SourcePharmacoepidemiol Drug Saf 2007 Apr; 16(4)
In Scandinavian countries, pharmacists have not reported adverse drug reactions (ADRs), either due to legislative restrictions or because of lack of tradition. From 1 January 2005, Norwegian pharmacists have been encouraged by the Norwegian Medicines Agency to take a larger role in the reporting of ADRs.To explore pharmacists' attitudes towards pharmacovigilance and their experiences with ADR reporting, to evaluate the effect of an educational programme and to compare these findings to the attitudes in a control group.From September 2004, pharmacies in two of Norway's five health regions were invited to attend a 3-month ADR reporting study, and 39 pharmacies were recruited. One pharmacist from each pharmacy participated in a 1 day pre-study educational programme and a 1 day post-study evaluation meeting. Pharmacists involved in the study answered a questionnaire (A) regarding their attitudes to ADR reporting (active group). A control group answered the same questionnaire. One reminder was sent. The active group evaluated the study by answering questionnaire A once more and an evaluation questionnaire (B). Qualitative aspects of ADR reporting were discussed with the active group post-study.The response rate for questionnaire A was 97% (n = 158) in the active group, 74% (n = 184) in the control group and the response rate for questionnaire A and B post-study was 68% (n = 105) in the active group. Pharmacists in the active group had more positive attitudes to ADR reporting after taking part in the study than the control group (p < 0.001). Lack of time, confidence and knowledge of reporting rules could potentially prevent them from reporting ADRs.The pharmacists had positive attitudes towards pharmacovigilance, but very little experience with reporting. The educational programme clarified their role and increased their knowledge about the reporting requirements.
MeshAdultAdverse Drug Reaction Reporting SystemsAttitude of Health PersonnelCase-Control StudiesEducation, Pharmacy, ContinuingFemaleHealth Knowledge, Attitudes, PracticeHumansMaleMiddle AgedNorwayPharmacistsPharmacoepidemiologyProfessional CompetenceProspective StudiesQuestionnairesResearch Design
Journal Article Multicenter Study