E-DRUG: French Regulator maintains confusing brand names
-------------------------------------------------------------------------
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
Etienne Schmitt
Hospital pharmacist - France
Head of Prescrire Programme Preventing the Preventable
E-mail: eschmitt@prescrire.org