Monitoring of adverse drug reactions in psychiatry outpatient department of a tertiary care hospital in Central India

Sunil Mahakalkar, Prashant Tiple, Bhagyashri Mohod, Nikhil Dhargave


Background: Adverse drug reactions (ADRs) are prevalent in patients taking psychotropic medications and can occur even at the normal doses used in the management of acute and maintenance phases of psychiatric disorders. Pharmacovigilance have cardinal role in alerting the healthcare providers from the possible ADRs and thus protecting the patients who are using psychotropic medications. To Monitor and estimate the incidence and nature of ADRs in psychiatry OPD of tertiary care hospital in central India and assess the causality, preventability and severity of documented ADRs.

Methods: A prospective observational study was conducted in psychiatry out-patient department (OPD). Patients diagnosed with any psychiatric disorder and receiving psychotropic medications was included in the study. The recorded data were filled in the ADR form obtained from pharmacovigilance program of India (PvPI). Causality assessment was done using Naranjo scale and severity was assessed using Hartwig scale and preventability assessment using modified Schumock and Thornton’s scale.

Results: The incidence rate of ADR was found to be 15.8%. A total of 61 ADRs were documented. Weight gain 14 (18.1%) followed by nausea 11 (14.2%) was the most commonly reported ADR. Atypical antipsychotics were the most common class of psychotropic drugs implicated in ADRs. Clonazepam 21 (27.2%) followed by amitriptyline 20 (25.9%) were associated with a maximum number of ADRs. Majority of the suspected ADRs were probable in nature (40.9%) followed by possible type (31%).

Conclusions: Study revealed a moderate incidence of ADRs in patients attending the psychiatry OPD.  Majority of the ADRs reported during the study were mild in nature and definitely preventable type.


Adverse drug reaction, Pharmacovigilance, Psychiatry outpatient department, Psychotropic medications

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Satoskar RS, Rege NN, Bhandarkar SD. Pharmacology and Pharmacotherapeutics. 24th ed. New Delhi: Elsevier; 2017:40.

Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: A meta-analysis of prospective studies. JAMA. 1998;279:1200-5.

Ramakrishnaiah H, Krishnaiah V, Pundarikaksha HP, Ramakrishna V. A prospective study on adverse drug reactions in outpatients and in patients of medicine department in a tertiary care hospital. Int J Basic Clin Pharmacol. 2015;4:515-21.

Sengupta G, Bhowmick S, Hazra A, Datta A, Rahaman M. Adverse drug reaction monitoring in psychiatry out-patient department of an Indian teaching hospital. Indian J Pharmacol. 2011;43:36-9.

Haddad PM, Sharma SG. Adverse effects of atypical antipsychotics: Differential risk and clinical implications. CNS Drugs. 2007;21:911-36.

Prajapati HK, Joshi ND, Trivedi HR, Parmar MC, Jadav SP, Parmar DM, et al. Adverse drug reaction monitoring in psychiatric outpatient department of a tertiary care hospital. Natl J Integr Res Med. 2013;4:102-6.

Mishra S, Swain TR, Mohanty M. Adverse drug reaction monitoring of antidepressants in the psychiatry out patients department of a tertiary care teaching hospital. J Clin Diagn Res. 2013;7:1131-4.

Solanke B, Mahatme MS, Dakhale G, Hiware S, Shrivastava M, Waradkar P. Adverse drug reaction profile at psychiatry outpatient department of a tertiary referral centre in Central India. Int J Basic Clin Pharmacol. 2013;2:341-3.

Pahari N, Tripathi SK, Maity T, Gupta BK, Bagchi C, Mondal DK. Evaluation and analysis of adverse drug reactions of second-generation antipsychotics in a psychiatry out-patient department. Int J Pharm Pharm Sci. 2012;4:158-62.

Thomas M, Boggs AA, Paula DB, Siddiqi S. Adverse drug reactions in hospitalized psychiatric patients. Ann Pharmacother. 2010;44:819-25.

Faich GA. US adverse drug reaction surveillance 1989 1994. Pharmacoepidemiol Drug Saf. 1996;5:393-8.

Verma S, Gulati Y. Fundamentals of Pharmacovigilance. Ch 2. Hydrabad: Paras Medical Publisher; 2017: 9.

Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I, Roberts EA, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther. 1981;30:239-45.

Hartwig SC, Siegel J, Schneider PJ. Preventability and severity assessment in reporting adverse drug reactions. Am J Hosp Pharm. 1992;49:2229-32.

Budnitz DS, Pollock DA, Weidenbach KN, Mendelsohn AB, Schroeder TJ, Annest JL. National surveillance of emergency department visits for outpatient adverse drug events. JAMA. 2006;296:1858-66.

Patel TK, Bhabhor PH, Desai N. Adverse drug reactions in a psychiatric department of tertiary care teaching hospital in India: Analysis of spontaneously reported cases. Asian J Psychiatr. 2015;17:42-9.

Lucca JM, Ramesh M, Parthasarathi G, Ram D. A Prospective Surveillance of Pharmacovigilance of Psychotropic Medicines in a Developing Country. Psychopharmacol Bull. 2016;46(1):54-66.

Rothschild, Jeffrey, Mann, Klaus, Keohane. Medication safety in a psychiatric hospital. General hospital psychiatry. 2007;29:156-62.

Macaluso M, Kazanchi H, Preskorn SH. How the pharmacokinetics and receptor-binding profile of lurasidone affect the clinical utility and safety of the drug in the treatment of schizophrenia. Expert Opin Drug Metab Toxicol. 2015;11(8):1317-27.

Sridhar SB, Thamer ASS, Jabbar R. Monitoring of adverse drug reactions in psychiatry outpatient department of a Secondary Care Hospital of Ras Al Khaimah, UAE. J Basic Clin Pharm. 2016;7(3):80-6.

Prajapati HK, Joshi ND, Trivedi HR, Parmar MC, Jadav SP, Parmar DM, et al. Adverse drug reaction monitoring in psychiatric outpatient department of a tertiary care hospital. Natl J Integr Res Med. 2013;4:102-6.

Nithya P. Adverse drug reactions monitoring to various psychotrophic drugs in psychiatry department of a tertiary care hospital, Chennai. J Pharmaceutical and Biological Sci. 2013; 2(2):19-25.

Lahon K, Shetty HM, Paramel A, Sharma G. A retrospective study of the metabolic adverse effects of antipsychotics, antidepressants, and mood stabilizers in the psychiatry outpatient clinic of a tertiary care hospital in south India. Int J Nutr Pharmacol Neurol Dis. 2012;2:237-42.