By JIM SALTER
2013-09-28 03:22 AM
ST. LOUIS (AP) -- The potential use of propofol in a Missouri execution next month is raising concerns that the anti-death penalty European Union could limit its export, endangering the supply of the vital anesthetic to thousands of hospitals and clinics across the United States.
Convicted killer Allen Nicklasson is scheduled to die by injection one minute after midnight on Oct. 23. Missouri changed its execution procedure last year to include propofol as the lethal drug. Nicklasson's execution will be the first to use propofol.
Propofol is far and away America's most popular anesthetic, according to information from the American Society of Anesthesiologists. About 50 million vials are administered annually in some 15,000 U.S. hospitals and clinics -- about four-fifths of all anesthetic procedures. The society said in a statement that propofol is popular because it works quickly and patients wake up faster with fewer side effects such as post-operative nausea.
Roughly 85 percent of the U.S. supply of propofol is made in Europe by the German company Fresenius Kabi. Export is controlled by the European Union.
Capital punishment is outlawed in Europe, and a regulation prohibits trade in goods which could be used for executions. The EU is currently reviewing whether to add propofol to the regulation.
EU spokeswoman Maja Kocijancic said that if added, propofol would be subject to export controls, not a complete ban.
Still, the measure could have a drastic impact on the availability of propofol in the U.S., said Matt Kuhn, a spokesman for Fresenius Kabi USA.
"It's our belief they would be compelled to impose export controls," Kuhn said Friday. "How soon it would be after an execution is not clear."
"It's a real concern and it could have enormous public health implications," he said.
Fresenius Kabi has launched a website specifically to address the ramifications of using propofol in a U.S. execution, http://propofol-info.com.
The U.S. agency that regulates drugs, the Food and Drug Administration, is also worried about any move that could impact access to propofol. FDA spokeswoman Erica Jefferson said the agency is weighing how best to reach out to European officials to ensure that propofol remains readily available.
"We do consider this a critical need," Jefferson said. "Without the drug we're concerned that surgeries would be delayed and patients would be at risk."
Until recently, Missouri and other states with the death penalty used virtually the same three-drug protocol. That changed in recent years as drug makers stopped selling the traditional execution drugs to state corrections departments because they didn't want them used in lethal injection.
The Missouri Department of Corrections turned to propofol, which drew headlines in 2009 when pop star Michael Jackson died after overdosing on the drug. So far, it is the only state to do so.
Nicklasson, convicted of killing a man who stopped to help after Nicklasson's car became disabled on Interstate 70 in 1994, is scheduled for execution on Oct. 23. Joseph Franklin is scheduled to be put to death on Nov. 20 for the 1997 shooting death of Gerald Gordon at a St. Louis area synagogue. Franklin has also been convicted of racially-motivated killings in Utah and Wisconsin, and bombing a synagogue in Tennessee.
Missouri corrections spokesman David Owen has said the state has enough propofol for the two planned executions and one more, the last batch expiring in February 2015. He did not return messages seeking comment for this article.
The European regulation 1236/2005 controls export of goods used in "capital punishment, torture or other cruel, inhuman or degrading treatment or punishment."
Kocijancic said the review to determine if propofol should be added is in "final stages," but she declined to speculate when a decision would be made.
"If propofol is added to the EU list of the regulation 1236/2005, we would then apply export controls," Kocijancic said in a written response to questions from The Associated Press. Supplies to U.S. hospitals and clinics would require authorization, "but would still be possible," she wrote.
If propofol is added to the regulation, Fresenius Kabi would have to apply for a separate export license for every shipment, "a process that could take 3-6 months in every instance," the website said. The result, it said, would be "a significant market shortage of this medically necessary drug across the U.S."
The U.S. has dealt with propofol shortages before, most recently in 2012 due to manufacturing problems. The American Society of Anesthesiologists said shortages resulted in less optimal outcomes, longer recovery times, medication errors, even deaths.