April 16, 2012 -- Seven U.S. anesthesiologists have reported that drug shortages resulted in deaths of their patients, according to a new survey from the American Society of Anesthesiologists.
Although the online survey completed by 3,063 of the organization's 28,000 practicing anesthesiologists cannot be considered scientific, it opens a window to the growing shortage of anesthetics and painkillers used before, during and after surgery, and the potentially fatal consequences when those are unavailable.
Seven doctors responded to the question "How has a drug shortage impacted your patients?" by checking the option, "Has resulted in death of a patient," according to survey results exclusively obtained by ABCNews.com.
"We have a warning here. We are bound to trace this warning down and find out the extent of it," American Society of Anesthesiologists President Dr. Jerry A. Cohen said in an interview. "Are these the canary in the mine? I don't know. I worry that they are."
Because the survey was anonymous, Cohen said he couldn't determine where the reported deaths occurred, how the patients died, or be sure all seven reports were reliable. "Six we're absolutely sure were reported," Cohen said.
ASA had questions about "data points" in one responder's answers that cast doubts on one of the death reports, he explained. "It's unusual to have anybody report a death due to a drug shortage," Cohen said.
Responses to a similar ASA survey in 2011 included two reports of patient deaths, but those weren't made public, Katherine Looze, an ASA spokeswoman, revealed in response to a question from the ABC News Medical Unit.
Going forward with surgeries when they're short of needed drugs can put anesthesiologists in a legal bind, Cohen said. "We are at risk," he added. "If I proceed, if I don't have the drug I need -- and know I don't have the drug I need -- and I have a bad outcome, I'm responsible."
Among survey respondents (3,033 Americans and 30 from abroad), 97.6 percent reported being currently short of at least one drug and 96 percent said shortages forced them to use substitutes for particular patients and procedures. When they used alternatives to their top-choice drugs, some of their patients experienced nausea and vomiting, spent longer in surgery or took longer to recover from sedation or anesthesia, the survey revealed.
The drugs survey respondents most often couldn't get were the workhorses of local and general anesthesia, such as propofol, a milky white intravenous sedative and anesthetic that works in just 40 seconds. It's best known as the drug that led to the death of pop superstar Michael Jackson. Another is succinylcholine, a quick-acting paralytic agent frequently given to help insert a breathing tube into a patient's airway. There's also fentanyl, a powerful synthetic opioid used to knock patients out and to treat operative and post-op pain.
Anesthesiologists also reported problems getting thiopental, also known as sodium penthothal, an ultra-short acting barbiturate that's used less frequently today in hospitals, but remains in demand for the lethal cocktail many states use in executions. The shortage has left some prisoners longer on death row.
Shortages Lead to Substitutions, Delays, Canceled Surgeries
If supply problems force anesthesiologists to switch from shorter-acting to longer-acting drugs, it can be harder to bring some patients out of anesthesia. More than half of doctors who answered the ASA survey questions said they'd altered procedures to accommodate shortages. Those changes could have included switching from general anesthesia to epidural or regional anesthesia. Among survey respondents, 7 percent said shortages forced them to postpone a procedure; 4 percent said they had to cancel procedures.
Sometimes, second-choice drugs have unwanted side effects, said Cohen, an associate professor emeritus at the University of Florida in Gainesville. If fentanyl isn't available, he can substitute morphine, but "morphine causes nausea and vomiting systemically. If I use morphine in an epidural, it creates itching."
He might try Dilaudid, but "it doesn't quite have the same safety margin" and it lasts longer, he said. "I will have a delay in waking the patient up."
The association undertook the survey, in part, to have something to share with the Congress and other policymakers grappling with a nationwide crisis that has sent hospitals scrambling for antibiotics and anesthetics and brought them to the brink of being unable to treat some childhood cancers. Other medication shortages have forced parents to drive among pharmacies looking for medications to help their hyperactive children sit still and pay attention in class
President Obama issued an executive order in the fall that, among other things, gave the Food and Drug Administration power to respond more quickly to drug shortages. The FDA has since begun allowing overseas imports of key drugs for leukemia and cancer, and approved new suppliers to alleviate shortfalls.
But no one has yet determined how to alleviate a perfect storm of manufacturing problems, shrinking numbers of generic drug makers and increasing demand.
"One solution I think is to have a supply of drug that is not going to go away if we have several days of delay in a component for a drug reaching the manufacturer," Cohen said. "The only way to get around that is to stockpile."
"I've seen a lot more of this that I never dreamed would happen," said Cohen, who completed his residency in 1977. "When I started practicing, I thought whatever drugs I needed would always be there. Now I open the drawer and occasionally something isn't there."