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EMA: two surveys about the patient leaflet

 Advancing Healthcare Policy   In December 2023 and February 2024, Prescrire responded to two surveys organised by the European Medicines Agency (EMA) for the purposes of revising the template that serves as a basis for the patient leaflet (package leaflet) provided with medicinal products and of improving its content and structure.
Full article available for download (free)

The aim of the first survey was to shorten the length of these leaflets, and to make the information they contain more understandable and relevant to patients/users, while still complying with current legislation on their content and the order in which information is presented (1). The questions mainly concerned the table of contents, the order in which sections are displayed, and the presentation of adverse effects in order of frequency or severity.

The stated aim of the second survey was to make these leaflets more understandable and relevant to patients. The survey focused on two aspects: the inclusion of a "key information" section; and the addition of information on the drug's benefits (2).

Prescrire is in favour of adding a "key information" section, consisting of information about the drug's indications, the main benefits of the treatment and its adverse effects, as well as contraindications. Information about benefits and risks should be presented side by side, to help users assess the drug's harm-benefit balance (2).

With regard to the addition of information about benefits, Prescrire would like the published information to include: the proportion of patients who can expect to benefit from using the drug; the drug's effects on quality of life; the strength of the evidence for the claimed benefits; and the uncertainties that remain, in particular when data (concerning a long-term benefit or adverse effect, for example) are lacking or the level of evidence is too low (2).

References 
1- "Package Leaflet (PL) improvement survey" 6 December 2023: 11 pages.
2- "Package Leaflet (LP) improvement survey" 26 February 2024: 6 pages.

©Prescrire 1 December 2024

Source: "EMA: two surveys about the patient leaflet" Prescrire Int 2024; 33 (265): 307. Free.

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