Methadone is effective for opioid use disorder, so why aren’t more patients using it?

Because the Nineteen Seventies, methadone has been used to deal with opioid use dysfunction (OUD) with nice success—decreasing the probability of dying from an opioid overdose by 50% or extra. But for sufferers and prescribers alike, selecting the drug for OUD remedy is sophisticated.

That is as a result of methadone is topic to strict prescriber rules that different FDA-approved OUD medicines, like buprenorphine, aren’t—rules which have been unchanged for half a century. Beneath these tips, methadone could also be distributed solely by specifically licensed suppliers particularly amenities—which means your main care supplier cannot write you a prescription—and preliminary dosages are mounted, not personalised for every affected person.

Caleb Alexander, MD, MS, a professor in Epidemiology and founding co-director of the Heart for Drug Security and Effectiveness, and Michael Fingerhood, MD, director of Dependancy Medication on the College of Medication and professor in Psychological Well being, say these antiquated rules, together with restrictive monitoring applications and social stigma, are maintaining sufferers from accessing and health care providers from offering this lifesaving medicine.

What do we all know concerning the effectiveness of methadone as a remedy for opioid use dysfunction?

CA: One of many ironies of the opioid epidemic is how a lot hurt has occurred whereas we have now had efficient therapies on standby. Methadone, like different FDA-approved therapies for opioid use disorder (OUD), is secure and efficient and may cut back the probability of dying from an overdose by as much as 50%.

Not solely do we have now well-designed, rigorous randomized clinical studies, we have now systematic evaluations on the prime of the proof pyramid that synthesize all the info from these particular person research. And so they concur.

MF: Relying on the inhabitants, the discount in mortality charge could even be higher than that. If you happen to take a look at sufferers who’re on the highest danger of overdose dying, like somebody who has been launched from incarceration, for the primary two weeks after launch, the impression is probably going greater than 50%.

The proof for [the effectiveness of methadone] is overwhelming. All research level to the truth that methadone has a dramatic impression on saving lives by means of stopping opioid overdose.

How does it examine to different drugs used to deal with opioid use dysfunction?

MF: We have now three drugs which are authorized for treating opioid use dysfunction: methadone, buprenorphine, and naltrexone. Naltrexone is a pure opioid antagonist—a drugs that blocks the activation of opioid receptors in your central or peripheral nervous system—[that is administered by an] injection that lasts 30 days. The affected person acceptance charge for naltrexone just isn’t very excessive. It is very tough to get individuals previous their first injections to remain on it.

Then we’re left with methadone and buprenorphine—and each are very efficient. Typically, we have now a dialogue with sufferers about how every of [the medications] might match into their life. Methadone could be very regulated by way of particular remedy applications that present and dispense the drug. Buprenorphine we have had since 2002, and till then, there was little we might do in an workplace setting apart from methadone to alleviate opioid withdrawal and deal with opioid use dysfunction.

How does methadone work?

MF: Within the late Sixties, researchers confirmed that if a affected person has a long-acting oral opioid on their opioid receptor, they do not go into withdrawal. They do not get up the subsequent day sick. Actually, what most individuals with opioid withdrawal do is attempt to stop themselves from being sick. They are not truly excessive. Methadone on that receptor prevents the large swings between the consequences of opioid medicine and going into withdrawal.

What are the outcomes for individuals who obtain methadone remedy vs. those that do not?

CA: Dependancy is a illness of isolation characterised by chaos. People who find themselves within the throes of lively dependancy—their lives are dominated by the dependancy. The cravings and compulsions and urges to make use of could be ever-present, and so they’re extremely disruptive to any semblance of a wholesome and ordered life.

People who find themselves in methadone remedy and coming into restoration have elevated alternatives and probability of sustaining employment, of reconciling with family and friends members, of sustaining secure housing, of decreasing different high-risk behaviors that could be injurious to improved well being, wellness, and administration of different persistent circumstances they could have.

It isn’t nearly not dying, it is about dwelling. Methadone permits individuals to reintegrate with society and dwell wholesome and rewarding lives.

How is it regulated? Why are these rules so strict?

CA: The rules require that methadone be distributed solely by specifically licensed suppliers particularly settings and restrict individuals’s means to take dwelling methadone. Traditionally, pre-pandemic, it was all what we name DOT, immediately noticed remedy, the place you’ll go in [to a facility], get your methadone dose, and be noticed taking it. A few of these insurance policies relaxed throughout the pandemic.

Different medicine aren’t regulated this fashion, and I believe to a point, methadone has been topic to a little bit of exceptionalism. In any case, it isn’t as if different opioids which have been prescribed so closely are risk-free. And, the opioid epidemic just isn’t an epidemic of methadone overdose. It is an epidemic of overdose of different opioids.

MF: The rules [on methadone] are 50 years outdated, and so they’ve by no means been modified. They are saying that solely particular locations can dispense methadone. For the primary 90 days of remedy, each affected person should present up daily, and their preliminary dose should be 30 milligrams. On this age of fentanyl, that dose is miniscule and actually has little impression.

