HHS loosens restrictions on buprenorphine for opioid use disorder

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New internship guidelines published by U.S. Department of Health and Human Services (HHS) remove long-term barriers buprenorphine for the treatment of opioid use disorder (TUU).

Specifically, the Practice guidelines for the administration of buprenorphine for the treatment of opioid use disorder exempts physicians, medical assistants, professional nurses, and other eligible individuals from federal certification requirements related to training, counseling, and other ancillary services that are part of the current process to obtain a waiver to treat up to 30 patients with the drug.

“Increases in overdose deaths emphasize the need to expand access to evidence-based treatments, including buprenorphine that can be prescribed in office-based settings,” said Deputy Secretary of Health Rachel Levine, MD, in a statement.

“These guidelines provide another tool to help communities respond to the evolution of the overdose crisis, equipping providers to save lives in their communities,” he added.

With regard to the prescription of certain medicines covered by the applicable provisions of the Controlled Substances Act (CSA), such as buprenorphine, professionals licensed under state law who have a valid registration of the Administration of the application of drugs (DEA), may be exempt from certification requirements related to training, counseling, and other ancillary services.

Under the exemption, professionals are limited to treating no more than 30 patients at a time. The time spent practicing under the exemption will not qualify the professional for a higher patient limit.

In addition, under the exemption, physicians must be supervised by a physician registered with the DEA or work in collaboration with them, if state law requires them to work in collaboration with a physician or under the supervision of one when prescribing medications for the treatment of UDU. .

Record number of overdose deaths

This requirement does not apply to professionals who are employees or contractors of a U.S. department or agency acting within the scope of such work or contract.

According to the guidelines, professionals who do not want to practice under the exemption and the limit of 30 patients can apply for a waiver as established. protocols.

The exemption only applies to prescription drugs in Annex III, IV and V or to combinations of these drugs, included in the CSA, such as buprenorphine. It does not apply to the prescription, dispensing or use of Annex II drugs, such as methadone for the treatment of OUD, the HHS notes.

Before treating patients with buprenorphine for hydraulic impairment, professionals must obtain a waiver according to the CSA by submitting a notice of intent to the HHS Substance abuse and Mental Health Services Administration (SAMHSA) according to established protocols.

Provisional data from the Centers for Disease Control and Prevention show that more than 90,000 drug overdoses deaths in the United States are projected to occur during the twelve months ending September 2020, the highest number of overdose deaths recorded in a twelve-month period, and these deaths have continued to accelerate during the COVID-19 pandemic.

“The rise we have seen in opioid deaths during the COVID-19 pandemic is forcing us to do everything we can to make treatment more accessible,” said Tom Coderre, deputy secretary for mental health and substance use, who directs SAMHSA. a release.

“Americans with this chronic disease need and deserve easy access to life-saving evidence-based treatment options. These new guidelines are an important step forward in reducing treatment barriers and will ultimately help more people to find recovery “.

AMA assistance

In a statement, the American Medical Association (AMA) applauded the measure and noted that it will remove “regulatory barriers[e] stigma in patients with opioid use disorder “.

The AMA noted that patients with DUDE are struggling to find doctors authorized to prescribe buprenorphine and expressed hope that these new guidelines, which remove “onerous” regulations, will help them get the treatment they need.

“Buprenorphine treatment allows patients with opioid use disorder to lead a successful productive life. The policy announced today is a very important step in making this happen. In the future, the WADA is supporting the legislation to remove waiver requirements completely and will advocate for this in Congress, ”the statement said.

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