Archive for the ‘Buprenorphine’ Category

Don’t Sweat It

 

 

 

 

It’s that time of the year: it’s getting warmer, and patients are asking about ways to relieve the sweating that is sometimes a side effect of taking methadone or buprenorphine. I thought this would be a good time to re-run a past entry about this topic.

All opioids can cause sweating and flushing, but methadone is perhaps worse to cause sweating than other opioids. Buprenorphine also can cause sweating, but it is usually less of a problem than for patients on methadone.

We don’t know exactly why opioids make people sweat, but it is related to opioids’ effects on the thermoregulatory centers of the brain.

Excess sweating can also be caused by opioid withdrawal. If other withdrawal symptoms are present, like runny nose, muscle aches, or nausea, an increase of the methadone dose may help reduce the sweating.

At least half of all patients on methadone report unpleasant sweating, but some patients have sweats that are more than just inconvenient. These patients report dramatic, soaking sweats, bad enough to interfere with life.

What can we do about this sweating?

First, non-medication methods can be attempted. These methods include common sense things like wearing loose clothing, keeping the house cool, and losing weight. Regular exercise helps some people. Talcum powder, sprinkled on the areas that sweat, can help absorb some of the moisture. Antiperspirants can be used in the underarm area, but also in any area that routinely becomes sweaty. The antiperspirant can be applied at bed time so sweating won’t interrupt sleep. There are prescription antiperspirants, like Drysol or Xerac, but these sometimes can be irritating to the skin. Avoid spicy foods, which can also cause sweating.

Make sure the sweating isn’t coming from any other source, like an overactive thyroid, and check your body temperature a few times, to make sure you don’t have a fever, indicating the sweating could be from a smoldering infection. A trip to the primary care doctor should include some basic blood tests to rule out medical causes of sweating, other than the dose of methadone.

Some prescription medications can help, to varying degrees, with sweating.

Clonidine, a blood pressure medication that blocks activation of part of the central nervous system, blocks sweats in some patients.

Anti-cholenergic medicines, drugs block the effect of the neurotransmitter acetylcholine in the involuntary nervous system, block sweating. Anticholinergics tend to dry all secretions, causing such common side effects as dry mouth and dry eyes. These medications can cause serious side effects, so they must be prescribed by a doctor familiar with the patient’s medical history.

Some examples of anticholinergics include oxybutynin (also used for urinary leakage), bipereden (used in some Parkinson patients), scopolamine (also used for sea sickness), and dicyclomine (used for irritable bowel syndrome). All of these have been used for excessive sweating with various degrees of success, in some patients.

For unusually bad situations, Botox can be injected under the skin of the most affected areas, like armpits, palms and soles. Obviously, this is somewhat of a last-resort measure.

Patients affected with severe sweats, unresponsive to any of the above measures, need to decide if the benefit they get from methadone outweighs the annoyance of the side effects. In other words, if being on methadone has kept them from active drug addiction, which is a potentially fatal illness, it would probably be worth putting up with sweating, even if it’s severe.

Of course, discuss your symptoms with the provider prescribing buprenorphine or methadone. She can help you decide if your dose needs adjustment, if you need further medical workup, or some of the medications listed above are worth a try.

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Treating Acute Pain in Patients Prescribed Buprenorphine Products for Opioid Use Disorders

 

 

 

 

 

 

 

Many physicians still get confused about how to treat acute pain in patients who are prescribed buprenorphine products for opioid use disorder.

While buprenorphine products (whether Suboxone, Subutex, Zubsolv, Bunavail, or the generic forms of these) are partial opioids, when they are prescribed long-term for treatment of opioid use disorder, they don’t work very well for moderate or severe pain. These patients usually also need treatment with short-acting opioids.

Buprenorphine has a high affinity for the opioid receptors in the brain, which means this medication sticks to those receptors like glue. Other opioids, with lower affinities, have more difficult time exerting their effects in the central nervous system. This high affinity for receptors is one feature of buprenorphine that makes it work so well for patients with opioid use disorder, but we’ve worried that it also can complicate the treatment of acute pain in those patients.

If the pain is mild, sometimes pain relief can be improved by splitting the dose of buprenorphine. The anti-withdrawal effect of buprenorphine usually lasts longer than 24 hours. That’s why once -daily dosing works fine for this purpose. However, the analgesic (anti-pain) effect lasts from eight to twelve hours. That’s why patients with both opioid use disorder and chronic pain issues may feel better when they split their doses and take half in the morning and half at night. This approach may also help patients when experiencing mild to moderate acute pain.

Sometimes when patients on medication-assisted treatment for opioid use disorder have mild pain, non-opioid measures can help the patient. For example, many dental procedures are well-treated with anti-inflammatories like ibuprofen, rather than with opioids. Or a long-acting version of Novocain can give sustained numbness to the area.

