Strategy for Security

Jan 13, 2010

The pharmaceutical industry spends a fortune each year to secure its supply chain from the point of manufacturing right up to dispersal at the pharmacy. However, last year's heparin debacle proved that track-and-trace stickers on pill bottles, RFID equipment, and pedigree systems are useless if criminals can taint ingredients before they even make it to pill form.

Martin VanTrieste
Enter Rx-360, a non-profit consortium formed by pharmaceutical and biotech companies to address the security of product in the upstream supply chain between the raw material suppliers and the drug manufacturers. Pharm Exec talked to Martin VanTrieste, vice president of quality at Amgen, and Rx-360 spokesperson to find out more about this new group.

Q: Why was Rx-360 conceived? Can't individual companies handle their own security?

A: We feel that a lot of organizations are already working on protecting the product from the pharmaceutical company to the patient, but no one was really paying attention to the upstream piece. We focus on preventing the next heparin, melamine-type contaminations, economic adulteration of our products, or counterfeiting of raw materials before it gets to the manufacturer.

Q: So the group was created in direct response to the heparin incident?

A: Yes and no. After the heparin tragedy, there was a series of highly publicized events with melamine discovered in many different products—both in the pharmaceutical and the non-pharmaceutical space. And then you had the lead in the toys, and the pet food incident, not to mention the contaminated glycerin that continues to happen around the world.

Several quality heads from the major pharmaceutical companies at a conference realized that what happened to Baxter was really not a failure of their GMP (good manufacturing practices) system, but the introduction of non-ethical players, or even criminals, into the supply chain. We quickly came to the realization that this was a very complex issue, very global, and beyond the means of any one company—or any one government agency—because it was so widespread and complex. We formed this consortium to try to address the problem in a more holistic manner.

Q: Rx-360 is a group of people from many different pharma companies. How do you structure your organization with so many players?

A: We have a number of members within the organization who have contributed volunteers. So it is supported by the pharmaceutical industry, but it's based on our subject matter experts. It's the talent within our organizations getting together to say, "What's best out there? How can we put things in place to do a better job collectively?"

Q: What areas are you currently focusing on?

A: The main area is sharing of information—global, macroeconomic, political information. Using heparin as an example, there's not enough hogs in the United States to provide all the heparin that we consume in the US, and the world's largest consumer of pork products is China, so it's natural that heparin comes from China.

In 2007, there was a viral outbreak, which decimated the hog population in China. You would have assumed that the supply of heparin would have gone down, but almost the exact opposite happened. There was a significant price increase on all pork products due to the shortage, but heparin supplies actually went up—the yields went up.

When you go back and look with a retrospective eye, there was a signal that could have been seen: There was a shortage of the raw material, prices went up, that created an opportunity for someone who's unethical to make money. They figured out a way to do that. They entered the supply chain to take advantage of that situation. So, we scan the environment to see if there's anything else out there that can have an impact on our business, and share that information with the community.

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