The newly created nonprofit Remedy Alliance is expected to distribute mass amounts of naloxone to smaller community groups. The organizers of the group previously operated an informal buyer’s club for naloxone. They say they will be able to get more naloxone into the hands of people who use opioids due to agreements with drugmakers to buy naloxone at a discounted rate and a restructured system that allows grassroots groups to order naloxone directly through an online store, circumventing complicated federal regulations that have restricted the flow of naloxone. Food and Drug Administration rules say that only licensed wholesale distributors can distribute prescription medications unless they are for “emergency medical reasons.” Naloxone manufacturers said they do not know whether harm reduction groups qualified for the exception and have turned away groups that tried to buy naloxone directly. The nonprofit serves as an umbrella for harm reduction organizations that can receive naloxone when other groups are refused.
Source: It’s about to get easier to access affordable naloxone (Washington Post)
A study examining the prevalence of opioid use disorder (OUD) and the use of medications for opioid use disorder (MOUD) between 2010 and 2019 found that 86.6% of people in the United States with OUD are not receiving MOUD. The largest treatment gaps as of 2019 were found in Iowa, North Dakota and Washington, D.C., each at more than 95%. The smallest gaps were in Connecticut, Maryland and Rhode Island, though at least 50% of people who need MOUD still are not receiving it. The findings highlight the urgency of removing barriers to access and expanding availability of MOUD.
Source: Most people with opioid use disorder don’t have access to critical medications (The Hill)
The Food and Drug Administration (FDA) issued refuse-to-accept letters for more than 88,000 synthetic nicotine products in applications that do not meet the criteria for acceptance. The letters state that it is illegal to sell or distribute any new tobacco product that has not received premarket authorization. Of nearly 1 million applications submitted, the FDA has accepted over 350 for review. To date, no synthetic nicotine product has received a marketing granted order. The FDA also issued 17 new warning letters to manufacturers for marketing synthetic nicotine products without applying for marketing authorization and 102 letters to retailers for illegally selling synthetic nicotine products to underage purchasers.
Source: Perspective: Update on FDA Review and Enforcement of Non-Tobacco Nicotine Products (Food and Drug Administration)
The Senate passed their $740 billion compromise health care, climate change and tax package, the Inflation Reduction Act, and it now heads to the House. The final package includes an extension of the subsidies provided during the COVID-19 pandemic to help individuals purchase Affordable Care Act Marketplace plans. Under earlier pandemic relief, the subsidies were set to expire this year, but this bill would allow them to continue for three more years. The package remains robust, but elements of the original Build Back Better bill have slipped away, including a continuation of the $300 monthly child tax credit. The bill also did not include a provision to extend Medicaid coverage to about 2.2 million people living in the dozen states that have refused Medicaid expansion.
Source: What’s in Democrats’ big bill? Climate, health care, savings (Associated Press); The Health 202: The health care winners and losers in Democrats’ economic package (Washington Post)
Senators Rob Portman and Bob Casey introduced the Investing in Kids’ Mental Health Now Act (one-pager) to address children’s mental health. The bill would provide pediatric mental health care providers with a one-year Medicaid funding increase through an enhanced Federal Medical Assistance Percentages (FMAP). Pediatric mental, emotional and behavioral health care providers serving Medicaid patients in participating states would have access to the funding. The bill would also direct the Department of Health and Human Services to issue guidance on how to expand mental, emotional and behavioral telehealth services nationwide and on best practices to support children in crisis or in need of intensive mental, emotional or behavioral services.
Source: Portman, Casey Introduce Bipartisan Legislation to Invest in Children’s Mental Health (Rob Portman)
A Centers for Disease Control and Prevention Vital Signs report finds that too few people with hepatitis C are treated, despite the availability of medications to cure the infection. Fewer than one in three people with health insurance get treatment within a year of diagnosis. Treatment is lowest among patients in state-administered Medicaid plans. The highest rates of new infection are among adults under 40, but they have the lowest treatment rates by age group. Among this age group, hepatitis C is most commonly spready through injection drug use. To ensure people with hepatitis C are treated, health care providers, insurers, policymakers and public health professionals should remove eligibility requirements and preauthorization requirements, provide treatment where people already receive services (such as primary care offices, community clinics, syringe service programs, addiction treatment centers and correctional facilities), provide treatment in as few visits as possible, and expand the number of primary care providers treating hepatitis C.
Source: New CDC Data Reveal Less Than a Third of People Diagnosed with Hepatitis C Receive Timely Treatment for the Deadly, yet Curable, Infection (Centers for Disease Control and Prevention)
Hawaii Governor David Ige outlined plans for how the state will spend $78 million it is receiving from the settlement with opioid distributors (AmerisourceBergen, Cardinal Health and McKesson) and Johnson & Johnson. The state and its counties have agreed to spend the funds on treatment, prevention and education, with 85% directed at opioids and the remaining 15% on other substances. An advisory committee of county and state representatives will consult on how 85% of the money is spent statewide, and 15% will be spent at the county level in a manner determined by the county. Officials will first conduct a statewide assessment of needs.
Source: Hawaii details plans for $78M drug company opioid settlement (Associated Press)
Tennessee is suing Walgreens for contributing to the state’s opioid crisis by failing to maintain effective controls against the misuse of prescription opioids. It alleges violations of Tennessee’s Consumer Protection Act. The suit says Walgreens created a public nuisance and failed to perform due diligence or train its pharmacists on how to recognize suspicious activity for opioid misuse and diversion.
Source: Tennessee sues Walgreens over opioid prescription onslaught (Associated Press)
Florida Governor Ron DeSantis announced the expansion of a new, piloted substance use and recovery network. The network of addiction care, Coordinated Opioid Recovery (CORE), is the first of its kind in the nation. It is coordinated through the Department of Health, Department of Children and Families and the Agency for Health Care Administration. The program was first piloted in Palm Beach County for nearly 2 years and will be expanding in up to 12 counties. Residents can use CORE for stabilization and to receive medications for addiction treatment. DeSantis also announced the appointment of the first Statewide Director of Opioid Recovery.
Source: Governor Ron DeSantis Announces New Opioid Recovery Program in Florida (Rob DeSantis)
Synthetic substances are the future of drug trafficking. Plant-based substances require land and favorable climates, while synthetic substances have comparatively low barriers to entry. They are cheap and easy to make, potent and lucrative. As of the end of 2021, the United Nations Office on Drugs and Crime has documented more than 1,100 new psychoactive substances across 134 counties. None has yet captured the same kind of market share as fentanyl, but it is clear that people are searching for the next big thing. Most illicit substances could become homemade with the continued democratization of information, technology and commerce. This would require a rethinking of counterdrug policies. Homemade substances could promote increased substance use and addiction, but could also lead to a reduction in violent crime, corruption and other ramifications of the drug trade. Educating youth about the dangers of substance use will become even more important.
Source: The next generation of illicit drugs? Think ‘synthetic’ (STAT)