title: Influence of age, sex and seriousness on reporting of adverse drug reactions in Sweden.
abstract: OBJECTIVE
  To investigate how reporting of adverse drug reactions (ADRs) among adults in Sweden is associated to age and sex, in addition to seriousness of the reaction and drug utilisation.
  
  
  METHODS
  Individual case safety reports (ICSRs) reported by healthcare professionals to the national pharmacovigilance database 2008-2011 were related to defined daily dose (DDD) in the Swedish Prescribed Drug Register (SPDR) for individual's ≥20 years. Data were stratified into five age groups. Crude and adjusted (by age standardisation of prescribed drugs) reporting rate (RR) and reporting rate ratio was evaluated as well as impact of sex-dependent drugs.
  
  
  RESULTS
  Based on 9898 included ICSRs, the crude results show that overall RR was almost similar for both serious and non-serious reports and indicates highest RR in the youngest age group. Women had higher rates than men, with predominance for non-serious reports, contrary to men who had a higher RR of serious ones. Standardisation led partly to the same result, but age-related distribution was adjusted, with highest overall RR in the oldest age groups. Sex-dependent drugs had marginal impact on the results.
  
  
  CONCLUSIONS
  Age and sex have impact on spontaneous reporting of ADRs. After adjusting for dispensed drugs and by standardisation of age-related differences in prescribed drugs, results indicate that healthcare professionals more frequently reported ADRs for the oldest individuals and for women. Serious reports were more frequently reported for men. Copyright © 2017 John Wiley & Sons, Ltd.
authors.affiliation: Department of Usage, Medical Product Agency, Uppsala, Sweden.
authors.forename: Lennart
authors.initials: L
authors.lastname: Holm
authors.affiliation: R&D Centre Skåne, Skåne University Hospital, Lund, Sweden.
authors.forename: Elisabet
authors.initials: E
authors.lastname: Ekman
authors.affiliation: School of Health, Care and Social Welfare, Malardalen University, Sweden.
authors.forename: Kerstin
authors.initials: K
authors.lastname: Jorsäter Blomgren
mesh_terms: D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data*; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D016208:Databases, Factual; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D060735:Pharmacovigilance; D055553:Prescription Drugs / Q000008:administration & dosage / Q000009:adverse effects*; D012737:Sex Factors; D013548:Sweden / Q000453:epidemiology; D055815:Young Adult
chemical_list: D055553:Prescription Drugs
keywords: adverse drug reaction; age; drug prescriptions; pharmacoepidemiology; pharmacovigilance; sex; spontaneous reporting