Effects of Alzheimer's disease and related dementias on dental care usage and economic burden in older adults: a cross-sectional study.

AIM: Distinct subtypes of Alzheimer's disease (AD) and related dementias (RD) might have different effects on dental care usage and economic burden. To determine the effects of AD and RD on specific types of dental care usage (preventive and treatment visits) and dental care costs from different payers (total and out-of-pocket costs). METHODS: A cross-sectional study was conducted using the Medicare Current Beneficiary Survey in 2016. This study identified 4268 community dwelling older adults with and without Alzheimer's disease and related dementias (ADRD) from a nationally representative sample of Medicare beneficiaries. Dental care usage and costs are based on self-reported data. Preventive dental events included preventive and diagnosis events. Treatment dental events included restorative, oral surgery and other events. RESULTS: This study identified 4268 (weighted N=30 423 885) older adults, including 94.48% without ADRD, 1.90% with AD and 3.63% with RD. Compared with older adults without ADRD, those with AD had similar dental care usage, but those with RD were 38% less likely to have treatment visit (OR: 0.62; 95% CI: 0.41 to 0.94) and had a 40% reduced number of total treatment visits (incidence rate ratio: 0.60; 95% CI: 0.37 to 0.98). RD was not associated with dental care costs, but AD was associated with higher total costs (ß: 1.08; 95% CI: 0.14 to 2.01) and higher out-of-pocket costs (ß: 1.25; 95% CI: 0.17 to 2.32). CONCLUSIONS: Patients with ADRD were more likely to have adverse dental care outcomes. Specifically, RD was associated with lower treatment dental care usage and AD was associated with higher total and out-of-pocket dental care costs. Effective patient-centred strategies should be used to improve dental care outcomes in patients with distinct subtypes of ADRD.

Age and geographic disparities in acute ischaemic stroke prehospital delays in China: a cross-sectional study using national stroke registry data.

Background: Stroke has been the leading cause of death in China for decades. The extremely low intravenous thrombolysis rate is largely due to the prehospital delays that make patients ineligible for the time-sensitive therapy. Limited studies evaluated prehospital delays across China. We investigated prehospital delays in the stroke population across China and the associated age, rurality, and geographic disparities. Methods: A cross-sectional study design was employed using the Bigdata Observatory platform for Stroke of China in 2020, the nationwide, prospective, multicentre registry of patients with acute ischaemic stroke (AIS). Mixed-effect regression models were used to account for the clustered data. Findings: The sample contained 78,389 AIS patients. The median onset-to-door (OTD) time was 24 h, with only 11.79% (95% confidence interval [CI]: 11.56-12.02%) patients arriving at hospitals within 3 h. About 12.43% (95% CI: 12.11-12.74%) of patients 65 years or older arrived at hospitals within 3 h, which was significantly higher than the young and middle-aged patients (11.03%; 95% CI: 10.71-11.36%). After controlling for potential confounders, young and middle-aged patients were less likely to present to hospitals within 3 h (adjusted odds ratio: 0.95; 95% CI: 0.90-0.99) compared to patients 65 years or older. The 3-h hospital arrival rate was the highest in Beijing (18.40%, 95% CI: 16.01-20.79%), which was almost 5 times higher than that in Gansu (3.45%, 95% CI: 2.69-4.20%). The arrival rate in urban areas was almost 2 times higher than that in rural areas (13.35% versus. 7.66%). Interpretation: We found that the low rates of timely arrival at hospitals after a stroke is more salient in the younger population, rural settings, or those residing in less developed geographic regions. This study calls for more tailored interventions focusing on younger people, rural areas, and less developed geographic regions. Funding: The National Natural Science Foundation of China; CIHR, Grant/Award Number: 81973157, PI: JZ. Natural Science Foundation of Shanghai; CIHR, Grant/Award Number: 17dz2308400, PI: JZ. Funding from the University of Pennsylvania; Grant/Award Number: CREF-030, PI: RL.

Impact of National Volume-Based Procurement on the Procurement Volumes and Spending for Antiviral Medications of Hepatitis B Virus.

