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Nurse Practitioners’ Pivotal Role in Ending the Opioid Epidemic
The Journal for Nurse Practitioners 15 (2019) 323e327
Contents lists available at ScienceDirect
The Journal for Nurse Practitioners journal homepage: www.npjournal.org
Continuing Education
Nurse Practitioners’ Pivotal Role in Ending the Opioid Epidemic Dorothy James Moore, DNP, FNP-C a b s t r a c t Keywords: buprenorphine drug treatment medically assisted treatment opioid use disorder
A tremendous treatment gap exists for the care of persons with opioid use disorder. The vast majority of waivered practitioners, more than 90%, are in urban United States counties. The Comprehensive Addiction and Recovery Act of July 2016 enabled nurse practitioners to help fill that gap by prescribing buprenorphine for opioid use disorder. Free training is available for nurse practitioners who can play a key part in stemming the opioid epidemic in the US by obtaining a Drug Enforcement Administration waiver to prescribe buprenorphine, which is a mainstay treatment for opioid addiction. © 2019 Elsevier Inc. All rights reserved.
This CE learning activity is designed to augment the knowledge, skills, and attitudes of nurse practitioners so they may effectively utilize medication assisted treatment with buprenorphine for opioid use disorder as measured by a score of at least 70% on the CE evaluation quiz. At the conclusion of this activity, the participant will be able to: A. Describe the extent of the opioid epidemic, the population most affected, and the theory of MAT B. Identify the legislative changes of the CARA Act for NPs and how they can become buprenorphine prescribers C. Explain the pharmacokinetics of buprenorphine when used for MAT The author, reviewers, editors, and nurse planners all report no financial relationships that would pose a conflict of interest. The author does not present any off-label or non-FDAapproved recommendations for treatment. This activity has been awarded 1 Contact Hours of which 0.5 credits are in the area of Pharmacology. The activity is valid for CE credit until June 1, 2021.
The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act, signed into law October 24, 2018, establishes the ability of permanent nurse practitioners (NPs) to prescribe buprenorphine for opioid use disorder (OUD) as a part of medication-assisted
https://doi.org/10.1016/j.nurpra.2019.01.005 1555-4155/© 2019 Elsevier Inc. All rights reserved.
treatment (MAT). This legislation offers NPs a chance to play a pivotal role in reversing the opioid epidemic’s rising rates of addiction and overdose death in the United States. The SUPPORT Act supersedes the Comprehensive Addiction and Recovery Act (CARA) of July 2016, which provisionally enabled NPs and physician assistants (PAs) to take specialized training to obtain a Drug Enforcement Administration (DEA) waiver to prescribe buprenorphine for OUD on a 5-year trial basis ending in 2021. The SUPPORT Act also allows certified nurse specialists and nurse midwives to be waivered to treat patients with buprenorphine.1
Scope of the Issue More than 130 people die every day from opioid overdose2 in the US. Upwards of 2.4 million persons in the US suffer from substance abuse disorders related to opioids including abuse of prescription medications as well as heroin. By conservative estimates, only 20% of people with OUD receive treatment.3 Access to treatment is further limited by geography; providers tend to be clustered in large urban areas and are sparsely distributed in rural areas. Currently, there are 248,000 NPs licensed to practice throughout the US who could help fill the treatment void.4 From 2000 to 2015, when CARA was signed, more than 335,000 people died from opioid overdose in the US, about 6 times as many as US military casualties in the Vietnam War. By 2016, there were 2.1 million people in the US with OUD. That year 51,969 people died from opioid overdose; 19,413 deaths were from overdose on synthetic opioids other than methadone, 15,469 deaths were heroin overdose deaths, and 17,087 were overdoses of commonly prescribed opioids.5
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The opioid epidemic has particularly affected young adults. In 2016, 20% of the deaths for people aged 24 to 25 years involved opioids, and 67.5% of these were men. To contextualize these numbers in terms of other chronic conditions, in the US in 2016, heart disease accounted for 635,260 deaths; cerebrovascular diseases 142,142 deaths; diabetes 80,058 deaths; and nephritis, nephrotic syndrome, and nephrosis 50,046 deaths.6 Legislative Overview Beginning in 2000, when the Drug Addiction Treatment Act of 2000 (DATA 2000) became law, physicians with 8 hours of specialized training could prescribe buprenorphine for OUD in an outpatient setting. DATA 2000 represented a real change for patients with OUD because it enabled them to obtain buprenorphine in office-based clinics, a far less structured and often less stigmatizing treatment setting than opioid treatment programs that dispense methadone. However, DATA 2000 specifically prohibited advanced practice nurses, NPs, and PAs from prescribing buprenoprhine, even if they had controlled substance prescriptive authority and a DEA number.7 The number of physicians waivered to prescribe buprenorphine has lagged far behind the number of persons with OUD. In 2002, there were only 1,119 buprenorphine-waivered physicians. Throughout the years 2000 to 2015, the treatment gap continued to grow. In 2015, only about half of US counties had a physician who could prescribe buprenorphine. Not surprisingly, states with higher death rates had some of the lowest rates of buprenorphine prescribers.8 CARA and SUPPORT: Enabling NPs to Prescribe Buprenorphine President Obama signed CARA on July 22, 2016, as a response to the treatment gap for substance addiction patients and the worsening opioid epidemic. CARA approaches the opioid epidemic on 3 fronts: decriminalization of low-level drug violations, offering instead more referrals to treatment; more programs to expand distribution and the use of naloxone for firsts responders; and support of MAT by extending practice waivers to NPs and PAs.9 CARA follows state law regarding whether an NP works with a physician through a supervisory or collaborative relationship. If the state law requires that a physician supervise an