Driven by a confluence of factors, anesthesia drug shortages continue to bedevil hospitals and surgery centers, forcing anesthesiologists to seek new strategies for minimizing shortfalls and ensuring care continuity and safety.
“Drug shortages, particularly involving injectable generics, have been a significant and ongoing problem,” said Heather Cooley, director of Supply Chain Services for McKesson. The company’s distribution services handle about one-third of the pharmaceutical demand in the U.S.
“The shortages have eased somewhat in recent weeks after becoming particularly acute in January and February. But it’s not an issue that is going to go away.”
A survey conducted by the American Society of Anesthesiologists in 2012 found that 97.6% of responding anesthesiologists reported the shortage of at least one drug, most commonly fentanyl, thiopental or succinylcholine.1
That same year, nearly 400 drug shortages occurred nationwide, up from 251 in 2011 and just 61 in 1999, the first year that the Food and Drug Administration (FDA) began tracking shortage incidents.2 According to the Government Accountability Office (GAO), anesthetics and central nervous system drugs account for 17% of all shortages and are among the classes of drugs that typically experience the highest frequency of shortages.3
Multiple origins for shortages
Experts say the shortfalls stem from a range of causes. Generic medications are more susceptible to shortages because, unlike brand-names, most do not have back-up manufacturing lines to provide redundant production capacity. As a result, a line stoppage can have an immediate and far-reaching impact.4
Line stoppages can be triggered by quality control issues, such as bacterial contamination, or by the maintenance and repair of often-aging equipment. According to Anesthesiology News, six of the top 10 manufacturers of sterile injectable drugs received FDA warning letters between 2009 and 2012 for serious violations of manufacturing standards. Remediation can require equipment upgrades and inspections that either stop or slow production.5
Moreover, a quality issue with one medication can lead to a manufacturing shut-down of another, since generics often are made on production lines that are used to produce more than one kind of drug.6
Raw material shortages and supply and demand imbalances likewise factor into drug shortages, according to Cooley. She noted that an unexpected spike in flu cases in January 2014 led to a shortage in IV saline solution.
Addressing the problem
In an attempt to reduce the frequency and duration of shortages, the FDA enacted policies in 2013 that required pharmaceutical companies to report all potential discontinuances of drugs used in the prevention or treatment of serious or life-threatening conditions.
The policy has helped prevent many shortages, but the issue is far from resolved. As a result, Cooley says anesthesiologists should take steps independently to ease the impact of shortages.
Among these is the pursuit of a closer working relationship between a hospital’s anesthesiology and pharmacy departments. The objective is to improve communication about potential drug shortages so the organization can act quickly to manage risk for patients and the hospital.
“A plan should be in place that includes three components: Shortage assessment, preparation and contingencies,” Cooley said. “Responsibilities should be delineated, including who will take the lead in implementing the plan, coordinating between the pharmacy and clinicians, and monitoring supplies during a shortage.”
As part of this process, it is important to understand how pharmaceutical distributors communicate about potential shortages. For instance, information may be available through your online ordering platform. You should also communicate with your account representative, Cooley said.
Websites that focus on drug shortages, including those operated by the FDA and the American Society of Health-System Pharmacists, should be monitored:
If information isn’t available from a wholesale supplier, providers can also reach out to manufacturers to determine if the drug maker is shipping full or reduced orders to distributors. Inquiries should also be made about whether a drug in short supply can be purchased directly from the manufacturer.
McKesson’s Cooley said drug shortages are a chronic problem but that they can be managed effectively with care and planning. “The key is to be well-informed, to communicate across the organization and to act quickly when shortages develop,” she said.