Any of the three following methods can be used to treat acute pain in buprenorphine patients:

In the past, many experts recommended patients stop their dose of buprenorphine 24-36 hours prior to an expected painful procedure. (Of course, many things happen without warning, so this option isn’t always possible.) Patients were then treated with short-acting opioids such as oxycodone or hydrocodone until the pain situation resolved or improved. After the patient stopped taking short-acting opioids for 12-24 hours, the patient re-started buprenorphine.

Currently, a simpler process is being used. Many experts recommend buprenorphine patients stay on their usual dose and add short-acting opioids on top of the maintenance medication. Patients still get some analgesia, because buprenorphine rarely blocks the effects of other opioids completely.

A third option is to reduce the dose of buprenorphine to 2-8mg per day, then use short-acting opioids on top of this reduced dose. This way, reduction of the buprenorphine allows for some open opioid receptors, but the patient doesn’t have to come off buprenorphine completely. Plus, the buprenorphine still available appears to block some of the euphoria that short-acting opioids may cause.

Some patients do better with one of these options than the others, so I always ask about past experiences.

Years ago, one of my patients dosing on Suboxone films 24mg per day had to have emergency cardiac bypass surgery. I was worried, fearful that he would have inadequate pain relief after this big surgery. But he did very well. He had no significant pain post-operatively, and decided he only needed 8mg per day. He has done very well on this lower dose with no withdrawal.

Problems do arise. Some of my patients tell their other doctors, surgeons for example, that they are taking buprenorphine for pain. Perhaps they are embarrassed to tell these physicians that they are being treated for opioid use disorder, or maybe they are confused. But that information makes the surgeons think I’m going to manage pain postoperatively, which will not be the case. Most times a phone call can straighten out the misunderstanding.

Providers prescribing buprenorphine products need to help their patients manage the supply of short-acting opioids which may be prescribed by other physicians for acute pain. For example, I ask my patients if a dependable person in their household can hold on to the pill bottle and give medication to the patient as prescribed. We don’t want that person to be stingy or to overmedicate – merely to give out the medication as directed on the bottle’s label.

Buprenorphine prescribers can ask the patient to come back earlier than planned, perhaps a few days after a procedure, to check in about how things are going and get an extra counseling session if any cravings are triggered by either the short-acting opioids or the pain.

As I tell other physicians, just because my patients have opioid use disorder doesn’t mean they can never have opioids for acute pain. In some situations, pain medications are essential. But we can mitigate the risk with careful, short-term prescribing and good communication.

Product Review: Generic Buprenorphine/Naloxone tablets

 

 

I’m thrilled to be able to present an in-depth review, compiled by one of my patients, of the generic forms of the buprenorphine/naloxone combination tablets. My patient thoughtfully composed this to help other people prescribed these products, and to share his own experience and opinion:

In active recovery it is extremely important to maintain a predictable and consistent titration of dosage in the slowest possible manner to reduce withdrawal. One patient has mostly eliminated the debilitating and relentless effects of withdrawal over a course of many years.

Years ago, this patient’s plan for recovery involved incredibly slow and methodical reduction of the suboxone tablets milligrams at a rate which would be monitored and progressively smaller. However, over the course of 2 years of slowly reducing the dosage, another factor came into play: that is the reported and vastly different half-life and strength in generic Suboxone.

At the beginning, this patient had been taking 2 of the 8mg tablets, or 16mg per day, for several months, after ending a habit which at its worst exceeded 120-140mg per day of OxyContin. Each year since ending any opiate pills, the suboxone was gradually reduced over the course of 12 years from 16mg per day to one-half of a 2mg/.5mg buprenorphine/naloxone tablet per day.

In August of 2018, Walgreens pharmacy reported to the patient that the Amneal NDC #65162-0416-03 became “unavailable for refill.” The reasons for this are unclear but it set into motion a series of trials of the several available 2mg/.5mg buprenorphine/naloxone tablets which resulted in the following analysis based on this patient’s experience:

NDC #65162-0416-03 is Amneal 2mg/.5mg buprenorphine/naloxone tablets. They are orange, small and compact with an “A” embossed on one side and a “14” on the other. Their price is about $8 per pill before insurance. Their taste is distinctive, not sweet nor bitter but a tolerable attempt most comparable to Saint Joseph’s baby aspirin, like a sweet and low version that is far less sweet. The half life is reported to be consistently close to 18 to 22 hours. The only real downside is that these little pills take an incredibly strong finger grip to manually break into a clean and even one-half pill. Even the most expensive pill cutter machines take great manual strength and accuracy to evenly break into halves without crumbs. This pill overall is an 8 on a ten scale largely due to its consistent half-life.

NDC #50383-0294-93 is from Akorn Inc. which produces a very low cost 2/.5mg buprenorphine/naloxone tablet, which are about $2 per pill. They are very small, white and come in a blister pack. They are so small and compact that it is all but impossible to cut in half. Their taste is bitterly distinctive and hardly tolerable as a sublingual. They taste as if the sublingual aspect was not considered at all. The half-life is reported to be consistently bad at no more than 6-8 hours at best. Strangely, these little pills are sometimes completely ineffective, and one wonders if there is any medicine at all in these pills. It would be disconcerting to think that these pills would be administered in a controlled, prison or public health environment as their bitter taste and ineffectiveness may lead one in recovery to compare this pill’s experience to one of all Suboxone pills and thereby keep one from seeking this type of maintenance. This pill is a 2 on a ten scale only because it might help one for a few hours.

