Federal regulators proposed rules to make permanent flexibilities for medications for opioid use disorder provided in response to COVID. The rules would allow doctors to initiate buprenorphine treatment via telehealth and allow stable patients to receive 14- to 28-day take-home supplies of methadone. The rules would eliminate a requirement that patients have a opioid use disorder for a year before beginning treatment at an opioid treatment program (OTP). They would also expand the definition of OTP treatment practitioner to include any provider appropriately licensed to dispense and/or prescribe approved medications (as opposed to only physicians); add evidence-based delivery models of care such as split dosing, telehealth and harm reduction activities; remove outdated terms such as “detoxification;” promote shared and evidence-based decision-making; promote mobile medication units; review OTP accreditation standards; and eliminate the annual report requirement for practitioners with a waiver to prescribe buprenorphine to up to 275 patients. Public comment is open until February 14.
Source: Addiction treatment got easier during Covid. A new proposal would keep it that way (STAT); SAMHSA Proposes Update to Federal Rules to Expand Access to Opioid Use Disorder Treatment and Help Close Gap in Care (Substance Abuse and Mental Health Services Administration)
The Office of National Drug Control Policy launched a national data dashboard of nonfatal opioid overdoses. Widespread access to this data will help first responders target life-saving interventions such as naloxone and help inform service providers as they connect people to addiction treatment. The Nonfatal Opioid Overdose Dashboard is informed by the National Emergency Medical Services Information System (NEMSIS), which consists of electronic patient care records completed by nearly 95% of all EMS agencies nationwide. The dashboard allows for comparisons of jurisdiction and county-level data to national averages in population rate of nonfatal opioid overdose, average number of naloxone administrations per patient, average EMS time to reach an overdose patient and the percent of nonfatal opioid overdose patients not transported to a medical facility for further treatment. The data will be available every Monday with a two-week lag. It will evolve to incorporate nonfatal overdoses involving any/all substances, directional change at the jurisdictional level, impact according to major demographic categories, patient outcomes, leading clinical measures, etc.
Source: Biden-Harris Administration Launches First-of-its-Kind National Data Dashboard for Non-Fatal Overdoses (Office of National Drug Control Policy)
The Department of Justice announced the entry of a court order that resolves the government’s long-running civil racketeering lawsuit against the largest U.S. cigarette companies. The lawsuit was filed in 1999, and following a 2004-2005 trial, the court found that the companies had defrauded consumers about the health dangers of smoking. This order imposes the last of several corrective remedies ordered by the court. Defendants are now required to display signs in stores featuring corrective statements about the health effects and addictiveness of smoking. The order will go into effect July 1, 2023 and gives defendants three months to post the statements. Retailers will display the signs for 21 months.
Source: Court Issues Order Requiring Cigarette Companies to Post Corrective Statements; Resolves Historic RICO Tobacco Litigation (Department of Justice)
Congress passed the First Step Act four years ago, requiring that the Bureau of Prisons offer more incarcerated people addiction medications. Yet, federal prisons are treating less than 10% of the roughly 15,000 people who need it. At the end of October, 21 prisons were not offering any addiction medication, and 59 were treating 10 or fewer people. The rest of the 121 facilities were each treating a few dozen people at most. There is a widespread misperception among prison staff that Suboxone substitutes one addiction for another. There is broad discretion among prison staff about who qualifies for treatment. The Bureau requires patients to get approval from multiple health care providers, and each step has its own lengthy waitlist. The Bureau is treating increasingly more people since it launched its medications program, however – in 2019, 41 people were receiving medications, compared to 1,035 in October.
Source: Federal Prisons Were Told to Provide Addiction Medications. Instead, They Punish People Who Use Them. (The Marshall Project)
Juul has agreed pay $1.7 billion to settle about 5,000 lawsuits by school districts, local governments and individuals in a Northern California court case. The proposed agreement on the multidistrict litigation would wrap up personal injury, consumer class action, government and Native American tribe cases in a deal that Juul said it had secured an investment to fund. The settlement does not end claims against Altria, which owned a 35% stake in Juul. It does not offer funds immediately but will open up a claims process. The agreement involved about 10,000 plaintiffs, many of whom claimed they had not been aware that the product could be more addictive than cigarettes. The plaintiffs also argued that the e-cigarettes were unreasonably dangerous because of their attractiveness to young people. They made a wide range of claims, from racketeering to fraud and unjust enrichment.