NP, that physician must also be waivered to prescribe buprenorphine. CARA stipulates that waivered NPs and PAs during their first year of being waivered can prescribe to no more than 30 patients at a time, and that after 1 year of prescribing buprenorphine, NPs and PAs can petition to increase their patient load to 100 patients through the Substance Abuse and Mental Health Services Administration (SAMHSA). The 2018 SUPPORT Act10 expands CARA and states that NPs who provide MAT in a qualified practice setting may immediately treat 100 patients. Details of the SUPPORT Act as it pertains to NPs can be found in Section 3201 of the act. Qualified practice settings where NPs may immediately take on a higher caseload must provide professional coverage for medical emergencies after hours, provide case management services including follow-up and referral services, use health information technology, be registered with their state prescription monitoring program, and accept third-party payment.11 As a result of the CARA Act, as of November 2018, there were approximately 6,843 NPs qualified to prescribe buprenorphine to patients in the US with OUD.12 MAT MAT is an evidence-based approach to addiction treatment that uses medication, integrated with counseling and other behavioral
therapies to provide holistic, patient-centered care. MAT is widely recognized as the most effective care for persons with OUD. In addition to being supported by SAMHSA, MAT is endorsed by many professional organizations, including the American Association of Nurse Practitioners (AANP) and the American Psychiatric Nurses Association (APNA).13,14 MAT for OUD improves patient survival rates and offers many other harm reduction benefits. Patients stay in treatment longer than with abstinence-based treatment programs. MAT decreases illicit opioid use and associated criminal activity in people with substance abuse disorder. MAT reduces the chances of contracting human immunodeficiency virus, hepatitis C, or an abscess from contaminated needle injections. Patients are able to lead more stable lives with MAT because they are not experiencing the ups and downs of withdrawal and the anxiety and danger when searching for their next fix.7,15 Medications to Treat OUD There are 3 drugs approved by the US Food and Drug Administration (FDA) for treating OUD: methadone, naltrexone, and buprenorphine. Methadone is an opioid agonist. It is dispensed in a liquid form or 40-mg tablets, usually daily, at specially regulated opioid treatment centers. For many patients, methadone treatment is lifesaving, but for others, the requirement of daily clinic visits for methadone dosing is burdensome. Some patients find it hard to travel and hold down jobs with the structure of opioid treatment center care and often see the centers as punitive and stigmatizing.16 Naltrexone is an opioid antagonist, usually given as a once a month injection. In order to begin naltrexone treatment, a person must completely withdraw from opioids, a requirement that is challenging for many.17 Naltrexone is much less commonly used for OUD than methadone or buprenorphine.18 First created as a pain medication in the 1960s, buprenorphine is a partial opioid agonist. In a small percentage of patients, it can create mild euphoric sensation and in sufficient quantities, especially when mixed with benzodiazipines, may induce respiratory depression. However, most buprenorphine users report no sense of euphoria but say they feel normal for the first time since starting opioids. Overdose is rare. One analysis found buprenorphine to be 6 times safer than methadone.19-21 Buprenorphine has very low oral bioavailability. It is absorbed through the oral mucosa sublingually and not by the gut. The halflife of buprenorphine is long, 24 or more hours. It binds very tightly to opioid receptors and dissociates slowly from those receptors, making it difficult for a person to feel any euphoria from additional opioids that might be taken along with buprenorphine. Buprenorphine can continue to suppress opioid withdrawal symptoms for 2 to 3 days after a person stops using it.21 Another important feature of buprenorphine is that is has an effective ceiling, usually around 24 mg. This means that after the ceiling is reached, taking more medication will not have an increased effect on the patient. This ceiling is a safety feature compared with other opiates because the patient is not driven to consume escalating doses to chase a high euphoric feeling. This means that a person is much less likely to overdose on buprenorphine when compared with full opioid agonists like methadone or heroin.22 Buprenorphine Naloxone for MAT Buprenorphine naloxone is often called the gold standard for MAT. The combination of buprenorphine and naloxone was approved 2002 by the FDA for outpatient OUD treatment. It is most commonly dispensed as a sublingual film or tablet. Most
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practitioners who prescribe buprenorphine for MAT, prescribe the combination product of buprenorphine naloxone. The addition of naloxone is intended to make it very difficult for someone to abuse buprenorphine naloxone by crushing and injecting it. Naloxone, a complete opioid antagonist, is not well absorbed through the oral mucosa, but when injected, it blocks the effects of all opioids, including buprenorphine, at least for a short while because the half-life of naloxone is around 1 hour. Buprenorphine naloxone is the usual choice for treating MAT because it is less likely to be abused than buprenorphine alone.23 A Brief Overview of Treatment Approach Viewing OUD disorder as a chronic, potentially relapsing condition is key to understanding treatment modalities based on MAT using buprenorphine. Many experts have described addiction not as a moral failing or lack of willpower but rather as a brain disease comprised of 3 recurring stages: binge and intoxication, withdrawal and negative effect, and craving.24 Just as with other chronic conditions such as cardiovascular disease, diabetes, or kidney disease, treating OUD requires consistent, ongoing care. With OUD, just as with other chronic conditions, there can be periods of relapse and issues with nonadherence to treatment regimens that require individualized care and support. NP-led primary care clinics can be an ideal venue for this care. Finding the best daily dose for most patients requires