Health Care & Law
نویسنده
چکیده
INTRODUCTION For more than a decade, drug shortages have made headlines. Shortages also have forced P&T committees in many hospitals and health care delivery organizations to make contingency plans for providing safe and effective therapies when conventional and preferred drugs are not available. An article published in P&T in 2011 described several concerns associated with drug shortages and substitutions, including safety risks, cost implications, and the domino effect that shortages can have when the inability to acquire one agent leads to unexpected demand for another.1 The passage of health care reform legislation (the Patient Protection and Affordable Care Act) encouraged the formation of new entities that share in the savings generated from following best practices, avoiding duplication and waste, and coordinating care across sites of service.2 Such groups include accountable care organizations (ACOs), integrated delivery systems, hospitals, and provider groups that enter into bundled payment arrangements. In many cases, these entities take on some degree of financial risk, which gives them incentives to find efficiencies in patient care. By assuming responsibility for improving patient outcomes and generating cost savings, however, these entities also incur increased legal risk. Within this context, it becomes important for health care providers not only to assess how drug shortages may affect their ability to deliver safe, cost-effective care but also to implement action plans that can help to mitigate the legal risks. This article explores how the potential for medication errors, costs, and efficacy concerns create legal risks for emerging health care provider organizations.
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