Abstract
BackgroundSpontaneous or voluntary reporting of suspected adverse drug reactions (ADRs) is one of the vital roles of all health professionals. In India, under-reporting of ADRs by health professionals is recognized as one of the leading causes of poor ADR signal detection. Therefore, reviewing the literature can provide a better understanding of the status of knowledge, attitude and practice (KAP) of Pharmacovigilance (PV) activities by health professionals.MethodsA systematic review was performed through Pubmed, Scopus, Embase and Google Scholar scientific databases. Studies pertaining to KAP of PV and ADR reporting by Indian health professionals between January 2011 and July 2015 were included in a meta-analysis.ResultsA total of 28 studies were included in the systematic review and 18 of them were selected for meta-analysis. Overall, 55.6% (95% CI 44.4–66.9; p<0.001) of the population studied were not aware of the existence of the Pharmacovigilance Programme in India (PvPI), and 31.9% (95% CI 16.3–47.4; p<0.001) thought that "all drugs available in the market are safe". Furthermore, 28.7% (95% CI 16.4–40.9; p<0.001) of them were not interested in reporting ADRs and 74.5%, (95% CI 67.9–81.9; p<0.001) never reported any ADR to PV centers.ConclusionThere was an enormous gap of KAP towards PV and ADR reporting, particularly PV practice in India. There is therefore an urgent need for educational awareness, simplification of the ADR reporting process, and implementation of imperative measures to practice PV among healthcare professionals. In order to understand the PV status, PvPI should procedurally assess the KAP of health professionals PV activities in India.
Highlights
IntroductionThere are between 60,000–80,000 brands of drugs available in the Indian market that are irrationally prescribed and misused [1]
India is home to one of the largest drug consuming populations in the world
Studies pertaining to KAP of PV and adverse drug reactions (ADRs) reporting by Indian health professionals between January 2011 and July 2015 were included in a meta-analysis
Summary
There are between 60,000–80,000 brands of drugs available in the Indian market that are irrationally prescribed and misused [1]. This may be due to lack of medication safety practices, and failures in the regulatory environment. The misuse and faulty prescribing account for considerable development of adverse drug reactions (ADRs) that are one of the major causes of mortality and morbidity, unplanned hospitalization, and increased healthcare cost, worldwide [2,3,4,5]. Post-marketing safety studies have been shown to be very important in identifying possible risk factors associated with the use of new drugs in the general population and the contribution of health professionals is significant in reporting suspected ADRs to strengthen signal detection. Reviewing the literature can provide a better understanding of the status of knowledge, attitude and practice (KAP) of Pharmacovigilance (PV) activities by health professionals
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