NDC #00406-8005-03 is from SpecGX Inc. which produces a lower cost 2mg/.5mg buprenorphine/naloxone sublingual tablet which are about $3.50 per pill. They are smallish and orange and come shaped as a stop-sign. Their taste is also distinctive, not sweet nor bitter but very similar to the AMNEAL described above. Their taste is also a less sweet version of Saint Joseph’s baby aspirin. The half-life is reported to be less than AMNEAL version at only 10 to 12 hours, however. The same breakability issues pervade this orange pill as they are compact and hard to divide. This pill is a 5 on a ten scale only because it helps consistently but only for up to 10 hours.

NDC #00054-0188-13 is from Hikma 2mg/.5mg buprenorphine/naloxone tablets. They are a shade lighter orange, a bit larger than the other orange pills but with a “54/122” embossed on one side and blank on the other. Their price is about $5 per pill before insurance. Their taste is a bit less bitter than the others; however, still distinctive, and a tolerable orange taste. The half life is reported to be very consistent at 20 to 24 hours. They easily and manually break into a clean and even one-half pills without much crumbling at all. This pill overall is a 9 on a ten scale because it does what it is supposed to: be consistently manufactured to be predictably effective to keep withdrawal symptoms to a manageable minimum.

I hope my readers find this information useful. This is not a scientific evaluation but rather a patient’s rather extensive experience with generic buprenorphine/naloxone products. I am grateful to him for the time and trouble it took him to compile this.

 

Advice for New Prescribers

 

 

 

The medical care providers of this nation are being encouraged get training necessary to prescribe buprenorphine products (brand names Suboxone, Zubsolv, Bunavail, Sublocade, and the generics) for the treatment of opioid use disorder in their patients. We need more good prescribers, because even after twenty years into this opioid situation, only about twenty percent of patients who need treatment can get it.

I’ve written on this topic a few times in the past, but this blog entry will contain some advice directed to new prescribers of buprenorphine products. Hopefully it will help them have good experiences prescribing medication-assisted treatment.

Here are some ideas that work for me at my office:

Treat the patient with opioid use disorder with the same attitude and compassion that you would for any other patient with a potentially fatal chronic illness. If you can’t do that, then don’t treat patients with substance use disorders. Patients detect negative attitudes such as distain and dislike even when those attitudes are communicated non-verbally. For whatever reason, if you can’t put judgment aside, then work on your own issues before you attempt to treat suffering people trying to get well.

Patients will resent a physician with a bad attitude. That will contaminate the relationship with predictable results.

For example, I talked to one physician who had his waiver to prescribe buprenorphine from an office setting. I asked him why he wasn’t using his waiver to treat patients, since there were so many in our community that needed help.

He told me the visits with the first two patients went poorly. He said both these patients threatened his life and the lives of his family members. After that, he decided not to risk treating anyone with opioid use disorder.

I was shocked. I’ve never, in the thirteen years I’ve been prescribing from an office practice, had any patient threaten my life, though I’ve made some angry at me. I had to wonder what kind of bedside manner this doctor had, for his first two patients to want to kill him. That sounds like I’m blaming the doctor, and maybe I am, but his experience was so contrary to my own that I had to wonder what was going on. I suspect his patients didn’t feel respected by him.

I’ve had one patient threaten me with bodily harm, but that was at an opioid treatment program in Gastonia, NC, more than a decade ago. The patient was an avowed KKK member, tall and large, with tattoos of hate groups on his muscular arms. I might have been worried, except at the time he threatened me, he was so impaired on benzos that I could have pushed him over with a finger. I’d just told him he couldn’t dose with methadone that day, due to impairment. The next week, he greeted when we passed in the hall. I assume he had been in a blackout from his benzodiazepine ingestion the week before and didn’t remember our previous interaction.

Be clear with your patients about your expectations. At the first visit, I sit with the patient and go over a patient agreement form. I adapted it from a SAMHSA website where you can find helpful forms, tools, and ideas.

https://pcssnow.org/resources/clinical-tools/

https://www.samhsa.gov/medication-assisted-treatment/training-resources/publications

In that agreement, I outline my expectations. I have paragraphs indicating that disruptive or violent behavior won’t be tolerated and are grounds for immediate dismissal from my practice. In thirteen years, I’ve never had one patient become rowdy or disruptive. Having said that, I do realize other prescribers have had different experiences.

I ask patients to keep and be on time for appointments, and if they don’t show up and don’t call, they will be charged for the missed visit. I tell patients I won’t call in prescriptions if they miss a visit. Having said that, I’m also flexible enough to know that things do come up – cars break down, traffic jams occur, etc. In the winter, travel can be treacherous, so that’s another factor to be dealt with. All I ask is that the patients communicate problems early so we can find a reasonable solution.

