Continuing Drug Shortages a Problem for Anesthesiologists

Caroline Helwick

October 28, 2011

October 28, 2011 (Chicago, Illinois) — Drug shortage is an issue throughout the healthcare system today, but it is particularly concerning for anesthesiologists, because more central nervous system (CNS) drugs are in short supply than any other class of drugs. Although progress in trying to prevent shortages is being made, shortages in 2011 are expected to exceed those seen in 2010, according to a discussion held here at the American Society of Anesthesiologists (ASA) 2011 Annual Meeting.

"Drug shortages have had an impact on most of our practices. The bottom line is that without having the drugs we need, it's hard to safely take care of our patients," said Arnold J. Berry, MD, MPH, ASA vice president for scientific affairs and professor of anesthesiology at Emory University, Atlanta, Georgia.

According to the US Food and Drug Administration (FDA), 178 drugs were in short supply last year; by August 31 of this year, the list had already topped 200. This included at least 34 CNS drugs, Dr. Berry noted.

The Drug Shortage Survey of 1373 ASA members conducted in April revealed that 90% of respondents reported a shortage of at least 1 drug and 98% had experienced a shortage during the previous 12 months. In about 50% of cases, drug shortages resulted in less optimal outcomes (such as postop nausea and vomiting), changes in procedures, or prolonged postop recovery times. Anesthesiologists postponed or cancelled 10% of procedures.

The most shortages were for propofol (88%), the drug most frequently used to induce anesthesia and provide sedation for diagnostic and therapeutic procedures. Other common shortages were of succinylcholine (80%), neostigmine (52%), and epinephrine (17%).

The ASA began receiving reports of propofol shortages from its members in mid-2009, after 2 American manufacturers stopped production. This led to increased use of other induction agents, and the domino effect created shortages of those as well. The shortage was effectively alleviated in many locations when the FDA permitted the importation of the European formulation of propofol.

Multiple Stakeholders Working Together

Part of the problem, Dr. Berry said, is that the FDA has a limited ability to control drug shortages. The agency cannot dictate production quantity and must rely on the voluntary participation of industry. Furthermore, at this point, the agency is primarily interested in shortages of drugs considered "medically necessary."

But the FDA has prevented shortages after receiving early notification from industry of an impending shortage — 38 in 2010 and 99 in 2011. When notified of a problem, the FDA can encourage other firms to ramp up production, can expedite helpful regulatory processes, and can allow temporary importation of substitute drugs, as it did with propofol, Dr. Berry explained.

It is important for all stakeholders to work together, he emphasized. In November 2010, the ASA and the American Society of Health-System Pharmacists convened multiple stakeholders at a Drug Shortage Summit to address the causes of and possible solutions to drug shortages. The FDA convened its own workshop last month, where ASA representatives met with Kathleen Sebelius, secretary of the US Department of Health and Human Services.

Jason R. Byrd, JD, ASA's director of Practice Management, Quality and Regulatory Affairs, said the society strongly supports legislation that is currently before the Senate and House that would provide the FDA with key tools to manage the problem. The Preserving Access to Life-Saving Medications Act would require drug manufacturers to give early notification to the FDA of any incident that will likely result in a drug shortage.

The Industry Perspective

"This is a multistakeholder issue, and addressing the broader concerns of drug shortages requires a collective effort," agreed Thomas G. Moore, PharmD, who is president of Hospira — "a global specialty pharmaceutical and medication delivery company" — and is based in Lake Forest, Illinois. "Many drug shortages can be prevented, but we need early dialogue."

Correcting some common misconceptions, Dr. Moore said that most drug shortages are not caused by a manufacturer's decision to voluntarily discontinue supplying the product or to withhold a drug to push prices up.

He cited as the key problem "regulatory compliance and product quality issues." These alone are the underlying reasons for half the drug shortages, he said. However, in the majority of these cases, there is no "quality problem per se" with a drug; rather, there is a compliance issue with manufacturing guidelines or issues regarding regulatory actions that must be taken, he explained.

"We want to meet the FDA guidelines of good manufacturing practices, but actions taken (such as requirements for remediation) are a significant cause of the drug shortages we see today," he said.

According to Dr. Moore, "significant efforts" are underway within the pharmaceutical industry to address problems — one being for manufacturers to commit to "early warnings and actions."

"It's a complex problem that requires a lot of collaboration and communication, and I'm pleased to say that I think we're finally starting to see some of that occur between the various stakeholders," he noted.

Dr. Berry and Mr. Byrd have disclosed no relevant financial relationships. Dr. Moore is employed by Hospira.

American Society of Anesthesiologists (ASA) 2011 Annual Meeting: Presented October 16, 2011.


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