Regulations coming for opioid treatment drug providers

Regulations coming for opioid treatment drug providers

By MARY SELL, Alabama Daily News

A bill approved on the final day of the legislative session will require more regulation of a drug used in the outpatient treatment of opioid addiction.

“What we’re trying to do is set up some guidelines of how opioid addiction ought to be treated in today’s world,”  said Sen. Larry Stutts, R-Tuscumbia, sponsor of Senate Bill 425. “(The goal is to steer) people toward buprenorphine, and away from cash methadone treatment.”

Buprenorphine, under the brandname Suboxone, is a low-grade opiate. It blocks cravings for opioids, without the same level high as methadone. But in order to treat addiction, its use needs to come with treatment, supporters of Stutts’ bill say.

“This is the new wave of pill mills,” Paul Trivette, government affairs director for Pathway Healthcare, an addiction recovery provider with six locations in Alabama, said recently.

Pathway leaders advised Stutts on the legislation and what some other states have done.

Trivette said Pathway’s goal is to create a “level playing field” for treatment. Though buprenorphine prescribers have to be federally registered, some medication doesn’t come with treatment at out-patient clinics, Trivette said.

While some addiction clinics take care to follow proper medical protocols, Trivette argued that many are tantamount to “pill mills” due to lack of regulations.

“There’s no counseling, there is no therapy, there’s no drug testing,” he said. “Ultimately, patients are paying for a prescriptions, but there’s no getting better.”

According to the federal Substance Abuse and Mental Health Services Administration, the number of newly certified physicians allowed to prescribe buprenorphine in Alabama has increased every year since 2000. There were 134 last year.

Pathways chief medical officer, Brent Boyett, is from Hamilton, Ala., in Stutts’ district, the senator said.

“We wrote our bill from, here’s where we want to go, let’s get there,” Stutts, a medical doctor, said about the regulations. “I want our bill to be a template for other states.”

The bill passed unanimously in the Senate and House in the last days of the legislative session. It became law this week and went into effect immediately

Senate Bill 425 requires the Alabama Board of Medical Examiners to by Jan. 1, 2020 to adopt rules for the prescribing of medications containing buprenorphine for the treatment of opioid use in outpatient settings.

A 17-member working group that includes addiction specialists will draft the rules.

Stutts’ bill says the rules addressed will include: appropriate dosing; minimum requirements for counseling, behavioral therapy and case management; drug screening; and the appropriate number of visits.

Alabama’s opioid drug problem is well documented. Its 2017 prescription rate of 107 per 100 people was the highest in the nation. There was an 11 percent increase in opioid-related deaths in Alabama from 2016 to 2017, making it one of about 20 states with “statistically significant” increases, according to the Centers for Disease Control and Prevention.

Public Health Officer Dr. Scott Harris said there is a push to get addicts into medically assisted treatment that combines medications and therapy.

Harris said he was not opposed to Stutts’ bill. He said buprenorphine has street value and like any drug, there is potential for abuse.

“They have a reasonable goal that all pain patients are treated the same,” he said. “They have a goal of getting rid of cash-only clinics.”

Co-sponsors on SB425 were Sens. Greg Reed, R-Jasper and Jim McClendon, R-Springville.