Clinical Study to Assess Risk of Adverse Events Associated with Drugs Repurposed for COVID-19
The study aims to perform a medication risk stratification using drug claims data and to simulate the impact of the addition of various repurposed drugs on medication risk shortages in elderly people.
Tabula Rasa HealthCare (TRHC) has announced the beginning of a clinical study assessing the risk of adverse drug events (ADEs) associated with drugs repurposed for the treatment of the coronavirus disease (COVID-19) in older adults on multiple medications.
The study aims to perform a medication risk stratification using drug claims data and to simulate the impact of the addition of various repurposed drugs on medication risk shortages in elderly people.1
“Our study systematically explores current research and validated indices related to drug-induced long QT syndrome (LQTS), in addition to consider the various mechanisms of action for these drugs to induce LQTS,” said Jacques Turgeon, BPharm, PhD, Tabula Rasa Healthcare chief scientific officer, in an email to Pharmacy Times®. “To our knowledge, this is the first quantitative comparison of risk for a prolonged QT interval and torsade de pointes in the use of hydroxychloroquine, chloroquine, remdesivir or lopinavir/ritonavir.”
The TRHC Precision Pharmacotherapy Research and Development Institute utilizes the MedWise™ solution to determine each patient’s MedWise Risk Score™ (MRS), which according to Turgeon, is important for health care practitioners when they select the medication therapy with the greatest potential to improve outcomes and to minimize the risk for ADEs.
“Our research team is specifically looking at the impact of these drug on the total medication risk score, which includes parameters such as: FDA Adverse Event Reporting System relative odds ratio score; aggregated anticholinergic cognitive score; aggregated sedative burden score; competitive inhibition burden score; and drug-induced long QT-JT index score,” Turgeon said in an email to Pharmacy Times®. “These results allow us to identify the subgroup of patients at increased risk of toxicity if exposed to one or another COVID-19 repurposed drug used off-label.”
MedWise™ is a platform that is able to identify accumulative multi-drug interactions to help manage patients’ medication regimens. Further, the MRS assesses which patients are at the highest risk for ADEs and require the most immediate medication management attention. This score is calculated using active medication ingredients of a patient’s entire medication profile, including OTC medications.2,3
“Our study allows the simulation of the impact of adding, one at a time, each COVID-19 repurposed drug to the actual medication regimen of a large number of older adults with polypharmacy, without exposing them to these drugs,” Turgeon said in an email to Pharmacy Times®. “Such simulations make it possible to calculate the impact of the proposed COVID-19 new drugs, on the medication risk score, which has been shown to be associated with the risk of drug-related adverse events and medical expenditures.”
In terms of continuing studies on this topic, Turgeon told Pharmacy Times® that similar research is being conducted using drug claims data from a larger number of patients from an insurance provider in Medicare and Commercial populations.
“The primary goal of this new study will be to identify potential multi-drug interactions and potentially reduce the risk of (ADEs) developing in these patients infected with COVID-19,” Turgeon said in an email to Pharmacy Times®. The study can be found on the National Institutes of Health website, according to Turgeon.
- Tabula Rasa Healthcare. Simulation of risk of adverse drug events associated with the initiation of drugs repurposed for the treatment of COVID-19 in frail elderly adults with polypharmacy. Clinicaltrials.gov. https://clinicaltrials.gov/ct2/show/NCT04339634?recrs=d&cond=COVID-19&draw=2. Published April 14, 2020. Accessed May 14, 2020.
- MedWise Risk Score™. Tabula Rasa Healthcare. https://www.tabularasahealthcare.com/our-technology/medication-risk-score/. Accessed May 14, 2020.
- MedWise™- Medication Decision Support. Tabula Rasa Healthcare. https://www.tabularasahealthcare.com/our-solutions/technology-products/medwise-advisor/. Accessed May 14, 2020.