Introduction: Although persistent inhibition of HBV replication by antiviral therapy has shown to slow disease progression, cost-related access barriers to these essential medicines are becoming salient. The national volume-based procurement (NVBP) was piloted in China and led to substantial reduction in the list price of prescription drugs. To examine the impact of NVBP on selected antiviral medication costs per defined daily dose (DDD), procurement volumes, and spending. Methods: We employed an interrupted time series design to examine changes in cost per defined daily dose (DDD), procurement volumes, and spending for NVBP bid-winning antiviral medications (tenofovir disoproxil fumarate and entecavir) in 11 pilot cities from 2017 to 2020. Procurement transaction data were obtained from 9,454 hospitals in the Chinese Hospital Pharmaceutical Audit (CHPA) database. In the secondary analysis, the control group comprised two non-NVBP drugs (adefovir and lamivudine) procured in 11 cities not exposed to the NVBP. Results: Cost per DDD of the two hepatitis B virus (HBV) antiviral medications reduced by CNY1.598 (p = 0.002) immediately following the implementation of NVBP, dropping from an average cost of CNY16.483 per DDD at baseline to CNY6.420 at the end of the observation period. NVBP implementation resulted in a substantial reduction in daily costs of antivirals and an increase in monthly procurement volumes by 6.674 million DDDs (p = 0.017), while monthly spending was reduced by CNY138.26 million (p = 0.002). In the secondary ITS analysis with a control group, the average cost per DDD of the NVBP bid-winning antivirals declined by CNY4.537 (p < 0.001), monthly procurement volumes increased by 7.209 million DDDs (p = 0.002), and monthly spending dropped by CNY138.83 million (p < 0.001). Conclusion: Volume-based procurement piloted in China may be effective for reducing price and total expenditures and improving drug utilization, which is especially important for HBV patients who need constant access to antiviral therapies.

Evidence of Chinese Herbal Medicine Use From an Economic Perspective: A Systematic Review of Pharmacoeconomics Studies Over Two Decades.

Objectives: Pharmacoeconomics evaluation (PE) is increasingly used in the healthcare decision-making process in China. Little is known about PE conducted in Chinese Herbal Medicines (CHMs). We aimed to systematically review trends, characteristics, and quality of PE of CHMS. Methods: We systematically searched both Chinese (CNKI, WanFang, and VIP) and English (Pubmed) databases. Studies were included if they were PE studies comparing both costs and outcomes between two or more interventions published in Chinese or English. Assessment of the quality of studies was conducted using the Quality of Health Economic Analyses (QHES) instrument. T-test and Chi-square tests were used to compare the studies before and after the first edition of China Guidelines for PE published in 2011, and between studies published in Chinese and English. Results: A total of 201 articles were included. There was an increasing trend of PE studies on CHMs during the study period. The top three studied diseases were central nervous system (CNS), mental, and behavioral disorders; cardiovascular diseases; and blood, immune and endocrine diseases. The average QHES score for the included studies was 63.37. Cost-effectiveness analysis (CEA) accounted for the majority (76.6%) of the included studies. Only a quarter of the articles (27.4%) were funded, and there were significantly more studies funded after the publication of China guidelines for PE. About 96.5% of studies did not specify evaluation perspectives and 89.6% of studies had a sample size of less than 300. Around half of the studies (55%) used incremental analysis, but only a few of them considered using a threshold. Half of the studies lacked sensitivity analysis. There was no significant improvement in the quality of studies published after the publication of China Guidelines for PE, and English articles had significantly higher quality than Chinese articles. Conclusion: This study identified several problems in PE studies on CHMs, including having small sample sizes, lacking necessary research elements, and using single evaluation methods. The quality of PE studies on CHMs was not sufficient. Researchers need to understand the standardized way to conduct PE studies and improve the quality and level of PE studies on CHMs.

Analysis of Time to the Hospital and Ambulance Use Following a Stroke Community Education Intervention in China.

