[Patient-oriented package inserts for drugs. Historical overview and current status].

Abstract

After a short note on terminology, in this review article a survey is given of former and existing initiatives concerning the Patient Package Insert (PPI) in the USA and in Western Europe, with emphasis on the situation in Belgium. Arguments in favour of and against the PPIs are given, based upon the literature. The need for drug information for the general public is illustrated by a number of studies. Content and presentation of the PPI as a source of drug information are discussed. Studies on the impact of PPIs on satisfaction, knowledge, compliance, adverse drug reactions emotions, risk/benefit-decisions etc. are reviewed. Finally, attention is drawn to remaining problems and to the needs for further research.