Work

Class-level drug safety surveillance in hospital practice: A pharmacovigilance analysis of 84 therapeutic subclasses from a South Asian tertiary care center

Year: 2026

Type: article

Abstract: Post-marketing drug surveillance is critical for strengthening pharmacovigilance in low- and middle-income settings. This study provides the first class-level pharmacovigilance analysis from a South Asian tertiary hospital, generating safety signals across 84 drug subclasses and evaluating concordance between Proportional Reporting Ratio (PRR) and Reporting Odds Ratio (ROR) methods. We conducted a retrospective cross-sectional analysis of electronic health records (2018–2022), comprising 718,088 drug administration events. Adverse drug reactions (ADRs) were identified using ICD-9-CM/ICD-10-CM codes. Disproportionality analyses using PRR and ROR were applied to each subclass. PRR identified positive signals in 5 subclasses, while ROR identified 7. The seven concordant or overlapping high-risk subclasses included antitubercular agents (PRR 3.24; ROR 4.14), anesthetic muscle relaxants (2.44; 2.84), aminoglycosides (2.24; 2.55), immunosuppressants (2.19; 2.47), neurologic sedatives (2.06; 2.29), antineoplastic cytotoxic agents (1.95; 2.15), and general anesthetic agents (1.88; 2.06). Concordance between PRR and ROR was high (96.4% agreement; κ ≈ 0.80; McNemar p = 0.48). Signal strength correlated inversely with overall drug exposure (ρ = −0.34). This analysis establishes baseline class-level risk estimates in a developing pharmacovigilance environment, identifies disproportionately high-risk drug classes, and supports the robustness of PRR and ROR as complementary screening tools for regional drug safety monitoring. • First South Asian class-level drug safety surveillance analysis. • Seven high-alert therapeutic classes identified from 718,088 cases. • PRR and ROR methods showed 96% agreement in signal detection. • High-volume drugs showed inverse associations masking potential risks.

Source: Exploratory Research in Clinical and Social Pharmacy

DOI: 10.1016/j.rcsop.2026.100711

Authors: Abdullah Umer, Adam Khan Mohmand, Naimal Mouzam Khan, Ainan Arshad, Sher M. Sethi

Institutions: Aga Khan University, Aga Khan University Hospital

Language: English

Topic: Pharmacovigilance and Adverse Drug Reactions

Subfield: Toxicology

Field: Pharmacology, Toxicology and Pharmaceutics

Domain: Life Sciences

SDG: Good health and well-being

Open Access status: gold

Estimated APC paid: $2,140