U.S. Raises Cap on Number of People Who Can Receive Buprenorphine

Doctor listening to the patient

(DGIwire) – For those with opioid addiction, a key component to medication-assisted treatment is prescription buprenorphine. However, until mid-2016, there was a strict cap in place: qualified U.S. doctors were allowed to treat up to 100 patients per year with the drug. Now that cap has been loosened: in July 2016, in an effort to expand treatment for opioid addiction, the U.S. Department of Health and Human Services said it would allow doctors to prescribe buprenorphine to 275 patients at a time and that rule went into effect in August 2016.

The earlier 100-person cap had been put in place to try to keep tight control of the medication, but left many people unable to find a doctor who could prescribe buprenorphine to them, according to The Wall Street Journal. More than 47,000 Americans died of drug overdoses in 2014—a record that exceeded the number killed in car accidents, according to the Centers for Disease Control and Prevention—and the biggest drivers of those deaths were opioid painkillers and heroin.

Not every doctor will take advantage of the raised prescribing cap, but those who do could help up to 90,000 additional people receive buprenorphine treatment in the first year of the new regulation, according to officials from the Department of Health and Human Services and the White House Office of National Drug Control Policy. About 650,000 Americans received buprenorphine to treat opioid addiction in 2014, so the expanded cap could potentially boost that pool by about 14 percent, the Journal reported.

In tandem with the debate over the number of patients each doctor can treat with buprenorphine is the issue of how the drug can best be administered.

“There are numerous prescribing options for buprenorphine currently available,” says Dr. Mark Sirgo, President and CEO of BioDelivery Sciences. “One approved formulation of buprenorphine is the first that has a buccal (inside the cheek) administration. The ability of this treatment to stick on the inside of the cheek, unlike sublingual products that need to be kept in place under the tongue until they dissolve, allows patients to talk, swallow and go about normal daily activities while the medication is being consistently absorbed.”

Additionally, the buccal formulation allows for twice the bioavailability (drug absorbed into the body) of buprenorphine compared to the market leader in this category. As a result of the improved absorption of buprenorphine, plasma concentrations can be achieved with half the standard dose, which may help reduce the potential for misuse and diversion and potentially lessen the incidence of certain side effects.

With lawmakers having increased the number of patients who can potentially be prescribed buprenorphine, those who might be facing addiction should talk to their doctors about treatment options.