NPC Archive Item: January Drug Safety Update from MHRA/CHM

NOTE – This is an archive post from the NPC and has not been updated since first publication. Therefore, some hyperlinks may no longer be working.

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29th January 2009

The Medicines and Healthcare products Regulatory Agency (MHRA) and the Commission on Human Medicines (CHM) have published the January edition of Drug Safety Update (DSU). This issue highlights important medicines management information with particular attention to drug safety advice regarding piperacillin/tazobactam, tacrolimus (Advagraf and Prograf), and temsirolimus▼ (Torisel). Each of these drugs has raised particular concern due to the risk of serious patient safety incidents involving medication.

What is the background to this?
Generic piperacilin/tazobactam products have different compatibilities with other medicines compared to Tazocin (the brand leader), raising a risk of serious medication errors.

Severe infusion-related hypersensitivity reactions have occurred in patients receiving temsirolimus▼. Patients must be closely monitored throughout infusion, and appropriate supportive care should be available. Up to April 3rd 2008, the marketing authorisation holder for temsirolimus▼ had received 46 spontaneous reports of infusion-related hypersensitivity reactions, one of which had a fatal outcome.

Tacrolimus (Advagraf and Prograf)
Prograf and Advagraf are not interchangeable and should not be substituted without careful therapeutic monitoring. Prograf and Advagraf contain the immunosuppressant tacrolimus, which has a narrow therapeutic index.

As of December 10th, 2008, medication errors with Prograf and Advagraf have been reported in seven EU countries; most reports were from the UK. Errors have fallen into one of three categories:

  • Prescribing errors by hospital doctor or GP (6 reports)
  • Dispensing errors by pharmacist, related to generic or brand prescribing (41 reports)
  • Administration errors by doctor, nurse, or patient (8 reports)

What does this mean to medicines management?
Medicines management has an important role to play in reducing medication errors and any adverse drug events caused by these medication errors. Healthcare professionals involved in medicines management need to be aware of the new safety information and advice regarding these drugs.  They should act quickly to improve the care taken with regard to their prescribing, dispensing, administration and monitoring. Systems, processes and procedures should be systematically reviewed.

How does this relate to other publications or evidence?
The National Patient Safety Agency has produced a seven step plan to reduce medication errors.1 This report provides a detailed description of the learning from reported medication incidents.

Drug Safety Update (DSU) is an essential read for everyone whose professional practice involves medicines. It is published every month in electronic format only.  Health professionals need to read the healthcare advice signposted in the January 2009 issue regarding these drugs, make use of the educational materials and resources available to raise patient awareness, and improve their communication links to share important sources of information that will help lead to better practice.

All healthcare professionals have a responsibility to identify contributing factors to medication errors and to use that information to further reduce their occurrence. A multidisciplinary approach to solving the problem of medication errors needs to be taken.2

Yellow Card Scheme
Please remember you can report suspected adverse events involving medicines using a yellow card at

Item details
Drug Safety Update


  1. National Patient Safety Agency. The fourth report from Patient Safety Observatory. Safety in doses: medication incidents in the NHS. London: NPSA 2007 2806_RevisedPSOforweb.pdf
  2. Williams, D. J. P. (2007). Medication Errors. J R Coll Physicians Edinb 2007; 37:343–346 [online] Available at:

National Prescribing Centre, 2008. Reducing medication errors – Five Minute Guide