There are additionally rules {that a} bodily examination should be performed earlier than the affected person can provoke remedy. There cannot be initiation of methadone through telemedicine; every thing needs to be in particular person. And physicians, nurse practitioners, and doctor’s assistants can prescribe oxycodone or morphine, but there are guidelines that they cannot prescribe medicine for opioid use dysfunction with out additional specialised coaching.

There was some slight coverage leisure throughout COVID. SAMHSA [Substance Abuse and Mental Health Services Administration], in coordination with the DEA, introduced that there might be take-home doses for the primary time inside these first 90 days of remedy.

How do we alter these rules?

CA: I believe we have now to acknowledge the protection and medical worth of those medicines and their vital function in managing opioid use dysfunction. There are various circumstances the place we do not have secure and efficient therapies. This is not considered one of them. Methadone is secure and efficient.

Sure, it is vulnerable to diversion. So too is each different opioid. Sure, one can overdose from it. So can also one overdose from many different opioids. We have handled it as if it is a black swan. It is an opioid, and it has some distinctive options that require care and warning. However I believe clinicians are as much as the duty. Insurance policies that make it simpler for clinicians to prescribe methadone are vital.

MF: I believe persons are realizing that there is no proof that diversion of methadone occurred at a higher degree throughout COVID, when a variety of these guidelines had been relaxed. There isn’t any proof that there have been overdoses associated to diversion of methadone. COVID taught us that for methadone, stress-free the strict 90-day rule of displaying up daily had no damaging impression.

Are there different obstacles to prescribing methadone—bias, or insurance coverage restrictions for instance?

CA: Fortuitously, in 2023, we’re at some extent the place it should be fairly onerous to seek out an insurer imposing draconian restrictions on therapies for opioid use dysfunction. I believe insurers have come round and usually will reimburse such therapies as they need to be.

I’d not be stunned if there’s some choice towards [prescribing] buprenorphine. You may prescribe it in main care, you may give somebody a 30-day provide of tablets, and many others. For methadone, it’s a must to go to a particular clinic and are available in every day for remedy and be noticed swallowing the capsule. It introduces this sense that methadone is one way or the other extra problematic.

MF: I deal with sufferers with buprenorphine for opioid use dysfunction within the main care setting, the place I combine in therapies of hypertension, diabetes, and their different well being issues on the similar time. There are individuals with opioid use dysfunction who do not need to present up at a spot that they generally view negatively, and maybe self-stigmatize going to a program moderately than having the ability to obtain medicine for opioid use dysfunction in a “common” medical middle.

One other problem has been the punitive nature of some outpatient methadone remedy applications. Slightly than reward, they work by means of a punishing mannequin. There’s additionally a strict rule associated to attending teams and having common conferences with counselors. That is not of profit for each affected person, and a few applications are understaffed—they do not have sufficient counselors. The remedy of opioid use dysfunction could be very pharmacologic. To not say there are not any sufferers who profit from counseling, nevertheless it’s 90% medicine and 10% different issues.

If it had been as much as you, how would methadone be prescribed and administered?

MF: As a doctor, I ought to have the ability to prescribe methadone for opioid use dysfunction the identical approach I prescribe buprenorphine, after which a affected person ought to have the ability to fill it at a pharmacy. That is already occurred in Canada and European nations.

The rationale it hasn’t occurred [in the U.S.] is as a result of nearly all of methadone remedy applications are for-profit. They attempt to perpetuate the present guidelines with a concern that we will lose our for-profit methadone treatment applications if we permit any change within the guidelines of how methadone is used.

CA: There are greater than 20,000 merchandise authorized by the FDA, and plenty of of them have toxicities equal to or higher than that of methadone.

There’s one important query, one elephant within the room, which is, ought to this simply be prescribed and distributed like different medicines in medical follow? There are some extra restrictions you would put in place. One center floor may be a setting that requires prescriber certification, and the FDA has a program for that. That may be probably the most politically expedient method that appeases those that are involved about liberating up entry to this drugs.

However in case you take a look at the enormity of harms that proceed to happen from overdose within the U.S., and weigh that towards the unbelievable advantages and effectiveness of those medicines, it is onerous to not conclude that we have to make modifications that make methadone extra accessible, simpler to prescribe, and simpler for sufferers to take.

What is the greatest misperception you encounter about methadone?

MF: In all probability the most important misperception for each buprenorphine and methadone is that you simply’re simply substituting one drug for one more. That is simply stigmatizing and demonstrates a lack of awareness of dependancy as a mind dysfunction. We would not say to someone who’s diabetic, who we’re prescribing medicine for, that if they may simply cease consuming and drop some pounds and train, they would not want medicine. You additionally continuously hear individuals say, “I do not consider in methadone or buprenorphine.” If somebody goes to a 12 Step assembly, individuals would possibly say, “You are not in restoration in case you’re on medicine.” That is actually unlucky.