The traditional drug supply chain is often considered to be simple and safe: the manufacturer makes the drug, sends it to wholesalers, who distribute it to pharmacies. Yet vulnerabilities provide opportunities for criminals and terrorists to exploit it for their own reprehensible purposes.
Counterfeits and the Gray Market
Roughly 10 percent of drugs go through the secondary, or "gray" market, where drugs can change hands many times before reaching the patient, representing a gaping drug supply vulnerability. With 3.5 billion prescriptions filled annually, approximately 350 million prescriptions are potentially affected.
This vulnerability has resulted in patient harm. Investigative reporter Katharine Eban in her book Dangerous Doses exposed the underworld of fake drugs and gray market sales from car trunks and strip clubs by convicted illicit drug dealers, netting them millions of dollars, while subjecting unsuspecting patients to deadly fakes.
The Internet
Around the world, criminals have used the Internet to infiltrate the drug supply on a large scale. International agencies have issued health warnings that drugs purchased via the Internet are largely fake or tainted.
Internet operations manufacturing 500,000 fake pills a day and yielding millions of dollars in sales have been found. Customs and Border Protection have seized thousands of fakes, including recent seizures of fake Tamiflu. Health agencies around the world note that international organized crime and, in fact, governments such as North Korea, are entering into this high profit, low risk trade. Rep. Mark Souter, chairman of the House Subcommittee on Criminal Justice, held hearings on Taliban strategies to induce an anthrax scare so that citizens would buy Taliban-made deadly "treatment" via the Internet, making the West pay for its own demise.
Approaches to Crime and Terrorism
When addressing crime and terrorism, exploiting the drug supply must be interdisciplinary. Technology investment is vital. Radio-frequency ID (RFID) tags are being developed and pilot tested to track and authenticate medicines. But technology cannot be the only solution, since RFID - as well as other promising technology - only track packaging, not product.
Coordination of technology must occur with intelligence activities, including FBI and Customs and Border Protection investigations and international data sharing efforts. A reporting system that integrates Web, e-mail, and other data entry available to agencies, patients, and providers to report suspect drugs, would be ideal for intelligence, GIS thematic mapping, and investigation purposes.
Finally, patient and provider awareness is critical. Patients must understand the risks associated with suspect sources, and providers must have a high index of suspicion for fake medications when therapeutic failure occurs for no apparent reason.
By Bryan A. Liang
Bryan A. Liang is a professor at California Western School of Law in San Diego, where he directs the Institute of Health Law Studies. As a physician and an attorney, Liang's research and writing focuses on the interface between law, medicine, economic incentive structures, and patient safety. Drug supplies issues will be addressed at the Institute of Health Law Studies' annual health policy conference, "Terrorism, International Crime, and Medicine Security: Issues in a Global Marketplace," June 9, 2006 in San Diego. For more information, go to wwwliforniaWestern.edu/ihls. Dr. Liang can be reached at balcwsl.edu.
CALIFORNIA WESTERN SCHOOL OF LAW.
View drug information on Tamiflu capsule.