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.

 

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My “Hopeless” Patient

 

 

 

 

 

(Details have been changed to protect patient identity)

I have a patient in my office-based practice whom I see only every two months. If you had told me ten years ago, when I first met him, that he would become a stable and productive member of society, I would have scoffed. If you told me he would someday have over three years of freedom from active addiction, I would have rolled my eyes in disbelief.

I think of this person when I’m tempted to write off any patient as hopeless.

He was one of the worst. I first met him when I worked at an opioid treatment program (OTP) over ten years ago. He was often impaired and belligerent. At least once he had to be transferred to another OTP, due to aggressive behavior towards the staff and other patients. He was belligerent with me too, and I dreaded my appointments with him. He had a terrible cocaine addiction, and almost all his drug screens were positive for cocaine and benzodiazepines. On several occasions I referred him to a local inpatient program, but he left against medical advice or was asked to leave.

A few years after I left that OTP, he called my office-based practice to ask if he could switch to buprenorphine. The woman making appointments scheduled him with me.

The next week, looking at my schedule, I remember saying, “Oh HELL no. I’m not seeing this guy. He’s not going to stabilize in an office-base practice.” But he had already paid to hold his appointment slot, so I felt obligated to see him. My plan was to tell him he wasn’t appropriate for an office-based program, and to recommend inpatient treatment, as I had so many times in the past.

At the first visit, he was less belligerent than I recalled, and had been free from cocaine for several months. He appeared to have a little more insight into his behavior and his addiction. I sensed he had a strong desire for change. Skeptically, I agreed to start him on buprenorphine, secretly assuming he would drop out of treatment after a few weeks.

From the start, his use of illicit opioids dropped impressively. From that point of view, he made immediate progress.

However, during his first year in treatment in my office-based practice, he had periodic relapses to cocaine. He’d come into my office, fling himself into a chair, and say, “Don’t bother giving me a drug screen. I messed up. I got high on cocaine and then took benzos to come down.” I was impressed with his honesty and I was impressed by how much his relapses bothered him. I was also impressed when he made – and kept – appointments with a psychologist for addiction counseling. He was dismayed and frustrated, because he said he didn’t really enjoy using drugs anymore, but still couldn’t stop using them. This angered and baffled him.

He’d get so frustrated with his own behavior that he would start crying. The first time it happened, I was uncomfortable and worried. He was the ultimate tough guy, more likely to yell than cry. I worried the tears meant a severe mental illness. As time went on, we both got more comfortable with his tears. I saw he was experiencing the pain of his powerlessness over addiction.

He’d been in and out of 12-step recovery for years, and didn’t feel like the meetings helped him much, but he’d go once in a while. He kept going to counseling, though he was only able to afford sessions once or twice per month. He kept his frequent appointments with me. Above all else, he kept his appointments.

I had moments of grave concern, worried he really wasn’t stable enough for me to be treating him in an office-based setting, and on several occasions mentioned my concerns to him.

In my own mind, I also worried about how someone reviewing his chart would view me as a doctor. If someone from the DEA or Department of Health and Human Services wanted to review his chart, they would think I was careless with this patient, and that I should have referred him back to the methadone clinic. During his relapse years, I worried that I was giving this patient inadequate treatment, yet knowing him as I did, I didn’t think he would ever go back to an OTP or inpatient treatment. I also really believed he was going to make progress in recovery, though I didn’t have much to justify my belief.

I also leaned on him to consider an inpatient program. He was set against both an opioid treatment program and an inpatient program, saying he was sick of being treated like a child, and that he didn’t do very well when people told him what to do.

I saw what he meant.

In opioid treatment programs, sometimes a milieu of “us versus them” can be pervasive. Despite using kind and collaborative counseling approaches, patients often feel they are unfairly told what they can and can’t do.

They are right, of course. Opioid treatment programs have to follow an amazing number of state, federal, and local regulations in order to stay open. These rules rankle patients, who feel like they’re being treated like children by irrational parents.

I do get that.

In an office-based setting, there’s more freedom to individualize treatment. By that I don’t mean patients can or should get by with less care. But I have more flexibility, and more opportunities to build rapport with patients in my office than in the OTP.

Addiction treatment literature describes a type of counseling known as motivational interviewing (MI), or motivational enhancement. I’ve read books about this practice, and though I’m a beginner compared to experienced therapists, I do try to use MI methods where I can.

