US: Lawmakers Worry X-Waiver Elimination Could Stir Buprenorphine Diversion

House members also look for ways to stop drug trafficking on Snapchat

Could dropping the “X-waiver” have unintended consequences? That’s what some House members suggested during a hearing on ways to address the fentanyl crisis, along with other healthcare issues.

“Sometimes … medications are dangerous, potentially, and even though we want more access, we still have to stick with science, and make sure the proper individuals, who are properly trained, are the only ones that have the ability to prescribe these medications,” said Larry Bucshon, MD (R-Ind.), vice-chair of the House Energy & Commerce Health Subcommittee, which held Wednesday’s hearing.

Medication assisted treatment (MAT) is “an important tool in the right circumstances,” said Bucshon, a cardiovascular and thoracic surgeon, but without “proper guardrails” it could lead to harm. Moreover, because buprenorphine is “itself an opioid,” the medication is “extremely vulnerable for misuse and diversion,” he added. For that reason, Bucshon said he remains opposed to the “broad expansion of prescribing authority” as a means of expanding access to buprenorphine. Bucshon said he finds it unfortunate that not all of his colleagues agree with this view and as a result, prescribing authorities have “dramatically expanded” access to the drug.

Buprenorphine a ‘Street Drug’?

In an omnibus spending bill passed in late December, Congress eliminated the “X-waiver,” the requirement that providers obtain a special waiver through the Drug Enforcement Administration (DEA) to dispense certain narcotics, including buprenorphine, which is often administered as a sublingual film. The bill also allows community health aides to dispense buprenorphine and other narcotics used in maintenance or detoxification treatment without having to register through the DEA.

Asked whether he was aware of buprenorphine’s use as a “street drug,” Neeraj Gandotra, MD, chief medical officer at the Substance Abuse and Mental Health Services Administration (SAMHSA) said buprenorphine is primarily used for treatment or “withdrawal mitigation.” Bucshon countered that “multiple peer-reviewed articles and even some NIH and DOJ [Department of Justice] intelligence [suggest] that it is a significant risk — that buprenorphine [is] being a diverted drug.”

Rep. Diana Harshbarger, PharmD (R-Tenn.), raised similar concerns later in the hearing stating that “[t]here are people who take those strips, heat them up, and use them as injectables.” But she also expressed concern about stopping access to buprenorphine for those who need it.

Asked by Bucshon what SAMHSA is doing to prevent “possible diversion” of buprenorphine, Gandotra said that his agency has partnered with professional societies to ensure that practitioners are trained in diagnosing and treating substance use disorder “irrespective of the X-waiver.”

Bucshon also pressed Jon DeLena, associate administrator of business operations for the DEA, to explain how that agency will respond when “we start seeing [buprenorphine] on the street.” DeLena echoed Bucshon’s own comments about the need for “guardrails.” While helping individuals access treatment is important, “it has to be done in a way that does not contribute to overprescribing, misprescribing, or diversion of that substance,” he said.

Timothy Westlake, MD, an emergency medicine physician from Wisconsin who spoke later in the hearing, said he would “much rather see buprenorphine abused than fentanyl or oxycontin or oxycodone. And the people that are abusing it for substance use disorder are going to be abusing something. It kind of falls into the same [category as] … harm reduction.”

Harshbarger expressed concern about potential disruptions in access to needed treatment when the public health emergency ends, asking DeLena when the DEA plans to release its proposed rule on providing controlled substances via telemedicine. DeLena said the agency is “very close,” but did not provide a specific timeframe.

Scheduling Fentanyl-Like Substances

Subcommittee members also debated whether fentanyl-like substances should be classified as Schedule 1 drugs. Republicans spoke in favor of the HALT Fentanyl Act, which would permanently schedule all fentanyl-like substances as Schedule 1 drugs.

In May 2021, President Biden signed legislation that temporarily extended a Trump-era order classifying all fentanyl-like drugs as Schedule 1 controlled substances. Proponents say the order helped law enforcement prosecute drug traffickers, but criminal justice reform advocates oppose the extension, because Schedule 1 drugs require mandatory minimum sentences, which they argue would lead to more incarcerations and exacerbate racial disparities in prison.

“I’m concerned that this class-wide scheduling approach sets a precedent of guilty until proven innocent,” said Rep. Tony Cárdenas (D-Calif.), referring to provisions around mandatory minimum sentencing. He said the bill imposed “harsh federal penalties” and excludes any mention of testing the substances to see if they are possibly harmless or if they could have “therapeutic value.” “We could be overlooking the next naloxone,” Cárdenas said.

Rep. Morgan Griffith (R-Va.) argued that the legislation does not impede research on fentanyl-related substances, and even “makes it easier to get through the pathways to get research done.”

Social Media’s Role in Drug Trafficking

Lawmakers also discussed the problem of drugs being trafficked to teenagers over social media. Molly Cain, a parent advocate from Spokane, Washington, spoke of her 23-year-old son Carson’s death in 2020 from a fentanyl overdose. Her son had been prescribed alprazolam (Xanax) for anxiety during college, and at 22 was diagnosed with cancer of the appendix.

The day after Thanksgiving, Cain, after not hearing back from her son, found him dead on his living room floor. She waited 3 months for a toxicology report to confirm that he’d died from fentanyl poisoning. In the meantime, she began receiving pictures of drugs from a person on Snapchat on her son’s phone. The DEA investigated, and the person Cain believes sold her son the drugs that killed him served less than 24 hours in jail. Cain said she reached out to Snapchat and the business claimed it had filters in place to prevent illicit activity.

“I think that they’ve been given a free pass… and I think it’s time we start holding them accountable,” she said. Cain said her son bought pills to help relieve his anxiety, but instead they cost him his life.

Rep. Kim Schrier, MD (D-Wash.), a pediatrician, said she is working on legislation to “make sure families have the tools to keep their children safe.” She also spoke about the importance of education and awareness for children, prescribers, and patients, and asked another witness where parents can find guidance about speaking to their children about drugs.

“Today is a different world than I grew up in with social media… but it’s also the world of ‘Take one pill and you die,'” said Stephen Loyd, MD, chief medical officer for Cedar Recovery, headquartered in Mount Juliet, Tennessee. “Most of us have some kind of experience with things in our past that maybe we could have handled better,” said Loyd, who is himself in recovery for opioid use disorder. Children need to know their parents aren’t perfect, he said.

Loyd’s son was age 9 when Loyd sought help for his substance use problem. And he was open with his son and daughter about what he was going through. Loyd also urged parents to warn children that “just because it comes out of a bottle that a doctor wrote a prescription for, it is not okay.”

Schrier agreed, adding that “anything anybody hands you, whether they tell you it’s ibuprofen or… Adderall … that could be the pill that ends your life.”

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