Importance: Prehospital delay (time from symptom onset of stroke to the door of a hospital) in patients with stroke is long in China. With the goal of improving public awareness and knowledge of stroke recognition, Stroke 1-2-0 was developed in China as an education program to prompt rapid response to the onset of stroke based on clinical practice in China, and examination of its outcomes is needed. Objective: To investigate the association of the Stroke 1-2-0 educational campaign with prehospital delay for patients with ischemic stroke. Design, Setting, and Participants: In a population-based cross-sectional study, all patients with ischemic stroke events were admitted to the Minhang Hospital, which is the only tertiary care hospital with a stroke center that provides acute stroke care in Xinzhuang county, Shanghai, China. The study period was from January 1, 2016, to December 31, 2019, and data analysis was performed from January 1 to July 31, 2021. Exposures: A multifaceted Stroke 1-2-0 educational campaign comprising slides, videos, brochures, and posters distributed in the community. Main Outcomes and Measures: Proportion of patients with hospital arrival within 3 hours and use of an ambulance to seek medical care, as well as the odds of seeking medical attention within 3 hours after the stroke before vs after initiation of the multifaceted educational campaign. Results: A total of 2857 patients (1774 men [62.1%]; mean [SD] age, 69.83 [12.66] years) with stroke were identified, including 503 in the precampaign period and 2354 in the postcampaign period. Following the multifaceted campaign, the median (IQR) prehospital delay time decreased from 18.72 (7.44-27.84) hours to 6.00 (2.00-16.35) hours (P < .001). After the implementation of the Stroke 1-2-0 campaign, the proportion of patients with hospital arrival time within 3 hours increased from 5.8% to 33.4% (P < .001) and use of an ambulance increased from 3.2% to 30.6% (P < .001). In an interrupted time series analysis, the initiation of the Stroke 1-2-0 campaign was associated with significantly increased odds of arriving at the hospital within 3 hours (odds ratio, 8.01; 95% CI, 7.17-8.95; P < .001) and use of an ambulance (odds ratio, 9.41; 95% CI, 8.24-10.74; P < .001). Conclusions and Relevance: The persistent multifaceted campaign using the Stroke 1-2-0 program was associated with reduced prehospital delay and improved timely arrival rate and ambulance arrival rate for patients with stroke. These findings suggest that Stroke 1-2-0 can be adopted in other regions of China to possibly improve health outcomes and reduce clinical burdens for all patients with stroke.

Trend and effects of high-deductible health insurance plans in the health care system: financial access problems in management of cognitive impairment.

BACKGROUND: High-deductible health plans (HDHPs) are characterized by higher deductibles and lower monthly premiums compared with a typical health plan. HDHPs may reduce, or delay, needed care, which will ultimately lead to poorer access to care for chronically affected participants. OBJECTIVES: To (1) investigate the HDHP enrollment trend and (2) determine the effects of HDHPs on financial access problems for individuals with self-reported cognitive impairment. METHODS: Data between 2010 and 2018 were obtained from the National Health Interview Survey (NHIS). Individuals with cognitive impairment were identified if they were limited by memory difficulties. Problems regarding financial access to health care were assessed based on 6 survey questions from the Centers for Disease Control and Prevention. Multivariable logistic regressions were implemented to evaluate the effects of HDHPs. RESULTS: This study identified 1,148 individuals with cognitive impairment, representing 3.9 million individuals in the United States from 2010 to 2018. A nearly 2-fold increase in HDHP enrollment with cognitive impairment was observed from 2010 (20.9%) to 2018 (41.9%). This increase is similar to that reported for noncognitively impaired individuals. After controlling for possible confounding variables, cognitively impaired individuals with HDPHs were more likely to have overall financial access difficulties compared with those without HDHPs (OR = 1.17, 95% CI = 0.88-1.56, P = 0.271), but this likelihood was not statistically significant. CONCLUSIONS: HDHPs are intended to support effective care options and reduce health care costs. However, our research found that among individuals with cognitive impairment, those with HDHPs experienced some financial access problems, such as affording medical care, follow-up care, and specialists, than those without HDHPs, indicating that HDHPs might have unintended consequences for health care usage. DISCLOSURES: No outside funding supported this study. The authors have no conflicts of interest or financial interests to disclose.

