title: Incidence of Adverse Drug Reactions in Indian Hospitals: A Systematic Review of Prospective Studies.
abstract: This systematic review estimated the incidence of ADRs that lead to hospitalization (ADRAd) and that developed during hospitalization (ADRIn) and factors affecting in Indian population. Two independent investigators searched the electronic databases describing ADRs. Due to high heterogeneity, incidence of ADRAd and ADRIn were presented as median (interquartile range-IQR). We performed the subgroup analysis of incidence based on characteristics of the included studies. The meta-analysis (generic inverse variance method with random effect model) was possible for the fatal ADR incidence. The risk factors for ADRs were also explored from the included studies. We used 'Review manager software version 5.0' and 'Graph Pad Prism version 6.0' for the analysis. Of 77 fully evaluated references, 21 prospective studies were selected. The median incidence of ADRAd and ADRIn were 2.85% (IOR: 1.25 - 3.93%) and 6.34% (IQR: 3.36 - 16.37%), respectively. The subgroup analysis found high incidence rate with studies conducted in intensive care units, elderly age groups, with intensive monitoring, duration of > 1 year and multidisciplinary team. The fatal ADR incidence was 0.08% (95% CI: 0.00-0.15%). Important risk factors for ADRs included elderly, female sex and polypharmacy. The hospitalized patients have a significant burden of ADRs. The multiple factors may have affected their occurrence.
authors.affiliation: Department of Pharmacology, GMERS Medical College, Gotri, Vadodara-390021 (Gujarat), India. dr.tkp2006@yahoo.co.in.
authors.forename: Tejas K
authors.initials: TK
authors.lastname: Patel
authors.forename: Parvati B
authors.initials: PB
authors.lastname: Patel
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000639:trends*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000175:diagnosis* / Q000453:epidemiology*; D005260:Female; D006760:Hospitalization / Q000639:trends*; D006801:Humans; D015994:Incidence; D007194:India / Q000453:epidemiology; D008297:Male; D011446:Prospective Studies