E-DRUG: French Regulator maintains confusing brand names
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Dear E-druggers,
Prescrire urges the French Health Products Agency (ANSM) to revise its draft recommendations on drug brand names to maximise patient safety, abandon national of labelling that causes confusion and medication errors.
The public consultation organised by the ANSM provides an opportunity to point out that the European Medicines Agency (EMA) guideline on brand names does not give sufficient consideration to patients' interests or to human factors at each stage of brand name development, at both industry and administrative level.
Prescrire and the International Medication Safety Network (IMSN) have developed constructive proposals to shift the focus of European policy in this area towards patient safety, in particular the EMA and all national drug regulatory agencies should:
- publish a list of brand names that have led to name confusion;
- facilitate the reporting of drug name errors by health professionals and patients;
- adopt and publish a method for assessing the risk of confusion before marketing authorisation;
- stop accepting umbrella brands;
- adopt stricter standards for the naming of fixed-dose combinations;
- revert to more prudent use of abbreviations and suffixes, as these lead to confusion;
- involve patients in the search for improvements.
International nonproprietary names (INNs) are constructed using informative common stems. As a result, errors caused by confusion between INNs are less frequently reported than brand name confusion errors. It is therefore important to display INNs prominently on drug packaging.
The ANSM also mentioned that recommendations on drug labelling are currently being developed. Having systematically analysed the packaging of thousands of medicinal products, Prescrire is aware of the urgent need for higher drug packaging and labelling standards and encourage the ANSM to rapidly launch a public consultation on its draft recommendations on labelling.
More details at http://english.prescrire.org/en/79/207/46302/5207/4785/SubReportDetails.aspx
Étienne Schmitt
Hospital pharmacist - France
Head of Prescrire Programme Preventing the Preventable
E-mail: eschmitt@prescrire.org