Pharmaceutical Drugs

Strategic Findings

• The availability of diverted pharmaceutical drugs is high and increasing, fueled by increases in both the number of illegal online pharmacies and commercial disbursements within the legitimate pharmaceutical distribution chain.

• The implementation of pedigree systems such as Radio Frequency Identification (RFID) could help to eliminate the introduction of counterfeits as well as deter the diversion of commonly abused drugs from the legitimate pharmaceutical supply chain.

• Rates of past year use for pharmaceuticals are stable at high levels.

• Demand for prescription narcotics may decline as some users switch to heroin, particularly in areas where law enforcement efforts curb the diversion and availability of prescription drugs.

Overview

The legitimate prescribing and commercial disbursement of pharmaceutical narcotics, depressants, and stimulants ensure the ready availability of such drugs throughout the country, even in remote and small communities (see Figure 8). However, the illicit diversion and theft of pharmaceuticals--currently at very high levels nationally--from legitimate supplies have been curbed somewhat in some areas, such as Kentucky, Michigan, Nevada, and Utah, through education, sustained law enforcement pressure, reduced access in pharmacies, and the implementation of Prescription Monitoring Programs (PMPs).⁸ Wider employment of additional antidiversion measures such as newer pharmaceutical shipment tracking technology may further reduce large-scale diversion of pharmaceuticals. Working against the progress of law enforcement in reducing pharmaceutical diversion is a consistent rise in the number of Internet pharmacies from which individuals are able to acquire drugs without examination or a prescription. Furthermore, in areas where law enforcement has been successful in reducing illicit availability of pharmaceuticals, many individuals are simply switching to other drugs of abuse as a substitute for pharmaceuticals.

Figure 8. Commercial disbursements of commonly abused pharmaceuticals,* United States, 2000-Midyear 2005.

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Source: Drug Enforcement Administration.
*Commonly abused pharmaceuticals include codeine, methylphenidate, oxycodone, hydromorphone, hydrocodone, meperidine, methadone, morphine, fentanyl, cocaine, d-methamphetamine, d-amphetamine, and dl-amphetamine.

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Despite widespread diversion of pharmaceuticals nationally, the availability of pharmaceuticals has been reduced in some areas: The widespread, ready availability of diverted pharmaceutical drugs throughout the country is evidenced not only in ample law enforcement reporting but also in NDTS 2006 data. These data show that 78.8 percent of state and local law enforcement agencies report either high or moderate availability of diverted pharmaceuticals in their area. Although this percentage is high, it represents a slight decrease since 2005 (80.8%), when survey data suggests illicit availability peaked after several years of consistent increases. The reduction appears to be most pronounced in areas where state-level legislation to implement PMPs has been passed, particularly in Kentucky, Michigan, Nevada, Ohio, and Utah. According to DEA, individuals seeking diverted pharmaceuticals in states that have implemented PMPs have, in some cases, turned to traveling to nearby states that do not operate PMPs to illegally obtain pharmaceuticals. As of June 2006, 32 states had enacted legislation requiring PMPs, and 16 additional states were proposing, preparing, or considering such legislation. Implementation of PMPs in more states will result in a reduction in many types of pharmaceutical diversion. U.S. General Accounting Office reporting indicates a reduction in diversion case investigation time by as much as 90 percent in states with PMPs, including Kentucky, Nevada, and Utah, as well as a reduction in indiscriminate prescribing and doctor-shopping.

Increased implementation of drug pedigree systems like Radio Frequency Identification technology will decrease diversion of pharmaceuticals: RFID tags (transponders) attached to or placed within product packaging enable companies to continuously track, trace, and authenticate the chain of custody for pharmaceuticals--even individual prescription bottles--facilitating a safer and more secure legitimate pharmaceutical supply chain.⁹ Mandatory use of the RFID pedigree system for prescription drug shipments is under consideration by the U.S. Food and Drug Administration (FDA); in fact, FDA has recommended widespread use of RFID in the pharmaceutical supply chain by 2007. Several recent small-scale industry pilot programs involving OxyContin and Viagra have reportedly proven successful. Such use on commonly abused pharmaceuticals would deter theft from the legitimate drug supply chain, thereby further reducing the availability of diverted pharmaceuticals in the United States. The resultant reduction in pharmaceutical diversion could be significant, as the quantity of pharmaceuticals diverted through theft from legitimate sources, particularly pharmacies, is approximately 6.8 million dosage units (excluding liquids and powders) each year. Furthermore, RFID will aid law enforcement in pharmaceutical diversion investigations through tracing sources of supply, recovering stolen shipments, and identifying vulnerable areas in the supply chain.

