New Buprenorphine Prescribing Guidelines Give Clinicians Better Ability to Treat Opioid Withdrawal
Author: Christine Zink, MD
Drug overdose is the leading cause of injury-related death in the United States.1 In 2019, over 70,000 people died from a drug overdose, and over 70% involved a prescription or illicit opioid. Prescription opioid use has been a significant contributor to the opioid epidemic since the early 2000s.2 The amount of prescribed opioids peaked in 2012, with more than 255 million prescriptions dispensed. Since then, the dispensing rate has steadily declined to half of the number of prescriptions dispensed in 2012, and fallen to its lowest level in 15 years.2 Yet, opioid-related mortality continues to rise, mainly due to illicit fentanyl use.3
At the same time that the number of opioid overdose deaths has increased, clinicians have witnessed a rise in opioid withdrawal symptoms in people hoping to combat their addiction. People who develop tolerance and dependence on opioids after using them for a long time experience withdrawal symptoms when they reduce or suddenly stop taking them.4 Withdrawal symptoms are similar no matter the type of opioid used and include vomiting, diarrhea, anxiety, sweating, chills, insomnia, yawning, and myalgias.4 The duration of withdrawal symptoms varies from person to person and can depend on the type of opioid taken. The course of withdrawal is also complicated by drug reuse to combat withdrawal symptoms.4 People who take short-acting opioids like immediate-release morphine, oxycodone, hydrocodone, and fentanyl can develop withdrawal symptoms within 8 to 24 hours after the last use.4,5 The withdrawal symptoms can continue for approximately 10 days. People who use long-acting opioids like methadone or extended-release oxycodone, hydrocodone, and fentanyl may not develop withdrawal symptoms until about 1 to 3 days after the last use, and the duration of withdrawal can last 2 weeks or longer.4,5
Withdrawal symptoms are incredibly uncomfortable for the patient and can be difficult for the clinician to treat. In comparison to other substances of abuse, withdrawal from opioids is not often life-threatening.5 Several different medications are used to treat opioid withdrawal and the associated symptoms, yet the effectiveness and clinician comfort with each medication varies. In general, opioid receptor agonists like buprenorphine and methadone are superior to alpha-2 adrenergic agonists like clonidine and lofexidine.6 Buprenorphine and methadone have comparable efficacy in a supervised setting, but since buprenorphine is a partial mu-receptor agonist, it is more easily administered from an office-based setting. Additionally, it has greater safety in overdose compared to methadone.6 Buprenorphine can be administered as a combination with naloxone in a 4:1 ratio.6 The addition of naloxone discourages intravenous buprenorphine abuse since naloxone can precipitate withdrawal. This combination medication is called Suboxone. It should not be used in individuals who recently ingested or used an opioid.
The American Medical Association (AMA) reports that prescriptions for buprenorphine and naloxone have increased marginally despite the continued rise in opioid overdose mortality.3 Relatively few clinicians have been trained or feel comfortable prescribing buprenorphine or Suboxone. Some of this limited knowledge and effort to institute medication-assisted therapy for opioid abuse and withdrawal stems from prescribing restrictions that have been in place up until this year. To offer this treatment to more people during the opioid epidemic, the Department of Health and Human Services (HHS) released new buprenorphine practice guidelines and removed a longtime requirement for federal training and certification before physicians begin prescribing medicines like buprenorphine.7 The HHS knows that medication-based treatment promotes long-term recovery from opioid use disorder, and they want to empower clinicians to use evidence-based treatments from an office-based setting.7 Previously, physicians were required to complete an 8-hour training course on medication-assisted therapy, and other clinicians, like physician associates and nurse practitioners, were required to complete 24 hours of training.8,9 Those training requirements are now lifted. The new practice guidelines for the administration of buprenorphine for treating opioid use disorder state that7:
- Clinicians, including physicians, physician associates, nurse practitioners, and others licensed under state law who possess a valid DEA registration, may be exempt from the certification requirements related to training, counseling, and other ancillary services when prescribing certain medications like buprenorphine.
