Policy News Roundup: November 17, 2022

Key reads

More than 3 million adolescents use tobacco products

A new study from the Food and Drug Administration and Centers for Disease Control and Prevention based on the 2022 National Youth Tobacco Survey found that more than 3 million U.S. middle and high school students (11%) reported current tobacco use in 2022. For the ninth consecutive year, e-cigarettes were the most commonly used product among youth, followed by cigars, cigarettes and smokeless tobacco. Non-Hispanic American Indian/Alaska Native youth reported the highest percentage of any tobacco use (13.5%). Non-Hispanic White youth reported the most e-cigarette use (11%), and Black youth reported the most combustible tobacco use (5.7%). Higher levels of use were also reported among students with mostly F grades, with severe psychological distress, who identified as transgender and who identified as lesbian, gay or bisexual.

Source: More than 3 million middle and high school students reported using tobacco in 2022 (CNN)

Fentanyl can make it harder to start buprenorphine treatment

Fentanyl appears more likely than other opioids to cause severe withdrawal for patients put on buprenorphine. Patients with opioids in their system can feel precipitated withdrawal when administered buprenorphine, so doctors often wait several hours until patients start experiencing withdrawal before they administer buprenorphine, which at that point treats withdrawal symptoms. With fentanyl, sometimes doctors must wait a day or longer. Even some patients experiencing withdrawal find their symptoms worsen with buprenorphine, which risks patients returning to fentanyl use or refusing to try buprenorphine again. Doctors have not reached a consensus, with some starting to administer larger amounts of buprenorphine or using common medications to treat withdrawal symptoms. Others are “microdosing” buprenorphine in increasing amounts over several days to avoid a sudden, large dose that causes withdrawal, or administering naloxone to patients who are not overdosing to create a short period of intense withdrawal that buprenorphine then alleviates. Convincing doctors to prescribe buprenorphine has long been a challenge, and this increased difficulty threatens to reverse recent progress.

Source: Fentanyl isn’t just causing overdoses. It’s making it harder to start addiction treatment (STAT)

Senate Finance releases legislation draft on behavioral health integration

The Senate Finance Committee released a discussion draft of legislation to better integrate mental and physical health services and expand access to crisis care and follow up services. It includes policies that would increase payment rates to help providers integrate care; create a standardized payment in Medicare for mobile crisis response services; create a bundled payment in Medicare for crisis stabilization services; and ensure peer support specialists may participate in integration services in Medicare. It would also make mobile crisis services a permanent state option eligible for federal Medicaid match funding; direct the Centers for Medicare and Medicaid Services (CMS) to issue best practices to states for building a crisis care continuum in Medicaid and to health care providers on integration; direct CMS to conduct an analysis of integration models in Medicaid; establish CMS technical assistance for providers; and require CMS to issue guidance outlining flexibilities and best practices for partnering between states, Medicaid and community-based organizations to address health-related social needs.

Source: Finance Committee Unveils Mental Health Care Integration (U.S. Senate Committee on Finance)

SAMHSA issues guidelines on youth behavioral health crisis care

The Substance Abuse and Mental Health Services Administration released a new report, National Guidelines for Child and Youth Behavioral Health Crisis Care, which describes the need to improve crisis response services for children, youth and families and provides guidance on how communities can address gaps in care. It offers best practices, implementation strategies and practical guidance, as well as additional technical guidance in a companion report. The guidelines recommend that crisis services for children and families ensure that youth have someone to talk to (crisis call centers), someone to respond (mobile response teams) and a safe place to be (crisis receiving and stabilization services). Crisis response systems should partner with agencies across the continuum of care for youth (schools, family and peer support, community organizations, child welfare, juvenile justice and pediatricians). Crisis care providers should be trained to respond to the diverse needs of all youth (e.g., different ages, races/ethnicities, sexual/gender identities, immigration status, housing status and intellectual/developmental disabilities).

Source: HHS Releases New National Guidelines for Improving Youth Mental Health Crisis Care (Substance Abuse and Mental Health Services Administration)

FDA suggests certain naloxone products could be safe and effective for over-the-counter use

The Food and Drug Administration (FDA) issued a Federal Register notice that may help facilitate the development and approval of certain nonprescription naloxone products, including through the switch of certain products from prescription to nonprescription status. It includes a preliminary assessment that certain naloxone products – up to 4 mg nasal spray and up to 2 mg autoinjector for intramuscular or subcutaneous use – may be approvable as safe and effective for nonprescription use. This is intended to facilitate the development and approval of nonprescription naloxone products but is not a final determination that certain products are safe and effective for nonprescription use and does not mandate an immediately effective switch to nonprescription/over-the-counter availability. To make the determination final, the FDA needs additional data, such as product-specific data on nonprescription user interface design, including packaging and labeling. More data is also needed for higher dose products and other forms (ex. vials, ampules, syringes).

