Missouri Adopts Propofol for Execution by Lethal Injection

As of May 15th, Missouri has adopted this protocol for execution by lethal injection using propofol. (Note the misspelling of the brand name Diprivan.) APP manufactures both Diprivan and generic propofol, Hospira only the generic. The American Society for Health-System Pharmacists reports that the drug is in short supply due to "manufacturing delays" at Hospira.

Given the new protocol, the Missouri Attorney General has petitioned the Missouri Supreme Court to set execution dates for the nine death row inmates who do not already have a date set. All prisoners and their attorneys were also informed, and legal challenges to the untested execution protocol are to be expected.

I tell the detailed story of lethal drugs for injection in my posts below, but here is a summary. Hospira was the only US-approved source of the sodium thiopental that was originally used for lethal injection, but the Italian manufacturing facility with which they contracted refused to produce the drug without guarantees that their output would not be used for executions. Hospira's company policy does not prevent the sale of their products for this purpose. Nebraska fraudulently obtained thiopental from the Indian manufacturer Naari under the guise of having drug samples shipped to Zambia for approval and registration in that country. Naari has requested that the Nebraska Supreme Court order the return of their product, to no avail. After thiopental became hard to obtain, pentobarbital began to be used. It is now unavailable from Lundbeck, the only US-approved supplier, due to the company's enforcement of a shipping procedure designed to prevent the sale of their product for executions. Texas obtained some of their product by deceit, using a DEA registration number for the long-shuttered Huntsville Prison Hospital, and refused to return it to the manufacturer. Texas Attorney General Greg Abbott recently upheld an open records request that revealed that the state has supplies for 23 executions because the Texas Department of Criminal Justice is not following its own protocol and mixing a backup dose. (See syringes 1A, 2A, 3A, and 4A in the Missouri protocol for an example of how backup doses are prepared.)

Shortage of injectable pentobarbital for execution by lethal injection

Shortage of injectable pancuronium

Shortages of Drugs for Lethal Injection

Shortage of injectable potassium chloride

Shortage of sodium thiopental for lethal injection

Nebraska's thiopental for lethal injection

Shortages of Drugs for Lethal Injection

Shortage of injectable pancuronium: Pancuronium is the second of  three drugs injected during an execution by lethal injection in Texas. The only US-approved supplier is Hospira, which cites manufacturing delays as the reason why new supplies of the drug will not be available until April 2012. See my previous post, Shortage of injectable pancuronium. Last month Lancet published an open letter from  Dr. David J. Nicholl and 24 other physicians to Michael Ball, Hospira's CEO, and his response was published in the same issue. The physicians asked the company to make changes in its distribution of the drug to prevent it being used for executions. The company's response was that it has publicly opposed the use of its drugs for lethal injection, that restricting distribution might affect the availability of pancuronium to patients who needed it, and that the physicians' concerns were best addressed to governments, legislators and regulatory bodies. The Guardian reports on restrictions put in place by the European Commission. 

Shortage of injectable thiopental and the US response; Purchases from Dream Pharma, West London:  Hospira was also the sole US supplier of thiopental, formerly the first drug injected during an execution by lethal injection in Texas. It discontinued this drug because the manufacturing facility in Italy refused to produce the drug without guarantees that it would not be used for executions. As thiopental stocks diminished in 2010 and 2011, At least ten US states (PDF, p. 8) purchased thiopental from middleman Matt Alavi, a businessman with a one-man West London company, Dream Pharma, located behind a driving academy. The vials were shipped FedEx under unapproved and illegal environmental and regulatory conditions. When Brandon Rhode was executed with this drug, his eyes remained open, meaning that the anesthetic didn't work and that he was almost certainly suffering from suffocation because the pancuronium injection paralyzes the muscles. He would also have experienced burning pain throughout his body from the injection of the third component for lethal injection, potassium chloride, which stops the heart. He would have been unable to express this pain because of the pancuronium-induced paralysis. Emmanuel Hammond was grimacing with pain during his execution and his eyes first closed and then fluttered open according to Attorney Sheri Johnson. Attorney Dale Baich gave the British High Court a sworn statement that Jeffrey Landrigan’s eyes remained open during the lethal injection process. Through the efforts of various rights organizations this thiopental was surrendered to the appropriate drug agencies or seized by the DEA for unlicensed importation and distribution of a controlled substance. The most publicized seizures were the thiopental purchased by the state of Georgia and CorrectHealth, a company which has the Georgia state contract for medical care in its correctional system, from Dream Pharma. Dr. Carlo Anthony Musso, the owner of CorrectHealth, sold his thiopental to Kentucky and Tennessee, violating more controlled-substance laws. After a complaint from the Southern Center for Human Rights, the DEA seized the thiopental from all three states. The SCHR then petitioned the Georgia Composite Medical Board for revocation of Dr. Musso's medical license, which would end his supervision of executions in Georgia. 

US government requests importation from Germany: Also in 2011, US Commerce Secretary Gary Locke requested importation of thiopental from Germany.  Der Spiegel reported that his counterpart, German Vice Chancellor Philipp Rösler, declined. Thus the US has been cut off from legal importation of drugs for lethal injection from the European Union. 

Purchases from India: In 2010 and 2011 various US states inquired about and some purchased thiopental from India.  The Sunday Guardian reports that Navneet Verma, managing director of Kayem Pharmaceuticals, bought vials of thiopental with English labels from Mumbai company Neon Laboratories for sale to Nebraska and South Dakota because his existing stock was labeled in Portuguese for use in Angola. The Times of India reports that Kayem consists of a Mumbai office and storeroom, with a kitchen on a balcony. This seems very similar to the questionable situation with Dream Pharma. Later in 2011, Mr. Verma reversed his decision to sell more thiopental to various US states that had sent him inquiries.

