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 10^th 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 März/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 13^th 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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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. 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 1^st 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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