Americans rely extensively upon prescription medications to maintain health and quality of life. According to the National Center for Health Statistics, in 2002, at least 1.5 billion drugs were prescribed to patients in physician offices, 196 million in US emergency departments, and 140 million in outpatient settings.1 Almost twothirds of visits to physician offices and hospital outpatient departments had at least one drug associated with the visit, and 7% of visits had five or more drugs.2 In 2004, US pharmacies dispensed over 3.5 billion prescriptions to patients.3 Estimates indicate that annual expenditures for prescription drugs in the US top $230 billion dollars each year4-and there is every indication that these numbers will only increase.5
Prescription drug use is not simply associated with acute provider visits but is a standard part of US life. At least 44% of all citizens report using prescription drugs in the last month, and, indeed, 17% reported using at least three or more.6 Seniors use a large fraction of these medicines. Greater than 80% of seniors use at least one drug, 50% report taking at least three prescription drugs, and at least 20% of seniors take at least five prescription medications.7 Although seniors account for only 13% of the population, as patients they account for more than one third of all prescriptions, and as payers they account for more than 40% of each dollar spent on drugs each year.8 It is estimated that seniors alone spent more than $70 billion on prescription medicines in 2005.9
Prescription medications have become a powerful tool in the medical arsenal against disease and promotion of health and quality of life. Yet the success of prescription drugs and their extensive use has attracted unsavory characters interested in exploiting vulnerable patients and the market for medicines. These opportunistic creatures introduce and peddle counterfeit drugs through vulnerabilities in the drug distribution system. In the United States, counterfeits are a growing problem, but our closed, domestic system has so far maintained a high level of safety.10 However, the rest of the world has and does experience increasing problems with fake medicines, in great part due to extensive movement of drugs in and out of countries through licit and illicit importation." Hence, without extensive new infrastructures involving safety systems, appropriate laws and regulations, investment in technology, and coordination of these components, allowing large scale importation of drugs into the United States could very well import other countries' counterfeit drug problems into our own.
This paper reviews some of the issues associated with counterfeit drugs and drug importation. In Part II, the characteristics of counterfeit drugs are reviewed, including their scope, known epidemiology, associated types of harm, and reasons for production and sale. In Part III, the interactions of counterfeits and importation are outlined, including the international experience and policy concerns that result. The Pharmaceutical Market Access and Drug Safety Act of 2005, often known as the Dorgan bill, is also assessed. In Part IV, issues associated with Internet pharmacies and accountability are discussed. In Part V, thoughts on reform are presented and proposed, and deeper issues of price and research and development, focusing upon international cooperation, are considered. Finally, in Part VI, the paper concludes.
Counterfeit drugs are a worldwide problem. The World Health Organization (WHO) has reported that a significant fraction of the world's drug supply is counterfeit.12 While the scope of the problem is unknown, the WHO estimates that up to 60% of drugs in some developing countries are fake, and up to 20% in some developed countries are fake.13 Overall, approximately 10-15% of all drugs sold in the world are counterfeit.14 Through importation and reimportation, fake drugs enter into country supplies and end up in drug stores,15 and, ultimately, in patients who ingest or are injected with them. …