[Comparative study of a new package insert for benzodiazepines adapted for patients]

Abstract

A standardized, patient-oriented package insert for benzodiazepines has been compared with four package inserts printed by manufacturers for these drugs. The leaflets were submitted to 222 hospitalized patients randomly allocated to two groups; 108 received a manufacturer's notice and 114 the standardized notice. The patients were interviewed two or three days later and found the standardized notice more comprehensible than those of the manufacturers. Two independent experts assessed the adequacy of the notices and also found the standardized notice more appropriate for patients. The patients answered a questionnaire about the effects of the drugs and the precautions while using them. Those who had read the standardized notice were significantly better informed than those who had read manufacturers' notices. However, the level of understanding varied largely from one item to another, and depended on the level of education and age.