EMA Releases Draft Guides to Reduce and Report Medication Errors

Regulatory NewsRegulatory News | 16 April 2015 |  By 

To address the risk of medication errors, the European Medicines Agency (EMA) has released two new draft documents intended to guide regulators and industry in reporting, evaluating and preventing medication errors.

Medication errors are mistakes made when prescribing, dispensing and administering medicine. The agency says these errors are the "most common preventable cause of undesired harmful effects" related to medicine in the EU. According to EMA, these errors have an annual cost ranging from €4.5 to €21.8 billion and can affect up to 5.3% of inpatients.


The driving force behind the draft guides is the 2012 EU pharmacovigilance legislation, which requires the reporting of all adverse reactions related to medication errors. Companies and regulators are also required to input reported adverse events in the EudraVigilance database.

In 2013, EMA and the Heads of Medicines Agencies (HMA) agreed on a joint action plan on medication errors that sought to increase pharmacovigilance efforts and reduce the risk of medication errors to patients. The plan outlined several deliverables, including the drafting of the two guides released by EMA this week.

The Guides

The first document, Good practice guide on risk minimization and prevention of medication errors, is intended to help healthcare professionals and drug makers reduce the risk of medication errors and provide an overview of the main causes of these errors.

Medication errors can be made by healthcare professionals, patients and consumers. Familiar examples include when a drug is given to the wrong patient or when a patient is instructed to take the wrong amount of medication. Patients can also cause medication errors, which commonly occur when a patient taking multiple medications confuses the doses.

Pharmaceuticals companies also play a key role in minimizing the risk for medication errors. By considering the types of medication errors that are likely to occur early in a product's development and marketing, a company can take measures to ensure that its product is named, labeled and packaged in such a way that would reduce the chance of error or confusion.

Companies should also consider the impact certain changes to a product could have related to medication errors, including changes or differences in:

  • concentration or strength
  • pharmaceutical form
  • composition
  • method of preparation
  • route of administration
  • different administration device
  • patient population or indication
  • appearance or design

The second document, Good practice guide on recording, coding, reporting and assessment of medication errors, gives technical advice and definitions to regulators and pharmaceutical companies related to medication errors.

Companies are instructed to record and report errors, whether or not they are associated with an adverse event. For errors resulting in an adverse event, companies are required to submit an individual case safety report (ICSR) and include the event in a periodic safety update report (PSUR). Errors that are not associated with an adverse event, including potential and intercepted errors, should still be recorded and included in a PSUR.

Stakeholders responsible for reporting adverse events related to medication errors should also be familiar with the following EU and international guidelines:


EMA Press Release


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