With the arrival of summer—sometimes called "trauma season"—emergency departments (EDs) are seeing an uptick in injuries, but an ongoing drug shortage means providers are "scrambling to come up with alternatives to" their go-to treatments, Katie Thomas writes for the New York Times.
What drugs are in low supply—and why?
FDA in a recent report found 39 drug shortages occurred in 2017—many of which "have been for critical drug products," such as injectable opioids, IV fluids, Mylan's EpiPen, and the heart drug diltiazem.
The agency attributed the recent drug shortages to manufacturing issues and hurricane disruptions.
For example, many of the crucial drugs facing a shortage are products that produce low margins, the Times reports. As a result, many companies have stopped making the drugs while others that continue to manufacture the products have stopped investing in their facilities, which has led to recalls, quality issues, and plants shutting down, according to the Times.
Matters became worse last year when Hurricane Maria made landfall in Puerto Rico, which is "a major center of pharmaceutical manufacturing," the Times reports. The hurricane worsened shortages of small saline bags and IV fluids, according to the Times.
Further, restrictions on the amount of narcotics a company is allowed to produce have led to opioid shortages, the Times reports.
Why this year's drug shortage is affecting patient care
According to the Times, physicians, nurses, and pharmacists over the years have scrambled behind the scenes to "cobble together fixes [to address drug shortages] that are often invisible to patients," but now health care professionals are saying the "latest shortages are more directly affecting patient care."
A survey by the American College of Emergency Physicians showed nine out of 10 ED physician respondents said they did not have access to crucial medication and about four in 10 respondents that said their patients had been negatively affected by the drug shortage.
For instance, at Norwegian American's ED, a patient had presented with a racing heartbeat. The staff would have normally given the patient the heart drug diltiazem, also called Cardizem, but the hospital did not have any. As a result, they gave the patient adenosine and metoprolol—two drugs that did not work, according to the Times. Ultimately, the hospital admitted the patient overnight and gave him a drip of the drug esmolol, but his heart continued to beat quickly at 140 beats per minute.
Erin Fox, who tracks drug shortages at the University of Utah, said, "We've had all of these shortages before at different times, but what's harder about it right now is that it's all at once."
How companies, FDA are addressing the shortage
Pfizer executives said they are investing in the company's manufacturing facilities, pledging to spend at least $1.3 billion over the next five years and $800 million by the end of 2018. Navin Katyal, the general manager for the Pfizer's injectables in the United States, said several of the drug supplies the company manufactures will not be produced at their normal levels until next year, but the company does expect to ease some of the most critical drug shortages by the end of 2018.
FDA to help address the shortage has allowed Pfizer to sell products that under normal conditions would have been recalled. For instance, Pfizer in May sold morphine and other drugs with cracked syringes that instructed health care providers to filter the drugs before using them.
Still, FDA Commissioner Scott Gottlieb said the agency has not addressed the underlying problem that several manufacturers earn low margins for products that are critical but difficult to produce.
Gottlieb said he plans to act soon on a request from federal lawmakers that he examine drug shortages more broadly. For instance, FDA might implement new requirements on manufacturers concerning the production of treatments, Gottlieb said. At the same time, FDA might work with CMS to increase Medicare reimbursements for drugs, Gottlieb said.
He said, "Today it's one drug, tomorrow is going to be another drug. We've got to think of something more holistic and comprehensive" (Thomas, New York Times, 7/1; Paavola, Becker's Hospital Review, 6/21; Baker, "Vitals," Axios, 7/2; FDA report accessed 7/2).
Advisory Board's take
Rebecca Tyrrell, Senior Consultant, Pharmacy Executive Forum
By one estimate, drug shortages cost U.S. hospitals $446M annually—$230M generated by the need to purchase more expensive therapeutic substitutes, and $216M by increased labor costs. Additionally, shortages can have a profound and widespread effect on patient safety and outcomes, as well as staff burnout.
What's troubling about the current state of affairs is that there are so many active shortages all at once. While there were only 105 new shortages in 2017, there were a total of 175 ongoing shortages requiring active management by health systems.
While a range of individuals within the hospital are affected, pharmacists bear the brunt of managing shortages and minimizing their impact. The time needed to complete tasks such as communicating with manufacturers and wholesalers, compounding and repackaging preparations, modifying policies and clinical protocols, and updating medication administration systems has more than tripled since 2004.
There are several strategies progressive health systems are employing to bolster their defenses:
- Adding dedicated pharmacy FTEs (at least 0.5 to 1) to manage shortage-related response efforts
- Centralizing inventory to ensure cross-site visibility
- Budgeting for shortages to account for increased acquisition and personnel costs
- Getting 503B certified to enable the preparation of drugs and IV fluids in-house
- Educating legislators on shortages and advocating for mitigation strategies
To learn more about drug shortages and what your hospital can do to address the issue, view the briefing on drug shortages in the executive's guide to pharmacy issues.