Medical Device Link.

Originally Published PMPN January 2004

Viewpoint

Lewis T. Kontnik

Fake pharmaceuticals are in the news everywhere. And more stories about counterfeits are showing up daily. How big is the problem? While various numbers are tossed around, no one has hard statistics. 
The press often states that 7–10% of the world’s drugs are fakes, attributing that estimate to the World Health Organization (WHO). In fact, WHO never put forth this number. One of its early conference participants cited these percentages but never substantiated them. 

FDA says that the number of counterfeiting cases is up. From 1997 through 2000, there were 4–6 a year. In 2001 there were 20, and in 2002 there were 22. Likewise, FDA numbers represent cases opened but not statistics on the extent of the problem. 

Dr. Lembit Rago with WHO points out that governments and industry organizations around the world have statistics, but they don’t share them. For example, WHO funded studies in Asia and Africa during 2001. The Asian study found that 38% of the 130 blister packs of malaria medicines that its researchers bought were fakes and contained no active ingredients. Likewise, of the 581 samples purchased in Africa, 48% were defective. Many were fake. The Pharmaceutical Security Institute (PSI) has done similar field surveys in Latin America. It reportedly found rates of counterfeiting from 25 to 40%. 

Some still claim that counterfeiting is a victimless crime. But the facts disprove this where medicines are concerned. The most reported case of fatalities occurred in Haiti in 1990. A total of 89 children died after taking cough syrup made with fake glycerin containing antifreeze. In 1996, more than 2500 Nigerians reportedly died after receiving fake meningitis vaccines. In spring 2003, nearly 20 million doses of fake Lipitor were recalled from pharmacy shelves across the United States. 

Product diversion is rampant and is fostered by corporate complicity. In the United States, there is a criminally tainted secondary distribution market in medicines. Some of the product moving through these channels is the result of dumping, closeouts, and discounting overstocks. But some is obtained by fraud (Medicaid or closed-door pharmacy abuse), and some is stolen. There are holes in the Prescription Drug Marketing Act’s (PDMA) system for tracking product from manufacturer to dispenser. As a result, this secondary distribution channel opens the door for the insertion of fakes. 

Growing media attention is forcing Congress, FDA, and companies to confront the issue. On October 15, 2003, FDA held public hearings on the issue (www.fda.gov/oc/initiatives/counterfeit). Drug manufacturers, distributors, pharmacists, patients, and security suppliers are advocating steps to fight the problem. 

Criticizing the federal government for not taking charge, the State of Florida recently adopted an end-to-end pedigree requirement for tracking 30 high-risk medicines. This is likely to be a paper-based system. 

Distributors, under the banner of the Health Distributors Management Association (HDMA), say a paper-based system would cripple the industry. They argue for delaying pedigree requirements until the Electronic Product Code (EPC) system can be implemented, which should be early in 2005. The EPC was developed by the MIT AutoID Center, the UCC, and other collaborators (www.epcglobalinc.org). Manufacturers appear split on these issues. However, they do favor strong enforcement.

What should pharmaceutical packagers do? Get ready. Congress passed a Medicare bill that does not pry the U.S. borders open to drugs from around the world. Therefore the battlefront is likely to remain the Internet, express-mail imports, smuggling, and the domestically produced fakes. 

FDA promised its final report in mid-January. The report could be late. It is also unlikely to prescribe an industry-wide security packaging solution. 

FDA commissioner Mark McClellan commented at the agency’s October 15 hearing: “We need these fresh, inno-vative ideas for keeping our drug supply secure at an affordable price today more than ever. . . . In some ways, the pharmaceutical industry is behind other industries where secure track and trace approaches and secure anticounterfeiting technologies have become more widespread.”

With this invitation, manufacturers (as well as some distributors and dispensers) should seek private security packaging and tagging solutions. A year ago, there was little interest from industry. But the threat of more attacks, regulation, and possible liability are changing this. 

It is time for pharmaceutical packagers to do their homework and invest in security solutions. They must understand the legal, regulatory, and political drivers behind the issue. They should survey the security field and analyze how to implement security systems. They should also determine if business practice changes are needed to protect high-risk medicines. 

The range of potential solutions is vast. These include everything from unit-dose packaging and bar codes on individual pills to close distribution of product and electronic supply-chain visibility. 

Packagers should discuss how their customers are approaching this security issue. They may want to consult with experts in the field to expedite preparation. Dedicated packagers have an opportunity to protect patients and bolster profits. But they need to have programs in place to do so.

Lewis T. Kontnik is an authority on the global pharmaceutical counterfeiting problem. He has been quoted widely in the press and on radio and TV. Kontnik is coauthor of Counterfeiting Exposed (Wiley, 2003) and Protecting Medicines: A Manual of Anticounterfeiting Solutions (Reconnaissance, 2002). He is the pharmaceutical facilitator for the recently completed FDA Product Surety Project. Kontnik has worked with individual companies, industry associations, and governments to help stimulate constructive solutions and countermeasures. He serves as technical consultant to www.safemedicines.org and consults and speaks internationally on various anticounterfeiting topics. He is a member of the Washington, DC, bar. Kontnik can be reached via e-mail at lew@lewkontnik.com or 303/506-3313. For more information, go to www.lewkontnik.com.  

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