Increased Scrutiny of Opioids Could Alter Prescribing Practice
By Emily P. Walker, Washington Correspondent, MedPage Today
Published: May 28, 2009
GAITHERSBURG, Md., May 28 -- If a formal risk reduction plan for opioid painkillers increases the regulatory burden on physicians, they may simply stop prescribing such drugs, to the detriment of patients in severe pain, the FDA was told Thursday.
The FDA's Center for Drug Evaluation and Research wrapped up a two-day public hearing here to get input from physicians, pain patients, pharmacists, hospice workers, addiction groups, and others to decide what factors it should consider in drafting a Risk Evaluation and Mitigation Strategy (REMS) aimed at reducing adverse events caused by opioids.
The REMS would be the largest to date and govern all extended-release opioid drugs, with the possibility of including regular-release opioids.
As use of opioid drugs for pain management has grown, so has abuse of the drugs.
Data from the National Survey on Drug Use and Health in 2007 suggested that 33 million people over the age of 12 used an opioid for a nonmedical purpose at some point. Most obtained the drug for free from a friend or relative.
Physicians who prescribe opioids must register with the Drug Enforcement Agency (DEA), but several witnesses testified that the drugs might be less likely to be misused if more regulations were imposed on physicians who prescribe opioids.
One suggestion heard repeatedly from witnesses on Thursday was to require physicians to have patients sign a contract when they are given a prescription for opioids. In the contract, the patient would pledge to use the drugs only as intended and not to distribute them to anyone else. Some physicians already do this, but it's not a requirement.
Others would like physicians to undergo intensive training on prescribing opioids for pain management.
Ardis Hoven, M.D., an internal medicine and infectious disease specialist in Lexington, Ky., and an American Medical Association board member, told the panel that the FDA should first launch an intensive communication effort before mandating such requirements for physicians.
Tougher regulations might lead to physicians to shy away from prescribing the entire class of Schedule II drugs and prescribe the less-potent -- and less-regulated -- Schedule III agents instead, Dr. Hoven said.
Schedule II agents include morphine, oxycodone, pure hydrocodone, and methadone. A handful of hydrocodone and morphine combination products are listed in Schedule III, but the analgesic options in this class are relatively scarce.
If a REMS does end up imposing requirements on physicians, positive incentives should be put in place to fund and support training in pain management, such as waiving the fee clinicians now must pay to the DEA for the privilege of prescribing Schedule II drugs, according to Dr. Hoven.
According to the DEA, a clinician who prescribes controlled substances has an obligation to take "reasonable measures" to prevent the drug from being diverted to those who use it for a nonmedical purpose, an attorney who represents physicians told the panel.
But clinicians do not currently have the tools to enforce proper distribution and use of narcotics, and need more support and training, said Jennifer Bolen, founder of the Legal Side of Pain and the Pain Law Institute.
"It's dangerous and irresponsible to use physicians to teach the law," Bolen said.
She said state medical licensing boards, health insurance plans, and law enforcement officials must play a big role in enforcing the REMS.
FDA officials acknowledged the interplay of the FDA and the DEA on the issue of opioids. While the FDA normally focuses on the safety of drugs for medical purposes, it can't ignore the fact that millions of people use the drugs to get high.
But the FDA is not a criminal enforcement agency, said John Jenkins, M.D., director of the Office of New Drugs at the FDA.
"Our authority deals with medical use of these products," he said.
Still, the two-day hearing was peppered with emotional testimonies from people whose family members overdosed on opioid drugs that they obtained illegally.
One suggestion from a number of speakers is that the FDA require opioid manufacturers to put serial numbers or microchips in opioid tablets, linked to the prescription that released them to a patient. That way, if law enforcement officials seize pills, the prescriber and patient can be easily traced.
The FDA is already considering serial numbers on some classes of medication for a different reason -- to confirm the integrity of the supply chain.
Other speakers suggested creating opioid medications that are "less abusable" such as crush-proof pills.
However, formulations intended to thwart abuse have been tried before. That was the original intent behind Oxycontin, the brand of extended-release oxycodone that ended up widely abused.
While it's up to the FDA to decide what a REMS will look like, it's the responsibility of drug companies to enforce the new regulations.
According to Dr. Jenkins, it could be a lengthy process, and the FDA might convene an advisory committee before any REMS is finalized.
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