an individualized approach that involves practitioner experience and close patient assessment. Thus, the most provider-intensive time in prescribing buprenorphine is the induction period when patients stop the opioids they are abusing and are titrated to a dose of buprenorphine that suppresses withdrawal symptoms. The best method for buprenorphine induction is still under study and depends on many factors, including whether the patient is abusing a long-acting or short-acting opioid.25 Most providers use the Clinical Opiate Withdrawal Scale to determine when to start treatment. Because buprenorphine has such a high affinity for the brain’s mu-opioid receptors, patients should be in mild to moderate withdrawal before starting buprenorphine (Clinical Opiate Withdrawal Scale score of 6 to 12).26 Waiting to begin buprenorphine until the patient is in severe withdrawal subjects the patient to needless discomfort and risks treatment failure. Home-based, or unobserved, buprenorphine inductions are becoming increasingly common. With this method, patients are given instructions for titrating their dose and begin taking medication at home. During the first few days of treatment, until a steady state dose is achieved, patients may need additional provider support. With MAT, treatment goals are individualized, and the time patients remain on buprenorphine varies from case to case, with 2 years being a minimum interval suggested by some clinicians. While under treatment, patients must be monitored to prevent risk of diversion. Checking state prescription drug databases and conducting random urine toxicology screens are best practice recommendations. Ongoing counseling or support group services are also recommended. Longer treatment intervals are associated with lower relapse rates.27
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reports that substance abuse costs over $600 billion annually. Effective treatment that can steer people away from drug-related criminal activity is much more cost-effective than jail, which costs at least $24,000 per year.28 According to the US Department of Defense, the average cost of providing outpatient treatment using buprenorphine for a stable patient including medication and twice-weekly visits is about $126 a week or $6,552.00 annually.29 This cost is at par with that of treating other chronic diseases. By comparison, the estimated costs for treating Medicaid patients annually in 2015 were $3,219 to $4,674 for diabetes and $4,968 to $6,491 for chronic obstructive lung disease.30 Stakeholder Opposition and Support: Barriers to Care The true opposition to NPs (or anyone) prescribing buprenorphine ranges from philosophical opposition to MAT and concerns regarding patient diversion of buprenorphine to issues with pharmacy distribution, insurance prior authorization requirements, and other structural barriers. There are few stakeholder physician or pharmaceutical opponents on record against NPs prescribing buprenorphine. However, most practitioners prescribing buprenorphine for OUD will agree that merely expanding the number of providers with addiction training does not address other barriers to providing care for this population. At the time of this writing, Tennessee is the only US state that does not allow NPs to prescribe buprenorphine for OUD. In January 2018, the Tennessee state legislature passed a bill authorizing a work group to convene to study the issue. That report is due to be submitted February 1, 2019.31 It is fair to say that Tennessee has moved very conservatively in general in adopting policies for addiction treatment. In the 22 states where NPs have full practice, NPs can then independently prescribe and manage MAT with buprenorphine. In the 28 states where NP practice is limited, NPs can be supervised by a physician waivered to prescribe buprenorphine for OUD. This can become quite a hurdle for NPs because the number of waivered physicians is limited, particularly in rural areas.32 The American Academy of Physician Assistants, the AANP, and SAMHSA have all advocated that the condition that a supervising physician be waivered be reinterpreted to include physicians who otherwise meet the requirements of CARA.33 Philosophical Resistance to MAT Within some addiction treatment circles, there is opposition to MAT because it is seen as simply replacing one drug with another. For instance, Narcotics Anonymous meetings typically advocate that participants be completely drug free. Also, many privately operated inpatient drug treatment regimens require that patients go through detox and then maintain complete drug abstinence through counseling and other social support. In the addiction treatment community itself, there is pressure from some for patients to be chemical-free and clean and sober, a stigmatizing but frequently heard term.34 Misuse and Diversion
Cost of Treatment The cost of treating a person with OUD disorder is a bargain compared with the ongoing costs to society in terms of increased criminal activity and medical bills. These costs include use of the criminal justice system, transmission of infectious diseases, lost days from work, accidents causes by persons driving under the influence, and many more. The National Institute on Drug Abuse
One risk factor for misuse and diversion is the inability to access buprenorphine legally35 because some persons use illicit buprenorphine as a bridge to prevent withdrawal until they can obtain their drug of choice. Others mix buprenorphine with a benzodiazepine, some attempting to amplify the euphoric feeling that may occur with buprenorphine.36 This is a potentially lethal combination, and the few deaths associated with buprenorphine have been
