DEA Revises Rule on Prescribing Painkillers
Thursday, September 7, 2006
The Drug Enforcement Administration yesterday overturned a two-year-old policy that many pain specialists said was limiting their ability to properly treat chronically ill patients in need of powerful, morphine-based painkillers.
While defending its efforts to aggressively investigate doctors who officials conclude are writing painkiller prescriptions for no "legitimate medical purpose," the agency agreed with the protesting experts that it had gone too far in limiting how doctors prescribe the widely used medications.
The unusual turnaround was welcomed by relieved doctors, who said it will help restore "balance" in government policy between the needs of pain patients and the effort to control prescription drug abuse and diversion.
Specifically, the DEA proposed a formal rule that would allow doctors with patients who need a constant supply of morphine-based painkillers to write multiple prescriptions in a single office visit. Under the new rule, a doctor can write three 30-day prescriptions at a time -- two of them future-dated -- to be filled a month apart.
Two years ago, the agency clamped down on the common practice of writing such multi-month prescriptions, which it said were probably illegal and were contributing to the growing abuse of prescription painkillers.
As a result of the DEA's position, many doctors began requiring patients to come in each month for a new prescription -- office visits many doctors considered medically unnecessary but essential to keep them out of trouble with the DEA.
Yesterday, DEA Administrator Karen Tandy said the agency had been wrong in limiting the multiple prescriptions and had made the tough decision to reverse course. She said the DEA received more than 600 comments from doctors, patients and others about its policies on narcotic painkillers, many of them strongly opposed to the agency's position on limiting refills.
"Think about how hard it is for anybody to go out publicly and say, 'We think this is probably prohibited by law,' " she said, referring to the earlier decision to prohibit multiple refills. "And then you listen to people and then you say, 'You know what? You're right,' and we're going to propose a rule that interprets this correctly. And that's what we've done."
When the DEA issued its restrictive 2004 drug refill guidelines, many pain specialists saw it as a sign that relations between their profession and the agency had deteriorated badly. They also complained that DEA arrests and prosecutions of doctors treating pain were creating a "chill" on medical practice and denying patients drugs they needed.
Agency officials had earlier worked for two years with pain and hospice experts on a "frequently asked questions" guideline to advise doctors on how to prescribe controlled drugs in a way that would not get them into trouble with law enforcement. The agency briefly posted the guidelines on its Web site in 2004 but then pulled them down and disavowed them.
One of the doctors involved with writing the guidelines -- who became a critic of the DEA when they were abruptly discarded -- called Tandy's actions yesterday "a very positive step forward in restoring that necessary cooperation between practicing physicians and the DEA."
Howard Heit, a Fairfax County pain and addiction specialist, also said the new policy will help patients get better care by allowing doctors more flexibility in prescribing controlled drugs.
But Siobhan Reynolds, who created the Pain Relief Network several years ago to help defend pain doctors who she said were being unfairly arrested and prosecuted, disagreed and said the new DEA policy has changed little.
"Ms. Tandy states here, as she has on many occasions, that doctors need not fear criminal prosecution as long as they practice medicine in conformity with what these drug cops think is 'appropriate,' " Reynolds said. "If that isn't a threat, it will certainly pass for one within the thoroughly intimidated medical community."
The use of prescription narcotics rose sharply over the past decade as knowledge grew on how to control intractable pain and specialists found what they considered better ways to help patients. That growing use, however, has led to abuse as well, and to scores of deaths and injuries associated with prescription narcotics.
In addition to publishing its new policy statement and rulemaking yesterday, the DEA began posting extensive information on its Web site about doctors who have been arrested and prosecuted for their prescribing practices. Tandy said that she hopes doctors will review the cases so they will see that only "egregious" offenders are being prosecuted.