Characterization of the Adverse Drug Reactions Associated with Psychotropic Medications Based on a Spontaneous Reporting Systems Database: A Retrospective Analysis

Purpose: Adverse Drug Reaction (ADR) reports using spontaneous reporting systems are known to assist in the identification of new, rare, and serious ADRs in clinical practice. Research characterizing ADRs in patients taking psychotropics in Qatar is scarce. This study aims to describe psychotropic-related ADRs’ characteristics, risk factors, severity, causality, and preventability. Patients and Methods: This is a retrospective chart review of patients within Hamad Medical Corporation’s (HMC) Mental Health Services (MHS) between 2018– 2022. ADR reports submitted to the Spontaneous Reporting System database were electronically extracted and analyzed. Data on the type, frequency, onset, severity, and outcomes of adverse reactions, along with patient demographics and comorbidities, were extracted and summarized using quantitative methods. Results: A total of 908 reports were analyzed. Most ADRs were reported in males (543, 59.83%), in the year 2020 (256, 28.2%). Most reactions were categorized as “moderate” (67.7%), followed by “mild” reactions (30.9%). Extrapyramidal symptoms (EPS) were the highest reported ADRs (46.5%) followed by gastrointestinal side effects (13.3%) and hyperprolactinemia (13.2%) with Haloperidol as the most reported offending agent. Around half of the ADRs were classified as probable and 65.0% were deemed not preventable Psychotropic polypharmacy remained a significant independent risk factor for EPS, increasing the odds of by 45% (OR = 1.45, 95% CI [1.08– 1.95], p = 0.015). Conclusion: This is the first study to describe the characteristics of psychotropic-related ADRs reported within HMC mental health services in Qatar. Most ADRs were moderate in severity with EPS being the most common ADR and haloperidol as the most reported suspected offending agent. Patterns discovered in this study can aid in enhancing patient safety through educating health care providers on predicting and minimizing preventable ADRs. Keywords: adverse drug reaction, extrapyramidal symptoms, hyperprolactinemia, patient safety, antipsychotic agents, antidepressant agents