EMA releases good practice guides on preventing medication errors
Three documents have been released on this subject
Good practice guides designed to improve the reporting, evaluation and prevention of medication errors have been released by the European Medicines Agency (EMA). One of these advises pharmaceutical companies about their pharmacovigilance data obligations. It covers the recording, coding, reporting and assessment of medication errors associated with suspected adverse reactions.
The goal is to spread information to minimise errors in prescribing, dispensing, preparing or administering authorised medicines.
A second guidance focuses on the role of pharma manufacturers (and other healthcare players) in preventing such mistakes happening in the first place. It stresses not only how companies should collate all solicited and unsolicited reports of suspected adverse reactions, but also how they should consider options for risk minimisation and prevention and take appropriate measures. The guidance notes how pharmaceutical companies 'shall operate a risk management system for each medicinal product and monitor the outcome of risk minimisation measures', contained in a risk management plan or laid down as a marketing authorisation condition.
About the guidance, EMA said: '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 mandating reporting of suspected adverse reactions (directive 2010/84/EU and regulation No. 1235/2010), the guides aim to support industry and regulators in implementing these legal requirements.
Meanwhile, the Agency has also released special guidance focusing on the risk of medication errors linked to new high-strength insulin (higher than the EU-wide standard of 100 units/ml concentration) and other medicines containing insulin. The agency is concerned about harm being caused by over- or under-dosing, and is proposing a strategy to address this risk in a harmonised way across the EU.