The anaesthetic propofol has somewhat a macabre nature as not only did it gather worldwide notoriety as a contributory factor in the death of Michael Jackson in 2009 but last year was named by Missouri’s Department of Corrections as a viable form of capital punishment.
Now as they re-enter the propofol market, both Teva Pharmaceuticals – who will begin producing small batches for the first time since manufacturing woes caused propofol to be discontinued in 2010 - and Hospira have laid out measures to ensure their products will not be used in lethal injections.
Teva Vice President of US Corporate Communications, Denise Bradley, told this publication that once propofol is relaunched next month, Teva will be “limiting the sale and distribution of this product to customers who agree to use best efforts not to sell or distribute to correctional facilities.”
Dan Rosenberg, Hospira spokesman, also told that as part of a review into the distribution of products, Hospira has been striving towards a goal of “restricting distribution for unintended use.”
He said: “Hospira will cease the direct sale to U.S. state prison hospitals of products, specifically pancuronium bromide, potassium chloride and propofol, that we believe are part of some states' lethal injection protocols.”
Though Hospira “historically sold these products to the prison hospitals with the belief that they are used for medical care,” the drugmaker has since written separately to every state to inform them Hospira does not “condone the use of [its] drugs in capital punishment.”
Further measures, according to Rosenberg, will include approaching “distribution partners to add such restrictions to our distribution contracts.”
Lethal Injection
The state of Missouri was the first to opt for propofol in its lethal injection programme, replacing the three-drug method of capital punishment used in 33 states. According to Fox News, the state’s Department of Correction was forced to make the change due to a shortage of sodium thiopental as drugmakers refused to supply the drug on moral grounds.
In response to the switch, German company Fresenius Kabi announced in a letter to healthcare providers a series of measures similar to what Teva and Hospira are proposing. Fresenius said that because it manufactures propofol in Europe, it is subject to EU regulations which “prevents products that may reasonably be expected to be used in executions from being exported from the EU.”
It also warned: “Should Propofol begin to be used in executions in the US, inadequate access to Propofol in the US is a likely consequence.”
Return to Propofol
Last August when Fresenius issued its response, the company was the sole US supplier of propofol, following problems with manufacturing at both Teva and Hospira.
Hospira’s Clayton, NC plant closed-down last year due to manufacturing issues highlighted in a US FDA (Food and Drug Administration) warning letter in 2010. The plant has progressed somewhat though manufacture of propofol has only recently re-commenced and, according to Rosenberg is presently “only able to service [its] contracted customers on a direct basis.”
Outsourcing
Teva’s return comes almost four years after the company was forced to recall over 57,000 bottles of injectable propofol due to a potential endotoxin bacteria contamination. The drug had been produced at the Irvine, California facility which saw manufacturing put on pause in 2010 due to concerns regarding quality and though manufacturing recommenced the following year, propofol had been dropped from Teva’s portfolio.
Following Teva’s decision last month to offload Irvine, we asked Bradley where propofol would now be produced.
“The product is being manufactured by a third party,” she said. “We anticipate launching in April with very limited quantities in the beginning.”
According to the US FDA, the drug is being manufactured by Corden Pharmaceuticals in Italy, on behalf of Teva.