New Prescription Drug Safety Plan

By Michelle Meadows

The Bush administration has announced a comprehensive plan to improve prescription drug safety, citing a significant increase in the nonmedical use of prescription drugs in recent years.

"The nonmedical use of prescription drugs has become an increasingly widespread and serious problem in this country," said John P. Walters, director of the White House Office of National Drug Control Policy (ONDCP), during the plan's unveiling on March 1, 2004.

About 6 million Americans abused prescription drugs during 2002, according to the most recent National Survey of Drug Use and Health conducted by the Substance Abuse and Mental Health Services Administration. Nearly 14 percent of young people between ages 12 and 17 have abused prescription drugs at least once, the survey found.

Narcotic pain relievers, tranquilizers, stimulants, and sedatives trailed only marijuana in the list of drugs abused by Americans in 2002. While self-reported abuse of illicit drugs, including cocaine and heroin, has fallen over the past years, prescription drug abuse has increased and is now more prevalent than abuse of all other drugs except for marijuana.

Walters was joined by Surgeon General Richard H. Carmona, M.D., M.P.H., former FDA Commissioner Mark B. McClellan, M.D., Ph.D., Karen Tandy, administrator of the Drug Enforcement Agency (DEA), and U.S. Rep. Tom Davis, R-Va.

"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," said McClellan. The Bush administration's strategy strives to balance the need for effective pain treatment with the prevention of prescription drug abuse.

Part of the FDA's role involves appropriate product labeling of a class of prescription pain relievers called opioids. Examples are morphine, codeine, and oxycodone. The FDA will ensure that labeling clearly relays conditions for safe and effective use and will consider the use of risk management programs during the drug approval process. These safety programs include elements to ensure the identification of appropriate patients, the safe and informed use of the product by both practitioners and patients, and monitoring for potential abuse problems.

The FDA emphasizes the importance of education for physicians, pharmacists, and the public about appropriate use of opioids, and the risks of misuse or nonmedical use. These risks include fatal overdose, particularly for people who experiment with these strong pain relievers. The FDA is collaborating with the DEA, the ONDCP, state medical boards, and professional medical organizations to encourage more physician education and training in pain management and treatment.

In collaboration with the FDA, the DEA will step up investigative efforts and enforcement actions against the illegal sale and use of prescription drugs. Tandy noted that her agency is not targeting legitimate doctors who prescribe drugs for pain relief. "Doctors acting within the norms have nothing to fear from DEA," Tandy said.

The illegal sale and purchase of prescription drugs over the Internet continues to pose challenges. There are hundreds of thousands of Web sites selling prescription drugs, and they tend to disappear as quickly as they pop up, Tandy said. The DEA will use technology to track and prosecute illegal Internet pharmacies.

Davis, who is chairman of the House Government Reform Committee, discussed a bill called the Internet Pharmacy Consumer Protection Act, which would prohibit Web sites from giving out prescriptions without the appropriate involvement of a physician. The bill would also require Web sites to display information on the businesses, physicians, and pharmacists associated with the Web site.

During the event, Mark Surks of Kendall Park, N.J., spoke about the role of the Internet in the death of his son Jason, 19, who overdosed on the anti-anxiety medication Xanax in December 2003. "My son's connection was not some creep on a street corner," Surks said. "All he had to do was point his Internet browser at any number of Web sites." Surks said he discovered that his son was on an automatic renewal plan. He received drugs every month from Mexican pharmacies, and payment was automatically removed from his bank account. "I think he looked at these drugs as safe," Surks said.

Surks said he often talked with his son about risks--walking around dangerous neighborhoods at night, sexual disease and pregnancy, and drug use. "With all of that, something still went very wrong."

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