We can supervise methadone dosing outside of OTPs

Methadone is a highly effective U.S. Food and Drug Administration-approved medication for the treatment of opioid use disorder (OUD), curbing withdrawals and helping patients feel well enough to reclaim their lives. It reduces illicit drug use by one-third, increases treatment retention four-fold, and cuts the risk of overdose death by up to 80 percent. However, methadone is one of the most heavily regulated prescription drugs in the United States, and people with OUD can only access it through a system of specialized but restrictive clinics called opioid treatment programs (OTPs).

The OTP-only system—which requires many patients to visit the clinic in person up to six days per week to take their methadone under direct supervision—makes the treatment inaccessible or unappealing to many. Meanwhile, research demonstrates that treatment outcomes and quality of life improve significantly with access to take-home doses. Fortunately, efforts are on the rise to improve patients’ access to methadone outside of OTP clinics: The Substance Abuse and Mental Health Services Administration (SAMHSA) recently relaxed guidelines to allow OTP patients a larger number of take-home doses earlier in their recovery. And recently introduced legislation would permit specialist physicians to prescribe and pharmacists to dispense the medication.

Critics of expanding take-home or pharmacy-based access to methadone often claim that the supervised dosing offered at OTPs ensures adherence and minimizes diversion—the procurement, distribution, or use of prescription drugs outside of formal legal channels. However, methadone treatment, like any medical treatment, works best when it is individualized to patient circumstances and needs, and clinicians should have the flexibility to adapt care as appropriate. For example, access to quality counseling and social support services can be important parts of recovery for some patients. And although many patients do not require or benefit from strict monitoring of their methadone, others find supervised dosing helpful. Indeed, providing options that facilitate supervised methadone consumption outside of OTPs could potentially safely open up the benefits of take-home doses to more vulnerable and less stable patients. Here, we review the evidence around three approaches that could help optimize safety as methadone access is expanded, whether via increased take-home doses or provider prescribing.

Pharmacist Supervision

Research from the United States and abroad demonstrates that OTPs are not the only facilities capable of providing in-person supervision of methadone consumption.

Several countries allow providers to prescribe methadone to their patients, who may access it via a community pharmacy. While some patients simply take their methadone home as they would with a typical prescription, pharmacists in some countries—Canada and the United Kingdom, for example—support care by directly observing methadone ingestion. This supervised dosing may occur on a daily or near-daily basis (as it would at an OTP in the United States), or it may occur only when the patient picks up a “batch” of take-home doses, to ensure the patient has been adherent to their medication and thus maintains appropriate tolerance to safely continue at the prescribed dose.

In the United States, pharmacist dispensing of methadone for OUD is rare due to overregulation, but a handful of pilot programs have assessed office-based and OTP prescribing paired with pharmacist dispensing. In these programs, supervised dosing occurs in a private room or screened-off area at the pharmacy—providing more privacy than is available at many OTPs—and may take place either on a regular basis or when patients pick up their take-home doses.

Data from initiatives that incorporate pharmacist observation of methadone consumption in the United States and abroad suggest that the approach protects patient and community safety. Furthermore, pharmacist-observed dosing improves access—the United States has more than 61,000 pharmacies compared to roughly 2,000 OTPs—which leads to better treatment retention (up to 98 percent).

Remote Observation

In recent years, the proliferation of telehealth has highlighted new ways for providers to remotely deliver quality care to their patients, including those with OUD. For example, the COVID-19 pandemic spurred SAMHSA to permit telehealth for buprenorphine initiation and counseling services for methadone patients. Furthermore, two key technologies—video monitoring and electronic pill boxes—have the potential to support methadone patients within or beyond the OTP system. Both facilitate remote supervision of methadone dosing and, if used appropriately, can improve medication access while supporting adherence and reducing the risk of diversion or misuse.

Video Monitoring

While SAMHSA did not permit methadone initiation via telehealth, the pandemic did present an opportunity to try video technology for remote observation of take-home doses. Using a smartphone app, patients record themselves taking their methadone and send the video to an OTP counselor, who uses a purpose-designed portal to asynchronously observe the video. Patients and providers found the technology relatively easy to use, and while some reported room for improvement, this need did not present a usability barrier.

This approach allowed greater take-home access while still ensuring adherence and minimizing diversion risk. This enhanced flexibility improved patients’ ability to stay in treatment while still meeting work and family obligations and saving time and money on transportation. Although video observation can ensure that an individual patient is taking their medication as intended, it does not provide security for take-home doses. Most methadone patients are unlikely to need additional security for their medication, but some housing situations could increase the challenge of safe storage.

Electronic Pillboxes

Another potential technology that would enable the monitoring of methadone dosing outside of the OTP is the electronic pillbox. These wireless boxes contain as many as 28 medication cells that can be unlocked individually and remotely. Patients and providers mutually agree on an appropriate window of time for unlocking the cells, and providers are electronically alerted to both expected (i.e., patient removing the medication and replacing the pill cup as intended) and unexpected activity (i.e., missing a dose or tampering with the box) that occurs outside of that window. The boxes rely on a built-in micro cell phone that connects to the manufacturer’s monitoring station and, thus, operates independently of the patients’ cellular or internet services. These locking devices address some concerns about the safe storage of take-home methadone doses.

Trials carried out during the COVID-19 pandemic demonstrated that electronic pillboxes were generally well-received by patients, supported adherence, and were effective for reducing diversion and misuse risk—evidenced by few instances of box tampering and rare indications that doses were taken outside of the agreed-upon times. This allowed providers to “adequately manage patients who would not otherwise qualify for large quantities of take-home methadone.” Despite the general success of this approach, some patients found the boxes too large (trial boxes were 14” by 11” by 2” and weighed 5.5 pounds empty) and struggled with technical issues. In addition, because dosing is not directly observed, adherence cannot be guaranteed, which is a potential limitation that could be relevant to expanding doses for less stable patients.  

Combined

A third strategy for supporting expanded access to take-home methadone via remote observation or monitoring combined video observations with the electronic pillboxes. This approach is likely overkill for most methadone patients, but it could offer a solution for individuals who are not yet stable but face excessive barriers to reaching an in-person site to take their medication. A 2016-2018 trial of this combined approach found that patients adhered well to the protocol, with minimal evidence of nonadherence or diversion attempts. Furthermore, 98 percent of participants were still in treatment after 12 months, and the vast majority saved time and money on reduced transit to OTPs and were better able to participate in work, family, and other “prosocial” activities.

Conclusion

The United States’ persistent overdose crisis is driving a growing push for better access to methadone—one of the most effective evidence-based treatments for OUD. U.S. policy is slowly moving toward a more patient-centered approach to OUD, presenting an opportunity for providers to embrace novel tools. Resources that facilitate monitored dosing of the medication outside of OTPs could improve the patient experience while alleviating concerns about adherence, misuse, and diversion.