Factors to Consider Before Prescribing Buprenorphine
Abstract
Recent changes in rules regarding waivers for buprenorphine prescribing and the FDA approval of several buprenorphine formulations were among topics discussed at IPS: The Mental Health Services Conference.
Buprenorphine is one of three medications approved for the treatment of opioid use disorder (OUD). A panel of experts shared important updates on this medication at IPS: The Mental Health Services Conference in October.
Petros Levounis, M.D., noted that with the recent approvals of both one-month-long buprenorphine injections as well as six-month intramuscular buprenorphine rods, physicians now have a range of options when considering the best dosing strategy for OUD patients.
John Renner, M.D., a professor of psychiatry at Boston University School of Medicine and vice chair of APA’s Council on Addiction Psychiatry, began the session by updating the audience about the most recent changes in rules regarding waivers for buprenorphine prescribing in office-based settings.
In late 2016, the Substance Abuse and Mental Health Services Administration (SAMHSA) expanded the number of patients that trained physicians may treat using buprenorphine from 30 to 100. To prescribe buprenorphine, physicians must complete eight hours of training and register with the Drug Enforcement Agency. In addition, physicians who have prescribed at their 100-patient limit for one year can apply to SAMHSA to increase their limit to 275 patients.
The passage of the Comprehensive Addiction and Recovery Act in 2016 expanded the types of health care professionals who are eligible to prescribe buprenorphine. Following 24 hours of training, physician assistants and nurse practitioners can also receive waivers to prescribe buprenorphine. They are capped at treating 30 patients.
Key Points
Key updates to buprenorphine prescribing over the past two years include the following:
Under guidelines from the Substance Abuse and Mental Health Services Administration, physicians with a buprenorphine-prescribing waiver can now treat up to 275 patients after spending one year at the 100-patient cap.
Nurse practitioners and physician assistants can also receive buprenorphine waivers after completing 24 hours of training.
FDA approvals for buprenorphine products include a generic sublingual film, a month-long depot injection, and six-month-long implantable rods.
If fentanyl exposure is known or suspected in a patient, the patient should be in moderate withdrawal before buprenorphine is started.
Research suggests brief but regular medication-monitoring visits can be as effective as behavioral therapy, providing a treatment path that takes patient time into consideration.
Bottom Line: While no drastic changes in buprenorphine practice have occurred in recent years, new drug formulations and changes to waiver requirements may help increase access to this treatment.
Thanks to the approval of several buprenorphine formulations in recent years, prescribers have more options than ever before, Petros Levounis, M.D., chair of psychiatry at Rutgers New Jersey Medical School, told IPS attendees. Most exciting, he said, was the approval of a generic buprenorphine sublingual this year.
“This has been a Holy Grail of manufacturers for some time,” Levounis said. In 2017, the FDA also approved the first once-monthly buprenorphine depot injection. As with long-acting antipsychotics, it is hoped that this depot formulation will help patients who have trouble adhering to a daily medication regimen. Another option is extended-release buprenorphine rods (brand name Probuphine). These rods, which last six months, release the equivalent of 8 mg buprenorphine daily. Levounis noted that physicians may be slower to prescribe Probuphine because they prefer to prescribe higher daily doses of buprenorphine (in the 12 mg to 16 mg range). Additionally, because Probuphine requires implantation and removal, physicians must complete a training course to be certified to do these procedures. Levounis said that many psychiatrists might be uncomfortable doing these implants. Regardless of the route of administration, the critical issue with new patients is getting them properly initiated on buprenorphine. Current guidelines suggest that a patient should be in mild withdrawal before starting buprenorphine, which equates to a Clinical Opiate Withdrawal Scale (COWS) score of 8 to 10. The rise of fentanyl-laced products, however, is forcing physicians to rethink this approach, Renner said.
Fentanyl is a potent product and stays in the body longer than the opioids with which it is typically mixed. Therefore, if a physician suspects or is unsure about the presence of fentanyl, Renner said the physician should wait until the patient is in moderate withdrawal (COWS score of 13 to 15) before initiating buprenorphine to ensure their system is clear of fentanyl; otherwise, the buprenorphine will precipitate rapid and severe withdrawal symptoms. (The COWS score guideline of 13 to 15 is also used when switching patients from methadone, which also has a long metabolic half-life in the body, to buprenorphine.)
While buprenorphine was the focus of the session, the presenters reminded everyone that this medication is just one part of a comprehensive substance use treatment program. Behavioral therapies and interventions, such as peer support, are important to maintain patient engagement.
Historically, said Renner, many physicians believed that behavioral therapy for substance use disorder should be intensive, including both individual and group therapy sessions. Recent studies have shown that patients with substance use disorders who have brief (15- to 20-minute sessions) but regular visits with their physician to discuss medication use experience benefits that are similar to those of patients who participate in full therapy sessions that make use of cognitive-behavioral therapy or other psychotherapies.
John Renner, M.D., says that if psychiatrists suspect a patient with OUD has taken fentanyl, buprenorphine should not be initiated until the patient is in moderate withdrawal to make sure all the fentanyl is cleared.
Renner said that a switch to shorter counseling visits makes sense from both patient and physician perspectives. “In the past, patients might be doing really well on buprenorphine but are told they still need to attend all their weekly individual and group sessions,” he said. “It made people who were ready to resume normal functioning feel like they had to choose between therapy and real-world activities like employment.”
Eventually, if all goes well, patients will be stable, functional, and likely ready to reduce their daily buprenorphine dose. That naturally leads to the question of how low can maintenance buprenorphine be? Can a patient even be taken off completely?
“Detoxification is risky,” Renner said. “Studies have shown that buprenorphine withdrawal results in poor outcomes even when psychosocial treatments are still provided to patients.”
Levounis agreed with that assessment. “What I’ve seen in my clinical experience is that most people can get down to about 2 mg of buprenorphine daily, but then they hit a wall,” he told the audience. It’s possible that some patients might be able to be completely tapered off buprenorphine, but he encouraged close monitoring of such patients for several weeks following the taper. ■
