title: A survey of spontaneous reporting of adverse drug reactions in 10 years of activity in a pharmacovigilance centre in Portugal.
abstract: OBJECTIVE
  Reporting of adverse drug reactions (ADRs) may differ between countries.
  
  
  METHODS
  In a retrospective descriptive study we analysed the potential causative drugs and clinical situations related to spontaneously reported ADRs over 10 years to a regional pharmacovigilance centre in Portugal.
  
  
  RESULTS
  We collected 3165 cases (36% of all national reports) of ADRs reported by doctors (54%), pharmacists (31%), and nurses (15%), 56% of which were classified as serious, 22% as unexpected and 13% as both serious and unexpected. According to World Health Organization causality criteria of ADRs related to drugs, 67% where probable, 20% possible, 7% conditional, 6% certain and 1% unclassifiable or unlikely. There was a predominance of females (66%, P < 0.005) both for total and serious ADRs. Physicians, while working in hospitals, reported more (68%) and more serious ADRs (75%) than those working in primary care (29%). Pharmacists working outside hospitals reported more (90%) than those working in hospitals. Drugs more frequently associated with ADRs were antibiotics (22%), followed by vaccines (16%), drugs acting on the nervous system (15%), non-steroidal anti-inflammatory drugs (14%) and those working on the cardiovascular system (11%). The most common systems, organs or disorders affected by ADRs were skin manifestations (21%), followed by general disorders (20%), gastrointestinal/hepatobiliary disorders (15%), nervous system disorders (11%) and immune system disorders (6%).
  
  
  CONCLUSIONS
  Our study shows a general commitment of Portuguese health professionals to ADR reporting with a clear predominance of serious rather than non-serious ADRs. This study may help to improve the recognition of the general aspects of ADRs occurring in Portugal.
authors.affiliation: Faculty of Medicine, Northern Pharmacovigilance Centre, University of Porto, Porto, Portugal; Faculty of Medicine, Centre for Research in Health Technologies and Information Systems (CINTESIS), University of Porto, Porto, Portugal.
authors.forename: Joana
authors.initials: J
authors.lastname: Marques
authors.forename: Inês
authors.initials: I
authors.lastname: Ribeiro-Vaz
authors.forename: Altamiro Costa
authors.initials: AC
authors.lastname: Pereira
authors.forename: Jorge
authors.initials: J
authors.lastname: Polónia
mesh_terms: D000293:Adolescent; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data*; D000368:Aged; D002648:Child; D002675:Child, Preschool; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology* / Q000503:physiopathology; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D008875:Middle Aged; D009726:Nurses / Q000706:statistics & numerical data; D010595:Pharmacists / Q000706:statistics & numerical data; D060735:Pharmacovigilance; D010820:Physicians / Q000706:statistics & numerical data; D011174:Portugal / Q000453:epidemiology; D012189:Retrospective Studies; D012720:Severity of Illness Index; D055815:Young Adult
keywords: adverse drug reactions; pharmacovigilance; spontaneous reporting