The workshop was opened by EMA Director Guido Rasi who stated that, although the reporting of suspected adverse drug reactions to the EMA-administered EudraVigilance database forms an integral part of the new pharmacovigilance legislation, medication errors are extremely common and they lead to high numbers of fatalities. Hence, a harmonised approach for dealing with them is needed in the EU.

Peter Arlett, EMA head of Pharmacovigilance and Risk Management stated that the overall goal of the workshop was to raise awareness about the reporting, evaluation and prevention of medical errors; to create a common understanding of what constitutes a medication error (there exists no legal definition in EU), as well as of the new legal requirements under pharmacovigilance rules for reporting cases; to gather knowledge of relevant issues at national level and share information on good practices. The outputs will be synthesized into a workshop report with key recommendations, and it is hoped that concrete operational improvements will follow suit.

In his keynote lecture, David Cousins of the NHS Commissioning Board (UK) identified medication errors as a major public health burden; however, many such errors were preventable. They occur on a daily basis in all healthcare settings and processes, from prescribing to dispensing and administering medicines. Some examples are related to wrong dosage (e.g. incidental overdosing, confusing loading and maintenance doses) and frequency, skill-based and attention-based mistakes made by health professionals (e.g. lack of knowledge of using insulin pens), diagnostic errors, drug or fluid management, changes in packaging, etc. He therefore emphasised the need for a broader view of patient safety, as well as greater understanding of systems of use and of the human factor since ’’making errors is part of the human condition’’. He called for closer cooperation between patient safety and pharmacovigilance advocates to create greater awareness of professional practice and also stated that it is vital to establish a link with the use of medical devices for prescribing, preparing and administering medicines, including electronic systems. Moreover, new methods for identifying and communicating risks are needed, going beyond mere signal detection. Finally, medication errors could be avoided through better use of technology, e.g. e-prescribing and dispensing, and extending the use of bar codes to patient safety and not just anti-counterfeiting purposes, a point also stressed by EPHA member Jurate Svarcaite of the Pharmaceutical Group in the European Union (PGEU), representing community pharmacists.

The other workshop presentations covered many interesting areas including the following:
- Need for a standard definition of medication errors
- Industry perspective: identifying and addressing medication errors during drug development, evaluation and post-authorisation;
- Medication errors in risk groups, like paediatric and older patient communities, the latter also being affected by polypharmacy effects;
- Reporting needs at patient and healthcare professional levels;
- Product-naming (generic vs brand names, similar names of different products) and related professional issues (illegible handwriting, using acronyms, etc.);
- Labelling / package leaflet issues (confusion caused by inconsistent approaches, benefits of using user-friendly nomenclature, design and colour);
- Steps patients can take to minimise medication errors, the need to educate patients re: self-administration of medicines (e.g. no sharing) and taking appropriate action if errors should occur.

The November 2012 European Commission report on patient safety was also discussed at the meeting in support of actions such as finding common terminologies and indicators, exchanging good practices, and developing more research on patient safety.

For more information

- European Medicines Agency - Medication errors
- EMA Position Paper on potential medication errors in the context of benefit risk balance and risk minimisation measures (draft)


EPHA related articles:

Last modified on March 29 2013.