Elsevier

American Heart Journal

Volume 175, May 2016, Pages 130-141
American Heart Journal

Curriculum in Cardiology
The impact of drug shortages on patients with cardiovascular disease: causes, consequences, and a call to action

https://doi.org/10.1016/j.ahj.2016.02.004Get rights and content

Shortages of cardiovascular drugs have become increasingly common, representing an ongoing public health crisis. Given few therapeutic alternatives to many of the drugs in short supply, these shortages also pose a major challenge for cardiovascular care professionals. Although changes in the regulatory environment have led to some improvements in recent years, problems involving manufacturing processes remain the most common underlying cause. Because of the complex nature of drug shortages, sustainable solutions to prevent and mitigate them will require collaboration between regulatory agencies, drug manufacturers, and other key stakeholder groups. In this report, we describe the scope of the cardiovascular drug shortage crisis in the United States, including its underlying causes and the efforts currently being made to address it. Furthermore, we provide specific recommendations for how cardiovascular care professionals can be involved in efforts to limit the impact of drug shortages on patient care as well as policy changes aimed at preventing and mitigating them.

Section snippets

Current state of cardiovascular drug shortages

The US Government Accountability Office (GAO) recently highlighted the threat posed by drug shortages with data from the University of Utah Drug Information Service (UUDIS).2 Although the US Food and Drug Administration (FDA) also provides information on drug shortages that may significantly impact public health, the UUDIS defines shortages more broadly, including those that affect how a pharmacy must prepare or dispense a product or those that require the use of alternative agents that may

Causes of cardiovascular drug shortages

The underlying causes of drug shortages were not well elucidated until after an analysis by the US FDA was published in 2011.6 In this report, manufacturing and economic factors were cited as the principal drivers of drug shortages, although the two were not mutually exclusive and may have together influenced drug supply. Of the 127 drug shortages from 2010 to 2011 listed in the FDA report, the most common factors resulting in supply disruptions were problems at the manufacturing facility

Heparin

Beginning in 2007, serious injuries and deaths were linked to contaminated heparin products manufactured in China, which led to a massive recall by Baxter Healthcare in February of that year.11 From January 1, 2007, to May 31, 2008, 149 deaths in 11 countries (81 in the US) were associated with the administration of heparin to patients who subsequently developed hypersensitivity and/or hypotension. Researchers at the FDA attributed these reactions to oversulfated chondroitin sulfate (OSCS), a

Impact of cardiovascular drug shortages on patients, providers, and health systems

The absence of a mandatory national reporting system for adverse drug events has made it difficult to quantify the effect of drug shortages on patients with CVD. Most of the data on their impact have been generated from surveys conducted by the Institute for Safe Medication Practices (ISMP). In an ISMP survey from 2010, 1 in 5 clinicians reported that patient harm had occurred as a result of a drug shortage.22 Specific examples included adverse drug events attributed to incorrectly compounded

Current efforts to prevent and mitigate cardiovascular drug shortages

Over the last 5 years, several government agencies and stakeholder organizations have launched initiatives to address drug shortages (Figure 3). In November 2010, a Drug Shortages Summit was convened by the American Society of Health-System Pharmacists (ASHP), the American Society of Clinical Oncology (ASCO), ISMP, and the American Society of Anesthesiologists.32 Recommendations from the summit included a call for changes in the regulatory oversight of the FDA and improved communication among

Call to action: recommendations for cardiovascular care professionals and policymakers

Given the detrimental impact of drug shortages on patients with CVD, the writing group makes the following recommendations (summarized in Table III):

  • Recommendations for cardiovascular care professionals

    • Form diverse, multidisciplinary task forces to prevent and mitigate drug shortages.

      Every institution involved in the care of patients with CVD should form a task force charged with addressing drug shortages. For institutions that exist as part of a larger network, a task force at the system level

Conclusion

As detailed in this review, cardiovascular drug shortages remain common and represent a significant threat to public health and a major challenge for cardiovascular care professionals. Although the causes of these shortages are often multifactorial, most involve manufacturing processes. Given few alternatives to many of the therapies used for CVD, shortages have impacted patients in a variety of ways. The dilemmas resulting from these shortages have also heightened frustrations among clinicians

Disclosures

No extramural funding was used to support this work. The authors are solely responsible for the drafting and editing of this paper and its final contents.

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