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.

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Physician Burnout

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

On my last post about the Tenth Annual NC Addiction Medicine Conference, I lacked room to write about an outstanding presentation by Clark Gaither, MD., about physician burnout. It was probably the best presentation I’ve heard on the topic.

Providers, meaning not only physicians but also physician assistants and nurse practitioners, are being asked to do more and more in less and less time. Some providers feel like we are working a production line, as if we’re stamping out widgets. There’s not enough time to do what we have been trained to do. This leads to feelings of frustration and burnout.

At his presentation, Dr. Gaither quoted a phrase that resonated with me. It describes the frustrations of being asked to do more and more busy work that takes time away from the real practice of medicine: “A thousand betrayals of purpose.”

Isn’t that a great phrase?

Thankfully, besides giving presentations, Dr. Gaither also works to prevent physician burnout. Besides being the Medical Director of our state’s Physicians Health Program, he still finds time to work with companies and individuals to address burnout, and also has a blog with good information. Here’s his web address: http://www.clarkgaither.com/

I’ve dealt with burnout, too. I’ve written about it on my blog, and even got honorable mention in a physicians’ writing contest for an essay I wrote. The actual topic was about work/life balance, which can be an aspect of burnout. Here’s what I had to say on the topic:

“Every Sunday evening, a blanket of gloom shrouded me as I contemplated my upcoming work week. I felt trapped by my work contract, my financial obligations, and my family’s expectations. I couldn’t envision how I could change my life.

In reality, I was the only person who could make changes.

My inability to enjoy work baffled me. I’d finally achieved what I worked for through college, medical school, and residency. I was a board-certified physician of Internal Medicine, well-trained, and prepared to care for patients in a rural practice setting.

This was in the early 1990’s, and in my area, hospitalists didn’t exist. I saw patients in the office by day, at the hospital by night, and squeezed in a dozen or so nursing home patients during free time. I worked around seventy hours per week as I raced down the road to burnout.

During those years, I was a thirsty person trying to drink from a fire hose. It was good stuff, but too much for me.

Then I developed a medical issue, which in retrospect could have been avoided or mitigated by a less stressful work situation. I took a few years off work to regain my health. What at first felt like a personal health disaster eventually became my opportunity to re-organize my life into a full and happy existence, with time to enjoy everything I love. This included taking care of sick patients.

During my two-year hiatus, I missed being a physician. Though I now had an identity outside of medicine, I missed patient interactions and the intellectual challenges. I wanted to return to work, but in new circumstances.

Initially, I thought the solution was to work part-time. That helped, but though I was well-rested, I was dissatisfied with primary care practice. That’s not where my heart was.

I networked with other physician friends, scoured the internet for different practice settings, and became involved with a physician support group near me. I kept an open mind and considered areas outside of mainstream medicine: occupational medicine, working for insurance companies and drug companies, and doing locum tenens work. I considered new areas like forensic medicine and considered going back to complete a different residency. I made thoughtful decisions based on my research.

Eventually I found my niche in Addiction Medicine, after I agreed to work for a physician friend who was the medical director of an addiction medicine facility. I got additional training and eventually became certified in Addiction Medicine, now a recognized medical specialty by the American Board of Medical Specialties.

Now, I look forward to my work days. I constantly face new challenges, I get paid reasonably well, and I feel like I’m helping not only my patients, but also their families and the community. I feel like I do more good in one day than I did in a month at my Internal Medicine practice, where I treated the sequellae of addiction, but never the cause.

I love the company I work for, and they respect my judgment and support my medical decisions. I work as much as I want for this company and have time for my own small office-based buprenorphine practice.

I feel blessed to have found my niche, but I also had to do some foot work to get to this point. Here are my suggestions for physicians who want to make changes in their work environments:

