Adverse drug event risk assessment by the virtual addition of COVID‐19 repurposed drugs to Medicare and commercially insured patients’ drug regimens: A drug safety simulation study
| Autor: | Matt K Smith, Jacques Turgeon, Matthew Hafermann, Veronique Michaud, Pamela Dow, Sweilem B Al Rihani, Malavika Deodhar, Ravil Bikmetov |
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| Rok vydání: | 2021 |
| Předmět: |
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Pharmacovigilance Elderly Cytochrome P-450 Enzyme System Medicine Drug Interactions General Pharmacology Toxicology and Pharmaceutics Child media_common Aged 80 and over education.field_of_study Framingham Risk Score General Neuroscience Articles General Medicine Middle Aged Long QT Syndrome Child Preschool Female Public aspects of medicine RA1-1270 Risk assessment Simulation Adult Drug medicine.medical_specialty Adolescent media_common.quotation_subject Population RM1-950 Medicare Adverse drug events Antiviral Agents Risk Assessment Article General Biochemistry Genetics and Molecular Biology Young Adult COVID‐19 Internal medicine Humans Computer Simulation education Aged Retrospective Studies Polypharmacy business.industry Drug Repositioning Infant Newborn COVID-19 Infant Drug interaction United States COVID-19 Drug Treatment Clinical trial Therapeutics. Pharmacology business Administrative Claims Healthcare |
| Zdroj: | Clinical and Translational Science Clinical and Translational Science, Vol 14, Iss 5, Pp 1799-1809 (2021) |
| ISSN: | 1752-8062 1752-8054 |
| Popis: | Drug safety is generally established from clinical trials, by pharmacovigilance programs and during observational phase IV safety studies according to drug intended or approved indications. The objective of this study was to estimate the risk of potential adverse drug events (ADEs) associated with drugs repurposed for coronavirus disease 2019 (COVID‐19) treatment in a large‐scale population. Drug claims were used to calculate a baseline medication risk score (MRS) indicative of ADE risk level. Fictitious claims of repurposed drugs were added, one at a time, to patients’ drug regimens to calculate a new MRS and compute a level of risk. Drug claims data from enrollees with Regence health insurance were used and sub‐payer analyses were performed with Medicare and commercial insured groups. Simulated interventions were conducted with hydroxychloroquine and chloroquine, alone or combined with azithromycin, and lopinavir/ritonavir, along with terfenadine and fexofenadine as positive and negative controls for drug‐induced Long QT Syndrome (LQTS). There were 527,471 subjects (56.6% women; mean [SD] age, 47 years [21]) were studied. The simulated addition of each repurposed drug caused an increased risk of ADEs (median MRS increased by two‐to‐seven points, p |
| Databáze: | OpenAIRE |
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