New webpage and good practice guide on medication errors available from EMA

emea_strap_url_cmyk_rev_en_std_cent.eps MASTERThe European Medicines Agency (EMA) has published a good practice guide on medication errors to improve the reporting, evaluation and prevention of medication errors by regulatory authorities and pharmaceutical industry throughout the European Union (EU). This EMA good practice guide on medication errors complements the guideline on good pharmacovigilance practices (GVP) and other existing guidelines published by the EMA. It consists of two parts:

  • the first part details how suspected adverse reactions that are caused by medication errors should be recorded, coded, reported and assessed. EMA expects this will improve reporting and learning from medication errors for the benefit of public health.
  • the second part of the guide clarifies key principles of risk management planning by the EMA in relation to medication errors.

In parallel, EMA has launched a webpage highlighting measures recommended by the Agency to prevent medication errors for specific medicines. Although this information is also available in the European public assessment reports (EPAR) of these medicines, the purpose of these documents is to increase awareness of the additional measures recommended by EMA in order to ensure that a specific medicine is used correctly and to reduce the risk of medication errors. On November 27, 2015, EMA made following documents available on this new webpage:

  • Questions and answers on recommendations to prevent administration errors with Velcade (bortezomib) (20/01/2012)
  • European Medicines Agency recommends measures to ensure safe and effective use of Strensiq (26/06/2015)
  • Guidance on prevention of medication errors with high-strength insulins (27/11/2015)
  • Guidance on prevention of medication errors with diabetes medicines containing insulin and a non-insulin active substance (27/11/2015)
  • Compliance card to be given to patients using Farydak - Compliance card will ensure correct use and avoid medication errors (27/11/2015)

EMA efforts to communicate on any additional measure decided upon at EU level to prevent medication errors are welcome. However, as stated since a long time by the International Medication Safety Network (IMSN) members, education and information do not significantly reduce errors on their own, because they rely on memory. In particular, IMSN recommends that regulations for medicines naming, labelling and packaging in all countries should be strengthened to: require safer design and field testing before release for use; incorporate human factors theory; promote safer use in practice.

In October 2013, the International Medication Safety Network issued recommendations to regulators, pharmaceutical industry and healthcare providers as part of a comprehensive, worldwide solution to the problem of unsafe medicines naming, labelling and packaging. Download PDF

During the 2013 Paris Conference on safer naming, labelling and packaging of medicines, Dr. Michael Cohen, chairperson of IMSN, proposed that regulators and other stakeholders join IMSN at a summit to address this global threat to patient safety. This summit is expected to be held during fall 2015.