Archive for the ‘Methadone dosing’ Category

Guest Dosing at Opioid Treatment Programs

 

 

 

 

“Guest dose unto others as you would have others guest dose unto you.”

I think all opioid treatment program physicians should follow this twist on the Golden Rule.

That is to say, when OTP physicians are contemplating the appropriateness of approving one of our patients to be guest dosed at another OTP, we need to consider whether we would want to be on the receiving end of a similar patient.

First, let me explain what guest dosing is for my readers who may be unfamiliar with it.

Patients of opioid treatment programs have to dose daily on their medication, unless they meet criteria for take home doses. For buprenorphine (formerly known as Suboxone or Subutex) regulations have loosened in many states, so that take home doses are granted much earlier. (The federal regulations have completely dropped the time in treatment requirement for take home doses of buprenorphine.)

But for methadone, patients have to dose at the facility each day for at least the first ninety days, and after that, if doing well, they can get up to three take homes per week for the next ninety days, then up to four per week after a half of a year, and so on.

What happens if the patient needs to go out of town before they are eligible for these take homes?

There are three options: leave treatment, the worst option, because of the increased risk of death for patients who leave treatment; special take home doses, often risky if the patient isn’t able to take them as prescribed; and guest dosing.

Guest dosing means a patient of one treatment program can be dosed at another program if that patient travels to another area. All opioid treatment programs send their patients for guest dosing and allow guest dosing for patients of other facilities. It should be a smooth and simple process, under ideal circumstances.

But sometimes circumstances get complicated.

Most difficult are the last-minute guest dosing requests. These tend to come at particularly stressful times for the patient, because often a patient’s family member is sick, or just passed away. The patient needs to be with his family.

Setting up guest dosing at the last minute is more difficult for the referring clinic, the accepting clinic, and the patient. Most clinics ask for 24-48 hours advance notice for guest dosing, but some situation don’t allow that much time. We do the best we can, try to explain circumstances to the receiving clinic, and usually are able to work out something.

Guest dosing requires good communication between clinics. Usually the home clinic needs to fax a form with the patient’s picture, their dose, and any take home doses to be dispensed. Most receiving clinics like to see at least the last three drug screen results. Some receiving clinics ask for a doctor’s signature to assure the physician is aware of the guest dosing request. Then when the guest dosing patient arrives at the receiving program, the nurse calls to verbally confirm all of the info on the guest dosing request.

Some opioid treatment programs charge steep guest dosing fees, affecting the patients’ ability to pay for guest dosing. Some clinics charge a one-time fee to set up guest dosing, and after that pays the same as any other patient dosing at that clinic. Some programs charge elevated fees every day the patient guest-doses.

As the medical director, I am consulted any time one of our patients wants to guest dose at another clinic, and any time a patient from another clinic wants to guest dose. We have general guidelines for guest dosing, but often have to consider other factors.

For example, at both of the treatment centers where I work, we prefer not to guest dose patients during induction. Induction is the riskiest time of treatment, and usually lasts at least thirty days. But each request must be considered and the risk/benefit analyzed. What about if a patient admitted three weeks ago finds out a close relative is dying, and wants to be with them? I might agree with guest dosing such a patient, if she is doing well, isn’t actively using benzodiazepines or alcohol, and won’t be gone for many days.

Some clinics won’t allow guest dosing for any patient with positive drug screens. Generally I would agree with that, but for me it depends on what the drug is, and why the patient needs to go out of town, and for how long. For example, if a patient is stable on his dose, but is still smoking marijuana with every drug screen positive for THC, I’d still support guest dosing if this patient needs to work out of town. I’m not OK with continued illicit marijuana use, but the problems caused by missing a work opportunity may be greater than problems caused by marijuana use. If that same patient were using benzodiazepines or alcohol, I probably wouldn’t agree with guest dosing, due to the much higher risk of methadone when combined with these drugs. If the marijuana-smoking patient wanted to guest dose out of town in order to attend a friend’s bachelor party…I’d be hesitant, as I’ve heard rumors that these events tend to involve heavy drinking of alcohol. I’d have to talk to the patient.

Guest dosing in patients on buprenorphine used to be difficult, since so many OTPs weren’t using buprenorphine. Now, most OTPs do offer both buprenorphine and methadone to their patients in treatment, so they can accept guest dosing for both.