MI encourages treatment providers to listen closely to the patient, clarify what the patient is saying, and ask the patient to participate in solving problems. MI is a collaborative type of counseling, believing patients know more about how to help themselves than more traditional counseling techniques give them credit for knowing. MI also teaches that confrontations with patients aren’t usually helpful.

At the OTP, this patient had a hard time controlling his temper when an authority figure (me) confronted him about drug use and bad behavior. In my office setting, I didn’t confront him but asked him to describe how his relapse happened, and asked him what he thought triggered the overwhelming desire to use the drugs. I asked him what he thought could be helpful for next time, and he had some good answers.

This approach worked well. The time between relapses grew longer, and he appeared to have more and more insight into what caused him to relapse and how he could avoid those situations.

For example, in the past, he got into physical fights at his work place, would get fired, and go use cocaine. At one session, he told me how he’d love to punch his boss in the face. He said it would feel good, but only for a few minutes, and then he would lose another job. He didn’t like his job, but wanted to leave it on his own terms.

Eventually, that’s what he did – he gave a 2 week notice, and left with another job already lined up. Sadly, he couldn’t afford health insurance at his new work. I told him to petitioned Reckitt-Benckiser’s program of free medication for one year for patients in dire financial conditions, and he met their requirements. I also agreed reduced my office fee temporarily, until he got back on his feet.

Then his mother was diagnosed with end-stage cancer. He worked at night so he could help take care of her during the day. He was less angry but more depressed, and he finally agreed to start taking an antidepressant medication. During her prolonged illness, he still struggled with occasional illicit drug use, but he was able to work full time and also help care for his mother. He was very distraught when she died, but happy he’d been able to spend time taking care of her at the end of her life. Ironically, the rest of his family, who had once written him off as the black sheep, came to depend on him during this difficult time for them all.

Since then, he’s been diagnosed with several chronic medical problems, but he has a good job that he likes, and he has good insurance coverage. This allows him to see his primary care doctor regularly. He helps his father around the house and helps financially when he can.

He gradually transformed into a productive member of society.

I have come to enjoy his visits. He’s actually very funny, with a droll sense of humor. His last positive urine drug screen was more than three years ago, and this was his last illicit drug use.

His life isn’t perfect. He has problems with relatives, and has some unmet goals in his life that he’s working on, but looking at him now, you wouldn’t guess he once had serious and life-threatening issues with addiction.

A couple of times a year, we discuss whether he wants to taper off buprenorphine. So far, he said he doesn’t want to risk it, and prefers staying on buprenorphine. I agree with him; he’s doing so well now, I don’t want to risk making changes that could harm him.

What helped this patient? Was it relief from an overly authoritarian opioid treatment program system? Did he age out of his addiction and youthful antics, as so many people do? Did he benefit from the motivational enhancement counseling I tried to provide? Or was he sick of the addiction, and just needed a little help while he got better on his own? I don’t know, but it’s been a delight to be even a small part of his recovery.

When I’m tempted to write off a patient as hopeless, I think of him.

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.

Complex Connections: Pain, Opioid Use, Suicide, and Opioid Use Disorder

 

 

 

Early this month, the New England Journal of Medicine published a review article about this topic. This article, titled, “Understanding Links among Opioid Use, Overdose, and Suicide,” summarized what we know so far about the twin epidemics of suicide and opioid use disorder. [1]

According to the authors, as unintentional opioid overdoses have risen over the past few decades, so have suicide rates, with both more than doubling from 2000 to 2017. We know that opioid use increases risk of unintentional overdose, but it’s been found that opioid use also increases the risk of suicide. People with opioid use disorders are more likely to commit suicide than people with other types of substance use disorders.

Why is this?

The article points out some specific pathways that cause vulnerability to overdose and suicide.

Pain causes changes in the brain that alters its reward system. We know patients with chronic pain are at increased risk for suicide, as well as riskier use of opioids. When opioids became more available at the turn of the century, due to efforts to treat pain more adequately, the average dose per capita increased seven-fold between 1997 and 2007. This availability increased the numbers of people who developed opioid use disorder, which is linked to both unintentional overdose and suicide. Higher doses of prescribed opioids are associated with higher risk for both unintentional overdose and suicide.

This article explained the two primary theories about the connection between increasing rates of both suicide and opioid overdose deaths.

