"We were stunned," says Jim McDonough, director of Florida's Office of Drug Control. Since the Sunshine State previously hadn't reported drug overdose deaths caused by prescription painkillers, "we were not cognizant of the extent of the problem." State officials moved to curb the use of these drugs by alerting law enforcement officers, directing resources to new task forces, and investigating the marketing practices of pharmaceutical drug companies--in particular, those of Purdue Pharma, the manufacturer of a painkiller, OxyContin, that was responsible for a number of overdose deaths in Florida and other states.
Since then, Florida has experienced a decline in the number of overdose deaths due to oxycodone and hydrocodone. And last November, an investigation by Florida's attorney general's office into Purdue Pharma's operations resulted in the company's agreeing to provide $2 million toward the development of software that would electronically track all prescriptions written and received in Florida; the software is contingent on Florida passing required legislation to create an "electronic registry" and will be provided to other states that want a similar system.
Florida isn't alone in its efforts to address the prescription-drug predicament. The escalating abuse of drugs such as OxyContin, Vicodin, Percoset and Ritalin presents law enforcement, rehabilitation and regulatory challenges across the country. Initially considered a problem in rural states, it is now a concern for urban and suburban localities as well.
DOCTOR SHOPPING
To be sure, the illicit use of prescription drugs is not a new issue; for years, many pharmaceuticals have been classified as "controlled substances" by the federal Drug Enforcement Administration because of their effects and their addictiveness. However, drug enforcement officials say the problem has multiplied in recent years for a number of reasons, including the increased number of drugs produced, the high potency of newer prescription drugs and more aggressive marketing by drug companies.According to the National Drug Abuse Council, more than 9 million Americans abuse prescription drugs. These drugs are diverted from legal use in a variety of ways, including prescription forgery, illegal sales by physicians and theft from pharmacies. In some cases, "patients" concurrently receive prescriptions from multiple doctors, a practice known as "doctor shopping."
Kentucky has been hit particularly hard by prescription-drug abuse. In Appalachian Mountain towns plagued by poverty and other social ills, recreational drugs--legal and illegal--are commonly used. There is "a cultural history of solving problems through medication," says Michael Townsend, director of Kentucky's Division of Substance Abuse.
In recent years, many local residents began misusing a particularly dangerous painkiller: OxyContin, introduced in 1995 primarily for patients with diseases such as cancer that cause high levels of pain. The pills have a time-release mechanism that medicates patients over the course of approximately 12 hours, but recreational drug users discovered that if the pills were crushed and snorted, the time- release component was disabled--allowing all of the pain medication to take effect at once. The resulting high--a sense of euphoria and a flushing of the skin, followed by extreme drowsiness--is similar to that of heroin. Heroin, morphine and drugs whose active ingredients are oxycodone and hydrocodone, such as OxyContin and Vicodin, are opiates, drugs that simulate the effects of opium and are highly addictive.
Although OxyContin is perhaps the most publicized illicitly used prescription drug because of the number of overdose deaths attributed to it and its overwhelming financial success--$1 billion in sales in 2000--many other prescription drugs are used recreationally. Depressants are used in conjunction with stimulants such as cocaine to bring users "down" after the stimulant's high. In 2001, there were 1,378 overdose deaths in Florida caused by prescription depressants. Animal tranquilizers are used to enhance the effects of Ecstasy, and Ritalin is taken illegally as an upper.
A well-connected network of drug users trades information on how best to acquire and use new prescription drugs. "The grapevine picks up on new drugs faster than the experts," says McDonough. This often results in officials being caught unaware as to which drugs to monitor and target for law enforcement efforts.
Many states are reforming prosecution efforts to combat abuse. In order to accommodate the surge in suspects, Kentucky doubled the number of its drug courts. Eastern Kentucky currently has 32 drug courts for adults, juveniles and families, with 40 more in the planning stages. In 2002, Florida became the first state to prosecute doctors for homicide when unlawful prescriptions led to overdose deaths.
