EMA Publishes Medication Error Good Practice Guide

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The agency promotes safer use of drugs and prevention of medication errors through a new webpage and practice guide.

The European Medicines Agency announced on Nov. 27, 2015 the publication of a good practice guide on medication errors and the launch of a webpage that hosts recommended measures for the prevention of medication errors for specific medicines. The guide was created “to improve the reporting, evaluation and prevention of medication errors by regulatory authorities and pharmaceutical industry throughout the European Union.” The webpage “will include clear and easy-to-understand information to patients and healthcare professionals to further promote the safe use of medicines.”

According to EMA, medication errors among hospitalized patients are the cause of 18.7–56% of adverse events. While labeling and leaflets are designed to ensure correct usage of drugs, additional measures are sometimes needed. EMA plans to communicate those additional measures through the new webpage. “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,” EMA stated in a press release.

The new guide details how suspected adverse reactions that are caused by medication errors should be recorded, coded, reported, and assessed. It also “clarifies key principles of risk management planning in relation to medication errors and 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 complements the guideline on good pharmacovigilance practices and other existing EMA guidelines.


Source: European Medicines Agency