As of August 2016 slightly more than 37000 physicians had been waivered to prescribe buprenorphine according to an ACP position paper Photo by Hemera
As of August 2016, slightly more than 37,000 physicians had been waivered to prescribe buprenorphine, according to an ACP position paper. Photo by Hemera

Primary care takes on opioid addiction

There's a lot that primary care clinicians can do to treat opioid addiction, but stigma about the condition, as well as laws and other regulations, throw up barriers.

Opioid use disorder kills hundreds of Americans each week, despite the availability of treatments that can cut mortality risk by more than half. With some education and empathy, however, internists can intervene to change this dynamic, according to experts.

The National Institute on Drug Abuse reports that using medications to treat opioid use disorder increases retention in treatment programs and decreases overdose, drug use, infectious disease transmission, and criminal activity. The scientific evidence supporting medication as a solution has grown in confluence with an epidemic of opioid overdoses that, according to CDC estimates, kills 142 Americans every day.

As part of an effort to expand access to addiction treatment, which itself involves controlled substances, the Drug Addiction Treatment Act of 2000 (DATA-2000) allowed physicians to provide office-based treatment. The first of the medications that could be prescribed as part of office-based treatment were approved in 2002: buprenorphine (Subutex and other trade names) and the abuse-deterrent formulation of buprenorphine/naloxone (Suboxone and other trade names).

“We've really gotten to the point now where there's a lot that primary care providers can do, so it's a wonderful time to be doing this work,” said internist and addiction medicine specialist Miriam Komaromy, MD, FACP, associate professor of medicine at the University of New Mexico Health Sciences Center in Albuquerque. “Yet we pretend it's somehow optional or something we don't need to deal with.”

Training to treat

Under federal law, physicians may opt to take an eight-hour course on prescribing buprenorphine, a partial opioid agonist and one of two medications with clear evidence of effectiveness for treating opioid addiction. The other evidence-based medication, methadone, must be dispensed at a certified opioid treatment program (commonly known as a methadone clinic) because federal law prohibits physicians from prescribing it to treat opioid use disorder, Dr. Komaromy noted.

People with opioid use disorder who receive opioid agonist treatment with methadone have less than one-third the mortality risk of those who do not receive it, according to a systematic review and meta-analysis published in 2017 by The BMJ. Opioid agonist treatment with buprenorphine also appears to be associated with a reduction in mortality, although this finding was based on fewer studies, the reviewers said. Patients who discontinued treatment with either drug had increased mortality risk.

But the legal stipulations around providing such treatment reflect the stigma surrounding the disease, said ACP Member Laura Fanucchi, MD, MPH, a primary care internist for patients with HIV and addiction and assistant professor at University of Kentucky College of Medicine in Lexington.

Although psychosocial counseling is important in treating addiction medication seems to be the most effective component of treatment one that can have an effect within days Photo by iStock
Although psychosocial counseling is important in treating addiction, medication seems to be the most effective component of treatment, one that can have an effect within days. Photo by iStock

“I think it's really illustrative of our whole culture around opioid use disorder that there is no special training required to prescribe the range of full opioid agonists, but when we talk about prescribing treatment for opioid use disorder, there's endless rules and regulations,” she said.

Other obstacles to treatment include physicians' attitudes and beliefs. “I hear comments like, ‘We don't want those patients in our office, in our waiting room,’ etc., but the reality is that addiction doesn't discriminate,” said internist and researcher Chinazo Cunningham, MD, MS, professor of medicine at Albert Einstein College of Medicine and associate chief of the division of general internal medicine at Montefiore Medical Center in New York City. “So I tell people that ‘those patients' are your neighbors, your colleagues, your family members, your friends.”

The medical obligation to treat is further compounded by the many opioids that physicians have prescribed for the last decade, she noted. “We are part of the problem; we absolutely need to be part of the solution,” Dr. Cunningham said.

The mandated training curriculum for prescribing buprenorphine is available through several organizations (e.g., the American Society of Addiction Medicine) and may be completed entirely online, entirely in person, or split between both settings, explained Dr. Komaromy. Some programs are offered free of charge (see sidebar for resources).

Physicians who complete the training program can then apply for a waiver from the U.S. Drug Enforcement Agency (DEA) to prescribe buprenorphine to patients with opioid use disorder. Waivered physicians may treat up to 30 patients in the first year and may apply to increase their patient cap to 100 in the second year. Since 2016, the law also allows experienced prescribers who meet certain requirements to increase their limit even further, to 275 patients.

Evidence suggests that even waivered physicians tend to prescribe buprenorphine to relatively few patients. In a study of more than 3,200 buprenorphine prescribers with nearly 250,000 patients, researchers found that prescribers' median monthly census was just 13 patients, according to a research letter published in 2016 by JAMA.