Source: Juul Agrees to Settle Thousands of Vaping Lawsuits (New York Times); Vaping Settlement by Juul Is Said to Total $1.7 Billion (New York Times)
CVS and Walgreens have agreed to pay a combined $10.7 billion to settle opioid litigation. The funds will be distributed to states, local governments and tribes and will go toward opioid crisis abatement and remediation programs. CVS will pay $4.9 billion to states and political subdivisions and $130 million to tribes. Walgreens will pay $4.95 billion, plus more than $750 million in fees for attorneys and costs. The pharmacies have also agreed to implement robust controlled substance compliance programs that will require additional layers of opioid prescription reviews and institute new mandatory training programs. Neither company admitted to wrongdoing.
The New York City health department is piloting a drug checking program at a few centers that serve people who use substances. The program uses a scanner (FTIR machine) that can detect what substances are in a baggie without destroying the substances. That provides an incentive for people to participate. Substances tested often contain fentanyl, which is unsurprising. A test strip can tell someone whether their drugs contain fentanyl, but for people who use opioids, fentanyl can be difficult to avoid altogether, and the strips do not determine the amount of fentanyl. FTIR machines can detect the amount and can detect other dangerous substances in the supply, such as xylazine, as they arise. Because of the training required to use the machines, the city is rolling out the pilot slowly. The practice is already yielding valuable insights, such as the presence of xylazine in New York, which led the health department to send an alert to organizations working with people who use substances.
Source: NYC launches drug checking program to spot fentanyl before people overdose (Gothamist)
Every hospital emergency department in Colorado agreed to offer take-home naloxone to any patient treated for overdose. Now, in its second year, the Colorado Naloxone Project is distributing naloxone to labor and delivery units. Hospitals almost never give take-home medicine. Patients normally leave with prescriptions to fill at a pharmacy, but studies have shown patients rarely fill naloxone prescriptions. Under this Maternal Overdose Matters (MOMS) initiative, hospital staff screen new mothers/gestational parents through conversations or a written form, then offer naloxone to take home. The protocol is intended to flag new mothers/gestational parents who are currently using substances or have history of addiction, as well as those who say a family member/friend has used substances or who were prescribed opioids after giving birth. Some hospitals have questioned how the protocol fits with legal requirements to report suspected child abuse and neglect, including babies born dependent on opioids. There are many situations in which a new mother/gestational parent would want naloxone that would not include abuse or neglect.
The Bloomberg American Health Initiative at Johns Hopkins released a report outlining 10 practical steps to address major causes of declining life expectancy in the U.S., including COVID, overdose, gun-related homicide and suicide, teen suicide, motor vehicle crashes, and heart disease, stroke and diabetes. The ideas include that the federal government, states and localities should make the use of medications for opioid use disorder the standard of care; health agencies should expand harm reduction services; schools should invest in easily accessible, confidential and comprehensive adolescent health care in schools; and regulators and automakers should embrace the implementation of driver impairment detection technology.
Source: New Report Details Steps to Reverse Decline in U.S. Life Expectancy (Johns Hopkins University)
As fentanyl flooded into the U.S., blunders by successive administrations allowed the crisis to worsen. Presidents from both parties failed to take effective action. The Drug Enforcement Administration was slow to respond as Mexican cartels supplanted Chinese producers. The Department of Homeland Security failed to ramp up scanning and inspection technology at official crossings, instead channeling $11 billion toward construction of a border wall that does little to stop fentanyl traffickers. The Office of National Drug Control Policy spent years fending off elimination, struggled to create an effective strategy, lost its Cabinet seat and remains sidelined. The Department of Health and Human Services has not tracked the rise of fentanyl and does not know how many Americans are using it. The Centers for Disease Control and Prevention is unable to track overdose deaths in real time, and its published data, one year behind, is obscuring the picture of what is happening on the ground in 2022.
Source: Cause of death: Washington faltered as fentanyl gripped America (Washington Post)