Original Article Monitoring Adverse Effects of Antipsychotics and Antidepressants: A Population Based Study Satya Sree Rallabandi1, Sai Samanth Makula1, Vasudeva Murthy Sindgi2, Bandari Jagadeesh Babu2, Usha Sree Puneem1,* 1Department of Pharmacy Practice, Jayamukhi College of Pharmacy (Affiliated to Kakatiya) University, Warangal, Telangana, INDIA. 2Department of Pharmacology, Jayamukhi College of Pharmacy (Affiliated to Kakatiya) University, Warangal, Telangana, INDIA. ABSTRACT Aim: To monitor the nature and incidences adverse effects of both antipsychotics and antidepressants medicines in the psychiatry outpatient department. Objectives: Reporting the incidences of adverse effects and to establish the frequency of a specific class of drug. Identifying the system affected and the assessment of the management of the adverse effects by the physician. For the study, we have adopted Global Assessment Scale (GAS), Simpson-Angus Extra pyramidal Side Effects Scale (SAS) and The Antidepressant Side-Effect Checklist (ASEC). Materials and Methods: A prospective cohort study carried out in the psychiatry out-patient department. All the patients attending psychiatry outpatient department enrolled based on the pre-specified inclusion criteria and monitored for adverse effects. Causality also assessed by WHO-UMC causality assessment system and Naranjo Causality Assessment. Results: The incidence rate of adverse effects (46.07%) and 560 adverse effects documented. Weight gain (n=29, 9.2%) followed by drowsiness (n=27, 4.82%) are most commonly reported adverse effects. Atypical antipsychotics (n=279, 49.82%) were the most common class of psychotropic drugs implicated in adverse effects. Escitalopram (n=93, 37.80%) followed by olanzapine (n=53, 21.54%) associated with a maximum number of adverse effects. Central nervous system (n=225, 40.17%) was the most affected organ system followed by gastrointestinal system (n=130, 23.21%). Conclusion: Study revealed moderate incidences of adverse effects in patients attending the psychiatry outpatient department. Majority of the adverse effects reported during the study were mild in nature and not preventable. The role of a clinical pharmacist clearly elucidated regular intensive monitoring of adverse effects may improve the quality of patients’ care, reduction in the treatment cost and augmentation of the medication adherence among patients. Key words: Adverse effects, Pharmacovigilance, Antipsychotics, Antidepressants, Extra pyramidal side effects. INTRODUCTION and mortality in health care system and more than two million serious adverse drug According to WHO, Adverse drug reaction DOI: 10.5530/ijopp.14.3.38 is defined as “a response to a drug that is reactions occurring yearly. Studies conducted on hospitalized patient populations assess Address for noxious and unintended and occurs at doses correspondence: normally used in the man for the prophylaxis, that 6.7% of hospitalized patients have a Dr. Usha Sree Puneem diagnosis or therapy of disease, or for serious adverse drug reaction with a fatality Department of Pharmacy 2 Practice, Jayamukhi College of 1 modification of physiological function.” rate of 0.32%. The cost of drug-related Pharmacy (Affiliated to Kakatiya) Adverse effects of antipsychotics and morbidity and mortality is $136 billion University, Warangal - 506009, Telangana, INDIA. antidepressants range from mild forms such annually, that is more than the total cost of 3 Phone no: +91-6303673570 as nausea, headache to most severe forms cardiovascular or diabetic care. Furthermore Email Id: ushasree.puneem@ like sudden coma and cardiac death. Extra one of the five injuries or deaths per gmail.com pyramidal side effects of antipsychotics are hospitalized patient are due to ADRs.4 In (akathisia, tardive dyskinesia) devastating to India, to monitor the adverse events and their the extent that could restrict the patients burden on patients, Government launched from continuing the medication. Adverse a National Pharmacovigilance Programme effects (AE) of drugs used in psychiatric (NPvP), after the failure of regional centres care occur at minimum doses prescribed and of WHO Programme for International Drug 5 are one of the leading causes of morbidity Monitoring. www.ijopp.org Indian Journal of Pharmacy Practice, Vol 14, Issue 3, Jul-Sep, 2021 191 Rallabandi, et al.: Incidences Adverse Effects of Antipsychotics and Antidepressants In the present study, we identified the incidence of adverse medications and patients experiencing adverse effects effects of antipsychotics and antidepressants. Adverse due to medication error or experiencing symptoms due to effects are categorised according to the major class of withdrawal and mentally ill patients who failed to describe drugs causing