Underused Weapon In the War on Addiction

Buprenorphine could save thousands more lives than it does—if it weren’t for legal barriers, a fear of disruptive patients, and insurance red tape. And it can be prescribed in the primary care physician’s office.

Timothy Kelley
Senior Contributing Editor

Numbers tell part of the story of the nation’s opioid crisis. The CDC says 91 Americans die daily from opioid overdoses, which have killed more than 300,000 since 2000—and the death rate is rising.

But to John Machata, MD, of Wickford, R.I., some of the numbers have faces. He remembers the call he got not long ago about a former patient he hadn’t seen in a year, a fisherman who had lost his insurance and couldn’t stick with his drug rehab program. The call was from the coroner; Machata’s patient was in the morgue.

“The obituary page is a sad punctuation mark on a percentage of my patients,” he says. “In our tiny state of 1 million, we’re losing almost a person a day to drugs. That feels like a lot to me.”

Doctors say opioid use disorder patients divide roughly half-and-half between recreational drug users who got into trouble and patients who were given an opioid pain-relief prescription (in many cases during the 1990s heyday of the “pain is the fifth vital sign” gospel) and became addicted. The former group often has chosen heroin; the latter group often ends up on heroin because it’s cheaper and easier to get than oxycodone or whatever other pain-relief opioid got them hooked. Of course, a tailspin awaits the untreated addict of either origin, no matter how well-born, well-educated or well-intentioned. That’s why any tool that even hints it could help this patient population more, or reduce its death toll, is a very big deal.

John Machata, MD

Wider use of buprenorphine, the partial opioid agonist, would save many lives, says primary care physician John Machata, MD, of Wickford, R.I. “It’s almost an ideal drug, both for the patient and the practitioner.”

Machata is a primary care dinosaur, a solo doc who lacks not only a secretary and a nurse but even a biller. Still, on the treatment of opioid use disorder in primary care, his perspective is up-to-the-minute. He’s been at the game for a decade, and he’s convinced that many lives could be saved if the nation made wider use of buprenorphine.

“It’s an almost ideal drug, both for the patient and the practitioner,” says Machata.

Buprenorphine is a partial opioid agonist that attaches to the opioid receptors but has a “ceiling effect”—at a moderate dose the effect plateaus and is not increased by taking more. It’s nearly overdose-proof unless combined with other sedating drugs. While it provides a high for the opioid-naïve, it’s a ho-hum experience for individuals with opioid tolerance. All it does is stave off his or her withdrawal symptoms and block opioid craving. That’s why the doctors who believe in it find it a useful tool for putting lives back on track.

Buprenorphine was classified as a Schedule III drug by the FDA in 2002, at the same time the agency approved the sublingual tablets Subutex (buprenorphine hydrochloride) and Suboxone (buprenorphine hydrochloride and naloxone hydrochloride). The FDA deemed buprenorphine safer than the Schedule II drug methadone, widely dispensed in clinics as a therapeutic surrogate for heroin. Noting that “there have not been enough addiction treatment centers to accommodate all patients desiring therapy,” the FDA said in 2002 that the two new products were the first opioid agonists available to treat opioid addiction in doctors’ offices under the Drug Addiction Treatment Act of 2000 (DATA).

In November 2017, a promising new tool was added to doctors’ armamentarium when the FDA approved a once-a-month injection of buprenorphine called Sublocade. “It’s going to be a game changer because it means people don’t need to take a tablet or a film every day, or two or three times a day,” says Daniel P. Alford, MD, a Boston University professor of medicine who directs two addiction-related programs at Boston Medical Center.

Not enough doctors prescribing

Using primary care doctors’ offices instead of methadone clinics or psychiatric facilities? That’s not just a possible money saver; it makes sense from a treatment perspective. Many physicians who prescribe buprenorphine champion its effectiveness, says Joseph Hyde, a technical expert lead for JBS International, a consulting firm with contracts with the federal Substance Abuse and Mental Health Services Administration. Besides, there aren’t enough psychiatrists (see “Shrinking the Psychiatric Shortage,” page 20). Indeed, this seems to be a rare instance where there’s no specialty turf war going; unfortunately, there are plenty of patients to go around.

Lucas Buffaloe, MD

Primary care physicians have the skills and training necessary to address the comorbidities that often accompany opioid use disorder, says family physician Lucas Buffaloe, MD, of Columbus, Mo.

Lucas Buffaloe, MD, a family physician in Columbia, Mo., is one believer. Primary care is the place to treat opioid use disorder, he says, because “these doctors have the skills and training necessary to address the comorbidities that often go with it.” Not surprisingly, such patients often have mental health diagnoses, and those in their 40s and beyond often suffer from diabetes, hypertension, or heart disease as well, he explains.

Under DATA, physicians have to apply for an “X” waiver on their DEA licenses. After eight hours of training about managing opioid use disorder, including the safe use of buprenorphine, they can be certified first to manage 30 patients, then, potentially, move up to larger panels of 100 or 275. The top-level waiver limit was increased to 275 recently after lobbying by the American Academy of Family Physicians. But no one seems to have heard of a doctor yet reaching the 275-patient limit. And even AAFP board member Alan Schwartzstein, MD, of Oregon, Wis., agrees that “the better answer is getting more family physicians to start prescribing.” In hard-hit Rhode Island, Machata reports, there are finally enough doctors available to manage patients on buprenorphine: His phone isn’t ringing off the hook as it was even a year ago. But other doctors interviewed by Managed Care say there aren’t enough yet in Massachusetts, Missouri, North Carolina, Utah, or Wisconsin, and that seems to be the case nationally.

