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ema draft medication errorsApril 22 2015

Draft proposals to help prevent medication errors while improving reporting and evaluation of them have been issued by the European Medicines Agency.

One of the two guides focuses on the prevention of medication errors and describes the main sources and types of these errors. It also proposes measures to minimise the risk of errors throughout the life cycle of a medicine.

The other looks at how suspected adverse reactions arising from medication errors should be documented and assessed. It also makes recommendations for manufacturers and suppliers of medicines on how to report information that has been brought to their attention but has not caused an adverse event.

Changes in EU pharmacovigilence legislation were introduced in 2012 meaning the reporting of all suspected adverse reactions resulting from medication errors became mandatory, says the EMA. “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.”

Included in the first document are number of adverse events that have arisen relating to the pharmaceutical presentation of a medicine: its format, whether route of administration, and adverse events relating to devices. It also makes design proposals for dosage formats to help address problems.

One recommendation is that choice of colour should be considered in product design. An example is, given: “Pharmacists have raised concerns that a fixed-dose combination of vilanterol and fluticasone furoate with indications in the maintenance treatment of asthma and COPD may be used in error for the relief of symptoms of for reliever inhalers, blue being a common choice of colour for reliever inhalers in some EU Member States.”

With regards recording, coding, reporting and assessing medication errors, EMA sets out a number of definitions, and describes structures and processes for reporting events. It considers, for example, how a pharmacist should record the potential for an error due to the similarity in medicine names.

Alongside these documents, the EMA has also issued a draft addendum dealing with the risk of medication errors linked to high-strength insulin and other medicines containing insulin.

Among the key safety messages for health professionals included in this document are:

•    there is a need for the prescriber, nurse or pharmacist to explain to the patient the key differences in appearance of the different short and long acting insulin products that are being prescribed.
•    pharmacists should be aware that insulins are now available in different strengths.
•    pharmacists are recommended to ask patients/carers to visually identify the strength of insulin dispensed in order to ensure patients/carers are able to read  the dose counter of the pen device.

Comments on the draft proposals should be submitted by June 14 2015.

Links:

EMA announcement    

EMA ‘Good practice guide on risk minimisation and prevention of medication errors’    

EMA ‘Risk minimisation strategy for high strength and fixed combination insulin products, addendum to the good practice guide on risk minimisation and prevention of medication errors’    

EMA ‘Good practice guide on recording, coding, reporting and assessment of medication errors’    

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