title: Adverse drug reactions in a psychiatric department of tertiary care teaching hospital in India: Analysis of spontaneously reported cases.
abstract: The epidemiological data are limited for the spontaneous adverse drug reaction (ADR) reporting system in psychiatry and its comparison with intensive monitoring studies in terms of causative drugs, seriousness, preventability and drug interactions. This spontaneous ADR reporting study was carried out over a period of three years in the psychiatry department. We adopted WHO definition for an ADR, Naranjo's algorithm for causality, WHO-ADR terminology for the labeling of involved organ-system, International conference on harmonisation (ICH) E2A guidelines for seriousness, modified Schumock and Thornton's criteria for preventability and Medscape drug interaction checker for drug interactions. Two subgroup analyses were performed to find out the risk factors for the serious and preventable reactions. A total of 97 ADRs from 67 patients were included for analysis. The incidence of 'overall' and 'serious ADRs were 0.69% (95% CI: 0.54%, 0.88%) and 0.18% (95% CI: 0.12-0.29%), respectively. The females experienced more ADRs than males. The most commonly reported ADR, incriminated pharmacology group and drug, were extrapyramidal movement disorders (22.68%), atypical antipsychotics (35.62%) and escitalopram (13.91%), respectively. One out of five and one out three reactions were considered as 'serious' and 'preventable', respectively. The drug interactions contributed in 34.02% reactions. The factors significantly associated with 'serious' reactions were typical antipsychotics [OR: 5.47 (1.68, 17.87)], central and peripheral nervous system disorders [OR: 24.00 (5.12, 112.5)] and extrapyramidal reactions [OR: 14.03 (4.43, 44.43)]. The polypharmacy [OR: 5.85 (1.90, 18.03)] was significantly associated with 'preventable' reactions. The spontaneous reporting system is efficient to detect serious reactions and preventable reactions.
authors.affiliation: Department of Pharmacology, GMERS Medical College, Gotri, Vadodara, Gujarat, India. Electronic address: dr.tkp2006@yahoo.co.in.
authors.forename: Tejas K
authors.initials: TK
authors.lastname: Patel
authors.affiliation: Department of Pharmacology, GMERS Medical College, Gotri, Vadodara, Gujarat, India.
authors.forename: Prakash H
authors.initials: PH
authors.lastname: Bhabhor
authors.affiliation: Department of Psychiatry, GMERS Medical College, Gotri, Vadodara, Gujarat, India.
authors.forename: Nimisha
authors.initials: N
authors.lastname: Desai
authors.affiliation: Department of Psychiatry, GMERS Medical College, Gotri, Vadodara, Gujarat, India.
authors.forename: Saurabh
authors.initials: S
authors.lastname: Shah
authors.affiliation: Department of Pharmacology, GMERS Medical College, Gotri, Vadodara, Gujarat, India.
authors.forename: Parvati B
authors.initials: PB
authors.lastname: Patel
authors.affiliation: Department of Psychiatry, GMERS Medical College, Gotri, Vadodara, Gujarat, India.
authors.forename: Ela
authors.initials: E
authors.lastname: Vatsala
authors.affiliation: Department of Psychiatry, GMERS Medical College, Gotri, Vadodara, Gujarat, India.
authors.forename: Sanjibani
authors.initials: S
authors.lastname: Panigrahi
mesh_terms: D000293:Adolescent; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data*; D002648:Child; D004347:Drug Interactions; D064420:Drug-Related Side Effects and Adverse Reactions / Q000175:diagnosis / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control / Q000523:psychology; D036262:Empirical Research; D005260:Female; D006801:Humans; D015994:Incidence; D007194:India / Q000453:epidemiology; D007223:Infant; D008297:Male; D008875:Middle Aged; D011567:Psychiatric Department, Hospital / Q000706:statistics & numerical data; D011619:Psychotropic Drugs / Q000009:adverse effects / Q000145:classification; D012720:Severity of Illness Index; D062606:Tertiary Care Centers / Q000706:statistics & numerical data
chemical_list: D011619:Psychotropic Drugs
keywords: Adverse drug reaction; Causative drugs; Drug interactions; Preventable reactions; Serious reactions