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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.

ABSTRACT: 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 < 0.001). The increase in ADE risk was mainly driven by an increase in CYP450 drug interaction risk score and by drug-induced LQTS risk score. The Medicare group presented a greater risk overall compared to the commercial group. All repurposed drugs were associated with an increased risk of ADEs. Our simulation strategy could be used as a blueprint to preemptively assess safety associated with future repurposed or new drugs.

SUBMITTER: Smith MK

PROVIDER: S-EPMC8251090 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Background/objectivesBenzodiazepines (BZDs) are widely prescribed to older adults. Although prescribing has declined in the U.S. Department of Veterans Affairs (VA), Medicare introduced BZD coverage in 2013. It is unknown whether declines in the VA have been widespread among older adults in the United States.DesignObservational study in traditional fee-for-service Medicare, commercial insurance, and the VA.SettingUnited States, 2013-2017.ParticipantsAdults aged 55 and older in traditional Medicare (234,290,693 person-months), commercial insurance (337,827,125 person-months), and the VA (256,590,369 person-months).Measurements(1) Change in BZD and BZD-opioid co-prescribing modeled by Poisson regression over time; and (2) standardized ratios of BZD and BZD-opioid co-prescribing, using Medicare as the reference.ResultsFrom April 2013 to December 2017, the monthly percentage of adults aged 55 and older who received BZDs fell from 10.4% to 9.3% in Medicare, 6.6% to 6.5% in commercial insurance, and 5.7% to 3.0% in the VA. Monthly BZD-opioid co-prescribing over the same time fell from 4.0% to 3.0% in Medicare, 2.3% to 2.0% in commercial, and 2.2% to .6% for the VA. Age- and sex-adjusted rates of decline for BZD and BZD-opioid co-prescribing were statistically significant for all systems. Annual BZD rate reductions were .98 (Medicare), .99 (commercial), and .87 (VA; P < .001 for all); co-prescribing rate reductions were .95, .99, and .75 (P < .001 for all). Using standardized ratios accounting for demographic and clinical characteristics, both prescribing and co-prescribing were lowest for the VA relative to Medicare (standardized BZD ratio = .40; 95% confidence interval [CI] = .39-.40; standardized BZD-opioid co-prescribing ratio = .35; 95% CI = .35-.35). Prescribing in commercial insurance was also lower (BZD = .65; 95% CI = .65-.65; BZD-opioid co-prescribing = .65; 95% CI = .65-.65).ConclusionBZD prescribing has declined much more to older adults receiving care through the VA than Medicare or commercial insurance. Other systems may learn from strategies implemented in the VA.

Project description:ObjectiveTo describe trends in the rate and daily dose of opioids used among commercial and Medicare Advantage beneficiaries from 2007 to 2016.DesignRetrospective cohort study of administrative claims data.SettingNational database of medical and pharmacy claims for commercially insured and Medicare Advantage beneficiaries in the United States.Participants48 million individuals with any period of insurance coverage between 1 January 2007 and 31 December 2016, including commercial beneficiaries, Medicare Advantage beneficiaries aged 65 years and over, and Medicare Advantage beneficiaries under age 65 years (eligible owing to permanent disability).Main endpointsProportion of beneficiaries with any opioid prescription per quarter, average daily dose in milligram morphine equivalents (MME), and proportion of opioid use episodes that represented long term use.ResultsAcross all years of the study, annual opioid use prevalence was 14% for commercial beneficiaries, 26% for aged Medicare beneficiaries, and 52% for disabled Medicare beneficiaries. In the commercial beneficiary group, quarterly prevalence of opioid use changed little, starting and ending the study period at 6%; the average daily dose of 17 MME remained unchanged since 2011. For aged Medicare beneficiaries, quarterly use prevalence was also relatively stable, ranging from 11% at the beginning of the study period to 14% at the end. Disabled Medicare beneficiaries had the highest rates of opioid use, the highest rate of long term use, and the largest average daily doses. In this group, both quarterly use rates (39%) and average daily dose (56 MME) were higher at the end of 2016 than the low points observed in 2007 for each endpoint (26% prevalence and 53 MME).ConclusionsOpioid use rates were high during the study period of 2007-16, with the highest rates in disabled Medicare beneficiaries versus aged Medicare beneficiaries and commercial beneficiaries. Opioid use and average daily dose have not substantially declined from their peaks, despite increased attention to opioid abuse and awareness of their risks.

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Project description:BackgroundMuch of the literature about the costs of metastatic pancreatic cancer is focused on the Medicare population, but the cost in the commercially insured population is not well-documented. Differences in treatment patterns between commercially insured and Medicare patients with metastatic pancreatic cancer can provide insights into healthcare utilization and the total cost of care.ObjectiveTo compare the total cost of care for commercially insured versus Medicare patients with metastatic pancreatic cancer who are receiving National Comprehensive Cancer Network (NCCN)-recommended treatment regimens.MethodsWe identified 3904 patients (mean age at diagnosis, 56 years) with metastatic pancreatic cancer using International Classification of Diseases, Ninth/Tenth Revision diagnosis codes in claims data in the 2014-2018 MarketScan commercial database and 28,063 patients (mean age at diagnosis, 73 years) with metastatic pancreatic cancer in the 2014-2017 Medicare Parts A, B, and D 100% research identifiable data files. We calculated the total cost of care and resource utilization by NCCN-recommended (category 1) treatment regimen, including 5-fluorouracil, leucovorin, oxaliplatin, and irinotecan (FOLFIRINOX); gemcitabine plus nab-paclitaxel; gemcitabine monotherapy; and liposomal irinotecan. All patients had ≥2 claims with a pancreatic cancer diagnosis more than 30 days apart and ≥1 subsequent claims with a secondary malignancy diagnosis for metastatic disease.ResultsThe mean total cost of care was 186% higher in the commercially insured cohort than in the Medicare cohort. Excluding gemcitabine monotherapy, the total cost of care for patients with metastatic pancreatic cancer was similar between the regimens used in each cohort, ranging from $95,426 to $116,325 in the commercial insurance group and from $39,777 to $40,390 in the Medicare group. The components of hospital-based inpatient and outpatient costs varied between similar regimens in both cohorts. The inpatient admission patterns of patients' regimens were consistent across the 2 cohorts, with patients receiving gemcitabine monotherapy or liposomal irinotecan having the lowest overall number of admissions in each cohort.ConclusionsThe treatment patterns varied across the regimens but were largely consistent between the commercially insured and the Medicare patients who received the same regimen for metastatic pancreatic cancer; the ratio of total cost of care was 3:1 (commercially insured to Medicare). The total costs of care were similar across the regimens in each cohort, but the components of the total cost varied. These results can inform clinical guidelines and pathways for pancreatic cancer therapy as new evidence and treatment options emerge, and in the context of increasing value-based care models.

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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.

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