The first theory says that both types of deaths are “deaths of despair,” meaning they occur in people whose general economic conditions are falling. Due to lack of opportunities, social isolation, legal problems and/or economic inequalities, people feel desperate, and look for ways to cope. Opioids dull emotional pain as well as physical pain, but according to this theory, also cause worse depression. This increases suicide risk and overdose risk. This theory is called the demand-focused hypothesis.

Or it could be the other way around, as the second theory explains: increased use of opioids causes decline in social function and increased risk of opioid use disorder, which may increase depression. This is called the supply-focused hypothesis. Studies that show increased suicide risk with higher doses of prescribed opioids would tend to support this hypothesis

To tell the difference, we need quality longitudinal studies to show which occurs first. We don’t have such studies, and we need them. The authors say it’s important to know which theory is more accurate, since public policy approaches to fix the problems would be different if one theory is more correct than the other.

Of course, sometimes we don’t know if a death in unintentional or suicide. Sometimes the people involved don’t even know. I’ve talked to many patients with opioid overdose history. When I’ve asked if it was a suicide attempt, they answer, “I don’t know. I just wanted to feel better. If I died, so be it.” How do we classify such an event?

For sure, opioid use disorder brings despair. Some of my patients tell me that they want to live, but they also want their painful struggle to stop. Since death would be one route of release, it becomes a more acceptable option. Hearing this magnifies the importance of getting patients into treatment.

Or maybe the person alters their description of the event, after they survived. If they admit to suicidal intent, they might fear an involuntary commitment to a psychiatric facility, which usually means enforced opioid withdrawal (at least in my area…in some states, psychiatric facilities do provide MAT), so they claim the incident was accidental.

There are shared risk factors for both types of deaths. Both suicide and overdose deaths are more than twice as likely to happen to men than women. White or Native American people have higher rates of both compared to black or Asian people, and highest rates are found in those in their middle years, 41-64.

All mental health conditions are related to higher risk of unintentional overdose, as well as increased risk of suicide. Risks of both events are even higher in people with both mental illness and opioid use disorder.

Knowing the profiles of people at highest risk, can we use that data to intervene and prevent both causes of death? Yes, if they can access help. These patients do the best when both opioid use disorder and mental disorders are addressed at the same time.

Many prescription monitoring programs use numerous factors to determine who is at highest risk for overdose death. Those patients could be given more attention, with detailed assessment and referral to appropriate treatment.

North Carolina added an overdose risk score to its prescription monitoring program recently. It needs fine-tuning, since scores are adjusted upward for factors not always under a patient’s control. For example, I had a patient who is prescribed two Suboxone 8mg films per day. Her pharmacy doesn’t always have them in stock, forcing her to go to other pharmacies. When she does this, her overdose risk score goes up, but it’s not due to anything my patient is doing. In fact, instead of getting discouraged and giving up, she does what she needs to do to stay in treatment. That should adjust her score downward, in my opinion. But the data collectors at the state level have no idea why she’s at multiple pharmacies and assume it’s risky behavior.

I was happy to see this article emphasized the importance of increasing access to medication-assisted treatment for patients with opioid use disorder as a life-saving measure. Of course, they also emphasized a combined approach to treatment, with inclusion of evidence-based forms of counseling.

This study addresses the dilemma of the patient with chronic pain. We know that higher opioid doses are associated with increased risk of overdose death, but we don’t have data that shows tapering that dose reduces the risk of overdose or of suicide. Many practitioners now advocate reduction of patients’ opioid doses to at, or below, the 90 mg MME (morphine milligram equivalents) recommended by the CDC (Center for Disease Control and Prevention) for reducing risk. Might such a reduction make pain worse and trigger suicidal intent? We don’t know.

Some patients on chronic opioids develop hyperalgesia, a condition where the body becomes more sensitive to pain due to adaptations from chronic opioid use. Often those patients feel better as opioids are tapered, but this is far from a universal experience for pain patients.

What I learned from this article was that while we know pain, opioid use, suicidality, and opioid overdose are linked, we are far from understanding precisely how one condition influences the others. So far, we have developed profiles of patients most likely to be at risk, and we should be talking to those patients, doing better assessments. Then we need to increase access to care using evidence-based treatments.

We see the best outcomes when mental illnesses are treated along with opioid use disorders.

  1. Bohnert et al., “Understanding Links among Opioid Use, Overdose, and Suicide,” New England Journal of Medicine, January 3, 2019, pp71-79.

