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Global pork shortage will impact heparin supplies, says Rx360

By Gareth Macdonald , 17-Oct-2012

Heparin could be in short supply next year with higher feed prices and welfare costs forcing pig farmers to reduce the size of their herds.

According to a recent European Commission (EC) report the European pig population has declined 1.7 per cent this year so far and will shrink further in 2013.

The commission suggests that the additional investment required to comply with animals welfare laws that come into force next year has already seen some farmers halt production.

Similarly, British farmers group the National Pig Association (NPA)  has warned of likely pork product shortages and a decline in the size of the UK pig herd citing increasing feed prices - rather than investment requirements - as the key factor.

Outside Europe the trend is repeated. In the US President Barack Obama introduced a pork buying programme to support the industry, which has also seen feed prices rise as a result of drought in the country. A comparable plan has also been implemented in China.

But, 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 meat animals.

Pharmaceutical supply chain organisation Rx360 was one of the first to express concerns, citing the role previous shortages played in the problems with heparin in recent years.

"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 organisation advises pharmaceutical 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 issued similar advice earlier this year.  In the draft guidance the US Food and Drug Administration (FDA) called on manufacturers to investigate the heparin supply chain to cut the likelihood of the crude material being adulterated intentionally.

Know the identity and role of the actual manufacturer of crude heparin and any repackers and distributors who handle crude heparin before receipt and use”, the Agency wrote.

Manufacturers should audit their suppliers of heparin, both crude and API (active pharmaceutical ingredient) forms, to make sure they comply with cGMPs (current good manufacturing practices).

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