Author(s): Vessal G, Mardani Z, Mollai M
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Abstract OBJECTIVE: Adverse Drug Reactions (ADRs) are a major cause of patient morbidity and mortality. Spontaneous reporting of ADRs remains the cornerstone of pharmacovigilance and is important in maintaining patient safety. In order to determine whether our pharmacovigilance system could be improved, and identify reasons for under-reporting, a study to investigate the role of pharmacists in ADR reporting was performed in Shiraz. SETTING: The pharmacies in Shiraz, capital of Fars province in Iran. METHODS: A questionnaire was prepared to investigate knowledge and attitude of pharmacists regarding ADR reporting. The questionnaire was given to 200 pharmacists who participated in a pharmacist association meeting. MAIN OUTCOMES MEASURED: The knowledge of pharmacovigilance practice, reasons for not reporting ADR, and perceptions of the Iranian pharmacists on pharmacovigilance practice were evaluated. RESULTS: The response rate was 55\% (n = 110). 29\% of the respondents were not aware of the Iranian Pharmacovigilance Center. More than half of those responding felt that ADR reporting should be voluntary, while 26\% felt it was a professional obligation. As for the purposes of ADR reporting scheme, 60\% of the pharmacists falsely believed that monitoring ADR spontaneous reports aims at measuring the incidence of ADR. 42\% of the pharmacists indicated that they have suspected an ADR without reporting it. Doubt about causality was the major reason for not reporting an ADR. Although our ADR center states that all suspected reactions to any drug on the market must be reported, only 17\% of the respondents seemed to be aware of this responsibility. CONCLUSION: Our pharmacists have little knowledge regarding the operation, purposes, and usefulness of ADR spontaneous reporting system. However, education and training will be important in maintaining and increasing ADR reports from pharmacists.
This article was published in Pharm World Sci
and referenced in Journal of Pharmacovigilance