Patient Package Inserts for Prescription Drugs in an International Pharmaceutical Company

Abstract

Development of a patient package insert (PPI) necessitates multidisciplinary input. Patients require information which is scientifically founded yet highly readable, comprehensive yet concise and relevant. Health professionals demand that the PPI is concordant with the summary of product characteristics (SPC) in order to achieve consistency in the provision of patient information. These objectives are met by selecting patient-relevant data from the SPC, and involving a medical communications consultant to ensure optimal clarity. Pictographs improve readability, but text length must be carefully considered. Patients, pressure groups, and legislative bodies demand comprehensive information. Some studies, however, suggest that extensive information may interfere with the effectiveness of communication with regard to comprehension and retention. Other aspects to be considered include product liability and the environmental consequences of PPI production, in addition to the organizational and financial impact on the pharmaceutical industry. At present, the need for PPIs in Third World countries is less urgent because of the scope of medical practice, and because of difficulties related to drug distribution and language problems.