gms | German Medical Science

Background: Drug product information is very important, but in particular the patient package leaflet is hardly comprehensible for many patients and sometimes even scares them. In addition, information given by the physician is not always sufficient. Adherence / compliance are affected with negative consequences on the health care system.

Aim: Profound patients’ knowledge about benefit/risk of any drug therapy is important for drug therapy safety and adherence. Therefore, in particular patient package leaflets should meet patients’ needs. Also physicians should receive current and comprehensive product information as well as material to support them in patient consultation.

Methods: Some pharmaceutical companies and representatives of patient and senior organizations are cooperating in the working group „AG Beipackzettel“ in order to create patient package leaflets which motivate patients to read them. Only information that is read and understood contributes to a safe use of the drug.

Results: Patients have summed up their requests in 7 key points that should be observed for the creation of patient package leaflets. Improvements could already be implemented in practical examples on national and EU level.

Conclusion: Improvements are indeed possible - also in the current legal framework. Nevertheless, possibilities are very limited; therefore the overall concept of product information needs an update. The new concept should be created in cooperation with authorities as well as with patients, physicians and pharmacists. A platform for a continuous exchange should be established for this purpose.