Regulatory Focus™ > News Articles > EU Regulators Identify Methods of Reducing Medication Errors, Seek Path Forward

Posted 23 May 2013 | By Alexander Gaffney, RAC

EU Regulators Identify Methods of Reducing Medication Errors, Seek Path Forward

EU regulators with the European Medicines Agency (EMA) have announced the issuance of six recommendations stemming from a workshop they recently conducted regarding methods to reduce medication errors.

That workshop, held in February 2013, brought together regulators across the EU in the hopes of raising awareness around new legal requirements for reporting medication errors and to generate best practices for EU regional regulators.

Those errors, as defined by the agency, include "unintended errors in the prescribing, dispensing or administration of a medicine while in the control of a healthcare professional, patient or consumer."

"They are the single most common preventable cause of adverse events in medication practice," EMA added.

The outcome of that workshop is a report issued by the agency that calls for six recommended actions to be implemented by regulators:

  1. The definitions and terminologies associated with medication errors need to be harmonized and further developed throughout the EU to support more nuanced reporting and cross-border reporting.
  2. Regulators must build partnerships between themselves, national patient safety authorities, the EMA and the European Commission.
  3. Regulators need to develop new methods of identifying medication errors through postmarketing surveillance data it now obtains from various sources.
  4. Regulators must support research into how to reduce medication errors.
  5. Regulators must build their capacity to accommodate patient, consumers and healthcare perspectives into the development of safe medication practices.
  6. Regulators must systematically assess the risks of a drug throughout its lifecycle and seek ways to prevent medication errors as it progresses from being used in narrow patient populations to wider ones.

EMA said it is now working with regional regulators and the European Commission to prioritize these recommendations and seek paths toward implementation.


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