How manufacturers can prevent the sale of their drugs for use in executions

Today, pharmaceutical manufacturers seeking to restrict the sale of their drugs for use in executions can benefit from the experience of several companies which have paved the way.  These companies have designed and implemented restricted distribution systems which have proven to be effective at preventing abuse of medicines in executions.

Lundbeck put such a system in place in July 2011, and APP and others have since followed suit, designing comprehensive restricted distribution systems for other drugs used in executions.

The controls implemented by APP on propofol in September 2012 have proven to be effective. Missouri, which changed its execution protocol to include propofol in May 2012, has never carried out an execution using the drug and has chosen to abandon attempts to procure it altogether, redrafting its protocol to include a different drug. Further states which were considering moving to propofol (including Texas), have also been forced to abandon these plans and redraft their protocols.

Fresenius Kabi website: Why Propofol shouldn’t be used in executions

Case Studies:

 

Detailed below are two distribution models put in place by Lundbeck and APP to control the distribution of pentobarbital and propofol respectively. We include these two models because they represent two different categories of drug: the first (pentobarbital) a relatively niche drug with a small patient population and application; the second (propofol) a very popular drug with wide and frequent application. Both models have been proven to be effective, and manufacturers should choose which one to opt for according to the particular properties of the drug they are trying to control (ie. What is the size of the patient population? How often is the drug used?)

 

Case Study 1: the Lundbeck model

 

In 2011, Lundbeck implemented a new restricted distribution system for pentobarbital, a drug which had recently been chosen for use in executions in states across the USA.

Their previous distribution model [Figure 1 below] did not restrict the number of distributors and end-users who were entitled to purchase the product. This meant that prisons could very easily purchase pentobarbital for executions directly from distributors (primary, secondary or tertiary) or retail pharmacies.

The new distribution model [Figure 2 below], limits the number of distributors to one: Cardinal SPS. Cardinal SPS has a contract with Lundbeck which means it is authorised to sell pentobarbital to an approved list of end-users only; it is not authorised to sell on to prisons or secondary/tertiary distributors or retail pharmacies which might in turn sell the product on to prisons.

The end-users are approved by Lundbeck, and do not include prisons or entities affiliated with prisons. Cardinal SPS uses a drop-ship system to deliver the product to the approved end-users, meaning that Lundbeck retains legal control over the product until it reaches the end-user.

Conclusion: The system is working, and no further supplies of Lundbeck pentobarbital have been sold to prisons for use in executions since the distribution controls were put in place on 1 July 2011.

All supplies bought prior to the distribution controls expired (at latest) in November 2013, meaning that prisons have had to stop using Lundbeck’s product altogether.

 

Figure 1: Old Pentobarbital Distribution Model

Figure One

No controls in place to prevent prisons buying up supplies of Lundbeck pentobarbital for use in executions across the USA.

 

 

Figure 2: new pentobarbital distribution model

Drop-ship distribution system to ensure supplies reach legitimate medical users of Lundbeck pentobarbital and are not sold to prisons for use in executions.

Drop-ship distribution system to ensure supplies reach legitimate medical users of Lundbeck pentobarbital and are not sold to prisons for use in executions.

 

 

Case Study 2: the APP model

 

Unable to purchase pentobarbital from Lundbeck, states tried to find new drugs to use in lethal injection executions. In May 2012, Missouri changed its execution protocol to propofol.

APP is the largest supplier of propofol to the US market, and implemented a new restricted distribution system on propofol in September 2012 to prevent its medicine from being sold to prisons for use in executions.

Propofol has a far larger patient population than pentobarbital, and is administered about 50 million times annually in the USA. APP’s old distribution system [Figure 3] did not allow the company to maintain control of the product through the supply chain, enabling prisons to purchase the product for use in executions. Under the new distribution system [Figure 4], there are 14 trusted distributors (listed below). Each distributor has signed a contract with the manufacturer which authorises them to sell to legitimate medical users only, not to prisons or to secondary/tertiary distributors or retail pharmacies who might sell on to prisons [see contractual language terms below].

As with the pentobarbital system, the manufacturer specifies to the distributor who is entitled to purchase the product (legitimate medical users) and who is not (prisons for use in executions). The distributor has an automated order system which enables it to establish whether the order ought be filled or blocked the moment an order comes in (based on a range of factors including: the name of the purchaser, the address, the zip code, the DEA licence number).

Conclusion: The restricted distribution system for propofol is working. Not only has Missouri not been able to use any of the propofol it purchased prior to the controls being put in place, no further sales of APP propofol have been made to Missouri prison or any other state prison for use in executions since September 2012.

 

Sample Contractual Language

Manufacturers who have agreed new contracts with their customers in line with the new distribution agreements have inserted a clause similar to the below to ensure that the product is sold only for the purposes for which it is intended, and not to prisons for use in executions.

Accordingly, Customer shall not sell the Restricted Products to any other wholesaler, distributor, retailer or other re-seller, including Customer’s subsidiaries and affiliates, and shall instruct any customers to whom Restricted Products are sold, including Customer’s subsidiaries and affiliates, that they may not sell or otherwise transfer the Restricted Products to any wholesaler, distributor, retailer, institution or any third party.

 

Figure 3: Old Propofol Distribution Model

Figure Three

No controls in place to prevent prisons buying up supplies of APP propofol for use in executions across the USA.

 

 

Figure 4: New Propofol Distribution Model

Figure Four

Tight controls in place to ensure that APP propofol reaches legitimate medical users across the USA, but is not sold to prisons for use in executions.

 

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