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Advancing healthcare policy

Drug packaging and patient safety

Advancing healthcare policy

Drug packaging and patient safety: Actions

Reinforcing the safety and ease of use of the drug packaging autorised in Europe. Our actions below.

Methotrexate: room for improvement in packaging and patient information (May 2018)

Prescrire took part in the informal consultation undertaken by the Pharmacovigilance and Risk Assessment Committee (PRAC, the EMA’s medicines safety body), regarding medication errors due to daily instead of weekly administration of methotrexate in non-oncologic indications, and evaluating the effectiveness of risk minimisation measures intended to prevent such errors. Prescrire urges that several root causes which are within the remit of the European Medicines Agency, such as regulation, packaging, labelling and medication safety awareness, not be overlooked. Read on...
Drug therapy and medication safety for older people clearly require more attention (January 2018)

Prescrire's response to a public consultation organised by the European Medicines Agency on the development of medicines for use in the older population presented a list of possible ways of improving drug therapy for older people, in particular with regard to pharmaceutical research and development, information, packaging, usability, prescribing habits and treatment practices. Read on...
French drug agency's recommendations on packaging labelling: a welcome first step, to be optimised (November 2017)

Prescrire participated in the consultation on recommendations by the French drug regulatory agency (ANSM) regarding the labelling of drug packaging for oral solid formulations. These recommendations are a welcome first step, and should be further improved. Read on...
French drug agency's recommendations on dosing devices: a step forward (September 2017)

In 2016, the French drug regulatory agency (ANSM) published recommendations for companies regarding dosing devices. These recommendations are welcome, and should be extended. Read on...
The proposed recommendations on drug brand names by France's Health Products Agency: a plan that maintains dangerous name confusion (December 2016)

Prescrire urges the French Health Products Agency (ANSM) to revise its draft recommendations on drug brand names in a way that maximises patient safety, abandoning national practices of brand names and labelling consisting of a hotchpotch of terms that cause medication errors by creating confusion. The ANSM is also urged to stop legitimising the continued presence of umbrella brands on the market, given the dangers they pose for patients, by challenging their regulatory compliance. Read on...
Is there a need for insulin at 200 units per ml? Why use a new and poorly established analogue? (December 2012)

In an open letter, Prescrire alerts the European Commission to the dangers of over-hasty authorisation of insulin degludec at twice the concentration of other available insulins, which is liable to cause medication errors with serious consequences for patients. If a tangible need for a more concentrated insulin could outweigh the risk of serious errors inherent in the coexistence of two concentrations, why is the European Union implementing this difficult change using a new substance, whose risks are relatively unknown, rather than a better established insulin? Read on...
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)

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, 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. Read on...
Packaging of medicines for paediatric use: Prescrire's response to EMA (December 2011)

Prescrire’s response to the public consultation on EMA/CHMP/QWP/180157/2011
"Draft -Guideline on Pharmaceutical Development of Medicines for Paediatric Use":
a pragmatic overview and 20 constructive proposals. Read on...
Packaging for non-prescription medicines: Prescrire's response to EMA (June 2011)

Prescrire's response to the public consultation on EMA/275297/2010 "Draft - QRD recommendations on pack design and labelling for centrally authorised non-prescription human medicinal products" argues that the EMA and the European Commission need to rethink the regulations governing self-medication and safe, easy-to-use medicines. This consultation does not go far enough, as it seeks to accommodate the pharmaceutical companies. Read on...