In the U.S., about 250,000 to 300,000 individuals are receiving methadone and an estimated 400,000 to 600,000 individuals are receiving buprenorphine for the treatment of their opioid use disorder, according to primary care internist, addiction medicine specialist, and researcher David A. Fiellin, MD, professor of medicine, emergency medicine, and public health at Yale School of Medicine in New Haven, Conn.

“At one level, DATA-2000 and the advent of buprenorphine and office-based and primary care-based treatment has effectively doubled the capacity of the U.S. health care system to provide the most effective treatment,” he said.

Yet overall physician uptake has not kept up with the need. “The downside is, the estimates are that there are probably only 15% to 20% of those individuals in the U.S. with opioid use disorder who are currently receiving the most effective treatment strategy. Internists can play a critical role in increasing access to this treatment to help address the current opioid overdose crisis,” said Dr. Fiellin.

As of August 2016, slightly more than 37,000 physicians, or fewer than 4% of prescribers, had been waivered to prescribe buprenorphine, according to an ACP position paper titled “Health and Public Policy to Facilitate Effective Prevention and Treatment of Substance Use Disorders Involving Illicit and Prescription Drugs,” which was published in March by Annals of Internal Medicine. As of one year later, about 39,211 prescribers have been certified, according to the Substance Abuse and Mental Health Services Administration (SAMHSA), although Dr. Cunningham noted that listing certification on the SAMHSA website is voluntary and these numbers might therefore be higher. Nonetheless, it's clear that the number of waivered buprenorphine prescribers is not enough, said Dr. Komaromy. “There are very few places in the country where the capacity meets the needs, which is a shame,” she said. “People are dying because of it.”

In addition, cost of the medication varies by insurance status but can be a barrier for patients. At the federally qualified health center where Dr. Cunningham works, subsidized pharmacies allow patients to fill their buprenorphine prescriptions for a sliding-scale fee. “But in other places, it can run $300 a month, copays can be $50 to $75, so that can definitely be an issue that could be a barrier to receiving treatment,” she said.

Although Medicaid provides coverage for buprenorphine, “The prior authorization process is very laborious and time intensive, and it's certainly a barrier for patients getting good care and access to care,” added Dr. Fanucchi. In contrast, Dr. Fiellin said the process is not an issue in Connecticut, where most of his patients are on Medicaid and have no copay.

Medicaid coverage varies by state, and some have restrictions where treatment is only covered for one year, said Pooja Lagisetty, MD, MSc, a researcher and outpatient primary care internist at the Veterans Affairs (VA) Ann Arbor Healthcare System and clinical lecturer in the division of internal medicine at the University of Michigan. “That goes against the evidence because we know that if we keep patients maintained on [buprenorphine] indefinitely, they actually have a lower chance of relapsing,” she said.

Access to buprenorphine treatment may improve, however, with recent legislation that as of 2016 allows nurse practitioners and physician assistants in some states to obtain their DEA waivers after completing 24 hours of buprenorphine training.

Other medication options

Although patients generally prefer buprenorphine as first-line treatment, some may opt for methadone, especially those who have used the medication in the past and found it to be effective, said addiction medicine specialist Sarah E. Wakeman, MD, a Massachusetts General Hospital primary care internist and assistant professor of medicine at Harvard Medical School in Boston.

Patients may also prefer methadone if they want a treatment program with more structure, including visiting a treatment facility every day to receive the medication, she noted.

In the past, methadone was thought to be a more effective analgesic than buprenorphine and therefore best for patients with chronic pain and opioid addiction, Dr. Wakeman added. “But increasingly, we're recognizing that buprenorphine actually can be quite effective in terms of analgesia, so I think that's less and less of a defining line,” she said.

Methadone may be a more familiar medication to physicians but is not typically used in the outpatient setting, noted Dr. Fiellin. “I think most of us are comfortable with it, especially because we worked and trained in hospitals and we've cared for patients who are receiving it as an outpatient,” he said. “But it's not something that's part and parcel of what we do on a regular basis, especially in an outpatient setting.”

Another familiar medication, naltrexone, was approved by the FDA for the treatment of opioid addiction in 1984 and is commonly prescribed to patients with alcohol use disorder. However, oral naltrexone is an opioid antagonist, which means that opioid cravings can make it difficult for patients to adhere to the medication, experts said.

Naltrexone hasn't been studied as much for opioid use disorder as either buprenorphine or methadone, Dr. Cunningham noted. “There are some studies that show it's effective as long as people take it,” she said. “A lot of the challenge is that people don't take it, and part of the reason why is because they don't feel that great on it.”

The medication blocks all opioids, including the endogenous ones the body produces, Dr. Cunningham said. “Those are the things that make us feel good when we eat chocolate or have sex or go for a run … the naltrexone blocks that, too,” she said.

