Title: Tools to Improve Reporting of Adverse Drug Reactions - A Review
Abstract:Pharmacovigilance is a process that needs time, vision, dedication, expertise and continuity. Underreporting of spontaneous adverse drug reaction (ADR) is a threat to pharmacovigilance. The major fact...Pharmacovigilance is a process that needs time, vision, dedication, expertise and continuity. Underreporting of spontaneous adverse drug reaction (ADR) is a threat to pharmacovigilance. The major factors found to be responsible for underreporting of ADR include inadequate risk perception about newly marketed drugs, fear factor, diffidence, lack of clarity of information on ADR form about reporting, lethargy, insufficient training to identify ADRs, lack of awareness about existence of pharmacovigilance program and ADR monitoring center in the institute and inadequate risk perception of over-the-counter (OTC) product and herbal medicines. ADR reporting is an important aspect of an efficient and effective pharmacovigilance program. Despite comprehensive and stringent phases of clinical trials and surveillance efforts, unexpected and serious adverse drug reactions (ADRs) repeatedly occur after the drug is marketed. Although Medwatch, Yellow Card, CDSCO form, etc. are the protocol forms of ADR collection and reports, a number of countries design and use their respective ADR forms. The reporting of adverse drug reaction may start locally, perhaps in one hospital, then extend to other hospitals and family practices in the region, and progress step by step into a national activity. The present study focuses on the different tools or ways to improve ADR reporting so as to decrease the physical and economic burden due to ADRs. If any of these methods were implemented there could be a significant change in the reporting level.Read More
Publication Year: 2013
Publication Date: 2013-01-01
Language: en
Type: review
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Cited By Count: 3
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