“We need more boots on the ground,” says Ronald J. Prucha, MD, a family physician in Cary, N.C., who has been prescribing buprenorphine for five years. He says the medication makes it possible to get addicts off the street and into a structured routine, giving them a chance to begin rebuilding their lives. Many physicians—Prucha among them—also encourage or even require patients being treated for opioid use disorder to attend Narcotics Anonymous meetings, receive psychological counseling, or both. “But there are not enough people writing Suboxone,” adds Prucha. “We need more doctors willing to manage these patients, and managed care organizations could really push for that.”

Rewarding task

One of the reasons doctors don’t treat drug addicted patients is fear that seedy or misbehaving individuals in their waiting rooms would scare other patients. “These are patients who do require a little bit more attention than the average patient,” Buffaloe concedes, partly because of the damage addiction has wrought in their lives.

Prucha agrees. Before he moved for other reasons from Virginia to North Carolina, he says, he was in a four physician practice with three “conservative” colleagues. “I did begin to attract a clientele that was less than savory,” he recalls, “and that became a bone of contention.”

Physicians with buprenorphine waivers say it’s wise to venture into this area gradually and seek advice from a mentor with experience in the field while figuring out what Hyde calls “the nuts and bolts of working with this population.” And it’s important to decide in advance what will be the boundaries of one’s practice with buprenorphine patients. Given the shortage of waivered physicians, Hyde warns: “If you put something in the newspaper or on a state or federal website, you run the risk of a jillion people calling you on the phone.”

But doctors in this field also agree that treating this condition can be one of medicine’s most rewarding tasks. “Other than treating hypo- and hyperthyroidism—in which you give medication and patients feel much better right away—nothing else you do in primary care is as satisfying,” says Alford.

Some doctors have a personal motivation to treat addiction. For Machata, it’s a family touched by alcohol abuse. And many more physicians, says Prucha, could be taught “how easy it is to manage buprenorphine patients once you feel comfortable doing it. But nobody wants to fool with it. It’s easier to bury your head in the sand and say, ‘Oh, somebody else will manage that.’”

Part of the problem: insurers

Another impediment to treatment is health insurers. Family physician Joel D. Porter, MD, of Intermountain Healthcare in Layton, Utah, thinks plans should make it easier for providers to receive the training necessary to prescribe buprenorphine—and also incentivize doctors “to receive their waiver and to manage patients with substance use disorder.”

“It sounds good for an organization to say it wants to be on the front lines of the opioid epidemic,” says Prucha. “But I say, ‘Put your money where your mouth is. Try to educate more of your providers to be Suboxone writers.’”

Most health insurers require preauthorizations for buprenorphine prescriptions (though Rhode Island plans no longer do, says Machata) and that’s a time-gobbling hassle. Physicians fear sounding petty when they object to small delays and time-wasting procedures, but delays can be dangerous, and primary care doctors’ time is already a string pulled taut. When Buffaloe describes the preauthorization back-and-forth, part of the problem seems to be old-fashioned clunky computer communications.

“By the time the patient takes a prescription to the pharmacy, the pharmacy runs it through the insurance company, the insurance company faxes it to my office, I fax it back to the insurance company, and the insurance company gives authorization to fill the prescription, it may be that two or three days have passed,” says Buffaloe. “And for a patient who’s just starting treatment for opioid addiction, those two to three days can really be critical. They may be enough, in some cases, for patients to lose motivation for treatment altogether.”

Pharmacies come in for criticism too. Prucha grows impatient with a well-intentioned CVS questionnaire apparently meant to “do due diligence and prove they’re not just handing the drug to someone who’s not properly screened.” A pharmacist calls him to ask him a series of questions such as “When was the patient’s last drug series?” and “When was his last office visit?”

“Apparently they have to get the information directly from the physician,” says Prucha. “I’ve already spent an hour with this guy as a new patient, and now I’m having to spend another seven or eight minutes. It sounds trivial, but it adds up.”

When addiction is a maybe

Daniel P. Alford, MD, a professor of medicine at Boston University, would like the option of prescribing sublingual buprenorphine to treat severe chronic pain in patients who are at high risk for prescription opioid addiction. “Payers won’t pay for it unless the patient has an opioid use disorder diagnosis because it’s more expensive than other analgesics,” he says. “That makes sense. But what if it’s someone who I think may have an opioid use disorder but I’m not 100% sure, and I’m not ready to put that on their problem list yet? I’d like to be able to prescribe buprenorphine for both the person’s pain and what might be an opioid use disorder—and without labor-intensive preauthorization.” And isn’t managed care supposed to mean spending a little now to keep a patient from going off the rails, thus avoiding a big expenditure later?

Alford admits there isn’t yet “robust evidence” comparing buprenorphine in those situations with other opioid analgesics to find out if it holds its own in cost-effectiveness. But he’d like to see the further research done, so we learn more.

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