In 2006, the FDA approved an extended-release injectable version of naltrexone (Vivitrol) in conjunction with counseling to prevent relapse of opioid dependence after opioid detox. “[Naltrexone] meets a lot of people's conception of what a medication should be: It's a nonopiate,” said Dr. Fiellin.

The extended-release form has since been aggressively marketed through direct-to-consumer advertising. “There's a lot of pushing of naltrexone, and I think the reason why is because it's not a controlled substance” and therefore doesn't carry the same risks of opioid agonists, such as diversion, said Dr. Cunningham.

Patients must go through withdrawal from opioids for at least seven to 10 days before receiving the naltrexone injection to avoid precipitating withdrawal, which is the biggest challenge from an outpatient perspective, said Dr. Fiellin. “[Abstinence] can be very difficult, if not impossible, before they get started on the medication,” he said.

Dr. Fanucchi said she has had some success with both injectable and oral naltrexone in her practice. “I have some outpatients who are doing very well on naltrexone,” she said, including some with predominant alcohol use disorder who have elected to continue oral naltrexone rather than receive the injection. “Patients that have opioid use disorder and want to try treatment with naltrexone, I recommend the injection if the patient is willing, simply because of the risk of overdose with not continuing to take the oral” and going back to using opioids.

Naltrexone does not yet have robust evidence of its effectiveness for opioid use disorder, noted Dr. Lagisetty. “We have trials to show that it's feasible and acceptable, but we don't know if patients want it, we don't know if patients will continue to take it, and we don't know how it fares compared to drugs like methadone and buprenorphine that have been on the market for much longer,” she said.

Dr. Wakeman added that comparative analyses between naltrexone and methadone or buprenorphine have shown that the latter two drugs are far more effective treatments for opioid addiction. Nonetheless, the most important step in any treatment discussion is discerning what the patient wants, she advised.

“There are some patients that really prefer to try naltrexone,” but they make up the minority of individuals with severe opioid use disorder, she said. Candidates for naltrexone are highly motivated to abstain and have a low risk of relapse (e.g., pilots motivated by their employment, younger people who haven't been using long and don't have severe use disorders), Dr. Wakeman said.

Naltrexone might also be a good choice for those with limited options, such as people in prison, Dr. Cunningham said. “But out in the world, where people have options, they're choosing with their feet, and it's not with naltrexone.”

The road to remission

Medication as treatment for opioid use disorder is widely referred to as “medication-assisted treatment,” but multiple experts believe that the term is problematic because it implies that medications are not the cornerstone of treatment.

“There are a number of us in the field who avoid the moniker ‘assisted.’ … We never talk about medication-assisted treatment for diabetes or for hypertension, right? We just talk about medication as treatment,” said Dr. Fiellin.

The term perpetuates the pervasive perception that treatment for substance use disorders is behavior modification and, if necessary, assistance with a medication, said primary care internist and addiction medicine specialist Jeanette M. Tetrault, MD, FACP, associate professor of medicine at Yale School of Medicine. “It doesn't have to be that way,” she said. “That may work for some patients, but it doesn't work for everybody.”

Although psychosocial counseling is important, medication seems to be the most effective component of treatment, Dr. Fiellin said. Within days of starting opioid agonist treatment, many patients with opioid use disorder start interacting differently with their families, stop spending money they don't have, and experience dramatic improvements in their level of function, he said. “It's hard to see such a profound and positive change in other disorders that we provide care for on a regular basis in primary care,” said Dr. Fiellin.

After physicians start prescribing buprenorphine, they realize how simple the regimen actually is, Dr. Cunningham said. “As primary care providers, we manage things that are much more complex and more challenging all the time,” she said.

As with treating other chronic diseases, treating opioid use disorder with buprenorphine or methadone can be a lifelong endeavor. “Often, to get off the medication, there have to be serious behavioral changes,” said Dr. Cunningham, likening it to how a patient with diabetes may need to lose 50 pounds to discontinue insulin. “It's hard to change your behaviors, so the reality is that most people need the medication indefinitely to manage their opioid use disorder as best they can.”

If patients are interested in discontinuing buprenorphine for opioid use disorder, Dr. Fiellin said he works with them to slowly taper their dose by 2 mg a month or every other month. “I've had a small number of patients who have tapered off, and some of those have relapsed after six months or a year,” he said.

When a patient with opioid use disorder needs to restart medication after relapse, it's important to welcome him or her back and and say, “I'm glad you're here,” said Dr. Fanucchi. “Because then, each of those encounters is an opportunity for harm reduction,” such as caring for abscesses in patients who inject drugs, providing naloxone kits in case of overdose, screening for sexually transmitted infections, and making sure patients use clean needles and syringes.