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caused by mixing it with benzodiazapines.37 In the US, it is known that both buprenorphine and buprenorphine naloxone are diverted and that buprenorphine naloxone films are easily smuggled into prisons.38 The scope of this issue is not well quantified and deserves caution and care on the part of MAT providers. Supply Scarcity and Stigma at the Pharmacy Accessibility to medication is not consistent and often seems to be at the whims of a drug manufacturing and distribution system that is heavily burdened with drug shortages. It is not unusual, even in urban areas, for a practitioner or patient to call 3 or 4 pharmacies in order to find buprenorphine naloxone in stock. Pharmacies are often reluctant to order ahead because they do not want it known that they have back stock of buprenorphine products. Patients become anxious toward the end of their prescription, not knowing if they will be able to get it filled in a timely manner, adding to the stress for practitioners managing their care. Also, some pharmacists are not comfortable filling prescriptions for OUD, and patients say they feel stigmatized and interrogated when they go to pick up their medication.39,40 Record Keeping, Drug Testing, and Prescription Drug Monitoring Databases Caring for patients with OUD with MAT requires some extra steps that practitioners may feel are too complicated and timeconsuming. The provider must keep careful records and always be ready for a DEA inspection. Because of the DEA limits on the number of patients who can be treated (ie, 30 in the first year and 100 with approval the next year), the practitioner must also keep a careful record of the number of patients being actively treated. The number of prescriptions and the number of pills/films prescribed must be carefully recorded because best practice is not to allow early refills in order prevent abuse or diversion. Patients should also be randomly drug tested, which can be a urine or saliva test performed in the practitioner’s office. This is done to confirm that patients are taking their buprenorphine and to screen for additional opioids or benzodiazepines to prevent drug overdose.41 Providers should also check their state’s prescription monitoring database, if one exists, before prescribing to guard against doctor shopping and multiple concurrent prescriptions or prescriptions for substances that may be harmful to the patient, particularly benzodiazepines or opioids. Some states have mandated prescription monitoring database checks as a legal requirement before practitioners prescribe any controlled substance.42 For the NP already involved in primary care, it is possible to add patients with OUD to one’s panel without incurring additional costs, although these patients may require more consultation time and monitoring. For some practitioners, the stigma of addiction is a driver for not wanting to take on OUD patients. For others, the extra paperwork, drug testing, and worry about diversion are not worth the effort. Some practitioners do not feel comfortable with these measures and also fear that these patients may be disruptive or bothersome to their non-OUD patients. All of these challenges make people reluctant to take on OUD patients. They can be high-touch patients, requiring more time than many practitioners have to devote to them. However, the converse can also be true, and the rewards of seeing someone truly turning their life around are immeasurable.43 How to Become a Buprenorphine Provider To qualify for a waiver, NPs must already possess a DEA license to prescribe scheduled pain medications and complete at least 24
hours of education through a qualified provider (ie, the 8-hour DATA-waiver course that is required for physicians for treating OUD and an additional 16 hours of training). Both of these are selfpaced, online courses provided at no cost through a partnership between the AANP, the American Society of Addiction Medicine, American Academy of Physician Assistants, and the APNA. Information on obtaining a buprenorphine waiver can be found on the SAMHSA website.44 Training to obtain a waiver to prescribe buprenorphine is provided through the Providers’ Clinical Support System (PCSS) MAT. PCSS is an initiative funded by SAMSHA that provides national training and mentoring to educate health care providers. The initial 8-hour and the 16-hour courses focus on the foundational practices in MAT including the use of buprenorphine; issues related to the assessment of persons with OUD; and the role, responsibilities, and limitations of a provider as outlined in current regulations. The 2 courses provide 24 contact hours, 21 in pharmacology. Topics included in the courses are the appropriate use of FDA-approved drugs for treating OUD, record keeping, substance use monitoring and diversion control, patient assessments, overdose reversal, counseling, and recovery support.45 In addition to training sessions, PCSS offers a no-cost mentoring program and an email service for clinical questions that are answered by moderators who are clinical experts. The APNA also offers free continuing education courses on effective treatments for OUDs targeted to advanced practice.
NPs Can Play an Important Role Even with the increase in the number of buprenorphine providers since CARA, including NPs and PAs, a treatment gap still exists in OUD care. Ninety percent of waivered practitioners are in urban US counties. At least 30% of rural providers who obtained waivers are not actively treating OUD patients, and 40% of those rural providers who are treating patients for OUD are not accepting new patients. Also, most providers are not treating to the full capacity their waiver permits. Those with a 100-patient waiver were treating on average 56.9 patients, and those with a 30-patient waiver were on average treating 8.8 patients.46 The need is great for NPs to step in and treat OUD patients. MAT is a process, not a quick fix. It is a long-term commitment to care both on the part of the provider and the patient. It involves not only medication but also counseling and support. In a society that looks for a 1-pill solution to disease, MAT is challenging for some people to accept. NPs, who can provide wholistic, patient-centered care, are well positioned to step in and take on the role of caring for patients with OUD. By viewing OUD as a chronic disease that can be managed in a primary care context, NPs can have a tremendous impact on improving access to treatment for patients with OUD, particularly in rural and underserved areas. Buprenorphine naloxone MAT improves the quality of life of patients with OUD, returning them to work and reducing comorbidities. Most importantly, it saves lives.
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Dorothy James Moore, DNP, FNP-C, is an assistant professor at Valley School of Nursing, San Jose State University in San Jose, CA. She is available at [email protected]. In compliance with national ethical guidelines, the author reports no relationships with business or industry that would pose a conflict of interest.
