Importance of distribution controls

In order to best prevent the drug from being used for purposes other than its FDA approved indications, Fresenius Kabi does not accept orders for Propofol from any department of correction in the U.S. In addition, the company has voluntarily implemented tight distribution controls. The aim is to protect the supply of Propofol for patients who rely on this medically necessary drug and to secure the availability of the drug in all clinically approved settings. Affected U.S. healthcare providers have been informed of the measures taken on August 28, 2012. Letter to healthcare providers

 

Fresenius Kabi has voluntarily put in place several distribution controls:

 

• Fresenius Kabi does not accept orders from correctional institutions. 
• In 2012, the company limited its distribution network from 34 to 14 authorized distributors/wholesalers. This was the minimum number of distributors needed to assure next-day delivery anywhere in the United States. Currently, the list of authorized distributors/wholesalers counts 16.
• Each distributor/wholesaler has signed a contractual commitment that they will not sell or distribute to correctional facilities. 
• Fresenius Kabi is imposing a contractual obligation to assure that wholesalers will distribute Propofol to authorized health care providers only. 
• Fresenius Kabi is in exchange with experts to ensure the effectiveness of the distribution controls on a rolling basis.

 

As one of the world’s most widely used anesthetics Propofol must be readily accessible at all times and in all care settings, especially in emergencies. It requires elaborate logistics, since distribution controls should never endanger patient care.