DEA announces new proposed rules for prescribing via telemedicine
The Drug Enforcement Administration proposed permanent rules for the prescribing of controlled medications via telemedicine. The rules reinstate some of the requirements for prescribing that were waived during COVID to enable doctors to write millions of prescriptions for drugs such as OxyContin or Adderall without meeting patients in person. The new rules will require patients to see a doctor in person at least once to get an initial prescription for Schedule II medications, such as Vicodin, OxyContin, Adderall and Ritalin. Refills could be prescribed over telehealth. Schedule III-V substances (such as codeine, Xanax and Ambien) and buprenorphine to treat opioid use disorder could be prescribed via telehealth for an initial 30-day dose, but patients would need to see a doctor at least once in person to get a refill. The rule seeks to keep expanded access to telemedicine that helped many get needed treatment, while also balancing safety and addressing concerns that some companies were improperly prescribing addictive substances.
Source: Feds seek to limit telehealth prescriptions for some drugs (Associated Press); DEA Announces Proposed Rules for Permanent Telemedicine Flexibilities (Drug Enforcement Administration)
Americans view opioids as the top public health threat
A survey found that Americans view opioids (26%), obesity (21%) and guns (17%) as the main threats to public health at the moment. Republicans see fentanyl and other opioids as the biggest threat (37%), while Democrats say it’s guns (35%). Seventeen percent of Democrats also identified opioids as the greatest threat. Opioids were the top health concern of 32% of people with a high school diploma or less, compared to 25% of people with some college and 20% of those with a bachelor’s degree or higher. The survey found 3% ranked smoking and tobacco products as the top threat, and 2% percent ranked alcohol abuse as the top threat, ranking as seventh and eighth overall. Half of the respondents selected lowering costs for health care and prescription drugs as the top priority for government efforts and policies on public health, with only 7% selecting preventing deaths from overdoses and accidents.
FDA files first civil monetary penalties against e-cigarette makers
The Food and Drug Administration (FDA) filed civil money penalty (CMP) complaints against four tobacco product manufacturers for manufacturing and selling e-liquids without marketing authorization. This is the first time the FDA has filed CMP complaints against tobacco product manufacturers to enforce the Federal Food, Drug, and Cosmetic Act’s premarket review requirement for new tobacco products. The FDA previously warned each of the companies that by making and selling their e-liquids without marketing authorization, they were in violation of the FDA’s requirements and that failure to correct the violations could lead to enforcement action, such as a CMP. The companies continued to make and sell the unauthorized products. The FDA will seek the maximum amount for a single penalty for each company, $19,192.
Source: FDA Files Civil Money Penalty Complaints Against Four E-Cigarette Product Manufacturers (Food and Drug Administration)
FDA sets plan to strengthen tobacco program
The Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP) outlined the steps it plans to take in response to an external evaluation by the Reagan-Udall Foundation. The plans will include the release of a five-year strategic plan and comprehensive policy agenda by the end of the year. CTP has committed to providing regular updates on the progress of these activities. They will include steps to optimize the framework for tobacco product application reviews; increase compliance and enforcement, including additional action to remove illegal products, particularly e-cigarettes that attract youth, from the market; and enhance and increase its public communications to provide greater transparency about the approach to compliance and enforcement.
Source: FDA Outlines Steps to Strengthen Tobacco Program (Food and Drug Administration)
FDA issues import alert to restrict entry of xylazine
The Food and Drug Administration (FDA) issued an import alert to restrict the unlawful entry of xylazine active pharmaceutical ingredients and finished dosage form drug products into the country. The action aims to prevent the drug from entering the U.S. market for illicit purposes, while maintaining availability for its legitimate uses in animals. It is designed to ensure that imports of drugs containing xylazine into the country are intended for the legitimate veterinary supply. These include active pharmaceutical ingredients en route for processing by a manufacturing facility that makes FDA-approved xylazine, for compounding of animal drugs at state-licensed compounding pharmacies or by licensed veterinarians, as well as approved finished products being imported into the U.S. Under the import alert, xylazine offered for import is subject to heightened FDA scrutiny, and the FDA may detain the shipment if it appears to be in violation of the law.
Source: FDA Takes Action to Restrict Unlawful Import of Xylazine (Food and Drug Administration)
DEA determines hemp-derived synthetic cannabinoids with intoxicating effects are illegal controlled substances
The Drug Enforcement Administration (DEA) says that both delta-8 and -9 THC-O are to be considered illegal controlled substances. The DEA’s position on the legal status of the cannabinoids came following an inquiry by an attorney. The DEA sent a response highlighting that delta-8 and -9 THC-O do not occur naturally in the cannabis plant and can only be obtained synthetically and therefore do not fall under the definition of hemp. Both synthetic cannabinoids are considered Schedule I controlled substances. The gray market of hemp-derived cannabinoids came to life following the 2018 Farm Bill, which federally legalized the cultivation of the hemp plant with a THC level below 0.3%. The DEA’s letter represents an official determination of the control status of THC-O. It applies not only to THC-O but also to other hemp-derived synthetic cannabinoids with intoxicating effects, such as HHC. The DEA previously classified delta-8 THC products as not controlled substances as long as they are extracted from the natural plant, not synthesized.