Patients who miss appointments, don’t call, and won’t answer our calls to find out what’s going on will have problems at my practice. It may or may not be their fault, but if it doesn’t work out they will need to find a new provider.

My agreement also says I won’t “fire” a patient before I talk to them face-to-face. Patients tell me they’ve been dismissed by a practice by letter, for some issue or another. I think that’s cowardly, and disrespectful to the patient. If there’s a reason I feel I can no longer to continue treatment as we are, I owe it to the patient to tell them exactly what the problem is. Sometimes we can find solutions short of termination and sometimes we can’t. At least the patient will know I respect them enough to talk to them, and they will know the basis of my decision. They will also get a referral to a new provider, or at least a recommendation.

Be careful with patient selection and try to match the patient with the best level of care.

Not every patient will do well in an office-based setting. For example, if a patient has been using buprenorphine products illicitly by insufflation or injection, that patient probably is best treated in an opioid treatment program, where observed dosing is done.

Most patients need to be on the combination products buprenorphine/naloxone. Adverse reactions do occur with the monoproduct, but they are rare, and drug diversion is not. If a new patient needs the monoproduct, I refer them to an opioid treatment program where they can be properly observed.

If that patient has been treated in another office-based setting with medical records that support their progress and compliance on the monoproduct, my recommendation would be different. Many factors influence my treatment decisions, so I need all the information I can get to make the best decisions.

This leads me to my next recommendation: get old records. Make the effort to get records from a previous practice. Sometimes patients, to curry favor with a new prescriber, will tell tales about how awful their last prescriber was. That may be true…or there may be more to the story, so get records to get a better idea of what happened at the last practice.

Don’t falsify your own records. It’s unethical and probably illegal to bill for services you document but don’t provide. To get higher insurance reimbursements, physicians sometimes chart long review of systems and/or physical exams than were performed. This is called “up-billing.” I suspect up-billing when I see records with four pages of single-spaced type for each visit, but then notice the same four pages for each monthly visit, with no changes.

I blogged before about a patient whose records recorded an exam saying “consistent with eight-month pregnancy” for every monthly visit for over a year. Yeah…kind of suspicious…using that cut-and-paste feature, I think.

If you do telemedicine, make sure you have some sort of medical personnel on site with the patient to look for physical finding you may miss with telecommunications. I just admitted a patient to our opioid treatment program who had been on Suboxone for six months from a provider he only saw online. This patient was injecting his medication, but his prescriber couldn’t see it. His most prominent tracks were on the side of his neck, which could be hidden with a high collar. Obviously, this could have ended in disaster had the patient not realized he needed a higher level of care.

Be careful about lab schemes. If a laboratory diagnostic service is charging patients $500 for one drug screen, it’s probably a scam. In past years, these organization popped up like mushrooms in manure, saying they could do extensive lab testing for all patients, but only charge those with insurance. Uninsured would get free testing.

As it turns out, some of those companies charged outrageous fees to the insurance companies, including Medicaid and Medicare, for expensive and unnecessary testing, in get-rich-quick schemes. Here’s a link to an article that explains how this works:

https://www.healthcarefinancenews.com/news/report-urine-based-drug-tests-helping-some-doctors-soak-profits

Good providers don’t want to sully their name by associating with shady laboratory service providers. Physicians can do good point-of-care testing on site for $10 or less. Sometimes patients need more extensive testing, and this can be decided on a case-by-case basis rather than testing every patient for dozens of drugs that aren’t commonly used in the community where you practice.

Be aware of what drugs are trending in your area and make sure they are included in your drug testing protocol. In the past, heroin was rare in rural areas, but that’s changed. As I’ve discussed on this blog, heroin frequently contains fentanyl, a much more powerful opioid that’s responsible for many overdose deaths.

Ask your new patients what drugs are being used in your community. They can be great sources of information, as can local addiction medicine educational conferences, and your local law enforcement officials.

Make friends with the medical director at your local opioid treatment program. Most physician medical directors at opioid treatment programs are happy to work collaboratively with office-based providers. We share patients all the time and need to do what’s best for the patient. We don’t need to look at each other as competitors, because there are more than enough patients for everyone, unfortunately. Let’s work together to get people into treatment, and to match the patient with the right level of care.

It can be a relief for an office-based provider to know they have a facility willing to deliver a higher level of care when necessary. Sometimes the patient may need inpatient treatment, but at other times it might be an opioid treatment program, where the patient may come daily for dosing and oversight.

Again, some patients, in an effort to curry favor with a new prescriber, may talk disparagingly about another treatment facility, so don’t take a patient’s word that an opioid treatment program does an awful job.

Decades ago in my previous life as a primary care physician, I learned that the new patient who tells me how wonderful I am compared to their last terrible doctor will soon be saying the same thing to another new doctor, about how terrible I am. I know there are terrible doctors, but there are also some patients that can’t be pleased no matter how good the physician.

