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

Authors

  • Carla Pires Instituto de Investigação do Medicamento (iMed.UL). Departamento de Sócio-Farmácia. Faculdade de Farmácia. Universidade de Lisboa. Lisboa. Portugal.
  • Afonso Cavaco Departamento de Sócio-Farmácia. Faculdade de Farmácia. Universidade de Lisboa. Lisboa. Portugal.
  • Marina Vigário Laboratório de Fonética. Faculdade de Letras. Universidade de Lisboa. Lisboa. Portugal.

DOI:

https://doi.org/10.20344/amp.5526

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.

Downloads

Download data is not yet available.

Author Biography

Carla Pires, Instituto de Investigação do Medicamento (iMed.UL). Departamento de Sócio-Farmácia. Faculdade de Farmácia. Universidade de Lisboa. Lisboa. Portugal.

I worked as a community pharmacist and consulter, since 1998. Actually I am working at the Faculty of Pharmacy; Department of Socio Pharmacy; University of Lisbon as a PhD student (FCT grant). My main interests are social health practice and oral and written communication. Example of publications: 1) C PIRES. Clinical and Therapeutic analysis of type 2 Diabetics in Portuguese Community Pharmacies. Acta Med Port 2011; 24(S2): 449-456. http://www.actamedicaportuguesa.com/pdf/2011-24/suplemento-originais/449-456.pdf; and 2) C PIRES & A CAVACO. Exploring the perspectives of potential consumers and healthcare professionals on the readability of a package insert: the case study of an over-the-counter medicine. European Journal of Clinical Pharmacology. DOI 10.1007/s00228-014-1645-6 (IN PRESS).

Published

2015-02-27

How to Cite

1.
Pires C, Cavaco A, Vigário M. Problems Identified in the Package Leaflets of the Portuguese Non-Generic Medicines. Acta Med Port [Internet]. 2015 Feb. 27 [cited 2024 Mar. 29];28(1):21-8. Available from: https://actamedicaportuguesa.com/revista/index.php/amp/article/view/5526