Problems Identified in the Package Leaflets of the Portuguese Non-Generic Medicines

Abstract

Introduction: All medicines for human use are marketed with a package leaflet. Every package leaflet must contain an initial list mentioning all sections of the document in accordance to the European template Quality Review of Documents, being not to extensive, i.e. comprising approximately 1500 words. The so-called mixed leaflets contain information about medicines with more than one strength/ pharmaceutical form, and only exceptionally are authorized. In this context, the objectives of the present study comprised the identification of issues in all package leaflets of Portuguese non-generic medicines: 1. to confirm the presence of an initial list, 2. to quantify the number of mixed leaflets, and 3. to evaluate their length (in number of pages).
Material and Methods: Consultation of the leaflets, in a public database (Infomed), according to the classification of the National Prescribing Guide (1st trimester 2012). The data collected was subject to quality control and statistical analysis.
Results: Identification of 2729 package leaflets, representing 3080 medicines. A total of 2042 leaflets were evaluated, with 181 (8.9%) missing the initial list and 351 (17.2%) being mixed. The average number of pages was 6.9 (SD=2.6), the minimum = 2 and the maximum = 26.
Discussion: In some cases, readability and comprehension of some Portuguese leaflets might be compromised since: 1) some leaflets did not contain an initial list, 2) were classified as mixed leaflets, and/or 3) were classified as too extensive.
Conclusion: Regulatory authorities and marketing authorization holders might need to take into consideration these issues during the development and approval of package leaflets.
Keywords: Pamphlets; Drug Labeling; Portugal.