The pharmaceutical supply chain

Matt Buttell

Tightening the security of the pharmaceutical supply chain is becoming a key issue for the industry. The fight to avoid contaminated ingredients finding their way into medicines is hotting up, with the formation of a new international consortium now having received its European debut.

Back in January the Chicago Tribune listed the tainted heparin scandal as the No.1 Top 10 local business stories of 2008. The scandal saw more than 80 Americans die and hundreds more left sickened after receiving injections of heparin, a blood thinning drug.

According to findings of an investigation, batches of heparin manufactured in Baxter International's Chinese facility had been tainted with a contaminant that caused severe allergic reactions in patients who received the doses. As a result, batches of Baxter's heparin were recalled.

Now, formed in the wake of the heparin scandal - now estimated to have claimed 250 lives - the Rx-360 group has been formed. According to the group's plans, the consortium is looking to establish a new set of rules, that can be applied to the global pharmaceutical supply chain. These rules will establish a global, consistent and audit-able set of quality standards so that the industry can reduce the risk of future contamination.

Contamination concerns may have been bolstered by the heparin scandal, but the incident isn't an isolated one. According to Rx-360 research, hundreds of fatalities have also been linked to contaminated glycerine being used as a 'filler' or excipient in many pharmaceutical products.

Strategy

Rx-360's strategy to combat contamination is centralized on sharing supplier audits so that they can be conducted more efficiently. Currently suppliers of active pharmaceutical ingredients (APIs) face numerous and routine inspections by regulatory agencies, drug makers and third-party auditors, but despite such audits, the heparin and glycerine scandals highlight how the pharmaceutical supply chain is not always as secure as it should be.

The consortium believes part of the problem is that the audit burden is also huge for the drug makers. Chairman of the Rx-360 group and vice president of quality at US biotechnology company Amgen, Martin van Trieste explained: "The vast majority of us simply don't have the resources to audit all our suppliers right now."

As such, the consortium hopes that by sharing the workload between its members, the number of audits for each supplier will be greatly reduced, thereby lessening the burden on individual suppliers and allowing each audit to be more thorough by assessing the supplier's own supply chain security processes instead of simply adhering to good manufacturing practices.

What's more, Rx-360 says that audits current cost between $7,000 and $10,000 each, but that the cost can be reduced to $800 to $2000 by sharing audits; they explain that if 100 members share 50 audits, that represents a saving of between $50 and $80 million each year.

BRIDGE

Current issues for the pharmaceutical supply chain don't just end at security issues. Another key issue is related to tracking products from their place of origin to their point of sale, and a separate European consortium is now looking to bridge the gap in the pharmaceutical supply chain standards.

Three years ago, the BRIDGE (Building radio frequency identification for the global environment) project received 7.5 million euros in EU funding so that it could begin tracking pharmaceutical projects throughout their journey to their final destination, something that is essential in ensuring that worldwide pharmaceutical supply chains deliver excellent-quality products. It has now delivered exciting new tracking techniques using radio wave technology.

The structures put in place by BRIDGE, now being used by the European Federation of Pharmaceutical Industries and Associations (EPFIA, are now being considered by the California Food and Drugs Administration to be used as the first globally accepted tracing structure by the pharmaceutical industry.

 

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