Effect of Pharmacist Involvement on Patient Reporting of Adverse Drug Reactions in Bulgaria
Keywords:
Adverse drug reactions, Pharmacists, ReportAbstract
Background: The World Health Organization (WHO) defines pharmacovigilance as “the science and activities relating to the detection, assessment, understanding and prevention of adverse affects or any other possible drug-related problems”. Adverse drug reactions (ADRs) are a significant cause of morbidity and mortality and contribute to the incidence of adverse events, resulting in increased healthcare costs. Healthcare providers need to understand their role and responsibility in the detection, management, documentation, and reporting of ADRs, all essential activities for optimizing patient safety. Pharmacists have an important responsibility in monitoring the ongoing safety of medicines. The aim of the study is to reveal what is the clinical responsibility of the pharmacist in the early detection of ADRs.
Methods: The study is an observational one. A questionnaire was prepared to investigate knowledge and attitude of pharmacists regarding ADR reporting. The questionnaire was given to 415 pharmacists. The study was conducted from May 2017 till September 2017 in Sofia, the capital of Bulgaria. We have used a documentary and statistic methods as well. The questionnaire includes questions on Factors Associated with ADR Reporting, which have been years of work experience as a pharmacist, the habit of detecting ADRs as part of pharmacists‘ duties, having the basic knowledge needed to report ADRs and the most frequently cited reasons for not reporting ADRs.
Results: 401 of the pharmacists surveyed work in an open-air pharmacy and 14 in a hospital pharmacy. 58.5% of the respondents are master pharmacists and 41.5% are managers of pharmacies. Lower reporting rates by pharmacists are observed in Bulgaria. Most of the respondents unanimously shared that they did not report on the ADRs either on the Bulgarian Drug Agency or the Yellow Card.
Conclusion: Underreporting of ADRs is a common phenomenon in spontaneous post-marketing surveillance programs. Underreporting may delay signal detection and cause underestimation of the size of a problem. It is important to address within the pharmacy profession that ADR surveillance is a priority and a professional responsibility.
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