Breaking barriers to buprenorphine

The woman was a typical primary care patient: middle-aged with obesity, hypertension, and uncontrolled diabetes. But she needed extra help. When life stresses reignited a previous addiction to pain pills, she called her doctor's office to ask for a referral to a buprenorphine prescriber.

But she didn't need a referral after all. Her primary care doctor, Ellie Grossman, MD, MPH, had been prescribing the office-based, FDA-approved medication to treat opioid addiction for more than 10 years.

“It was really satisfying to be able to say, ‘Hey, we do that in primary care here. I got that,’” said Dr. Grossman, a Massachusetts-based internist who is also board-certified in addiction medicine. “Now, our relationship has changed. I'm seeing her more often than I used to, but I'm still just her primary care doctor who manages her diabetes, her hypertension, her obesity, and her opioid use disorder.”

Opioid-related overdoses now kill more people each year than car accidents, according to the CDC. But despite heightened awareness of the opioid crisis, treatment still eludes many patients who are struggling with addiction. There are patient-specific reasons for this, like not being ready to seek treatment. But primary care doctors may throw up their own barriers to providing addiction treatment, such as fearing that treating such patients will be too challenging.

Patients with opioid use disorder can be complicated, Dr. Grossman acknowledged, but not more so than many other medically complex patients internists see every day. And, she added, “Even if you don't necessarily want to think of yourself as an addiction doctor, there's enough addiction out there that it's in your practice.”

Primary care internists from across the country who have successfully begun prescribing buprenorphine shared their challenges, success stories, and words of wisdom for the many clinicians who may be interested in adding the lifesaving medicine to their toolkits.

Taking the first step

To prescribe buprenorphine, physicians must complete an eight-hour training curriculum and obtain a special waiver through the U.S. Drug Enforcement Agency (DEA). Perhaps intimidatingly, this waiver is commonly called an “X” number or license. The waiver program comes from the Drug Addiction Treatment Act of 2000, which allowed physicians to provide office-based treatment for opioid addiction with Schedule III, IV, or V controlled substances.

Buprenorphine is the only Schedule III drug approved to treat opioid use disorder; methadone and other full-opioid agonists are Schedule II. In 2002, the FDA approved buprenorphine (Subutex and other trade names) and the abuse-deterrent formulation of buprenorphine/naloxone (Suboxone and other trade names) for this purpose. Prior to this legislation, the Harrison Narcotics Tax Act of 1914 criminalized the use of narcotics, effectively prohibiting physicians from prescribing opioids to treat people with addiction.

Dr. Grossman obtained her DEA waiver shortly after office-based treatment was approved. At first, she felt unsure and remembers asking a colleague to review her very first buprenorphine prescription to make sure it looked right. “I probably hadn't done that since I was an intern one month out of medical school,” she said. “But because of the weight in your mind related to the regulatory environment, it just makes you nervous.”

On top of the many clinicians who don't have an X number to prescribe buprenorphine, a large number have a waiver but don't actually prescribe. Joseph Sellers, MD, FACP, an internist in upstate New York, has had his X license for three years but said he didn't write a single script in the first year because “It just seemed so complex to me and so overwhelming.”

Hesitation is common among physicians because the special training process implies that buprenorphine is a dangerous drug and that prescribing it is a daunting task, said Beth Eagleson, MD, FACP, an assistant professor of medicine at University of Massachusetts Medical School–Baystate and a general internist at the Baystate Brightwood Health Center/Centro de Salud in Springfield, Mass.

“I want to take some of the fear out of that,” she said. “It is a safe medication, and just because there's a waiver doesn't mean there are a lot of obstacles or challenges to prescribing this medication.”

As part of a grant-funded program, the University of Massachusetts teamed up with Cobleskill, N.Y.-based Bassett Healthcare to get 28 primary care doctors their X licenses, discuss difficult cases, and provide support to the entire primary care network, said Dr. Sellers, who is medical director of the health system's eastern region. Now, the practices have about 250 patients on buprenorphine to treat opioid use disorder.

The experience changed Dr. Sellers' initial impression that providing office-based addiction treatment would be challenging. “It's not difficult. You're internal medicine. You take care of really complex people. It's not like that's not what we do for a living,” he said.

The required eight-hour training for physicians to get the waiver is available through several organizations (and sometimes free of charge), and it can be completed online, in person, or split between both settings. Era Kryzhanovskaya, MD, an assistant professor of medicine at the University of California, San Francisco (UCSF), recently completed the course and is now in her second year of prescribing buprenorphine at an academic university-based clinic.

