FDA approves first OTC naloxone
The Food and Drug Administration (FDA) approved Narcan naloxone nasal spray for over-the-counter, nonprescription use – the first naloxone product approved for over-the-counter use. The action paves the way for Narcan to be sold directly to consumers in places like drug stores, convenience stores, grocery stores and gas stations, as well as online. The move was long sought by public health officials and treatment experts. FDA Commissioner Robert Califf encouraged the manufacturer to make it available as soon as possible and at an affordable price. Although over-the-counter status will make Narcan more widely available, cost could remain a barrier. Currently, a two-dose pack of prescription Narcan is often free to people covered by Medicaid or private insurance, or has a copay of less than $10, but insurance does not cover most over-the-counter medicines. Whether an exception will be made for Narcan could take months to resolve. This month, two pharmacy chains in New York and New Jersey were charging $98 and $73 for customers without insurance. The manufacturer declined to disclose the price it plans for the over-the-counter Narcan.
Source: F.D.A. Approves Narcan for Over-the-Counter Sales (The New York Times); FDA Approves First Over-the-Counter Naloxone Nasal Spray (Food and Drug Administration)
Despite decreases in drug use, teen overdoses rise due to fentanyl
Teen overdose deaths have doubled in three years, despite a historic decline in drug and alcohol use among high school students, due to fentanyl. In many cases, teens do not know they are buying fentanyl. While fewer kids are using substances, fentanyl is so lethal that more are dying. Fentanyl is often even more dangerous for adolescents than for adults, as they are generally smaller and weigh less, and the typical teen who experiments with counterfeit pills will not have the opioid tolerance of adults with opioid use disorder. Teens often buy counterfeit pills online through social media. The article quotes Partnership to End Addiction’s Vice President of Prevention Research and Analysis, Linda Richter, who explains that kids aren’t looking for fentanyl, but it is mixed into pills that people think are ecstasy, stimulants, depressants and other substances without people knowing. She says that teens respond well to fact-based messages about emerging peril in the market.
Source: Teen overdose deaths have doubled in three years. Blame fentanyl. (The Hill)
Lawmakers introduce bill to expand parity and increase access to behavioral health care
Senators Bennet (D-CO) and Wyden (D-OR) introduced the Better Mental Health Care for Americans Act (summary) to expand access to mental and behavioral health care for Americans on Medicare, Medicare Advantage, Medicare Part D and Medicaid. The bill would require parity in Medicare Advantage, Medicare Part D and Medicaid; ensure that Medicare Advantage plans maintain accurate and updated provider directories; encourage mental and behavioral health integration with physical care by increasing reimbursement rates for Medicare and Medicaid; and establish a demonstration project to increase access to integrated mental health and behavioral health care for children across different settings, like schools. The measure would also increase accountability and oversight of integrated mental and behavioral health care under Medicare, Medicaid and private insurance plans; and require the Centers for Medicare and Medicaid Services to develop and implement plans to better align payments, measure access and quality and improve prevention services for mental and behavioral health care. Partnership to End Addiction endorsed this bill.
Source: Bennet, Wyden Introduce Bill to Increase Access to Mental and Behavioral Health Care for Kids, Seniors, and Low-Income Americans (Michael Bennet)
Bill introduced to ensure pre-trial detainees retain Medicaid coverage
Senators Cassidy (R-LA), Merkley (D-OR), Tillis (R-NC) and Markey (D-MA) and Representative Trone (D-MD) introduced the Due Process Continuity of Care Act, which would amend the Medicaid Inmate Exclusion Policy to ensure that pre-trial detainees are not kicked off Medicaid prior to being found guilty of a crime. The bill would also provide $50 million in planning grants to provide additional support to states, counties and local jails for implementing the policy, improving the quality of care provided in jails and enhancing the number of available providers to treat this population. Most inmates in local jail have mental health and/or substance use disorder. A modified version of the bill was signed into law last Congress as part of the Consolidated Appropriations Act of 2023, but it only applied to minors.
Source: Cassidy, Colleagues Reintroduce Bicameral Bill to Provide Medicaid Due Process for Americans Awaiting Trial (Bill Cassidy)
SAMHSA issues recommendations for SUD training requirement curricula
The Substance Abuse and Mental Health Services Administration (SAMHSA) released recommendations for the requirement enacted in the Consolidated Appropriations Act, 2023 for prescribers to complete at least eight hours of training on substance use disorder (SUD). The guide does not establish legally binding standards for curricula, but rather describes recommended core elements for entities authorized to provide the training. Recommended elements include: use of validated screening tools for SUD and risk factors for substance use; diagnosis and assessment of individuals who screen positive for SUD; initiation and management of medications for SUD; consideration of polysubstance use and co-occurring mental health disorders; and patient and family education on safety and overdose prevention. They also include use of patient-centered decision making and paradigms of care; impact of stigma, trauma and social determinants on substance use and recovery; collaborating with other disciplines to facilitate access to medications and referrals to services such as case management; legal and ethical issues involved in the care of patients with SUD; assessment of patients with pain; components of developing an effective pain treatment plan; managing patients on opioid analgesics; and recognizing signs of opioid use disorder in the setting of prescribed opioids.
