DEA,SAMHSA relax OTP/OBOT regulations due to COVID‐19

Opioid treatment programs (OTPs) that dispense methadone got a fast and clear reprieve from federal authorities last week in the face of COVID‐19. The Drug Enforcement Administration (DEA) and the Substance Abuse and Mental Health Services Administration (SAMHSA) issued policies that give OTPs flexibility in take‐homes, limiting the frequency of face‐to‐face contact and opportunities for transmission of COVID‐19. There is also greater flexibility for office‐based opioid treatment (OBOT) with buprenorphine.     

DEA proposal for mobile methadone finally released

The federal Drug Enforcement Administration (DEA) has issued a long‐awaited proposed rule that would allow opioid treatment programs (OTPs) — treatment programs that use methadone — to transport the medication to patients via “conveyances” (such as vans). This means that patients would no longer have to go to the brick‐and‐mortar OTP.     

Former SAMHSA official on need for mobile methadone

Bob Lubran was at the Substance Abuse and Mental Health Services Administration (SAMHSA) when the methadone mobile units were seen as vital — long before the current opioid crisis. The former head of SAMHSA's Division of Pharmacologic Therapies (DPT), Lubran told ADAW last week that the mobile units were being approved up until the Drug Enforcement Administration (DEA) stopped them in 2007 due to a legal issue. We were curious about what went on behind the scenes at SAMHSA after the approvals were shut down, during the same years when the opioid crisis was growing.     

Briefly Noted

Last week, a letter from Senators Edward J. Markey (D‐Mass.), Elizabeth Warren (D‐Mass.), Jeanne Shaheen (D‐N.H.), Dianne Feinstein (D‐Calif.) and Maggie Hassan (D‐N.H.) asked the Department of Health and Human Services (HHS) and the Substance Abuse and Mental Health Services Administration (SAMHSA) to immediately increase the patient cap — the maximum number of patients a physician can prescribe buprenorphine for — from 275 to 500. In addition, the letter requests that SAMHSA immediately process requests for emergency patient‐limit increases. “You can and should take immediate action to ensure that patients with OUD [opioid use disorder] are not denied the medication they need, do not exacerbate the strain on our nation's emergency departments and hospitals, and, most importantly, are not added to the COVID‐19 death count,” write the senators in their letter to HHS Secretary Alex Azar and SAMHSA Assistant Secretary Elinore McCance‐Katz, M.D. “We must empower our heroic health care providers to treat and save as many lives as possible in this time of crisis.” For the letter, go to https://www.markey.senate.gov/imo/media/doc/HHS%20SAMHSA%20Letter%20re%20Buprenorphine%20Prescriber%20Limits.pdf .     

Senators call for $2 billion in supplemental SAMHSA funding

As the fourth stimulus bill, the HEROES Act, awaits action by the Senate, 19 senators sent a letter last week to Senate and House leadership calling for increased investments in substance use disorder programs during the COVID‐19 pandemic. The letter, from Senators Tammy Baldwin (D‐Wisconsin) and Jeanne Shaheen (D‐New Hampshire), along with 17 other senators (all Democrats), calls for “$2 billion in funding for the Substance Abuse and Mental Health Services Administration (SAMHSA) to administer supplemental grant allocations under the Substance Abuse Prevention and Treatment (SAPT) Block Grant program and the State Opioid Response (SOR) grant program.”     

Briefly Noted

A report from the Substance Abuse and Mental Health Services Administration (SAMHSA) and the Centers for Disease Control and Prevention published in Drug and Alcohol Dependence this month, based on a national survey of 46 opioid treatment programs (OTPs), concludes that buprenorphine and Vivitrol are not given equal footing with methadone as medications used by OTPs. All three are approved by the Food and Drug Administration for the treatment of opioid use disorder. Barriers, including costs, are identified. In addition, the report charges that services for HPV, HIV and other infectious diseases are not adequately integrated into OTPs, and that the reach of OTPs should be expanded. The report, “Characteristics and Current Clinical Practices of Opioid Treatment Programs in the United States,” is by Christopher M. Jones and colleagues; Elinore F. McCance‐Katz, M.D., Ph.D., is the senior author.     

Pharmacy model for methadone,NAS link to demographics

In “Methadone Matters: What the United States Can Learn from the Global Effort to Treat Opioid Addiction,” senior author Jeffrey H. Sabet, M.D., and colleagues write about the lack of access to methadone treatment, in particular, for opioid use disorder (OUD) in the United States. They look at three pharmacy‐based models that exist in other countries. In their article, published online Feb. 6 in the Journal of General Internal Medicine, they promote the model of patients picking up methadone from pharmacies, as is done in, for example, Canada. The study was funded by the National Institute on Drug Abuse (NIDA) (from the United States) and cited by many as a call to reform the current opioid treatment program (OTP) system in the United States, where patients often prefer buprenorphine simply because they don't have to abide by methadone regulations.     

Briefly Noted

Drug‐Free Communities (DFC), a significant prevention grant program totaling more than $101 million and administered by the Substance Abuse and Mental Health Services Administration (SAMHSA), will be moving to the Centers for Disease Control and Prevention (CDC), but the change is mainly one that affects interagency machinations in Washington and not the end recipients of the funding — drug‐free coalitions. The Office of National Drug Control Policy (ONDCP) will retain the program and policy oversight. The funding will go to the ONDCP, and then be distributed to the CDC instead of to SAMHSA, as it has been in the past. The DFC grant program funds anti‐drug coalitions ‐‐ there are more than 700 across the country. Most are members of Community Anti‐Drug Coalitions of American (CADCA), which has 5,000 members. The CDC will be the new agency that subcontracts with the ONDCP to do the day‐to‐day administration of the DFC program. The change was announced Feb. 4 at CADCA's National Leadership Forum by ONDCP Director James Carroll. For a 2019 fact sheet on DFC, see https://www.whitehouse.gov/wp‐content/uploads/2019/12/FY‐2019‐DFC‐Fact‐Sheet‐20191220‐converted.pdf .     

