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Objectives: The objective of this study was to boost pharmacovigilance activity in our psychiatry referral hospital and highlight the pharmacist's role in preventing, detecting, and managing adverse drug reactions (ADRs). Our goal was to promote patient safety and compliance with psychotropic medication by identifying ADR patterns among hospitalized patients in our psychiatry hospital. We aimed to assess and evaluate the causality, severity, and management of documented ADRs along with establishing a hospital-based ADR reporting platform., Methods: We enrolled adult patients (18-60 years) admitted to our psychiatric facility between 1 September 2020 and 30 September 2021 who received at least one psychotropic agent for at least two months. Patients with a history of substance abuse, pregnant females, and patients on clozapine were excluded. Medical records were examined for demographics, clinical details, and psychotropic-related ADRs. ADRs were analyzed for causality using Naranjo's algorithm, for severity using modified Hartwig and Siegel, and for preventability using modified Schumock and Thornton scales., Results: Among 506 admitted patients, 327 suspected psychotropic-related ADRs corresponding to 217 (42.9%) patients, were recorded. Hormonal ADRs were five times higher in men, while the odds of neurological ADRs were significantly higher for women. Otherwise, other ADRs were not statistically affected by gender. Combined therapy was associated with high odds of ADRs, whereas cardiovascular and neurological ADRs were statistically related to monotherapy. Neurological (47.4%) ADRs predominated, followed by cardiovascular (18.7%), and hormonal (15.0%). ADRs were more prevalent among antipsychotics, followed by antidepressants, then mood stabilizers. According to the Naranjo algorithm, some (22.9%) of ADRs were definite, while the majority (74.3%) were probable. As per the Hartwig severity scale, the majority (74.0%) of ADRs were moderate, and the rest (26.0%) were mild. The Modified Schumock and Thornton assessment questionnaire revealed that 75.2% of ADRs were unpreventable, 19.3% were probably preventable, and 5.5% were preventable. In 46.8% of the cases, a new medication was required to manage the emerging ADRs; one-third of ADRs necessitate the replacement of the suspected medication. Close monitoring without any pharmacological intervention was sufficient in 23.2% of cases, while dose reduction was the solution in 7.6% of cases., Conclusions: ADR monitoring in the psychiatry setting by a multidisciplinary team helps recognize the initial signs of ADRs, contributing to better compliance. Hospital-based reporting programs or data-capturing tools will aid in the spontaneous and active assessment of ADRs by healthcare practitioners., (Copyright © 2024, Oman Medical Journal.)

Background: The U.S. Food and Drug Administration (FDA) revised the labels of sodium-glucose transporter 2 (SGLT2) inhibitors in December 2015 to inform users regarding the risk of diabetic ketoacidosis (DKA). As more drugs of this class are approved and their indications are expanded, this serious adverse effect has been increasingly reported., Objective: This review evaluated observational studies to inform the prevalence of SGLT2-inhibitor-associated DKA compared with other antihyperglycemic agents., Methods: A systematic review was conducted in PubMed and EMBASE until 19 July 2022 (PROSPERO: CRD42022385425). We included published retrospective cohort active comparator/new user (ACNU) and prevalent new user studies assessing SGLT2-inhibitor-associated DKA prevalence in adult patients with type 2 diabetes mellitus (T2DM) against active comparators. We excluded studies which lacked 1:1 propensity score matching. The JBI Checklist for Cohort Studies guided the risk-of-bias assessments. Meta-analysis was conducted based on the inverse variance method in R software., Results: Sixteen studies with a sample of 2,956,100 nonunique patients met the inclusion criteria. Most studies were conducted in North America (n = 9) and adopted the ACNU design (n = 15). Meta-analysis of 14 studies identified 33% higher DKA risk associated with SGLT2 inhibitors (HR = 1.33, 95% CI: 1.14-1.55, P < 0.01). Meta-regression analysis identified the study location (P = 0.02), analysis principle (P < 0.001), exclusion of chronic comorbidities (P = 0.007), and canagliflozin (P = 0.04) as significant moderator variables., Conclusions: Despite limitations related to heterogeneity, generalizability, and misclassification, the results of this study show that SGLT2 inhibitors increase the prevalence of DKA among adult T2DM patients in the real world. The findings supplement evidence from randomized controlled trials (RCTs) and call for continued vigilance., Competing Interests: Disclosure The authors declare no conflict of interest., (Copyright © 2023 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.)