1. Decide what parts of your work makes you happy, and what parts are not so enjoyable. Use your imagination and try to picture what your perfect job would look like. You may not recognize your perfect work opportunity unless you have an idea of what it looks like.
2. Keep an open mind and investigate niches of medicine you haven’t considered. Consider working for a locum tenens company as a way to get paid while you investigate different aspects of medicine.
3. Adjust your financial priorities. If you want to work fewer hours, you may need to jettison some life luxuries. You can make trade -offs. If you want a vacation home on the beach and a big boat, you may need to work more hours than a physician who is content with a cabin in the woods.
4. Don’t get discouraged by false starts. More than one practice setting failed to work out for me in the long term. I considered that all part of the learning process.
5. Remember the lessons you learn and try not to repeat mistakes. Several years after I found an enjoyable work situation, leadership changed. I was told that I needed to see more patients, and that my usual pace of six patients per hour was too slow.I recognized this practice was no longer a good fit for me. By this time, I knew my limits, and knew I wouldn’t be happy trying to meet new expectations. I told my physician employer that I planned to move on, and that he should start looking for my replacement. I told him that I didn’t have the temperament for what he needed in a physician and wished him well. We parted on amicable terms, and I found a place that fit me much better only a few months later.
6. Expect to feel some fear. Life changes are risky, but we are talking about reasonable, calculated risks. Decide how much risk you can tolerate and proceed accordingly. For example, if financial insecurity would ruin your peace of mind, don’t quit your present job until you find a new one.
7. Don’t allow your identity to be completely defined as a physician. As good as it can feel to be a physician, remember it’s only a portion of who we are. It’s also essential to cultivate our identities as parents, husbands, wives, and the dozens of other things important to us. That way, we aren’t as dependent on work for our sense of well-being. Particularly in this uncertain age of medicine, we must be grounded in other areas of our lives.

Physicians have more control over our lifestyles than we believe. We may feel stuck, trapped in situations we don’t like, but in truth, most of us have the financial and emotional resources to change our lives into something better. We have survived rigorous training and have skills to continue to change.

Trying something new is uncomfortable and scary, and sometimes doesn’t work out. But if you feel like I felt – that cold blanket of dismay over your shoulders every Sunday evening –doing nothing, staying stuck – that’s the much bigger risk.”

It was on my 40^th birthday when my physician boss told me I had to see more patients per hour to keep my job. It didn’t feel like a very good birthday, but that was the day that I decided to look for another area of medicine, so it turned out to be a wonderful gift.

Later that same year, I accidentally worked for a week at an opioid treatment program (long story). I became fascinated with treating opioid use disorder with methadone. I couldn’t believe I’d never been taught about the tons of evidence supporting this treatment, either in medical school or residency. I could see it helped patients so much, but there was so much stigma.

Data 2000 had been passed just the year before, and around 2002 I got my waiver to prescribe buprenorphine from an office-based setting. I didn’t start prescribing buprenorphine until 2006, because I was worried an office-based practice wouldn’t give me enough support. I’d become accustomed to the team-based system of OTPs. But when I did start prescribing, I loved it.

Finding an area of medicine where I could make a difference doused the fire of my burnout.

Not every day is filled with rainbows and roses, but for the most part I enjoy my day, my work, my patients, and my coworkers. I know that I am blessed.

The Tenth Annual NC Addiction Medicine Conference: A Success

 

I just got back from Asheville, the location of the yearly spring conference on Addiction Medicine. This meeting is sponsored by the NC Governor’s Institute on Drug Abuse and the North Carolina chapter of the Society of Addiction Medicine, among others.

I’m glad I took an extra day off work to go to the pre-conference. Last year the preconference was one of the best parts of the whole meeting, and this year was the same. I went to the Motivational Interviewing (MI) preconference, and got a nice refresher on the basic principles of MI. I also got a chance to practice my skills during the session, which can be daunting while being watched by other people.

MI is like that. When done by someone extremely skilled at this counseling technique, it looks so easy. I tell myself, “I can do that, no problem.” Then when given an opportunity, I get brain freeze and it’s not so easy. Like any skill, the only way to get better is to do it and keep doing it, and maybe have a person who is skilled at MI give feedback from recorded sessions (with patient permission, of course). I know the counselors at my OTP submitted recordings to their clinical supervisor for feedback on how well they adhere to MI technique. This feedback can be key.

The first day of the conference proper kicked off with an address by Dr. Elinore McCance-Katz, MD, PhD, who is the Assistant Secretary for Mental Health and Substance Use, SAMHSA. She talked about the federal response to the opioid use disorder epidemic, which includes strengthening the public health surveillance, supporting research, providing Narcan, advancing the practice of pain management and improving treatment access, among other things.

Then she talked about SAMHSA’s response to the opioid epidemic, including the STR grants authorized under the CURES Act, then about the State Opioid Response act, which has a budget of $1.5 billion. She also discussed four or five other important SAMHSA measures.

