Will Loss of Lethal Injection Drug Harm Surgical Patients?

FRIDAY Jan. 28, 2011 -- Anesthesiologists say they have grave concerns over a decision by a drug manufacturer to halt production of a long-used and powerful anesthetic because of the medication's use in lethal injections in prison executions.

Hospira, of Lake Forest, Ill., had intended to produce Pentothal (sodium thiopental) at its plant in Italy, but abandoned that plan last week when authorities there demanded that the drug not be used for executions in America.

There are no other sources of Pentothal available to American physicians, and experts noted that while there are newer anesthetics on the market, Pentothal is a safer alternative for certain patients because it does not lower blood pressure as drastically as its newer counterparts do.

The American Society of Anesthesiologists (ASA) issued a statement saying that its members are "extremely troubled" that they will no longer have access to Pentothal, which has been used in preoperative sedation since the 1940s.

"We've seen the fairly sudden disappearance of a very common and popular drug," said ASA president-elect Dr. Jerry Cohen, an associate professor of anesthesiology at the University of Florida College of Medicine. "It's a drug we would be better off having because it serves certain numbers of our patients, and we put them at higher risk when we use alternatives. This is going to be a real problem for safety."

Pentothal used to be the most widely used drug for preoperative medication, but has been superseded by newer anesthetics such as propofol and etomidate, explained Bona E. Benjamin, director of medication-use quality improvement for the practice development division of the American Society of Health-System Pharmacists.

However, Pentothal is often preferred for certain types of patients, usually because it does not cause blood pressure to drop as severely for an extended period, Cohen and Benjamin said.

One group of patients that benefits from Pentothal is people with cardiovascular problems, such as the elderly or those with heart disease. Expecting or delivering mothers also are normally given Pentothal because there's less chance that the anesthetic will cross through the placenta into the baby and reduce its blood pressure.

"Typically, Pentothal is used for instances in an emergency C-section, where you already have compromise of the baby," Benjamin said. "You don't want the baby to receive medication that would further compromise [it]."

There's also concern over using propofol in nursing mothers because the anesthetic has been shown to filter into the woman's breast milk, she added.

Pentothal also is preferable to other anesthetics for sedation during neurosurgery, because it does not affect intracranial pressure as drastically, Cohen said.

"It's an important drug for anesthesiologists to have as an option," Benjamin said. "If the drug has a valid therapeutic use, when it is taken off the market we all have to scramble to make sure the patients are taken care of."

Cohen said that without Pentothal, anesthesiologists and physicians likely will have to go ahead and use the newer anesthetics on at-risk patients, then monitor carefully to make sure the side effects don't have detrimental effects on their health.

"You can deal with it," he said, giving the example of a baby who has been exposed to propofol during C-section delivery. "You can ventilate the baby until it wears off. But it's not as easy as simply using Pentothal."

Cohen noted that Pentothal has been used for decades and currently causes just one anesthesia-related death in every 200,000 cases. Using the other sedation drugs would expose some patients to an unwarranted health risk.

"It's as safe as flying on a major airline," he said. "If you start making compromises on the anesthetic techniques you use, you would expect over time you would have a higher rate of anesthetic-related complications and deaths. The idea of introducing a problem because I can't have the drug that I want is not in the best interest of patient health."

Benjamin and Cohen are not optimistic that any compromise could be worked out that would limit Pentothal's use strictly to medical purposes. Hospira can't make that guarantee on its own, and the company chose to withdraw from the market rather than take the chance that Italian authorities would hold it liable for any capital punishment deaths caused by Pentothal.

"It really would require legislation," Cohen said. "That is a political problem that would have to be solved by our political institutions."

Posted: January 2011


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