From The Corner Lab - Blog Posts

Heparin Supply May Be Impacted By Global Pork Shortage

Posted by Jim Menoutis on Wed, Oct 17, 2012 @ 04:43 PM

According to recent reports an anticipated decline in the global pig population may result is heparin shortages next year.  The decline is due in no small part to the increasing costs for feed and other animal welfare costs to farmers. In the US, the on-going drought in the farm belt has had a significant impact. In response, President Barack Obama introduced a pork buying program to support the industry. A comparable plan has also been implemented in China.

In the EU, a recent European Commission (EC)report noted that the European pig population  population  has declined 1.7 per cent this year so far and will continue to shrink further in 2013. The commission noted that the additional investment required to comply with animals EC welfare laws that come into force next year has already seen some farmers halt production.

And, while most of the pork industry focus is on the likely impact on the food supply, the shortages will also affect the drug industry, particularly heparin makers which source the ingredient from mucosal tissues of harvested animals.

One of the first to express concern about the impact to the heparin supply  was  the pharmaceutical supply chain organization  Rx360.  Noting the  role that the previous shortage played in the problems with heparin, it stated  "In 2007, a viral outbreak in the Chinese swine herd led to a pork shortage, creating an opportunity to exploit the heparin market. Unethical individuals adulterated crude heparin with a cheaper abundant material. The adulterated heparin eventually was administered to patients and subsequently a significant increase in patient adverse events was reported."

The organization has advised drug firms to contact their suppliers to confirm they will continued to be able to provide raw materials and stresses that detailed analysis of supply chains is a must, particularly for ingredients that are vulnerable to substitution.

The FDA has issued similar advice.  In a draft guidance the US Food and Drug Administration (FDA)called on manufacturers to investigate the heparin supply chain to cut the likelihood of the crude material beingadulterated intentionally. ā€œKnow the identity and role of the actual manufacturer of crude heparin and any repackers and distributors who handle crude heparin before receipt and useā€, the Agency wrote.

Topics: Heparin, heparin supply, heparin shortage, adulterated heparin