(U) Combating Diversion - National Prescription Drug Threat Assessment 2009 (UNCLASSIFIED)

PDMPs limit traditional diversion methods by enabling practitioners and pharmacists to monitor patients' prescription drug use and intervene when diversion and/or abuse are suspected. As of January 1, 2009, 3230 states had implemented operational PDMPs31 in an effort to stem the diversion of CPDs; another 6 states and one U.S. territory had enacted legislation requiring PDMPs. (See Figure 10.) In 2007 nearly 9,600 prescribers, dispensers, and law enforcement officials received formal training on the use of PDMPs, according to BJA. Also in 2007, administrators of operational PDMPs responded to nearly one million report requests made by prescribers, dispensers, or individuals authorized to conduct investigations; these respondents subsequently generated more than 56,000 reports providing prescribers or dispensers with information on patients who may have been abusing prescription drugs and/or doctor-shopping during that year. Additionally, a 2002 GAO report32 determined that state PDMPs improved the timeliness of law enforcement and regulatory investigations by at least 80 percent and that the programs had deterred doctor-shopping in the three states involved in the study. Moreover, a 2006 Simeone Associates, Inc. evaluation of PDMPs nationwide indicated that the presence of a PDMP reduced the per capita supply of prescription pain relievers and stimulants, decreasing the probability of abuse for these drugs. According to the Simeone study, states that are proactive in their approach to regulation may be more effective in reducing the per capita supply of prescription pain relievers and stimulants than states that take a reactive approach.

Figure 10. Status of Prescription Drug Monitoring Programs as of January 1, 2009

PDMPs often affect diversion levels in neighboring states. When states implement PDMPs, diversion activity often increases in neighboring states without PDMPs or with PDMPs that do not share data gathered, according to law enforcement reporting and GAO officials. For example, law enforcement agencies in Florida reported in 2008 that CPD distributors and abusers from Alabama, Georgia, Massachusetts, and North Carolina often travel to Florida to obtain CPDs from pain clinic doctors, in part because Florida does not have an operational PDMP. Additionally, law enforcement agencies in Kentucky, a state that has an operational PDMP, report that distributors transport CPDs, particularly OxyContin®, from Michigan and, to a lesser extent, Dayton and Cincinnati, Ohio; Miami and Tampa, Florida; and Philadelphia, Pennsylvania, to Kentucky for local distribution.33 Law enforcement agencies in New England report that trafficking organizations hire individuals as "runners" and provide them with airline tickets and cash to travel to Florida to obtain CPDs, primarily oxycodone products; the organizations then sell the drugs in New England. Law enforcement agencies in the District of Columbia area report that individuals in Virginia and West Virginia travel to neighboring states to obtain and fill prescriptions in order to avoid having the transactions recorded in the PDMP databases in Virginia and West Virginia. Interstate information-sharing requirements vary among PDMPs, creating potential diversion opportunities for abusers and distributors. To facilitate information sharing between states, BJA has provided technical assistance and funding for a project through which public and private technology solutions providers, the IJIS Institute, and PDMP representatives are working to establish a nationwide information-sharing platform that will facilitate the interstate exchange of PDMP data. Currently (early 2009) the technical aspect of the project is in final development, and initial testing between states is being planned. Additionally, through the Harold Rogers Prescription Drug Monitoring Program (HRPDMP), BJA competitively awards state PDMP planning, implementation, and enhancement grants and makes available to the states, via Brandeis University and the Alliance of States with Prescription Drug Monitoring Programs, technical assistance on fulfilling project goals and objectives. Implementing new PDMPs and facilitating the interstate exchange of PDMP data are priorities for HRPDMP funding.

Investigative cooperation between DEA, ISPs, package delivery services, and financial services companies has made it increasingly difficult for rogue Internet pharmacy operators to conduct business. Rogue Internet pharmacy operators rely on traditional commercial businesses such as ISPs, package delivery services, and financial services businesses to ensure that their Internet transactions are completed in a timely and discreet manner and that their orders are expeditiously shipped. In an effort to prevent the use of their services in illicit enterprises, many of these businesses report suspected diversion activity to DEA and cooperate in subsequent investigations. Moreover, many financial institutions, including major credit card companies and third-party payment providers, prevent rogue Internet pharmacies from accepting their payment systems for purchases involving the illegal sale of CPDs; some financial institutions have explored the use of third-party web-crawling services34 to identify sites involving potentially illegal CPD activities. When they identify such a site, the financial institutions remove access to their payment systems from the site. In FY2007, with the cooperation of commercial businesses, DEA initiated 132 Internet investigations, a 17 percent increase from FY2006, when 113 Internet investigations were initiated. As a result of these investigations, DEA seized approximately $39 million in cash, bank accounts, property, and computers in FY2007, a 319 percent increase over FY2006. In the first quarter of FY2008, DEA initiated 27 Internet investigations and seized $9.2 million.