But since buprenorphine is such a safer medication than methadone, usually we can get permission for take home doses, if the patient doesn’t already qualify for them. Even though federal regulations dropped the time-in-treatment requirements for take homes in buprenorphine patients, my state still requires time in treatment, unless we ask for an exception, which is usually granted.

So who should not be approved for guest dosing? As above, patient in induction shouldn’t be guest dosed unless there are extreme extenuating circumstances – death in the family, personal medical crisis, or other extraordinary circumstance.

Sometimes I get frustrated not with patient of other treatment programs, but with the people who work at other treatment programs.

For example, last weekend we had a patient show up on a Saturday for guest dosing with no advance notice. Ordinarily, we ask for 48 hours’ notice to make sure guest dosing goes smoothly. Since it was a Saturday, our nurse had to stop dosing our own patients, call me for permission to guest dose her, and then call her home clinic for needed information.

We had already guest dosed this patient a few times within the past few months, so we kind of knew her. Otherwise, I’d have been tempted to say no, because it’s an inconvenience to our waiting patients and a hassle for our nurse. But it seemed harsh to deny her due to her clinic’s ineptitude.

If we had sent a patient to another OTP with no advance notice, I can almost guarantee they would say no, too bad, your counselor should have set this up days ago.

The whole goal of treatment is to help drug addicts regain their ability to live a normal life. Opioid treatment programs should make every effort to remove obstacles to travel during treatment, while still following state and federal regulations. And of course, the freedom to travel and guest dose must be balanced with patient safety. Ideally, the decisions regarding guest dosing should be made by the physician, who is informed by the input of the treatment team, so that the best possible decisions can be made.

Oh, and please, OTP counselors everywhere… it is “guest” dosing, not “guess dosing.” I cringe every time I see that written in any records from any program. We do not guess a dose. We do guest dose patients.

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Bad Weather Take Home Doses for Opioid Treatment Program Patients

We’ve had some snowy days in my area, and this means administrators at our opioid treatment program must decide if we should provide extra take home doses to patients for the days when travel will be treacherous.

Because take home doses are closely regulated at opioid treatment programs, both for methadone and buprenorphine, we must get special permission from state and federal regulatory agencies to give extra take home doses. We do this by submitting what’s called an “exception request.” This is an online form where we describe why we are requesting an extra take home, and for whom it will apply. Part of our job is assuring the authorities we won’t give extra take homes to patients who can’t manage them safely.

Ultimately, it’s up to me, the medical director, to decide the risk level of each patient. Which is more dangerous, driving on snowy roads to get to the opioid treatment program to dose, or having an extra take home bottle of medication? I need input from the staff to make the best decisions, so this can be time consuming.

Admittedly, my program failed our patients this last week.

The trouble is, we must decide when to submit a request for extra take homes about 48 hours in advance. It may take a day to submit online and get the medical director’s signature, the state opioid treatment authority signature, and the federal agency signature. Then we must give out the extra take home one day before the harsh weather is predicted.

Sometimes it’s hard to forecast bad weather. Early this month, we got an extra take home exception for a day when ice was predicted. In our area, a few degrees can make the difference between ice and rain. As it turned out, no ice fell and it was a perfectly normal day for driving.

I think that over-reaction was in our minds when we were monitoring the weather last week. At first, weather was expected for late Tuesday night. We were expected to get 1-2inches. We discussed if we should submit an exception, and finally did so late Monday night. I signed it, and it was approved by state and federal authorities, but we chose not to enact the exception Tuesday morning, based on updated forecasts.

It was not the right decision.

Tuesday night, it began to snow during the wee hours. By early morning, we had 3-4 inches and it kept snowing until afternoon. Somehow the forecasted 1-2 inches turned into 8 inches, at least on my side of the Brushy Mountains.

I live in the Brushy Mountains, and have a very steep driveway. Really, really steep. Imagine the steepest paved road you’ve ever driven on, and crank that up a few more degrees and you have my driveway. Plus, it has two curves in it. The only way I can get my small Toyota down the driveway would be to ride it like a luge sled, so it stays in the garage during bad weather.

My fiancé has a four-wheel drive vehicle, so he takes me to work, or I call a co-worker to come get me and I walk down my driveway to the road.