The course she took consisted of presentations that were recorded at various conferences and covered the chemical properties of buprenorphine, how to manage patients on the medication, and other related topics, she said. “The material was delivered in a format that was understandable and the questions were reasonable … so that part of it was really easy to do,” she said.

The hardest part? “Finding the time to sit down and do it. Actually, I did it during one of my vacation days,” Dr. Kryzhanovskaya said, adding that it took about six hours and lots of note-taking. She completed the waiver requirements with supplementary in-person training at a California Society of Addiction Medicine conference.

Working through challenges

Aside from the unique process of obtaining a DEA waiver, other challenges await new buprenorphine prescribers. What Dr. Sellers sees as the biggest challenge for primary care doctors is adding yet another task to their busy days. “Most physicians think (and it's true) they are already working way too hard and working way too long. They think, ‘Oh my gosh, can I take on another thing?’” he said.

But the patients are already in the clinic, presenting with infections and endocarditis on top of regular health maintenance, Dr. Sellers said. “They're coming in, and because you're not asking, you don't know who in your practice is using substances,” he said. “If you don't have a solution, you usually don't ask the question.” Now, the health system has a solution to offer as part of routine primary care that increases retention in treatment programs and decreases overdose, drug use, infectious disease transmission, and criminal activity, according to the National Institute on Drug Abuse.

Treating addiction in primary care also allows physicians to screen for other substance use-related health problems, such as hepatitis C and HIV, another crisis that involved needles and a stigmatized population, Dr. Sellers noted. “But back 30 years ago, we had a society that was much more judgmental and disapproving of people's sexual behaviors and their private lives,” he said. “Thank goodness we've gotten beyond that.”

Many patients who come to the clinic will already know what their buprenorphine dose is because they've been self-treating with medication they bought off the street. “And why they do that is because there are barriers to getting care,” Dr. Sellers said. “I think it's absolutely crazy that we have such an effective treatment and not every physician in the country is getting educated and utilizing it with the appropriate patients.”

However, patients with opioid addiction may not realize they have an opioid use disorder or may not be ready to begin treatment, which is also a barrier to care, Dr. Eagleson noted. “That just takes time and empathy and meeting patients where they are,” she said.

Despite a high prevalence of opioid use disorder in San Francisco, “It's still not that frequent that we get someone who's like, ‘Yes, I have an opioid use disorder, and yes, I am open to treatment,’” said Dr. Kryzhanovskaya. “It's just a matter of us finding people in the right personal headspace for it. We have to engage patients, meet them where they're at, and offer treatment when possible.”

In general, patients who seek treatment for opioid use disorder recognize that getting treatment is a privilege, said Dr. Grossman, an instructor in medicine at Harvard Medical School in Boston who presented on the topic at ACP's Internal Medicine Meeting 2018. “They want that medication, and they want that relationship with the provider and the health care team, so in general they're actually lovely to work with,” she said.

But another challenge, especially for solo practitioners, is allowing for flexibility and short-term schedule adjustment. Many patients with addiction have socioeconomic challenges that can affect their ability to attend appointments as scheduled, Dr. Grossman noted.

“They may miss an appointment but be running out of medication and so desperately need to see you the next day or two days later. You have to expect that that will happen,” she said. Fortunately, although these visits tend to be high-frequency, they also tend to be relatively short, Dr. Grossman added. “They're actually not that hard to squeeze into an existing clinic session on an ad hoc basis, but that is easier if you work in a larger practice or have available ancillary support than if you are a solo provider,” she said.

Logistical challenges with buprenorphine include navigating health care coverage. While California's Medicaid patients are covered, patients with private insurance require more effort up front, Dr. Kryzhanovskaya said. “What I find myself doing is having to call or submit prior auth after prior auth about why buprenorphine is a safer alternative and why we need to treat patients with opioid use disorder,” she said, though she hasn't had trouble getting insurance companies to approve it once she's reached out.

New regulatory developments may further increase access to buprenorphine. The FDA approved the first generic forms of Suboxone film in June 2018, which has made a difference in cost from a broad perspective, Dr. Eagleson said. And a long-acting buprenorphine formulation, a monthly injection that is sold under the brand name Sublocade, became FDA-approved in November 2017.

The injection is not yet seeing widespread use due to logistical issues like insurance coverage and medication storage, experts said. But Dr. Eagleson, whose clinic recently started using it, said it holds promise for some of her patients in particular. “I think it can be a real game-changer in terms of our patients for whom there's a risk of diversion because you can't sell something that's a depot injection,” she said.