Finally, get involved with organizations that can help you. You don’t need to re-invent the wheel; as I mentioned above, help is available from several sources.

Go to the SAMHSA website mentioned above and you will find helpful resources. Or you can go to the American Society of Addiction Medicine website for information: https://www.asam.org/  You may decide to go to one of their excellent conferences.

Go to the Providers’ Clinical Support System (PCSS) website and search their educational offerings at https://pcssnow.org/ They have archived webinars, mentoring programs, and other great things available.

If you work in North Carolina, there is the UNC ECHO program, which offers live teleconferences three days per week on issues surrounding medication-assisted treatment of patients in the office setting. You can hear cases presented and listen to input from experts and other prescribers, while getting free (yes I said free) CME hours. Once involved, you can present your own difficult cases to get help with difficult patient situations. You can go to their website at: https://echo.unc.edu/ or leave me a comment with your email and I can connect you to the organization.

It can be difficult to persuade new prescribers that treating patients with opioid use disorder is rewarding and fun. I became a physician because I wanted to help people, sappy as that sounds. I didn’t feel the sense of satisfaction during the decade I worked in primary care, for whatever reason, that I now feel working in the field of Addiction Medicine.

Tapering Off Suboxone: Three Patients’ Success Stories

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

This year I’ve had three long-term patients taper off the buprenorphine products I was prescribing. All three are doing well and are happy with their treatment outcome. Since tapering off buprenorphine products can be challenging, I thought I’d share their stories, to help other people who wish to taper off buprenorphine. (Note that when I say buprenorphine, I mean to include all the brands and generics: Suboxone, Zubsolv, Bunavail, generic combination product buprenorphine/naloxone and the generic monoproduct buprenorphine.)

The first patient had been on buprenorphine for over ten years. She saw one of the first physicians to prescribe buprenorphine, and I inherited her from this prescriber after he retired.

When she started Suboxone, which at that time were only available in tablet form, she stabilized at eight milligrams. She stayed on that dose for about four years. She saw her prescriber monthly for the first year and a half, then every other month. By the time she started seeing me, she had cut her dose to 4mg per day without too much difficulty. When the suboxone films were available, we switched to those, both because that’s what her insurance would pay for and because I thought she could taper more easily with films.

Over the first year with me, she brought her dose down to 2mg per day, reducing by a half milligram every three or four months. I then switched her to the 2mg films, and she continued to cut off more and more from her films. I gave her some guidance, but she largely managed her taper on her own.

After a year or two, she asked me to prescribe only fifteen films per month, since she was taking half of a film per day. A year later, she had dropped to only a forth of a film per day, and needed only eight films per month. This slowly progressed until she had brought her dose down to one-sixteenth of a two milligram film which she took every other day.

That’s right…she was taking .125milligrams every other day. Her urine drug screen still showed positive for buprenorphine at her visits. I told her I thought she could stop taking that dose and not have any withdrawal symptoms, but she told me she still felt withdrawal if she missed her every other day dose. I didn’t push her; I didn’t mind prescribing only one 2milligram film per month!

She continued at this dose for over a year. When she missed a visit earlier this year, I asked my staff to call her. Sure enough, she forgot to take her dose for several days, and didn’t feel any withdrawal. I offered to see her one more time, to talk about relapse prevention and options to give her insurance against a relapse (Vivitrol), but she didn’t want another visit. I congratulated her and told her if she had questions or problems in the future to call us.

During her last year or so, we talked regularly about relapse prevention. We made plans for what to do if she had a catastrophic medical problem that required pain medication (broken bone, surgery, etc.). We discussed other big relapse triggers, such as strong negative emotions, and being around people who had opioids or other drugs.

This patient was very involved with 12-step recovery. Even after so many years of recovery, she went to three or more meetings per week. She had a sponsor and served as a sponsor to newer members. She had relatives in 12-step programs, and most of her friends were members of 12-step recovery groups.

The second patient also tapered her dose over years. I knew her for around fifteen years, first as a patient at an opioid treatment program, where she dosed on methadone. She did well from the start, though she had some slips with non-opioid illicit drugs.

She didn’t care for the restrictive nature of the opioid treatment program, so when she’d been doing well there for several years, I told her about the new option of buprenorphine treatment through an office setting. She decided that was what she wanted to do, and proceeded to taper her methadone dose, slowly.

Once she was down to 30mg, which took about six months, she made an appointment with an office-based physician, who started her at suboxone 16mg per day. When that physician retired less than a year after she started Suboxone, she transferred to my office-based program.

By the time she transferred to my office-based program, she was down to 12mg per day. Just like the first patient, she steadily tapered her own dose. She reduced her dose by an estimated milligram of Suboxone every four months.

I say estimated because cutting the Suboxone films is largely guesswork, and the manufacturer says there are no studies to show buprenorphine is evenly distributed over the film. While that’s true, buprenorphine is so long-acting that I wonder how much variation patients get in their blood levels, even with uneven distribution.

