Regulatory agencies’ recommendations for medicine information leaflets: Are they in line with research findings?

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Abstract

The design of medicine information leaflets can determine whether a leaflet will be read or discarded by patients. It may also influence patients’ ability to understand the information about their medicines within the leaflet. Researchers compared regulatory agencies’ recommendations for medicine information leaflet design from New Zealand, the United Kingdom, the European Union, and the United States against recommended good design principles to determine the appropriateness, comprehensiveness, and consistency of their recommendations. Recommendations for medicine information leaflets varied between the regulatory agencies. There were some inconsistencies between the recommendations and some gaps were identified. There was little regulatory guidance given to creators of medicine information leaflets in New Zealand compared to other countries, and this could lead to manufacturer-produced information leaflets of a poorer quality. Up-to-date and enforceable guidance for creators of medicine information leaflets should be provided in all countries to ensure they are of an appropriate standard.

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