Lethal Injections, Drug Shortages, and Pharmacy Ethics

Most pharmacists probably think about the lethal injection of convicted prisoners in abstract philosophical terms. Is the death penalty a morally acceptable way of dealing with those found guilty of heinous crimes? Should it be legal to put criminals to death, or is life in prison without the possibility of parole a better alternative? Is this final solution to a terrible social problem a punishment for the offender or a deterrent to others who might consider engaging in the aberrant behavior that could lead to the death penalty?

Perhaps the dilemma is more concrete: Is a lethal injection a more humane way to end a person’s life than other forms of execution like the electric chair, gas chamber, hanging, or a firing squad? The relevance of these questions may depend on whether one lives in a state where the death penalty is legal. Even in states where the practice is not legal, pharmacists may be asked to ship drugs to states that do execute the condemned.

Drug Shortages

Irrespective of how one feels about the death penalty, pharmacists may have to face some ethical decisions if they become involved in distributing drugs for lethal injection.^1,2 Recent shortages of drugs used for lethal injections has brought some of these questions into media scrutiny.

Currently, there are 32 states where the death penalty is legal.³ Three other states (New Mexico, Connecticut, Maryland) ruled more recently that the death penalty is unconstitutional but still have prisoners on death row because the laws were not retroactive.⁴ All states that permit the death penalty allow execution to be conducted by lethal injection.⁵ Certain federal crimes also warrant the death penalty by lethal injection.⁶ Although the concept of lethal injection for the purpose of executing a prisoner was first introduced in 1888, it was not until 1982 that Texas became the first to use it.⁷ The method by which a lethal injection is carried out has wide variability ranging from the use of a single drug to a combination of three various and different drugs.⁶ The three-drug “cocktail” typically involves use of a barbiturate, a paralytic, and potassium chloride solution.

Most states once used sodium thiopental as the barbiturate. However, no domestic company has produced this drug since 2009.⁸ A supplier of the drug from outside the United States was not registered with the FDA, thereby causing it to be misbranded under the Food, Drug, and Cosmetic Act.⁹ Nonetheless, the FDA stated in 2011 it would not block the importation of the product under its “enforcement discretion.” On July 23, 2013, a federal Court of Appeals ruled that the FDA must prohibit the importation of misbranded or unapproved new drugs, including those made by unapproved manufacturers abroad.¹⁰ Under that ruling, the FDA cannot release any of the products currently on hand for the purpose of conducting an execution by lethal injection of this drug. As a result, many states have switched to sodium pentobarbital as the “drug of choice” for the three-drug cocktail.

In June 2013, the only U.S. company approved to manufacture thiopental (Hospira) announced it will no longer produce the drug. This decision came after a global campaign by death penalty opponents and pressure by Italian government officials after the company sought to shift production of the drug to an Italian plant.¹¹ The Italian government has stated it will not allow the export of any drugs that will be used in executions.¹² As the shortage of thiopental became acute in 2012, California and Arizona obtained shipments of the drug from England. The British government has since refused to allow exports of drugs for use in capital punishment, a policy that is under consideration by the entire European Union. As a result, many states have been forced to substitute pentobarbital, which has been used alone or in concert with other drugs in all executions in the U.S. over the past 2 years. This drug, commonly used as a sedative, is more readily available. Pentobarbital is widely used in veterinary medicine for animal euthanasia and is also used in physician-assisted suicide in Oregon.¹¹

Some states (Arizona, Georgia, Idaho, Ohio, South Dakota, Texas, Washington) have used a single anesthetic, primarily pentobarbital, to induce death, and three others (Arkansas, Kentucky, Louisiana) have announced their intent to use this method of execution in the future. However, pentobarbital has become a concern when used for capital punishment. It was used in a U.S. execution for the first time in December 2010, when it was administered as the first ingredient in a three-drug cocktail for a lethal injection given to an Oklahoma inmate. The drug also has limited FDA approval in smaller doses as a mild anesthetic and to treat some seizures. Many physicians say they no longer administer it to people for medical purposes. Recently, a domestic manufacturer of pentobarbital has stated it will no longer supply the drug for purposes of assisting executions.¹³

Missouri has announced plans to use propofol as its single drug.⁶ As might be expected, this decision was met with criticism. Propofol, made famous by its role in Michael Jackson’s death, has never been used in a lethal injection and could cause unnecessary pain, opponents argue. “This is an experiment with a human subject,” said Richard Dieter, a death penalty opponent and executive director of the Death Penalty Information Center in Washington, DC. “This will be sort of a brute force approach where you give them enough and they die.”¹⁴ If administered incorrectly, propofol could lead to serious and painful muscle contractions. The drug is generally injected by a medical professional, but Missouri state law no longer requires a physician to be present for an execution.¹⁵

