108 research outputs found
The Law, Economics, and Medicine of Off-Label Prescribing
There is a major dissonance in the current structure of regulating new drugs that have more than one medical indication. Physicians are authorized to prescribe these drugs for all indications including those beyond their approved purposes. However, product manufacturers are expressly prohibited from marketing or promoting their drugs for any purpose other than those which have been specifically indicated. While prescribing physicians are encouraged to gain medical information on any additional indications, they cannot obtain it from one of its most likely sources: the drug’s supplier. The Second Circuit Court of Appeals’ recent opinion in United States v. Caronia has challenged this regulatory structure. For the three states in the Second Circuit, although not the rest of the country, the FDA’s regulations prohibiting promotion of non-approved indications have been restricted. In this Article, we review the legal, economic, and medical aspects of the FDA’s current regulatory approach, and explore the likely consequences of a widespread adoption of the Caronia rule
The Law, Economics, and Medicine of Off-Label Prescribing
There is a major dissonance in the current structure of regulating new drugs that have more than one medical indication. Physicians are authorized to prescribe these drugs for all indications including those beyond their approved purposes. However, product manufacturers are expressly prohibited from marketing or promoting their drugs for any purpose other than those which have been specifically indicated. While prescribing physicians are encouraged to gain medical information on any additional indications, they cannot obtain it from one of its most likely sources: the drug’s supplier. The Second Circuit Court of Appeals’ recent opinion in United States v. Caronia has challenged this regulatory structure. For the three states in the Second Circuit, although not the rest of the country, the FDA’s regulations prohibiting promotion of non-approved indications have been restricted. In this Article, we review the legal, economic, and medical aspects of the FDA’s current regulatory approach, and explore the likely consequences of a widespread adoption of the Caronia rule
The critical elements of effective academic-practice partnerships: a framework derived from the Department of Veterans Affairs Nursing Academy.
BackgroundThe nursing profession is exploring how academic-practice partnerships should be structured to maximize the potential benefits for each partner. As part of an evaluation of the U.S. Department of Veterans Affairs Nursing Academy (VANA) program, we sought to identify indicators of successful partnerships during the crucial first year.MethodsWe conducted a qualitative analysis of 142 individual interviews and 23 focus groups with stakeholders from 15 partnerships across the nation. Interview respondents typically included the nursing school Dean, the VA chief nurse, both VANA Program Directors (VA-based and nursing school-based), and select VANA faculty members. The focus groups included a total of 222 VANA students and the nursing unit managers and staff from units where VANA students were placed. An ethnographic approach was utilized to identify emergent themes from these data that underscored indicators of and influences on Launch Year achievement.ResultsWe emphasize five key themes: the criticality of inter-organizational collaboration; challenges arising from blending different cultures; challenges associated with recruiting nurses to take on faculty roles; the importance of structuring the partnership to promote evidence-based practice and simulation-based learning in the clinical setting; and recognizing that stable relationships must be based on long-term commitments rather than short-term changes in the demand for nursing care.ConclusionsDeveloping an academic-clinical partnership requires identifying how organizations with different leadership and management structures, different responsibilities, goals and priorities, different cultures, and different financial models and accountability systems can bridge these differences to develop joint programs integrating activities across the organizations. The experience of the VANA sites in implementing academic-clinical partnerships provides a broad set of experiences from which to learn about how such partnerships can be effectively implemented, the barriers and challenges that will be encountered, and strategies and factors to overcome challenges and build an effective, sustainable partnership. This framework provides actionable guidelines for structuring and implementing effective academic-practice partnerships that support undergraduate nursing education
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Newly Insured Californians Would Fall by More than 1 Million Under the Affordable Care Act Without the Requirement to Purchase Insurance
