Focus on stopping diversion: Federal officials announce crackdown on illegal use of prescription painkillers
■ Physicians are concerned that new safeguards could limit appropriate use of pain medications.
Washington -- For the first time, the federal government is directing its fight against illegal drug use toward the abuse of legal drugs.
The Bush administration's top drug enforcement officials announced in early March a coordinated effort to confront the rapidly growing practice of diverting prescription drugs for illicit use. But it has left physicians and patient advocates concerned that the net cast upon illegal drug use could stifle appropriate treatment as well.
"The nonmedical use of prescription drugs has become an increasingly widespread and serious problem in this country, one that calls for immediate action," said Drug Czar John Walters. "The federal government is embarking on a comprehensive effort to ensure that potentially addictive medications are dispensed and used safely and effectively."
The National Drug Control Strategy will include greater scrutiny of labeling and marketing of opiate drug products, wider dissemination of educational materials for doctors regarding appropriate pain management, and a crackdown on Internet pharmacies that provide controlled substances illegally.
"This represents a somewhat new kind of threat," Walters said. "These drugs are legal, they have legitimate medical uses that need to be preserved, and they [sometimes leave] people to think they are safer and not subject to abuse. But they are."
Nonmedical use of prescription drugs now ranks second only to marijuana use as the most common abuse of drugs in the United States.
Emergency department visits resulting from narcotic pain reliever abuse have increased 163% since 1995, according to statistics from the Drug Abuse Warning Network, a nationwide system monitoring drug-related ED episodes.
A study from the University of Michigan in Ann Arbor found that one out of every 10 high school seniors had used the narcotic Vicodin last year, more than double the rate of cocaine, Ecstasy or methamphetamine use.
Karen Tandy, administrator of the Drug Enforcement Agency, said diversion could occur through theft of the drugs from pharmacies or physician offices, or by ordering medications from Internet "pill mills," which sell the drugs with limited or no physician oversight.
"We also find what is actually a very small number of unscrupulous doctors who are in business to deal drugs, not in the business of practicing medicine," she said.
Officials are also taking steps to reduce "doctor shopping," in which patients get prescriptions from multiple physicians. Twenty states have implemented prescription monitoring programs that track the dispensing of drugs and can identify potential doctor shopping.
In 2000, the five states with the lowest per capita number of prescriptions for OxyContin, a commonly abused prescription drug, all had monitoring programs, while the five states with the highest number of prescriptions per capita all lacked such safeguards.
The Bush administration has earmarked $10 million to start monitoring programs in 11 additional states by next year and to encourage states to share data to detect border-crossing abusers. In total, the administration has proposed $138 million to fight drug diversion.
Balancing prevention and pain control
The American Medical Association said more work is needed to prevent the illegal distribution of prescription drugs, particularly over the Internet. But the Association cautioned that controls must strike a balance between promoting pain relief and stopping drug misuse.
"Preventing prescription drug abuse is a vital goal. However, it is just as crucial that those in chronic pain have continued access to pain relief medications," said AMA Trustee Rebecca J. Patchin, MD. "It is critical that in the rush to address drug abuse, we do not unintentionally discourage patients and physicians from appropriately treating chronic pain."
The AMA launched a pain management education program in 2003 to provide primary care physicians with information about the assessment and management of pain. Some 95,000 physicians have ordered the self-study continuing medical education program, and an additional 3,000 have reviewed the program online.
The Bush administration will work with the AMA to get those CME materials out to more physicians, said Mark McClellan, MD, PhD, who at press time was Food and Drug Administration commissioner.
"When used correctly, opioids play a very important role in the management of pain," Dr. McClellan said. "The FDA's job is to maximize the potential benefits that patients receive from these drugs, while at the same time minimizing the risks associated with these products."
Patient advocates, however, have decried the use of prescription monitoring programs and other initiatives they say are limiting access to pain medications.
"With prosecutors and federal agents eager to score points in their war on drugs, Americans in severe pain raise every kind of alarm on law enforcement's radar screen," said Siobhan Reynolds, executive director of the Pain Relief Network in New York City. "Doctors already turn them away in droves. Prescription drug monitoring programs only ensure that patients in pain won't get care."
Reynolds cites a study from the University of Wisconsin Pain and Policy Studies Center, Madison, which found that doctors prescribe fewer opioids, even when opioid drugs are indicated, if they know the government is monitoring them.
Drug Czar Walters said the new safeguards would not impede the proper practice of medicine.
"We must ensure that pain medications are still available for legitimate medical needs," he said. "This should not be a tradeoff where more people suffer pain in order to stop addiction and in order to stop abuse."
House Government Reform Committee Chair Tom Davis (R, Va.) said he planned to introduce legislation to address the illegal sale of prescription drugs over the Internet.
The measure would require Web sites selling medications to include more identifying information and would allow state attorneys general greater leeway in shutting down Internet pharmacies located in other states. The bill would require patients to have an appropriate relationship with the prescribing physician to complete a purchase.