Miriam Schechner, Marietta Rottenkolber, Clara Weglage, Vita Brišnik, Annette Haerdtlein, Bruce Guthrie, Ulrich Jaehde, Eva Grill, Tobias Dreischulte
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Traditional detection methods, such as expert reviews or diagnostic coding, are limited in scalability and sensitivity.</p><p><strong>Objective: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":""},"PeriodicalIF":3.8000,"publicationDate":"2025-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Implied ADR-Admissions: A Cohort Study Introducing a Novel Administrative Data Approach for Identifying Drug-Related Hospitalisations.\",\"authors\":\"Miriam Schechner, Marietta Rottenkolber, Clara Weglage, Vita Brišnik, Annette Haerdtlein, Bruce Guthrie, Ulrich Jaehde, Eva Grill, Tobias Dreischulte\",\"doi\":\"10.1007/s40264-025-01614-w\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Adverse drug reactions (ADRs) are a key contributor to unplanned hospitalisations, particularly in patients with polypharmacy. 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Implied ADR-Admissions: A Cohort Study Introducing a Novel Administrative Data Approach for Identifying Drug-Related Hospitalisations.
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.
期刊介绍：
Drug Safety is the official journal of the International Society of Pharmacovigilance. The journal includes:
Overviews of contentious or emerging issues.
Comprehensive narrative reviews that provide an authoritative source of information on epidemiology, clinical features, prevention and management of adverse effects of individual drugs and drug classes.
In-depth benefit-risk assessment of adverse effect and efficacy data for a drug in a defined therapeutic area.
Systematic reviews (with or without meta-analyses) that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by the PRISMA statement.
Original research articles reporting the results of well-designed studies in disciplines such as pharmacoepidemiology, pharmacovigilance, pharmacology and toxicology, and pharmacogenomics.
Editorials and commentaries on topical issues.
Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Drug Safety Drugs may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances.
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