title: [Problems identified in the package leaflets of the Portuguese non-generic medicines].
abstract: BACKGROUND
  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).
  
  
  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.
  
  
  CONCLUSIONS
  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.
  
  
  CONCLUSIONS
  Regulatory authorities and marketing authorization holders might need to take into consideration these issues during the development and approval of package leaflets.
authors: Instituto de Investigação do Medicamento (iMed.UL). Departamento de Sócio-Farmácia. Faculdade de Farmácia. Universidade de Lisboa. Lisboa. Portugal.
authors: Carla
authors: C
authors: Pires
authors: Instituto de Investigação do Medicamento (iMed.UL). Departamento de Sócio-Farmácia. Faculdade de Farmácia. Universidade de Lisboa. Lisboa. Portugal.
authors: Afonso
authors: A
authors: Cavaco
authors: Marina
authors: M
authors: Vigário
mesh_terms: D032882:Comprehension; D018592:Cross-Over Studies; D004348:Drug Labeling / Q000592:standards*; D006801:Humans; D011174:Portugal