Barriers to treating youth with medications for OUDs

Strategies to get medications to treat opioid use disorder (OUD) to young people immediately after diagnosis are urgently needed, a study published in the September issue of JAMA Pediatrics concluded. Young people with OUDs who receive naltrexone, methadone or buprenorphine are more likely to stay in treatment, yet these medications are underused. Only one in four youths receive medications for OUD shortly after diagnosis. For youths under 18, it's one in 21.     

Stop Stigma Now plans for future

Stop Stigma Now is planning to combine the names of NDRI‐USA and Stop Stigma Now, in a move that the organization hopes will give it more gravitas. Stop Stigma Now is a growing force in the methadone treatment patient community, which has been eclipsed by the general move to buprenorphine and naltrexone in media coverage.     

Methadone and buprenorphine superior to all other treatments

A very important insurance‐based retrospective study shows clearly what the clinical trials have already shown: Agonist treatment for opioid use disorder (OUD) is better than abstinence‐based or antagonist‐based treatment in terms of reducing overdose and opioid‐related morbidity. (Buprenorphine and methadone are opioid agonists, naltrexone/Vivitrol is an antagonist.)     

Physicians,hospital face $9 million lawsuit following fatal OD

Two years ago, Victor Williams, a 56‐year‐old Black man, died from a fatal overdose of fentanyl and fentanyl analogs. He was at home, but his family didn't have any naloxone, because he had not been given any by his treatment provider, despite multiple previous ODs. He had an opioid use disorder (OUD) and instead of being prescribed methadone or buprenorphine, he was prescribed Schedule II analgesics in the hospital. Just hours before his fatal OD, the hospital discharged him after an accidental heroin poisoning.     

Cannabis and alcohol use in young adults: Connections

People with HIV, as well as those who are uninfected, do well on long‐term treatment with opioids (methadone or buprenorphine), researchers have found. There is a strong dose‐response relationship between mortality (all causes), unnatural death and overdose, with the higher morphine equivalent daily doses having the best outcomes, according to the study, by Ajay Manhapra, M.D., and colleagues and published online Sept. 16 in the Journal of Drug and Alcohol Dependence. “Opioid risk mitigation approaches should be expanded to address the potential effects of higher dose on all‐cause mortality in addition to unnatural and overdose fatalities,” the researchers conclude in the abstract. For the study, there were 22,996 patients on long‐term treatment, 6,578 (29%) with HIV and 16,418 (71%) uninfected. Among 5,222 (23%) deaths, 12% were unnatural deaths and 6% overdoses. The study, “All‐cause mortality among males living with and without HIV initiating long‐term opioid therapy, and its association with opioid dose, opioid interruption and other factors,” also found that benzodiazepine use was associated with overdose.     

Parrino perspective from 2019 AATOD conference: Positives and negatives

Opioids have put the American Association for the Treatment of Opioid Dependence (AATOD) front and center when it comes to medication‐assisted treatment with methadone in particular, but also with buprenorphine and naltrexone. Mark W. Parrino, AATOD president, told the 2,000 or so attendees at the AATOD conference in Orlando last week about the positives and negatives that have occurred in the past year. Amid all the festivity and “magic” of Disney and the deluxe Coronado Springs Resort, there are very serious issues facing the field in terms of growth and patient care.     

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 ).     

More from Louis Baxter on doctors taking MAT

The question of whether or not doctors and other health care professionals on medication‐assisted treatment (MAT) are safe to practice medicine has been debated for the last few years since the advent of Food and Drug Administration (FDA)–approved MAT for opioid use disorder (OUD). The newly approved medications have been primarily buprenorphine formulations for OUD, naltrexone formulations for OUD and alcohol use disorder (AUD), and, most recently, an alpha 2‐adrenergic medication that specifically targets amelioration of opioid‐withdrawal symptoms from OUD (lofexidine). Quite frankly, the question of safety about medications to treat substance use disorder (SUD) has been asked since the development of methadone for OUD treatment more than 30 years ago.     

EMTs authorized to carry buprenorphine in New Jersey

Last month, the New Jersey state health commissioner issued an executive directive allowing medical directors of New Jersey's 21 Mobile Intensive Care Unit (MICU) programs to carry buprenorphine, which can be used to mitigate opioid‐withdrawal symptoms following an overdose reversal with naloxone. People who are revived with naloxone after an overdose go through withdrawal, which can be intense and painful. Only an opioid, like buprenorphine, can reverse these symptoms.     

