The Virginia Board of Medicine, backed by the state, has banned the use of buprenorphine with the exception of treating pregnant patients in both office based opioid treatment (OBOT) programs and in opioid treatment programs (OTPs). OTPs may use the mono-product for on-site administration but no longer may use it for take-homes. Part of a broad set of regulations aimed at opioid prescribing in general, including for pain, this was a surprising turn of events in a state where OTPs have been dispensing take-home buprenorphine mono-product for years.
The reasoning for the decision by the Board of Medicine was that the mono-product would be diverted.
“Approximately 1,100 Virginians died of an opioid overdose in 2016, a 30% increase over 2015,” said Maria Reppas, communications director for the Richmond Department of Behavioral Health and Developmental Services (DBHDS). “DBHDS has worked closely with the Board of Medicine and other state agencies, state and local organizations, and concerned citizens to address this epidemic,” she added. “DBHDS supports the actions of the Board of Medicine to improve patient health and safety in the treatment of the deadly epidemic disease of opioid addiction.”
In Virginia, there “continues to be concern about diversion of buprenorphine products, which contributes to opioid abuse,” she said, noting that the sublingual combination product containing naloxone was developed to curtail this risk. The governor’s task force therefore recommended that the Virginia Board of Medicine, in collaboration with DBHDS, convene a workgroup of physicians experienced with utilizing buprenorphine to review standards of care from a variety of sources. The result was a guidance document, which then became the regulations.
Buprenorphine with naloxone cannot be melted down and injected, as the naloxone would render the buprenorphine inactive. However, the generic mono-product is much less expensive than the combination buprenorphine-naloxone product.
Mark ParrinoOTPs Respond
Mark Parrino, MPA, president of the American Association for the Treatment of Opioid Dependence (AATOD), wrote to William L. Harp, MD, executive director of the Virginia Board of Medicine, in February, describing the regulations governing take-home medication from OTPs. The OTPs are also conservative in providing the patient with any take-home medication. From the letter:
“Generally speaking, most patients are being medicated at the OTP five days per week,” the letter continued. When take home medication is provided to the patient through the OTP, the patient must meet eight clinical standards, which have been enforced since the regulatory authority of the Food and Drug Administration that continued under the regulatory oversight of the Substance Abuse and Mental Health Services Administration (SAMHSA).
“These criteria include absence of recent drug abuse, which is determined through toxicology reports in addition to established regularity of clinic attendance, absence of serious behavioral problems, absence of known recent criminal activity, stability in the patients’ home environment, length of time in comprehensive maintenance treatment, ensuring that take home medication can be safely stored within the patient’s home and whether the rehabilitative benefit the patient derives from decreasing the frequency of clinic attendance outweighs potential risk. Compliance with the regulations is mandatory.
“The Virginia Department of Behavioral Health and Developmental Services gave approval to OTPs to begin using the mono-formula of buprenorphine in OTPs under the rules and regulations that are in place or all methadone maintained patients,” Mr. Parrino’s letter noted.
Coal Country
Mr. Parrino also noted that in Virginia, the coal mining industry is biased against treatment using methadone. Despite the fact that it would be a violation of the Americans with Disabilities Act, employers would likely terminate someone even for the therapeutic use of methadone. The same bias does not exist for buprenorphine, which is why some patients in Virginia prefer it.
There were about 600 patients in Virginia being treated in OTPs with the mono-buprenorphine product at the time the ban went into effect.
About 300 patients were being treated using the mono-buprenorphine at the four Acadia Healthcare treatment centers in Virginia. The same criteria used for take-home privileges for patients being treated with methadone were used for take-home buprenorphine, said Ed Ohlinger, Acadia Healthcare’s Regional Director for Virginia and North Carolina.
The history is this: 10 years ago, the Virginia State Opioid Treatment Authority (SOTA) gave OTPs permission to give take-home buprenorphine-naloxone–at the time, the only available product was the Suboxone tablet. About 5 years ago, when the tablet was replaced with film, the price became unaffordable for patients. But the generic mono-product was affordable, and that’s what the OTPs were dispensing.
“We know the mono-product brings to treatment people who wouldn’t come if the only medication available was methadone,” said Mr. Ohlinger. “The coal mining industry has a zero tolerance for methadone,” he said. “This is a longstanding Appalachian phenomenon.”
Absorbing Costs of the Combination Product
So when the new rules were announced, Acadia switched all of its mono-buprenorphine patients in Virginia to the combination product, and—at least for now—is absorbing the added costs. “We have not increased their rates to stay in treatment, as we continue to work closely with the medical board,” said Mr. Ohlinger, who was in the process of appealing the regulations to get a special exemption for OTPs. “We’re incurring significantly higher medication costs at the present time. We’re not passing that on until we get through an appeal and see where we go—it is what it is, and Acadia has chosen to do the right thing.”
Of the 300 patients being treated by Acadia at the time of the ban, nine have transferred to treatment programs in North Carolina either because of an allergy to naloxone or because they have not done well on the combination product in the past, said Mr. Ohlinger.
Possible Appeal
But things are looking up. At the end of March, representatives of the Virginia Board of Medicine attended part of the Virginia Provider Association’s 10-year anniversary conference. “We had a very frank, very open, positive 45-minute conversation where we clearly delineated for them why we are different from OBOTs [office-based opioid treatment],” said Mr. Ohlinger.
There is a problem with diverted mono-buprenorphine, as found in recent arrests and other criminal activities. “But this is mono-product that was coming out of OBOTs in North Carolina, Tennessee, and Kentucky,” he said. “I know that some OBOT practices do a really good job, but we know that some don’t provide any services” other than induction and prescribing of buprenorphine.
The situation is reminiscent of what happened a decade ago, when methadone diverted from pain clinics was blamed on OTPs. “This is history repeating itself,” said Mr. Ohlinger.
The Board of Medicine officials “walked us through the process for filing an appeal, or through a process that could exempt us from the regulations,” said Mr. Ohlinger. “They were very open-minded to our explanation about what we do.”
A decision from the Board of Medicine was expected in early April.
For more information, see:
http://leg1.state.va.us/cgi-bin/legp504.exe?171+ful+HB2167ER.
https://www.dhp.virginia.gov/medicine/newsletters/OpioidPrescribingBuprenorphine03142017.pdf.