S Schmiedl1,2, M Rottenkolber3, J Szymanski1,2, B Drewelow4, W Siegmund5, M Hippius6, K Farker6,7, I R Guenther6,7, J Hasford3, P A Thuermann1,2. 1. a Philipp Klee-Institute for Clinical Pharmacology , HELIOS Clinic Wuppertal , Wuppertal , Germany. 2. b Department of Clinical Pharmacology, School of Medicine, Faculty of Health , Witten/Herdecke University , Witten , Germany. 3. c Institute for Medical Information Sciences, Biometry, and Epidemiology , Ludwig-Maximilians-Universitaet Muenchen , Munich , Germany. 4. d Institute of Clinical Pharmacology, Center for Pharmacology and Toxicology , University of Rostock , Rostock , Germany. 5. e Institute of Clinical Pharmacology , University of Greifswald , Greifswald , Germany. 6. f Department of Clinical Pharmacology , Institute of Pharmacology and Toxicology, Jena University Hospital, Friedrich Schiller University Jena , Jena , Germany. 7. g Sophien- und Hufeland-Klinikum Weimar , Weimar , Germany.
Abstract
BACKGROUND: Studies evaluating the impact of age and potentially inappropriate medication (PIM) on avoidable adverse drug reactions (ADRs) are scarce. METHODS: In this prospective, multi-center, long-term (8.5 years) observational study, we analysed ADRs leading to hospitalization in departments of internal medicine. ADRs causality and preventability were assessed using standardised algorithms. PIM was defined based on the PRISCUS-list. Multivariate analyses and estimation of ADR incidence rates were conducted. RESULTS: Of all 6,427 ADR patients, a preventable ADR was present in 1,253 (19.5%) patients (elderly patients ≥70 years: 828). Risk factors for preventable ADRs in elderly patients were multimorbidity, two to four ADR-causative drugs, and intake of particular compounds (e.g. spironolactone) but not sex, PIM usage, or the total number of drugs. Regarding particular compounds associated with preventable ADRs, highest incidence rates for preventable ADRs were found for patients aged ≥70 years for spironolactone (3.3 per 1,000 exposed persons (95% CI: 1.4-6.6)) and intermediate-acting insulin (3.3 per 1,000 exposed persons (95% CI: 1.6-6.1)). CONCLUSION: Avoiding PIM usage seems to be of limited value in increasing safety in elderly patients whereas our results underline the importance of an individualized medication review of the most commonly implicated drugs in preventable ADRs (supported by BfArM FoNr: V-11337/68605/2008-2010).
BACKGROUND: Studies evaluating the impact of age and potentially inappropriate medication (PIM) on avoidable adverse drug reactions (ADRs) are scarce. METHODS: In this prospective, multi-center, long-term (8.5 years) observational study, we analysed ADRs leading to hospitalization in departments of internal medicine. ADRs causality and preventability were assessed using standardised algorithms. PIM was defined based on the PRISCUS-list. Multivariate analyses and estimation of ADR incidence rates were conducted. RESULTS: Of all 6,427 ADR patients, a preventable ADR was present in 1,253 (19.5%) patients (elderly patients ≥70 years: 828). Risk factors for preventable ADRs in elderly patients were multimorbidity, two to four ADR-causative drugs, and intake of particular compounds (e.g. spironolactone) but not sex, PIM usage, or the total number of drugs. Regarding particular compounds associated with preventable ADRs, highest incidence rates for preventable ADRs were found for patients aged ≥70 years for spironolactone (3.3 per 1,000 exposed persons (95% CI: 1.4-6.6)) and intermediate-acting insulin (3.3 per 1,000 exposed persons (95% CI: 1.6-6.1)). CONCLUSION: Avoiding PIM usage seems to be of limited value in increasing safety in elderly patients whereas our results underline the importance of an individualized medication review of the most commonly implicated drugs in preventable ADRs (supported by BfArM FoNr: V-11337/68605/2008-2010).
Entities:
Keywords:
Adverse drug event; PRISCUS; adverse drug reaction; elderly patients; hospital admission; potentially inappropriate medication (PIM); preventability
Authors: Ulrich Thiem; Stefan Wilm; Wolfgang Greiner; Henrik Rudolf; Hans-Joachim Trampisch; Christiane Müller; Gudrun Theile; Petra A Thürmann Journal: Ther Adv Drug Saf Date: 2020-05-12
Authors: Tatjana Huebner; Michael Steffens; Roland Linder; Jochen Fracowiak; Daria Langner; Marco Garling; Felix Falkenberg; Christoph Roethlein; Willy Gomm; Britta Haenisch; Julia Stingl Journal: BMJ Open Date: 2020-04-27 Impact factor: 2.692