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Multicenter Study
. 2007 Apr;16(4):429-34.
doi: 10.1002/pds.1298.

Pharmacists' attitudes towards the reporting of suspected adverse drug reactions in Norway

Anne G Granas  1 , Marit Buajordet, Hanne Stenberg-Nilsen, Pernille Harg, Anne M Horn
Affiliations
Multicenter Study

Pharmacists' attitudes towards the reporting of suspected adverse drug reactions in Norway

Anne G Granas et al. Pharmacoepidemiol Drug Saf. 2007 Apr.

Abstract

Background: 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.

Objective: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

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