Buprenorphine update: Looser rules and a helpful injectable

SAN FRANCISCO – As the opioid epidemic continues to grow and evolve, the federal government is trying to make it easier for clinicians to treat abusers with the drug buprenorphine, psychiatrists told colleagues at the annual meeting of the American Psychiatric Association. And an injectable version of the drug is making a big difference.

While overall overdose numbers are grim, “the work we’re doing to get people on buprenorphine is working, and our efforts to get people in treatment are paying off,” John A. Renner Jr., MD, of Boston University, said in a presentation at the APA meeting.

As Dr. Renner explained, the United States is now in the fourth wave of nearly a quarter-century of opioid overdose-related deaths. The outbreak began in 1999 as prescription opioids spurred deaths, and heroin overdoses began to rise in 2010. The third wave brought rises in deaths from synthetic opioids such as fentanyl in 2013. In 2015, the fourth wave – driven by deaths from combinations of synthetic opioids and psychostimulants like methamphetamines – started in 2015.

COVID-19 seems to have played a role too: In 2020, opioid overdose deaths spiked during the early months of the pandemic. In 2021, drug-related overdose deaths overall hit a high of 106,889, including 80,411 linked to opioids. In contrast, fewer than 20,000 drug-related overdose deaths were reported in 1999.

On the other hand, deaths from prescription drug overdoses are falling, Dr. Renner said, suggesting “improvement in terms of how clinicians are handling medications and our prescribing practices. But that’s being masked by what’s happened with fentanyl and methamphetamine.”

Buprenorphine (Subutex), used to treat opioid use withdrawal, is itself an opioid and can cause addiction and death in some cases. However, Dr. Renner highlighted a 2023 study that determined that efforts to increase its use from 2019 to 2021 didn’t appear to boost buprenorphine-related overdose deaths in the United States.

New federal regulations aim to make it easier to prescribe buprenorphine. Thanks to Congressional legislation, the Drug Enforcement Administration in January 2023 eliminated regulations requiring clinicians to undergo special training to get an “X-waiver” to be able to prescribe buprenorphine. But they’re not off the hook entirely: As of June 27, 2023, providers must have undergone training in order to apply for – or renew – a DEA license to prescribe certain controlled substances like buprenorphine.

“I’m afraid that people will be able to meet that requirement easily, and they’re not going to get good coordinated teaching,” Dr. Renner said. “I’m not sure that’s really going to improve the quality of care that we’re delivering.”

In regard to treatment, psychiatrist Dong Chan Park, MD, of Boston University, touted a long-acting injectable form of buprenorphine known by the brand name Sublocade. The FDA approved Sublocade in 2017 for patients who’ve been taking sublingual buprenorphine for at least 7 days, although Dr. Park said research suggests the 7-day period may not be necessary.

“We’ve utilized this about 2.5-plus years in my hospital, and it’s really been a game changer for some of our sickest, most challenging patients,” he said at the APA presentation. As he explained, one benefit is that patients can’t repeatedly avoid doses depending on how they feel, as they may do with the sublingual version. “On the first day of injection, you can actually stop the sublingual buprenorphine.”

Dr. Renner emphasized the importance of getting users on buprenorphine as fast as possible. If the treatment begins in the ED, he said, “they need to have a system that is going to be able to pick them up and continue the care.”

Otherwise, the risk is high. “We’re in a very dangerous era,” he said, “where the patient walks out the door, and then they die.”

Dr. Park had no disclosures, and Dr. Renner disclosed royalties from the APA.

SAN FRANCISCO – As the opioid epidemic continues to grow and evolve, the federal government is trying to make it easier for clinicians to treat abusers with the drug buprenorphine, psychiatrists told colleagues at the annual meeting of the American Psychiatric Association. And an injectable version of the drug is making a big difference.

While overall overdose numbers are grim, “the work we’re doing to get people on buprenorphine is working, and our efforts to get people in treatment are paying off,” John A. Renner Jr., MD, of Boston University, said in a presentation at the APA meeting.

As Dr. Renner explained, the United States is now in the fourth wave of nearly a quarter-century of opioid overdose-related deaths. The outbreak began in 1999 as prescription opioids spurred deaths, and heroin overdoses began to rise in 2010. The third wave brought rises in deaths from synthetic opioids such as fentanyl in 2013. In 2015, the fourth wave – driven by deaths from combinations of synthetic opioids and psychostimulants like methamphetamines – started in 2015.

COVID-19 seems to have played a role too: In 2020, opioid overdose deaths spiked during the early months of the pandemic. In 2021, drug-related overdose deaths overall hit a high of 106,889, including 80,411 linked to opioids. In contrast, fewer than 20,000 drug-related overdose deaths were reported in 1999.

On the other hand, deaths from prescription drug overdoses are falling, Dr. Renner said, suggesting “improvement in terms of how clinicians are handling medications and our prescribing practices. But that’s being masked by what’s happened with fentanyl and methamphetamine.”

Buprenorphine (Subutex), used to treat opioid use withdrawal, is itself an opioid and can cause addiction and death in some cases. However, Dr. Renner highlighted a 2023 study that determined that efforts to increase its use from 2019 to 2021 didn’t appear to boost buprenorphine-related overdose deaths in the United States.