I appreciate her passion. I wanted to stomp my feet and say “Amen,” when she endorsed using only evidence-based treatments to treat opioid use disorders. She said we should stop doing detox only, unless patients were provided with depot naltrexone injections before leaving detox. Then she said of lab testing in medication assisted treatment that cost thousands of dollars: “This is nonsense.” Yes. Thank you, Dr. McCance-Katz.

Next to speak was Kody Kinsley who gave the NC update on the state of addiction. He described how we have spent our grant dollars so far, and about how Medicaid will change in the future. He talked specifically about how Medicaid expansion could help our state. I don’t think he had to convince this audience. Most of us have seen how dismal medical care (not only substance use disorder treatment) can be for people with no insurance and no Medicaid.

He lost me when he started talking about SPAs. I didn’t know what he was talking about, but I quickly learned he wasn’t talking about places to go for massages and facials. I got so bogged down trying to decide what a SPA was that I missed much of the last part of his message.

A talk from Sandra Bishop-Freeman from the NC Department of Epidemiology and Public Health was scary as hell.

This isn’t a good time in history to be someone with substance use disorder in general, and opioid use disorder in particular. Fentanyl and its analogues are potent, and small packages of these products contain a great deal of opioid firepower. This means it’s easier to smuggle into the country. These fentanyl analogues are sometimes made into counterfeit pills, to fool authorities, but these counterfeits often end up on the street. A buyer may think he’s getting a Vicodin pill when it’s really fentanyl.

And now cocaine is being laced with fentanyl, fueling a twin epidemic. This is scary because cocaine has made a resurgence in my county, or maybe never left in the first place. But this fentanyl-laced cocaine could cause quick overdoses for people not intending to use fentanyl.

Then there’s news about a 1000% increase in deaths from methamphetamines, designer benzodiazepines, and combinations of Imodium and Kratom that are causing deaths.

It was a great and informative talk, but a bit depressing.

The last of the plenary speakers was Dr. Corey Waller, an entertaining and informative speaker. He talked about integrating substance use disorder treatment into hospital systems with specific and practical ideas about making this happen. In this talk and another later in the day, he inspired me to want to try again to work with my local hospital.

I love hearing new ideas and learning about current trends, and I also love seeing old friends and meeting new people working in the field. I was able to talk with four or five other doctors I’ve known for years, and catch up with what happening in their lives. That’s always fun.

I was one of three presenters at a morning workshop about updates and challenges of prescribing buprenorphine (and methadone) for patients with opioid use disorder. It went very well.

I can’t say I enjoy doing presentations, but there’s nothing like a presentation to force me to thoroughly investigate a topic, so I learn even if no one else does. And I feel good about doing the occasional presentation, because I’m doing my part to help educate new prescribers.

I had some material to cover toward the end of the session, and I thought the other two physicians would use up the bulk of our time. In other words, I didn’t think I would have to talk for very long. But the two other physicians were gracious and wanted to allow me enough time to talk, so they left me with a half hour.

That worked out well, because after my fifteen minutes talking about how opioid treatment programs and office-based buprenorphine providers could work together, we still had fifteen minutes for audience questions. And this audience asked some great questions, covering our most difficult issues: misuse of monoproduct versus combo product; co-occurring use of benzodiazepines either by prescription or illicit; law enforcement investigations of buprenorphine prescribers; when – if ever – to terminate treatment for noncompliance; maximum dose for buprenorphine products; the cost of treatment and grant funds, to name but a few.

During lunch, Dr. Frederick Altice gave an informative and concise presentations on Hepatitis C. He made me wish I had enough time to treat our patients at the opioid treatment program who have Hep C, instead of needing to refer them to the nearest FQHC (federally-qualified health center). It’s getting very easy to treat these patients, with liver biopsies and interferon being a thing of the past.

Late in the afternoon, I facilitated our closed opioid treatment program session. This session is meant only for providers working at OTPs, and we usually talk about topics specific to treatment at OTPs. This year, the topic was advocacy.

This topic was based on a case that I blogged about September 16, 2018. They provider involved in the case, Lisa Wheeler, PA, gave an excellent and passionate presentation about the specific case, but went farther into the issue. She explained how and why stigma exists, and the negative consequences we see when provider-based stigma cuts into patient care.