Patients with Substance Use Histories Denied Primary Care

Shocked and Appalled

 

 

 

 

 

One of my long-time and very stable patients saw me a few weeks ago for her yearly history and physical. That’s a minimum requirement for the patients I treat with methadone or buprenorphine at the opioid treatment program. For patients in treatment for many months, I no longer need to see them frequently for positive drug screens, dose adjustments, and other things, so we make sure to set aside time each year for me to catch up on how they are doing.

This isn’t only good medical care, but it’s fun for me. I love talking to patients and hearing the ways in which their lives have improved. It’s fun for them to discuss how they are accomplishing their life goals.

This day, after asking about the adequacy of her dose, her mood, her sleeping habits and biggest sources of stress, I asked about her overall health. To start with, I asked the name of her primary care physician. She told me she couldn’t get one, because of her history of opioid use.

I asked for further details: she called a local practice about becoming established as a patient, and part of their screening was to ask if she’d ever been prescribed opioids. She said yes, but that problem was in the past, and she didn’t need opioids now. She was then told that the practice wasn’t accepting any patients with a history of opioid use.

Merely opioid use, mind you – not opioid use disorder.

This wasn’t because of her insurance status, as she is covered by the largest private insurance carrier in the state, Blue Cross/Blue Shield of NC.

She said her feelings were hurt, and she started crying as soon as she got off the phone. She said, “They made me feel like a piece of shit.” She even teared up in my office as we were talking two weeks later.

This does not sit right with me.

I gave her the website of the North Carolina Medical Board and gave her the web address and phone number of where and how to file a complaint against that practice. I told her that denying entry to primary care for a patient because of past opioid use was immoral, if not illegal. I’m not a lawyer, but I figured if she let the medical board know, they could figure this out.

She hadn’t even told them she was on methadone. I know it’s a violation of the American with Disabilities Act, the ADA, to discriminate against someone with opioid use disorder who is in recovery on medication-assisted therapy. But I didn’t think that was the case for her, since she didn’t have time to tell them she was on methadone. By her description, their decision was based only on her history of receiving opioid prescriptions in the past.

I doubt there was any misunderstanding on her part, since she’s not the first patient we’ve had who reported similar situations. Also, local practices tell our patients on methadone or buprenorphine that they don’t have the “expertise” to care for them if they are taking methadone or buprenorphine from me.

This is ridiculous, since primary care physicians care for patients with specialty medications all the time. Cardiac patients on complicated heart medications still get primary care. HIV patients on powerful anti-viral medications still get primary care. Patients with opioid use disorder are no different.

But to be denied primary care merely because opioids have been prescribed in the past…it’s a step beyond the usual discrimination I see.

Of course, if the medical board does investigate, I expect that practice will blame the patient for misunderstanding, and say they accept all patients. Maybe…but at least they will be on notice that discriminatory practices can and will get them into problems. Hopefully they will be less likely to do this again.

No wonder local death rates increased. Not only are we dealing with the continued opioid use disorder epidemic with its opioid overdose death risk, but also with a lack of medical care for those people who survive opioid use disorder. It’s a double assault on patient health.

I live in a beautiful part on this country, but the medical care in this community often baffles me.

After a free-for-all on prescribing opioids, benzos and stimulants for a decade or two, the patients in this area for whom those were prescribed now can’t even get a primary care practitioner. It’s as if local doctors think that after the pendulum swung so far in one direction, it must swing too far in the other.

Common sense should dictate care – let’s not prescribe controlled substances willy-nilly but let’s not be stingy with opioids in cases of acute pain. And let’s not deny patients care if they’ve been prescribed opioids in the past.

What about repercussions from insurance companies? Will insurance companies allow certain prescribers to opt out of treating their covered enrollees because of past prescriptions?

Here’s another discriminatory wrinkle: life insurance companies are turning down coverage for people who have filled prescriptions for Narcan. A friend of mine sent me a link to this story:

https://www.npr.org/sections/health-shots/2018/12/13/674586548/nurse-denied-life-insurance-because-she-carries-naloxone

This is a link to the story of a nurse who was turned down for life insurance because she has filled a prescription for Narcan. This nurse works at an addiction treatment program and wanted to be able to revive people and save lives. The insurance company, Primerica, is now being criticized because it turned down her request for life insurance since she filled a Narcan prescription.

