Oncology Drug Shortages Worsening, Threatening Patient Care

Eastman, Peggy

doi:10.1097/01.cot.0000403835.67731.c7

Cited by 7 publications

(6 citation statements)

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“…This has been described in the oncology literature; however, this may also affect the ED. [28][29][30] For example, during previous influenza seasons, there have been shortages of both oseltamivir and influenza vaccines. This can have a Ketamine IV Methohexital IV Rocuronium IV Vecuronium IV major effect on the ED and may pose a public health hazard during an epidemic, when patients at high risk of complications go untreated and more patients present to the ED because of the lack of vaccination.…”

Section: Use Of Therapeutic Alternativesmentioning

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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Section: Use Of Therapeutic Alternativesmentioning

confidence: 99%

Critical Drug Shortages: Implications for Emergency Medicine

Mazer‐Amirshahi

Pourmand

Singer

et al. 2014

Academic Emergency Medicine

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“…1(p8) The list of drug therapies in short supply almost tripled between 2005 and 2010, with 178 drug shortages identified in 2010. 1 From January through October 2011, there were 220 shortages reported by the FDA. 2 Drug shortages have most frequently been identified for oncology drugs, followed by antibiotic therapies.…”

Section: Invited Commentarymentioning

confidence: 99%

“…We also have a uniform policy of not using medications from "gray market" vendors because we cannot ensure a proper chain of custody or the integrity of the medicat i o n , a l t h o u g h u s i n g t h e s e medications could give the appearance of lessening the gravity of the shortage. 1,21 Finally, we decided to adopt a practice that would halt any investigational uses of scarce drugs so as to conserve the supply, unless the study application was for a standard treatment (such as the control arm of a clinical trial). To date, we have had more than 1 year of experience using this policy with a number of different types of drugs in short supply.…”

Section: Policy Developmentmentioning

confidence: 99%

“…Unpredictable shortages of common and rarely used medications stem from a variety of causes, including insufficient supply, contamination of raw materials, manufacturing problems, and financial decisions to discontinue production of specific medications. [1][2][3][4] The shortages have been especially dramatic for chemotherapeutic agents. 5,6 Unexpected shortages have affected generic and brandname drugs, leading to similar results: the rapid failure of the supply chain, gener-ating significant deficiencies in prescription medications.…”

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confidence: 99%

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Coping With Critical Drug Shortages

Rosoff¹,

Patel²,

Scates³

et al. 2012

Arch Intern Med

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The number of critical medication shortages in the United States has reached an unprecedented level, requiring decisions about allocating limited drug supplies. Ad hoc decisions are susceptible to arbitrary judgments, revealing preformed biases for or against groups of people. Health care institutions lack standardized protocols for rationing scarce drugs. We describe the principles on which an ethically justifiable policy of medication allocation during critical shortages was created at our hospital. Based on supportable scientific evidence and with all clinically similar patients treated as similarly deserving of consideration, drugs were distributed according to a hierarchy of clinical need and predicted efficacy. We explain the ethical rationale for the procedures we adopted, how the policy was implemented at a large academic medical center, and more than 1 year of experience with a number of different medications. Our experience has demonstrated the feasibility and utility of formulating a rational and ethically sound policy for scarce resource allocation in an academic teaching hospital that could be used in a variety of health care settings. The method has proven to be reliable, workable, and acceptable to clinicians, staff, and patients.

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“…Oncology (including pediatric oncology) and anesthesiology are two areas that have been severely affected. A recent survey by the Association of Community Cancer Centers (Eastman, 2011) found that 94.4% of survey participants had experienced an oncology drug shortage. Table 1 lists some oncology drugs that have been in short supply during the past year.…”

Section: Introductionmentioning

confidence: 99%