Production Quotas

Aggregate production quotas represent those quantities of controlled substances in Schedules I and II that manufacturers may produce in the United States each year to provide for the estimated medical, scientific, research, and industrial needs of the United States; lawful export requirements; and the establishment and maintenance of reserve stocks. Bulk manufacturers base requests for a production quota on the estimated quantity needed to supply DEA registrants. The quantity requested is based on past sales of the finished product, the quantity exported, the number of businesses requesting the product, and the inventory remaining from the previous year. Bulk manufacturers are permitted to keep an average of 50 percent of their production quota in stock, and dosage manufacturers are permitted to keep 50 percent of their current year's allocation in stock annually.

DEA is combating CPD diversion, particularly Internet diversion, by holding distributors accountable for monitoring the supply of CPDs that they sell to businesses and requesting fines against those that do not diligently do so. In 2005 DEA established a "Distributor Initiative" to reemphasize to CPD distributors their responsibility under the CSA to notify DEA of any requests by customers to purchase suspiciously large quantities of CPDs. When distributors35 detect and report suspicious orders,36 DEA opens an investigation into the business suspected of diverting CPDs. Distributors that fail to report suspicious orders and sell unusually large quantities of CPDs to businesses can face administrative action by DEA. Since beginning the initiative in 2005, DEA has suspended the registrations of several wholesale distributors, four of which are owned by two Fortune 500 companies. Moreover, since the inception of the initiative, aggregate production quotas for several commonly abused prescription drugs have remained stable and have not increased as dramatically as in the past (see Figure 11), particularly from 2007 through 2008, indicating that distributors are adhering to the CSA by monitoring supplies of CPDs distributed to businesses.

Figure 11. Aggregate Production Quotas for Selected Schedule II Controlled Prescription Drugs, in Kilograms, 2004-2008

Footnotes

30. The Washington State Department of Health suspended the state's Prescription Monitoring Program in December 2008 because of state budget shortfalls.
31. Prescription drug monitoring programs (PDMPs) are systems in which CPD data are collected in a database, centralized by each state, and administered by an authorized state agency to facilitate the early detection of trends in diversion and abuse. Data collected include the physician visited, the number of times the physician is visited, the drugs for which each individual receives a prescription, the quantity of drugs prescribed, and the pharmacy or pharmacies that fill the prescriptions. Each state controls the language of its PDMP with regard to how the prescription information gathered as part of the program will be shared, not only within the state but also with other states. For instance, one PDMP may share information among law enforcement, treatment providers, physicians, and pharmacists within the state but not with any agency in other states. Another may opt to share its prescription data only with physicians and pharmacists nationwide, while a third may choose to share all its data with all other state agencies.
32. The cited report is the latest U.S. Government Accountability Office (GAO) study pertaining to PDMPs. It was released in 2004.
33. State PDMPs, such as the ones mentioned in this paragraph, vary in the way that they share data. Most that do share data require formal requests for the information. Individuals may obtain drugs in multiple states before they are suspected of doctor-shopping, and any formal requests are submitted through the PDMP(s). Compounding the situation, the time period for processing the data requests varies.
34. A web crawler is a program or automated script that methodically browses the Internet for up-to-date data. Web crawlers are mainly used to create a copy of each visited page for later processing by a search engine that will index the downloaded pages to provide fast searches. Crawlers can be used to gather specific types of information from web pages.
35. Distributors are frequently able to detect potential diversion activity in the supply chain because they can determine normal quantities of supply required by businesses of particular sizes, including their usual customers, and can readily identify potentially fraudulent orders.
36. 21 CFR §1301.74(b) defines suspicious orders as those deviating from the norm in size, frequency, or pattern.