E-DRUG: Prescrire on EMA and potential medication errors
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Dear E-druggers,
Prescrire responded to the EMA consultation on potential medication errors in the context of benefit risk balance and risk minimisation measures. The draft position paper that the European Medicines Agency released for consultation on 1st June 2012 is not about considering potential medication errors as part of the evaluation of all medicinal products before marketing authorisation is granted. It focuses on the risks generated by copies containing the same active substance as a medicinal product that is already marketed. The draft does not specify whether "umbrella" brands fall under the scope of this position paper, despite their dangers.
Poor packaging is a major cause of medication errors and Prescrire made two main proposals:
-the safety and usability of the packaging and labelling of new medicines must be assessed as part of the evaluation of Marketing Authorisation applications. Drug regulatory agencies must conduct this assessment and publish the results in a “medication errors public assessment report” well before the medicinal product is marketed;
-European authorities and national medicines agencies must re-examine existing medicinal products since the packaging of medicinal products is too often poorly designed and conducive to errors. They should begin with packaging items most frequently implicated in medication errors.
See Prescrire's response at:
http://english.prescrire.org/en/79/207/46302/2329/1884/SubReportDetails.aspx
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Christophe Kopp
Editor with Prescrire
Website: english.prescrire.org