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The Journal for Nurse Practitioners journal homepage: www.npjournal.org
Continuing Education
Nurse Practitioners’ Pivotal Role in Ending the Opioid Epidemic Dorothy James Moore, DNP, FNP-C a b s t r a c t Keywords: buprenorphine drug treatment medically assisted treatment opioid use disorder
A tremendous treatment gap exists for the care of persons with opioid use disorder. The vast majority of waivered practitioners, more than 90%, are in urban United States counties. The Comprehensive Addiction and Recovery Act of July 2016 enabled nurse practitioners to help fill that gap by prescribing buprenorphine for opioid use disorder. Free training is available for nurse practitioners who can play a key part in stemming the opioid epidemic in the US by obtaining a Drug Enforcement Administration waiver to prescribe buprenorphine, which is a mainstay treatment for opioid addiction. © 2019 Elsevier Inc. All rights reserved.
This CE learning activity is designed to augment the knowledge, skills, and attitudes of nurse practitioners so they may effectively utilize medication assisted treatment with buprenorphine for opioid use disorder as measured by a score of at least 70% on the CE evaluation quiz. At the conclusion of this activity, the participant will be able to: A. Describe the extent of the opioid epidemic, the population most affected, and the theory of MAT B. Identify the legislative changes of the CARA Act for NPs and how they can become buprenorphine prescribers C. Explain the pharmacokinetics of buprenorphine when used for MAT The author, reviewers, editors, and nurse planners all report no financial relationships that would pose a conflict of interest. The author does not present any off-label or non-FDAapproved recommendations for treatment. This activity has been awarded 1 Contact Hours of which 0.5 credits are in the area of Pharmacology. The activity is valid for CE credit until June 1, 2021.
The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act, signed into law October 24, 2018, establishes the ability of permanent nurse practitioners (NPs) to prescribe buprenorphine for opioid use disorder (OUD) as a part of medication-assisted
https://doi.org/10.1016/j.nurpra.2019.01.005 1555-4155/© 2019 Elsevier Inc. All rights reserved.
treatment (MAT). This legislation offers NPs a chance to play a pivotal role in reversing the opioid epidemic’s rising rates of addiction and overdose death in the United States. The SUPPORT Act supersedes the Comprehensive Addiction and Recovery Act (CARA) of July 2016, which provisionally enabled NPs and physician assistants (PAs) to take specialized training to obtain a Drug Enforcement Administration (DEA) waiver to prescribe buprenorphine for OUD on a 5-year trial basis ending in 2021. The SUPPORT Act also allows certified nurse specialists and nurse midwives to be waivered to treat patients with buprenorphine.1
Scope of the Issue More than 130 people die every day from opioid overdose2 in the US. Upwards of 2.4 million persons in the US suffer from substance abuse disorders related to opioids including abuse of prescription medications as well as heroin. By conservative estimates, only 20% of people with OUD receive treatment.3 Access to treatment is further limited by geography; providers tend to be clustered in large urban areas and are sparsely distributed in rural areas. Currently, there are 248,000 NPs licensed to practice throughout the US who could help fill the treatment void.4 From 2000 to 2015, when CARA was signed, more than 335,000 people died from opioid overdose in the US, about 6 times as many as US military casualties in the Vietnam War. By 2016, there were 2.1 million people in the US with OUD. That year 51,969 people died from opioid overdose; 19,413 deaths were from overdose on synthetic opioids other than methadone, 15,469 deaths were heroin overdose deaths, and 17,087 were overdoses of commonly prescribed opioids.5
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The opioid epidemic has particularly affected young adults. In 2016, 20% of the deaths for people aged 24 to 25 years involved opioids, and 67.5% of these were men. To contextualize these numbers in terms of other chronic conditions, in the US in 2016, heart disease accounted for 635,260 deaths; cerebrovascular diseases 142,142 deaths; diabetes 80,058 deaths; and nephritis, nephrotic syndrome, and nephrosis 50,046 deaths.6 Legislative Overview Beginning in 2000, when the Drug Addiction Treatment Act of 2000 (DATA 2000) became law, physicians with 8 hours of specialized training could prescribe buprenorphine for OUD in an outpatient setting. DATA 2000 represented a real change for patients with OUD because it enabled them to obtain buprenorphine in office-based clinics, a far less structured and often less stigmatizing treatment setting than opioid treatment programs that dispense methadone. However, DATA 2000 specifically prohibited advanced practice nurses, NPs, and PAs from prescribing buprenoprhine, even if they had controlled substance prescriptive authority and a DEA number.7 The number of physicians waivered to prescribe buprenorphine has lagged far behind the number of persons with OUD. In 2002, there were only 1,119 buprenorphine-waivered physicians. Throughout the years 2000 to 2015, the treatment gap continued to grow. In 2015, only about half of US counties had a physician who could prescribe buprenorphine. Not surprisingly, states with higher death rates had some of the lowest rates of buprenorphine prescribers.8 CARA and SUPPORT: Enabling NPs to Prescribe Buprenorphine President Obama signed CARA on July 22, 2016, as a response to the treatment gap for substance addiction patients and the worsening opioid epidemic. CARA approaches the opioid epidemic on 3 fronts: decriminalization of low-level drug violations, offering instead more referrals to treatment; more programs to expand distribution and the use of naloxone for firsts responders; and support of MAT by extending practice waivers to NPs and PAs.9 CARA follows state law regarding whether an NP works with a physician through a supervisory or collaborative relationship. If the state law requires that a physician supervise an NP, that physician must also be waivered to prescribe buprenorphine. CARA stipulates that waivered NPs and PAs during their