The European Medicines Agency has updated the template for package leaflets to make the information easier for patients to understand. Leaflets will now include less rigid language and new sections that provide greater information about a drug’s benefits. There will also be more information about the medicine’s use in children to comply with the requirements of pediatric regulation.
The update addresses feedback received during a five-year period of user testing. Stakeholders, including patients, pharmaceutical companies, and national regulatory agencies also contributed their opinions. In addition, the update takes into account the EMA’s 2009 report on the expectations of patients, consumers, and healthcare professionals regarding benefit–risk information, which explains how patients are becoming increasingly involved in choosing their own treatments. In particular, the report called for clear information that is easy to read and understand.
The readability of packaging leaflets and labels is an issue that Pharmaceutical Technology Europe touched upon in May during an interview with Professor DK Theo Rynor. He explained that a number of commonly-used phrases, such as “Avoid alcoholic drink”, are often misunderstood by patients.
According to a statement from EMA, the update also includes changes to the templates for the summary of product characteristics, labeling and 'Annex II', the section of the product information covering the conditions imposed on marketing authorizations. The updated templates are available in all official EU languages, together with an implementation plan.