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Background: Coronavirus disease 2019 (COVID-19) has been associated with an increased risk of stroke. It remains unclear whether the risk of stroke associated with a diagnosis of COVID-19 differed with oral anticoagulation (OAC) use. The aim of this study was to evaluate the association between COVID-19 infection, OAC use, and stroke in patients with atrial fibrillation (AF)., Methods: A retrospective cohort study was conducted in individuals with established AF using data from Optum's deidentified Clinformatics ® Data Mart Database. Cox proportional hazard models with time-dependent variables were employed to assess the association between possession of OAC, COVID-19 diagnosis in both inpatient and outpatient setting, and time to ischemic stroke., Results: A total of 561,758 individuals aged 77 ± 10 were included in the study, with a mean follow up time of 1.3 years. OAC use was associated with a reduced stroke risk [hazard ratio (HR) 0.85, 95% confidence interval (CI) 0.82-0.88]. COVID-19 infection was associated with an increased risk of stroke (HR 2.11, 95% CI 1.87-2.38); this increased risk was particularly pronounced for patients diagnosed with an inpatient diagnosis of COVID-19 (HR 3.95, 95% CI 3.33-4.68). There was no significant interaction between OAC use and COVID-19 diagnosis (p value = 0.96). As a result, the relative increase in stroke risk associated with COVID-19 did not differ between patients on OAC (HR 2.12; 95% CI 1.71-2.62) and those not on OAC (HR 2.11; 95% CI 1.83-2.43)., Conclusion: In a nationwide sample of patients with established AF, we found the relative increase in stroke risk associated with COVID-19 was independent of OAC use., (© 2024. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)

Importance: Drug shortages are a chronic and worsening issue that compromises patient safety. Despite the destabilizing impact of the COVID-19 pandemic on pharmaceutical production, it remains unclear whether issues affecting the drug supply chain were more likely to result in meaningful shortages during the pandemic., Objective: To estimate the proportion of supply chain issue reports associated with drug shortages overall and with the COVID-19 pandemic., Design, Setting, and Participants: This longitudinal cross-sectional study used data from the IQVIA Multinational Integrated Data Analysis database, comprising more than 85% of drug purchases by US pharmacies from wholesalers and manufacturers, from 2017 to 2021. Data were analyzed from January to May 2023., Exposure: Presence of a supply chain issue report to the US Food and Drug Administration or the American Society of Health-Systems Pharmacists (ASHP)., Main Outcomes and Measures: The main outcome was drug shortage, defined as at least 33% decrease in units purchased within 6 months of a supply chain issue report. Random-effects logistic regression models compared the marginal odds of shortages for drugs with vs without reports. Interaction terms assessed heterogeneity prior to vs during the COVID-19 pandemic and by drug characteristics (formulation, age, essential medicine status, clinician- vs self-administered, sales volume, and number of manufacturers)., Results: A total of 571 drugs exposed to 731 supply chain issue reports were matched to 7296 comparison medications with no reports. After adjusting for drug characteristics, 13.7% (95% CI, 10.4%-17.8%) of supply chain issue reports were associated with subsequent drug shortages vs 4.1% (95% CI, 3.6%-4.8%) of comparators (marginal odds ratio [mOR], 3.7 [95% CI, 2.6-5.1]). Shortages increased among both drugs with and without reports in February to April 2020 (34.2% of drugs with supply chain issue reports and 9.5% of comparison drugs; mOR, 4.9 [95% CI, 2.1-11.6]), and then decreased after May 2020 (9.8% of drugs with reports and 3.6% of comparison drugs; mOR, 2.9 [95% CI, 1.6-5.3]). Significant associations were identified by formulation (parenteral mOR, 1.9 [95% CI, 1.1-3.2] vs oral mOR, 5.4 [95% CI, 3.3-8.8]; P for interaction = .008), WHO essential medicine status (essential mOR, 2.2 [95% CI, 1.3-5.2] vs nonessential mOR, 4.6 [95% CI, 3.2-6.7]; P = .02), and for brand-name vs generic status (brand-name mOR, 8.1 [95% CI, 4.0-16.0] vs generic mOR, 2.4 [95% CI, 1.7-3.6]; P = .002)., Conclusions and Relevance: In this national cross-sectional study, supply chain issues associated with drug shortages increased at the beginning of the COVID-19 pandemic. Ongoing policy work is needed to protect US drug supplies from future shocks and to prioritize clinically valuable drugs at greatest shortage risk.