Source: Recommendations for Curricular Elements in Substance Use Disorders Training (Substance Abuse and Mental Health Services Administration)
SAMHSA issues warning about xylazine
The Substance Abuse and Mental Health Services Administration (SAMHSA) issued a letter to providers and grantees warning about the risks of xylazine. It provides information about the consequences of xylazine exposure, what practitioners can do to mitigate harm and how SAMHSA is responding to the emerging challenge. When a patient presents with possible exposure, practitioners should provide routine care for opioid intoxication, particularly the administration of naloxone. Providers should consider xylazine exposure if patients are not responding to naloxone or when there are signs of exposure (e.g., severe necrotic skin ulcerations). An individual suspected of using substances containing xylazine should receive counseling about the dangers of the substance and harm reduction. Because xylazine is most often a contaminant with opioids, the individual should be offered medications for opioid use disorder. SAMHSA’s efforts to expand access to addiction treatment will be critical in reducing exposure to illicit fentanyl that may be contaminated with xylazine.
Source: Dear Colleague Letter – Xylazine (Substance Abuse and Mental Health Services Administration)
State and local news
States increasingly embrace fentanyl test strips
A consensus is developing that widespread distribution of fentanyl test strips can be an effective, if limited, way to reduce fentanyl’s impact. Over the past year and a half, 16 additional states have passed laws legalizing the strips. Bills to legalize them are pending in almost every remaining state where they are still barred. The strips are emerging as a sliver of common ground in a debate over the overdose crisis, in which one side prioritizes law enforcement and the other safer use and treatment. For people who use pills, ketamine, cocaine or MDMA, for example, the strips can be particularly important because people without an opioid tolerance are at higher risk of fentanyl overdose. Others, including many who previously used heroin, have become dependent on fentanyl, and a positive result is unlikely to stop them from using the substance, but it can act as a reminder to use more cautiously. For people who seek out fentanyl, a new kind of strip that tests for xylazine may be more useful.
Source: Hidden Fentanyl Can Kill. Test Strips Can Help Make Drug Use Safer. (The New York Times)
Juul and Altria face trial in Minnesota for marketing e-cigarettes to kids
Juul and Altria are facing their first trial this week over claims they created a public nuisance by marketing addictive e-cigarettes to minors. Minnesota seeks to force the companies to pay for measures to remedy the harms of addiction. It says Juul sold its e-cigarettes in sweet flavors and promoted them on social media to appeal to underage consumers. Juul’s attorney said the purpose of Juul was to convert adult smokers to a less dangerous product, not lure kids. He said e-cigarettes are not safe but are not deadly. He argued Juul did nothing to intentionally drive youth demand and that growth in youth vaping was due to increasing adult demand resulting in “leakage” to kids. Altria’s attorney denied assertions that Altria invested in Juul because it ultimately wanted to hook kids on cigarettes. He said Altria bought a passive stake because Juul had found the key to successfully switching adult smokers to a less harmful product, while Altria’s e-cigarettes had failed in the marketplace.
Source: Juul, Altria face first trial over claims of marketing e-cigarettes to teens (Reuters); At trial, Minnesota says e-cigarette maker Juul targets kids (Associated Press)
Other news in addiction policy
New test strips can detect xylazine
Xylazine test strips will soon be available. The new test strips will be distributed by BTNX, a Canada-based company that also manufactures a popular brand of fentanyl test strips. BTNX said the new strips will be priced at $200 per box of 100, substantially higher than the price of fentanyl test strips. Some strips are already available for purchase, with more in production. Validation testing showed the strips to be highly sensitive and did not record any false negatives. They did, however, come up positive for samples that did not contain xylazine but did contain lidocaine. Though most states have passed bills to update drug paraphernalia laws to allow fentanyl test strips, such legislation has been narrowly tailored to fentanyl, meaning the xylazine test strips would not be covered.
Source: Newly available test strips can detect lethal ‘tranq’ in drug supply (STAT)
Pharmaceutical companies are using opioid crisis to sell unneeded, expensive naloxone products
In recent years, companies have introduced new naloxone products, including a mechanized injector that gives voice commands, a prefilled syringe pen, an ultra-high-dose nasal spray and an autoinjector the Pentagon purchased for use in the event of a terrorist attack. While this seems like a win-win case in which pharmaceutical companies are saving lives and turning a profit, a special report by STAT asserts that in reality, pharmaceutical companies have used the opioid crisis and fear of fentanyl to aggressively market high-cost naloxone products that divert resources from cheaper versions. What is needed is an abundant supply of cheap naloxone, packaged at reasonable doses and in simple, low-tech delivery systems. However, there is little money to be made in selling generic versions, so companies instead are creating high-dose, mechanically complex products that sell at higher prices. The new products threaten to shut out consumers who cannot afford them. Organizations such as schools, nonprofits, police departments and local public health agencies buying a few doses of the new, expensive versions for the same price as hundreds of doses of generic naloxone is a dangerous diversion of resources.
Source: How the drug industry uses fear of fentanyl to extract more profit from naloxone (STAT)