Viewpoint: It`s Time to Get Buprenorphine Behind the Pharmacy Counter

The many barriers to access to medication treatments for opioid use disorder justify considering “novel and potentially controversial solutions,” in the words of two Boston University-based physicians writing last week in JAMA. They suggest that making buprenorphine available on an emergency basis behind the counter of pharmacies would save lives, limit diversion of the medication and encourage more individuals to pursue long-term treatment.

“Historically, medications have been made available without a prescription when they are relatively safe and effective and the public can easily comprehend indications for their use. Buprenorphine meets these conditions,” wrote the co-authors, Payel Jhoom Roy, MD, of BU's School of Medicine and Michael D. Stein, MD, of the School of Public Health.

The authors stated in their viewpoint article, published online July 8, that buprenorphine could be handled by pharmacies in a fashion similar to emergency contraception, while being subject to age and quantity restrictions similar to those that have long been in place for the cold medicine pseudoephedrine because of its association with methamphetamine production.

“I definitely think this proposal pushes the envelope,” Roy tells Addiction Professional. Nonetheless, the goals are clear: approaching the response to the opioid crisis from more of a harm reduction standpoint, and facilitating a pathway to long-term recovery for more people.

“Every single time we make it easier for people to choose buprenorphine over fentanyl, it reduces risk,” Roy says.

Her own interest in the subject stemmed partly from meeting a growing number of patients who were interested in treatment and had already tried buprenorphine without a prescription (obtaining it from others in an attempt to self-manage their withdrawal).

At the same time, with much of practice shifting toward making the drug available immediately rather than forcing patients to prove that they really want treatment, she says the timing appears right for lifting some of the barriers around finding a physician with both the authority and capacity to prescribe to new patients.

How it could work

The published article suggests that the circumstances under which buprenorphine could be offered without a prescription would have to be clearly defined. Examples could include situations in which an individual with an opioid use disorder is awaiting enrollment in outpatient treatment or is experiencing severe withdrawal, or when a person who has successfully tapered off buprenorphine believes he/she is at imminent risk of relapse to opioid use.

The authors suggest that limiting initial quantities to around a three-day supply “could encourage patients to seek long-term treatment from a clinician with a DEA waiver for their medical and psychosocial needs.”

The article states that a behind-the-counter system overseen by pharmacists could mitigate several of the challenges around more widespread use of buprenorphine, including:

• Possible adverse effects associated with using buprenorphine in combination with another sedating substance.

• Concerns about diversion. This has occurred in large part among individuals who have not been enrolled in treatment and are seeking to avoid overdose, the authors state.

• The need for physician monitoring, which for individuals visiting a pharmacy would be replaced in part by guidance from pharmacists. The latter would require increased pharmacist education around the drug, the article points out.

Roy says that under the current system in which physicians face significant regulatory requirements, there are numerous barriers to taking in more patients at many practices. This often leaves waivered physicians significantly short of the maximum number of buprenorphine patients they are allowed to treat.

Opposite viewpoint

While some leaders are advocating fewer restrictions on access to buprenorphine, other jurisdictions are seeing a push toward more regulation of the medication, not less.

Two bills currently being considered by Pennsylvania state legislators would impose new state requirements on buprenorphine prescribers, in addition to the existing federal requirements. One bill would require prescribers to be registered with the state and would mandate that buprenorphine patients be enrolled in a state-licensed specialty substance use treatment program. The other would require physicians to ensure that their patients on medication are participating in counseling.

The measures are largely supported by state-licensed treatment facilities that do not use buprenorphine and that say the prescribing of the drug has been fraught with abuses by a group of unscrupulous prescribers.