The study analyzed data from the University of Utah Drug Information Service, which receives drug shortage reports submitted through a public site administered by the American Society of Health-System Pharmacists. Two practicing emergency room physicians assessed whether the reported shortages had to do with drugs used in ERs, then looked at whether they were associated with lifesaving or acute conditions.
Of the nearly 1,800 drug shortages reported between 2001 and 2014, nearly 34 percent were used in emergency rooms. More than half (52.6 percent) of all reported shortages were of lifesaving drugs, and 10 percent of shortages affected drugs with no substitute. The most common drugs on shortage are used to treat infectious diseases, relieve pain, and treat patients who have been poisoned. Though the number of shortages fell between 2002 and 2007, they’ve risen by 435 percent between 2008 and 2014.
That’s nothing less than a public health crisis, said Jesse Pines, director of the office for clinical practice innovation at George Washington University School of Medicine & Health Sciences and the study’s senior author. Shortages “are real, they’re happening, and they’re getting worse,” he said. Pines, who practices emergency medicine, said that though emergency rooms are implementing things like providing posters with quick alternative drug options, there’s no obvious way to cut shortages.
The primary reasons given for shortages were manufacturing delays (25.6 percent), supply and demand (14.9 percent), and availability of raw materials (4.4 percent). Pharmaceutical companies listed “business decision” as the reason for a shortage 2.1 percent of the time. But in over 46 percent of the shortages studied, there was no reason given.
Pharmaceutical Research and Manufacturers of America (PhRMA), an industry group, points the finger at secondary wholesalers. “The manufacturer of a drug has no influence or control over the prices charged by a secondary wholesaler to a hospital or pharmacy,” the group said in a statement on its website. Supply chain issues and raw materials shortages can also play into shortages.
The Healthcare Distribution Management Association, a wholesaler industry group, writes that "many factors" may result in product shortages and that they typically happen with "insufficient warning and often [require] significant time and resources to manage."
Could Food and Drug Administration intervention solve the problem? Not exactly: Though the FDA has issued a long-term strategic plan to prevent drug shortages, it admitted it cannot require pharmaceutical companies to make certain drugs, produce more of a drug or change the amount distributed. “There are a number of factors that cause or contribute to drug shortages that are outside of FDA’s control,” the agency wrote in an infographic about the issue.
Ironically, increased FDA oversight might even create more shortages — researchers note that rather than invest in infrastructure or submit to enhanced inspections, businesses may decide simply to stop producing drugs. “This is one of the byproducts of a focus on cost in health care,” explained Pines. “There may be a demand for medication, but it may not be in a company’s best interest to produce it because the amount they can charge is often lower than the amount it costs to manufacture it.”
It seems simple enough: If companies produce more drugs, more drugs will be available to ERs. But given that the majority of drugs on shortage in emergency rooms are sterile injectables with low profit margins, don’t expect that to happen anytime soon. “There are many ways to mitigate drug shortages, but there’s no magic bullet to solve them,” said Pines. “This could and potentially will get worse.”
This post has been updated.
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