Just like with the first patient, we switched her to the 2mg film once she got to a 2mg per day dose. She continued to reduce on her own. She would cut her dose and wait for a month or two before going down again. I saw her only every two months, given her stability. She had negative drug screens, always kept her appointments, and lead a productive life. I gave her as much advice as I could, but I was impressed that she was able to listen to her body and taper only as fast as she was comfortable.

Once she was taking one-eighth of a 2 milligram film (.25mg), she stopped her medication. I saw her for one last planned visit, and we talked about how she felt. At that point, she’d been off buprenorphine for four weeks. She noticed aches and pains more intensely than in the past, but said it wasn’t anything ibuprofen or Tylenol couldn’t fix. It took a little longer to get to sleep, but she was still functioning well as a mother to her four children. She was ecstatic to be finished with medication-assisted treatment, and she knows that – heaven forbid – if she does relapse, to call quickly and come to see me to get back on buprenorphine.

Again, we had been discussing relapse triggers for months. We also discussed naltrexone, available as a once monthly shot called Vivitrol, as insurance against a relapse but she decided against it. She felt she didn’t need it.

She did individual counseling while she was a patient at the opioid treatment program, but hasn’t done much counseling recently. She saw a therapist many years ago, after a traumatic life event, but didn’t feel she needed to continue with this. She tried 12-step recovery but didn’t feel it was right for her.

Initially I worried she wouldn’t make progress in her recovery without continuing to see a therapist, but when I saw how well she was functioning in life, I decided not to push the issue. The only counseling she got was with me, during our 20-minute office visits. I’m not a trained therapist, but I like to think I have developed some skills over the years.

Her life changed completely over the past ten or so years she’s been on medication-assisted treatment. Early on, she let go of drug-using friends and acquaintances. She became focused on what was important to her: her young family and her extended family. She got a part-time job after her youngest child started school, to afford some extras for the family. Her husband is in his final stages of taper from buprenorphine, and she hasn’t rushed him, letting him take his own time, just like she did.

Drug use holds no allure for her; she hasn’t had any cravings or desires for any sort of drugs for years.

My third patient to taper off this year just saw me several weeks ago. It’s been over eight years since she used any illicit drugs. At her last visit, she declared this to be her last visit, saying her last buprenorphine had been taken six weeks prior, and that she felt fine.

She has been at a dose of less than 8mg for about two years, and less than 2mg per day for at least the last eight months. She tapered on the generic combination tablets, buprenorphine/naloxone 2/.5mg, cutting them into quarters. Once she got to one-quarter per day (.5mg), she took one of these quarters every other day for several weeks and then stopped completely.

Again, we’ve been discussing relapse prevention for literally years. Again, she decided against starting naltrexone as a safety net against relapse, feeling she didn’t need this medication. She was happy and smiling and was very kind when she thanked me for helping her these past years. I told her it was truly my pleasure, and I was honored to be even a small part of her success.

These three patients have common themes in their successes. All three had very support families who didn’t rush them to get off buprenorphine or shame them from being on it. I also didn’t pressure them. I said I’ll do everything I can do to help you taper off this medication, but there’s nothing wrong with staying on it either, if that’s what you prefer.

This left the decision in their hands. All three said this was important, since they had control over when/if/how they tapered. Once I told one of these patients to listen to her body, since she was the expert on her body and how it felt. This resonated with her, and she thanked me for saying that. She felt that took the pressure from her to try to meet someone else’s expectations.

These three patients all tapered their dose very gradually, over periods of not days or weeks, but months and years. While such slow tapers can be frustrating, not to mention expensive, to people who want a quicker exit off medication, maybe slow tapers allow the body more time to adjust to changes in dosage.

Two of the three patients exercise regularly at a gym. The third is also active, and walks nearly daily. Exercise usually helps us to feel better, both physically and emotionally. I wonder if exercise also boosts endorphin, our body’s own opioid. I’ve started recommended patients start a reasonable exercise program in advance of starting a dose taper.

All three of these patients have faced serious adversity in the past and survived it. This tells me they have skills they can use in their recovery. All three had tremendous resolve to do what was necessary to get their lives back. They kept at it, accepted the few setbacks that came their way as part of the process, and kept moving forward, even though progress was slow at times.

I admire all these patients. All have excellent prognosis, and we’ve talked about how opioid use disorder is a chronic illness. They need to be on guard against relapses the rest of their lives, and if relapse happens, I think they will know what to do.

I have another crop of patients who are dosing at 4mg or less of buprenorphine per day, all in the process of tapering. I’ll update my blog with those stories after they taper.

 

Not Dying: A Worthy Goal

 

 

A new study about opioid overdose death and treatment of opioid use disorders was published in the Annals of Internal Medicine this month. [1]

It showed that people who experience a non-fatal overdose have a significantly reduced risk of death if they start on medication-assisted treatment with methadone or buprenorphine. Naltrexone was also examined but limited data prevented conclusions about the use of this medication.