AE’s, spectrum of AE’s and organ systems their conditions excluded from the study. affected. Antecedent to adverse effects noticed and causing the patients’ non-adherent to their medication. Study Material Causality assessed using WHO-UMC causality assessment system and Naranjo Causality Assessment. Patient profile form used to collect the details. Standard scales are used to document the adverse effects included the following: Glasgow Antipsychotic Side-effect Scale MATERIALS AND METHODS (GASS); Simpson-Angus Extra pyramidal Side Effects The main objective was to determine the incidence of Scale and The Antidepressant side effect checklist AE’s in patients attending Psychiatric Department of (ASEC). Jayakrishna Psychiatric Care and Counselling Center, Warangal (U), India and to assess the physician in the Study Procedure management of the AE’s. Secondary objective was to Patients’ details recorded in the data collection forms. To determine the frequency of adverse effects in a specific record experienced adverse effects patients are provided drug class and to categorize them according to the organs with different scales. All the adverse effects reported by affected. This prospective cohort study employed to the patients, caretakers and observed by the consulting review the adverse effects. A total number of 176 patients physician documented. were included during the study period. The documented adverse effects classified according to Patients adept enough to read and write and the caretakers the type of psychiatric disorder, class of drugs, spectrum attended the patient at least once a week for one hour of adverse effects, organ systems affected; Incidence of provided a consent form and took approval to participate adverse effects and causality assessment. in the study. In contrast to that, illiterate patients or caretakers with verbal consent. The patient was included in the study only after obtaining the consent of his/her RESULTS participation. The study was approved by Institutional Patients (N=382) screened for the adverse effects during review board (Approval number- 14353D1006 / JCP/ their visit to the hospital throughout the study period of IRB/2018/07). six months (March, 2018 to August, 2018), from which 176 patients were found to be experiencing at least one Recruitment adverse effect. The overall incidence of adverse effects The patients provided forms to fill with details about the observed to be 46.07%. The schizophrenic patients AE’s experienced by them. If the patient is mentally ill (n=85, 48.29%) and patients affected with depression to the extent that he/she cannot read or understand the (n=91, 51.70%) included for our final analysis of the scales mentioned in forms entrusted with caretakers. In study. Antipsychotics adverse effects outnumbered contrast, if the patients or caretakers cannot understand (314, 56.07%) the antidepressants (246, 43.92%) adverse the scales containing questions with reference to AEs, effects. conversed by the study conductor to record the data. The Prevalence of the Adverse effects in female patients study included a sample of 176 subjects and conducted (n=103, 58.5%) is higher than male (73, 41.4%). Majority for a period of six months from March 2018 to August of the patients who were treated by antipsychotics or 2018. antidepressants were in the age group of 25-50 years (n=111, 63.0%) followed by the age group below 25 years Study Population (n=38, 21.7%) and less affected age group observed in Patients of both genders, all age groups and diagnosed above 50 years (n=27, 15.3%). The incidence of disease with a psychiatric disorder according to The Diagnostic manifestation in rural patients (n=94, 53.40%) is slightly and Statistical Manual of Mental Disorders-IV and higher than urban patients (n=82, 46.59%). Distressing experiencing at least one adverse effect are part of the events considerably found to be the root cause in study. Patients receiving at least one antipsychotic or patients (n=133, 75.56%) and no preceding event in rest antidepressant medication during the study period were of the patients (n=43, 24.43%). Patients (n=68, 38.6%) also included in the study. In contrast, patients who were included regardless of their duration of disorder are not receiving an antipsychotic or antidepressant observed below 1 to 5 years followed by with psychiatric 192 Indian Journal of Pharmacy Practice, Vol 14, Issue 3, Jul-Sep, 2021 Rallabandi, et al.: Incidences Adverse Effects of Antipsychotics and Antidepressants illness (n=41, 23.29%) with more than 5 years. In this in patients, weight gain (29, 9.2%) was dominant, followed study the 129 (73.2%) patients’ on monotherapy and by frequency of drowsiness is 27 and with orthostatic patients on polytherapy constituted 26.7%