Deprescribing Antipsychotics Based on Real-World Evidence to Inform Clinical Practice: Safety Considerations in Managing Older Adults with Dementia.

Background: Antipsychotics are commonly used in dementia patients but have potential risks that often outweigh clinical benefits. Limited studies have assessed the healthcare utilization and medical costs associated with antipsychotic use, especially those focused on cumulative days of use. Objectives: To examine clinical and economic burdens associated with different cumulative days of antipsychotic use in older adults with dementia in the United States. Methods: This study used Medicare Current Beneficiary Survey (2015-2017). Older (≥65 years) Medicare beneficiaries with dementia, without concurrent schizophrenia, bipolar disorder, Huntingon's disease, or Tourette's syndrome were included. Antipsychotic use was measured using Medicare Part D prescription events. Healthcare utilization was measured as inpatient services, outpatient services, and emergency room (ER) visits. Total medical costs were classified as Medicare and out-of-pocket costs. The logistic regression, negative binomial regression, and generalized linear model with a log link and gamma distribution were used to examine factors, healthcare utilization, and medical costs. Survey sampling weights were applied to generate national estimates. Results: Among older adults with dementia, 13.18% used antipsychotics. Factors associated with antipsychotic use were being Hispanic (OR: 2.90; 95% CI: 1.45, 5.78), widowed (OR: 3.52; 95% CI: 1.46, 8.48), and single (OR: 3.25; 95% CI: 1.53, 6.87). Compared to non-users, antipsychotic use was associated with higher inpatient visits (IRR: 2.11; 95% CI 1.53, 2.90), ER visits (IRR: 1.61; 95% CI: 1.21, 2.13), total costs (ß: 0.53; 95% CI: 0.36, 0.71), Medicare costs (ß: 0.49; 95% CI 0.26, 0.72), and out-of-pocket costs (ß: 0.66; 95% CI: 0.35, 0.97). With the increase in cumulative days of antipsychotic use, the magnitude of clinical and economic burdens was decreased. Conclusion: The significant clinical and economic burdens associated with antipsychotic use, especially with short-term use, provide real-world evidence to inform clinical practice on deprescribing antipsychotics among community-dwelling geriatric dementia patients.

Cost-Related Medication Nonadherence (CRN) on Healthcare Utilization and Patient-Reported Outcomes: Considerations in Managing Medicare Beneficiaries on Antidepressants.

Background: Many patients face a financial burden due to their medications, which may lead to poor health outcomes. The behaviors of non-adherence due to financial difficulties, known as cost-related medication non-adherence (CRN), include taking smaller doses of drugs, skipping doses to make prescriptions last longer, or delaying prescriptions. To date, the prevalence of CRN remains unknown, and there are few studies about the association of CRN on self-reported healthcare utilization (Emergency room (ER) visits and outpatient visits) and self-reported health outcomes (health status and disability status) among older adults taking antidepressants. Objectives: The objectives were to 1) examine the CRN prevalence, and 2) determine the association of CRN on self-reported healthcare utilization and self-reported health outcomes. Methods: This study was a cross-sectional study of a sample of older adults from the Medicare Current Beneficiary Survey (MCBS) who reported having used antidepressants in 2017. Four logistic regressions were implemented to evaluate the association of CRN, and self-reported healthcare utilization and self-reported health outcomes. Results: The study identified 602 participants who were Medicare beneficiaries on antidepressants. The prevalence of CRN among antidepressant users was (16.61%). After controlling for covariates, CRN was associated with poorer self-reported outcomes but not statistically significant: general health status [odds ratio (OR): 0.67; 95% confidence interval (CI): 0.39-1.16] and disability status (OR: 1.34; 95% CI: 0.83-2.14). In addition, CRN was associated with increased outpatient visits (OR: 1.89; 95% CI: 1.19-3.02), but not associated with ER visits (OR: 1.10; 95% CI: 0.69-1.76). Conclusion: For Medicare beneficiaries on antidepressants, CRN prevalence was high and contributed to more outpatient visits. The healthcare provider needs to define the reasoning for CRN and provide solutions to reduce the financial burden on the affected patient. Also, health care providers need to consider the factors that may enhance patient health status and healthcare efficiency.

