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Schechner, Miriam; Rottenkolber, Marietta; Weglage, Clara; Brišnik, Vita; Haerdtlein, Annette; Guthrie, Bruce; Jaehde, Ulrich; Grill, Eva ORCID logoORCID: https://orcid.org/0000-0002-0273-7984 und Dreischulte, Tobias ORCID logoORCID: https://orcid.org/0000-0003-2345-5377 (2025): Implied ADR-Admissions: A Cohort Study Introducing a Novel Administrative Data Approach for Identifying Drug-Related Hospitalisations. In: Drug Safety [Forthcoming]

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Abstract

Background: Adverse drug reactions (ADRs) are a key contributor to unplanned hospitalisations, particularly in patients with polypharmacy. Traditional detection methods, such as expert reviews or diagnostic coding, are limited in scalability and sensitivity.

Objective: This study introduces and evaluates a novel scalable method, implied ADR-admissions, that links drug exposures to adverse events using administrative data to improve the detection of plausible drug-related hospitalisations.

Methods: A retrospective cohort study was conducted using linked health data from 123,662 individuals aged ≥ 40 years with polypharmacy in two Scottish health boards. Implied ADR-admissions were defined as emergency hospitalisations with one of 15 adverse events plausibly linked to drug exposure (based on a structured consensus process) within the prior 90 days. Incidence was compared with three existing approaches: adverse event-admissions (regardless of drug exposure), explicit ADR-admissions (explicitly coded as ADRs) and preventable ADR-admissions (with prior medication error). Multivariate logistic regression was used to identify predictors of implied ADR-admissions.

Results: Over 1 year, 2.6% experienced an implied ADR-admission, compared with 5.7% with adverse event-admissions, and 0.4% with explicit ADR-admissions. For gastrointestinal bleeding, the implied ADR-admission incidence was 20 times higher than the preventable ADR-admission incidence. Key predictors for implied ADR-admissions included prior hypokalaemia-related hospitalisation and use of potentially inappropriate medications.

Conclusions: The implied ADR-admission approach has improved specificity relative to broad adverse event definitions while enhancing sensitivity beyond methods that rely solely on explicit ADR codes or pre-specified medication errors. It offers a scalable automated tool for pharmacovigilance, though further validation is needed prior to routine use in medication safety monitoring.

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