Dealing With Medication Errors - EMA Calls For Coordinated EU Approach

Editor's Choice
Main Category: Regulatory Affairs / Drug Approvals
Article Date: 03 Mar 2013 - 0:00 PST


The European Medicines Agency (EMA) conducted a workshop aimed at a coordinated EU approach to tackling medication errors, which included proposals on how such errors are reported and prevented.

EMA says that national patient safety authorities, EMA, the European Commission and national competent authorities need to liaise closely to tackle the issue of medication errors which cause considerable harm in Europe.

EMA wrote today, at the end of the workshop which started on 28th February, that "This collaboration should engage patients and healthcare professionals."

The workshop brought together over 150 people from all stakeholder groups to find a way forward for improved reporting and effective prevention of medications errors.

EMA informs that EU pharmacovigilance legislation provides a clear legal framework for sharing information on medication errors that cause harm.

Since July 2012, legislation has required that all cases of suspected adverse drug reactions caused (or suspected to be caused) by medication errors be reported to the EU database of adverse drug reaction - EudraVigilance.

Sharing data on adverse drug reactions at European Union level has been shown to result in prompter identification of emerging safety issues, which makes it easier to prevent future errors through earlier detection of risks.

EMA's Pharmacovigilance Risk Assessment Committee (PRAC) says it will issue a best practice document and operational proposals for reporting and prevention of medication errors this year.

Medication errors in Europe and the world

EMA defines medication errors as:

"..unintentional errors in the prescribing, dispensing, or administration of a medicine while under the control of a healthcare professional, patient or consumer. They are the most common single preventable cause of adverse events in medication practice."

According to World Alliance for Patient Safety 2010, medication errors cost between EUR4.5 billion (US$5.84 billion) and EUR21 billion (US$27.27 billion) annually worldwide. They are "the single most preventable cause of adverse events in medication practice and a major public-health burden".

Medication errors include mistakes in clinical practice in the processes of:

• prescribing
• supplying
• dispensing
• preparing
• administering
• monitoring

In Europe, the following medication error rates were reported by the World Alliance for Patient Safety (2010):

• Primary care - 7.5% at prescription stage (primary care means general practice)
• Primary care - 0.08% at dispensing stage
• Hospital setting - from 0.3% to 0.1% at prescribing stage
• Hospital setting - form 1.6% to 2.1% at dispensing stage
• Ambulatory care - 7.5% at prescription stage (ambulatory care means any medical care that is given on an outpatient basis)
• Ambulatory care - 0.08% at dispensing stage

What are EMA's responsibilities regarding medication errors?

EMA has to facilitate the reporting of adverse drug reactions due to medication errors to EudraVigilance. EudraVigilance is a database designed to receive, process, store and make available data submitted electronically and support its analysis.

EMA also facilitates coordination between regulatory authorities in EU Member States, national patient-safety authorities, and national pharmacovigilance centers. "This is intended to enable the mutual exchange of information on adverse reactions resulting from medication errors and effective reporting to EudraVigilance."

Legal requirements

The new European Union pharmacovigilance legislation has brought with it some changes related to medication errors:

• Adverse reactions definition - now includes noxious and unintentional effects resulting not only from the authorized use of a drug at normal dosages, but also from errors and uses from off-label usage (outside the terms of the marketing authorization of the medication) - this includes the abuse and misuse of the drug. This is described in the guideline on Good Pharmacovigilance Practices.


• European Union Member States have to operate a pharmacovigilance system to gather data that is useful for the monitoring of medicines. "This includes information on suspected adverse reactions arising from use of a medicine within the terms of the marketing authorisation as well as from use outside these terms: this includes overdose, misuse, abuse and medication errors, as well as suspected adverse reactions associated with occupational exposure."


• Reports of adverse reactions caused by a medication error must be made available to the EudraVigilance database and to any relevant body, institution or organization within that Member State that is responsible for patient safety. Doctors, nurses and other healthcare professionals, as well as patients will be able to report these suspected adverse reactions directly online using standard web-based forms.

The February/March 2013 Workshop in medication errors

The aim of the workshop was to raise awareness of the new legal requirements and provisions among stakeholders involved in reporting, evaluating and preventing medication errors. The following themes were covered:

• What exactly is a medication error?
• What are the new legal requirements for reporting medication error cases at EU level?
• Understand how medication errors are managed at national level
• Discuss best practice for the prevention of medication errors
• Discuss and propose how to streamline efforts and resources between national competent authorities, patient-safety organizations, and pharmacovigilance centers
• Improve cooperation at international and national levels

Guidance from EMA

Module VI of the GVP guideline lays out the structures and process for reporting medication errors.

EMA's CHMP (Committee for Medicinal Products for Human Use) issued a Draft-Position Paper in 2012 on the potential for medication errors in the context of benefit-risk balance and measures to minimize risk. The document concentrated on medication errors that occur when a newly-introduced drug is confused with an existing one, or vice-versa.

Written by Christian Nordqvist
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

• Additional
• References
• Citations