Unpredictable Drug Shortages: An Ethical Framework for Short-Term Rationing in Hospitals

Rosoff, Philip M.

doi:10.1080/15265161.2011.634483

Cited by 48 publications

(46 citation statements)

References 33 publications

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“…The first task was to define the ethical challenges raised by managing pediatric oncology drug shortages within individual institutions. Recognizing substantial previous work on this aim, [17][18][19][20] the WG' s second aim (reported here) focused on how stakeholders might coordinate efforts related to drug shortages. The steering committee synthesized recommendations from the face-to-face meeting and iteratively circulated these to the WG for comment, modification, and approval.…”

Section: Methodsmentioning

confidence: 99%

Chemotherapy Drug Shortages in Pediatric Oncology: A Consensus Statement

et al. 2014

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Shortages of essential drugs, including critical chemotherapy drugs, have become commonplace. Drug shortages cost significant time and financial resources, lead to adverse patient outcomes, delay clinical trials, and pose significant ethical challenges. Pediatric oncology is particularly susceptible to drug shortages, presenting an opportunity to examine these ethical issues and provide recommendations for preventing and alleviating shortages. We convened the Working Group on Chemotherapy Drug Shortages in Pediatric Oncology (WG) and developed consensus on the core ethical values and practical actions necessary for a coordinated response to the problem of shortages by institutions, agencies, and other stakeholders. The interdisciplinary and multiinstitutional WG included practicing pediatric hematologist-oncologists, nurses, hospital pharmacists, bioethicists, experts in emergency management and public policy, legal scholars, patient/family advocates, and leaders of relevant professional societies and organizations. The WG endorsed 2 core ethical values: maximizing the potential benefits of effective drugs and ensuring equitable access. From these, we developed 6 recommendations: (1) supporting national polices to prevent shortages, (2) optimizing use of drug supplies, (3) giving equal priority to evidence-based uses of drugs whether they occur within or outside clinical trials, (4) developing an improved clearinghouse for sharing drug shortage information, (5) exploring the sharing of drug supplies among institutions, and (6) developing proactive stakeholder engagement strategies to facilitate prevention and management of shortages. Each recommendation includes an ethical rationale, action items, and barriers that must be overcome. Implemented together, they provide a blueprint for effective and ethical management of drug shortages in pediatric oncology and beyond.

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Section: Methodsmentioning

confidence: 99%

Chemotherapy Drug Shortages in Pediatric Oncology: A Consensus Statement

et al. 2014

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“…5,6 Drug shortages can also contribute to medication errors and increased health care costs. 7,8 Shortages have had a dramatic effect on the practice of emergency medicine, as many commonly used medications in the emergency department (ED) have been affected.…”

Section: Introductionmentioning

confidence: 99%

“…[1][2][3][4] Although typically associated with oncology drugs, drug shortages can affect a wide variety of medications and can lead to delays in treatment, suboptimal treatment, or no treatment being available when indicated. 5,6 Drug shortages can also contribute to medication errors and increased health care costs. 7,8 Shortages have had a dramatic effect on the practice of emergency medicine, as many commonly used medications in the emergency department (ED) have been affected.…”

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confidence: 99%

Critical Drug Shortages: Implications for Emergency Medicine

Mazer‐Amirshahi

Pourmand

Singer

et al. 2014

Academic Emergency Medicine

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Prescription drug shortages have become increasingly common and more severe over the past decade. In addition, reported shortages are longer in duration and have had a greater effect on patient care. Some of the causes of current drug shortages are multifactorial, including the consolidation of drug manufacturers, quality problems at production plants that restrict the supply of drugs, and a lack of financial incentives for manufacturers to produce certain products, particularly generic medications. Generic injectable medications are most commonly affected by shortages because the production process is complex and costly for these drugs, and profit margins are often smaller than for branded medications. Many commonly used emergency department (ED) generic injectables have been affected by shortages, including multiple resuscitation and critical care drugs. Several reports have shown that shortages can potentially have major effects on the quality of medical care, including medication errors, treatment delays, adverse outcomes, and increased health care costs. Currently, no published data exist outside of case reports that directly link ED-based drug shortages to overall patient safety events; however, there are several examples in the ED where first-line therapies for life-saving medications have been in short supply, and alternatives have higher rates of adverse events, narrower therapeutic indexes, or both. Aside from increasing notification about shortages, the U.S. Food and Drug Administration has little power to coerce manufacturers to produce medications during a shortage. Therefore, ED providers must learn to mitigate the effects of shortages locally, through active communication with pharmacy staff to identify safe and effective alternatives for commonly used medications when possible. Particularly given the effect on critical care medications, therapeutic alternatives should be clearly communicated to all staff so that providers have easy access to this information during resuscitations. This review focuses on the etiology of drug shortages, their effect on the ED, and potential solutions and mitigation strategies.ACADEMIC EMERGENCY MEDICINE 2014;21:704-711 © 2014 by the Society for Academic Emergency Medicine P rescription drug shortages have become increasingly common and more severe over the past decade, a trend that is projected to continue into the foreseeable future.1-4 Although typically associated with oncology drugs, drug shortages can affect a wide variety of medications and can lead to delays in treatment, suboptimal treatment, or no treatment being available when indicated. 5,6 Drug shortages can also contribute to medication errors and increased health care costs. 7,8 Shortages have had a dramatic effect on the practice of emergency medicine, as many commonly used medications in the emergency department (ED) have been affected. 3,9 This review will focus on the etiology of drug shortages, their effect on the ED, the role of the U.S. Food and Drug Administration (FDA), and potential ...

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“…The American Journal of Bioethics, 12(1): 10-22, 2012 Rosoff's proposals for short-term rationing at times of drug shortages rightly exclude the possibility of giving priority to "people such as senior hospital administrators or medical staff, major donors to the institution (or their family members), important political figures" (Rosoff 2012). Indeed, this is what we intended by the criterion of reciprocity, which is cited by Rosoff in his article.…”

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confidence: 99%

Interventions and Persons

Hurst

2012

The American Journal of Bioethics

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Unpredictable Drug Shortages: An Ethical Framework for Short-Term Rationing in Hospitals

Cited by 48 publications

References 33 publications

Chemotherapy Drug Shortages in Pediatric Oncology: A Consensus Statement

Chemotherapy Drug Shortages in Pediatric Oncology: A Consensus Statement

Critical Drug Shortages: Implications for Emergency Medicine

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