A group of physicians who work at opioid treatment programs were discussing this issue of severe weather take home exceptions on our monthly conference call last week. We pondered the factors that help us decide:

  1. Since buprenorphine has a greater margin of safety than methadone, I’m willing to grant bad weather take home doses for buprenorphine patients, unless there are other concerns to be considered.
  2. Patients in the induction phase of treatment, the riskiest time in treatment for methadone patients, shouldn’t get extra take homes.
  3. Patients who already receive take home doses for Sundays and holidays are likely OK for bad weather days, too.
  4. Patients using alcohol or benzodiazepines are at higher risk, and may not be appropriate for extra take home doses.
  5. Patients who live in a home with other people with active substance use disorders may not be able safely to store their medication, and may not be appropriate for the extra take home.
  6. Patients who have had recent episodes of suspected diversion won’t get extra take homes.
  7. Patients who live around the corner, are healthy, and can easily walk to the opioid treatment program don’t need extra take homes.
  8. Patients who live in more treacherous terrain or longer driving distance may need take homes. Our opioid treatment program is in the foothills of the mountains, but some patients live in a spur off the Appalachian Mountains called the Brushy Mountains. We have some steep and winding roads.

That’s a rough idea of most of the factors that go into deciding who should get take homes and who shouldn’t.

Then there are transportation issues. I mistakenly thought Medicaid-funded patients, who ride a transportation service that contracts with Medicaid to provide transportation to medical appointments, could get their usual ride to the opioid treatment program. Later I found out they have only a few four-wheeled vehicles. On one of our worst snow days, they only transported dialysis patients and others with “life-threatening illnesses.” My patients weren’t transported.

So, now I know that I cannot count on this agency to get patients to treatment on bad weather days.

As a group, OTP physicians are re-evaluating criteria for extra take homes in these bad weather situations, along with some help from our SOTA (State Opioid Treatment Authority). I feel fortunate to live and work in a state with an active SOTA. These remarkable people are tireless in their quest to continually improve the quality of care for patients at opioid treatment programs. They are valuable allies for physicians.

Because that’s the bottom line: we all want the best and safest care possible for our patients.

Media Maintains Methadone is Menacing Mountains

 

NEWS CAT

Last week, a colleague of mine directed my attention to local news coverage of the opioid use disorder epidemic. It’s a four-part series titled “Paths to Recovery.”

Anytime the press covers opioid use disorder and its treatments, I feel hope and dread. I hope the report will be fair and unbiased, and give the public much-needed information. And I dread the more likely stigmatization and perpetuation of tired stereotypes about methadone as a treatment for opioid use disorder.

Overall, the four segments of this news report had some good parts, and some biased parts. It was not a particularly well-done series, and could have benefitted from better editing. It was disjointed and contained non-sequiturs, which I suspect confused viewers.

In the introduction to the first segment, the report says their investigators have spent months digging into treatment options in the area. Their conclusion: there’s a variety of options and treatment is not one-size-fits-all. The report goes on to give statistics about how bad the opioid use disorder situation has become, and they interviewed a treatment worker who says we’re two years in to this, and the community doesn’t grasp the seriousness of the situation. They also interviewed some harm reduction workers, and discussed naloxone rescue for overdoses and needle exchange.

So far, so good, except that of course we are more like two decades into the opioid crisis, not two years.

Part two of this series was “Mountain methadone clinics.” As soon as I saw the dreadful alliteration, I cringed, fearing the content of the segment.

This report didn’t say good things about methadone. In fact, one physician, supposedly the medical director of a new opioid treatment program in the area, says on camera, “Methadone is very dangerous. It has some effects on the heart. The rhythm of the heart, it has some drug interactions.” He went on to say that at the right dose, people could feel normal, and that it replaced the endorphins that were lacking, but I worry people will remember only that a doctor said methadone was a very dangerous drug.

Methadone can be dangerous, if you don’t know how to prescribe it, or if you give a person with opioid use disorder unfettered access to methadone. But in the hands of a skilled and experienced physician, at an opioid treatment program with observed dosing, methadone can be life-saving.

The news report outlined the failings of existing methadone programs in the area, saying staff had inadequate training, and failed to provide enough counseling for patients. It said one program made a dosing error and killed a patient, while another program had excessive lab errors.

All of that sounds very bad.

No positive aspects were presented as a counterpoint to that bleak picture. I felt myself yearning for an interview with a patient on methadone who has gotten his family back, works every day, and is leading a happy and productive life. Of course, those people are hard to find, since they are at work and harder to find by the media, even reporters who have supposedly been “working for months” on this story.

