english.prescrire.org > Topics > Advancing healthcare policy > Drug packaging and patient safety > Actions > Safety and usability of packaging and labelling: assessment prior to marketing authorisation for all medicinal products (11/2012)

Advancing healthcare policy

Drug packaging and patient safety

Drug packaging and patient safety: Actions
Safety and usability of packaging and labelling: assessment is required prior to marketing authorisation for all medicinal products, not just for copies of existing drugs (November 2012)

Paris, 29 November 2012

Poor packaging is a major cause of medication errors. In its response to the European Medicines Agency's public consultation on potential medication errors in the context of benefit risk balance and risk minimisation measures (1), Prescrire calls for the safety and usability of the packaging and labelling of new medicines to be assessed as part of the evaluation of marketing applications. Prescrire calls also for a re-examination of all the packaging of existing medicinal products.

> Click here to download Prescrire's response (pdf, 175 Ko)

Summary

  • The draft position paper that the European Medicines Agency (EMA) 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.
  • The identification of potential medication errors should result in measures to prevent their occurrence. Yet the EMA simply asks that a "risk management plan" be put in place, providing hardly any additional risk-prevention measures beyond those required whenever marketing authorisation (MA) or a variation is granted.
  • Prescrire's response to the EMA consultation details several concrete proposals that should enable health authorities to effectively reduce the risk of errors associated with medicines and related devices. Prescrire's two main proposals in order to effectively prevent preventable medication errors are that:
    • the safety and usability of the packaging and labelling of new medicines must be assessed as part of the evaluation of MA 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. They should also use various opportunities throughout the medicinal product's life (when examining applications for a major MA variation, in case of expanded distribution (when a hospital-only medicine is made available in the ambulatory sector), on reclassification, or during worksharing procedures to assess paediatric data under Article 45 of the Paediatric Regulation of 2006).

©Prescrire November 2012

References:
1. European Medicines Agency "Position paper on potential medication errors in the context of benefit risk balance and risk minimisation measures – Draft (EMA/274183/2012)" 24 May 2012: 6 pages.

> Click here to download Prescrire's response (pdf, 175 Ko)