Background: The COVID-19 pandemic profoundly disrupted the delivery of medical care. It remains unclear whether individuals diagnosed with new onset disease during the pandemic were less likely to initiate treatments after diagnosis. We sought to evaluate changes in the treatment initiation of patients newly diagnosed with atrial fibrillation (AF) after the onset of the COVID-19 pandemic., Methods: In this retrospective cohort study, we identified individuals with incident AF from 01/01/2016-09/30/2021 using Optum's de-identified Clinformatics® Data Mart Database. The primary outcome was initiation of oral anticoagulation (OAC) within 30 days of AF diagnosis. Secondary outcomes included initiation of OAC within 180 days of diagnosis, initiation of warfarin, direct oral anticoagulants (DOACs), rhythm control medications and electrical cardioversion within 30 days of diagnosis. We constructed interrupted time series analyses to examine changes in the outcomes following the onset of the pandemic., Results: A total of 573,524 patients (age 73.0 ± 10.9 years) were included in the study. There were no significant changes in the initiation of OAC, DOAC, and rhythm control medications associated with the onset of the pandemic. There was a significant decrease in initiation of electrical cardioversion associated with the onset of the pandemic. The rate of electronic cardioversion within 30 days of diagnosis decreased by 4.9% per 1,000 patients after the onset of the pandemic and decreased by about 35% in April 2020, compared to April 2019, from 5.53% to 3.58%., Conclusion: The COVID-19 pandemic did not affect the OAC initiation within 30 days of AF diagnosis but was associated with a decline in the provision of procedures for patients newly diagnosed with AF., (© 2023. The Author(s).)

Objective: COVID-19 has caused tremendous damage to U.S. public health, but COVID vaccines can effectively reduce the risk of COVID-19 infections and related mortality. Our study aimed to quantify the association between proximity to a community healthcare facility and COVID-19 related mortality after COVID vaccines became publicly available and explore how this association varied across racial and ethnic groups., Results: Residents living farther from a facility had higher COVID-19-related mortality across U.S. counties. This increased mortality incidence associated with longer distances was particularly pronounced in counties with higher proportions of Black and Hispanic populations., (© 2023. The Author(s).)

Importance: The burden of atherosclerotic cardiovascular disease (ASCVD) in the US is higher among Black and Hispanic vs White adults. Inclusion of race in guidance for statin indication may lead to decreased disparities in statin use., Objective: To evaluate prevalence of primary prevention statin use by race and ethnicity according to 10-year ASCVD risk., Design, Setting, and Participants: This serial, cross-sectional analysis performed in May 2022 used data from the National Health and Nutrition Examination Survey, a nationally representative sample of health status in the US, from 2013 to March 2020 (limited cycle due to the COVID-19 pandemic), to evaluate statin use for primary prevention of ASCVD and to estimate 10-year ASCVD risk. Participants aged 40 to 75 years without ASCVD, diabetes, low-density lipoprotein cholesterol levels 190 mg/dL or greater, and with data on medication use were included., Exposures: Self-identified race and ethnicity (Asian, Black, Hispanic, and White) and 10-year ASCVD risk category (5%-<7.5%, 7.5%-<20%, ≥20%)., Main Outcomes and Measures: Prevalence of statin use, defined as identification of statin use on pill bottle review., Results: A total of 3417 participants representing 39.4 million US adults after applying sampling weights (mean [SD] age, 61.8 [8.0] years; 1289 women [weighted percentage, 37.8%] and 2128 men [weighted percentage, 62.2%]; 329 Asian [weighted percentage, 4.2%], 1032 Black [weighted percentage, 12.7%], 786 Hispanic [weighted percentage, 10.1%], and 1270 White [weighted percentage, 73.0%]) were included. Compared with White participants, statin use was lower in Black and Hispanic participants and comparable among Asian participants in the overall cohort (Asian, 25.5%; Black, 20.0%; Hispanic, 15.4%; White, 27.9%) and within ASCVD risk strata. Within each race and ethnicity group, a graded increase in statin use was observed across increasing ASCVD risk strata. Statin use was low in the highest risk stratum overall with significantly lower rates of use among Black (23.8%; prevalence ratio [PR], 0.90; 95% CI, 0.82-0.98 vs White) and Hispanic participants (23.9%; PR, 0.90; 95% CI, 0.81-0.99 vs White). Among other factors, routine health care access and health insurance were significantly associated with higher statin use in Black, Hispanic, and White adults. Prevalence of statin use did not meaningfully change over time by race and ethnicity or by ASCVD risk stratum., Conclusions and Relevance: In this study, statin use for primary prevention of ASCVD was low among all race and ethnicity groups regardless of ASCVD risk, with the lowest use occurring among Black and Hispanic adults. Improvements in access to care may promote equitable use of primary prevention statins in Black and Hispanic adults.

