Identification and management of adverse effects of antipsychotics in a tertiary care teaching hospital

Objective: Antipsychotics have revolutionized psychiatry by allowing significant numbers of patients in long-term hospital settings to be discharged and successfully maintained in the community. However, these medications are also associated with a range of adverse events ranging from mostly annoying to rarely dangerous. This study is carried out to identify the adverse drug reactions (ADRs) to antipsychotics and its management in psychiatric patients.Methods: Prospective interventional study was conducted in the psychiatric unit of a tertiary care hospital. Patients of any age and either sex prescribed with at least one antipsychotic were included and monitored for ADRs.Findings: Among the 517 patients receiving antipsychotics, a total of 289 ADRs were identified from 217 patients at an overall incidence rate of 41.97%. Sixty-seven different kinds of ADRs were observed in the study patients. Central and peripheral nervous system was the most commonly affected system organ class (n = 59) and weight gain (n = 30) was the most commonly observed ADR. Olanzapine was most commonly implicated in reported ADRs (n = 92) followed by risperidone (n = 59). Of the 289 ADRs, 80% required interventions including cessation of drug and/or specific/symptomatic/nonpharmacological treatment.Conclusion: This post marketing surveillance study provides a representative data of the ADR profile of the antipsychotics likely to be encountered in psychiatric patients in an Indian tertiary care hospital.研究目的：抗精神病药物彻底革新了精神病学领域，使大量长期住院患者得以出院，并在社区中获得成功的维持治疗。然而，此类药物亦可引发一系列不良事件，其严重程度从多数轻微不适到罕见的致命风险不等。本研究旨在识别精神病患者使用抗精神病药物所致的药品不良反应（adverse drug reactions, ADRs）及其临床处置方案。方法：本研究于某三级医院精神科病房开展前瞻性干预研究，纳入所有年龄、性别不限且至少接受一种抗精神病药物治疗的患者，对其药品不良反应进行监测。结果：在517例接受抗精神病药物治疗的患者中，共计从217例患者中识别出289例药品不良反应，总体发生率为41.97%。本研究共观察到67种不同类型的药品不良反应，其中中枢及外周神经系统为最常受累的系统器官分类（n=59），体重增加（n=30）为最常见的单项不良反应。奥氮平（olanzapine）是引发报告不良反应最频繁的药物（n=92），其次为利培酮（risperidone，n=59）。在289例不良反应事件中，80%需要采取干预措施，包括停药及/或针对性治疗、对症治疗或非药物治疗。结论：本项上市后监测研究提供了印度某三级医院精神科患者中临床可能出现的抗精神病药物不良反应特征的代表性数据。