InterviewCrisis threatens drug supply-chain - Baxter executive

18 March 2009 21:33  [Source: ICIS news]

NEW YORK (ICIS news)--The discovery early last year that a heparin product made by Baxter Healthcare had been deliberately adulterated reflects the precarious state of the world’s drug supply, a Baxter executive said on Wednesday.

“I honestly believe we are dealing with a drug crisis, a crisis affecting product supply,” said Matt Anderson, corporate director of global supplier-quality for Baxter.

Anderson participated in a panel on the risks inherent to supply-chain globalisation as part of DCAT Week ‘09, a pharmaceutical industry conference organised by the Drug, Chemical and Associated Technologies Association (DCAT).

“This event cries out for action for us to reduce the risk of this happening again,” he said.

Over 50 people in the US died last year after taking the heparin, which had been adulterated with an inexpensive heparin mimic, oversulphated chondroitin sulphate (OSCS). Baxter was the first firm to identify the problem, Anderson said, but ultimately over a dozen companies in the US and Europe found OSCS in their heparin products.

The adulteration was traced back to China, but the original source was never identified, he said.

Baxter determined that “resting on old standards was no longer enough” and established several objectives for improvement, Anderson said.

First, he said, the company must have a risk-reduction plan that includes enhanced, standardised training for auditors. The company hopes that the training would improve the auditors' ability to identify problems during audits.

The company must also look at risk in a new way, he said, which includes anticipating how counterfeiters might attack Baxter’s supply chain; identifying high-risk products; and the use of role playing to enhance the development of emergency action plans.

Noting that the driving force for the adulteration of heparin was the temporary scarcity of pigs (the source of heparin) in China, Anderson said Baxter was also piloting a political/economic surveillance programme to identify factors affecting the degree of risk.

Baxter was also increasing knowledge of its supplier base in an effort to take greater ownership of its supply chain, the executive said.

Anderson suggested that the pharmaceutical industry should look to other industries for potential solutions. For example, Baxter is investigating methods for detecting adulteration based on the tools used in airports to spot explosive residues on luggage.

“There are many examples out there,” Anderson said. “We just have to look for them.”

Finally, he said the effort to secure the supply chain must be integrated throughout the company to the highest level.

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By: Clay Boswell
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