She presented the full case, explaining how a patient of hers, brand new to treatment, was diagnosed with endocarditis and told that per hospital policy, she couldn’t get a second surgery on an infected artificial heart valve. She was also denied visitors and was forced to give up all electronics in order to be admitted for treatment, leaving her with no cell phone or internet access and very lonely indeed.

Lisa Wheeler also gave us the glorious follow up of the case: she – eventually, after long hours of advocacy by Lisa and other people – was transferred to UNC Chapel Hill where she underwent life-saving cardiac surgery. She now is doing very well, healthy, with seven months of recovery.

Then we had a general discussion about other cases we’ve seen where healthcare providers denied care to patients on medications to treat opioid use disorder. Of the twenty or so providers in the room, many had similar cases.

We talked about what we can do to combat stigma, and came up with some general ideas. Sometimes just calling our colleagues, to try to educate them in a friendly way, can be the best approach. We can be informal and friendly, and educate in a gentle way. We need to remember that many providers didn’t get much education about substance use disorders and their treatment during medical school or residency. Those of us working in this field can be a source of information for other providers, who often change their approach when they have more facts.

When bias is egregious and causes harm to patients, sometimes it’s necessary to get more outspoken with advocacy. We identified the Legal Action Center, located in New York City, as a group with some materials that can be useful. They have a MAT “toolkit” with sample letters, to be adapted to specific situations, such as if a patient is charged with driving while impaired while on a stable dose of methadone or buprenorphine. There’s a sample letter to send to a patient’s lawyer, to help explain MAT with its benefits. ( https://lac.org/mat-advocacy/ )

In the end, a handful of providers agreed to form a committee to try to form better advocacy ideas. I’ll keep you informed how that goes.

The entire conference was great, and I’ve only described part of the first day. I could go on & on, but in the interest of keeping this blog post to a readable length, I’ll end with an exhortation to my readers: if you provide treatment to people with substance use disorders, you need to go to this yearly conference. Now there’s also an “Essentials” conference in Raleigh in the fall, which presents a second opportunity to learn.

You can go to this website for more details: https://addictionmedicineconference.org/

This Should Never Happen

 

I had a frustrating admission to the opioid treatment program last week. The patient wasn’t frustrating; she was delightful. Her experience with the healthcare system was frustrating and disappointing.

This nice lady (details have been changed to protect her privacy) has been going to a local pain management group for several years, with some success. About five months ago, she expressed a desire to taper off her prescribed opioids because she didn’t like worrying about running out of medication. She thought if she worried about withdrawal, it was a sign of opioid use disorder (which she called addiction).

The pain clinic provider listened to her concerns, then switched her to Suboxone in divided doses. It’s not clear if the provider thought the patient had evidence of opioid use disorder, or if he thought switching the patient to suboxone would help manage symptoms of pain, or if he was trying to keep the patient happy.

At any rate, the patient felt well on a relatively low, divided dose of Suboxone. She was able to go about her daily business with relatively less pain for some months.

Then she unexpectedly became pregnant.

That’s when the problems began. The patient says her prescriber got excited about her treatment, and what should be done during her pregnancy. This doctor told her the suboxone could damage her pregnancy and he couldn’t prescribe for her any more. She was also told it was very dangerous to come off Suboxone while pregnant.

As an aside, I need to inform readers that in the past, only the monoproduct buprenorphine was approved for pregnancy. Researchers and physicians worried the combination product, with both buprenorphine and naloxone, could cause withdrawal and side effects. Now, I have information from experts that the combo product is just as safe as the monoproduct. Professionals at the University of North Carolina’s Horizons Program, which treats pregnant women with opioid use disorder, say that the combination product, buprenorphine with naloxone added, can be safely used. This program, which was part of the landmark MOTHER trial back in 2010, has done renowned work for years.

Anyway, after hearing conflicting information from her pain management physician, the patient didn’t know what to do. She was terminated as a patient at this pain medicine practice because she became pregnant, but also told that if she stopped taking Suboxone, it could kill her unborn child. The pain clinic referred her to office-based prescribers of buprenorphine products in a nearby city.

When she called these practices, she was asked questions over the phone about her opioid use disorder. The patient answered honestly, but she was turned down for treatment since she didn’t meet criteria for opioid use disorder.

Not one of her providers or potential providers mentioned going for evaluation at an opioid treatment program. Her obstetrician didn’t give specific instructions for her, instead telling her to taper off her Suboxone if she could.