Induction on the medication can be another challenge. Buprenorphine, a partial opioid agonist, has a high affinity for the mu opioid receptor and “will displace a full opioid agonist from the receptor, causing unpleasant opioid withdrawal symptoms for patients that have not adequately prepared for the induction,” explained ACP Member Paula J. Lum, MD, MPH, professor of medicine at UCSF and program director of the UCSF primary care addiction medicine fellowship at San Francisco General Hospital. “That's one of the challenges of getting a patient onto buprenorphine who is using heroin or prescription opioids on a daily basis,” she said.

To avoid precipitated withdrawal, a person should be in an opioid-free state, Dr. Lum said. “Practically, patients need to be heroin-free for at least 12 hours and off longer-acting opioids for between 48 and 72 hours before the first buprenorphine dose,” she said. “The first dose is given when the patient demonstrates mild to moderate opioid withdrawal.”

At Dr. Kryzhanovskaya's clinic, patients do both in-office and at-home inductions. For inductions in the office, patients bring in their buprenorphine, and she'll observe them take a dose after documenting they are in withdrawal using the Clinical Opiate Withdrawal Scale.

“Then, we make sure they tolerate it well, and we reassess them in about an hour, so it does take up clinic space to keep the patient in a room where I am constantly checking up on them,” she said. “It also takes MD hours because it's tough to see many other patients while you're also initiating somebody on buprenorphine.”

The San Francisco Department of Public Health developed an outpatient buprenorphine induction clinic to which physicians can send patients to be evaluated, educated, and prepared, then induced and stabilized on a target dose before being transferred back to their primary care clinicians for maintenance treatment, Dr. Lum noted. “It's quite a lovely model, particularly for recently waivered clinicians, who are just getting their feet wet and can use that extra support,” she said, adding that the clinic is available only for patients in the public health system who are either uninsured or on Medicaid.

These days, however, Dr. Lum said she rarely uses the outpatient induction clinic because as buprenorphine becomes more available, many of her patients have experience with the medication and understand how to induce themselves. After evaluating and assessing her patients, she counsels them about how to prepare to start the medication at home. Then, she'll simply print out a basic home-induction instruction sheet (several protocols are available, including a popular cartoon developed by the New York University School of Medicine), give it to patients, and tell them to call her pager number if they have trouble. “If anything, they usually wait longer than I would as a physician to start the medicine because they're so worried about precipitating withdrawal,” Dr. Lum said. She also prescribes or supplies patients with a “kick pack,” consisting of mostly over-the-counter medications to alleviate opioid withdrawal symptoms they may experience between their last opioid use and first buprenorphine dose.

For Cheryl J. Ho, MD, a homeless health care primary care internist and addiction medicine specialist at Santa Clara Valley Health and Hospital System in San Jose, Calif., home-based inductions have become the norm, since asking patients to come to the clinic in withdrawal presents too much of a challenge for many. The only exception is inducing from a long-acting opioid like methadone, which is a much trickier process, she noted. “I feel like if you can do ‘home-based’ inductions in a homeless population, then you can absolutely do it in a nonhomeless population because of the increased social stability,” Dr. Ho said.

However, sometimes the easiest way for doctors to start prescribing buprenorphine is to accept a transfer of a patient who's already on the medicine, she suggested. “I found that that has helped lower the barrier a bit on some of the providers that we've coached to start because I think people are always scared of the induction (which, to be honest, if you do home-based, it's not that scary),” Dr. Ho said.

Effective models of care

Yet another challenge of buprenorphine prescribing is successfully incorporating it into one's practice. One of the most popular formats is a nurse-led model, in which nurses perform the bulk of routine assessments and monitoring once patients are stable.

At Dr. Sellers' practice, a preformatted note in the electronic health record guides nurses through asking questions, counting up patients' medication, and checking urine toxicology for adherence. “I tend to see everybody once a month, but some of the people are seeing one of my nurses every week,” he said.

While Dr. Eagleson has past experience as a solo practitioner at a community health center, she said she prefers the nurse-led model at her current practice, which also has behavioral health care on site. However, some practices will find it challenging to adopt this type of model if their nurses are not already seeing patients on their own, billing, and reporting back to the prescribers, she noted. As part of the Comprehensive Addiction and Recovery Act of 2016, potential buprenorphine prescribers now include nurse practitioners and physician assistants who complete 24 hours of training and obtain their DEA waivers.

