Droughts have led to higher corn and feed prices causing many farmers to decrease their swine herds which could result in shortages of heparin and other porcine derived products
A world shortage of pork next year is now unavoidable, says Britain's National Pig Association (NPA);[1].   The world’s pig farmers are warning of a shortage of bacon and pork next year because pig-feed has become unaffordable following disastrous growing and harvesting weather. Governments are becoming increasingly concerned. The pharmaceutical industry should be on alert as well - reductions in pig products could lead to shortages of heparin and other porcine products.   Pharmaceutical-grade heparin is derived from mucosal tissues of harvested meat animals such as swine intestine or bovine lung.  The vast majority of pharmaceutical heparin is produced from swine. Roughly one swine is required to produce one human dose of heparin. New data shows the European Union pig herd is declining at a significant rate.  This trend is being mirrored around the world. Pig farmers have reportedly been plunged into loss by high pig-feed costs, caused by the global failure of corn and soy harvests.  NPA estimates that pork production could fall by as much as 10 percent in the second half of next year. Around the world, pig farmers are selling their herds because they can no longer afford to feed their pigs. In the United States the government has introduced a pork-buying program in a bid to keep its pig farmers in business. And the Chinese government is putting pork into cold storage, as a buffer against shortages next year. We must learn from past events, conduct thorough risk assessments and implement risk mitigation activities to ensure the quality of our products and protect the patients we serve.  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 (over-sulphated chondroitin sulfate).  The adulterated heparin eventually was administered to patients and subsequently a significant increase in patient adverse events was reported. [2][3][4]  “The heparin crisis of 2008 is a vivid reminder of the importance of closely monitoring supply chains and assuring the ability of companies to maintain adequate supply,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Companies must be ever-vigilant in protecting the quality and supply chains of their products.”
Rx-360 recommends the following: Firms who use heparin or other porcine derived products should consider taking the following actions:   1. Contact your supplier and assure their ability to supply.   2. Assess and understand the entire supply chain, including workshops that provide crude heparin or intermediates to the API producers to identify vulnerabilities that could cause supply interruptions and product authentication concerns.  Assessments should also include a review to assure the supplier has an effective system to qualify their suppliers and to assure the traceability of drug components throughout production. 3. Secure your supply from a trusted supplier.    4. Conduct full analytical testing upon receipt of material using scientifically sound sampling plans and required methods.  Specifically for heparin, use approved methods to detect over-sulphated chondroitin sulfate.   5. Contact the appropriate regulatory authorities promptly if you suspect adulteration or a potential product shortage. 6. Review recommendations and screening methods for adulterants in heparin from the FDA and USP[5][6]. Rx-360 is continuing to monitor the situation and will publish updates as necessary. To stay abreast of recent developments related to Rx-360 Alerts, click here. References: British National Pig Association 20-September-2012 Press Release Harris, Gardiner (April 22, 2008). "U.S. Identifies Tainted Heparin in 11 Countries". New York Times. Archived from the original on 12 June 2008. Retrieved 2008-06-11. Harris, Gardiner; Walt Bogdanich (March 6, 2008). "Drug Tied to China Had Contaminant, F.D.A. Says". New York Times. Archived from the original on 21 March 2008. Retrieved 2008-03-19. Pew Health Group, “After Heparin – Protecting Consumers from the Risk of Substandard and Counterfeit Drugs” FDA Heparin Webpage  USP Heparin Webpage