108 research outputs found

    The Law, Economics, and Medicine of Off-Label Prescribing

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    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

    Get PDF
    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.

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    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

    Disproportionate-Share Hospital Payment Reductions May Threaten The Financial Stability Of Safety-Net Hospitals

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    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 2.044billionin2010to2.044 billion in 2010 to 2.363-2.503billionin2019,withunmetDSHcostsof2.503 billion in 2019, with unmet DSH costs of 1.381-$1.537 billion

    Hospitals during recession and recovery: Vulnerable institutions and quality at risk

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    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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