Compares the estimated number and percentage of currently uninsured Californians who will be insured by 2019 under the Affordable Care Act with the individual mandate and without. Highlights the need for the mandate to ensure affordable coverage
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Achieving Equity by Building a Bridge From Eligible to Enrolled
Calls for multilingual outreach and enrollment efforts to enable Californians of color and those with limited English proficiency to benefit from the Health Benefit Exchange. Recommends targeting high-need groups and strengthening data collection
Disproportionate-Share Hospital Payment Reductions May Threaten The Financial Stability Of Safety-Net Hospitals
Safety-net hospitals rely on disproportionate-share hospital (DSH) payments to help cover uncompensated care costs and underpayments by Medicaid (known as Medicaid shortfalls). The Affordable Care Act (ACA) anticipates that insurance expansion will increase safety-net hospitals' revenues and will reduce DSH payments accordingly. We examined the impact of the ACA's Medicaid DSH reductions on California public hospitals' financial stability by estimating how total DSH costs (uncompensated care costs and Medicaid shortfalls) will change as a result of insurance expansion and the offsetting DSH reductions. Decreases in uncompensated care costs resulting from the ACA insurance expansion may not match the act's DSH reductions because of the high number of people who will remain uninsured, low Medicaid reimbursement rates, and medical cost inflation. Taking these three factors into account, we estimate that California public hospitals' total DSH costs will increase from 2.363-1.381-$1.537 billion
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Comparing Factors Associated with Increased Stimulant Use in Relation to HIV Status Using a Machine Learning and Prediction Modeling Approach
Stimulant use is an important driver of HIV/STI transmission among men who have sex with men (MSM). Evaluating factors associated with increased stimulant use is critical to inform HIV prevention programming efforts. This study seeks to use machine learning variable selection techniques to determine characteristics associated with increased stimulant use and whether these factors differ by HIV status. Data from a longitudinal cohort of predominantly Black/Latinx MSM in Los Angeles, CA was used. Every 6 months from 8/2014-12/2020, participants underwent STI testing and completed surveys evaluating the following: demographics, substance use, sexual risk behaviors, and last partnership characteristics. Least absolute shrinkage and selection operator (lasso) was used to select variables and create predictive models for an interval increase in self-reported stimulant use across study visits. Mixed-effects logistic regression was then used to describe associations between selected variables and the same outcome. Models were also stratified based on HIV status to evaluate differences in predictors associated with increased stimulant use. Among 2095 study visits from 467 MSM, increased stimulant use was reported at 20.9% (n = 438) visits. Increased stimulant use was positively associated with unstable housing (adjusted [a]OR 1.81; 95% CI 1.27-2.57), STI diagnosis (1.59; 1.14-2.21), transactional sex (2.30; 1.60-3.30), and last partner stimulant use (2.21; 1.62-3.00). Among MSM living with HIV, increased stimulant use was associated with binge drinking, vaping/cigarette use (aOR 1.99; 95% CI 1.36-2.92), and regular use of poppers (2.28; 1.38-3.76). Among HIV-negative MSM, increased stimulant use was associated with participating in group sex while intoxicated (aOR 1.81; 95% CI 1.04-3.18), transactional sex (2.53; 1.40-2.55), and last partner injection drug use (1.96; 1.02-3.74). Our findings demonstrate that lasso can be a useful tool for variable selection and creation of predictive models. These results indicate that risk behaviors associated with increased stimulant use may differ based on HIV status and suggest that co-substance use and partnership contexts should be considered in the development of HIV prevention/treatment interventions
Hospitals during recession and recovery: Vulnerable institutions and quality at risk
For generations, American hospitals have been considered recession-proof, but there is reason to believe the current economic crisis is an exception. Hospitals have shown declining financial margins and decreased admissions. The severe recession has adversely affected many hospitals' finances, creating a risk of closure and constraining plans for expansion. We believe there is also a risk of harming clinical quality, through decreased staffing that may limit the momentum of the hospital quality movement, especially in fiscally vulnerable institutions. We consider ways the federal government could aid hospitals by promoting hospital quality while providing employment. Journal of Hospital Medicine 2010;5:302–305. © 2010 Society of Hospital Medicine.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/77425/1/654_ftp.pd
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