EMA Issues Good Practice Guide on Medication Errors

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 12-01-2015 12:30


The 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). In parallel, the EMA has launched a webpage highlighting measures recommended by the agency to prevent medication errors for specific medicines. This page will include clear and easy-to-understand information to patients and healthcare professionals to further promote the safe use of medicines.

A medication error is a mistake in the use of a medicine that can be harmful for a patient. Medication errors can occur for many reasons at the time of prescribing, dispensing, storing, preparation, or administration of a medicine. It is estimated that among hospitalised patients 18.7% to 56% of adverse events are caused by medication errors.

In the EU, national competent authorities and the EMA play a key role in identifying and reducing the risk of medication errors before and after the authorization of a medicine. For all medicines, the presentation, labeling, and leaflet are designed to prevent medication errors. However, in some cases, additional measures are needed to ensure that the medicine is used correctly, for example by introducing educational programs for healthcare professionals and patients. The EMA will now systematically communicate on any additional measure decided upon at EU level to prevent medication errors. The new webpage will offer a reference point to patients and healthcare professionals for key advice on how to prevent medication errors in order to ensure the safe use of medicines.

The good practice guide on medication errors complements the guideline on good pharmacovigilance practices (GVP) and other existing guidelines published by the agency. 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. The goal is to improve reporting and to learn from medication errors for the benefit of public health. The second part of the guide clarifies key principles of risk management planning in relation to medication errors. It describes the main sources and types of medication errors and proposes options to minimize the risk of medication errors throughout the lifespan of a medicine.

The guide was released for public consultation from April 14, 2015 to June 14, 2015. It is one of the key deliverables of the EMA/Heads of Medicines Agencies (HMA) joint action plan on medication errors agreed in 2013.

Source: European Medicines Agency


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