Impact of Medicare prescription drug (Part D) coverage expansion on utilisation and financial burden of benzodiazepines among older adults: an interrupted time series analysis.

OBJECTIVE: Benzodiazepines were excluded from Medicare Part D coverage since its introduction in 2006. Part D expanded coverage for benzodiazepines in 2013. The objective was to examine the impact of Medicare Part D coverage expansion on the utilisation and financial burden of benzodiazepines in older adults. DESIGN: Interrupted time series with a control group. SETTING: Nationally representative sample. PARTICIPANTS: 53 150 468 users of benzodiazepines and 21 749 749 users of non-benzodiazepines (an alternative therapy) from the Medicare Current Beneficiary Survey between the pre-expansion (2006-2012) and post-expansion (2013-2017) periods. INTERVENTION: Medicare Part D coverage expansion on benzodiazepines. PRIMARY AND SECONDARY OUTCOME MEASURES: Annual rate of benzodiazepines and non-benzodiazepines, average number of benzodiazepines and non-benzodiazepines and average cost of benzodiazepines and non-benzodiazepines. RESULTS: After Medicare Part D coverage expansion, the level of the annual rate of benzodiazepines increased by 8.20% (95% CI: 6.07% to 10.32%) and the trend decreased by 1.03% each year (95% CI: -1.77% to -0.29%). The trend of the annual rate of non-benzodiazepines decreased by 0.72% each year (95% CI: -1.11% to -0.33%). For the average number of benzodiazepines, the level increased by 0.67 (95% CI: 0.52 to 0.82) and the trend decreased by 0.10 each year (95% CI: -0.15 to -0.05). For the average number of non-benzodiazepines, the level decreased by 0.11 (95% CI: -0.21 to -0.01) and the trend decreased by 0.04 each year (95% CI: -0.08 to -0.01). No significant level and trend changes were identified for the average cost of benzodiazepines and non-benzodiazepines. CONCLUSIONS: After Medicare Part D coverage expansion, there was a sudden increase in the utilisation of benzodiazepines and a decreasing trend in the long-term. The increase in the utilisation of benzodiazepines did not add a financial burden to older adults. As an alternative therapy, the utilisation of non-benzodiazepines decreased following the coverage expansion.

Big Data and Real-World Data based Cost-Effectiveness Studies and Decision-making Models: A Systematic Review and Analysis.

Background: Big data and real-world data (RWD) have been increasingly used to measure the effectiveness and costs in cost-effectiveness analysis (CEA). However, the characteristics and methodologies of CEA based on big data and RWD remain unknown. The objectives of this study were to review the characteristics and methodologies of the CEA studies based on big data and RWD and to compare the characteristics and methodologies between the CEA studies with or without decision-analytic models. Methods: The literature search was conducted in Medline (Pubmed), Embase, Web of Science, and Cochrane Library (as of June 2020). Full CEA studies with an incremental analysis that used big data and RWD for both effectiveness and costs written in English were included. There were no restrictions regarding publication date. Results: 70 studies on CEA using RWD (37 with decision-analytic models and 33 without) were included. The majority of the studies were published between 2011 and 2020, and the number of CEA based on RWD has been increasing over the years. Few CEA studies used big data. Pharmacological interventions were the most frequently studied intervention, and they were more frequently evaluated by the studies without decision-analytic models, while those with the model focused on treatment regimen. Compared to CEA studies using decision-analytic models, both effectiveness and costs of those using the model were more likely to be obtained from literature review. All the studies using decision-analytic models included sensitivity analyses, while four studies no using the model neither used sensitivity analysis nor controlled for confounders. Conclusion: The review shows that RWD has been increasingly applied in conducting the cost-effectiveness analysis. However, few CEA studies are based on big data. In future CEA studies using big data and RWD, it is encouraged to control confounders and to discount in long-term research when decision-analytic models are not used.

Gender Disparities in Anti-dementia Medication Use among Older Adults: Health Equity Considerations and Management of Alzheimer's Disease and Related Dementias.