Source: Delta-8 And -9 THC-O Are Controlled Substances, DEA Says (Forbes)
State and local news
Products containing synthetic cannabinoids are easy to buy even in states without legal marijuana
In Kansas, which has not legalized medical marijuana nor decriminalized marijuana, merchants are selling quasi-legal products containing slightly tweaked versions of marijuana to skirt the laws – products containing delta-8 THC, delta-10 THC, THC-O or HHC. The products are widely available, often in fruit and candy flavors. The shops are operating in the open. Public health officials fear that the minor changes made to the chemical structure of marijuana could change the way it impacts the body. There is early research showing that THC-O produces a toxic gas when vaporized, and the same reaction likely played a role in the vaping lung injury outbreak in 2019. It is also unclear whether these products actually contain what they say because there is no regulation. States around the nation, including those with legal marijuana, are struggling to contend with the rise of these products.
NYC Mayor Adams plans to roll out new mental health/addiction plan
New York City Mayor Eric Adams is poised to roll out a mental health plan that will consist of three plans – one to reduce overdose deaths and help people with addiction, one for people with serious mental illness and one to address the mental health needs of children and families. It will set a goal of reducing overdose deaths by 15% over the next four years. The harm reduction plan includes expanding the city’s syringe service programs and building them out to make primary care and basic services, such as food and laundry, available on site. The plan also calls for new instruments in drug-checking technology. The plan for children and families will focus on early identification and prevention of mental health concerns by training school personnel to recognize warning signs and will create a virtual mental health platform for high schoolers. A task force will assess the impacts of social media on youth and develop public awareness campaigns. It will call for policies to facilitate the coverage of mental health services for patients who do not have a specific diagnosis, a common hurdle to preventative care.
Michigan provides student loan repayment for medical providers offering OUD treatment
The Michigan Department of Health and Human Services is offering student loan repayment to eligible medical providers if they begin providing or expand opioid use disorder treatment programs through the Michigan Opioid Treatment Access Loan Repayment Program. The goal is to increase the availability of opioid use disorder treatment across the state, especially in areas where treatment is difficult to access. The program is being funded through opioid settlement funds. The program is available to medical and osteopathic doctors, psychiatrists, nurse practitioners, physician assistants and substance use disorder counselors who begin offering or expand opioid treatment. Providers in a variety of settings are eligible.
Source: Student loan repayment program provides incentive for medical providers to offer opioid use disorder treatment (Michigan Department of Health and Human Services)
Alaska faces unique challenges in fentanyl crisis
An influx of fentanyl into Alaska in the last two years has vexed law enforcement, overwhelmed health systems and affected struggling Native communities. Drug traffickers have carved out a lucrative market for synthetic drugs in Alaska, since they can extract higher profit margins in a remote region. Fentanyl is a national crisis, but Alaska faces unique challenges due to its location, size and limited law enforcement resources. Alaska has the country’s largest proportion of population identifying as American Indian/Alaska Native, groups who have long struggled with systemic lack of resources, trauma and addiction. Alaska officials struggle with intercepting shipments of fentanyl, since large swathes of the state are only accessible by smaller boats and airplanes that help the drug reach destinations undetected. Alaska tribal courts have prosecuted drug dealers, but most communities rely on law enforcement hundreds of miles away. There are only seven treatment clinics in the state.
Source: How Alaska became one of fentanyl’s deadliest frontiers (CBS)
Other news in addiction policy
Clinical trial will compare buprenorphine and methadone provided in an office setting to patients who use fentanyl
A new clinical trial set to launch this year will attempt to compare patients’ ability to remain in treatment when prescribed buprenorphine or methadone in an office setting. Scientific literature hints that methadone has better outcomes with respect to retention and decreases in illicit substance use, but there is no literature on patients primarily using fentanyl. Since the proliferation of fentanyl, many patients have found that buprenorphine treatment induces intolerable withdrawal symptoms. Many lawmakers, experts and advocates argue that methadone should be accessible via doctors and pharmacies. While past studies have attempted to compare methadone and buprenorphine head-to-head, they have only analyzed patients already in stable recovery. The new trial will be the first to focus on relatively less stable patients who have not yet entered treatment. This is a more meaningful study population, as the beginning of treatment is typically a bigger challenge. Six sites will each have two doctors who prescribe methadone and a partner pharmacy that dispenses it. The Drug Enforcement Administration has indicated that it plans to cooperate with the study and grant exceptions that would allow doctors to prescribe the drug and retail pharmacies to dispense it.