Source: FDA Announces Preliminary Assessment that Certain Naloxone Products Have the Potential to be Safe and Effective for Over-the-Counter Use (Food and Drug Administration)

Many banned vape, CBD and other products remain easily accessible

The Food and Drug Administration’s (FDA) enforcement is lacking, with illegal products widely available. STAT bought unapproved products around the FDA’s campus, including an unapproved cough medicine linked to children’s deaths, CBD gummies and vapes at common stores. The smoke shop closest to the FDA’s campus had numerous varieties of kratom. STAT found CBD products in CVS, gas stations and the smoke shop, ranging from over-the-counter pain creams to edibles containing CBD, HHC and Delta 8 THC. STAT bought a disposable gummy bear-flavored vape decorated with characters from “Family Guy” at a gas station. The same product comes in other fruit/dessert flavors, all adorned with cartoon characters. New nicotine pouches and lozenges from Zyn and Velo were ubiquitous in gas stations and convenience stores. Both have pending applications with the FDA, but the products are illegal for now. Even products the FDA actively and formally banned were still being sold, such as blu vapes.

Source: The FDA has banned certain vapes and medicines. We still bought these 13 products in its backyard (STAT)

Trump repeatedly proposes death penalty for drug dealers

In speeches at rallies across the country in advance of the midterms and in his speech announcing his 2024 presidential run, former president Donald Trump repeatedly proposed the death penalty for drug dealers. Trump falsely claimed that every drug dealer during their life will kill an average of 500 people with the substances they sell and that instituting the death penalty would bring down crime by 75-80% and is “the only answer.” The claims are easily debunked or cannot be verified. Trump also claimed that China has no “drug problem” because of its harsh treatment of drug traffickers, and suggested that the country executes drug dealers quickly, with little due process, and that this should be a model for the U.S. However, China has a large number people who use substances. The Chinese government itself reported that “there were 1.49 million registered drug users nationwide” and has admitted that this is a significant undercount.

Source: The debunked claims and faux ‘facts’ supporting Trump’s plan to execute drug dealers (Washington Post); Fact check: 20 false and misleading claims Trump made in his announcement speech (CNN)

R.J. Reynolds sues to stop California's newly approved flavored tobacco ban

R.J. Reynolds filed a federal lawsuit to challenge the constitutionality of California’s ban on flavored tobacco products the day after voters overwhelmingly approved it. The lawsuit renews an industry argument that local and state governments do not have the right to challenge federal law under the Tobacco Control Act, which gives the Food and Drug Administration the authority to regulate tobacco. The argument was rejected by the U.S. Court of Appeals for the Ninth Circuit in March after Reynolds sought to overturn Los Angeles County’s ban on flavored tobacco. Reynolds is trying to appeal to the U.S. Supreme Court.

Source: R.J. Reynolds Sues California Over Flavored Tobacco Ban (New York Times)

Colorado votes to decriminalize psychedelic mushrooms

Colorado passed a ballot initiative to decriminalize psychedelic mushrooms for people 21+ and to create state-regulated “healing centers” where participants can experience it under supervision. Colorado becomes the second state, after Oregon, to vote to establish a regulated system for substances like psilocybin and psilocin. The initiative would take effect in 2024 and allow an advisory board to add other plant-based psychedelics to the program in 2026.

Source: Colorado voters decriminalize psychedelic mushrooms (Associated Press)

Walmart proposes $3.1 billion opioid settlement

Walmart proposed a $3.1 billion settlement over opioid claims. Walmart said it “strongly disputes” allegations in lawsuits from state and local governments that its pharmacies improperly filled prescriptions for opioids, and the company does not admit liability in the settlement. The settlement would represent about 2% of its quarterly revenue. The company would pay most of the settlement over the next year if it is finalized. Walmart would have to comply with oversight measures, prevent fraudulent prescriptions and flag suspicious prescriptions. The plan would have to be approved by 43 states by December 15, and local governments could sign on by March 31, 2023.

Source: Walmart offers to pay $3.1 billion to settle opioid lawsuits (Associated Press)

Adderall shortage could fuel a broader substance use crisis

An opinion piece argues that failing to address the shortage of Adderall could trigger two major public health crises. Many people who have been taking the stimulant will lose access, which carries serious physical and mental health risks. Amphetamine withdrawal symptoms are not easily addressed with other medications. Instead of enduring withdrawal, some are likely to turn to alternative stimulants like crystal meth, fueling a broader crisis. The response to the prescription opioid crisis taught us that dependence and addiction do not disappear when the pills do. For those losing access to prescription amphetamine, illicit alternatives, especially meth, are readily available. Crisis events and cardiac arrests involving stimulants are already at an all-time high, and injection is helping drive infectious disease cases. Street stimulants are being contaminated with fentanyl, increasing the risk of opioid overdose. The Food and Drug Administration can ease the Adderall shortage by attracting and fast-tracking approval for international manufacturers and helping rapidly develop domestic production.

Source: Op-Ed: Don’t let Adderall scarcity trigger a repeat of the opioid epidemic (Los Angeles Times)