And then…of course they interviewed patients who had misused methadone. One person criticized his opioid treatment program because they allowed him to increase his dose to 160mg per day, and he said “…that’s a lot. I didn’t need that much…” and goes on to admitting to selling his take home medication. Another patient said the methadone made him “sleep all the time.” Another patient said methadone made him “high all the time.”

There will always be such patients…ready to lie to treatment providers to get more medication than needed, break the law by selling that medication, and then blame it all on the people trying to help them. Unable to see their own errors, they blame it all on someone else, or on the evil drug methadone.

Every program has such patients. But these people can also be helped, if they can safely be retained in treatment long enough, and get enough counseling.

Even though these patients are few, they get far more media attention compared to the many patients who want help and are willing to abide by the multitude of rules and regulations laid on opioid treatment programs by state and federal authorities. These latter patients are why I love my job. I see them get their lives back while on methadone. They become the moms and dads that they want to be. They go back to school. They get good jobs and they live normal lives. They don’t “sleep all the time,” as the patients on this report said.

But not one such patient was interviewed for this report.

As I watched this segment, I thought back to an interview the A. T. Forum did with Dr. Vincent Dole, one of the original researchers to study methadone for the treatment of opioid use disorders. This was in 1996, before our present opioid crisis gained momentum.

A.T. FORUM: It seems that, over the years, methadone has been more thoroughly researched and written about than almost any other medication; yet, it’s still not completely accepted. How do you feel about that?

  1. VINCENT DOLE:It’s an extraordinary phenomenon and it has come to me as a surprise. From the beginning of our research with methadone we were able to rehabilitate otherwise hopeless addicts that had been through all of the other treatments available. I expected methadone would be taken up very carefully by the addiction treatment community, but with some enthusiasm. Instead of that, we’ve had endless moral and other types of objections which are really irrelevant to the scientific data.

I was surprised, because my background in research had led me to expect that the medical community was a very critical but nonetheless objective group that would respond to solid, reproducible data. Instead I find that we still get the anti-methadone argument of substituting one addictive drug for another.

This is ignoring the scientific data showing that, as a result of methadone treatment, people who have been hopelessly addicted and anti-social and excluded from any normal life or family, are in a wonderful way becoming responsive to social rehabilitation and today constitute a very large number of people who are living normal lives. The fact that people, especially medical practitioners, would dismiss that as unimportant simply staggers me!

[http://atforum.com/interview-dr-vincent-dole-methadone-next-30-years ]

 

What would Dr. Dole think now, twenty more years later, during a terrible wave of death from opioid use disorders, about the continued stigmatization of methadone?

Then next segment was about buprenorphine, and how it can be prescribed in a doctor’s office, making it a better choice for patients. It wasn’t a bad segment, and contained some useful information. Physicians who were interviewed had nothing but good things to say about buprenorphine.

Or rather, they had good things to say about Suboxone.

The brand Suboxone was heavily promoted by this piece. Not once did the reporter use the drug’s generic name, buprenorphine. Every time, the medication was called by its brand name, Suboxone, and every picture of the medication was of Suboxone film. No mention was made of the other brands: Zubsolv, Bunavail, Probuphine, or even that there are generic combination buprenorphine/naloxone equivalents for Suboxone film, for less than half the price.

I know buprenorphine is kind of a mouthful for non-medical reporters, but still, I thought it was odd to use only the name of one brand: Suboxone. It’s as if this was a commercial for that drug company. Indivior, the manufacturer of Suboxone, must be delighted with this coverage. To me, it felt like an advertisement rather than journalism.

Another segment was about sober recovery homes. The investigative reporter talked to owners of sober recovery houses and the tenants at those homes. She said NC has no regulations or standards for recovery homes. She talked on screen to a patient advocate who says patient brokering is going on in Asheville, as well as lab scams at recovery homes where the patients’ best interests aren’t at the heart of the way these homes function.

She talked to Josh Stein, NC Attorney General, about passing laws to better regulate these sober homes, and he agreed that if these laws were needed, they should be passed.

No controversy with that one.

There was a segment about how there’s not enough beds in residential facilities for patients with opioid use disorder who want help. I agree, though I’m not sure this is breaking news for anyone. I don’t think there’s ever been enough beds to meet the treatment need.

Overall, I was left with a bitter taste after this reportage. The news program missed an opportunity to educate viewers about all evidence-based treatments for opioid use disorder, but ended up doing an advertisement for Suboxone and denigrating methadone.