Another Indian company, Naari, was duped by an Indian purchaser, Chris Harris, who stated that he was buying samples to ship to Zambia for approval and importation to that country. Instead, the drugs were sent to Nebraska, and Naari has protested to the Chief Justice of the Nebraska Supreme Court and started legal proceedings for their return. The Indian Express reported other details of this story. 

Shortage of injectable pentobarbital: Texas and other states reacted to the thiopental shortage by changing the first drug to pentobarbital. See my previous posts, Shortage of injectable pentobarbital for execution by lethal injection, update 1, and update 2.When asked for an opinion last year, Texas Attorney General Greg Abbott told the Texas Department of Criminal Justice that the information about stocks of injectable pentobarbital for execution is a public record  The TDJC later stopped releasing this information based on a Texas Supreme Court ruling that security concerns may sometimes trump the open records law, and has asked the AG for an opinion on a new open records request. Based on the previous request, Maya Foya, an investigator for the London-based human rights organization Reprieve, estimates that TDJC has 27 vials of pentobarbital. The Hunstville Item reports TDJC's response that it has a supply sufficient for the executions scheduled in 2012. As noted earlier, the vials have a two year expiration date, making present prison stocks unavailable for executions after 2013.

Last year a letter to US Attorney General Eric Holder revealed that Texas purchased its supply of drugs for lethal injection using a DEA registration number belonging to the Huntsville Prison Unit Hospital that closed 28 years ago. The DEA requires renewal of this registration information every three years, so if renewal occurred, the registration information was false. Controlled substances such as these drugs must also be stored and dispensed from a pharmacy, hospital or clinic with appropriate DEA registration, according to a prescription written by a physician who is also registered with the DEA. In summary, the TDJC illegally obtained and its employees are in illegal possession of injectable pentobarbital, a schedule II controlled substance. Scott Henson speculates in a blog post that this situation has arisen because the University of Texas Medical Branch at Galveston will not allow TDJC the use of their various state and federal authorizations to handle controlled substances as part of their contract to provide medical care to Texas state prison inmates.

Purchase from H. Lundbeck A/S: The Danish company Lundbeck was misled by the old prison hospital DEA registration number and supplied Texas with pentobarbital. Since my three earlier posts, they have published the company's Detailed Position on the subject. I am confident that their letters to Governor Perry and TDJC were not heeded.

Shortage of injectable pancuronium

The American Society of Health-System Pharmacists reports a shortage of pancuronium for injection. This drug shortage impacts surgery and intubation. In both procedures it is used to temporarily paralyze the skeletal muscles. This is an instance in which changing to one of the alternatives can cause confusion and errors because medical personnel may not be familiar with the different time of onset, duration of effect (see table), and the agent used to reverse the effects. For example, pancuronium's effects are routinely reversed with neostigmine, but if you use succinylcholine to paralyze the skeletal muscles, neostigmine increases the effect.

Injectable pancuronium is the second drug administered for lethal injection, and Hospira is now the only US-approved manufacturer. This further complicates the implementation of death warrants because of the shortage of injectable pentobarbital, the first drug administered for lethal injection. Links to my previous posts are given below.

Shortage of injectable pentobarbital for execution by lethal injection 

Shortage of injectable pentobarbital for execution by lethal injection - Update

Shortage of injectable pentobarbital for execution by lethal injection - Update 2

Reuters reports that yesterday the state of Virginia executed Jerry Terrell Jackson using pentobarbital. A spokesman for H. Lundbeck A/S of Denmark, Matt Flesch, in an interview with the BBC, said:

"We're in the business to improve people's lives, so the use of pentobarbital to end people's lives contradicts everything that we're in business to do."

Since the company has previously stated that it has never sold directly to prisons, the drug must have been diverted before the company reorganized their distribution system to prevent its use for lethal injection. Please read my prior posts for more information.

Shortage of injectable pentobarbital for execution by lethal injection - Update

On ScienceBlogs today, Isis the Scientist references the same press release from H. Lundbeck A/S as my previous post, with the following addition:

"This makes me wonder about the future of Nembutal [trade name for pentobarbital] in places with the death penalty.  Many US prisons have hospital facilities with in [sic] staff doctors and nursing staff.    Will prisoners in prisons in states that still have the death penalty continue to have access to Nembutal as a therapeutic option?  Or, has Lundbeck made plans to stop supply for these purposes out of fear that prisons will re-purpose the drug for executions?"

I also found the comments worthwhile. The comment by daedalus2u is especially interesting:

"The [sic; they] do say that they have never sold any to prisons...."

"If they [Lundbeck] put a clause requiring the purchaser to say they will not allow it to be diverted under penalty of perjury, that makes it a criminal offense to divert it. It is a Class II controlled substance, so diversion of it is already illegal. Lundbeck is perfectly within their rights to consider diversion for lethal injection an unapproved use just like injection to get high is an unauthorized use."

Once again, this comment is worth reading in its entirety.

Shortage of injectable pentobarbital for execution by lethal injection

H. Lundbeck A/S, a global pharmaceutical company located in Denmark, is the only US licensed provider of pentobarbital. Their press release makes clear the company's determination to do whatever necessary to avoid the use of their drug for execution by lethal injection. Currently they have reorganized their distribution system with the intent of supplying the drug for therapeutic purposes only, and will continue to evaluate how their drug is being used. The drug has a two year expiration date, making present prison supplies unavailable for executions after 2013. The state of Texas has enough for the eight executions scheduled, but will not comment on supplies available after Lawrence Russell Brewer's execution September 21st.