- Clinicians utilizing the exemption are limited to treating no more than 30 patients at any one time.
- Under the exemption, physician associates, nurse practitioners, and other clinicians who require physician supervision must collaborate with a DEA registered physician when prescribing medication to treat opioid use disorder.
- Clinicians who do not wish to practice under the exemption and its 30-patient limit may seek a waiver per established protocols.
- The exemption applies only to prescription schedule III, IV, and V drugs covered under the controlled substances act, such as buprenorphine. It does not apply to the use of schedule II medications like methadone.
- Before treating patients with buprenorphine for opioid use disorder, clinicians are required to obtain a waiver and submit a notice of intent to HHS’s Substance Abuse and Mental Health Services Administration.
Several major medical groups such as the AMA praise this move by HHS.10 The AMA published their own overdose epidemic report in September 2021, and one of their suggestions includes the removal of barriers to evidence-based care for patients with substance use disorder.3 This training requirement change will give clinicians a better chance at fighting the opioid epidemic, particularly in rural areas of America where potentially no provider could offer this treatment under the previous guidelines.
Even though HHS no longer requires the 8- or 24-hour training before prescribing medications like buprenorphine, clinicians may still want access to training since it is often not taught in schools. The American Academy of Addiction Psychiatry offers an 8-hour and 24-hour training to learn how to use buprenorphine for opioid use disorder. The American Psychiatric Association also offers a few 8-hour training activities. Learn more about and view questions related to HHS’s new guidelines here. The full guidelines are available online, and you can apply for your X-waiver here. Learn more about and earn free opioid CME for opioid use disorder treatment options at Pri-Med.
2. Centers for Disease Control and Prevention. US opioid dispensing rate maps. Updated September 17, 2021. https://www.cdc.gov/drugoverdose/rxrate-maps/index.html
3. American Medical Association. 2021 overdose epidemic report: physicians’ actions to help end the nation’s drug-related overdose and death epidemic–and what still needs to be done Updated September 17, 2021. https://www.ama-assn.org/system/files/ama-overdose-epidemic-report.pdf
4. Srivastava AB, Mariani JJ, Levin FR. New directions in the treatment of opioid withdrawal. Lancet. 2020 Jun 20;395(10241):1938-1948.
5. Walker LK. Opioid withdrawal: signs, symptoms, and addiction treatment. American Addiction Centers website. Updated August 3, 2021. https://americanaddictioncenters.org/withdrawal-timelines-treatments/opiate
6. Sevarino KA. Medically supervised opioid withdrawal during treatment for addiction. UpToDate, Inc. Updated August 18, 2020. https://www.uptodate.com/contents/medically-supervised-opioid-withdrawal-during-treatment-for-addiction
7. US Department of Health and Human Services. HHS releases new buprenorphine practice guidelines, expanding access to treatment for opioid use disorder. Updated April 27, 2021. https://www.hhs.gov/about/news/2021/04/27/hhs-releases-new-buprenorphine-practice-guidelines-expanding-access-to-treatment-for-opioid-use-disorder.html
8. The American Academy of Physician Assistants. New guidelines for buprenorphine treatment provide exemption to burdensome training requirements. Updated April 28, 2021. https://www.aapa.org/news-central/2021/04/new-guidelines-for-buprenorphine-treatment-provide-exemption-to-burdensome-training-requirements/
9. American Association of Nurse Practitioners. Practice guidelines for the administration of buprenorphine for treating opioid use disorder. https://www.aanp.org/advocacy/federal/federal-issue-briefs/practice-guidelines-for-the-administration-of-buprenorphine-for-treating-opioid-use-disorder
10. Schroeder KR. Most doctors can prescribe opioid treatment medication after rule change. Dayton Daily News. January 25, 2021. https://www.daytondailynews.com/news/most-doctors-can-prescribe-opioid-treatment-medication-after-rule-change/DHJWCWKFBFBWBDEINNMM2TE7EM/