New federal regulations aim to make it easier to prescribe buprenorphine. Thanks to Congressional legislation, the Drug Enforcement Administration in January 2023 eliminated regulations requiring clinicians to undergo special training to get an “X-waiver” to be able to prescribe buprenorphine. But they’re not off the hook entirely: As of June 27, 2023, providers must have undergone training in order to apply for – or renew – a DEA license to prescribe certain controlled substances like buprenorphine.

“I’m afraid that people will be able to meet that requirement easily, and they’re not going to get good coordinated teaching,” Dr. Renner said. “I’m not sure that’s really going to improve the quality of care that we’re delivering.”

In regard to treatment, psychiatrist Dong Chan Park, MD, of Boston University, touted a long-acting injectable form of buprenorphine known by the brand name Sublocade. The FDA approved Sublocade in 2017 for patients who’ve been taking sublingual buprenorphine for at least 7 days, although Dr. Park said research suggests the 7-day period may not be necessary.

“We’ve utilized this about 2.5-plus years in my hospital, and it’s really been a game changer for some of our sickest, most challenging patients,” he said at the APA presentation. As he explained, one benefit is that patients can’t repeatedly avoid doses depending on how they feel, as they may do with the sublingual version. “On the first day of injection, you can actually stop the sublingual buprenorphine.”

Dr. Renner emphasized the importance of getting users on buprenorphine as fast as possible. If the treatment begins in the ED, he said, “they need to have a system that is going to be able to pick them up and continue the care.”

Otherwise, the risk is high. “We’re in a very dangerous era,” he said, “where the patient walks out the door, and then they die.”

Dr. Park had no disclosures, and Dr. Renner disclosed royalties from the APA.

SAN FRANCISCO – As the opioid epidemic continues to grow and evolve, the federal government is trying to make it easier for clinicians to treat abusers with the drug buprenorphine, psychiatrists told colleagues at the annual meeting of the American Psychiatric Association. And an injectable version of the drug is making a big difference.

While overall overdose numbers are grim, “the work we’re doing to get people on buprenorphine is working, and our efforts to get people in treatment are paying off,” John A. Renner Jr., MD, of Boston University, said in a presentation at the APA meeting.

As Dr. Renner explained, the United States is now in the fourth wave of nearly a quarter-century of opioid overdose-related deaths. The outbreak began in 1999 as prescription opioids spurred deaths, and heroin overdoses began to rise in 2010. The third wave brought rises in deaths from synthetic opioids such as fentanyl in 2013. In 2015, the fourth wave – driven by deaths from combinations of synthetic opioids and psychostimulants like methamphetamines – started in 2015.

COVID-19 seems to have played a role too: In 2020, opioid overdose deaths spiked during the early months of the pandemic. In 2021, drug-related overdose deaths overall hit a high of 106,889, including 80,411 linked to opioids. In contrast, fewer than 20,000 drug-related overdose deaths were reported in 1999.

On the other hand, deaths from prescription drug overdoses are falling, Dr. Renner said, suggesting “improvement in terms of how clinicians are handling medications and our prescribing practices. But that’s being masked by what’s happened with fentanyl and methamphetamine.”

Buprenorphine (Subutex), used to treat opioid use withdrawal, is itself an opioid and can cause addiction and death in some cases. However, Dr. Renner highlighted a 2023 study that determined that efforts to increase its use from 2019 to 2021 didn’t appear to boost buprenorphine-related overdose deaths in the United States.

New federal regulations aim to make it easier to prescribe buprenorphine. Thanks to Congressional legislation, the Drug Enforcement Administration in January 2023 eliminated regulations requiring clinicians to undergo special training to get an “X-waiver” to be able to prescribe buprenorphine. But they’re not off the hook entirely: As of June 27, 2023, providers must have undergone training in order to apply for – or renew – a DEA license to prescribe certain controlled substances like buprenorphine.

“I’m afraid that people will be able to meet that requirement easily, and they’re not going to get good coordinated teaching,” Dr. Renner said. “I’m not sure that’s really going to improve the quality of care that we’re delivering.”

In regard to treatment, psychiatrist Dong Chan Park, MD, of Boston University, touted a long-acting injectable form of buprenorphine known by the brand name Sublocade. The FDA approved Sublocade in 2017 for patients who’ve been taking sublingual buprenorphine for at least 7 days, although Dr. Park said research suggests the 7-day period may not be necessary.

“We’ve utilized this about 2.5-plus years in my hospital, and it’s really been a game changer for some of our sickest, most challenging patients,” he said at the APA presentation. As he explained, one benefit is that patients can’t repeatedly avoid doses depending on how they feel, as they may do with the sublingual version. “On the first day of injection, you can actually stop the sublingual buprenorphine.”

Dr. Renner emphasized the importance of getting users on buprenorphine as fast as possible. If the treatment begins in the ED, he said, “they need to have a system that is going to be able to pick them up and continue the care.”

Otherwise, the risk is high. “We’re in a very dangerous era,” he said, “where the patient walks out the door, and then they die.”

Dr. Park had no disclosures, and Dr. Renner disclosed royalties from the APA.