This large cohort study, done in Massachusetts on adults age 18 and older, covered the four years from 2011 and 2015. Subjects were identified as people who experienced at least one non-fatal opioid overdose and survived at least for 30 days afterward. Patients were excluded if they had a diagnosis of cancer.

This turned out to be a huge study, with over seventeen thousand study subjects.

In the year prior to the overdose event, 26% had received at least one medication to treat opioid use disorder. Twenty-two percent received opioid detoxification at least once. Forty-one percent had received an opioid prescription in the preceding year, and 28% received a prescription for a benzodiazepine within the previous year.

For these same patient, in the year after their nonfatal overdose, 30% received at least one medication for opioid use disorder (13% got buprenorphine, 8% got methadone, and 4% got naltrexone. The other 5% received more than one medication.)

People younger than 45 were more likely to received treatment with medication, as were people with diagnoses of anxiety or depressive disorders.

In the year after overdose, 4.6 of the people with a prior non-fatal overdose died, and of those, 2.1% died from opioid-related causes.

For patients treated with medication for opioid use disorder, both the all-cause mortality and opioid mortality rates were significantly reduced; they were cut approximately in half.

Patients who started n methadone after their non-fatal overdose had markedly reduced risks for both all-cause mortality and opioid-related mortality, with the adjusted risk at around half what it was for untreated patients. Results for patients on buprenorphine were nearly the same; they had not quite the degree of risk reduction as with methadone, but still significantly lower risk of death than patients on no medications.

There were no associations between risk of death for patients started on naltrexone, but the authors noted this was a smaller group, so any differences weren’t statistically significant. Of note, most of those patients were only treated for a month or two.

So what does this study tell us?

We have another study that shows medication-assisted treatment with methadone or buprenorphine reduces the risk of death, this time in people with at least one prior non-fatal opioid overdose. In this study, being methadone or buprenorphine reduced deaths from all-cause mortality, as well as opioid-related mortality.

We also see, again, that only a minority of people, 30%, with nonfatal overdose were started on life-saving medication.

I was surprised the percent of people referred for medication-assisted treatment was that high. This study was done in Massachusetts, a state that’s probably at the forefront of opioid use disorder treatment. They have some excellent providers and physician leaders, and better methods to pay for treatment in that state.

I don’t think rural areas in North Carolina come close to a 30% referral rate. I’d be amazed if 2-3% were referred for evidence-based treatment with medication. I suspect most people here who survive near-fatal opioid overdoses aren’t directed, referred, or even informed about medication-assisted treatments. People get referred to OTPs around here by concerned friends and family members, but rarely by physicians.

It has started to change. In our area, of the three OB/GYN groups, we have one practice that refers patients to us. The LME (local management entity, which contracts with the state to see people on Medicaid and those with no insurance) has referred less than a handful of people for treatment. That’s a dramatic improvement from seven years ago when the LME told patients to get off methadone.

But back to the study. So even in one of the most progressive states, only 30% of people got life-saving treatment.

Let’s picture a patient who has a near-fatal episode of a different chronic disorder. Thankfully, the patient survives this episode. There’s a treatment medication for this disorder that will reduce the patient’s risk of dying by half over the next year. What do you think would happen if this patient wasn’t given or referred for that life-saving treatment?

There would be an outcry. There would be wringing of hands and rending of garments, and possibly gnashing of teeth. There would be lawyers…malpractice lawyers, swarms of them.

Yet this exact situation happens over and over, again and again, in emergency departments across this nation.

To be fair, this article doesn’t say why the patients who survived a near-fatal overdose weren’t started on medication. Maybe emergency department personnel offered this medication but the patients refused.

Realistically, there are significant barriers to starting medication-assisted treatment of opioid use disorder. Methadone can only lawfully be prescribed from a properly-licensed opioid treatment program. Maybe emergency department physicians gave referrals to OTPs, but the patients didn’t show up. Maybe they referred to office-based buprenorphine prescribers.

Every time I do an intake on a patient entering treatment with MAT, I ask if there’s been an overdose in their history. Much of the time, the answer if “Yes.” I then ask what kind of recommendation for treatment they got. Most times the patient looks at me blankly. They can’t think of any kind of treatment recommendation or referral. One patients said, “They told me to quit using drugs.”

Telling people to quit using drugs IS NOT treatment for opioid use disorder. It’s sad that I even have to write this, as it should be well-known by all medical personnel.

All of us working in this field need to keep chugging along. We need to put this article in our mental back pocket, ready to talk about if/when the time comes when we hear stale old beliefs about medication-assisted treatments.

This study points to the bottom line: “We are using medications that reduce the risk of dying by half, for people who have had a prior nonfatal overdose.” Not dying is a huge benefit of treatment, perhaps the ultimate benefit.

It is long past time for medical professionals to set aside their personal opinions and what they think they know, in favor of hard data. Methadone and buprenorphine reduce the risk of dying, and patients with opioid use disorder must be informed & encouraged about these treatments. To do otherwise is malpractice.