Objective: The prevalence of Alzheimer's disease and related dementias (ADRD) in women is higher than men. However, the knowledge of gender disparity in ADRD treatment is limited. Therefore, this study aimed to determine the gender disparities in the receipt of anti-dementia medications among Medicare beneficiaries with ADRD in the U.S. Methods: We used data from the Medicare Current Beneficiary Survey 2016. Anti-dementia medications included cholinesterase inhibitors (ChEIs; including rivastigmine, donepezil, and galantamine) and N-methyl-D-aspartate (NMDA) receptor antagonists (including memantine). Descriptive analysis and multivariate logistic regression models were implemented to determine the possible gender disparities in the receipt of anti-dementia medications. Subgroup analyses were conducted to identify gender disparities among beneficiaries with Alzheimer's disease (AD) and those with only AD-related dementias. Results: Descriptive analyses showed there were statistically significant differences in age, marital status, and Charlson comorbidities index (CCI) between Medicare beneficiaries who received and who did not receive anti-dementia medications. After controlling for covariates, we found that female Medicare beneficiaries with ADRD were 1.7 times more likely to receive anti-dementia medications compared to their male counterparts (odds ratio [OR]: 1.71; 95% confidence interval [CI]: 1.19-2.45). Specifically, among Medicare beneficiaries with AD, females were 1.2 times more likely to receive anti-dementia medications (Odds Radio: 1.20; 95% confidence interval: 0.58-2.47), and among the Medicare beneficiaries with only AD-related dementias, females were 1.9 times more likely to receive anti-dementia medications (OR: 1.90; 95% CI: 1.23-2.95). Conclusion: Healthcare providers should be aware of gender disparities in receiving anti-dementia medications among patients with ADRD, and the need to plan programs of care to support both women and men. Future approaches to finding barriers of prescribing, receiving and, adhering to anti-dementia medications by gender should include differences in longevity, biology, cognition, social roles, and environment.

Lowering drug prices and enhancing pharmaceutical affordability: an analysis of the national volume-based procurement (NVBP) effect in China.

To cope with the increasing healthcare costs brought about by the universal health insurance programme, national volume-based procurement (NVBP) was implemented in China to reduce drug prices. However, the impact of NVBP remains unknown. We reported the effects of the NVBP pilot programme on medication affordability and discussed the challenges and recommendations for further reforms. A total of 25 molecules won the bidding in the NVBP pilot programme, and price cuts ranged from 25% to 96%. Medication affordability was measured as the number of days' wages needed to pay for a course of treatment, and the medication was identified as affordable if the cost of a treatment course was less than the average daily wage. After the NVBP, the proportion of affordable drugs increased from 33% to 67%, and the mean affordability improved from 8.2 days' wages to 2.8 days' wages. Specifically, for rural residents, the proportion of affordable drugs increased from 13% to 58%, and the mean affordability improved from 15.7 days' wages to 5.3 days' wages. For urban residents, the proportion of affordable drugs increased from 54% to 71%, and the mean affordability improved from 5.9 days' wages to 2.0 days' wages. Implementing the NVBP substantially improved medication affordability. In future reforms, a multifaceted approach addressing all issues in the health system is needed to enhance medicine access.

Medical costs and associated racial/ethnic and sex disparities in erythropoiesis-stimulating agent use: anemia management under the Medicare reimbursement policy.

