title: [Pharmacovigilance in Portugal: Activity of the Central Pharmacovigilance Unit].
abstract: BACKGROUND
  The aim of this study was to characterize the spontaneous reports of adverse events that were received by the Central Portugal Regional Pharmacovigilance Unit.
  
  
  METHODS
  Spontaneous reports received between 01/2001 and 12/2013 were considered. The annual reporting ratios were estimated. The cases were characterized according to their seriousness, previous description, causality assessment, origin and professional group of the reporter, type of adverse event and pharmacotherapeutic groups of the suspected drugs most frequently reported.
  
  
  RESULTS
  The Pharmacovigilance Unit received 2408 reports that contained 5749 adverse events. In 2013, the reporting rate was estimated at 171 reports per million inhabitants. Fifty-five percent of the reports were assessed as serious. Ninety percent of the cases were assessed as being at least possibly related with the suspected drug. The suspected drugs most frequently reported were anti-infectives for systemic use (n = 809, 33%). The most frequently reported adverse events were "Skin and subcutaneous tissue disorders" (n = 1139, 20%). There were 154 (6.4%) reports resulting in life-threatening situations and/or death, and 88 (3.6%) containing at least one adverse event assessed as serious, unknown and certain or probable.
  
  
  CONCLUSIONS
  The present results are in line with those found in other studies, namely the seriousness and type of the adverse events and the pharmacotherapeutic groups of the most frequently reported suspected drugs.
  
  
  CONCLUSIONS
  In the last years, the Central Portugal Regional Pharmacovigilance Unit has registered a growth in the reporting rate in general, as well as an increase in the reporting of unknown and serious adverse drug reactions.
authors.affiliation: Unidade de Farmacovigilância. Centro AIBILI âÄì Associação para Investigação Biomédica e Inovação em Luz e Imagem. Coimbra. Portugal. Faculdade de Farmácia. Universidade de Coimbra. Coimbra. Portugal.
authors.forename: Francisco
authors.initials: F
authors.lastname: Batel-Marques
authors.affiliation: Unidade de Farmacovigilância. Centro AIBILI âÄì Associação para Investigação Biomédica e Inovação em Luz e Imagem. Coimbra. Portugal. Faculdade de Farmácia. Universidade de Coimbra. Coimbra. Portugal.
authors.forename: Diogo
authors.initials: D
authors.lastname: Mendes
authors.affiliation: Unidade de Farmacovigilância. Centro AIBILI âÄì Associação para Investigação Biomédica e Inovação em Luz e Imagem. Coimbra. Portugal. Faculdade de Farmácia. Universidade de Coimbra. Coimbra. Portugal.
authors.forename: Carlos
authors.initials: C
authors.lastname: Alves
authors.affiliation: Unidade de Farmacovigilância. Centro AIBILI âÄì Associação para Investigação Biomédica e Inovação em Luz e Imagem. Coimbra. Portugal.
authors.forename: Ana
authors.initials: A
authors.lastname: Penedones
authors.affiliation: Unidade de Farmacovigilância. Centro AIBILI âÄì Associação para Investigação Biomédica e Inovação em Luz e Imagem. Coimbra. Portugal. Centro Hospitalar e Universitário de Coimbra. Coimbra. Portugal. Faculdade de Medicina. Universidade de Coimbra. Coimbra. Portugal.
authors.forename: Patricia
authors.initials: P
authors.lastname: Dias
authors.affiliation: Unidade de Farmacovigilância. Centro AIBILI âÄì Associação para Investigação Biomédica e Inovação em Luz e Imagem. Coimbra. Portugal. Centro Hospitalar e Universitário de Coimbra. Coimbra. Portugal.
authors.forename: Angelina
authors.initials: A
authors.lastname: Martins
authors.affiliation: Unidade de Farmacovigilância. Centro AIBILI âÄì Associação para Investigação Biomédica e Inovação em Luz e Imagem. Coimbra. Portugal. Faculdade de Ciências da Saúde. Universidade da Beira Interior. Covilhã. Portugal.
authors.forename: Luiz Miguel
authors.initials: LM
authors.lastname: Santiago
authors.affiliation: Unidade de Farmacovigilância. Centro AIBILI âÄì Associação para Investigação Biomédica e Inovação em Luz e Imagem. Coimbra. Portugal. Faculdade de Medicina. Universidade de Coimbra. Coimbra. Portugal.
authors.forename: Carlos
authors.initials: C
authors.lastname: Fontes-Ribeiro
authors.affiliation: Unidade de Farmacovigilância. Centro AIBILI âÄì Associação para Investigação Biomédica e Inovação em Luz e Imagem. Coimbra. Portugal. Faculdade de Farmácia. Universidade de Coimbra. Coimbra. Portugal.
authors.forename: Margarida
authors.initials: M
authors.lastname: Caramona
authors.affiliation: Unidade de Farmacovigilância. Centro AIBILI âÄì Associação para Investigação Biomédica e Inovação em Luz e Imagem. Coimbra. Portugal. Faculdade de Medicina. Universidade de Coimbra. Coimbra. Portugal.
authors.forename: Tice
authors.initials: T
authors.lastname: Macedo
mesh_terms: D000293:Adolescent; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data*; D000368:Aged; D000369:Aged, 80 and over; D002648:Child; D002675:Child, Preschool; D003430:Cross-Sectional Studies; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D008875:Middle Aged; D060735:Pharmacovigilance; D011174:Portugal; D055815:Young Adult