ASHP Guidelines on Managing Drug Product Shortages in Hospitals and Health Systems

Fox, Erin R.; Birt, Annette; James, Ken; Kokko, Heather; Salverson, S. M.; Soflin, Donna L.

doi:10.2146/ajhp090026

Cited by 185 publications

(204 citation statements)

References 6 publications

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“…The organization has drafted guidelines for the management of shortages and purchasing guidelines for pharmacies. 48,49 The ASHP website also provides therapeutic alternatives to drugs in current shortages when available. 47 In response to widespread drug shortages, many institutions have attempted to develop specific evidence-based protocols for substitutions when possible.…”

Section: Nongovernmental Effortsmentioning

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: Nongovernmental Effortsmentioning

confidence: 99%

Critical Drug Shortages: Implications for Emergency Medicine

Mazer‐Amirshahi

Pourmand

Singer

et al. 2014

Academic Emergency Medicine

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“…9 The need for such triage, and its ethical implications, has been recognised by many organisations, which have attempted to develop guidelines for resource allocation in the setting of drug shortages. These guidelines have tended to emphasise the need for procedural integrity and justice, engaging all stakeholders-including clinicians, patients and managers-in decisions about how scarce resources should be allocated, and aiming for consistency, objectivity, transparency, accountability and clear methods for communicating decisions (for examples see references 9,17,19,[22][23][24]. It has also been noted that organisations have an ethical obligation to prepare for drug shortages by conserving supplies and by ensuring that the organisation is ready to respond to any shortage that arises.…”

Section: How Drug Shortages Challenge the Delivery Of "Just" Health Carementioning

confidence: 99%

Why drug shortages are an ethical issue

Lipworth¹,

Kerridge²

2013

AMJ

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REVIEWPlease cite this paper as: Lipworth W, Kerridge I. Why drug shortages are an ethical issue. AMJ 2013, 6, 11, 556-559. http://doi.org/10.21767/AMJ.2013.1869 AbstractDrug shortages are a growing problem in developed countries. To some extent they are the result of technical and organisational failures, but to view drug shortages simply as technical and economic phenomena is to miss the fact that they are also ethical and political issues. This observation is important because it highlights both the moral and political imperative to respond to drug shortages as vigorously as possible, and the need for those addressing shortages to do so in ethically and politically sophisticated ways. This brief article outlines the ethical issues that need to be considered by anyone attempting to understand or address drug shortages.

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“…13,14 The American Society of Health-System Pharmacists (ASHP) has developed guidelines to deal with such shortages. 15 …”

Section: Troubles Within the Channels Of Distributionmentioning

confidence: 99%