Buprenorphine and methadone both work under the same principle: they are long-acting opioids which, when dosed properly, prevent withdrawal and craving while also blocking illicit opioids. While buprenorphine is a safer drug with fewer drug interactions, it isn’t strong enough for everyone. Methadone has countless studies to support its use to treat opioid use disorder, showing it reduces death, increases employment, decreases crime… but why go on, since facts don’t seem to matter as much as sound bites.

In my opinion, WLOS bungled an opportunity.

Methadone Overdose Deaths: First Two Weeks

Methadone

 

Methadone is a tricky drug to start, due to the narrow margin between therapeutic dose and fatal dose. Making it more difficult, people vary a great deal in the rate at which they metabolize methadone.  Some people have a methadone half -life as short as 15 hours, while others have half- lives as long as 60hours. The average is 22 hours. So even for people with a high tolerance to other opioids, increasing methadone too quickly can be deadly.

Methadone’s long half-life makes it good for a maintenance medication, since after stabilization, there’s not much fluctuation in the blood levels. However, the long half-life makes it more difficult to adjust the dose. The change I make in a patient’s dose today may not be fully experienced by the patient for five or more days.

The tolerance to the anti-pain effect of methadone builds faster than the tolerance to respiratory suppression, adding to the danger. When methadone is used inappropriately, patients may take more methadone to relieve pain, but by the time the pain is gone, they could easily have taken a methadone overdose.

All of this explains why the first two weeks of methadone maintenance treatment are the most dangerous. According to some studies, death rates for patients starting methadone at opioid treatment programs are actually higher during the first two weeks than when using illicit opioids. (1, 2)

Even so, it’s a risk worth taking, given the proven life-saving benefits of methadone (and buprenorphine) maintenance

Patient overdose during the first two weeks is a serious concern for doctors working at opioid treatment programs. We must do all we can to keep patients safe. It’s a fine line; if we start at too low of a dose or go up too slowly, we risk having our patients drop out of treatment. And if we increase the dose too quickly, it increases the risk of overdose…

The American Society of Addiction Medicine (ASAM) recently updated their methadone induction guidelines. In past years, doctors working at opioid treatment programs (OTPs) tended to start patients at 30-40mg and increase the dose rather quickly. Now, the expert ASAM panel recommends a starting dose of 10-30mg. If that dose isn’t sufficient to suppress withdrawal, a second dose can be given after three hours, so long as the total dose is not greater than 40mg. The expert panel recommends increasing the dose no more quickly than every five days, and no more than five milligrams at a time.

Some patients are more susceptible to overdose, and physicians should consider lower methadone starting doses for these people:

-Age over 60

-Using sedating drugs like benzodiazepines

-Regularly consume alcohol

-Are on prescription medications which can interact with methadone

-Medically fragile patients, for example patients with coronary artery disease, morbid obesity, -chronic obstructive pulmonary disease (COPD), or sleep apnea

-Have risk factors for prolonged QT interval, such as a recent heart attack, personal history of heart rhythm problems, or family history of heart disease

-Patients who have been abstinent from opioids for five or more days (e.g. recent incarceration, recent detoxification or hospitalization). These patients lose some of their tolerance and might be more prone to overdose with any opioid.

 

Interestingly, the degree of withdrawal that the patient has when entering treatment does not correlate with the dose of methadone they will need to get rid of withdrawal symptoms. In other words, one person in terrible withdrawal may need a smaller dose than another person with milder withdrawal. The degree of withdrawal that a patient feels is only partly due to opioid tolerance. Genetic makeup may be the reason why some people have more severe withdrawal than other people.

While I always ask my new patients how much opioid they have been using per day, that alone doesn’t determine methadone starting doses. There’s incomplete cross-tolerance between other opioids and methadone, meaning we can’t use the table of equianalgesic doses.

Last week I found an interesting article describing a large study of Canadian methadone patients, which will contribute even more to what we already know about risk during the first two weeks of methadone. This study showed which patient characteristics are associated with overdose death.

The study was done in Canada from 1994 until 2010, and covered over 43,000 patients enrolled in an opioid treatment program in those years. The study looked at all overdose deaths in this patient population and found 175 deaths deemed to be from opioids. These cases were matched with patients who entered treatment around the same time as the patient who died, creating a nested case-control study.

This study found, as expected, a higher degree of risk in the first few weeks on treatment. In this study, patients in the first two weeks of treatment were 16 times more likely to die in the first two weeks of treatment than any other time in treatment.

