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

Document Type

Article

Department

Medical College Pakistan; Internal Medicine

Abstract

Objective: 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.
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.
Results: PRR identified positive signals in 5 subclasses, while ROR identified 7. The seven 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).
Conclusion: 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.

AKU Student

yes

Publication (Name of Journal)

Exploratory Research in Clinical and Social Pharmacy

DOI

10.1016/j.rcsop.2026.100711

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