In Dr. Fanucchi's comprehensive HIV care clinic, there was initially fear that providing opioid agonist treatment would bring in more patients addicted to opioids. “But the reality was that the patients were already there; it's just that we weren't offering the treatments before,” she said. “Now, the patients are still there, except we're offering the treatment, so some people are really doing a lot better and taking their HIV medicine.”

Another concern physicians should set aside is their ability to meet the psychosocial needs of the patient population, said Dr. Fiellin. “In fact, most of the research indicates that many patients can do very well with medication and a low level of psychosocial support.” He suggested that primary care doctors initially take on patients with fewer concurrent issues, such as an untreated severe psychiatric comorbidity or untreated alcohol use disorder, and refer those with more complex needs to an appropriate specialty treatment program.

There are several models of providing opioid addiction treatment in primary care. “At the Ann Arbor VA, we have patients that begin treatment in an intensive outpatient program led by an addiction medicine specialist and then, once stable, continue treatment in the primary care setting,” Dr. Lagisetty explained. “It's really nice that way because they're on a dose that you can maintain them on, and we do this with a lot of the other diseases that we treat,” she said.

However, such hub-and-spoke models don't exist in many areas, said Dr. Fiellin. “I think some of the opioid treatment programs have found difficulty in identifying primary care practices to refer patients off to,” he said. In practice, a more common model involves registered nurses with some buprenorphine training who provide patient education and even brief counseling, Dr. Fiellin noted.

This nurse-led model or Massachusetts model puts nurses at the center while the doctors and other prescribers play a more peripheral role in ongoing buprenorphine treatment, Dr. Komaromy said. “They're the ones who are writing the prescriptions, but it's really the nurses who are keeping track of everybody and answering questions and helping make sure people don't fall through the cracks,” she said.

Being part of the solution is challenging for a physician workforce that, for the most part, hasn't received much education and training around addiction, said Dr. Cunningham. “When I was in medical school, in four years, I received one hour of training around addiction. What's sad is that I don't think that's really changed that much in the last 25 years,” she said. “If the doctors are poorly educated, poorly trained, and don't have the confidence to take this on, then they won't take it on.”

Mentoring programs and telemedicine can help improve physician knowledge about treatment for substance use disorders, according to the ACP position paper. Dr. Komaromy uses a web-based virtual learning network called ECHO to provide case-based learning to clinicians across the country. As associate director of the ECHO Institute, she runs the Opioid Addiction Treatment Project ECHO program.

The two-year program, which began in 2016, consists of 12 interactive sessions focused on opioid use disorder, Dr. Komaromy said. So far, clinical experts at five opioid ECHO centers across the country have reached about 350 eligible clinicians, who provide care at federally qualified health centers, she said. “It's a pretty efficient way to use the scarce time of the specialists to mentor that many primary care providers,” Dr. Komaromy said.

The telehealth model is expanding nationwide to promote access to treatment for substance use disorders, she said. In addition to multiple ECHO initiatives funded by federal entities like SAMHSA, 20 states have reported that they will use funds allocated by the 21st Century Cures Act to start their own opioid ECHO programs, Dr. Komaromy said.

Newly waivered physicians who are unable to access such comprehensive programs should begin their practice by prescribing to a small amount of patients and reaching out to mentors, suggested Dr. Tetrault, who mentors several clinicians across the country through the national SAMHSA-funded Providers' Clinical Support System.

Educating physicians in training is also important and becoming more common, she said. “It's become more recognized that chronic medical conditions and psychiatric conditions are so negatively affected by ongoing substance use,” said Dr. Tetrault. “If we don't give the trainees the tools to address the substance use, or at least have comfort in talking to patients about it and getting them linked to care, we're really not doing chronic disease management justice.”

This focus is long overdue, according to Dr. Cunningham, who has trained residents in addiction as part of Montefiore's program for 15 years. “It's new because it's hitting suburbs, it's hitting more affluent populations, but my clinic is in the South Bronx, and this is not new. … People were talking about incarcerating everybody, and now all of a sudden we've shifted from incarcerating to talking about treatment, which is great and that's how it should be. It's just the way in which we got to this point is a bit bittersweet,” she said.

Dr. Wakeman likened the epidemic of opioid addiction to HIV, another disease that was once given insufficient attention.

“It was really physicians and the house of medicine responding to a public health crisis and stepping up to offer treatment and to learn more … that changed the arc of that epidemic,” she said, adding that opioid overdose is now the No. 1 cause of death for Americans under age 50. “If the role of the physician is to relieve pain and suffering and to prevent people from dying, then this is a pretty important thing for physicians to learn how to do.”

HIV research didn't stop at the approval of two or three medications, Dr. Lagisetty added. “Hopefully, this will also spin on more research to develop newer treatment options for these patients so they don't just have three drugs on the market to treat them,” she said.