Supply Issues

One of the major problems in death penalty states is finding suppliers of the drugs used for lethal injection. Texas has 317 inmates on death row, but as of August 2013 it had only one dose of thiopental left. Its supply of pentobarbital has an expiration date of September 2013 and, to date, no alternative source has been determined.¹⁶ This is a significant problem because Texas performs about half the executions in the country right now. The states must scramble to obtain these drugs, including using overseas sources, but this is complicated by the fact that many of the manufacturers based in Europe do not want to participate in U.S. executions.¹¹ A recent court filing indicated that Ohio’s supply of pentobarbital will be gone by the end of September 2013.¹⁵

Many of the states purchase the drugs used for lethal injections from pharmacies. In the states where a combination of drugs is utilized, compounding pharmacies may become a source for the medications. Regardless, many states are having problems obtaining sufficient quantities of drugs to carry out lethal injection sentences. Pharmacies and pharmaceutical suppliers are increasingly concerned with backlashes from anti-death penalty protestors for being known as suppliers of ingredients used to intentionally end a person’s life.

Lethal Injection Secrecy Act

Georgia recently enacted the Lethal Injection Secrecy Act, which protects the identity of companies or individ-uals that manufacture, supply, or prescribe drugs used in executions.¹⁷ The constitutionality of this Act has been challenged, in part, on the basis that there is no evidence that the drug set to be used to execute a prisoner, pentobarbital, will work as intended. The attorney for the condemned man has stated that the drug was made by an “unregulated” out-of-state compounding pharmacy and, as such, could be expired or otherwise tainted, thus having the potential for causing problems during the execution. A trial court judge has blocked the execution saying that the law allows the state to withhold information that is essential in determining the effectiveness of the drugs. The Georgia Attorney General’s office argued that there is no evidence to show that the drug is substandard. Further, there are valid reasons for the state to protect the supplier of pharmaceutical preparations: “Once that compounding pharmacy’s identity is revealed, how will the Department of Corrections ever get another compounding pharmacy to sell to us?” ¹⁸ The Georgia Supreme Court will make a final determination. North Dakota has a similar secrecy law.

“States are having a tough time finding supplies; but that doesn’t mean officials should hide information about the process,” says Fordham University law professor Deborah Denno. “If, in fact, these drugs are not problematic, then Department of Corrections should have no concern about revealing what their sources are.”¹⁷

Analysis

The implications of drug shortages used for lethal injections for the pharmacy profession and individual pharmacists should be obvious. Some commentators allege, wrongfully, that compounding pharmacies are unregulated. Others question the very credibility of pharmacy ethics. And others wonder if pharmacists, cloaked behind a wall of secrecy, are supplying drugs that are tainted, out of date, unapproved, or mislabeled. Pharmacists who do supply drugs for lethal injections may be intimidated from doing so by vocal anti-death penalty advocates.

The American Pharmacists Association (APhA) Code of Ethics for Pharmacists does not directly address lethal injections or the death penalty, although several statements in the code could be construed to have implications on the subject.^1,19 Ultimately, each pharmacist must decide if supplying drugs for the purpose of ending another person’s life by lethal injection is something he or she might want to engage in. There is no one right or wrong answer.

REFERENCES

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2. Romanelli F. Lethal injection as a component of a therapeutics toxicology module. Am J Pharm Educ. 2011;75:117. www.ncbi.nlm.nih.gov/pmc/articles/PMC3175686/. Accessed September 9, 2013.
3. States with and without the death penalty. Death Penalty Information Center (DPIC). www.deathpenaltyinfo.org/states-and-without-death-penalty. Accessed September 7, 2013.
4. Authorized methods. DPIC. www.deathpenaltyinfo.org/methods-execution. Accessed September 7, 2013.
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9. 21 USC §§ 331(a), 352(c).
10. Cook v. FDA, Slip Op No. 12-5176 (1st Cir). www.cadc.uscourts.gov/internet/opinions.nsf/2E33B7631B436F6385257BB1005178CC/$file/12-5176-1448004.pdf. Accessed September 8, 2013.
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13. Mears B. States urge feds to help import lethal injection drugs. CNN. May 21, 2012. www.cnn.com/2012/05/21/politics/states-lethal-injection-drugs. Accessed September 9, 2013.
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16. Graczyk M. Texas execution drug shortage: state running out of pentobarbital. Huffington Post. August 1, 2013. www.huffingtonpost.com/2013/08/01/texas-execution-drug-shortage-running-out_n_3690893.html. Accessed September 9, 2013.
17. Lohr K. Where do drugs for lethal injections come from? Few know. National Public Radio. July 30, 2013. www.npr.org/2013/07/30/207026540/where-do-drugs-for-lethal-injections-come-from-nobody-knows. Accessed September 7, 2013.
18. Beasley D. State of Georgia high court to hear appeal on lethal injections. Reuters. August 26, 2013. www.reuters.com/article/2013/08/26/us-usa-execution-georgia-idUSBRE97P0QQ20130826. Accessed September 7, 2013.
19. Code of Ethics. APhA. www.pharmacist.com/code-ethics. Accessed September 9, 2013.

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