From starter OTP to acquisition by BayMark: A 3‐year journey

BayMark Health Services has acquired Counseling Solutions, a treatment provider focusing on methadone and buprenorphine treatment with locations in Chatsworth, Georgia, and Brasstown, North Carolina. When Zachary Talbott first started working to open his opioid treatment program (OTP) in Chatsworth more than three years ago, he had no plans to sell it (see ADAW, Aug. 17, 2015).     

Briefly Noted

We asked Jerry Rhodes, former top executive at CRC (now Acadia) and a leader in opioid treatment program management, what he thinks of methadone as a medication to be used in primary care to treat opioid use disorder (OUD), as some people — including former Office of National Drug Control Policy Director Michael Botticelli — recommended last year (see ADAW, July 16, 2018). “I take issue with that,” said Rhodes. “Methadone is a dangerous drug in an unregulated environment,” he told ADAW. Buprenorphine is prescribed this way, but “buprenorphine is a relatively safe drug, and methadone isn't,” he said. A veteran of many battles over methadone, including the near‐elimination of opioid treatment programs, Rhodes told ADAW that “you don't give unfettered access to methadone” to patients with OUD. “Be careful what you wish for” is his advice. This has the potential to cause harm, he said. “Only people who don't understand the history of its utilization would recommend this.”     

Bill to deregulate buprenorphine raises concerns among OTPs

The Mainstreaming Addiction Treatment Act (H.R. 2482) would deregulate buprenorphine. Adminstration of the medication is held to high standards when used in the treatment of opioid use disorder, like methadone. Also like methadone, those standards don't apply when the medication is used to treat pain. The bill only applies to buprenorphine.     

Briefly Noted

Clayton Stafford died after using Vivitrol, and his family is suing Alkermes, the manufacturer, saying that the medication doesn't adequately treat addiction, compared to buprenorphine and methadone, and that the manufacturer knew this. In the lawsuit, California‐based law firm Lieff Cabraser alleges that Stafford, his parents and his treatment providers were misled into thinking Vivitrol was an appropriate treatment for his opioid use disorder. “Clayton Stafford's tragic death could have been avoided,” notes Lieff Cabraser partner Fabrice N. Vincent, who filed the lawsuit on behalf of the Stafford family. “The well‐reported defects in Vivitrol made Clayton's overdose a near‐foregone conclusion, and had the Staffords received accurate information about Vivitrol's risks and effective deficiencies from Alkermes, they would never have consented to its use by Clayton.” Naltrexone doesn't work to treat addiction and cravings, but just to block the effects of opioids, according to the lawsuit (and many others agree with this). “Because the patient's addiction is not adequately treated, the patient requires indefinite Vivitrol use to merely block the euphoric effects and keep the patient from seeking opiates,” Vincent said. “Patients therefore remain highly likely to relapse despite indefinite use of Vivitrol.” The lawsuit also makes note of Alkermes' direct‐to‐consumer marketing campaign, which extended into influencing the criminal justice system to use Vivitrol. Stafford had been mandated to use Vivitrol. Last year, the Food and Drug Administration issued a warning letter to Alkermes stating that its advertising did not state that stopping Vivitrol can lead to relapse and overdose, as is clearly stated by the label and package insert (see “FDA warns Alkermes about OD risk on Vivitrol ads,” ADAW, Dec. 16, 2019, https://onlinelibrary.wiley.com/doi/10.1002/adaw.32566 ).     

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.     

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.     

ADA settlement exposes liability when providers refuse MAT patients

Gov. Andrew Cuomo of New York has added opioid use disorders (OUDs) to the list of approved conditions for which medical marijuana could be prescribed in the state, following the lead last month of New Jersey Gov. Phil Murphy, who limited such use as an “adjunct” to medications like methadone and buprenorphine (see ADAW, Jan. 28).     

Views on medication's role in treatment begin to converge amid deadly epidemic

In “Intervention stigma: How medication‐assisted treatment marginalizes patients and providers,” a researcher writes about one of the biggest paradoxes facing those treating and being treated for opioid use disorders (OUDs): the fact that the “gold standard” for treatment — methadone and buprenorphine — subjects both providers and patients to stigma, both within and outside addiction treatment communities.     

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.”     

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.     

SAMHSA guidelines for recovery housing emphasize MAT

If there's any question about the appropriateness of medication‐assisted treatment (MAT) using methadone and buprenorphine for recovery housing residents, it has been settled by the most recent report from the federal government: Don't ban it, and, furthermore, do it.