Our Vulnerable Supply Chain

October 02, 2009

What is going on with our Supply Chain? A better question is: what isn’t going on with our supply chain!

Many Americans are aware of the quality concerns of products coming from China, and perhaps they are aware of the quality issues related to India. Outside of our industry, there have been examples that were at the forefront of the news, such as the safety of children’s toys related to lead-based paint. As patients, we Americans assume that the issues related to pharmaceutical products are rare and that our medicines are safe. The infamous thought of “it can’t happen to me” calms our fears.

How accurate is our perception? Unfortunately, the issue of counterfeit medicine is more prevalent than most Americans are aware of….and certainly, most Americans don’t realize that the U.S. supply chain plays a large role in the problem. In a recent presentation Katherine Eban, author of Dangerous Doses, revealed the results of three years of her research into illegal trade of legal medications originating and ending in the United States. Eban described the real scenario where felons who were convicted of trafficking illegal drugs are able to obtain legitimate licenses from the State of Florida to run and operate a “pharmacy” in that state. The Florida government only requires that an individual fill out a 2 page form, which is then accepted without a background check or facility assessment. As a result, these “pharmacies” are mobile homes, basements, and garages owned by the felons or their families.

So the convicted felons own their own legal “pharmacies”, but how do they break into the legitimate trade of legal drugs? Here is one example. The felon illegally buys prescription medication from Medicare patients or veterans, then re-labels the medication for a higher strength (even though the content is still the same). The felon then sells these drugs back into the legal prescription drug market through wholesale distributors, who then sell it to your pharmacy in your neighborhood. Eban described how a felon in Florida purchased Epogen 2,000 unit vials ($38 per vial) from VA patients, relabeled the vials as Epogen 40,000 units ($643 per vial) and sold it back into the legal market. This vial made it up to the New England states where a 16 year old boy received it from his local CVS.

In other words: yes, the majority of counterfeit drugs come from China, followed by India, but it is happening in the U.S. as well.

What can we as an industry do about this? This is difficult to answer. Some will say to improve the transparency of the supply chain (pedigree), audit the supply chain, don’t put original COA data on new company letterhead, test every drum of every product/excipient beyond identity testing, and don’t rely on paper audits. However, none of these alone will solve the problem, and although it would be greatly reduced, even all of them combined won’t completely stop criminal activity.

1. Imagine the cost of implementing all of these actions. For many small companies, this would be enough to drive them out of business.

2. Suppliers can’t manage audits by every client, so how can on-site audits be conducted?

3. Closed portions of DMF’s greatly hinder the transparency.

So again, what can we do? The answer is that the industry needs to address this as an Industry. There are real solutions that can be implemented if we work together. This is not an option, but rather a requirement to protect patients around the world – including on your street and in your house.
As groups such as IPEA, RX-360, and the FDA explore new concepts, such as a 3rd party auditing strategy, the industry needs to support these efforts and participate.

 

 

Tags: IPEA , RX-360 , FDA , illegal trade , supply chain , pedigree , pharmacies , counterfeit medicine , Katherine Eban , Dangerous Doses , pharmaceutical products

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