Shah et al Journal of Drug Delivery & Therapeutics; 2014, 4(1), 49-52 49 © 2011, JDDT. All Rights Reserved ISSN: 2250-1177 CODEN (USA): JDDTAO Available online at http://jddtonline.info RESEARCH ARTICLE A LONGITUDINAL STUDY OF MONITORING ADVERSE DRUG REACTIONS AT PSYCHIATRY OUT-PATIENT-DEPARTMENT IN OUR TERTIARY CARE TEACHING HOSPITAL, SURENDRANAGAR *Shah VM 1 , Mehta DS 2 1 P.G. student, Department of pharmacology, C.U.S.M.C., Surendranagar, Gujarat, India 2 Professor & Head, Department of pharmacology, C.U.S.M.C., Surendranagar, Gujarat, India *Corresponding Author’s E-mail: Vidisha_pharmac@yahoo.com INTRODUCTION: Adverse drug reactions (ADRs) are as important in psychiatric practice as they are in any other branch of medicine. The safety of medicines is an essential part of patient safety. Global drug safety depends on strong national systems that monitor the development and quality of medicines, report their harmful effects, and provide accurate information for their safe use. ADRs are defined as an „unexpected, unintended, undesired or excessive response to a drug‟, which would include „allergic reactions and idiosyncratic reactions that are an abnormal susceptibility to a drug peculiar to the individual‟. 1 All noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reaction. 2 ADRs only affect a minority of those taking a particular drug. It is often seen that commonly prescribed drugs, elicit ADR in some, at the same time many remain unaffected. Pharmacovigilance is, “The Pharmacological Science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long term and short term side effects of medicines.” 3 Pharmacovigilance in psychiatry units can play a vital role in detecting ADRs and alerting physicians to the possibility and circumstances of such events, thereby protecting the user population from avoidable harm. 4 Many psychotropic drugs are available in India and their use is increasing day by day. Commonly used psychotropic drugs in psychiatry O.P.D. are the drugs used for psychoses, depression, epilepsy, mania, migraine and insomnia. These drugs are capable of causing a number of ADRs, 5,6 some of which may be fatal. Most commonly ADRs are seen with antipsychotics and mood stabilizers. ADRs associated with psychotropic drugs can lead to noncompliance, and at times discontinuation of therapy. 7 In India, pharmacovigilance activities are still in the nascent stage and the data of ADRs particularly related to psychotropic drugs need to be strengthened. 8 Objectives: To determine the incidence of ADRs and to assess the causality of ADRs in psychiatry O.P.D. at our tertiary care teaching hospital. MATERIALS AND METHODS: A longitudinal observational study was carried out at our psychiatry out-patient-department (OPD) in a tertiary care teaching hospital. This hospital caters to the health care needs of thousands of patients from Surendranagar city, many villages and town around the city. It was part of ongoing pharmacovigilance activity at the Institute which had the necessary administrative and Institutional Ethics Committee (IEC) clearance. The data was collected prospectively of the patients reporting to psychiatry OPD. The study was carried out for 3 months between May 2012 and July 2012. Out of 4169 patients attending to psychiatry OPD within these 3 months, the patients with ADRs were evaluated. Diagnosis of ADR was made by psychiatrist. All the doctors, residents, interns, and nursing staff were informed to notify any suspected ADRs. Patient details (age, sex, body weight), adverse event history, history of medication suspected of having caused the ADR, and details of concomitant medication use were recorded in ABSTRACT Objectives: Adverse Drug Reactions (ADRs) are common to the psychotropic drugs in our teaching hospital and here, we study to determine suspected ADRs in psychiatry O.P.D. Materials and Methods: In order to evaluate the incidence of ADRs in psychiatry O.P.D., we performed a longitudinal observational study between May 2012 and July 2012. All the patients were interviewed for basic details, history of medications and for the relevant history for ADRs. All details were captured in a format as adopted in the Indian National Pharmacovigilance Programme. Causality was assessed by criteria of World Health Organization-Uppsala Monitoring Center (WHO-UPC). Result: We observed 4169 patients (males 64.28%, females 35.71%, median age 40 years), of who 28 were diagnosed as having at least one ADR; Cases who had insufficient evidence about causality (WHO-UMC causality status "unlikely") were excluded from further analysis. Out of 28 events recorded, 12 (42.85%) were "probable" and 12(42.85%) were "possible". Rest of them was labeled as “certain". Total of 43 ADRs were noted in 28 patients. Maximum number of ADR noted was nausea which was followed by weight gain. Highest number of ADRs was reported with Amitriptyline and Duloxetine. Key Words: Adverse Drug Reactions (ADRs), Psychiatry O.P.D., Psychotropic drugs.