Now that they are being criticized for their stance, they issued a statement saying something to the effect that they support efforts to turn the tide on the opioid epidemic. But it appears that support doesn’t extend to offering life insurance to people who have obtained a Narcan kit.

This nurse applied at a second company and was turned down again, though she was told if she got a letter from her primary care doctor explaining why the Narcan was prescribed, they might re-consider. The trouble is, in Massachusetts, personal physicians don’t write prescriptions. To reduce barriers to receiving Narcan kits, the state allows any person who wants a kit to be able to get it under a standing order.

The physician behind this standing order is a well-known and well-respected physician, prominent in the Addiction Medicine field, Dr. Alex Walley.

Doctor Walley says he’s written other letters for similar situations where people are denied life insurance due to filling Narcan prescriptions to have on hand to save lives. He’s worried – obviously – that people will be discouraged from getting Narcan kits. These kits and their availability have been responsible for saving many lives in this nation.

These examples of poor decision making do nothing but extend the misery of people with opioid use disorder, in or out of treatment, and their families.

I’ve been working in my community for seven years, trying to inform and educate other medical providers about medication-assisted treatment. Most of the time, I feel positive, thankful to form good relationships with some providers and to coordinate care for my patients on medication-assisted treatments.

Then there are days when I feel so discouraged. it feels like there’s been no progress at all with deeply embedded bias and stigma against people with opioid use providers, their families, and the professionals who try to provide care to them.

 

Year in Review: 2018 and the Treatment of Opioid Use Disorders

This year has been difficult for many people, due to disasters both natural and unnatural. As in any year, good things also happened. Since my blog concentrates on opioid use disorder and its treatment with medication, this entry will focus on the positive events in my field. I’ll save the more negative events for another blog, when I’m feeling grumpy, for those days will surely come.

This last year, the problem of opioid use disorder is got essential attention from governmental agencies, the press, and the public in general. For too long, no one was talking or caring about this issue. Now, this widespread medical problem is getting the kind of attention that leads to change: financial attention.

Big money for treatment

The CURES grant money, approved by legislation in late 2016, made almost a billion dollars available to help treat opioid use disorder. That money was released starting in early 2017, and has helped many patients.

In mid-2018, legislation was passed to approve another near-billion dollars to treat opioid use disorder and its prevention. Called the State Opioid Response, or SOR, this money will be released through SAMHSA to each state’s single-state agency. This money must be used for prevention and treatment, and to increase availability to medication-assisted treatment with the three FDA-approved medications: methadone, buprenorphine, and naltrexone.

From my reading of SAHMSA’s description of the SOR grants (https://www.samhsa.gov/grants/grant-announcements/ti-18-015 ), most of the money will need to be used for treatment with MAT.

This is big money, and is intended for treatment that includes evidence-based treatment with medications. In other words, the abstinence-only, “we don’t believe in medications” type programs probably won’t qualify for these grant dollars.

I’d like to pause and say a big “Thank you!” to the legislators who wisely crafted this grant.

As an example of fiscal irresponsibility of the past, with CURES dollars, some areas of our state cycled patients through five-to-seven- day detox admissions that had very little chance of helping. We’ve known the abysmal data from such short stays for decades, yet many treatment dollars were flushed down that detox drain.

Now, to get grant money to pay for detox, patients will need to start on naltrexone (probably the month-long depot injection) prior to leaving the facility. This makes sense and should improve patient outcomes. They could also be started on methadone or buprenorphine, but presumable inpatient detoxification wouldn’t be needed to start these medications.

The end of a detox is a perfect time to use naltrexone. Once a patient has started on it, it’s much easier to continue, either at an opioid treatment program or even in a primary care office. Since it’s not a controlled substance, physicians and extenders don’t need a DEA number to prescribe this evidence-based medication.

We’ve seen the benefit of CURES grant money at our opioid treatment program, where patients are treated with either methadone or buprenorphine. (We also offer naltrexone, but don’t often get patients when they are suitable for this medication, since they are actively using opioids.)

Before CURES, self-pay patients had difficulty remaining in treatment, and often opted to taper out of treatment before they were ready. Now, we’ve seen those people stay in treatment and thrive. I don’t have data, but I’m sure it is being collected. Now with continued money from the SOR grants, we can continue to provide care to people who have no way to pay for care.

Sometimes people get angry about public funding for MAT. They feel that since they must pay for the treatment of their own chronic disease, patients with opioid use disorder should, too. I can’t comment on the fairness aspect, but I do know that each dollar tax payers spend on MAT saves between $4 – $11 in tax expenses, most of which is saved on incarceration costs, medical costs, and the like.

