EC Directive 92/27 requires that all medicines should be supplied with a patient information leaflet and be labelled with full information in accordance with the Directive. This has had a direct effect on the pharmaceutical industry resulting in a shift from production of bulk dispensing packs to patient packs. This study aimed to determine the impact of patient information leaflets from the user's perspective, identifying any positive or negative aspects.

Semi-structured interviews were carried out with 146 patients attending the diabetic clinic. Twenty-one patients (14%) claimed to have never received a patient information leaflet with any of their medicines. Of those patients (125) who acknowledged receiving these leaflets, 27 (22%) had never read the leaflet, 26 of whom stated that they would be more likely to if they were advised to do so by either their doctor or pharmacist. Ninety-eight patients had read the leaflet and reasons cited for having done so were largely a desire to know more about the medicines (95 patients) or that they had previously read other leaflets and had found them useful (63 patients) and indeed the majority of patients stated that they found the information either useful or very useful (88 patients). Thirty-seven patients reported that reading the leaflet had provided them with new information. Reading the leaflet had, however, caused concern to 15 patients and 10 of these went to see their doctor as a result. None of these patients had discussed their concerns with their community pharmacist.

This study clearly demonstrated that these leaflets were generally well received by patients. However, there is a need to complement the provision of a leaflet with verbal advice from all healthcare professionals. This may result in increased use of the leaflets; reduced levels of concern with subsequent positive effects on the need for further patient contact with precribers. The results of this study are limited in that the patient group was highly selective and the views of these patients may not necessarily be representative. In addition, it may be worthwhile repeating this study on patients either given prescriptions for an acute episode or when changing from an established therapy to a new one where the information contained in the leaflet may have a more pronounced impact. Repackaging drugs into smaller patient packs incorporating information leaflets is cited as being one of the main reasons for the recent limited availability and cost increase of generic medicines. While these leaflets may make patients better informed about their therapy, the changes in health status and health gain may not balance the increased drug acquisition costs. This requires further evaluation in large numbers of patients.