BACKGROUND: Before 2007, erythropoiesis-stimulating agents (ESAs) were the highest-expenditure drug in the Medicare system. In 2007, CMS issued a reimbursement policy change for ESAs used by cancer patients. However, empirical evidence is currently lacking to evaluate medical costs after the policy change, especially by sex and racial/ethnic groups. OBJECTIVE: To examine the impact of the Medicare reimbursement policy change and associated racial/ethnic and sex disparities on medical costs for cancer patients who were new users of ESAs. METHODS: This study was an exploratory retrospective treatment effectiveness study, which used SEER-Medicare linked data. A difference-in-difference design was used that incorporated a control group of patients with chronic kidney disease. A generalized linear model, with a log link and a gamma distribution, was used to examine medical costs. RESULTS: The Medicare reimbursement policy change was statistically significantly associated with an 11% (95% CI = 2%-20%) reduction in anemia-related costs, including a 10% (95% CI = 1%-19%) reduction in Medicare payment and an 18% (95% CI = 10%-26%) reduction in patient cost sharing. For total medical costs, the policy change was statistically significantly associated with a 12% (95% CI = 6%-18%) reduction, including an 11% (95% CI = 5%-18%) reduction in Medicare payment and a 14% (95% CI = 7%-20%) reduction in patient cost sharing. Medical costs were reduced in patients who were male and those who were White but remained the same for patients who were female and those who were Black, Hispanic, and other races or ethnicities. CONCLUSIONS: Anemia-related and total medical costs associated with ESAs used by cancer patients with chemotherapy-induced anemia were reduced after the Medicare reimbursement policy change. However, the policy change was only effective for patients who were male and those who were White. The policy change had no effect on patients who were female and those of racial/ethnic minorities. DISCLOSURES: This study was funded by the SPARC Research Grant. The funder had no role in any part of this study. This study used the linked SEER-Medicare database. The interpretation and reporting of the data are the sole responsibility of the authors. The authors have nothing to disclose.

Age and Gender Disparities in Adverse Events Following COVID-19 Vaccination: Real-World Evidence Based on Big Data for Risk Management.

Background: Two coronavirus disease 2019 (COVID-19) vaccines have received emergency use authorizations in the U.S. However, the safety of these vaccines in the real-world remains unknown. Methods: We reviewed adverse events (AEs) following COVID-19 vaccination among adults in the Vaccine Adverse Event Reporting System (VAERS) from December 14, 2020, through January 22, 2021. We compared the top 10 AEs, serious AEs, along with office and emergency room (ER) visits by age (18-64 years, ≥65 years) and gender (female, male). Results: There were age and gender disparities among adults with AEs following COVID-19 vaccination. Compared to younger adults aged between 18 and 64 years, older adults were more likely to report serious AEs, death, permanent disability, and hospitalization. Males were more likely to report serious AEs, death, and hospitalization compared to females. Conclusions: COVID-19 vaccines are generally safe but possible age and gender disparities in reported AEs may exist.

Impact of Cost-Related Medication Nonadherence on Economic Burdens, Productivity Loss, and Functional Abilities: Management of Cancer Survivors in Medicare.

Background: Cancer survivors are vulnerable to have medication nonadherence. We aimed to estimate the impact of cost-related medication nonadherence on economic burdens, productivity loss, and functional abilities among cancer survivors. Methods: A cross-sectional study was conducted using data from the National Health Interview Survey (NHIS), 2011-2018. Cost-related medication nonadherence was identified based on NHIS prompts. An ordinal logistic regression model was used to determine the impact of cost-related medication nonadherence on survivors' economic burden. Two negative binomial regression models were implemented to estimate the impact on productivity loss. In addition, four logistic regression models were used to determine the impact on functional abilities. The weighted analysis was used to generate national estimates. Results: Among 35, 773, 286 cancer survivors, 15, 002, 192 (41.9%) respondents reported that they experienced cost-related medication nonadherence. Compared to cancer survivors without cost-related medication nonadherence, those with nonadherence were significantly associated with an increased economic burden (OR: 1.89, 95% CI: 1.70-2.11). Also, cancer survivors with cost-related medication nonadherence were significantly more likely to have an increased bed disability day (IRR: 1.46, 95% CI: 1.21-1.76). In terms of the limitations, cancer survivors with nonadherence were significantly more likely to have both activity limitation (OR: 1.42, 95% CI: 1.25-1.60) and functional limitation (OR: 2.12, 95% CI: 1.81-2.49). Conclusion: Cost-related medication nonadherence increased economic burdens, productivity loss, and limitations in functional abilities among cancer survivors. Strategies are needed to help cancer survivors with cost-related medication nonadherence to be adherent to prescriptions.