NASADAD requests $250 million for Phase 4 stimulus

If there will be a Phase 4, as Rep. Nancy Pelosi (D‐California) has promised, of stimulus money to help America cope with the fallout from COVID‐19, the substance use disorder (SUD) treatment field hopes to get some of it this time. Publicly funded SUD treatment and prevention got nothing — nothing — from the $2 trillion CARES Act passed at the end of March (see “In case you haven't heard,” ADAW, April 3, https://onlinelibrary.wiley.com/doi/10.1002/adaw.32684 ).     

AATOD and NAMA praise DEA methadone van proposal

The two big organizations representing opioid treatment programs (OTPs), on the one hand, and methadone patients, on the other, were unified in cheering the long‐awaited proposal by the Drug Enforcement Administration (DEA) to allow clinics to transport the medication to patients via “conveyances,” or vans. These vans would obviate the necessity of traveling, sometimes for hours, to get medication. Both the American Association for the Treatment of Opioid Dependence (AATOD) and NAMA Recovery (NAMA) sent official comments to the DEA, citing three ways the vans can be used.     

Briefly Noted

Last month, the federal Food and Drug Administration (FDA) warned that combining gabapentin or pregabalin with central nervous system (CNS) depressants such as opioids could result in serious breathing problems for patients with underlying respiratory problems, or in the elderly. New labeling will be required on gabapentin and pregabalin, the FDA said. There is less evidence supporting such a risk in otherwise healthy people, the FDA said in the Dec. 19, 2019, warning. Gabapentin, first approved in 1993, is not a controlled substance. It is approved to treat various conditions, including seizures, nerve pain, fibromyalgia and restless legs syndrome. Pregabalin, first approved in 2004, is Schedule V on the Controlled Substances Act, the lowest‐risk category of controlled substance. “With the evolution of the opioid crisis, getting ahead of new concerns or addressing those that are already evident requires examining signs of misuse and abuse as soon as any signal emerges,” said Douglas Throckmorton, M.D., deputy director for regulatory programs in the FDA's Center for Drug Evaluation and Research, in announcing the warning. “Reports of gabapentinoid abuse alone, and with opioids, have emerged and there are serious consequences of this co‐use, including respiratory depression and increased risk of opioid overdose death. In response to these concerns, we are requiring updates to labeling of gabapentinoids to include new warnings of potential respiratory depressant effects.” Drug manufacturers are also being required to conduct clinical trials to evaluate the abuse potential of all gabapentinoids, particularly when combined with opioids, said Throckmorton. The downside is that prescribers could inadvertently increase opioid use by not using these medications, Throckmorton acknowledged, saying “we do not want to unintentionally increase opioid use by turning prescribers away from this class of pain medications.” For more information, go to https://www.fda.gov/drugs/drug‐safety‐and‐availability/fda‐warns‐about‐serious‐breathing‐problems‐seizure‐and‐nerve‐pain‐medicines‐gabapentin‐neurontin .     

Study: Elevated risk of substance use if parents use marijuana

Last month, JAMA Network Open published a study indicating that recent and past parental marijuana use confers a heightened risk for use of marijuana — and other substances — by their adolescent and young adult offspring who live in the same household. The article from the Substance Abuse and Mental Health Services Administration (SAMHSA), the National Institute on Drug Abuse and McLean Hospital is in line with federal anti‐marijuana policy (marijuana is still illegal under federal law, although states have legalized it, both recreationally, in some cases, and medically, in more).     

NASADAD to NIDA: Connect research to practice

When the National Institute on Drug Abuse (NIDA) sought input on its five‐year plan, the people responsible for publicly funded prevention, treatment and recovery — state directors — called for returning to the days of communication between federal agencies like the Substance Abuse and Mental Health Services Administration (SAMHSA) and between NIDA researchers and the service delivery system. In an Aug. 7 letter to NIDA's strategic planning team, Robert I.L. Morrison, executive director of the National Association of State Alcohol and Drug Abuse Directors (NASADAD), noted that each state alcohol and drug agency has a critical role to play in NIDA initiatives. This role includes.     

STR grants: How one physician in rural Florida is trying to help

If the State Targeted Response (STR) and State Opioid Response (SOR) grants from the Substance Abuse and Mental Health Services Administration (SAMHSA) grants are like an elephant — large, especially relative to funding for addiction treatment in general — they are also almost impossible to generalize about. But seeing one piece in context of the whole is essential in trying to find out where the money is actually going. The money goes to the single state authority (SSA) in charge of the Substance Abuse Prevention and Treatment (SAPT) block grant in each state, the person who knows most about what is needed in that state. The funding comes from the Substance Abuse and Mental Health Services Administration (SAMHSA). These grants added $2 billion‐plus to addiction treatment services for opioid use disorders for four years — and many expect this number to be doubled. For perspective, the entire SAPT block grant is under $2 billion and has been for decades.     

Methadone and buprenorphine in prison: Success in RI

The omnipresence of substance use disorder in prisons and jails cries out for treatment — and so do the inmates — but until recently, it has been scarce. Leading the way is the small state of Rhode Island, where Cranston‐based CODAC, an opioid treatment program (OTP), is providing methadone inside the state's jail/prison facility, with staff working alongside corrections (see ADAW, May 7, 2018).