Background: Atrial fibrillation (AF) is associated with a five-fold increased risk of stroke and a two-fold increased risk of death. We aimed to quantify changes in new diagnoses of AF following the onset of the COVID-19 pandemic. Investigating changes in new diagnoses of AF is of relevance because delayed diagnosis interferes with timely treatment to prevent stroke, heart failure, and death., Methods: Using De-identified Optum's Clinformatics® Data Mart, we identified 19,500,401 beneficiaries continuously enrolled for 12 months in 2016-Q3 2020 with no history of AF. The primary outcome was new AF diagnoses per 30-day interval. Secondary outcomes included AF diagnosis in the inpatient setting, AF diagnosis in the outpatient setting, and ischemic stroke as initial manifestation of AF. We constructed seasonal autoregressive integrated moving average models to quantify changes in new AF diagnoses after the onset of the COVID-19 pandemic (3/11/2020, date of pandemic declaration). We tested whether changes in the new AF diagnoses differed by race and ethnicity., Results: The average age of study participants was 51.0±18.5 years, and 52% of the sample was female. During the study period, 2.7% of the study sample had newly-diagnosed AF. New AF diagnoses decreased by 35% (95% CI, 21%-48%) after the onset of the COVID-19 pandemic, from 1.14 per 1000 individuals (95% CI, 1.05-1.24) to 0.74 per 1000 (95% CI, 0.64 to 0.83, p-value<0.001). New AF diagnoses decreased by 37% (95% CI, 13%- 55%) in the outpatient setting and by 29% (95% CI, 14%-43%) in the inpatient setting. The decrease in new AF diagnoses was similar across racial and ethnic subgroups., Conclusion: In a nationwide cohort of 19.5 million individuals, new diagnoses of AF decreased substantially following the onset of the COVID-19 pandemic. Our findings evidence pandemic disruptions in access to care for AF, which are concerning because delayed diagnosis interferes with timely treatment to prevent complications., Competing Interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: Hernandez has received consulting fees from Pfizer and Bristol Myers Squibb, outside of the submitted work. Our conflicts do not alter our adherence to PLOS ONE policies on sharing data and materials., (Copyright: © 2023 Hernandez et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: The US Centers for Disease Control and Prevention has repeatedly called for Coronavirus Disease 2019 (COVID-19) vaccine equity. The objective our study was to measure equity in the early distribution of COVID-19 vaccines to healthcare facilities across the US. Specifically, we tested whether the likelihood of a healthcare facility administering COVID-19 vaccines in May 2021 differed by county-level racial composition and degree of urbanicity., Methods and Findings: The outcome was whether an eligible vaccination facility actually administered COVID-19 vaccines as of May 2021, and was defined by spatially matching locations of eligible and actual COVID-19 vaccine administration locations. The outcome was regressed against county-level measures for racial/ethnic composition, urbanicity, income, social vulnerability index, COVID-19 mortality, 2020 election results, and availability of nontraditional vaccination locations using generalized estimating equations. Across the US, 61.4% of eligible healthcare facilities and 76.0% of eligible pharmacies provided COVID-19 vaccinations as of May 2021. Facilities in counties with >42.2% non-Hispanic Black population (i.e., > 95th county percentile of Black race composition) were less likely to serve as COVID-19 vaccine administration locations compared to facilities in counties with <12.5% non-Hispanic Black population (i.e., lower than US average), with OR 0.83; 95% CI, 0.70 to 0.98, p = 0.030. Location of a facility in a rural county (OR 0.82; 95% CI, 0.75 to 0.90, p < 0.001, versus metropolitan county) or in a county in the top quintile of COVID-19 mortality (OR 0.83; 95% CI, 0.75 to 0.93, p = 0.001, versus bottom 4 quintiles) was associated with decreased odds of serving as a COVID-19 vaccine administration location. There was a significant interaction of urbanicity and racial/ethnic composition: In metropolitan counties, facilities in counties with >42.2% non-Hispanic Black population (i.e., >95th county percentile of Black race composition) had 32% (95% CI 14% to 47%, p = 0.001) lower odds of serving as COVID administration facility compared to facilities in counties with below US average Black population. This association between Black composition and odds of a facility serving as vaccine administration facility was not observed in rural or suburban counties. In rural counties, facilities in counties with above US average Hispanic population had 26% (95% CI 11% to 38%, p = 0.002) lower odds of serving as vaccine administration facility compared to facilities in counties with below US average Hispanic population. This association between Hispanic ethnicity and odds of a facility serving as vaccine administration facility was not observed in metropolitan or suburban counties. Our analyses did not include nontraditional vaccination sites and are based on data as of May 2021, thus they represent the early distribution of COVID-19 vaccines. Our results based on this cross-sectional analysis may not be generalizable to later phases of the COVID-19 vaccine distribution process., Conclusions: Healthcare facilities in counties with higher Black composition, in rural areas, and in hardest-hit communities were less likely to serve as COVID-19 vaccine administration locations in May 2021. The lower uptake of COVID-19 vaccinations among minority populations and rural areas has been attributed to vaccine hesitancy; however, decreased access to vaccination sites may be an additional overlooked barrier., Competing Interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: IH reports consulting fees from Pfizer, outside of the submitted work.

