Technology-assisted methadone take-home dosing for patients with opioid use disorder
Methadone maintenance treatment (MMT) is the most prevalent and effective treatment for opioid dependence. Sometimes, ‘take home’ privileges are offered to patients with Opioid Use Disorder (OUD); however, it is limited to the patients with regular clinical and counseling attendance, and drug abstinence. Missing a methadone dose results in consequences, such as developing acute opioid withdrawal, or drug relapse.
In the context of the current public health emergency, routine travel to and from opioid treatment program (OTP) facilities for supervised dosing, together with contact with staff and other patients, might increase patients’ risk of illness. Recognizing this, the Substance Abuse and Mental Health Services Administration (SAMHSA), which oversees methadone regulations, issued new guidelines that allow clinically unstable patients to receive take-home methadone doses up to two weeks, and stable patients to receive up to a month.
Since this new SAMHSA guideline in March 2020, numerous trials have been conducted to capture the experiences of patients receiving split-doses of methadone. Also, a significant number of reviews evaluated the clinical feasibility and acceptability of using electronic medication dispensers.
Dunn KE, et al. at Johns Hopkins University School of Medicine, assessed feasibility, acceptability, and safety outcomes of the MedMinder “Jon”, an electronic and cellular-enabled pillbox.
Participants & Study Design
The study evaluated patients maintained on methadone self-referred or were referred by clinicians to complete a 13-week, within-subject, Phase II (NCT03254043) trial.
The inclusion criteria were:
- Patients ≥18 years old
- Patients who had been receiving methadone for ≥90 days
- Patients who received the same dose for ≥30 days
- Patients who had previously received ≥1 take-home dose
- Reported current chronic pain that averaged ≥5 over the past 24 hours on the Brief Pain Inventory survey
The exclusion criteria were:
- Pregnant women
- Medical or psychiatric illness that may interfere with study participation
- Patients planning to end methadone maintenance within 13 weeks
- Patients who were not receiving 10–100 mg of methadone
- Patients being treated for pain
All participants were given tablet methadone for a week before randomization. They remained on tablet methadone throughout the 13-week trial. The phase order included was: MedMinder pillbox to treatment-as-usual or treatment-as-usual to MedMinder pillbox.
MedMinder “Jon” – the locking pill dispenser
The commercially available and HIPAA-compliant Medminder “Jon” is an updated version of MedMinder “Maya”, the automatic pill dispenser. This 28-cell pillbox automatically spits out the medications at the right time and avoids the possibility of taking too many, wrong, or not enough pills. Unlike the “Maya”, the “Jon” comes with an additional locking feature.
User Interface (UI)
The MedMinder Jon pill dispenser with dimensions 14″ × 11″ × 2″ is designed to hold four daily doses of medication for the week. The primary interface is a series of cells containing a medication cup. The cells lock independently and open during pre-set time windows. The “Jon” pill dispenser doles out digital reminders – blinks, beeps, as well as auditory prompts like “did you take the medication”.
With most electronic pillbox brands, there is “dispensee”, the patient who consumes the medication, and “filler”, the person who puts in the medication and set up the dispensing windows. Medminder “Jon” pillbox is no exception.
It’s important to keep the “Dispensee” and “Filler” interfaces separate, especially when the dispensee and the filler are two different people. Furthermore, ‘stopping’ the patients from taking the medication from the wrong slot or at the wrong time, is also important. That’s where the lock in the “Jon” comes in handy.
How the pill dispenser communicates
Talking about how the electronic pillbox communicates, it does the following, say if a dose is set at 7 am. At 6:30 am the box starts a flashing light. If the dose isn’t taken yet, at 7 am it starts beeping. At 7:30 am, if the patient still has not taken the dose, the box will call the caregiver or family members on the phone.
The MedMinder automatic pill dispenser also allows recording messages in an actual voice and have that be the ‘reminder’.
How the pill dispenser connects
The MedMinder pill dispenser has autonomous cellular connectivity; it doesn’t require an Internet connection but a strong cell signal in the room where it is kept. Assigned staff members have access to each pillbox via a secure cloud-based server to set or modify dosing intervals and review reports.
An account in the MedMinder portal is the only prerequisite for setting the electronic pillbox up. After registering the product, patients can set up medication routines and basic notifications.
The MedMinder web portal allows caregivers to look at a variety of reports. For instance, missed doses or refills as well as an ‘Adherence score’.
Remote adjustment regimen
Patients or the caregiver can easily program the medication dispenser remotely. This, in turn, controls which slots light up and beep, and at what interval. However, the exact medication regimen depends on the methadone tablets/capsules that are slot into the pill dispenser. The MedMinder pharmacy makes it possible to have pre-filled trays that the patients can slot into the “Jon”. This also means he or she has to trust the pharmacy to ‘organize’ it correctly. And regimen adjustments may have a time lag between when you ask for them, and when the new batch is delivered.
Dispense with Cognitive Impairment
Locking away doses until it is time to take them is an important safety feature. Medminder “Jon” locking functionality addresses the situation of OUD patients with cognitive impairment who might get confused as to which pill cell/compartment to open and when. The “Jon” has independent locks for each cell, which can be unlocked automatically only at the set time. This, in turn, prevents drug abuse. A topical example is in the case of methadone, a heavily-regulated Schedule II drug. Numerous case studies reported that patients who receive methadone for opioid use disorder are at a high risk of abuse because they already had abused opioids. Lock in the “Jon” may also help prevent the wrong person from taking the pills.
No longer should caregivers worry about overdosing or mis-dosing.
The Re-filling Options
The locking pill dispenser is designed to suit both manual and pre-filling by a pharmacist or caregiver. MedMinder-supplied pre-filled trays help reduce the risk of medication errors and ensures continued methadone access for patients. The re-filling works on a schedule; it has weekly, bi-weekly, or monthly time frames, depending on the take-home dosing plan.
RESULTS & DISCUSSION
Being an alternative to standard methadone take-home dispensing during this pandemic, the MedMinder electronic pillbox is indeed a novel approach to monitor medication adherence in patients undergoing methadone maintenance. This technology-assisted shift enabled counselors and clinicians to more securely dispense take-home doses of methadone. By receiving consecutive doses, patients could better manage OUD and reduce exposure to COVID-19.
The safety and anti-tampering features of the pillbox, together with alerts and a responsive phone support line, facilitated effective methadone maintenance and reduced missed doses. The vast majority of the participants showed acceptance (86.3%) and willingness to recommend the electronic pill dispenser to others (95.4%); however, only 52.4% of the study population selected MedMinder Jon during the choice phase.
This study may have implications beyond methadone treatment during COVID-19. Worldwide, there is a critical need to expand opioid abuse treatment, with the rate of OUD patients needing treatment significantly outpassing the number of treatment facilities available. Furthermore, addressing methadone maintenance has become more pressing following the discovery that an increasing number of patients seeking OUD treatment have been using heroin mixed with fentanyl. Fentanyl, an opioid analgesic, can cause severe allergies to overdose, breathing failure, and possibly death.
Another implication is that the use of an electronic pillbox can increase the quality of life of patients belonging to rural settings; it reduces travel time to and from OTP facilities and the associated cost. Kelly et al. reported that people who showed acceptability to methadone treatment achieve better outcomes by remaining in the treatment program.
Additional research that sensitively measures substance abuse, methadone treatment, and treatment accessibility, are needed to augment these data. Further exploration of the feasibility and effectiveness of an electronic pillbox to make OUD treatment more accessible, not more restrictive is also needed.