EMA invites comments on draft good practice guides
The European Medicines Agency (EMA), on behalf of the European Union (EU) Regulatory Network, has released two draft good practice guides that aim to improve the reporting, evaluation and prevention of medication errors by regulatory authorities and pharmaceutical industry throughout the EU. The deadline for stakeholders to send their comments to EMA is 14 June 2015.
Medication errors are unintended mistakes in the prescribing, dispensing and administration of a medicine that could cause harm to a patient. They are the most common preventable cause of undesired harmful effects (adverse events) in medication practice and present a major public health burden.
With the entry into force of the EU pharmacovigilance legislation in 2012, reporting of all suspected adverse reactions resulting from medication errors became mandatory. Pharmaceutical companies and national regulatory agencies in the EU Members States are obliged to enter these adverse events in EudraVigilance, the EU adverse reaction collection and management system. The primary purpose of the two guides released today is to support industry and regulators in the implementation of these legal requirements.
One of the two guides focuses on the prevention of medication errors. It describes the main sources and types of these errors and proposes measures to minimise the risk of medication errors throughout the life cycle of a medicine.
The other guide provides guidance on how suspected adverse reactions that are caused by medication errors should be recorded, coded, reported and assessed. It also gives recommendations for marketing-authorisation holders on how to report information on medication errors that are brought to their attention but have not caused adverse reactions. This information must be provided in periodic safety update reports and in the risk management plans that are compulsory for all medicines. This allows a continuous evaluation of the benefits and risks of a medicine based on real life data by regulators.
The guidance released today is one of the key deliverables of the EMA/Heads of Medicines Agencies (HMA) joint action plan on medication errors agreed in 2013. It was developed in consultation with the European Commission’s Patient Safety Quality of Care Working Group and takes into account recommendations from stakeholders that were gathered during a workshop held at EMA in February 2013.
Minimising the risk linked to new insulin medicines
Also released for public consultation today is an addendum to this good practice guidance which focuses on the risk of medication errors linked to new high-strength insulin and other medicines containing insulins.
The guidance was developed by EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) over concerns that medication errors with these new medicines could harm patients through over- or under-dosing.
The guidance provides a strategy to proactively address this risk in a harmonised way across the EU. It may be revised as more experience with these medicines is gathered.
Stakeholders are invited to provide comments on the good practice guide and the addendum on insulins by 14 June 2015 to firstname.lastname@example.org.
The cover pages of the consultation documents provide specific questions on which stakeholders’ feedback is sought and detailed instructions on how to submit comments.
Posted on the EMA website on 14 April 2015