Drug shortages are a widespread problem in the United States, according to a national survey of hospital pharmacy managers and pharmacy leaders (PPMs). Of 719 PPMs surveyed, every respondent reported experiencing drug shortages in the past year, and 69.2% reported experiencing more than 50 shortages. Medication hoarding was reported by 81.3% of respondents.1

Researchers at the University of Chicago launched the survey to understand how common drug shortages are and how US hospitals respond to them. They sent the survey to members of the American Society of Health-System Pharmacists.

The investigators discovered that lack of advance notice and poor planning were contributing factors to frequent drug shortages. The vast majority (92.4%) of PPMs reported an average of less than 1 month from notification to active shortage, and 34.9% reported having no administrative mechanism in place to respond to shortages.

“Rationing was prevalent, particularly in large hospitals and academic or academically affiliated hospitals,” noted the researchers. “This survey of PPMs suggests that more systematic approaches are needed to address the common problem of drug shortages and consequent drug rationing,” they concluded.

FDA Unveils Plan

The problem of drug shortages has been well-known by the US Food and Drug Administration (FDA). In a feature article on FDA Voices months prior to the release of the PPM survey, Scott Gottlieb, MD, FDA commissioner, and Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, detailed steps the organization is taking to minimize the impact of drug shortages and restore critical medicines.2

“Ensuring that a necessary drug is available to a patient involves a lot of stakeholders working together at key stages of the development, manufacturing, marketing, and distribution of a medicine,” wrote the authors. “Yet, despite our extensive efforts to prevent these shortages, they continue to occur and persist for a myriad of reasons.”

Causes of Drug Shortages

The authors point to a “complex manufacturing system strongly influenced by the marketplace and economic challenges that face certain segments of the pharmaceutical supply chain” as underlying causes of drug shortages. “Some critical drugs are reimbursed at very low levels, leading to the potential for underinvestment in manufacturing or manufacturers exiting the market.”

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They note that, while sometimes drugs are priced too high, the opposite can be true. If a drug is priced too low relative to its cost to make, manufacturers have no incentive to produce it. This hurdle is typically seen in older generic medicines in sterile, injectable form.

Short-Term Strategies

The FDA has a staff dedicated to managing and minimizing the impact of drug shortages. The group can employ a number of strategies to mitigate or prevent shortages, such as expediting inspections of new facilities and review of new drug applications.

Although the FDA does not have the power to require manufacturers to produce and manufacture drugs that are in short supply, they can “urge manufacturers of similar or alternative products to ramp up production to meet an anticipated increased demand for their product.” In certain cases, the agency may look outside the United States for temporary importation of foreign manufactured drugs until the shortage is resolved.

Long-Term Plans

In July 2018, the FDA established the Drug Shortages Task Force to “investigate the root causes of drug shortages and take a new approach to advance long-term solutions to prevent shortages.” The authors describe a forward-leaning approach that involves engaging stakeholders to consider proposals for expanding the agency’s authorities, evaluating reimbursement policies, and incentivizing manufacturers to manufacture critical drugs.

References

  1. Hantel A, Siegler M, Hlubocky F, Colgan K, Daugherty CK. Prevalence and severity of rationing during drug shortages. JAMA Intern Med. Published Online March 25, 2019. doi:10.1001/jamainternmed.2018.8251
  2. Gottlieb S, Woodcock J. FDA is advancing new efforts to address drug shortages. US Food and Drug Administration. Updated November 19, 2018. Accessed April 4, 2019.