Personally, I’m happy my tax dollars go towards such a great investment.

Tolerance and inclusivity at some 12-step meetings

I see a trend of tolerance and inclusivity in the recovery communities…at least in my area.

In 2018, a new Narcotics Anonymous group started here with the express purpose of welcoming people on medication-assisted treatment for opioid use disorder. Since I work with patients on medication-assisted treatment, this delighted me. Some of them want to go to 12-step meetings, either Alcoholics Anonymous or Narcotics Anonymous, but don’t feel welcome at the existing groups. Now they have a meeting where they won’t be judged for being on medication, if they chose to share that fact.

This meeting was started by a handful of long-term members of Narcotics Anonymous with more than fifty years of recovery between them. They intended to honor the traditional primary purpose of all 12-step groups: to carry the message of recovery to those people still suffering. The founders of the meeting felt tearing down barriers for people on MAT was the best way to adhere to that primary purpose. At this new meeting, such NA members are full members, with the right to speak at meetings, do service work, sponsor and be sponsored.

The meeting started in February, and attendance ranged from two people to fourteen people per meeting. It’s still in a fragile state, with only a few people coming to nearly every meeting, but it’s a good start.

Some NA members have attended who didn’t share the group’s stated position on the topic. They too were welcomed warmly and asked to return frequently. Attendees don’t have to agree with the group’s position on MAT, as long as they respect the group and its members. Again, emphasis is on inclusivity. Also, the “still suffering addict” isn’t always a newcomer. Sometimes it’s the person with the most time in recovery, so everyone needs to be welcomed.

This is my opinion: if 12-step groups don’t embrace people seeking recovery who are on medications, they will become less relevant. If they fail to reach people on MAT, they will have failed their stated primary purpose, from a lack of open-mindedness and willingness, two of the essential spiritual principles of 12-step meetings.

Breaking Down Silos

I’ve seen and participated in more cross-specialty discussions about MAT in 2018.

In the past, medication-assisted treatment took place at opioid treatment programs (OTPs) and no medical providers outside the OTPs knew what happened there. Some providers and owners of the OTP companies preferred it this way; a low profile might mean no protesters outside, shouting NIMBY (not in my backyard) slogans. They tried to keep everything hush-hush, so the community wouldn’t try to expel them.

Now, providers at OTPs and owners of OTPs are asked to participate in the recovery efforts of people with opioid use disorders. Slowly, as communities desperate for answers have turned to the scientific literature for how best to treat opioid use disorder, they’ve re-discovered the literature that’s been the foundation of MAT at OTPs for decades.

Last year, I was asked to speak to a variety of groups about what we do at opioid treatment programs. In May, I spoke to a conference of U.S. probation and parole officers. In September, I was on a panel of people who spoke at a conference for pharmacists. Also in September, I was invited to talk to our state’s medical board, to explain more about medication-assisted treatment.

All these events were interesting. Some were enjoyable, and one, with the medical board, was transcendent.

I was a little worried about talking to this group, who make up the “doctor police.” When patients complain about a doctor, the medical board investigates. When physicians are suspected of medical incompetence, the medical board investigates. Each physician must have a license issued by the state medical board to work in our profession. By the nature of what they do, medical boards hold a great deal of power.

I was worried about my presentation, mostly because I had about fifteen minutes to explain a few decades’ worth of science, and to dispel the common myths held by most medical professionals about “methadone clinics.”

But it could not have gone better. Board members were welcoming and friendly. I did my presentation, finished just a little over time, and asked for questions. I got great questions that showed they grasped the complexities of treating people with opioid use disorder who have other challenges as well, and how best to treat them without abandoning them.

Another presentation was scheduled right after me, but the meeting halted while nearly all of the board members, who had been seated behind a raised dais, came to me to shake my hand and thank me for coming and tell me how important this work was. I was blown away by their kindness and support, and their eagerness to understand opioid use disorder and appropriate treatment.

I left there glowing. I felt like they understood, like they got what I was saying. The drive from Raleigh to Wilkesboro went by in a happy blur.

More opioid treatment providers

We have more treatment facilities available to treat opioid use disorders Since 2014, around 254 new opioid treatment programs, formerly called methadone clinics, have opened, according to a recent article in the Washington Post. [1]

Prior to that, the number of opioid treatment programs remained unchanged.

