Editor's note:With the change of the presidential administration, the new guidelines on buprenorphine prescribing have not taken effect. They may be delayed or revised. AAP News will continue to monitor the issue and update members.
New practice guidelines from the U.S. Department of Health and Human Services (HHS) should make it easier for pediatricians to provide treatment for opioid use disorder in their offices.
Under the guidelines, physicians with a Drug Enforcement Administration registration number no longer have to apply for a separate waiver (X-waiver) to prescribe buprenorphine, a partial opioid agonist. The exemption applies only to physicians (not other health care professionals) and does not cover methadone.
Physicians using the exemption can treat up to 30 patients at a time. The limit does not apply to hospital-based physicians who start treatment in the emergency department but don’t follow patients long term. The guidelines will take effect after they are published in the Federal Register.
“There's no question in my mind that this is good news,” said Lucien Gonzalez, M.D., M.S., FAAP, chair of the AAP Committee on Substance Use and Prevention.
The waiver not only was “rigmarole,” Dr. Gonzalez said. It also created a psychological barrier to prescribing buprenorphine by making physicians think, “Ooh, what's magic about this medication?” Yet, they may not think twice about prescribing Percocet, he said.
Buprenorphine was approved for use in patients 16 years and older by the Food and Drug Administration in 2002. Physicians could prescribe the medication in general medical settings but first had to complete eight hours of training and apply for the waiver.
In 2016, the AAP published a policy statement that encouraged pediatricians to offer medication for the treatment of opioid use disorder in adolescents and young adults. The AAP also has supported changes to make it easier to prescribe buprenorphine and endorsed a bill in 2020 that would have eliminated the need for a waiver.
Even though it’s no longer mandatory, Dr. Gonzalez recommends pediatricians still complete the training course, which covers the fundamentals of office-based opioid treatment, the process of buprenorphine induction and stabilization and maintenance. Other resources to get up to speed before prescribing buprenorphine are the medication’s package insert and information from the Substance Abuse and Mental Health Services Administration (see resources), he added.
The waiver exemption comes as deaths due to opioid overdoses are skyrocketing. More than 83,000 deaths were reported from June 2019 to June 2020, a 21% increase from the previous year and the highest number ever recorded in a 12-month period, according to provisional data from the Centers for Disease Control and Prevention.
The most recent figures from National Survey on Drug Use and Health showed that 87,000 12- to 17-year-olds and 227,000 18- to 25-year-olds in the U.S. had opioid use disorder in 2019.
“The medical evidence is clear: access to medication-assisted treatment, including buprenorphine that can be prescribed in office-based settings, is the gold standard for treating individuals suffering from opioid use disorder,” Adm. Brett P. Giroir, M.D., HHS assistant secretary for health, said in a news release. “Removing some of the certification requirements for an X-waiver for physicians is a step toward providing more people struggling with this chronic disease access to medication-assisted treatment.”