In addition to providing the medication, having a behavioral health component is essential to patients' success, experts agreed. When practicing with less support, Dr. Eagleson partnered with a local agency to make sure her patients had the social service connections they needed. “That was key because if you don't have those resources on site, you need to have a strong connection with someone in the community,” she said.

For Dr. Kryzhanovskaya, having only one or two social workers and a psychiatrist (who only takes certain insurances) for the entire clinic means that the burden often falls on clinicians to assess when patients are slipping due to mental health problems. “That's tough for us and for the patients. … We are still working on getting robust mental health and case management services, the things that would make a clinic that prescribes buprenorphine function really well and smoothly,” she said.

While addressing behavioral health is very important for a population who often has co-occurring mood disorders, there's no single correct model, noted Dr. Grossman, who serves as primary care lead for behavioral health integration at Cambridge Health Alliance in Somerville, Mass.

Some patients, especially those who have stable structures in life, such as a job and good relationships, can do well in a low-intensity primary care treatment setting, she said. Others, such as those with more severe mood disorders or co-occurring substance use disorders, need more help. To support these patients, Dr. Grossman's clinic has an embedded therapist and a weekly addiction recovery group, and she may also recommend other peer support groups, such as Narcotics Anonymous or Alcoholics Anonymous. “Those patients tend to have less structure in their lives, so they need more of a treatment structure to keep them going and get them on the right path,” she said.

For Dr. Sellers, the challenge that comes after helping people with sobriety is helping them reintegrate into the mainstream of society. “Many have been living in a subculture for five or 10 years, and they have a lot of things they have to develop to get the right skills and support so that they can get on with the kind of life that they'd like to have,” he said, adding that some of his clinics have brought in trained peer advocates who are in addiction recovery to provide support to patients.

After prescribing buprenorphine for a while, Dr. Ho said she realized that the medication was the relatively simple part and that managing patients' psychosocial complexities was more difficult. Because her clinical setting has a social worker, a psychologist, and a psychiatrist in the context of a primary care group clinic, it started offering shared medical appointments for patients with opioid use disorder to help avoid duplication of effort. “It actually made the experience of prescribing Suboxone in the primary care setting far easier,” Dr. Ho said.

About three to four of the clinicians (from three to four different disciplines) see about eight to 10 patients during the shared visits, which are about one hour long. One by one in the group setting, each patient's self-directed goals, recovery progress, and medication adjustments are addressed. No one is forced to share his or her experiences, and individual appointments are always offered.

“We've been surprised at the openness of the patients. We don't force them at all. People voluntarily share about their mental illness, drug relapses, and day-to-day life struggles. A real recovery community develops. And at the end of the shared medical appointment, I have a completed progress note and a Suboxone prescription ready,” said Dr. Ho.

Treating addiction is not something that doctors can do well on their own, experts agreed. “But when we treat addiction, it can be one of the most rewarding experiences in primary care practice,” said Dr. Lum. “Addiction medicine, at its best, is a team sport. … Like practicing primary care, if you don't have a staff in your practice who gets this and wants to be supportive, it's doable but that much harder to do on your own.”

And for Dr. Kryzhanovskaya, having mentors to advise her during challenging situations, such as unexpected urine toxicology results, helps her make more well-informed clinical decisions. “Feel comfortable reaching out because to be alone, isolated in a silo is probably the worst thing,” she recommended.

As Dr. Sellers gears up to get DEA waivers for the second half of his health system's primary care network, a new buddy system will pair new prescribers up with doctors in the network who have now been prescribing for more than two years. “Each of us is being asked to volunteer to give our cell number to another doctor so that they can call you 24/7 if they don't know what to do in a given situation,” he said. “They're just trying to make it as easy for people as possible.”

Since patients generally much prefer to get their addiction care within a primary care practice rather than in a substance use clinic, the health system has effectively removed a lot of the stigma to getting treatment, Dr. Sellers said. “Everybody, even our most skeptical people who maybe were reluctant or expressed a lot of stigma against the substance-using population to start, has turned around because they've seen people turn their lives around,” he said.

For example, Dr. Sellers' first buprenorphine patient, who started using opioids in college before dropping out, has since gone back to college, finished his degree, and now has a finance job. “Things like that really encourage you. … In our rural county, the No. 1 reason somebody's in family court having their children taken from them is opioid addiction, so we've got moms who've gotten their kids back,” he said. “Some really great outcomes.”