Thankfully the patient had a friend who knew about our opioid treatment program. This friend thought we could either help this patient or tell her where to go for help.

A day or two after the patient called our opioid treatment program, I did an admission history and physical exam for her. This means I listened to her complete history of opioid use, asked questions for clarification, and did a limited physical exam. When we finished, I told her I didn’t think she met criteria to be diagnosed with opioid use disorder,

How did I come to this conclusion? I asked a series of questions to determine if she met the criteria for opioid use disorder. She had tolerance to and withdrawal from prescribed opioids, but that’s not enough to meet diagnostic criteria. She hadn’t misused her medication by snorting or injecting and hadn’t taken more than prescribed. She didn’t use extra opioids from friends or family and didn’t ever run out early on her medications. She didn’t overuse her medication to the point of intoxication and didn’t use her medications to treat emotional states. She didn’t use alcohol to intensify effects. In short, she wasn’t my average patient.

But what was she supposed to do? Abandoned by her pain management physician, she was in a pickle. Clearly, continued treatment with buprenorphine, either mono or combo product, was the best thing for this patient and her fetus. Since she didn’t seem to have any alternatives, I admitted her to our opioid treatment program. It was the right thing to do.

I took her dose back to the 8mg per day that she’d been on, and I saw her again this past week. She felt fine, with no withdrawal, and we talked more about what to expect while on buprenorphine during pregnancy. I think she will do very well.

After she delivers, she can seek treatment at a pain clinic if that’s what she desires. Right now, she plans to taper off buprenorphine after delivery. That may work well, though tapering with a new baby at home sounds daunting to me. We will help her with whatever she desires.

We aren’t a pain clinic, and the once daily observed dosing isn’t necessary for this patient who has not developed opioid use disorder. It’s a much more intense level of care than she really needs. But we were willing to help her until she can find a better solution, for her well-being and the well-being of her baby.

She was thankful to have a solution and some answers but puzzled as to why other providers didn’t want to help her.

Pregnant ladies taking opioids, with or without opioid use disorder, are hot potatoes, at least in my region. No one wants to take care of them, so they get tossed to one provider after another. This patient’s experience is common.

You would think, now a few decades into this opioid use disorder epidemic, that we would have evidence-based guides to the treatment of these patients. We do, but providers are still reluctant.

Doctors get nervous about pregnant women taking drugs, licit or illicit. They fear extra liability comes with the extra person, the fetus. For many physicians, pregnant ladies are someone else’s problem, preferably their obstetricians’.

But obstetricians in this area, with rare exceptions, don’t want to take care of the substance use disorders. Some providers still think people who develop substance use disorders are bad people, or have bad morals, or are weak-willed. They prefer their patients take their drug use somewhere else for treatment.

How could this have been handled better?

I think the pain clinic should have continued to treat this lady with no interruptions in her care. They should have communicated with her obstetrician and coordinated care with the obstetrician. They should have been given the information that it’s now acceptable to continue the patient on Suboxone, and that pregnant patients don’t necessarily need to switch to the buprenorphine monoproduct, although that would have worked fine, too.

If the pain clinic physicians couldn’t manage this patient, they should not have dropped her until/unless they found her a new provider, instead of giving the patients a few phone numbers to call to seek help on her own. It felt to the patient like they were punishing her for becoming pregnant.

This opioid use disorder epidemic started about two decades ago. How long is it going to take for medical providers to learn how to manage or refer patients with opioid use disorder for proper care?

It’s kind of like flying a plane…if you don’t know how to land, maybe you shouldn’t take off in the first place.

Treatment Implications for Intravenous Buprenorphine Use

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

During the admission of new patients for opioid use disorder treatment, I ask about prior use of all drugs. I include the medications we use for treatment. I’ve done this since I started working at opioid treatment programs (OTPs) seventeen years ago.

Over the last few years, more patients say they’ve used illicit buprenorphine in the past. At first, I saw patients who were using it sublingually (under the tongue), as recommended, though still illicitly. Most of them wanted to see if this medication would work for them before they committed to the time and expense of entering a treatment program.

Over the past year I’m seeing more and more new patients who say they use buprenorphine intravenously. This past month, I’d estimate that a fourth of the patients who use buprenorphine illicitly are injecting it. Only a few said they snort buprenorphine.

This presents a big wrinkle to the treatment process.