first year of being waivered can prescribe to no more than 30 patients at a time, and that after 1 year of prescribing buprenorphine, NPs and PAs can petition to increase their patient load to 100 patients through the Substance Abuse and Mental Health Services Administration (SAMHSA). The 2018 SUPPORT Act10 expands CARA and states that NPs who provide MAT in a qualified practice setting may immediately treat 100 patients. Details of the SUPPORT Act as it pertains to NPs can be found in Section 3201 of the act. Qualified practice settings where NPs may immediately take on a higher caseload must provide professional coverage for medical emergencies after hours, provide case management services including follow-up and referral services, use health information technology, be registered with their state prescription monitoring program, and accept third-party payment.11 As a result of the CARA Act, as of November 2018, there were approximately 6,843 NPs qualified to prescribe buprenorphine to patients in the US with OUD.12 MAT MAT is an evidence-based approach to addiction treatment that uses medication, integrated with counseling and other behavioral
therapies to provide holistic, patient-centered care. MAT is widely recognized as the most effective care for persons with OUD. In addition to being supported by SAMHSA, MAT is endorsed by many professional organizations, including the American Association of Nurse Practitioners (AANP) and the American Psychiatric Nurses Association (APNA).13,14 MAT for OUD improves patient survival rates and offers many other harm reduction benefits. Patients stay in treatment longer than with abstinence-based treatment programs. MAT decreases illicit opioid use and associated criminal activity in people with substance abuse disorder. MAT reduces the chances of contracting human immunodeficiency virus, hepatitis C, or an abscess from contaminated needle injections. Patients are able to lead more stable lives with MAT because they are not experiencing the ups and downs of withdrawal and the anxiety and danger when searching for their next fix.7,15 Medications to Treat OUD There are 3 drugs approved by the US Food and Drug Administration (FDA) for treating OUD: methadone, naltrexone, and buprenorphine. Methadone is an opioid agonist. It is dispensed in a liquid form or 40-mg tablets, usually daily, at specially regulated opioid treatment centers. For many patients, methadone treatment is lifesaving, but for others, the requirement of daily clinic visits for methadone dosing is burdensome. Some patients find it hard to travel and hold down jobs with the structure of opioid treatment center care and often see the centers as punitive and stigmatizing.16 Naltrexone is an opioid antagonist, usually given as a once a month injection. In order to begin naltrexone treatment, a person must completely withdraw from opioids, a requirement that is challenging for many.17 Naltrexone is much less commonly used for OUD than methadone or buprenorphine.18 First created as a pain medication in the 1960s, buprenorphine is a partial opioid agonist. In a small percentage of patients, it can create mild euphoric sensation and in sufficient quantities, especially when mixed with benzodiazipines, may induce respiratory depression. However, most buprenorphine users report no sense of euphoria but say they feel normal for the first time since starting opioids. Overdose is rare. One analysis found buprenorphine to be 6 times safer than methadone.19-21 Buprenorphine has very low oral bioavailability. It is absorbed through the oral mucosa sublingually and not by the gut. The halflife of buprenorphine is long, 24 or more hours. It binds very tightly to opioid receptors and dissociates slowly from those receptors, making it difficult for a person to feel any euphoria from additional opioids that might be taken along with buprenorphine. Buprenorphine can continue to suppress opioid withdrawal symptoms for 2 to 3 days after a person stops using it.21 Another important feature of buprenorphine is that is has an effective ceiling, usually around 24 mg. This means that after the ceiling is reached, taking more medication will not have an increased effect on the patient. This ceiling is a safety feature compared with other opiates because the patient is not driven to consume escalating doses to chase a high euphoric feeling. This means that a person is much less likely to overdose on buprenorphine when compared with full opioid agonists like methadone or heroin.22 Buprenorphine Naloxone for MAT Buprenorphine naloxone is often called the gold standard for MAT. The combination of buprenorphine and naloxone was approved 2002 by the FDA for outpatient OUD treatment. It is most commonly dispensed as a sublingual film or tablet. Most
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practitioners who prescribe buprenorphine for MAT, prescribe the combination product of buprenorphine naloxone. The addition of naloxone is intended to make it very difficult for someone to abuse buprenorphine naloxone by crushing and injecting it. Naloxone, a complete opioid antagonist, is not well absorbed through the oral mucosa, but when injected, it blocks the effects of all opioids, including buprenorphine, at least for a short while because the half-life of naloxone is around 1 hour. Buprenorphine naloxone is the usual choice for treating MAT because it is less likely to be abused than buprenorphine alone.23 A Brief Overview of Treatment Approach Viewing OUD disorder as a chronic, potentially relapsing condition is key to understanding treatment modalities based on MAT using buprenorphine. Many experts have described addiction not as a moral failing or lack of willpower but rather as a brain disease comprised of 3 recurring stages: binge and intoxication, withdrawal and negative effect, and craving.24 Just as with other chronic conditions such as cardiovascular disease, diabetes, or kidney disease, treating OUD requires consistent, ongoing care. With OUD, just as with other chronic conditions, there can be periods of relapse and issues with nonadherence to treatment regimens that require individualized care and support. NP-led primary care clinics can be an ideal venue for this care. Finding the best daily dose for most patients requires an individualized approach that involves practitioner experience and close