France has decided to trial the use of electronic package leaflets for certain drugs in hospitals and community pharmacies in 2024, as part of its "ecological planning" strategy for the healthcare system (1-4). In hospitals, package leaflets would be replaced immediately with a QR code affixed to the box, enabling users to access an electronic version of the package leaflet, potentially accompanied by interactive forms or videos providing practical information. In community pharmacies, both formats would be provided at first, but the paper format would eventually be phased out and printed at the pharmacy if requested by the patient (2). The ministries concerned claim that the initiative is intended to reduce the carbon footprint of drugs, which are estimated to account for 20% of the total emissions generated by France's healthcare sector (3,5).
The package leaflet is the patient's main source of information about their treatments. In France, its inclusion in the packaging of every drug is still a legal obligation. It specifies the drug's authorised uses, recommended dosages, adverse effects, any contraindications to its use and its interactions with other substances or foods. It provides essential details about how and when to take the drug, and about any special warnings and precautions that must be taken, for example when driving or in certain situations such as pregnancy. Its presence in the box is crucial to medication safety (6).
Prescrire opposes the plan to phase out paper package leaflets, proposed in the revision of European pharmaceutical legislation that is currently in progress. The people most likely to suffer from the shift from paper to electronic leaflets are those who live in places with limited internet access or who are not comfortable using digital technology, such as older patients who often take multiple medications, and vulnerable patients (1). Members of the European Parliament have made the phasing out of paper package leaflets conditional on a "consultation of patients, carers and other relevant stakeholders" (7). Prescrire hopes that member states will go further in their defence of paper package leaflets.
The provision of an electronic package leaflet alongside the paper leaflet may indeed be an advance, provided that the electronic version comes from a reliable source, that it is dated and kept up to date, and that updates are clearly highlighted (6).
References
1- Prescrire Editorial Staff "European Commission public consultation on the revision of European pharmaceutical legislation: Prescrire's response" Prescrire Int 2024; 33 (259): 135-138.
2- J W "Médicaments: bientôt des QR codes pour remplacer les notices" 15 December 2023. lepoint.fr accessed 3 January 2024: 4 pages.
3- French Ministry of Health "Feuille de route. Planification écologique du système de santé" December 2023: 38 pages.
4- APM "Planification écologique: mise en place d'une feuille de route pour les produits et industries de santé" 15 December 2023: 3 pages.
5- The Shift Project "Décarboner la santé pour soigner durablement. Dans le cadre du plan de transformation de l'économie française. Rapport final V2", April 2023: 176 pages.
6- Prescrire Rédaction "Savoir trouver une notice à jour sur internet et identifier la dernière version" Rev Prescrire 2020; 40 (438): 297.
7- "Amendment 176 - Proposal for a directive - Article 63 - paragraph 3 - European Parliament legislative resolution of 10 April 2024 (…)": 1 page.
©Prescrire 1 September 2024
Source: "Phasing out patient leaflets in paper form: eco-responsible or irresponsible?" Prescrire Int 2024; 33 (262): 199. Free.
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