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

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 identifie

SUBMITTER: Umer A 

PROVIDER: S-EPMC12907660 | biostudies-literature | 2026 Mar

REPOSITORIES: biostudies-literature