patient assessment. Thus, the most provider-intensive time in prescribing buprenorphine is the induction period when patients stop the opioids they are abusing and are titrated to a dose of buprenorphine that suppresses withdrawal symptoms. The best method for buprenorphine induction is still under study and depends on many factors, including whether the patient is abusing a long-acting or short-acting opioid.25 Most providers use the Clinical Opiate Withdrawal Scale to determine when to start treatment. Because buprenorphine has such a high affinity for the brain’s mu-opioid receptors, patients should be in mild to moderate withdrawal before starting buprenorphine (Clinical Opiate Withdrawal Scale score of 6 to 12).26 Waiting to begin buprenorphine until the patient is in severe withdrawal subjects the patient to needless discomfort and risks treatment failure. Home-based, or unobserved, buprenorphine inductions are becoming increasingly common. With this method, patients are given instructions for titrating their dose and begin taking medication at home. During the first few days of treatment, until a steady state dose is achieved, patients may need additional provider support. With MAT, treatment goals are individualized, and the time patients remain on buprenorphine varies from case to case, with 2 years being a minimum interval suggested by some clinicians. While under treatment, patients must be monitored to prevent risk of diversion. Checking state prescription drug databases and conducting random urine toxicology screens are best practice recommendations. Ongoing counseling or support group services are also recommended. Longer treatment intervals are associated with lower relapse rates.27
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reports that substance abuse costs over $600 billion annually. Effective treatment that can steer people away from drug-related criminal activity is much more cost-effective than jail, which costs at least $24,000 per year.28 According to the US Department of Defense, the average cost of providing outpatient treatment using buprenorphine for a stable patient including medication and twice-weekly visits is about $126 a week or $6,552.00 annually.29 This cost is at par with that of treating other chronic diseases. By comparison, the estimated costs for treating Medicaid patients annually in 2015 were $3,219 to $4,674 for diabetes and $4,968 to $6,491 for chronic obstructive lung disease.30 Stakeholder Opposition and Support: Barriers to Care The true opposition to NPs (or anyone) prescribing buprenorphine ranges from philosophical opposition to MAT and concerns regarding patient diversion of buprenorphine to issues with pharmacy distribution, insurance prior authorization requirements, and other structural barriers. There are few stakeholder physician or pharmaceutical opponents on record against NPs prescribing buprenorphine. However, most practitioners prescribing buprenorphine for OUD will agree that merely expanding the number of providers with addiction training does not address other barriers to providing care for this population. At the time of this writing, Tennessee is the only US state that does not allow NPs to prescribe buprenorphine for OUD. In January 2018, the Tennessee state legislature passed a bill authorizing a work group to convene to study the issue. That report is due to be submitted February 1, 2019.31 It is fair to say that Tennessee has moved very conservatively in general in adopting policies for addiction treatment. In the 22 states where NPs have full practice, NPs can then independently prescribe and manage MAT with buprenorphine. In the 28 states where NP practice is limited, NPs can be supervised by a physician waivered to prescribe buprenorphine for OUD. This can become quite a hurdle for NPs because the number of waivered physicians is limited, particularly in rural areas.32 The American Academy of Physician Assistants, the AANP, and SAMHSA have all advocated that the condition that a supervising physician be waivered be reinterpreted to include physicians who otherwise meet the requirements of CARA.33 Philosophical Resistance to MAT Within some addiction treatment circles, there is opposition to MAT because it is seen as simply replacing one drug with another. For instance, Narcotics Anonymous meetings typically advocate that participants be completely drug free. Also, many privately operated inpatient drug treatment regimens require that patients go through detox and then maintain complete drug abstinence through counseling and other social support. In the addiction treatment community itself, there is pressure from some for patients to be chemical-free and clean and sober, a stigmatizing but frequently heard term.34 Misuse and Diversion
Cost of Treatment The cost of treating a person with OUD disorder is a bargain compared with the ongoing costs to society in terms of increased criminal activity and medical bills. These costs include use of the criminal justice system, transmission of infectious diseases, lost days from work, accidents causes by persons driving under the influence, and many more. The National Institute on Drug Abuse
One risk factor for misuse and diversion is the inability to access buprenorphine legally35 because some persons use illicit buprenorphine as a bridge to prevent withdrawal until they can obtain their drug of choice. Others mix buprenorphine with a benzodiazepine, some attempting to amplify the euphoric feeling that may occur with buprenorphine.36 This is a potentially lethal combination, and the few deaths associated with buprenorphine have been
