On November 18, 2009, the University of Southern California (USC) will offer a one-day course called “Building Pharmaceutical Anti-Counterfeiting Programs.” The course will be taught by experts from the field and will examine the nature of the criminal challenge, government and industry roles and responsibilities and technologies that can be used to disrupt the production and sales cycle of counterfeit drugs and medical devices.

We caught up with the program’s organizers, Dr. Frances Richmond from the USC School of Pharmacy, and Lew Kontnik of Amgen, to ask them a few questions about topics to be addressed during the seminar.

PSM: The World Health Organization (WHO) estimates that counterfeiting pharmaceuticals, on a global scale, is a $32 billion business. What have you seen in your years on the job? How dire is this situation for Americans?

Lew Kontnik: The best data probably comes from the Pharmaceutical Security Institute and its data shows that the number and gravity of counterfeit incidents are increasing with the greatest number of incidents taking place in Asia and Latin America. The fastest rate of growth in incidents is in Europe. The October issue of Smithsonian Magazine also reported a serious problem of counterfeit generic, life-saving drugs such as antimalarials in Southeast Asia.

Counterfeits continue to pose a threat to patients in the U.S., though this threat has diminished in recent years. Today, some of the greatest points of concern for Americans are shopping for medicines online, and the possibility of new laws that would allow imported medicines from other parts of the world into the U.S. supply chain.

 

PSM: Can you describe the role and responsibilities of pharmaceutical companies in protecting patients from counterfeit drugs? What is the area you think is most important for companies to be focusing on now?

Lew: The creation and insertion of counterfeits into the medicine supply chain is done after the point of primary control of the manufacturer. It’s the criminals who make the fakes and insert them into the supply chain—not the pharmaceutical companies.

Therefore, manufacturers generally collaborate with the law enforcement and other agencies to deter, detect and disrupt counterfeiting. Examples of these approaches include maintaining a secure supply chain; product authentication measures; analysis and response to threats in the system; and preparation for effective incident management and communications.

PSM: We don’t hear a lot about medical device counterfeiting, but it’s an important part of the seminar you’re co-hosting at USC on Nov. 18. Can you talk a little about the problem in size and scale?

Dr. Frances Richmond: There have only been a few high-profile situations of clear counterfeiting of final products or product components in medical devices over the last few years. These have included glucose strips; heparin that finds its way into heparin-coated devices; condoms; surgical mesh—and in other countries, reports of counterfeit blood pressure measuring devices or syringes are also reported.

It’s difficult to identify the scale of medical device counterfeiting for a few reasons. For instance, some of the products are falsified in a way that has minimal risk to patient health. For example, a counterfeit tensor bandage would probably not be detected unless it performed badly, so it is likely not to be reported or even detected. These are often viewed as trademark violations and tend to be of lower regulatory priority.

Secondly, the problem varies hugely by country. Concerns are highest in countries with poor regulatory systems. At the moment, this is not such a significant problem in the U.S. And products from overseas are not often intercepted because only two percent of imports are inspected at the borders.

PSM: How are consumers likely to encounter counterfeit medical devices and what can they do to protect themselves?

Dr. Richmond: Consumers can protect themselves in a few ways:

    1. Avoid purchasing medical devices or diagnostics from Web sites or other outlets with subpar reputations, as well as those that are suspiciously inexpensive or bought for personal use from other countries.
    2. Question products whose packaging seems to be different from what you’ve seen before, and ensure that sterile products are packaged securely.
    3. Don’t buy devices that are sold with excessively glowing claims by individuals or advertisements.
    4. If you experience device failure or other problem with the device, or if it seems falsified, report it.

It’s important to understand that the jobs of regulators and enforcement agencies are made more difficult if you become a willing participant in counterfeiting, and that includes buying substandard medical devices.