Question 9585 — pharmacy and medications

Summary

In January 2018, the National Agency for the Safety of Medicines and Health Products (ANSM) adopted recommendations relating to the labeling of external packaging of medicines in solid oral form (excluding homeopathy), for the attention of applicants and holders of marketing authorizations (AMM) and registrations. They were developed in collaboration with the members of the “errors” working group medicinal products” of the ANSM, bringing together professionals in the field. They were then transmitted, on several occasions, to the actors concerned by their implementation in order to take their observations into account, namely the representatives of the pharmaceutical industries, the representatives of community pharmacists and the representatives of patient associations via the Surveillance working group of the Interface Committee of manufacturers of the ANSM. The recommendations were also the subject of a public consultation on the ANSM website, allowing for the provision of external contributions. This broad consultation process allowed all stakeholders concerned to participate in the transparent development of recommendations relating to the labeling of medicines in solid oral form. These recommendations contribute to the job security of the medicine and the prevention of medication errors. They constitute a guide for operators when developing labeling and external packaging of medicinal products in solid oral form, with the aim of ensuring the readability and understanding of the labeling and avoiding any confusion. They specify the information that must be included in the labeling of medicinal products, in application of the requirements mentioned in Article R. 5121-138 of the Public Health Code, public health imperatives and thus guide the layout and typography of this information. These recommendations should be taken into account for the external packaging of new specialties when applying for an MA or prior to a modification of an MA having an impact on the labeling, and not on the packaging of medicines already marketed. Therefore, they are not intended to complicate existing packaging for patients, but to prevent any confusion and harmonize the labeling of medicines, with the essential objective of safety for patients. In fact, patients will remember the name of the molecule that has been prescribed to them rather than the commercial name of the drug, which will allow them to avoid overdoses. In this sense, it is a real measure of education which aims to reduce the number of medication errors.

Machine translation from French. The official text remains authoritative.

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