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caused by mixing it with benzodiazapines.37 In the US, it is known that both buprenorphine and buprenorphine naloxone are diverted and that buprenorphine naloxone films are easily smuggled into prisons.38 The scope of this issue is not well quantified and deserves caution and care on the part of MAT providers. Supply Scarcity and Stigma at the Pharmacy Accessibility to medication is not consistent and often seems to be at the whims of a drug manufacturing and distribution system that is heavily burdened with drug shortages. It is not unusual, even in urban areas, for a practitioner or patient to call 3 or 4 pharmacies in order to find buprenorphine naloxone in stock. Pharmacies are often reluctant to order ahead because they do not want it known that they have back stock of buprenorphine products. Patients become anxious toward the end of their prescription, not knowing if they will be able to get it filled in a timely manner, adding to the stress for practitioners managing their care. Also, some pharmacists are not comfortable filling prescriptions for OUD, and patients say they feel stigmatized and interrogated when they go to pick up their medication.39,40 Record Keeping, Drug Testing, and Prescription Drug Monitoring Databases Caring for patients with OUD with MAT requires some extra steps that practitioners may feel are too complicated and timeconsuming. The provider must keep careful records and always be ready for a DEA inspection. Because of the DEA limits on the number of patients who can be treated (ie, 30 in the first year and 100 with approval the next year), the practitioner must also keep a careful record of the number of patients being actively treated. The number of prescriptions and the number of pills/films prescribed must be carefully recorded because best practice is not to allow early refills in order prevent abuse or diversion. Patients should also be randomly drug tested, which can be a urine or saliva test performed in the practitioner’s office. This is done to confirm that patients are taking their buprenorphine and to screen for additional opioids or benzodiazepines to prevent drug overdose.41 Providers should also check their state’s prescription monitoring database, if one exists, before prescribing to guard against doctor shopping and multiple concurrent prescriptions or prescriptions for substances that may be harmful to the patient, particularly benzodiazepines or opioids. Some states have mandated prescription monitoring database checks as a legal requirement before practitioners prescribe any controlled substance.42 For the NP already involved in primary care, it is possible to add patients with OUD to one’s panel without incurring additional costs, although these patients may require more consultation time and monitoring. For some practitioners, the stigma of addiction is a driver for not wanting to take on OUD patients. For others, the extra paperwork, drug testing, and worry about diversion are not worth the effort. Some practitioners do not feel comfortable with these measures and also fear that these patients may be disruptive or bothersome to their non-OUD patients. All of these challenges make people reluctant to take on OUD patients. They can be high-touch patients, requiring more time than many practitioners have to devote to them. However, the converse can also be true, and the rewards of seeing someone truly turning their life around are immeasurable.43 How to Become a Buprenorphine Provider To qualify for a waiver, NPs must already possess a DEA license to prescribe scheduled pain medications and complete at least 24
hours of education through a qualified provider (ie, the 8-hour DATA-waiver course that is required for physicians for treating OUD and an additional 16 hours of training). Both of these are selfpaced, online courses provided at no cost through a partnership between the AANP, the American Society of Addiction Medicine, American Academy of Physician Assistants, and the APNA. Information on obtaining a buprenorphine waiver can be found on the SAMHSA website.44 Training to obtain a waiver to prescribe buprenorphine is provided through the Providers’ Clinical Support System (PCSS) MAT. PCSS is an initiative funded by SAMSHA that provides national training and mentoring to educate health care providers. The initial 8-hour and the 16-hour courses focus on the foundational practices in MAT including the use of buprenorphine; issues related to the assessment of persons with OUD; and the role, responsibilities, and limitations of a provider as outlined in current regulations. The 2 courses provide 24 contact hours, 21 in pharmacology. Topics included in the courses are the appropriate use of FDA-approved drugs for treating OUD, record keeping, substance use monitoring and diversion control, patient assessments, overdose reversal, counseling, and recovery support.45 In addition to training sessions, PCSS offers a no-cost mentoring program and an email service for clinical questions that are answered by moderators who are clinical experts. The APNA also offers free continuing education courses on effective treatments for OUDs targeted to advanced practice.
NPs Can Play an Important Role Even with the increase in the number of buprenorphine providers since CARA, including NPs and PAs, a treatment gap still exists in OUD care. Ninety percent of waivered practitioners are in urban US counties. At least 30% of rural providers who obtained waivers are not actively treating OUD patients, and 40% of those rural providers who are treating patients for OUD are not accepting new patients. Also, most providers are not treating to the full capacity their waiver permits. Those with a 100-patient waiver were treating on average 56.9 patients, and those with a 30-patient waiver were on average treating 8.8 patients.46 The need is great for NPs to step in and treat OUD patients. MAT is a process, not a quick fix. It is a long-term commitment to care both on the part of the provider and the patient. It involves not only medication but also counseling and support. In a society that looks for a 1-pill solution to disease, MAT is challenging for some people to accept. NPs, who can provide wholistic, patient-centered care, are well positioned to step in and take on the role of caring for patients with OUD. By viewing OUD as a chronic disease that can be managed in a primary care context, NPs can have a tremendous impact on improving access to treatment for patients with OUD, particularly in rural and underserved areas. Buprenorphine naloxone MAT improves the quality of life of patients with OUD, returning them to work and reducing comorbidities. Most importantly, it saves lives.
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Dorothy James Moore, DNP, FNP-C, is an assistant professor at Valley School of Nursing, San Jose State University in San Jose, CA. She is available at [email protected]. In compliance with national ethical guidelines, the author reports no relationships with business or industry that would pose a conflict of interest.