We’ve seen a push to get more primary care providers interested in prescribing buprenorphine for their patients with opioid use disorder, rather than referring all of them to specialty programs. Project ECHO at UNC started a few years ago, doing outreach to providers, and support to them in any way needed.

UNC ECHO now has three online interactive sessions per week for buprenorphine prescribers. In those sessions, cases are presented and feedback and suggestions are obtained from other providers. There’s also usually a short teaching session provided by one of the experts, on topics ranging from treatment during pregnancy to payment issues in an office-based practice. Besides providing essential guidance, providers get free continuing medical education credits.

More providers of medication-assisted treatment should mean fewer deaths from overdose. Multiple studies show reduced death risk when patients are on MAT, with an average reduction of death by three-fold.

I’m optimistic about treatment opportunities for people with opioid use disorders. I see a gradual lessening of stigma towards people who have this disorder, as well as towards the life-saving treatments for the disorder. I hope we continue to make progress in 2019.

  1. https://www.washingtonpost.com/national/health-science/some-states-add-more-methadone-clinics-to-fight-opioid-epidemic/2018/11/09/8cace992-e133-11e8-b759-3d88a5ce9e19_story.html?noredirect=on&utm_term=.59a7b585e0aa

 

Holiday Guide for Families

 

 

 

The holidays are upon us. For many people in recovery and their families, this means family celebrations and interactions. Many of us feel stress about this. No matter how much we love our relatives, there can be misunderstandings and hurt feelings. To help families identify what could lead to problems, I composed this guide last year, and I decided to re-run it this year:

What to do:

Do invite your loved one in recovery to family functions, and treat her with the same respect you treat the rest of the family. If you have resentments from her past behavior, you can address this privately, not at the holiday dinner table. Perhaps given how holidays can magnify feelings, it’s best to keep things superficial and cheery. Chose another time if you have a grievance to air.

Allow your relative some privacy. If the person in recovery wishes to discuss her recovery with the entire family, she will. Let her be the one to bring it up, though. Asking things like, “Are you still on the wagon or have you gone back to shooting drugs?” probably will embarrass her and serve no useful function.

Accept her limitations graciously and without comment. Holidays can be trigger for drug use in some people, and your relative may want to go to a 12-step meeting during her visit. Other people in recovery may need some time by themselves, to pray, meditate, or call a recovering friend. Allow them to do this without making it a big deal.

Remember there are no black sheep. We are all gray sheep, since we all have our faults. In some families, one person, often the person with substance use disorder, gets unfairly designated as the black sheep. She gets blamed for every misfortune the family has experienced. Don’t slip into this pattern at holiday functions.

What not to do:

Don’t ask the recovering person if she’s relapsed. If you can’t tell, assume all is well with her recovery. If she looks intoxicated, you can express your concern privately, without involving everyone.

Don’t use drugs, including alcohol, around a recovering person unless you check with them first. Ask if drug or alcohol use may be a trigger, and if it is, abstain from use yourself. If you must use alcohol or other drugs, go to a separate part of the house or to another location.

Being around drugs including alcohol can be a bigger trigger during the first few years of recovery, but any recovering person can have times when they feel vulnerable, so check with them privately before you break open a bottle of wine.

If your family’s usual way of celebrating holidays is to get “ all liquored up,” then understand why a recovering relative may not wish to come to be with family at this time, and don’t take it personally.

For some of us, remaining in recovery is a life and death issue, so please accept we will do what we must to remain in recovery, even if that means making a holiday phone call rather than making a holiday visit.

If your recovering loved one is in medication-assisted treatment with methadone or buprenorphine, don’t feel like you have the right to make dosage recommendations. Don’t ask “When are you going to off of that medication (meaning methadone or buprenorphine)?Your loved one may taper off medication completely at some point, or he may not. Either way, that’s a medical decision best made by the patient and his doctor. Asking when a taper is planned is not your business..

Refrain from giving hilarious descriptions of your loved one’s past addictive behavior, saying, “But I’m only joking!” This can hurt her feelings, and keep her feeling stuck with an identity as a drug user. She can begin to believe that with her family, being an addict is a life sentence.

Remember your loved one is more than the disease from which they are recovering. Some people have diabetes and some people have substance use disorders. These diseases are only a small part of who they are.

I hope this helps.

May all my readers have a Merry Christmas and Happy Holidays!