What information for the patient? Large scale pilot study on experimental package inserts giving information on prescribed and over the counter drugs.

Abstract

OBJECTIVE--To compare the acceptability and the degree of understandability of two drug information leaflets on three over the counter and two prescribed drugs. DESIGN--Prospective observational study. SETTING--Random sample of municipal pharmacies throughout Italy. SUBJECTS--A total of 6992 clients of the pharmacies who requested the study drugs over a period of four months. INTERVENTION--Exposure of patients to two information leaflets, one approved by the Ministry of Health, and the other an experimental sheet prepared by the research working group. MAIN OUTCOME MEASURES--The degree of acceptability of the information was assessed by using a pretested questionnaire. Comments concerning information needs were also encouraged and collected. RESULTS--6992 Clients responded to the questionnaire. Non-metropolitan (urban and rural) areas had the highest rate of participation. The participants strongly preferred the experimental leaflets to the approved leaflets, both with respect to accessibility of the contents (overall preference 78.1% v 17.8%) and ease of understanding the contraindications of drug use (90.2% v 73.7%). Basic attitudes related to the use of written information were similar among clients of different age groups, educational levels (though emerging people with primary school or lower educational levels showed slightly lesser understanding), and geographic areas. Up to 50% of those who took over the counter drugs indicated a disposition to change their drug seeking behaviour on the basis of the information in the experimental leaflet. The comments provided a useful complementary set of data on the information needs expressed by participants. CONCLUSIONS--The results of this pilot study indicate that patients will enter active programmes to investigate the provision of problem oriented drug information. Their information needs seem to concern both prescribed and over the counter drugs. More extensive and systematic work is required to develop an improved consumer oriented language for widely used drugs.