PRESCRIPTION MONITORING
The rehabilitation of addicts poses a problem for many states. OxyContin addicts, in particular, took many rural rehabilitation facilities by surprise. Those addicted to OxyContin have withdrawal symptoms resembling those of heroin addicts; in many cases, when OxyContin pills become too difficult or too costly to procure, addicts switch to heroin for its similar high. As a result, small towns with little experience with heroin addiction suddenly found themselves with a number of heroin addicts in need of treatment. In eastern Kentucky, there are five new private rehabilitation clinics providing methadone treatment; currently, Townsend estimates, there are more than 1,000 clients in treatment.To get at the root of the problem, 18 states have developed electronic registries that track all prescriptions written by physicians. Some of these databases have existed for years for public health purposes while others were created more recently for law enforcement reasons. According to a report by the U.S. General Accounting Office, Kentucky's database--installed in 1999--has proven highly effective in investigations of alleged "doctor shoppers" and corrupt physicians. Prior to the database, the report found, investigations of "doctor shoppers" lasted an average of 164 days; after the institution of the database, investigations required an average of 16 days.
While electronic registries are a popular solution with state governments, privacy advocates have fought the development of drug databases. They argue that the databases violate doctor-patient confidentiality and threaten quality patient care by intimidating doctors and scaring them away from prescribing certain drugs.
Several states are also scrutinizing the practices of pharmaceutical companies, alleging that aggressive and misleading marketing tactics contribute greatly to the problem. In recent years, federal laws relaxed the regulations surrounding drug marketing and advertising, allowing companies to market more of their drugs directly to consumers. This can result in patients requesting drugs without fully understanding their effects.
Morever, doctors often can incorrectly prescribe certain drugs if they are misled or poorly educated about a drug's effects or its purpose. Many states have examined the role that pharmaceutical companies' practices play in the illicit distribution and use of prescription drugs.
QUESTIONABLE MARKETING
Florida began investigating Purdue Pharma's marketing practices in the spring of 2001, concerned that the company's tactics were misleading and resulted in over-prescribing the drug. Purdue Pharma had launched a large marketing campaign, sending out hats, pens, and CDs to doctors to get the word out about the new drug. "While you might have found some of these tactics used by other companies, you found it over and over in the marketing of OxyContin," says Jody Collins, a Florida senior assistant attorney general. The marketing of OxyContin went "above and beyond the marketing of other drugs." In particular, Florida officials were concerned that the marketing of the drug recommended its use for patients with lower levels of pain--such as pain caused by arthritis--despite the drug's potency. In investigating Purdue Pharma, Collins says several questions were considered, including whether Purdue Pharma failed to disclose the level of dependency that could result from using OxyContin and whether the drug's side effects were properly described.Florida's investigation and a potential lawsuit contributed to the deal struck for Purdue Pharma to develop electronic registry software. The database will be similar to Kentucky's, but will provide online, real-time access.
Purdue Pharma disagrees that its marketing practices have encouraged the illicit use of OxyContin. J. David Haddox, senior medical director for health policy, says a number of factors contribute to improper usage and prescription of the drug, including physicians who are inadequately educated about pain management and the perception by users that the drug is "safe" because it has been approved by the Food and Drug Administration.
To improve education about OxyContin, Purdue Pharma conducts seminars and teleconferences for physicians and started a pilot program in several states that provides a prescription drug curriculum in high schools. The company also provides tamper-proof prescription pads to some 3,000 physicians to prevent prescription forgeries. "OxyContin is a new drug but the problem is old," says Haddox, who argues that the practice of recreational drug use needs to be examined, rather than the drugs themselves.
Kentucky's Townsend agrees that the abuse of prescription drugs is part of a larger problem and, while it may require innovative regulatory and enforcement approaches, the popularity and abuse of these drugs reflects the same policy failings as the use of "street drugs" such as heroin and cocaine. It's "still an era in Kentucky where we do not really recognize this as a medical problem. ... We still see this as a moral problem and that's reflected in our policies."
