Washington State will put in place later this year one of the most comprehensive efforts yet in the nation to prevent excessive prescribing of narcotic painkillers.
It will require doctors to consult a pain specialist if a patient's opioid dose increases above a certain level without improvement and to use a prescription monitoring program to thwart doctor-shopping.
Prescribers will have to maintain screening and treatment records and, for the first time in any state, enter a patient's progress in a statewide database.
"The only way to change the practice of medicine is to mandate a culture of measuring care, of knowing whether what you do is harmful or helpful," said Dr. Alex Cahana, a pain specialist who helped drive the initiative.
Washington State's tougher measures will not apply to cancer pain, end-of-life care or acute pain after an injury or surgery. Instead, they reflect the growing array of state, federal and medical industry actions to grapple with an epidemic of addictions, overdoses and deaths arising from more liberal use of prescription narcotics for chronic ailments other than cancer, such as back pain.
It won't be easy.
The scope of the problem is enormous, and medical practice is slow to change.
Americans comprise 4.6 percent of the world's population, yet consume 80 percent of the supply of narcotic painkillers. The initiatives also have triggered criticism over their potential chilling effect on pain care to suffering patients, micromanaging of doctors and cost to taxpayers.
"Everyone is trying to proceed rationally in an irrational situation. It's a little like trying to stop water from flowing to the oceans," said Dr. Paul Updike, director of chemical dependency at Sisters Hospital in Buffalo.
To work well, the response must thread a needle by reducing abuses while ensuring adequate access to painkillers for patients who need them. And the need is great.
An estimated 76.5 million Americans age 20 and older reported a problem with pain that persisted for more than 24 hours in a National Center for Health Statistics survey. Studies indicate that prolonged pain can cause depression, anxiety and substance abuse, as well as anguish at home and work.
Narcotic painkillers offer relief, and patients like Joanne Kushka, a Buffalo resident who suffers from fibromyalgia, don't want to see the medical community return to the era not so long ago when physicians were reluctant to use the drugs.
"Seven years ago, I went to a doctor who wouldn't take my pain seriously, so I know what it's like to deal with an unwillingness to prescribe," she said. "Now I take a painkiller as needed, and when I need it, I really need it."
On the federal level, attention has focused on law enforcement, such as the arrest in January of a Niagara Falls doctor accused of operating his medical office as if he were a drug dealer. But the response goes beyond criminal investigations.
Western New Yorkers turned over 652 pounds of controlled substances as part of the Drug Enforcement Administration "Prescription Drug Take-Back" program between October 2008 and November 2010. The program represents a key component of a national drug strategy released in 2010 by the White House Office of National Drug Control Policy.
The strategy also calls for expanding state prescription drug monitoring programs, informing the public of the risks of prescription drug abuse and educating doctors on appropriate opioid prescribing.
R. Gil Kerlikowske, director of the White House office, calls prescription abuse the "nation's fastest-growing drug problem" and sees raising awareness as a key part of the solution.
"Once you have more attention to it, people recognize the potential problem," said Kerlikowske, the former Buffalo police commissioner.
> FDA eyes policy change
Meanwhile, the Food and Drug Administration is immersed in a potentially major policy change for opioids that follows from legislation giving the agency authority to require that drugmakers do more to reduce safety risks.
Last year, advisory panels rejected an FDA proposal, saying it didn't go far enough.
The plan would have required drug companies to develop educational programs for doctors to use on a voluntary basis on patient selection, dosing and monitoring for long-acting painkillers, such as OxyContin. It also would have required manufacturers to provide FDA-approved education sheets that doctors could use to help guide patients on the safe use, storage and disposal of opioids.
Panelists wanted the training mandatory for doctors, perhaps as a requirement to obtain a DEA registration to prescribe narcotic painkillers. They also called for inclusion of the more-frequently prescribed immediate-release opioids, such as hydrocodone, one of the most abused prescription drugs in the U.S.
The FDA is expected to release a final plan this year. But agency officials, as well as others, voice skepticism over the government's ability to manage a mandatory training program of the enormity that would be needed. There are 750,000 medical professionals registered with the DEA to prescribe narcotic painkillers, and the immediate-release versions account for 91 percent of the 257 million opioid prescriptions dispensed by retail pharmacies.
"You can't fault the FDA for trying to make a dent. But there were 400,000 to 500,000 unique users of OxyContin alone last year. Good luck trying to mandate an education program," said Steven Passik, a pain care expert and clinical psychologist at Memorial Sloan-Kettering Cancer Center in Manhattan.
