Protecting a Global Supply Chain
Martin VanTrieste, Rx-360 Board of Directors

Martin Van Trieste  is the senior vice president of Quality at Amgen, Member of the PDA Board of Directors, Co-Founder, Past Chair and Member of Rx-360 Board of Directors.  Prior to joining Amgen, VanTrieste was with Bayer HealthCare’s Biological Products Division as vice president of Worldwide Quality and Abbott Laboratories as the vice president of Quality Assurance for the Hospital Products Division (now known as Hospira). While at Abbott, VanTrieste held various positions in Quality, Operations, and Research and Development. He started his career at Abbott in 1983 after
obtaining his Pharmacy degree from Temple University School of Pharmacy.

Globalization is impacting most industries and the pharmaceutical industry is no exception. On the positive side, it has enabled our industry to enter markets all over the world and provide life-giving medicines to millions of patients. With the benefits of globalization, however, come significant challenges and responsibilities. One of those challenges is ensuring the authenticity and quality of materials moving through the supply chain.  I recently had the opportunity to present on supply chain security, and as I was doing my research for the presentation, I became increasingly unsettled and overwhelmed by the magnitude of this problem.

I quickly realized that the challenges presented by a very complex, global supply chain, which spans numerous regions of the world and many regulatory jurisdictions, are too vast to take on at one time or with one solution. It was clear to me that there is no magic solution for this. I decided to break down the problem to make it more manageable, and using my knowledge of cGMP and security practices, I developed a layered strategy.

First, I had to accept that everything I was taught about GMPs is important, but this alone could not protect the supply chain from unethical players and criminals. They are playing by different rules and with the potential to make staggering amounts of money, they are playing to win. A different approach is required. We must learn from law enforcement and security professionals about solutions to implement so we can defend against these kinds of threats.

I have previously compared the profitability between different types of counterfeit products: a criminal can take $1,000 and convert it into $10,000 of profit counterfeiting a consumer product, like a DVD, watch or purse. That same $1,000 can be converted into $100,000 dealing in illicit drugs like cocaine. But, a criminal can take $1,000 and make $1,000,000 counterfeiting pharmaceuticals. These numbers are rough estimates, but they illustrate in a very real way the severity of the issue. It costs $60/kg to buy Viagra API in China or India, which can be converted into 25 mg tablets that would sell in US for up to $200,000.(1)

When speaking with law enforcement professionals, they tell us that crime prevention requires a three-pronged defense that involves deterring, detecting and disrupting criminal activity. As professionals within the pharmaceutical industry, we don’t have to wait for another attack--we can take action now. We can improve systems and techniques to deter, detect and disrupt criminal activity that threatens our supply chain.

With all of this in mind, I developed the following strategy:

• Use common sense  (I would like to keep the original text here)
• Embrace new ideas
• Adopt advanced technologies
• Always collaborate with other stakeholders

Common sense dictates that you understand your supply chain in detail. You must answer the following questions honestly:

• Who is the real manufacturer of the material? (Not the broker or distributor)
• Where is the real manufacturer of the material located?
• How many different organizations or links are in your supply chain?
• Is your supplier transparent?
• How is the material transported and stored from the manufacturer to your site?

It is critical to remember that every step in the supply chain represents an opportunity for risk. As such, common sense dictates that we work with trusted partners in the supply chain to mitigate that risk. To find those trusted partners we must perform thorough due diligence by understanding the supply chain and the players involved; building and maintaining a relationship with suppliers as well as staying in constant contact with them; and by all means providing routine oversight of suppliers and the supply chain.

When a trusted partner is not available, however, common sense dictates that you apply a robust risk management process that identifies and aggressively mitigates unacceptable risk. For example, one can qualify a new supplier by working with them to improve their performance or implement measures designed to deter and detect problematic activities. Such options include a person-in-the-plant, tamper evident seals and extensive sampling and testing schemes upon receipt.

Most importantly, when in doubt act quickly. Far too often, I have come across problems that have been encountered and solved before,but, due to organizational malaise they were not promptly implemented until after negative consequences were experienced.  How many times have you heard “I don’t have enough resources to work on that,” yet, an army of people are ready to swarm a problem when it arises?

Finally, common sense dictates that we require suppliers to utilize tamper evident seals. I can best describe what a good tamper evident seal is by first explaining what is unacceptable. 

A tamper evident seal is not:

• A piece of tape
• A piece of string
• A rubber band
• A knotted plastic bag
• A common electrical zip tie  

A good tamper evident seal has a unique serial number, is applied to every container and is tracked throughout the supply chain. When tampered with, it is easy to spot and the integrity of the seal is verified upon receip t. Most importantly, when something does not match, investigate!  Most discrepancies can be easily resolved with a quick phone call to the supplier.

There are many new ideas that can be adopted to secure the supply chain.  For example, right size testing, photographic libraries and pedigree systems can make it easier to detect security problems in the supply chain.

Right Size Testing is a concept that requires developing a raw material sampling and testing scheme using risk assessments that considers supply chain security and final product requirements.  So this Right Size Testing could accept a raw material based on an ID test, Compendial testing and / or special testing based on supply chain security risks or to protect the final product’s performance.

Pedigree Systems are processes that allow materials to be tracked from the point of manufacturer, through any distributors, re-packagers, etc that may occur, to the point of receipt at the pharmaceutical manufacturer.

Technology can be adopted to prevent and detect problems within the supply chain. And new technologies are becoming available every year. The use of sensors, tracking systems, taggants and hand held analytical instruments will deter and detect security problems.

It is also important for all of us to collaborate by sharing knowledge, best practices and resources so that we can attack this global complex set of challenges in a coordinated and more effective manner. If 100 different companies, 50 different countries and 10 different trade organizations develop independent solutions and approaches, the unintended consequences of this disorder could be disastrous. The only individuals that will benefit from this havoc are the unethical players and criminals who will exploit the chaos for their own personal financial enrichment.

In order to facilitate the level of collaboration required to address the complex challenges of the supply chain an international non-profit consortium was formed called Rx-360.  The mission of Rx-360 is to create and monitor a global quality system that meets the expectations of industry and regulators that assures patient safety by enhancing product quality and authenticity throughout the supply chain. 

Rx-360 will achieve their mission by detecting, deterring and disrupting negligent, unethical, or criminal behavior while improving quality by:

• Sharing information on the supply chain
• Developing and sharing new technologies
• Setting standards and adopting best practices such as excipient guidances published by IPEC
• Sharing audits and the burden of conducting audits

I am convinced that by developing simple, robust, sustainable solutions in a collaborative manner we will fortify our defenses, make it more difficult for unethical players and criminals to succeed and better serve patients.

History will be our judge and in the words of Horace Mann, “Let us not be content to wait and see what will happen, but give us the determination to make the right things happen.”

1. Fake Drugs: Causes, Consequences, and Possible Solutions, American Enterprise Institute for Public Policy Research, Roger Bate, Harvard Medical School, March 3, 2010  http://www.aei.org/speech/100125