Document Type

Article

Publication Date

1-12-2024

Identifier

DOI: 10.1371/journal.pone.0295410; PMCID: PMC10786368

Abstract

Documentation of adverse drug reactions (ADRs) is a key factor in guiding future prescribing. However, incomplete documentation is common and often fails to distinguish implicated drugs as true allergies. This in turn leads to unnecessary avoidance of implicated drug classes and may result in sub-optimal prescribing. Pharmacovigilance (PV) programs utilize a systematic approach to clarify ADR documentation and are known to improve patient safety. Yet it remains unclear if PV alters prescribing. Or, if the existence of the ADR documentation itself continues to prompt avoidance of implicated drugs. To address this, our work presents a retrospective cohort study assessing if clarification of antibiotic ADRs by a hospital-wide PV team was associated with future, safe, re-prescribing at a freestanding pediatric hospital in the midwestern United States. First, we compared the likelihood of future prescribing in an antibiotic class with an active ADR, as compared to alternative drug classes, between PV-clarified and non-clarified patients. Second, we assessed differences in adverse event rates 30-days after future prescribing based on PV clarification status. For robustness, analyses were performed on patients with ADRs in four antibiotic classes: penicillin-based beta-lactams (n = 45,642), sulfonamides/trimethoprim (n = 5,329), macrolides (n = 3,959), and glycopeptides (n = 622). Results illustrate that clarification of an ADR by PV was associated with an increased odds of future prescribing in the same drug class (Odds Ratio [95%-CI]): penicillin-based beta-lactams (1.59 [1.36-1.89]), sulfonamides/trimethoprim (2.29 [0.89-4.91]), macrolides (0.77 [0.33-1.61]), and glycopeptide (1.85 [1.12-3.20]). Notably, patients clarified by PV experienced no increase in the rate of adverse events within 30-days following the prescribing of antibiotics in the same class as an active ADR. Overall, this study provides strong evidence that PV reviews safely increase the rate of re-prescribing antibiotics even in the presence of an existing implicated drug ADR.

Journal Title

PLoS One

Volume

19

Issue

1

First Page

0295410

Last Page

0295410

MeSH Keywords

Child; Humans; Retrospective Studies; Pharmacovigilance; Anti-Bacterial Agents; Hospitals, Pediatric; Adverse Drug Reaction Reporting Systems; Drug-Related Side Effects and Adverse Reactions; Midwestern United States; Penicillins; beta-Lactams; Macrolides; Sulfonamides; Trimethoprim

Keywords

Retrospective Studies; Pharmacovigilance; Anti-Bacterial Agents; Pediatric Hospitals; Adverse Drug Reaction Reporting Systems; Drug-Related Side Effects and Adverse Reactions; Midwestern United States; Penicillins; beta-Lactams; Macrolides; Sulfonamides; Trimethoprim

Comments

This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Publisher's Link: https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0295410

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