ASA Update on Succinylcholine and Other Drug Shortages
The American Society of Anesthesiologists is acutely aware of the ongoing shortages of a number of anesthesia drugs, including the important neuromuscular blocking agent, succinylcholine. The ASA shares the many concerns expressed by members regarding the impact of these shortages on patient safety and the provision of optimal anesthesia care.
ASA leadership and staff have been working closely with Food and Drug Administration (FDA) officials and other organizations for nearly a year in an effort to resolve or, in the short term, minimize the impact of these drug shortages on patients and providers. In 2009, when ASA first learned of the impending shortage of propofol, ASA hosted a series of informational calls with the FDA and encouraged the Agency to authorize the importation of foreign Fresenius Propoven 1% to alleviate the impact of the domestic shortage.
Currently, both U.S. manufacturers of propofol are releasing product and FDA will continue to monitor the situation and authorize the importation of Propoven until demand can be fully met through domestic sources.
Unfortunately, shortages of succinylcholine persist due to problems stemming from the supply and quality of raw material needed to produce the product at Hospira, the largest manufacturer of the drug. Sandoz, the other manufacturer, has ramped up its production as much as possible and is doing its best to supply customers and provide emergency shipments as needed. However, the shortage will likely continue until Hospira is fully back online and able to meet the market demand. Sources from Hospira state that they are currently receiving enough raw material to produce product in limited quantities and they expect to be back to full production by the beginning of November.
Until full demand can be met, in December or later, it is likely that providers will continue to experience shortages of succinylcholine. Therefore, the ASA leadership has issued the following statement for providers:
“Anesthesia practices have recently had inadequate or limited supplies of succinylcholine. Information from the makers of the drug suggests that this shortage will persist for some months. ASA and the Food and Drug Administration’s Drug Shortage unit are pursuing all strategies to remedy the shortage.
Succinylcholine is a first line drug for emergency intubation, treatment of refractory laryngospasm and certain very brief anesthetics requiring muscular paralysis such as electroconvulsive therapy. In some instances, alternative approaches using other neuromuscular blockers or airway techniques may be appropriate.
In the absence of succinylcholine, anesthesiologists will need to exercise clinical judgment in determining which patients are particularly likely to require rapid onset, short duration muscle relaxation. In such instances, it is possible that procedures may need to be deferred until succinylcholine is available. As always, the risks of delay must be weighed against the risks of proceeding without this drug.”
Please be assured that ASA is doing all it can to help remedy these and other drug shortage situations. At ASA’s request and through its own initiatives the FDA has been exploring importation options for succinylcholine. Unfortunately, due to a variety of factors, no viable importation options exist at the moment that would bring product to the U.S. market faster than current efforts to ramp up domestic production. Further, ASA has plans to co-host a Drug Shortage Summit with manufacturers and other organizations to explore the root cause of these ongoing drug shortages and discuss possible solutions for the future. That meeting will likely occur sometime in early November. Further information will be forthcoming once the details are finalized.
In the meantime the best sources for ongoing drug shortage information continue to be the FDA’s Drug Shortage website and the American Society of Health-System Pharmacists’ (ASHP) website.
FDA Drug Shortage website: http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm
ASHP’s Drug Shortage website: http://www.ashp.org/shortages