After Moving Slightly Forward on Buprenorphine, Will We Shift Into Reverse?

The Department of Health and Human Services issued relaxed guidelines for physicians wishing to treat Opioid Use Disorder (OUD) with buprenorphine in the closing days of the Trump administration.

 While I argued here that the guidelines don’t go far enough, it was nevertheless a step in the right direction.

Even though outright repeal of the Drug Enforcement Administration’s so‐​called “X‐​waiver,” required of health care practitioners wishing to treat OUD with buprenorphine received bipartisan support in the last Congress, the Biden administration is considering rescinding the new buprenorphine guidelines that HHS issued prior to the inauguration—a step in the wrong direction.

Adding insult to injury, we now learn that Pennsylvania State Senator Michele Brooks (R) plans to reintroduce legislation to make it even more difficult than it already is for health care providers to prescribe buprenorphine to patients with OUD. The bill would prevent practitioners from prescribing buprenorphine to patients with OUD unless those patients are also enrolled in a state‐​licensed addiction treatment program, such as an abstinence‐​only or another type of rehab program. It would also tack on a fee of up to $500 to Pennsylvania providers wishing to prescribe buprenorphine for Medication Assisted Treatment (MAT).

A 2020 study by Harvard researchers showed MAT with either buprenorphine (provided in its abuse‐​deterrent form Suboxone) or methadone as the only treatments for opioid use disorder that are associated with reduced overdoses or “opioid‐​related morbidity.” The study compared the effectiveness buprenorphine and methadone with naltrexone, inpatient treatment programs, and intensive outpatient treatment programs.

Senator Brooks is concerned that the buprenorphine is getting diverted to the black market and fueling “Suboxone abuse.” But Suboxone is an abuse‐​deterrent formulation of buprenorphine. It is a combination of the opioid agonist buprenorphine with the opioid blocker (and overdose antidote) naloxone. When taken sublingually (as it is usually prescribed), the buprenorphine gets absorbed in an amount to prevent opioid withdrawal symptoms but not enough to give the patient a “high.” (Buprenorphine is a partial opioid agonist and is not particularly sought after by opioid users seeking euphoria.) The naloxone in Suboxone does not get absorbed via the sublingual or oral route. On the other hand, if the Suboxone recipient crushes, dissolves, and injects the drug, the naloxone blocks any effect that the intravenous buprenorphine might render.

Research shows that most people who seek Suboxone on the black market are simply trying to self‐​medicate for their opioid dependency because of the difficulty finding access to providers of MAT. They are not using it to get “high.” Some even try to gradually taper the drug in an effort to “detox.” And because buprenorphine is a partial opioid agonist, it has much less of an effect on the respiratory receptors, so it is very rare for people to overdose on it.

Senator Brooks should be less concerned about buprenorphine diversion and more concerned about the lack of providers with X‐​waivers who can provide an effective treatment to those with OUD. Senator Brooks—along with the Biden administration—should seek ways to make it easier, not harder, for people with Opioid Use Disorder to get access to buprenorphine.

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