Pharmacotherapy Management for COVID-19 and Cardiac Safety: A Data Mining Approach for Pharmacovigilance Evidence from the FDA Adverse Event Reporting System (FAERS).

BACKGROUND: Several pharmacological agents, such as chloroquine/hydroxychloroquine, have been promoted for COVID-19 treatment or pre-exposure prophylaxis. However, no comprehensive evaluation of the safety of these possible agents is available, and is urgently needed. OBJECTIVE: The purpose of this study was to investigate the risks of cardiac adverse events associated with the possible pharmacotherapies for COVID-19, including certain antimalarial, antiviral, and antibiotic drugs. PATIENTS AND METHODS: We conduced retrospective pharmacovigilance analyses of the US Food and Drug Administration Adverse Event Reporting System database. The reporting odds ratio (ROR), a data mining algorithm commonly used in pharmacovigilance assessment, was generated to quantify the detection signal of adverse events. RESULTS: Among individuals without coronavirus infection from 2015 Q1 to 2020 Q1, increased risks for cardiac disorders were found for antiviral agents such as chloroquine/hydroxychloroquine (ROR: 1.68; 95% confidence interval [CI] 1.66-1.70), lopinavir/ritonavir (ROR: 1.52; 95% CI 1.39-1.66), and antibiotics such as azithromycin (ROR: 1.37; 95% CI 1.30-1.44) and ceftriaxone (ROR: 1.92; 95% CI 1.80-2.05). Increased serious cardiac adverse events, including myocardial infarction, arrhythmia, and cardiac arrest, were also reported for these drugs. Further analyses of individuals with coronavirus infections revealed that 40% of individuals receiving chloroquine/hydroxychloroquine reported serious cardiac adverse events. Two cases resulted in QT prolongations and one case resulted in cardiac arrest. Chloroquine/hydroxychloroquine and azithromycin contributed to all the QT prolongation and cardiac arrest cases. CONCLUSIONS: The current pharmacotherapies for COVID-19 are associated with increased risks of cardiac adverse events. Variations in the cardiac safety profiles of these pharmacotherapies were also observed. Clinicians should closely monitor patients with COVID-19, especially those at high risk, using chloroquine/hydroxychloroquine and azithromycin.

Effects and safety of herbal medicines among community-dwelling residents during COVID-19 pandemic: A large prospective, randomized controlled trial (RCT).

BACKGROUND: Since the declaration of COVID-19 as a global pandemic by the World Health Organization, countries are struggling with a shortage of medical capacities. It would be essential if the risk for preventable comorbidities, such as the common cold, can be reduced or prevented, so that the scarce medical resources and facilities can be focused on COVID-19. PURPOSE: To evaluate the effects of two herbal medicines (Jinhaoartemisia antipyretic granules and Huoxiangzhengqi oral liquids) in reducing the risk of the common cold in community-dwelling residents in China during the COVID-19 outbreak. STUDY DESIGN: A prospective open-label, parallel-group, cluster-randomized controlled trial (RCT), was conducted in Chengdu, China. METHODS: A total of 22,065 participants from 11 communities were recruited during a period of one month. The trial started on 30 January and participants were followed up till 29 February 2020. Participants were randomly assigned to receive either a five-day herbal medicine therapy plus a reference manual or a reference manual only if they were allocated to the control group. The primary endpoint was the occurrence of patient-reported common cold symptoms. The secondary endpoint was the time in days from the receipt of herbal drugs/reference manual and the occurrence of the common cold symptoms. RESULTS: Use of herbal medicine reduced the risk of the common cold by 89.6% (95% CI, 52.9% to 97.7%) in all community-dwelling residents, and by 94.0% (95% CI, 52.1% to 99.2%) in residents aged between 16 and 59 years old. Sensitivity analyses showed similar results. CONCLUSION: This community-based RCT found that the use of a herbal medicine therapy (Jinhaoartemisia antipyretic granules and Huoxiangzhengqi oral liquids) could significantly reduce the risks of the common cold among community-dwelling residents, suggesting that herbal medicine may be a useful approach for public health intervention to minimize preventable morbidity during COVID-19 outbreak.