I see why people use intravenous buprenorphine. It has low sublingual bioavailability, at around thirty percent. That means injecting two or three milligrams gives the same blood level as eight milligrams sublingually. In the short term, people injecting buprenorphine feel like it saves them money. In the long term, I’m certain it will cost more than they can imagine.

Buprenorphine tablets and films were not designed to be injected. Pills and films have fillers in them, and they aren’t sterile. Heating a mixture prior to injection will kill off some of the bacteria, so that’s a harm reduction practice. Using a filter can remove some of the particulate matter, also reducing the potential for harm. However, heat and filters can’t remove all the risk of injecting.

People who snort buprenorphine also get higher blood levels than those who use this medication sublingually. Compared to intravenous use, it’s probably less risky to use in this manner, but still can cause problems with irritation to the mucosa of the nose and sinuses. We don’t know about long-term damage because – of course – no studies have been done on this topic, since the medication isn’t intended to be used intranasally.

People who have used opioids intravenously or intranasally often associate the act of injecting or snorting with euphoria. They can become addicted to the process of both means of ingestion. This can happen with buprenorphine too, though studies show most people who inject or snort are trying to keep themselves out of withdrawal with the medication, and not to feel euphoria.

Due to the ceiling on buprenorphine’s opioid effect, it is… arguably… one of the safest opioids a person could inject. But intravenous use is never safe.

Here’s only a partial list of complications from intravenous drug use:

1. Overdose resulting in death, brain damage from low oxygen, stroke or heart attack from prolonged low oxygen
2. Pulmonary edema (lungs fill with fluid)
3. Skin abscesses and cellulitis
4. Endocarditis (infection of heart valve that is life-threatening)
5. Deep vein thrombosis (blood clot)
6. Septic thrombophlebitis (infected blood clot)
7. Contracting infections: HIV, Hep C or B
8. Bacterial infections and abscesses in weird places like the spine, brain, joints, spleen, muscles, or eye
9. Necrotizing fasciitis – rapid, “flesh- eating” infection, also botulism
10. Pneumonia
11. Septic emboli – when infected clots break off and go to the lungs, brain from infected heart valves
12. Fungal blood/eye infections – (seen frequently when pills mixed with saliva are injected)

I have seen patients with every one of these complications. Most of them were in the distant past, when I was an Internal Medicine resident during the late 1980’s, but not all of them. Over the past year I’ve seen three patients with spinal abscesses from injecting drugs, though not necessarily buprenorphine.

When I posted about intravenous use of buprenorphine (November 2015), Dr. Wartenberg M.D. (pioneer in the addiction treatment field) wrote about the mitochondrial disease, which has caused liver failure, in European IV buprenorphine drug users. This disorder is specific to buprenorphine

So what are the treatment implications for a new patient who has injected buprenorphine?

First of all, these patients aren’t appropriate for office-based practices, even if the physician plans to prescribe the combination product with buprenorphine/naloxone. Clearly there are some patients who inject combination products, not only the monoproducts. Granted, it’s less common, but it still occurs.

But this is only my opinion. I can’t find any research that randomizes patients with histories of intravenous buprenorphine and/or buprenorphine/naloxone use to either care at opioid treatment programs with daily dosing, or care at office-based treatment settings.

There’s usually not enough oversight available at office-based practices to treat more complicated patients. I think they should be referred to opioid treatment programs, where they can be treated with methadone, or buprenorphine – with precautions.

Opioid treatment programs can do observed, daily, on-site dosing of buprenorphine.

At our OTP, we ask all buprenorphine patients to sit in a designated area while their dose dissolves. It usually takes around ten minutes, and they are watched by program personnel. Before they leave, each buprenorphine patient shows one of the staff their mouth, to show the medication is completely dissolved. It does feel a little “police-y” but we had a high incidence of diversion until we started this close observation. Some of the diversion was in patients who wanted to inject their dose later. This is particularly risky, given the bacteria that live in our mouths.

If a patient tries to spit out their medication, they meet with me. I’m rarely willing to continue to prescribe buprenorphine if it appears they are trying to divert their medication. I meet with the patient and we discuss the option of methadone. If they refuse methadone, we discuss depot naltrexone, or refer them to another form of treatment.

If patients with histories of injecting buprenorphine want treatment with buprenorphine, I tell them I’m willing to give it a try, but that they can’t expect take home doses for a very long time, after months of observed dosing and stability. So far, this approach seems to be working.

