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Safety updates

MHRA infusion device warning with 50mL syringes

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued two separate warnings of the risk of false occlusion alarms occurring with 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 has led to false occlusion alarms. To avoid this, the syringe pump occlusion alarm settings need to be adjusted by biomedical engineering departments. BD medical is recalling syringes of the old design to avoid the converse risk of a delay to the occlusion alarm being triggered when used in pumps that have been adjusted. For further details, 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 used in syringe pumps. For further details click here.


Drug updates

Sativex reclassified as schedule 4 part 1 Controlled Drug

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 license “for research 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.


Latest additions

Japanese translation of PCF now available!

A Japanese translation of the Palliative Care Formulary (PCF) is now available. It has been published by Igaku-Shoin and can be obtained from their website.

Prepared by Sarah Charlesworth and Andrew Wilcock

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