Psychotropic drugs were associated with a two-fold risk of overdose death overall, with antipsychotics associated with a 2.3-fold risk and benzodiazepines a 1.6-fold increased risk. Antidepressants were not associated with increased risk of overdose death. Alcohol use disorder diagnosis was also associated with a two-fold increase risk of overdose death.

Even more interesting, heart disease was associated with over five times increased risk of overdose death, and serious lung disorders (sleep apnea, COPD) were associated with a 1.7 times increase in overdose death.

This is a powerful study because it was so large.

This is information I can use. I’ve been stressing about patients whom I thought were at increased risk – those who use alcohol and benzodiazepines, and those with severe lung disease. While these patients are at higher risk, from this study it appears patients on anti-psychotics are at even higher risk. And I need to do a better job of getting patients to see primary care doctors, to screen for heart disease, which gave the highest risk of all.

As time goes on, I think we’ll get more information about which patients are at higher risk. Those patients need a higher degree of interaction with treatment center staff, and better coordination of care with mental health providers and primary care doctors. I know I plan to implement a system at the OTP where I work to make sure I see patients more often if they have the risk factors described.

Obviously any patient death is a terrible thing. Of course it’s worst for the family, but it also affects the treatment team. I feel badly for the families of those 175 patients in the Canadian study who died, but they gave us information that can hopefully help us provide better care for future patients.

 

  1. Caplehorn et al, “Mortality Associated with New South Wales Methadone Programs in 1994: Lives Lost and Saved,” Medical Journal of Australia, 1999 Feb 1;170(3):104-109
  2. Cousins et al, “Risks of drug-related mortality during periods of transition in methadone maintenance treatment: A cohort study,” Journal of Substance Abuse Treatment, October 2011, Vol 41(3); pp252-260.
  3. Leece et al, “Predictors of opioid-related death during methadone therapy,” Journal of Substance Abuse Treatment, Oct 2015,

Genetic testing for methadone metabolism

aaaaaaaaaaaaaaagenes

 

 

 

Genomic medicine is growing quickly. This is a branch of medicine that studies an individual’s genetic profile in order to be able to predict which medications may work best. This information can also predict if a patient will have a problem with a specific medication.

Some people have genes that make them slow metabolizers of methadone. This is a particular problem, since methadone is such a long-acting drug. Slow metabolizers are at increased risk of methadone accumulation, leading to over -sedation and overdose death. If we had a way to identify slow metabolizers, perhaps we could prevent these deaths, by starting them at lower methadone doses.

Researchers at Washington University in St Louis have discovered genetic subtypes that are associated with both faster methadone metabolism and slower methadone metabolism.

Researchers took blood samples from normal volunteers for genetic testing, and then gave these test subjects doses of methadone. As expected, these people metabolized methadone at markedly different rates. So far, that’s not news. We’ve known for years that people metabolize methadone at very different rates. But this study showed what genetic variants influenced the rate of methadone clearance. Two genetic subtypes for the gene for cytochrome P2B6 were found; one increased the metabolism of methadone and the other resulted in slower-than-usual metabolism of methadone.

Interestingly, the researchers found that African-American people were more likely to have the subtype of this gene giving slower methadone clearance. These patients may be at increased risk for overdose, if given the same dose as patients with the genetic subtype resulting in faster methadone metabolism.

To the best of my knowledge, it’s not yet practical to get genetic testing done on a patient before I start methadone. Specialty labs do offer the testing, but my patients could not pay for it, unless it was paid for by insurance, including Medicaid.

Even after I get the information, how would I use it? For sure, if a patient had the genetic makeup of a slow metabolizer, I would start at a lower dose and increase more slowly. But I have no studies to guide me – I would be using my best clinical judgment.

What about a patient with the genetic makeup of a fast metabolizer? Would I feel comfortable starting at a higher dose and increasing that dose more quickly?

No, I would not. Perhaps that patient has a lower risk of overdose, perhaps not. Again, I have no studies that tell me for this certain gene, start at “x” dose. I don’t know that we will ever have that sort of specific information, since factors other than genetics must be considered.

I hope in the future I’ll see a role for genetic testing for patients starting medication-assisted treatment of opioid addiction. However, we would need studies showing how we can use the information. For now, the expense, turn-around time of testing, and lack of real-life studies using genetic information make genetic testing unworkable.

