[Assessment of the comprehension of new rephrasing drug package inserts]

Abstract

Background: The information included in drug package inserts is often difficult for users to understand. The impact of rephrasing inserts on comprehension was assessed.

Subjects and method: A community double-blind clinical trial was undertaken with random allocation of subjects to unmodified or modified inserts, in which presentation and structure had been improved and technical content expressed in plain language. A questionnaire on comprehension of the use of four common drugs was administered to all participants. The following aspects were analyzed: indications, interval of administration, administration in relation to meals, contraindications, storage and what to do in cases of missing a dose or improvement in symptoms.

Results: 1,560 participants were included, among whom 770 randomly received the unmodified inserts. The mean proportion of correct answers was 45.7% in the unmodified insert group and 75.5% among those who received the modified version. In all groups of age, study level and employment status, participants with modified texts achieved a higher correct response rate than the unmodified group. An improvement > 73% in the correct response rate was observed in interval of administration, administration in relation to meals and what to do in cases of missing a dose. With the modified leaflet the odds ratio of successfully answering more than 70% of questions was 13.5 (95% confidence interval, 10.5-17.5) compared with the unmodified leaflet.

Conclusions: The comprehension of drug package inserts may be considerably improved by making simple changes in their content. These changes may contribute to accident prevention or inappropriate use of commonly prescribed drugs.