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040			_aAIKTC-KRRC _cAIKTC-KRRC
100			_aTandon, Vishal R. _98222
245			_aUnder-reporting of adverse drug reactions A challenge for pharmacovigilance in India
250			_aVol.47(1), Jan-Feb
260			_aMumbai _bWolter Kluwer _c2015
300			_a65-71p.
520			_aThe aim was to evaluate the extent and factors responsible for underreporting (UR) of adverse drug reactions (ADRs) in India. Materials and Methods: A retrospective observational, cross-sectional prospective questionnaire-based analysis was undertaken to evaluate the extent and factors for UR of ADRs in pharmacovigilance. Results: At the time, this report was prepared, 90 ADR Monitoring Centers (AMC) were operational in India. Indian AMC functional rate was 56.45%. The average number of Individual Case Safety Reports reported by our center via VigiFlow per month was 48.038. In a period of the 3 years the total number of ADRs reported was 3024. The average number of reports per month was 80.08. Active surveillance versus spontaneous reporting contributed 66.13% versus 33.86% of the total ADRs (P < 0.0001). Outpatient Department (OPD) contribution was 76.05% and indoor contribution was 23.94% of total reports (P < 0.0001). Department of Medicine (33%), followed by oncology (19.27%) and chest disease (13.49%) contributed maximally. The contribution of Pharmacology ADR monitoring OPD was 16.20%. Eye, ear, nose and throat and surgery, private Medical Colleges, hospitals in periphery, sub-district and district contributed no ADRs. ADR detection rates by clinical presentation, biochemical investigation and diagnostic tools were 84.33%, 14.57%, and 1.09% respectively (P < 0.0001). Reporting by postgraduate, registrars, consultants and nurses were 72.65%, 6.58%, 16.56% and 4.19% respectively (P < 0.0001). PG students in Pharmacology contributed an average number of 5.61 ADR reports/month. The lack of knowledge and awareness about Pharmacovigilance Programme of India (PvPI), lethargy, indifference, insecurity, complacency, workload, lack of training were the common factors responsible for UR. Major academic activity, exams, thesis and synopsis submission time influenced reporting of ADRs by postgraduate students.
650		0	_aPHARMACOLOGY _94774
700			_aMahajan, Vivek _927645
773	0		_tIndian Journal of Pharmacology _dAndheri - Mumbai Wolters Kluwer India Private Limited _x0253-7613
856			_uhttps://journals.lww.com/iphr/fulltext/2015/47010/under_reporting_of_adverse_drug_reactions__a.13.aspx _yClick here
942			_2ddc _cAR
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