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Confusion over lethal injection drug shortage status

By Fiona Barry , 23-Jan-2014
Last updated on 23-Jan-2014 at 16:58 GMT2014-01-23T16:58:29Z

The contentious drug Midazolam is no longer in short supply, the FDA has told In-PharmaTechnologist.com.

The benzodiazepine was used last week in a never-before-tested combination with the sedative hydromorphone for a state execution in Ohio. The prisoner’s family described Dennis McGuire’s death as “torture”.

Records from the Ohio department of corrections show McGuire took an uncommonly long 25 minutes to die. A local reporter who witnessed the death said McGuire “struggled, made guttural noises, gasped for air and choked for about 10 minutes”.

The inmate’s lawyer had warned before he was put to death that the drug risked “air hunger”, a painful difficulty in breathing. McGuire’s family has said it is considering suing the state of Ohio.

‘Stockpiling’

A lack of availability of conventional lethal injection drugs forced the Department of Justice to use Midazolam in McGuire’s case, as well as a Florida execution in October 2013, where it was part of a cocktail with vecuronium bromide and potassium chloride.  

The anaesthetic propofol was previously used but pressure campaigns resulted in Teva , Hospira and Hikma ceasing supply to prisons for use in the death penalty, in some cases stopping production altogether.

Maya Foa of the legal justice group Reprieve told In-PharmaReporter.com the charity had been observing states for several years, and found shortage scares made the penal system hoard lethal injection drugs, including Midazolam:

While the US states only need a few mg for an execution, they will stockpile them.”

Shortages?

When we spoke to the American Society of Health-System Pharmacists (ASHP), it confirmed that Midazolam is on its drug shortages list, but told us it had “not received reports linking the shortage of midazolam to its use in capital punishment or that patients have not received needed doses of medication as a consequence.

Whereas the ASHP deems “all manufacturers are unable to meet current demand” for Midazolam, the FDA told our reporter “current manufacturers are able to meet all current demand based on their reported inventories, production, and planned releases.

In this case,” said Erica V. Jefferson, FDA Assistant Commissioner for Media Affairs, “two firms are no longer producing midazolam, the remaining manufacturers have increased production to cover the shortfall, no further supply issues are anticipated by the manufacturers at this time,” and the FDA considered the shortage “resolved.”

While Reprieve’s Foa said she did not think there was a “causal link” between increased sales of Midazolam to penitentiaries and purported shortages of the drug in the general population, she told us the charity found “something deeply perverse about a state being allowed to buy up a life-saving medicine to torture and then kill a prisoner.

Manufacturers

Midazolam is manufactured by Hospira, Fresenius Kabi, Akorn, Wockhardt (currently banned from import by the FDA), Caraco, Sagent, West-Ward (which acquired Baxter’s Midazolam products in 2011) and until recently, Ben Venue.  

Hospira’s spokesman Daniel Rosenberg told In-PharmaTechnologist.com “Hospira doesn’t sell midazolam to US prisons that might improperly use the product in lethal injections. 

We have also implemented a restricted distribution system under which we have asked that Hospira-authorized distributors agree not to sell midazolam or other restricted products to U.S. prisons.

However, due to the complex supply chain and the gray market in the United States, Hospira cannot guarantee that a U.S. prison could not secure midazolam through other channels not under Hospira’s control. 

Regarding supplies, we have supply across most presentations and are working to recover on the remaining presentations in the portfolio by the second quarter of this year.

Fresenius Kabi had not replied to our requests for comment at the time of publication.

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