Opioid rules deter doctors in treating drug addicts

PHILADELPHIA — Doctors need no special training to prescribe the opioid pain pills widely blamed for fueling a national addiction crisis.

But prescribing the medicine considered the gold standard for addiction treatment is another story entirely.

Opioid-based medications that help curb cravings, prevent overdoses, and allow drug users to get through the day without the fear of painful withdrawal have been proved to help people achieve lasting recovery far more reliably than quitting without medical help.

But, doctors say, federal regulations surrounding these treatment medications — and the special physician training and monitoring required to dispense them — have deterred many of their colleagues from obtaining the license needed to prescribe the drug.

Just 3 percent of doctors in Pennsylvania and 4 percent of those in Philadelphia have the waiver needed to prescribe the treatment medicine buprenorphine, according to the U.S. Drug Enforcement Administration. And the problem is worse

in rural areas: Nearly 30 percent of rural Americans live in a county without a buprenorphine provider, according to new research from the Pew Charitable Trusts.

Methadone, the most heavily regulated opioid-based treatment drug, can only be dispensed at specially licensed clinics and often requires users to visit daily for the drug and for counseling. Buprenorphine can be taken in one’s home and is available in pill form, as a longer-acting shot, and as the brand-name drug Suboxone, which combines buprenorphine with the overdose-reversal drug naloxone.

There are differences between the two opioid-based medicines, but both are longer-acting and don’t produce the peaks and troughs associated with short-term opioids, like heroin, making them useful for people in treatment.

Physicians who want to prescribe buprenorphine need a license commonly known as an x-waiver from the DEA and the U.S. Substance Abuse and Mental Health Services Administration, after taking an eight-hour training course.

The American Society of Addiction Medicine’s eighthour training course, one of several offered on the Substance Abuse and Mental Health Services Administration’s website, identifies its “learning objectives” as teaching doctors how to apply for the waiver, to identify patients who would benefit from buprenorphine and to recognize other illnesses associated with opioid addiction.

From there, a doctor can treat up to 30 patients in the first year with the license and 100 in the second year, with a cap of 275 in the third year.

Another irony: These restrictions apply only to doctors prescribing these medications for a substance-use disorder. There’s no special license required to prescribe methadone for pain. And though buprenorphine is not approved by the U.S. Food and Drug Administration for pain, some providers are prescribing it off-label without an xwaiver.

The DEA’s Philadelphiaarea spokesman, Pat Trainor, said the x-waiver “allows doctors to help people to get medication-assisted treatment in their communities — and not have to go to a narcotic treatment program, so as to avoid the stigma of that,” he said, and added that primary care doctors not accustomed to treating addiction need training to do so.

But doctors who treat people with addiction say the regulations themselves create stigma and discourage more doctors from seeing substance-use disorder as a disease that they can treat.

“Doctors have basically been taught and raised and are functioning in a system where addiction is always someone else’s job,” said Priya Mammen, an emergency physician and public health advocate from South Philadelphia.

“The regulations treat these medications as qualitatively different from any other medication we prescribe. It gives off the impression that addiction is a specific kind of illness — but from all the literature, all the data we know, it’s a chronic disease. But it’s not treated like that in the system.”

Jeanmarie Perrone, the director of the division of medical toxicology in the University of Pennsylvania’s emergency department, has worked to expand her system’s buprenorphine program.

She believes doctors still should get some kind of training before beginning to prescribe buprenorphine and has helped implement classic behavioral incentives to get more doctors into training.

The university paid for xwaiver training courses for its physicians and allowed them to take the course online. They sent emails telling stories of Penn patients’ success on Suboxone.

“Each week they got an email sort of nudging them along in the process, saying, ‘It’s not too late to sign up, you still have time to finish this — and look what your colleagues are doing [with buprenorphine],” Ms. Perrone said.

About 75 percent of Penn’s full-time emergency department staff members now have x-waivers. Ms. Perrone said her goal is to create “a culture of buprenorphine in the whole city.” She is pinning her hopes largely on newer doctors and medical students whose training increasingly includes addiction medicine.

Most physicians who obtain an x-waiver likely will not hit their prescribing cap. Many doctors who get the x-waiver don’t even use it, said Leo Beletsky, an associate professor of law and health sciences at Northeastern University’s law school.

“It’s not enough to get people waivered,” he said. “You still have these issues around stigma. People don’t want to submit themselves to periodic DEA audits. They just don’t want to deal with this element of their practice.”

Where the caps can present challenges, Mr. Beletsky said, is in larger clinical settings. In Philadelphia’s men’s prisons, a just-launched Suboxone program has been paused because the prisons’ doctors already have hit their prescribing caps, Philadelphia broadcast outlet WHYY reported last month.

Bruce Herdman, the prisons’ chief of medical operations, said his doctors will be able to expand their prescribing caps to 275 patients each by midsummer. Until then, new inmates with substance-use disorder are being directed to an abstinence-only treatment program that includes cognitive behavioral therapy.

The prison also is looking to hire doctors with higher buprenorphine caps in the meantime.

“We have a great treatment to provide, and I don’t understand the logic behind this federal regulation,” Dr. Herdman said.