Analysis and reporting of adverse drug reactions at a tertiary care teaching hospital

Abstract

Objectives: To analyze and report adverse drug reactions (ADRs) in a tertiary care teaching hospital.

Methods: This was an observational study, conducted to analyze and communicate the ADRs reported from July 2016 to June 2017 in a south Indian tertiary care teaching hospital. On daily basis, ADRs reported by healthcare professionals (HCPs) were analyzed and the reports that meet pharmacovigilance programme of India (PvPI) reporting criteria were communicated to PvPI through a specified updated Indian Pharmacopoeia Commission (IPC) suspected ADR reporting form. In this study, ADRs were summarised based on demographics, drug, incidence, type of reaction and its outcome. Causality, severity, seriousness, and predictability were assessed through WHO causality assessment scale, Hartwig and Siegel Severity Assessment Scale and PvPI criteria.

Results: A total of 254 ADRs communicated to PvPI through specified, updated IPC suspected ADR reporting form. The incidence of ADRs in both males and females was identical. The occurrence of ADRs in adult patients (71.26%) was significantly higher than other age groups. Of total ADRs, most of them were with
Antibiotics (24.01%) followed by antipsychotics (11.42%). In causality assessment, a majority of ADRs (48.82%) were considered possibly related to the drug or treatment and 55.12% were mild in severity. Overall, 36.22% patients were recovered from ADRs. Most of the reported ADRs (54.33%) were probably preventable.

Conclusions: The results provided an insight to the HCPs on the importance of monitoring and reporting of ADRs. High-quality data gathered through a reporting system, most of the reported ADRs were probably preventable; the proper review of patient history and monitoring by HCPs can reduce the incidence of ADR. Our study results emphasize a need for establishing a pharmacovigilance centre to ensure the safe use of drugs.

Keywords: Adverse drug reaction, Pharmacovigilance, Reporting, Causality