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VOL. 130 | NO. 28 | Wednesday, February 11, 2015

Imminent Danger

Pharmaceutical supply chain safety a global challenge

By Don Wade

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The risk is real. And the evidence is in the charges of second-degree murder against the owner of New England Compounding Center Inc., and pharmacists and others employed by the company.

Dr. Kennard D. Brown, executive vice chancellor and chief operations officer of the University of Tennessee Health Science Center, frequently stresses the importance of pharmaceutical safety. 

(Daily News/Andrew J. Breig)

Last December, 14 people were charged in a 131-count federal indictment as the result of tainted drugs killing people in at least seven states, including Tennessee.

To Dr. Kennard D. Brown, it’s nothing less than a stern warning that governments and the pharmaceutical industry should heed.

Brown is executive vice chancellor and chief operations officer at the University of Tennessee Health Science Center and the story isn’t just an illustration, but a tragedy that hit close to home.

“They compounded a steroid and somehow or another the drug got into the pharmaceutical supply chain,” Brown said. “Our hospital in Nashville, in the Saint Thomas system, bought some of this steroid. The drugs were used on patients and I think we had seven or eight patients die. It wasn’t manufactured under GMP (Good Manufacturing Practices). There was mold in the steroid.

“So the problem for the pharmaceutical industry is supply chain integrity from the point of manufacturing to the bedside of a patient.”

It’s an especially concerning challenge in an era of terrorism, global drug counterfeiting and the public’s willingness to buy pharmaceuticals on-line when it’s not always clear from where the drugs originate and under what regulatory guidelines.

Because UTHSC soon will start construction on the Plough Foundation Pharmaceutical Manufacturing Facility at UTHSC, the subject is top of mind. Plough provided an initial $4.5 million grant to start construction, which Brown says will begin in May or June with the facility expected to be completed and operational 18 to 24 months later.

“We’ll do vials, syringes,” Brown said of the new facility. “We won’t do any tableting. We’re looking at the phase one, phase two clinical trial drugs, orphan drugs, niche drugs that are high-end and relatively exclusive.”

Brown is co-author of a proposal to improve pharmaceutical supply chain security through the use of global standards; the proposal also asserts this ultimately would be a cost benefit to major companies in the industry, such as U.S. pharmaceutical leaders Pfizer, Eli Lilly & Co., and Abbott Laboratories.

Ernest L. Nichols, Jr., Ph.D., associate professor of supply chain management and director of the FedEx Center for Supply Chain Management, University of Memphis, is another co-author. So is Cyril F. Chang, Ph.D., professor of economics and director of Methodist Le Bonheur Center for Healthcare Economics at the Fogelman College of Business and Economics at the University of Memphis.

Brown recently traveled to Hong Kong and the Philippines, as part of this pilot project, to make the case for global data standards as a way to increase pharmaceutical supply chain security. The report was prepared for the APEC Business Advisory Board.

APEC, which stands for Asia-Pacific Economic Cooperation, was founded in 1989 and is comprised of about 20 countries including the United States, Canada, China, Japan, Hong Kong, Korea, the Philippines and Russia, among others.

While the United States’ Drug Supply Chain Security Act of 2013 was a step in the right direction, Brown has issue with the slow way in which it would become the national standard.

“The problem with the FDA’s version is they give us 10 years to implement this thing. Well, how many lives are potentially lost over the 10-year implementation?” Brown said. “The argument we’re making in our proposal is that industry can govern itself. You can decide to serialize, track and trace. I’d like to think that industries are involved in this for the same kind of magnanimous reason that the university is involved in it. They’re concerned about patient safety.”

“Industry practice will lead. If you wait for the governmental entities to take the lead, as a practical matter, it’s not going to happen.”

–Dr. Kennard Brown
Executive Vice Chancellor and COO,

But if that’s not the primary motivation, well, there are others.

“It has a huge economic impact on the pharmaceutical industry,” he said. “Drug thefts, counterfeited products … there are national security implications. I heard one story that ISIS was already manufacturing counterfeit (drugs) to generate revenue.

“If a terrorist organization decided to make some contaminated product, much the way the Tylenol case played out, where you had this person put tainted products on the shelves and a number of people suffer some ill fate … some unsavory element could use (tainted products) as a literal weapon of mass destruction.”

Brown has started to speak with pharmacy stakeholders. He wants them to understand when UTHSC’s facility is open it will utilize data tracking and tracing to ensure the utmost security.

“Our delivery modality is to serialize any product that we manufacture so that when a nurse gets ready to give a patient an injection of a drug we manufacture in our facility, they will be able to look at the serial numbers on that drug and know that it’s the legitimate product.”

That’s also the message Brown hopes that governments and pharmaceutical companies worldwide hear and act upon. But he’s not in favor of waiting on those governments, be they on the other side of the world, in Washington, or even in Nashville.

“Industry practice will lead,” he said. “If you wait for the governmental entities to take the lead, as a practical matter, it’s not going to happen.”

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