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.
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 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.
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.
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.
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.
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.
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.
Recent news
- Calling all members - please complete our satisfaction survey!
- pH testing for nasogastric tube positioning is cost effective
- Hydromorphone injection now authorized in the UK
- Patient Safety Alert: Risk of death and severe harm from error with injectable phenytoin
- PCF5+ 2016 PDF now available
- Hydrocortisone 100mg/mL injection batch recall
- Medicines optimisation consultation
- Medical device alert: insulin delivery devices
- IV carbamazepine authorized in the US
- PCF5+ 2016 pdf available soon!
News archive
- 2016
- 2015
- 2014
- 2013
- 2012
- 2011
- 2010
- 2009
- 2008
- 2008
- 2007
- 2006
- 2005
- 2004
- 2003
- 2002
- 2001
- 2000