In an unusual move, a state government is developing regulations meant to stop doctors from prescribing higher doses of powerful — and often dangerous — pain killers for patients who are not benefiting from them.
The effort, in Washington State, represents the most sweeping attempt yet to stem what some experts see as the excessive use of prescribed narcotics, and it is being closely watched by medical professionals elsewhere. Among other things, Washington would apparently become the first state that would require a doctor to refer patients on escalating doses of pain killers for evaluation if they were not improving.
Experts in pain treatment and drug abuse prevention say the growing use of long-acting pain killers like OxyContin, fentanyl and methadone has been a crucial factor in a nationwide epidemic of overdose deaths, largely from the abuse of such drugs.
Nationwide, fatalities from prescription drug overdoses are the second-leading cause of accidental death behind car accidents and, in some states, are the leading cause, according to the Centers for Disease Control and Prevention.
Last year, narcotic pain killers accounted for 7 percent of all prescribed drugs, and the number of patients annually taking long-acting versions of these medications has increased about 30 percent over the last decade.
But a long-running debate has thwarted efforts to address the problem both at the federal and state level.
Drug makers and patient groups have complained that new restrictions would unfairly punish pain sufferers who rely on the drugs, while others, including some doctors and regulators, have argued that the drugs are potentially so dangerous that they need to be even more tightly controlled.
However, the Washington State initiative appears to reflect a growing view that the status-quo is no longer acceptable. Last Friday, an advisory panel to the Food and Drug Administration overwhelmingly rejected an agency proposal to better control drugs like OxyContin as too weak because it did not mandate special training for doctors who prescribe such medications.
The effort in Washington is also directed at controlling how doctors use narcotics to treat legitimate pain patients, not at people who illegally obtain the drugs for recreational use. While many patients benefit from pain killers, there is growing evidence from studies, including one in Washington State, that others suffer significant side effects, including lethargy, increased sensitivity to pain and, in the most severe instances, potentially fatal overdoses.
“This is not just about addicts but little old ladies with arthritis starting to die because of this kind of medical practice,” said Dr. Alex Cahana, a pain specialist involved in devising the regulations in Washington State.
Lawmakers in Washington State adopted voluntary narcotics use guidelines three years ago, but a statewide survey last year indicated that many doctors were not following them and about half were not even aware of them.
At the direction of the Washington State Legislature, a panel of doctors, nurses, regulators and others are compiling a set of medical practices that physicians and other prescribers would be legally expected to follow when treating patients with long-term pain from causes other than cancer.
The regulations would not affect how narcotics are used to treat patients with cancer or those at the end of life because experts agree that such patients should receive as much pain medication as necessary.
The panel is expected to require that, among other things, doctors refer patients to a pain specialist for review when their daily medication increases to a specified dosage level and they do not show improvement. The specialist can then determine whether to continue the drug, reduce it or use other treatments like physical therapy.
Recently, the Centers for Disease Control issued a similar recommendation to doctors.
Pain specialists and regulators in Washington State said they believed that the requirements were essential because doctors were giving high daily dosages of powerful drugs for ailments like back pain for far too long without evidence that the medications worked.
The law that created the new regulatory effort in Washington State did not propose specific sanctions or penalties. However, officials there said that a doctor who chose to ignore the new rules could face sanctions from state licensing boards, including potentially losing the right to practice. The company that makes OxyContin, Purdue Pharma, lobbied against the law, saying the new regulations could deprive patients of appropriate treatment.
The initiative sprang out of the efforts of Dr. Cahana and two other people, including a Washington State representative, James C. Moeller, who is also a substance abuse counselor.
Mr. Moeller, who works at a facility in Vancouver, Wash., run by Kaiser Permanente, said he had treated a steady procession of patients in recent years, nearly all of them young and physically dependent or psychologically addicted to high dosages of pain killers.
In the process, Mr. Moeller said, he realized that many doctors who prescribed such drugs had little training in either pain management or substance abuse. So, wearing his legislator’s hat, he drafted a bill to require doctors to take a training course to prescribe narcotics.
He said he quickly encountered opposition to the idea from a professional group that represented doctors. At that point, Dr. Cahana and the third man, Dr. Gary M. Franklin, the medical director of the state’s Department of Labor and Industries, stepped in.
The two doctors, through different routes, had arrived at the same conclusion — that too many pain patients were getting drugs at dosages that were too high for too long.
“There is a dissonance in not recognizing the nexus between poor pain management and the hyperconsumption of opioids,” said Dr. Cahana, who works at the University of Washington Medical Center in Seattle, using a medical term for narcotic pain killers like OxyContin.
For his part, Dr. Franklin, whose department oversees the state’s workers’ compensation program, said he had long seen the problem play out among claimants. “Injured workers were coming into the system with low back pain and dying two or three years later” from drug overdoses, he said.
This year, Dr. Cahana and Dr. Franklin testified during a legislative hearing on the proposed training requirement, suggesting that legislation should instead require a set of medical practices based on the best available evidence. Dr. Franklin said that a draft of rules would probably be finished by this fall and that the new regulations would be in place by next year.
A major hurdle to making the program work is the lack of pain management specialists, particularly in rural areas of the state, where patients on the narcotics could be referred for evaluation. Dr. Franklin said the state hoped to increase the use of telephone consultations as well as help to finance the training of doctors in pain treatment.
By BARRY MEIER
Published: July 28, 2010
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Move to Restrict Pain Killers Puts Onus on Doctors