The Urgent Need for Greater Access to Methadone in Addressing the Fentanyl Crisis

The Urgent Need for Greater Access to Methadone in Addressing the Fentanyl Crisis

The Fentanyl Crisis and the Overdose Epidemic

Over recent years, the increasing prevalence of fentanyl in the drug supply has resulted in an unprecedented overdose death rate and other severe consequences. Individuals with opioid use disorder (OUD) urgently require treatment not only to protect them from overdosing but also to assist them in achieving recovery. However, highly effective medications like buprenorphine and methadone are still underutilised. In the current crisis, it is crucial to make methadone more accessible, as it may offer unique clinical advantages in the fentanyl era.

Methadone’s Effectiveness in Treating OUD

Growing evidence suggests that methadone is as safe and effective as buprenorphine for patients who use fentanyl. A 2020 naturalistic follow-up study found that 53% of patients admitted to methadone treatment who tested positive for fentanyl at intake remained in treatment a year later, compared to 47% for patients who tested negative. Nearly all (99%) of those retained in treatment achieved remission. Another study reported that 89% of patients who tested positive for fentanyl at methadone treatment intake and continued treatment for six months achieved abstinence.

Preference for Methadone Among High-Risk Patients

Methadone may be preferable for patients at high risk of leaving OUD treatment and overdosing on fentanyl. Comparative effectiveness evidence from British Columbia indicated that individuals with OUD who were given buprenorphine/naloxone were 60% more likely to discontinue treatment than those who received methadone. More research is necessary to determine optimal methadone dosing for patients with high opioid tolerance due to fentanyl use and to establish effective induction protocols for these patients. A rapid escalation to a therapeutic dose might be required.

Barriers to Medication Treatment for OUD

Despite the benefits, only a fraction of individuals who could benefit from medication treatment for OUD (MOUD) receive it, primarily due to structural and attitudinal barriers. Data from the National Survey on Drug Use and Health (NSDUH) in 2019 showed that just over a quarter (27.8%) of individuals who needed OUD treatment in the past year received medication to treat their disorder. This proportion dropped to one in five by 2021, a year into the pandemic.

Efforts to Expand MOUD Access

Efforts have been made to expand access to MOUD. In 2021, the U.S. Department of Health and Human Services (HHS) advanced the most comprehensive Overdose Prevention Strategy to date, which included eliminating the X-waiver requirement for buprenorphine in 2023. However, in the fentanyl era, it is also essential to expand access to methadone, despite facing even greater attitudinal and structural barriers. People in methadone treatment, who must regularly visit an opioid treatment program (OTP), often encounter stigma from their community and providers. Additionally, people in rural areas may struggle to access or continue methadone treatment if they live far from an OTP.

Regulatory Changes and Their Impact

SAMHSA’s changes to 42 CFR Part 8 on January 30, 2024, were a positive step under the HHS Overdose Prevention Strategy. The new rule makes permanent the increased take-home doses of methadone established in March 2020 during the COVID pandemic and includes provisions like the ability to initiate methadone treatment via telehealth. Studies show that telehealth is associated with an increased likelihood of receiving MOUD and that take-home doses enhance treatment retention.

Safety and Benefits of Expanded Methadone Access

The changes implemented during the COVID pandemic have not been linked to adverse outcomes. An analysis of CDC overdose death data from January 2019 to August 2021 found that the percentage of overdose deaths involving methadone relative to all drug overdose deaths declined from 4.5% to 3.2%. Expanded methadone access was not associated with significant changes in urine drug test results, emergency department visits, or increases in overdose deaths involving methadone. An analysis of reports to poison control centres showed a small increase in intentional methadone exposures in the year following the loosening of federal methadone regulations but no significant increases in exposure severity, hospitalisations, or deaths.

Patient Feedback on Increased Take-Home Methadone

Patients have reported significant benefits from increased take-home methadone and other COVID-19 protocols. In a small qualitative study, patients at one California OTP reported increased autonomy and treatment engagement. Patients at three rural OTPs in Oregon reported increased self-efficacy, strengthened recovery, and reduced interpersonal conflict.

Methadone Prescribing and Dispensing Restrictions

The U.S. still imposes more restrictions on methadone prescribing and dispensing than most other countries. Concerns over methadone’s safety and the risk of diversion have made some physicians and policymakers hesitant to implement policy changes that would further lower the guardrails around this medication. Methadone treatment, whether for OUD or pain, is not without risks. Some studies have found elevated overdose rates during the induction and stabilisation phase of maintenance treatment, potentially due to starting at too high a dose, escalating too rapidly, or drug interactions.

Methadone and Overdose Risks

Increased methadone prescribing for pain two decades ago was associated with diversion and a rise in methadone overdoses. However, overdoses declined after 2006, along with methadone’s use as an analgesic, even as its use for OUD increased. Currently, 70% of methadone overdoses involve other opioids (like fentanyl) or benzodiazepines, indicating the significant role of drug interactions.

Feasibility of Methadone Dispensing Models

Recent trials of methadone dispensing models in pharmacies and other settings outside OTPs have not supported concerns that making methadone more widely available will lead to harms like overdose. In two feasibility studies, stably maintained patients from OTPs in Baltimore, Maryland, and Raleigh, North Carolina, who received their methadone from a local pharmacy found this model to be highly satisfactory, with no positive urine screens, adverse events, or safety issues. An older pilot study in New Mexico found that prescribing methadone in a doctor’s office and dispensing it in a community pharmacy, as well as methadone treatment delivered by social workers, produced better outcomes than standard care in an OTP for a sample of stably maintained female methadone patients.

The Role of Counseling in Methadone Treatment

Critics of expanded access to methadone outside OTPs sometimes argue that the medication should not be offered without accompanying behavioural treatment. However, data suggest that counselling is not essential for all patients. In wait-list studies, methadone treatment was effective at reducing opioid use on its own, and patients remained in treatment. Nevertheless, counselling may have benefits or even be indispensable for some patients to help them improve their psychosocial functioning and reduce other drug use. Personalising the intensity and level of support needed is a question that requires further investigation.

The Path Forward

Over the past two decades, the opioid crisis has accelerated the integration of addiction care in the U.S. with mainstream medicine. Yet methadone, the oldest and still one of the most effective medications in our OUD treatment toolkit, remains siloed. In the current era of powerful synthetic opioids like fentanyl dominating the statistics on drug addiction and overdose, it is time to make this effective medication more accessible to all who could benefit. The recent rules making permanent the COVID-19 provisions are an essential step in the right direction, but it will be critical to pursue other ways that methadone can safely be made more available to a wider range of patients with OUD. Although more research would be valuable, initial evidence suggests that providing methadone outside of OTPs is feasible, acceptable, and leads to good outcomes.

Source: National Institute on Drug Abuse

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