Confusion over Methadone Peak and Trough Levels

aaaasplit dose

Recently I’ve had patients write to my blog describing how their opioid treatment program doctors are using methadone blood levels to determine the correct dose. What they described to me was worrisome; patients’ doses rarely need to be checked with methadone peak or trough blood levels. Due to tolerance, a methadone blood level may be adequate for one patient, but far too low for other patients.

A patient’s dose of methadone needs to be determined on clinical grounds. This can include the patient’s description of withdrawal symptoms and their timing related to dosing, physical exam just before the patient is due for a dose, and evaluation of the patient three to four hours after dosing. It may also include an evaluation of ongoing illicit opioid use, other medical issues, and other medication or illicit drug use.

Opioid treatment program physicians rarely need to check methadone blood levels. I usually check peak and trough blood levels when I suspect a patient may be a fast metabolizer who may do better with split dosing. In such a case, the patient describes feeling fine for the first part of the day but in awful withdrawal by night time, despite taking a relatively higher dose. Then if the patient’s peak (highest level) is twice the trough (lowest level) I know they may feel better with twice a day dosing. Certain medications can induce the metabolism of methadone, making the patient metabolize methadone more quickly and drop the blood level. Often in this situation, split dosing helps.

I cringe when patients say things like, “my doctor checks a methadone blood level on everyone when they get to 80mg to see if they need to increase the dose or not.” For the vast majority of patients, getting this blood level won’t be helpful. If it’s used to determine the patient’s dose, it could be harmful. Many patients will still feel withdrawal while dosing at 80mg, even though they may have what would be considered a moderate blood level.

Our patients are tolerant to opioids. For this reason, methadone patients who are doing well, feel fine and have normal lives can have so-called “toxic” blood levels of methadone. A level that would kill someone unaccustomed to methadone may be just what my patient needs.

Some doctors think all opioid addicts want to go higher on their methadone dose than they need, and that these addicts would want limitless dose escalations unless the doctor stops this. In some patients, addiction may drive the addict to ask for dose increases even when not needed. Addiction often tells the patient “more is better.”

I’ve seen this problem too, but not as often as one might expect. More often, I’m the one advocating for a higher methadone dose. Don’t get me wrong, I do want to use the lowest effective dose. Some patients, due to fear of methadone and the stigma against it, are afraid to increase their dose. I point out that studies show patients do the best in methadone treatment if they are on a high enough dose to block the withdrawal symptoms and block the euphoria from other opioids. Particularly if the patient is still using illicit opioids, I recommend a dose increase.

Lab tests aren’t an adequate substitute for talking to the patient and examine the patient. As we used to say when I was in medical school, about a billion years ago, “Treat the patient, not the lab result.”

Revoking Methadone Take home Doses

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My decisions to revoke take home doses provoke more anger and outrage from my patients than anything else I do. This is a sensitive issue.

To understand their fury at losing take home doses, I need to describe how hard it is to get those take homes in the first place. Patients don’t waltz into treatment and get take home doses right away.

For patients on methadone at opioid treatment programs, (OTPs), eight criteria must be met before the patient can get any take home doses.
1. Time in treatment
2. Urine drug screens negative for illicit drugs and alcohol
3. Ability to store medication safely
4. Stable home environment, stable social relationships
5. No recent criminal activities
6. Regular clinic attendance – doesn’t frequently miss days
7. No behavioral problems at the opioid treatment program
8. Rehabilitative benefits of take homes outweigh the risk of take homes

Of all the requirements, time in treatment limits patients the most. Many patients do very well right from the start, with no drug use, criminal activity or any other complications. Even so, they must come every day the program is open (often 7 days per week) for a minimum of three months. After that, they can be granted two additional take home doses per week, as long as all of the other seven criteria are met. After three more months, they get one more take home per week, and so on. Once they get to the take home level where they come only once per week, they have to be compliant and in good recovery for at least one year before being allowed to get take homes every two weeks.

Patients expend time, money, and effort to get these take home doses.

That’s for methadone. For buprenorphine (Suboxone, Subutex, Zubsolv, etc.) there is no federal requirement saying how long a patient has to be in treatment to get a take home dose. So long as buprenorphine patients meet the other seven criteria, they can get take homes from the start, as far as the federal standard is concerned. However, state requirements may be stricter than federal requirements. For example, my state didn’t drop the time in treatment criteria for patients in opioid treatment programs on buprenorphine, but is willing to grant exceptions on a case-by-case basis, as long as the request is reasonable.

