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12 Am. J. Bioethics 1 (2012)

handle is hein.journals/ajbio12 and id is 1 raw text is: The American Journal of Bioethics, 12(1): 1-9, 2012 Copyright c Taylor & Francis Group, LLC ISSN: 1526-5161 print / 1536-0075 online DOI: 10.1080/15265161.2011.634483 Unpredictable Drug Shortages: An Ethical Framework for Short-Term Rationing in Hospitals Philip M. Rosoff, Duke University Medical Center Periodic and unexpected shortages of drugs, biologics, and even medical devices have become commonplace in the United States. When shortages occur, hospitals and clinics need to decide how to ration their available stock. When such situations arise, institutions can choose from several different allocation schemes, such as first-come, first-served, a lottery, or a more rational and calculated approach. While the first two approaches sound reasonable at first glance, there are a number of problems associated with them, including the inability to make fine, individual patient-centered decisions. They also do not discriminate between what kinds of patients and what types of uses may be more deserving or reasonable than others. In this article I outline an ethically acceptable procedure for rationing drugs during a shortage in which demand outstrips supply. Keywords: drug shortages, justice, rationing Both short- and long-term shortages of drugs have become a fact of life for hospitals, pharmacies and prescribers in the United States (Jensen et al. 2010; Steinbrook 2009). Coping with situations of scarcity has become a technical and ethical challenge for which few individuals and institutions are formally trained. Since remediating or repairing the causes of drug scarcity is unlikely, dealing with drug shortages will remain a challenge for years to come. In perhaps no other country in the developed world is health care in general, and medicine in particular, as com- moditized as in the United States. Most of its constituent parts reside in a general marketplace, to be traded or bought and sold between sellers and buyers. There are some obvi- ous exceptions in which the rules of the market either do not hold or are actually forbidden by law. For instance, the pol- icy toward essential childhood vaccines, where many states buy the vaccines from manufacturers and then distribute them free of charge or with a small administrative fee, max- imizes the chance of fair distribution to all. Another example is the law forbidding selling of solid organs for transplan- tation. But federal and state governments have little con- trol over the decisions of private companies to manufacture and sell one drug versus another. Whether a pharmaceu- tical company chooses to make drug X or drug Y is entirely up the company and is usually a business decision. Furthermore, decisions to produce drugs with little market potential are also financial ones, such as those influenced by government incentives like the Orphan Drug Act.' Even in those countries that have some variation of socialized or single-payer health care systems, such as in Europe, the supply of pharmaceuticals remains within the jurisdiction of the market. Some drug shortages are local or regional and may be traced to problems with local suppliers or distributers, while others are national, due to difficulties with the manufactur- ing process, or an overt business decision to cut back on production of a specific drug or discontinue making it with minimal forewarning. While it is true that drug companies must alert the Food and Drug Administration (FDA) about their problems and plans (especially to halt manufacturing a drug), this notification may offer little benefit to institu- tions in their ability to effectively find alternative sources of a drug or substitutes (U.S. 21 CFR, Part 207.30). Of course, when one company is the sole manufacturer of a drug for which there is no available surrogate, cessation of produc- tion can significantly impact patient care. Current practice places few limits on what doctors can prescribe or to whom. Those restrictions that do exist in the United States include the ability of the patient to pay or have his or her insurance company pay for the treat- ment (which often considers the chances of clinical success or presence of a drug on the insurance company formulary in their decisions) and, to a lesser extent, FDA approval of the drug or device for a specific use, although so-called off-label applications are both common and legal. Hence, while there may be some hint of minor restriction in medical decision making in day-to-day practice, there is no general, overarching applicable rationing scheme for drugs, treat- ments (like surgeries), facilities, or devices in the United States. ajob 1 1. The Orphan Drug Act of 1983 and its amendments and regulations: U.S. Public Law No. 97-414, January 4, 1983; U.S. Public Law No. 98-551, October 1984; U.S. Public Law No. 99-91, August 1985; U.S. Public Law No. 100-290, April 1988; U.S. 21 CFR Part 316. Address correspondence to Dr. Philip M. Rosoff, Trent Center for Bioethics, Humanities and History of Medicine, 108 Seeley G. Mudd Building, Box 3040, Duke University Medical Center, Durham, NC 27710, USA. E-mail: philip.rosoff@duke.edu

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