A shortage of willing drug suppliers has led many death-penalty states to seek controversial alternative and secretive, if states get their way, new drugs and suppliers.  A joint-investigation conducted by the St. Louis Public Radio and the St. Louis Beacon uncovered that Missouri’s lethal injection drug, pentobarbital, is coming from a compounding pharmacy in Oklahoma, which is not licensed to dispense drugs in Missouri.  Compounding pharmacies have largely been regulated only by state pharmacy boards and not by the FDA.  In other words, a pharmacy in Oklahoma may not meet the standards of a pharmacy in Missouri.

Ned Milenkovich, a pharmacist and attorney who serves on the Illinois Board of Pharmacy, said, “The purpose…is not to protect the pharmacy and the pharmacist, but to protect the public of the state and the citizens of Missouri…” He added that out-of-state pharmacies are usually required to register in the state with which they send their drugs.  Another expert, a former member of Missouri’s Board of Pharmacy agreed with Milenkovich’s opinion.

The legality of the Department of Corrections obtaining execution drugs from an out-of-state pharmacy is uncertain.  A federal judge recently described the source, which the state has been fighting to keep a state secret as a

“shadow pharmacy hidden by the hangman’s hood.”

Compounding pharmacies are unlike drug manufacturers, their mixtures are often unreliable and have a higher failure rate than anything regulated by the FDA.  The source raises not just legal, but ethical questions.  If the execution drug is too weak or doesn’t work the way it is supposed to, it could result in a painful or slow death, which is a violation of the U.S. Constitution not to mention a serious moral question in our justice system.

Missouri, like other states, has fought hard to restrict public oversight on this life and death issue, making it difficult to judge the legality and morality of their actions.  Under normal circumstances, selling a drug without a license is a crime punishable by up to 7 years in prison.  Given that the pharmacy is supplying to the state, charges are unlikely.

“When you violate Missouri law to carry out Missouri law, that seems contradictory,” said Tony Rothert of the American Civil Liberties Union of Missouri, “It’s not surprising.  The state has gone to great lengths to hide what it’s doing and to be secretive about what it’s doing. So it’s not surprising that there’s something there that the state was trying to cover up.”

Who is providing oversight?  If the FDA does not oversee the execution drug, if the Missouri Board of Pharmacy doesn’t license and oversee the compounding pharmacy in Oklahoma, then who is ensuring that the drug paid for by taxpayers is safe, legal, and meets standards?  Missouri seems to be relying on Oklahoma.

“It could be the case that they can’t find a pharmacy in Missouri to participate in this type of activity,” Milenkovich said, “Because when you take your oath of pharmacist practice or your oath of medicine [such as the Hippocratic Oath], a lot of people are…put off by the fact that they are preparing a medication that is not going to be helpful for a person, is not going to treat them, but is rather going to put them to death.”

Inmates are supposed to have the right to challenge the constitutionality of the state’s method of execution, and the courts are supposed to serve as a check on the state’s power.  But in Missouri, they have consistently executed people before courts could review their cases.  The ACLU’s Rothert said the state is basically saying, “trust us.  Even though everything that they’ve done with respect to the procuring of drugs and carrying out the death penalty in recent months has shown that we can’t trust them.  Instead what they’ve shown is that they will go to great lengths breaking Missouri law, disobeying court orders, in order to make sure executions are carried out.”

A recent Missouri Board of Pharmacy investigation found that 1 out of every 5 drugs made by a compounding pharmacy is subpar, compared to 1 out of every 50 regulated by the FDA.

Missouri’s next execution is scheduled for January 29th, but the execution protocol is currently under review by the courts.  Not that that will bother or stop Missouri.  Allen Nicklasson was one of the inmates executed before his appeals were exhausted, the court after his death dismissed his case as moot, but Judge Kermit Bye of the 8th Circuit Court of Appeals wrote in his dissention:

“Missouri executed Allen Nicklasson before this court had completed its review of Nicklasson’s request for a stay…that bears repeating. Missouri put Nicklasson to death before the federal courts had a final say on whether doing so violated the federal constitution…I am alarmed that Missouri proceeded with its execution of Allen Nicklasson…”

Judge Nanette Laghrey was also disturbed by the state’s actions when she ordered the identity of the pharmacy to be revealed to the defense.  The state’s legal team led by Attorney General Chris Koster openly defied the judge’s order.  A day after the deadline, the state delivered the envelope to the court not the defense.

“…litigation is not a game of chess…Rather, the pending dispute between the parties should be resolved on the merits after a reasonable opportunity for both sides to be heard…That is how it is normally done in America and it is a system that has worked quite well.”

[Note:  A recently passed law has improved the oversight of compounding pharmacies.  Compounding pharmacies that mass-produce drugs can be regulated by the FDA, but the process is entirely voluntary.]

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