Illegal Internet pharmacies are thwarting progress toward reducing pharmaceutical drug diversion: Pharmaceutical drugs appear to be increasingly diverted from legitimate and illegitimate sources of supply via the Internet; however, the amount obtained through such sources is not quantifiable. Pharmaceutical drugs obtained through Internet pharmacies often are provided without proof of prescription, consultation, or doctor's examination. There are no conclusive estimates regarding the number or location of operational Internet pharmacies because of the vastness of the Internet and the ease with which such sites can be established, closed down, and reopened under different domain names. The number of such pharmacies could range from hundreds to thousands, and many do not require prescriptions upon purchase.

Data from the DEA Automation of Reports and Consolidated Orders System (ARCOS) show that the number of commercial disbursements of individual doses of commonly abused pharmaceuticals¹⁰ dramatically increased by 108 percent between 2000 and 2004. ARCOS data for 2005 are available only through midyear; nonetheless, projected commercial disbursements of individual doses of commonly abused pharmaceuticals for 2005 indicate a continued high level of disbursements (see Figure 8).

Demand for diverted pharmaceuticals has fluctuated but remains relatively high: NSDUH data show that the estimated number of persons aged 12 or older reporting past year use of prescription-type pain relievers, tranquilizers, stimulants,¹¹ or sedatives¹² remained relatively stable from 2002 (14,680,000) to 2005 (15,172,000). Moreover, the rate of past year use among persons aged 12 or older reporting nonmedical use of prescription-type drugs in 2004 (6.2%) was second only to rates of use for marijuana (10.6%) and far surpassed rates of use for cocaine (2.4%) and heroin (0.2%).

Prescription narcotics abusers switching to heroin may lead to a decrease in demand for prescription narcotics: Pharmaceutical drug abuse is higher than rates of use for most illicit drugs (see Table 1 in Appendix B); however, many pharmaceutical drug abusers are substituting illegal drugs, particularly in areas where pharmaceutical drug diversion has been reduced. Although the extent of these substitutions is unclear--there are no reliable data available for analysis--law enforcement and public health reporting supports this assertion. According to field program specialist (FPS) reporting from California, Florida, Michigan, Ohio, and Wisconsin, some opiate abusers in these states who began abusing OxyContin have progressed to using heroin. Significant success in greatly reducing pharmaceutical drug diversion will quite likely result in further substitutions of illegal drugs by those individuals who are dependent on pharmaceuticals.

Intelligence Gaps

There is currently no means of quantifying the actual amount of pharmaceutical drugs diverted and available in the United States because illegal diversion occurs through several methods, including thefts from individuals, manufacturers, and dispensaries; prescription fraud; doctor-shopping, and illegal Internet sales. As a result, it is difficult to measure progress against reducing pharmaceutical diversion.

End Notes

8. Prescription Monitoring Programs (PMPs) are systems in which controlled substance prescription data are collected in a centralized database and administered by an authorized state agency to facilitate the early detection of trends in diversion and abuse.
9. The legitimate supply chain includes wholesale distributors, hospitals, clinics, manufacturers, narcotic treatment programs, pharmacies, practitioners, and other sources such as importers, exporters, and teaching institutions.
10. Commonly abused pharmaceuticals as defined by DEA include codeine, methylphenidate, oxycodones, hydromorphone, hydrocodone, meperidine, methadone, morphine, fentanyl, cocaine, d-methamphetamine, d-amphetamine, and dl-amphetamine.
11. Stimulants include both illicit and prescription methamphetamine.
12. Sedatives do not include over-the-counter drugs.

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