Tox in The Land: Medical Assisted Treatment 2023 Prescriber Updates
As of this year, providers with a DEA license can now prescribe buprenorphine as a treatment for opioid use disorder! Check out this great infographic by PGY2 Dr. Shauna Combs, along with best practices for prescribing buprenorphine for further clarification!
Buprenorphine Best Practice Prescribing FAQ
What is buprenorphine? (brand name = “Subutex;” “Suboxone” if combined with naloxone)
Buprenorphine is a partial agonist of mu-opioid receptors used to treat pain and opioid use disorder.
While buprenorphine has partial agonism at mu-opioid receptors and can cause some effects commonly associated with standard opioid medications (e.g., analgesia, sedation), it causes less of these effects than traditional full-agonist opioids like morphine, hydromorphone (Dilaudid), oxycodone, hydrocodone, heroin (diacetylmorphine), and the like.
Because it is a partial agonist, it is also a partial antagonist and can antagonize other opioids. This can block the effects of other opioid pain medicines at traditional doses, and can precipitate opioid withdrawal in patients who are on chronic opioids.
It will only have antagonist effects in patients actively on opioids, and will cause withdrawal in patients without chronic opioid use or patients who are already withdrawing from opioids (COWS ≥ 8).
Buprenorphine is most commonly prescribed in the outpatient setting as a sublingual tablet or strip, and can also be given intravenously or subcutaneously. A transdermal formulation is also available for pain. The sublingual formulation is the only form that is approved for management of opioid use disorder; additionally, there are long-acting injectable formulations that are approved for the management of opioid use disorder.
Onset of clinical effects is usually within 30-60 minutes. Duration of action ranges from 6 or more hours of clinical effects up to ~36 hours (biologic half-life).
Documented allergies and Iintolerances to buprenorphine that include gastrointestinal symptoms such as nausea, vomiting, diarrhea, etc and/or severe headaches, may be are likely signs of precipitated withdrawal OR may be signs of indicate true allergy/intolerance. This may be difficult to tease out.
Precipitated withdrawal is not a sufficient reason to discontinue or avoid buprenorphine when it is clinically indicated. To mitigate intolerance to the buprenorphine, you may need to order a specific generic formulation, or order brand-name medication, or use mono-buprenorphine.
Indications for prescribing buprenorphine:
Buprenorphine can be prescribed for treatment of pain, treatment of opioid withdrawal, and treatment of opioid use disorder.
If buprenorphine is being prescribed for treatment of pain, a special DATA-2000 “DEA-X” certification is not needed.
If buprenorphine is being prescribed for treatment of opioid use disorder, the DATA-2000 “DEA-X” certification IS needed.
Clinical Opioid Withdrawal Score (COWS):
COWS should be calculated on all patients with reported opioid withdrawal, concern for opioid withdrawal or opioid use disorder and risk for opioid withdrawal. Buprenorphine can be given for a score greater than 8 in a patient with recent opioid use.
OARRS & other considerations: See Overdose Risk Score
Patient instructions on how to take buprenorphine:
While buprenorphine comes in different formulations (intravenous, transdermal, and oral) it can be prescribed for opioid withdrawal and opioid use disorder in a daily oral formulation, a buccal film, or as a long-acting subcutaneous abdominal injection
The oral formulation comes as either a dissolving tablet or a film, which is not meant to be swallowed but rather dissolved in the mouth.
Instructions to patients:
Let Subutex or Suboxone tablets dissolve under your tongue; they are much less effective if swallowed.
Take no more than two tablets at a time; otherwise you may swallow them by mistake.
Wetting the mouth before placing the tablets under your tongue can help the tablets dissolve faster.
Do not smoke for 10 to 15 minutes before you take your medication. Not smoking seems to help the tablets dissolve faster.
Correcting common misconceptions:
Buprenorphine for opioid use disorder is not “replacing one addiction with another.” It is an evidence-based medical treatment.
Buprenorphine can be prescribed indefinitely for the treatment of a chronic medical condition, that is, opioid use disorder.
In comparison to other opioids, buprenorphine has multiple pharmacologic advantages, namely that it is safer than other opioids even in high doses, and it has substantially lower abuse potential than other opioids.
Buprenorphine has a more favorable side effect profile than other opioids, most notably with a “ceiling effect” on respiratory depression. Buprenorphine should not significantly depress respiratory status.
Additional elements of its favorable side effect profile include lack of cardiac conduction abnormalities, fewer gastrointestinal side effects compared to other opioids (e.g., less constipation, no effect on Sphincter of Oddi), less cognitive impairment, and no known effects on functioning of the immune system, the hypothalamic-pituitary axis, or the reproductive system. No dosing adjustment is necessary in kidney and liver disease.
While there are reports of buprenorphine-related deaths, the overwhelming majority of these involve other CNS depressant drugs. Furthermore, confirmation of buprenorphine on postmortem or forensic testing is difficult to interpret, given the drug’s extremely long biologic half-life and association with patients at risk for substance use. Historical population-level data confirms that buprenorphine is an unlikely primary or sole cause of death. Buprenorphine even exceeds safety standards for many over-the-counter medications.
An additional area of concern in regards to increasing buprenorphine availability is the potential for diversion and nonmedical use (aka, misuse) – however, compared to other opioids, buprenorphine has lower rates of nonmedical use.
Use of other substances (e.g., benzodiazepines, other illicit drugs) is not an absolute contraindication to buprenorphine.
Pregnant woman can receive buprenorphine-naloxone combination products (“Suboxone”); they are no longer limited to methadone or buprenorphine (“Subutex”) alone.
From the American College of Obstetricians & Gynecologists:
“Buprenorphine is available as a monoproduct or in a combined formulation with naloxone, an opioid antagonist, used to reduce diversion because buprenorphine combined with naloxone causes severe withdrawal symptoms when injected. However, naloxone is not orally active, so withdrawal symptoms do not occur when used sublingually as directed (47).
The buprenorphine monoproduct has been recommended during pregnancy to avoid any potential prenatal exposure to naloxone, especially if injected (50). However, recent studies that evaluated the use of the combination product buprenorphine with naloxone found no adverse effects, and outcomes were similar when compared with buprenorphine alone (51, 52).
The use of the combination product during pregnancy will likely expand as more safety data are accumulated.” See ACOG’s Opioid Use and Opioid Use Disorder in Pregnancy
CREATED BY: DR. SHAUNA COMBS, PGY2
FACULTY EDITING BY: DRs. LAUREN PORTER, RYAN MARINO, BRYAN ROSS