Most patients manage their take home doses perfectly. This fact gets lost in the hoopla over the few patients who don’t take their take home medication as prescribed. The actions of a few rogue patients, when made public, taint the reputations of all our patients. Their actions unfairly perpetuate stigma and bias against medication assisted treatment.

At any given time, you can google “methadone overdose on take home” or something similar and read news stories about patients who sold or gave their dose to someone who died as a result. It makes big splashy headlines and causes people in the community to wring their hands and lambaste opioid treatment programs for allowing people to get take home doses at all. In reality, many more people have died from methadone diverted from pain medicine clinics.

Part of my job as an OTP medical director is to decide, with the help and input of all staff, when a patient is taking the medication I prescribe as I prescribe it, and when it’s being misused.

Now obviously most people won’t tell OTP staff if they plan to misuse their medication, or divert it to someone for whom it was not intended, so OTPs have to have ways to assure patient compliance. One of those ways is called a “bottle recall.”

In a bottle recall, a staff person, usually the patient’s counselor, calls the patient at the given contact number and asks them to return to the facility within 24 hours so we can see that they have all their bottles and that bottles to be taken later in the week are still sealed and full of medication.

Yes, there are ways to falsify bottle recalls. In the past, patients would pull the plastic bottles apart at the seams, remove the methadone, fill the bottle with red Kool-Aid or similar, and glue the bottles back together. Some patients’ efforts were easily detected, and some do a slick job.

Now that we have pressurized seals on the take home bottles, we think it’s more difficult to get into the bottle without being detected, but some clever patient will invent a way to thwart the pressure seals…or already has done so.

If the patient fails a bottle recall, we must eliminate all take homes, at least temporarily. Sometimes patients don’t give us a working phone number, sometimes they say they never got the call, they just dropped their phone in a mud puddle and it wasn’t working, they got the message but forgot to return to the clinic, they just went out of town and only got the message when they got back, are out of town and can’t make it back for a bottle recall…we hear many reasons for a failed recall. Many are legitimate, and it’s nearly impossible to sort reality from lies.

According to patients, take home medication has been lost, stolen, left in hotel rooms, spilled in the sink, run over by cars, eaten by family pets, black bears, and other animals, burnt up house fires, and dumped out by angry spouses and highway patrolmen. In one creative story, the patient said a tree fell on her house during a storm. The great wind that felled the tree also created a sort of vacuum in her house, and a whirlwind sucked her medication bottle up, up into the sky as she watched helplessly.

Another patient said he couldn’t come in for a bottle recall because he buried his bottles in the back yard and forgot where he buried them, because he had Alzheimer’s dementia. Of course, I asked why he buried them, and he said, “So my wife wouldn’t get into them.” No, he didn’t get any more take homes.

Of course weird things can actually happen, and that’s the problem. What should I do if a patient who appears stable and who appears to be doing well, reports loss of medication? It’s a judgment call. With the help of the rest of the staff, we discuss the past stability of the patient and the believability of the report. We can’t look into the hearts of all our patients and tell who has criminal intent and who doesn’t. People can’t be perfectly assessed. I do the best I can, and with the help of the rest of the staff, make judgment calls about take home doses.

As the prescribing physician, I have a responsibility to make sure every patient who gets a take home stores it safely and takes it as directed. If a patient is unable or unwilling to do this, I have to revoke their take homes, at least for some period of time, especially if there’s evidence my patient is selling or giving away their medication.

Diversion of take home doses to someone other than the patient for whom it was prescribed is always a concern at opioid treatment programs. But we don’t want to limit freedoms for patients doing well because of the illegal activities of other patients. As with so many things relating to human behavior, it’s an issue of balance. I admit we don’t always get it right.

Some anti-methadone activists would like to change the law, and force patients on medication-assisted treatment to come daily for their doses, and eliminate take home doses. That would reduce the problem of diversion, but cause a bigger problem. It would disrupt the lives of thousands of MAT patients who take their medication as prescribed as they go about their life.

In the other extreme, some pro-MAT people say patients should be allowed to be prescribed methadone and buprenorphine a month at a time, just like medication for other chronic illnesses like diabetes and high blood pressure. But the medications I prescribe, methadone and buprenorphine, have street value, and can cause euphoria in people unaccustomed to taking opioids. Therefore, because of the properties of these medications, sound medical practice tells us we have to have some safeguards in place to detect medication misused and diversion.