  1. Larochelle et al., “Medication for Opioid Use Disorder after Nonfatal Opioid Overdose and Association with Mortality: A Cohort Study,” Annals of Internal Medicine, June 19, 2018

The Blues

 

This letter was published in the Raleigh News & Observer last week, about insurance coverage for treatment of opioid use disorder. It was written by Alex Gertner, an MD/PhD student at University of Chapel Hill’s School of Medicine and the Gillings School of Global Public Health.

I know Alex from his participation in UNC’s Project Echo, a program designed to connect new providers of office-based buprenorphine treatment with more experienced providers, for assistance and support. The goal of UNC ECHO is to get more primary care physicians and physician extenders to prescribe buprenorphine, so that people wanting treatment can get it more easily.

 

The opioid overdose epidemic continues to devastate North Carolina communities, even though effective treatments for opioid addiction exist that allow individuals to lead healthy, fulfilling lives. During this crisis, you might think that North Carolina’s largest private insurer would be helping as many people into treatment as possible, but that is unfortunately not the case.

As a medical student researching the opioid epidemic, I spend time in addiction clinics and talk with addiction providers from across the state. A complaint I hear from these providers is that Blue Cross and Blue Shield is making it harder for their patients to access treatment.

Buprenorphine is the main drug used to treat opioid addiction in office-based settings, like primary care offices. BCBS requires providers to request prior authorization to start buprenorphine. These prior authorizations can require days of back-and-forth discussions until approval, during which time a person seeking treatment is at risk of overdose. Sometimes authorizations are denied even after appeals from providers.

Part of the reason for these denials are BCBS’s criteria for approval, which conflict with evidence and best practices. As the criteria state, BCBS may deny a person buprenorphine if that person is using illicit drugs. But illicit opioid use is a symptom of addiction. That is like denying someone insulin because they have high blood sugar. The American Society of Addiction Medicine says that the use of addictive drugs only should not be a reason to suspend opioid addiction treatment.

BCBS will also deny buprenorphine if its thinks someone isn’t following a “psychosocial treatment plan,” such as counseling. Unfortunately, many communities across the state don’t have addiction counselors who take insurance. What’s more, evidence shows that counseling helps some people who get buprenorphine, but not others. Even if someone would benefit from counseling but isn’t getting it, that doesn’t justify withholding a medication that could save their life.

Office-based buprenorphine treatment doesn’t work for everyone. Some people need more specialized clinics known as opioid treatment programs. I called several of these programs and was told that BCBS rarely pays for this type of treatment. One provider told me people with BCBS seeking care at opioid treatment programs are better off being uninsured, because then they could access public funds to pay for treatment. Imagine if, at the height of the AIDS epidemic, insurers didn’t cover treatment at specialty HIV clinics. Drug overdoses are now claiming more lives than HIV at the height of the AIDS epidemic.

There are other ways in which BCBS is making it harder to get treatment, such as denying certain dosage formulations or charging high cost-sharing. Such actions may appear minor, but every disruption in treatment can lead to a potentially deadly relapse.

In contrast to BCBS, North Carolina’s Medicaid program covers treatment at opioid treatment programs and stopped requiring prior authorizations for the most common formulations of buprenorphine.

I wrote to BCBS to share these concerns. It said it follows CDC and FDA criteria for approving treatment. In fact, no CDC or FDA criteria recommend withholding buprenorphine because of illicit drug use or lack of psychosocial support. Federal recommendations stress the importance of access to opioid treatment programs.

The reason why BCBS applies such strict criteria may lie in a different part of BCBS’s response: “The street value of these products are high and these medications are used by addicts to maintain functionality between abuse, thus perpetuating the epidemic. A similar rationale is used for why we place prior authorization on extended release opiates.” It is true that buprenorphine has a street value, but that’s largely because it’s so hard to find treatment. Research shows that illicit buprenorphine use is mainly driven by attempts to self-treat addiction.

The use of the term “addict” in BCBS’s response is also troubling. The Office of National Drug Policy has stated that terms like “addict” can negatively affect perceptions of people suffering from addiction.

BCBS should end prior authorizations for commonly prescribed formulations of buprenorphine, align its approval criteria with best practices, and start covering opioid treatment programs. The opioid overdose epidemic is the public health challenge of our generation. How and whether North Carolina will emerge from this epidemic will depend in large part on BCBS’s response.

Read more here: http://www.newsobserver.com/opinion/article212771774.html#storylink=cpy

When I compare Alex’s vision and concern for such important health issues, I can’t help but to think of my days as a medical student. My concerns were narrow; I only cared about getting through medical school and into a good residency. But Alex is already working on an issue that’s so important to this country.

As you can tell from Alex’s letter to the editor, he understands the issues and eloquently advocates for Blue Cross/Blue Shield to deliver better assistance for patients with opioid use disorder. After I read his letter, the only thing I can say is “Amen!” All of the issues he listed have happened to my patients.

I pray Alex decides to work in the field of Addiction Medicine. We need him.