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 allows buprenorphine inductions based on telephone only

Last week, the Drug Enforcement Administration (DEA) said opioid treatment programs (OTPs) and Drug Addiction Treatment Act (DATA)–waived prescribers can treat new patients with buprenorphine based on a telephone call only. The Controlled Substances Act (CSA), enforced by the DEA, requires all new patients being treated with controlled substances to have an in‐person — or, for now, telemedicine — physical exam. Now, however, because of the coexisting COVID‐19 pandemic and opioid overdose crisis, the DEA has dropped this requirement. This follows the decision of the Substance Abuse and Mental Health Services Administration (SAMHSA) to allow exemptions from the OTP take‐home regulations allowing stable patients to be given 14 or 28 days of methadone doses, instead of coming in more frequently (see DEA, SAMHSA relax OTP/OBOT regulations due to COVID‐19, ADAW March 23, https://onlinelibrary.wiley.com/doi/10.1002/adaw.32664 ).     

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.     

Briefly Noted

Last week, Scott Gottlieb, M.D., abruptly and surprisingly resigned as commissioner of the Food and Drug Administration (FDA). He has pushed to reduce teenage vaping, been a vociferous supporter of medications to treat opioid use disorder and is noted in the field for his recommendation that methadone and buprenorphine patients should not be terminated from care for use of benzodiazepines. After he announced his resignation on March 5, vaping stocks surged. He was viewed as critical to protecting youths against nicotine and e‐cigarettes. “He was remarkably successful at keeping the agency moving forward at a difficult time and really focused on public health challenges, including the opioid epidemic and drug prices,” said Joshua M. Sharfstein, M.D., a former principal deputy commissioner at the FDA during the Obama administration, who is now a professor of health policy at the Johns Hopkins Bloomberg School of Public Health, told The New York Times. “He surprised a lot of people in his willingness to take some risks for public health.”     

H.R. 6: SUPPORT for Patients and Communities Act: The Substance Use‐Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act

Section 2005. Medicare coverage of certain services furnished by opioid treatment programs. This provision expands Medicare coverage to include Opioid Treatment Programs (OTPs) for the purposes of delivering Medication‐Assisted Treatment (MAT) to expand access to treatment options for Medicare beneficiaries. Currently, OTPs are not recognized as Medicare providers, meaning that beneficiaries receiving MAT at OTPs for their opioid use disorders must pay out‐of‐pocket. In 13 states, the highest rate of opioid‐related inpatient stays is among the over 65 population. Under the provision Medicare will pay the outpatient OTPs through bundled payments made for wholistic services, including necessary medications, counseling, and testing.     

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.     

Sign‐on letter requests more flexibility in methadone treatment during COVID‐19

A sign‐on letter spearheaded by the National Alliance for Medication Assisted Recovery (NAMA), and harm reduction groups, including the Urban Survivors Union (USU) and the Drug Policy Alliance (DPA) is calling for reducing restrictions on methadone and opioid treatment programs (OTPs), so that patients don't have to go to the clinics so often. Included in the over 100 signatories are Patty McCarthy Metcalf of Faces & Voices of Recovery, Ben Levenson of the Levenson Foundation (and former founder of Origins) and many addiction physicians, as well as drug user organizations. Many of the signers have said for months that OTPs should be eliminated entirely.     

Mallinckrodt donates hand sanitizers to all OTPs

Mallinckrodt, a pharmaceutical company that makes methadone and buprenorphine for opioid treatment programs (OTPs) as well as many other medications, started out making hand sanitizer for its own plant employees when the pandemic began this winter. It wasn't long, however, before the company recognized that OTPs needed hand sanitizer — like everyone else, they were unable to get it. So last month, the St. Louis–based company started distributing it — for free — to all OTPs, not only its customers.     

OTPs look toward criminal justice as major area for growth

Opioid treatment programs (OTPs), formerly known as methadone clinics, were set for a dramatic expansion several years ago when the opioid crisis was growing at an increasing rate, but now, that expansion is targeted toward one population of patients in particular: those in the criminal justice system. In particular, people who are in prison and jail are most likely to need — and not receive — treatment for opioid use disorder (OUD), and the nation's OTPs are ready to help.     

Fiellin: Keep the prescriber training for buprenorphine

It seems that almost everyone wants to deregulate buprenorphine for opioid use disorder (OUD) — with proposed legislation focused on getting rid of the Drug Addiction Treatment Act of 2000 (DATA 2000) waiver altogether (see ADAW, Oct. 11, “Bill to deregulate buprenorphine raises concerns among OTPs,” https://onlinelibrary.wiley.com/doi/10.1002/adaw.32510 ).     

Despite availability of screens and medications,most AUDs not treated: Study

There are three medications that are approved by the Food and Drug Administration (FDA) to treat alcohol use disorder (AUD): disulfiram (Antabuse), naltrexone and acamprosate. If you count both oral and injectable versions of naltrexone, there are four. Yet fewer than 9 percent of patients with AUD receive one of these medications, according to a review published in the August issue of the Journal of the American Medical Association by Henry Kranzler, M.D., and Michael Soyka, M.D. Rather, most of these patients receive only counseling, according to their study, which concluded that the first‐line treatment for people with moderate AUD should be medication along with brief counseling, or a referral to a more intensive psychosocial intervention.     

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.     

Sublocade trial data published: Better than placebo

Sublocade, a buprenorphine injection that lasts a month, was approved by the Food and Drug Administration (FDA) for the treatment of opioid use disorder more than a year ago (see ADAW, Dec. 11, 2017), but the data that led to the approval was not public. It was made public in an article by Sublocade manufacturer Indivior published Feb. 18 in The Lancet.     

AUD medications and postsurgery opioids: The latest

Topiramate's use as a treatment for alcohol use disorder (AUD) is not a new idea, Bankole Johnson, M.D. (now of ondansetron fame; see ADAW, March 25, April 1), reviewed it many times (see ADAW, Oct. 15, 2007; Feb. 11, 2008; June 16, 2008; Nov. 3, 2008; June 7, 2010; Jan. 31, 2011; Feb. 24, 2014). But a comprehensive review published recently in the Journal of Addiction Medicine is concise. While not approved by the Food and Drug Administration for AUD, topiramate can be prescribed off‐label, and should be considered as a treatment for the condition, according to Ajay Manhapra, M.D., and colleagues in the article, “Topiramate Pharmacotherapy for Alcohol Use Disorder and Other Addictions: A Narrative Review.” Like ondansetron and other possible AUD medications, including those that are approved (like acamprosate and naltrexone), topiramate doesn't work for everyone. But pharmacogenetic testing may help identify those who are likely to respond, according to the review. In addition, there are early studies indicating it could be used to treat cocaine and nicotine use disorder, as well as behavioral addictions.     

AATOD paper confronts methadone controversies

A policy paper released this month by the American Association for the Treatment of Opioid Dependence (AATOD) focuses on some of the challenges facing opioid treatment programs (OTPs) today. For example, it cites an article published in the New England Journal of Medicine (July 5, 2018) by Michael Botticelli that promotes the idea of methadone being available in primary practice settings for the treatment of opioid use disorder (OUD) (see ADAW, July 16, 2018). “AATOD recommends that this proposal should only be considered after careful, conservative, and thoughtful evaluation,” according to the policy paper. “As history and our policies have shown, we do not reject the public health model for increasing access to care for OUD, nor are we ignoring what has been learned about clinical standards of care to treat this illness. It is important to understand, however, the complexity of inducting a new patient into methadone maintenance treatment when developing policies for increasing access to medication assisted treatment.”