Drug Shortages: The Cycle of Quantity and Quality

Kweder, Sandra L.; Dill, Susie

doi:10.1038/clpt.2012.235

Cited by 57 publications

(67 citation statements)

References 1 publication

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“…During this process, these medications may also experience interruptions in supply. 1 One of the major factors that has contributed to the recent surge in drug shortages has been the changing landscape of pharmaceutical manufacturing, particularly as it pertains to generic injectable drugs. The manufacturing of sterile injectable products is often complex, costly, and specialized, and only small numbers of manufacturers make these products.…”

Section: Why Drug Shortages Occurmentioning

confidence: 99%

“…This includes issues such as microbial contamination, particulate matter found in vials, or tablet disintegration. 1 There may be a shortage of raw materials to make the medication or problems with shipping. 4 Another major reason for drug shortages is increased demand; for example, oseltamivir demand has exceeded supplies during influenza season.…”

Section: Why Drug Shortages Occurmentioning

confidence: 99%

“…At that time, the DSP had begun tracking drug shortage reports and became more active in resolving and mitigating the effects of shortages. 1 The DSP can serve various roles, depending on the characteristics of the particular shortage. In addition, the FDA has specialists with diverse knowledge to deal with different aspects of drug shortages.…”

Section: Mitigation Strategiesmentioning

confidence: 99%

“…Because of the lack of redundancy in the supply chain, it is more difficult for a small number of facilities to make up for production problems at one specific manufacturing plant. 1,4 Another related factor is that production facilities must meet manufacturing quality standards. Recently, the FDA has issued warnings to six of the top 10 manufacturers of sterile injectable products for severe violations of current good manufacturing practices.…”

Section: Why Drug Shortages Occurmentioning

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.…”

mentioning

confidence: 99%

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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: Why Drug Shortages Occurmentioning

confidence: 99%

Section: Why Drug Shortages Occurmentioning

confidence: 99%

Section: Mitigation Strategiesmentioning

confidence: 99%

Section: Why Drug Shortages Occurmentioning

confidence: 99%

mentioning

confidence: 99%

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Critical Drug Shortages: Implications for Emergency Medicine

Mazer‐Amirshahi

Pourmand

Singer

et al. 2014

Academic Emergency Medicine

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National Shortages of Generic Sterile Injectable Drugs

Donohue

Angus

2017

JAMA

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Evaluating quality reward and other interventions to mitigate US drug shortages

Naumov,

Noh,

Zhao

2024

J of Ops Management

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Drug shortages have been persistent in the United States for over a decade, posing serious threats to public health and the healthcare system. While previous research has investigated the causes and effects of drug shortages, there is a dearth of research exploring potential solutions to mitigate this problem. Using a system dynamics model of the US generic drug market, we evaluate the long‐term effectiveness of two existing policy interventions (expediting drug approvals and nudging manufacturers to ramp up their production) and the “quality reward” initiative that is being actively explored by the FDA and industry. Our results indicate that while the existing interventions can be helpful in addressing shortages, their long‐term effect seems limited. In contrast, quality reward can mitigate drug shortages in a sustainable way. However, a caveat of quality reward is the potential emergence of a monopolistic supply market with negative consequences. We suggest that a carefully designed quality disclosure mechanism can address this issue. To the best of our knowledge, this is the first study to quantitatively and comparatively evaluate the long‐term effectiveness of quality reward and other interventions on drug shortages and provide structural explanations for their performance.

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Drug Shortages: The Cycle of Quantity and Quality

Cited by 57 publications

References 1 publication

Critical Drug Shortages: Implications for Emergency Medicine

Critical Drug Shortages: Implications for Emergency Medicine

National Shortages of Generic Sterile Injectable Drugs

Evaluating quality reward and other interventions to mitigate US drug shortages

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