Concern is building among health professionals around the U.S. about the possibility of a severe shortage of one of the most widely used anesthetics in medicine. If Missouri carries out a plan later this month to execute a prisoner using propofol, there’s a good chance that exportation of the drug from Europe to the U.S. will be banned.
The threat of a shortage exists because most propofol used in the United States, about 85%, is sold by Fresenius Kabi through its pharmaceuticals division, APP Pharma. The company manufacturers it in Europe and ships it here. The problem is the European Union prohibits European manufacturers from exporting certain drugs used for capital punishment.
The Missouri execution is set for October 23rd with another prisoner scheduled to be executed on November 20th, also with propofol. The Missouri Supreme Court recently gave the state clearance to be the first to use propofol as an execution drug.
Propofol is a critically important anesthetic for surgical patients and it’s also widely used as a procedural sedation agent for patients undergoing colonoscopy and other procedures where doctors use an endoscope to look inside the body. Propofol is probably better known by the public as the drug associated with the death of Michael Jackson.
The export restrictions on European pharmaceutical manufacturers are based on an amendment to the European Union Torture Regulation that prohibits exportation of a list of products which could be used for the execution of human beings by means of lethal injection. Already, to the consternation of anesthesiologists who used it widely as an anesthetic, exportation of sodium pentothal was prohibited because it’s been used to carry out executions in several states that have the death penalty.
If the executions are carried out with propofol, it would almost certainly be added to the list by the EU and I’ve been told that it’s unlikely the sole US manufacturer of propofol, Hospira, would have the capacity to make up the difference. Teva, another company that has made propofol in the US has been off line with their product for some time and it’s not clear when they might return to the market. Both Fresenius Kabi and Hospira have statements on their website that protest use of the drug for capital punishment.
A shortage of propofol would truly amount to a public health crisis. By far it is used in most anesthetic procedures in the US - about 85% according to the American Society of Anesthesiologists. It works quickly and the level of sedation is easily controllable, with patients waking up almost soon after the drug stops infusing via an intravenous line.
When a manufacturing shortage occurred in 2010, our Institute began to receive reports of serious problems as supplies ran out. These ranged from delayed procedures to unintended intraoperative awareness when a patient was given too little propofol in an attempt to conserve supplies. There were also reports of prolonged hospitalization from intractable post-op nausea and vomiting with alternative sedation agents and numerous other reports about adverse effects experienced with less safe anesthetics that had to be employed.
At this point, various health professional groups and individuals have been making it known to Missouri officials that use of this drug would precipitate a health crisis. I understand that some federal efforts to persuade officials may also be under way. Let’s hope these efforts are successful. This is definitely not an anesthetic agent that we can afford to lose for an extended period.
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