Gunvor Nilsson

Patient information leaflets - patients' comprehension of information about interactions and contraindications

ObjectiveTo determine how well patients could correctly recognize and comprehend the various information items on patient information leaflets, and to explore the reasons underlying poor comprehensibility.MethodsLeaflets from 30 randomly selected, commonly prescribed medicines were examined by experts using protocols to evaluate leaflet layout, language and content. The same leaflets were also evaluated by patients who had their medicines dispensed at 24 randomly selected Swedish pharmacies. A questionnaire was used for the patients’ examination.ResultsThe results showed that most information on the leaflets is sound and is well comprehended by the patients. For two information items regarding ’risks of interactions’ and ’contraindications’ the patient scores were low, indicating poor comprehensibility.ConclusionLeaflets with low scores on warnings of interactions and contraindications were found to deliver more complex messages to older patients as compared to leaflets with high scores for these items.

A Method to Evaluate Patient Information Leaflets

The aim of this study was to develop a useful method for evaluating patient information leaflets by comparing the result of expert and patient evaluations. The hypothesis was that if there was a correlation between the results of these evaluations it would be acceptable to only do expert review for patient information leaflets currently in use. Experts and patients examined patient information leaflets from 30 common medicines, following European Union Directive 92/27 EEC, which outlined the legal requirements for patient information leaflets. The scoring system allowed a direct comparison between the outcomes of expert and patient examinations. We found a significant correlation between the expert and patient examinations of the content of the patient information leaflets. We conclude that patient information leaflets that score above average on the expert examination of content (ie, adherence to the directive) will also score above the average on the patient examination.