Medication errors are a major public health burden in the European Union (EU). They are the most common preventable cause of adverse events and are estimated to account for 18.7% – 56% of all adverse drug events among hospitalised patients in Europe. Medication errors are defined as an unintended failure in the medication process which leads to, or has the potential to, harm the patient. According to EU Regulations and Good Vigilance Practice (GVP) Module VI, all medication errors require recording, evaluation, risk minimisation, prevention and medication errors causing adverse reactions require reporting.

The Heads of Medicines Agencies recently agreed an action plan to reduce the prevalence of medication errors and improve how medication errors are managed. This included the development of EU guidance documents for regulators and industry. The draft guidelines, “Good practice guide on recording, coding, reporting and assessment of medication errors” and “Good practice guide on risk minimisation and prevention of medication errors” were published by the European Medicines Agency (EMA) on the 14 April 2015 for public consultation.

The guidelines provide information for Marketing Authorisation Holders (MAHs) on the recording, coding, reporting and assessment of medication errors and risk management planning related to medication errors. They are clear and comprehensive documents which include requirements for MedDRA coding, report follow-up, risk minimisation tools and methods to assess the effectiveness of error prevention.

Of particular interest is section 5.7.1 of the recording, coding, reporting and assessment guideline. Here, the EMA suggest MAHs include a disclaimer when reporting medication errors in case reports to the competent authorities, to avoid any potential liability when classifying medication errors. The proposed disclaimer states that the report is classified as a medication error based on pharmacovigilance legislation and guidance and does not allege that the healthcare professional reporter has contributed to, or is to be held liable for the occurrence of the medication error. Fear of litigation is one of the top contributing factors to under-reporting in a number of published studies on reporting rates worldwide. The disclaimer may be intended to address this known barrier to reporting and improve medication error reporting rates. However, it is also interesting to suggest that this sort of disclaimer is required. Clearly the pharmacovigilance case assessment performed by the MAH is not intended to judge the performance of the healthcare professional as there could be many contributing factors to a medication error.

Also of interest is Section 7.4 of the guidance on risk minimisation and prevention of medication errors, which emphasises the need for MAHs to collect and evaluate cases of medication error which did not result in an adverse drug reaction, such as intercepted and potential errors. MAH’s should be recording information on the type of error, step in the treatment process when it occurred (or would have occurred) and any contributing or mitigating factors to assess the potential risk to patients and effectiveness of any risk minimisation measures that may be in place.

The guidelines provide much needed clarity for this area. Public consultation closed in June 2015 and it is likely that it generated a lot of views and input from stakeholders. It will be interesting to see what the outcomes are when final versions are published.

Links to the consultation:

Good practice guide on recording, coding, reporting and assessment of medication errors: Can be found here

Good practice guide on risk minimisation and prevention of medication errors: Can be found here 

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