although written primarily with cancer patients in mind, PCF6 contains specific material relating to several other life-limiting diseases e.g. COPD, congestive heart failure, renal failure, and Parkinson's disease. PCF also includes a number of Quick Clinical Guides

The on-line version of the Palliative Care Formulary is updated continuously and will thus provide access to the most up to date content. Details of on-line subscription including combination packages for purchasing with the print version are available from our store. Further details on bulk purchasing of any format can be obtained by contacting hq@palliativedrugs.com.

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SMC accepts Epistatus 10mg oromucosal solution

17th November 2017

The Scottish Medicines Consortium (SMC) has accepted the Epistatus® brand of midazolam 10mg oromucosal solution for buccal administration for the treatment of prolonged, acute seizures in children and adolescents aged 10 to <18 years.

Note. This product was authorized earlier in 2017 (see our news item) Epistatus® oromucosal solution is 10mg/mL; this is double the concentration of the other authorized formulation of midazolam oromucosal solution (Buccolam®) in the UK, which is 5mg/mL and available as 2.5mg, 5mg, 7.5mg and 10mg prefilled oral syringes.

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Tranexamic acid 500mg tablet shortage

17th November 2017

We understand that there are currently limited supplies of generic tranexamic acid 500mg tablets due to a difficulty in manufacturers obtaining raw materials. Some supplies of branded tranexamic acid 500mg tablets (Cyklokapron), over the counter product (Cyklo-f) and some generic tranexamic acid 500mg tablets may still be available, however intermittent supply issues are expected until at least 2018.

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Gabapentin and pregabalin consultation on proposals to schedule under Misuse of Drugs Regulations

14th November 2017

The government have opened a consultation on proposals to schedule gabapentin and pregabalin under the Misuse of Drugs Regulations 2001. The preferred option, as recommended by the Advisory Council on the Misuse of Drugs (ACMD) is that these drugs should be controlled as Class C drugs (under the Misuse of drugs Act 1971) and placed in Schedule 3 (to the Misuse of Drugs Regulations 2001). Comments are welcome from all interested parties by 22 January 2018. 

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Paracetamol infusion risk management

30th October 2017

Risk management material for paracetamol 10mg/mL infusion has been produced by Actavis, highlighting the risks of dosing error and providing guidelines for correct administration.

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Gabapentin: risk of severe respiratory depression

25th October 2017

The MHRA has highlighted a rare risk of severe respiratory depression in patients taking gabapentin even without concomitant opioids. Dose adjustments may be necessary in patients at higher risk of respiratory depression, including the elderly, those with compromised respiratory function, respiratory or neurological disease, renal impairment, or taking other CNS depressants. This advice follows a European review and the SPC for gabapentin is being updated. 

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Solu-medrone 40mg: do not use in cows' milk allergy

25th October 2017

Solu-Medrone 40mg (methylprednisolone injection) uses lactose produced from cows’ milk as an excipient and may contain trace amounts of milk proteins. It should not be used in patients with a known or suspected allergy to cows’ milk, as serious allergic reactions have been reported.

Other strengths of Solu-Medrone do not contain lactose. Lactose-containing methylprednisolone medicines will be reformulated to remove any trace of milk proteins. Companies have been asked to take steps towards lactose-free formulations by 2019.

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Recombinant human erythropoietins: risk of severe cutaneous adverse reactions

24th October 2017

MHRA has informed healthcare professionals of the very rare risk of severe cutaneous reactions in patients treated with any recombinant human erythropoietin (r-HuEPO). The product information is being updated.

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Clozapine: potentially fatal risk of intestinal obstruction, faecal impaction, and paralytic ileus

24th October 2017

MHRA has reminded health professionals that clozapine has been associated with varying degrees of impairment of intestinal peristalsis ranging from constipation (very common), to intestinal obstruction, faecal impaction, and paralytic ileus (very rare). Patients should be advised to report constipation immediately and it should be actively treated. Particular care should be taken in patients receiving other drugs known to cause constipation (especially those with anticholinergic properties), patients with a history of colonic disease or lower abdominal surgery, and in patients ≥ 60 years. Clozapine is contra-indicated in patients with paralytic ileus.

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