Background Adherence to oral anticoagulation (OAC) is critical for stroke prevention in atrial fibrillation. However, the COVID-19 pandemic may have disrupted access to such therapy. We hypothesized that our analysis of a US nationally representative pharmacy claims database would identify increased incidence of lapses in OAC refills during the COVID-19 pandemic. Methods and Results We identified individuals with atrial fibrillation prescribed OAC in 2018. We used pharmacy dispensing records to determine the incidence of 7-day OAC gaps and 15-day excess supply for each 30-day interval from January 1, 2019 to July 8, 2020. We constructed interrupted time series analyses to test changes in gaps and supply around the pandemic declaration by the World Health Organization (March 11, 2020), and whether such changes differed by medication (warfarin or direct OAC), prescription payment type, or prescriber specialty. We identified 1 301 074 individuals (47.5% women; 54% age ≥75 years). Immediately following the COVID-19 pandemic declaration, we observed a 14% decrease in 7-day OAC gaps and 56% increase in 15-day excess supply (both P <0.001). The increase in 15-day excess supply was more marked for direct OAC (69% increase) than warfarin users (35%; P <0.001); Medicare beneficiaries (62%) than those with commercial insurance (43%; P <0.001); and those prescribed OAC by a cardiologist (64%) rather than a primary care provider (48%; P <0.001). Conclusions Our analysis of nationwide claims data demonstrated increased OAC possession after the onset of the COVID-19 pandemic. Our findings may have been driven by waivers of early refill limits and patients' tendency to stockpile medications in the first weeks of the pandemic.

DISCUSSION Since the pandemic, nationwide sales of PDE5-Is increased significantly, while the sale of other urologic medications remained constant. In response to the COVID-19 pandemic, most of the USA instituted lockdowns to minimize virus spread. However, the trend in sales of PDE5-Is increased after the pandemic declaration (coefficient for trend change=920,947, p value<0.001). [Extracted from the article]

Background: The drug supply chain is global and at risk of disruption and subsequent drug shortages, especially during unanticipated events.Objective: Our objective was to determine the impact of coronavirus disease 2019 (COVID-19) on drug purchases overall, by class, and for specific countries.Methods: A cross-sectional time series analysis of country-level drug purchase data from August 2014 to August 2020 from IQVIA MIDAS was conducted. Standardized units per 100 population and percentage increase in units purchased were assessed from 68 countries and jurisdictions in March 2020 (when the World Health Organization declared COVID-19 a pandemic). Analyses were compared by United Nations development status and drug class. Autoregressive integrated moving average models tested the significance of changes in purchasing trends.Results: Before COVID-19, standardized medication units per 100 population ranged from 3990 to 4760 monthly. In March 2020, there was a global 15% increase in units of drugs purchased to 5309.3 units per 100 population compared with the previous year; the increase was greater in developed countries (18.5%; P < 0.001) than in developing countries (12.8%; P < 0.0001). After the increase in March 2020, there was a correction in the global purchase rate decreasing by 4.7% (April to August 2020 rate, 21,334.6/100 population; P < 0.001). Globally, we observed high purchasing rates and large changes for respiratory medicines such as inhalers and systemic adrenergic drugs (March 2020 rate, 892.7/100 population; change from 2019, 28.5%; P < 0.001). Purchases for topical dermatologic products also increased substantially (42.2%), although at lower absolute rates (610.0/100 population in March 2020; P < 0.0001). Interestingly, purchases for systemic anti-infective agents (including antiviral drugs) increased in developing countries (11.3%; P < 0.001), but decreased in developed countries (1.0%; P = 0.06).Conclusion: We observed evidence of global drug stockpiling in the early months of the COVID-19 pandemic, especially among developed countries. Actions toward equitable distribution of medicines through a resilient drug supply chain should be taken to increase global response to future unanticipated events, such as pandemics. [ABSTRACT FROM AUTHOR]