> Monitoring scripts
In states, one of the major efforts to prevent doctor-shopping focuses on prescription monitoring.
The electronic databases operational in 43 states track patients taking controlled substances to identify those who might be selling or abusing the drugs.
Some of the programs are reactive, generating reports to doctors in response to inquiries about a patient. Others are proactive, identifying patients who visit multiple doctors or prescribers who write an unusual number of prescriptions.
Despite hopeful signs, the programs have yet to significantly affect abuse, said Aaron M. Gilson, a senior researcher at the University of Wisconsin's Pain & Policy Studies Group.
The programs are only as good as the timeliness of the information and number of practitioners who use them, and only about 20 percent of physicians nationwide know about the databases, he said.
"It's not clear the extent that prescription monitoring programs work or if they have a negative effect on prescribing," he said. "And for clinicians who use them, it's not clear in many instances what they should do with the information."
New York operates one of the oldest programs, but physicians say it is cumbersome and the alerts of suspicious activity often arrive too late.
"It could be improved. Usually, you get reports weeks after a prescription was written," said Dr. David Bagnall, a pain specialist who directs the Spine Center of Niagara and the fellowship at RehabNY.
Health Department spokesman Jeffrey Hammond responded that feedback about the system has been mostly positive.
> Linking state databases
Proposed legislation in New York would require doctors and pharmacists to access the data before prescribing a controlled substance. It also would require doctors, not just pharmacists, to report prescriptions for the drugs to the state database.
Ultimately, the goal is to link the state systems and make the information more timely.
Congress in 2005 passed the National All Schedules Prescription Reporting law to expand and coordinate the monitoring programs, but money was not appropriated to fund it until the Obama administration set aside $2 million in 2009.
That's considered a fraction of what will be needed, and funding is likely to remain an obstacle. In Florida, for instance, Gov. Rick Scott recently called for canceling plans for a drug-monitoring program because of the state's budget deficit. Florida is considered a haven for pill mills.
More than anything, experts say, deterring abuse will depend on better education of physicians and patients, as well as better professional guidance on prescribing painkillers and treating addiction.
A survey by the National Center on Addiction and Substance Abuse at Columbia University reflects the gaps in knowledge. It showed that only 40 percent of doctors were trained to identify prescription drug abuse and addiction, and less than half received instruction in pain management.
To make matters worse, a lack of research has created professional disagreement over such basic issues as the effectiveness of opioid therapy for chronic pain and the risk of addiction. For example, a 2009 study of 1,843 Washington State workers with back injuries from 2002 to 2005 found that only 26 percent of the patients on opioid painkillers saw their pain improve, and only 16 percent experienced improvement in physical function.
"All of this is not rocket science," said Dr. Richard D. Blondell, director of addiction medicine at Sheehan Health Network.
"The solution is research, education and training," he said. "You need a core of physicians who know what they are doing and who can disseminate the information to others."
> A balancing act
Bolstering medical school curriculums will take decades. Meanwhile, education often falls to local programs similar to one presented in December by insurer Independent Health and sponsored by drug manufacturers Purdue Pharma, Covidien and Reckitt Benckiser.
About 150 nonpain specialists listened as Buffalo-area experts in pain and addiction talked about such topics as appropriate prescribing, drug-seeking patients and identification of addiction. Unlike the 1990s, when the medical community urged aggressive pain treatment for chronic pain, the advice today is to use caution.
"Anyone who treats pain confronts a balancing act. They have an ethical, moral and professional obligation to treat it. They also must be ethically, morally and professionally concerned about drug addiction and diversion," said Ellen Battista, director of Pain Treatment Consultants of Western New York.
She and others stressed the need to think differently about the goal of treatment.
"Saying you want to be pain-free is a little like saying you want to be richer. When is enough enough?" Bagnall said.
The problem of prescription drug abuse is complex and resists easy solutions, experts say. Voluntary steps by the medical community and better public education help but may fall far short in stemming what has become a public health crisis.
"The burden of these drugs is not just addicts who overdose. So many people are touched by this tragedy -- elderly women, teenagers, infants born to addicted mothers, an explosion of admissions to detox centers and emergency rooms," said Cahana.
He defends Washington State's more extensive approach.
"We need to do more than take a few courses sponsored by drug companies," Cahana said. "We need to codify best practices and change pain management so that we don't assume from the start that giving narcotics is the best treatment."