title: Package leaflets of the most consumed medicines in Portugal: safety and regulatory compliance issues. A descriptive study.
abstract: OBJECTIVE
  Package leaflets are necessary for safe use of medicines. The aims of the present study were: 1) to assess the compliance between the content of the package leaflets and the specifications of the pharmaceutical regulations; and 2) to identify potential safety issues for patients.
  
  
  METHODS
  Qualitative descriptive study, involving all the package leaflets of branded medicines from the three most consumed therapeutic groups in Portugal, analyzed in the Department of Pharmacoepidemiology, School of Pharmacy, University of Lisbon.
  
  
  METHODS
  A checklist validated through an expert consensus process was used to gather the data. The content of each package leaflet in the sample was classified as compliant or non-compliant with compulsory regulatory issues (i.e. stated dosage and descriptions of adverse reactions) and optional regulatory issues (i.e. adverse reaction frequency, symptoms and procedures in cases of overdose).
  
  
  RESULTS
  A total of 651 package leaflets were identified. Overall, the package leaflets were found to be compliant with the compulsory regulatory issues. However, the optional regulatory issues were only addressed in around half of the sample of package leaflets, which made it possible to identify some situations of potentially compromised drug safety.
  
  
  CONCLUSIONS
  Ideally, the methodologies for package leaflet approval should be reviewed and optimized as a way of ensuring the inclusion of the minimum essential information for safe use of medicines.
authors.affiliation: School of Pharmacy, Research Institute for Medicines and Pharmaceutical Sciences, University of Lisbon, Lisbon, Portugal.
authors.forename: Carla
authors.initials: C
authors.lastname: Pires
authors.affiliation: Center of Linguistics, University of Lisbon, Lisbon, Portugal.
authors.forename: Marina
authors.initials: M
authors.lastname: Vigário
authors.affiliation: School of Pharmacy, Research Institute for Medicines and Pharmaceutical Sciences, University of Lisbon, Lisbon, Portugal.
authors.forename: Afonso
authors.initials: A
authors.lastname: Cavaco
mesh_terms: D032882:Comprehension; D054626:Consumer Health Information; D003257:Consumer Product Safety / Q000331:legislation & jurisprudence; D004348:Drug Labeling / Q000145:classification / Q000592:standards*; D004349:Drug Packaging / Q000145:classification / Q000592:standards*; D005062:European Union / Q000458:organization & administration; D006801:Humans; D007880:Legislation, Drug / Q000592:standards*; D011174:Portugal; D036301:Qualitative Research