The Trigger Tool Method for Routine Pharmacovigilance: A Retrospective Cohort Study of the Medical Records of Hospitalized Geriatric Patients.

Autor:	Marseau F; From the Pharmacovigilance, Pharmacoepidemiology, and Drug Information Centre, Department of Clinical Pharmacology, Rennes University Hospital, Rennes, France., Prud'Homm J; Geriatrics Department, Rennes University Hospital, Rennes, France., Bouzillé G; Univ Rennes, CHU Rennes, Inserm, LTSI - UMR 1099, Rennes, France., Polard E; From the Pharmacovigilance, Pharmacoepidemiology, and Drug Information Centre, Department of Clinical Pharmacology, Rennes University Hospital, Rennes, France., Oger E, Somme D, Osmont MN; From the Pharmacovigilance, Pharmacoepidemiology, and Drug Information Centre, Department of Clinical Pharmacology, Rennes University Hospital, Rennes, France., Scailteux LM
Jazyk:	angličtina
Zdroj:	Journal of patient safety [J Patient Saf] 2022 Mar 01; Vol. 18 (2), pp. e393-e400.
DOI:	10.1097/PTS.0000000000000820
Abstrakt:	Objective: The main objective was to assess the feasibility of the trigger tool method for the retrospective detection of adverse drug reactions (ADRs) in the Rennes University Hospital. The secondary objective was to describe the performance of the method in terms of positive predictive values (PPVs) and severity or preventability of ADRs. Methods: Using the Rennes University Hospital clinical data warehouse, pharmacovigilance experts performed a retrospective review of a random sample of 30 inpatient hospital medical records per month using the triggers "fall" and "delirium" to identify related ADRs among patients 65 years and older in 2018 in the geriatrics department. Using the Z test, we compared the proportion of medical records with a positive (identified) trigger related to an ADR, which were reviewed within 20 minutes using the reference of 50% reviewed within 20 minutes. Results: Among the 355 medical records reviewed, 222 had at least 1 trigger and 98 at least 1 related ADR. Among the 222 positive trigger medical records, 99.6% were reviewed in under 20 minutes (P < 0.001). The pharmacovigilance assessment took 3 months. The PPVs reached 53.9% (46.0%-61.7%) for falls and 21.0% (14.3%-27.5%) for delirium. Among the ADRs, 80% were serious and 53% were preventable. Conclusions: Given the low PPV of the triggers used and the considerable need for technical and human resources, the trigger tool method cannot be used as a routine tool at the pharmacovigilance center. However, it could be implemented occasionally for specific purposes such as monitoring the impact of risk minimization measures to prevent ADRs. Competing Interests: The authors disclose no conflict of interest. (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)
Databáze:	MEDLINE
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