[Planning a statistical inquiry for evaluation of patient information]

This article deals with the patient package insert and the information to the patient-consumer. The law in force states that the patient package insert is an informative instrument for the consumer so it should be exhaustive, comprehensible and immediate. A statistical investigation has been performed in order to evaluate the clearness of patient package insert and the quality of the drug information. The protocol consists of the methodology of the investigation, the study pilot, the sampling and, finally, the questionnaire.