When/if to grant these patients take homes remains a huge question. I don’t want to unduly burden patients by insisting they must come every day forever, but I also don’t want to give patients take home doses that could lead to a relapse back to intravenous use.

This isn’t a perfect system. But for the most part, we give people with a history of intravenous buprenorphine use a way to use buprenorphine as a treatment medication and as an alternative to methadone.

Criminally Pregnant, Again: Tennessee’s Fetal Assault Law Won’t Die

 

 

Tennessee lawmakers are trying to revive a version of the Fetal Assault Law, originally passed in 2014 but allowed to sunset in 2016, after the state saw worsening outcomes for pregnant moms and babies. [1, 2]

I wrote two blog entries when this law was first passed – you can read “Criminally Pregnant in Tennessee” Parts 1 and 2 from April 12, 2014 and April 26, 2014. The second blog entry was supposed to be satirical. (I won’t try that again, after two out of six commenters thought I was being serious about putting the “addicted babies” in jail.)

This is the proposed law, in part: Notwithstanding subdivision (c)(1), nothing in this section shall preclude prosecution of a woman for assault under §39-13-101 based on the woman’s illegal use of a narcotic drug, as defined in Section 39-17-402, while pregnant, if the woman’s child is born addicted to or harmed by the narcotic drug and the addiction or harm is a result of the woman’s illegal use of a narcotic drug while pregnant,”

To summarize, the Fetal Assault Law says that a pregnant woman can be criminally charged if her baby is born addicted to or harmed by an illegal drug used by the woman.

The wording of the bill is scientifically wrong, of course. Babies can’t be born addicted, since addiction is diagnosed only in the presence of obsession and compulsion to use the drug despite adverse consequences. Babies don’t have obsessions or compulsions, and even if they did, we wouldn’t know it. But I know what lawmakers meant. The lawmakers likely meant to say, “physically dependent,” but lack knowledge about substance use disorder science to know the proper terms.

These types of laws are nothing new. We know the problems that occur with these laws, and Tennessee should learn from examples from the past – their own recent past.

Amnesty International released a 69-page report in 2017, titled “Criminalizing Pregnancy: Policing Pregnant Women Who Use Drugs in the U.S.” This report summarizes research about laws that criminalize behaviors during pregnancy and give some overall data, but the report focused on two states: Tennessee and Alabama.

https://www.amnesty.org/en/documents/amr51/6203/2017/en/

It’s an interesting report, and worth a read. I wish Tennessee lawmakers would read it, because they would have more information about what happened during the two years the Fetal Assault Law was enacted in the years 2014 – 2016.

According to the Amnesty International report, here are the biggest problems seen under the law:

Deterrence of prenatal care: Predictably, pregnant women are less likely to seek prenatal care if they are using drugs and fear being arrested. Even the women who did seek prenatal care were sometimes drug tested without their consent and even without their knowledge.

Uneven application of the law: Some areas of Tennessee had far more cases charged than others, because of the decisions of the local prosecutors. A total of around one hundred women were charged under the Fetal Assault Law, mostly in the eastern part of the state, where there are few treatment facilities available for pregnant women, and in Memphis, in the far western part of the state.

Also, nearly all the women charged in Tennessee were either poor, minorities, or both. The county with the highest number of women charged under the Fetal Assault Law (Shelby County, where Memphis is located), was also ironically a county with lower rates of drug-exposed newborns than other parts of the state. However, that county’s residents are predominantly African-American. It looks as if the prosecutor in that county was more zealous about charging women under the Fetal Assault Law.

Adding to the problem, drug testing policy during pregnancy isn’t uniform. Poor and minority women are more likely to be drug tested, with one study showing that black women were 1.5 times more likely to be tested than non-black women, despite drug use rates that are approximately equal between races. Black women testing positive were ten times more likely to be reported to authorities than non-black women. (Kinins et al., 2007, Chasnoff et al., 1990)

Lack of availability of treatment: Ironically, more women were charged under the Fetal Assault Law in areas with fewer available treatment options. Even when pregnant women with substance use disorders desired treatment, there were few options. Only 19 of Tennessee’s 177 treatment centers open during 2014-2016 treated pregnant women. At the time this law was active, there were no opioid treatment programs in Eastern Tennessee. Even in parts of the state that had opioid treatment programs, the state-funded TennCare program doesn’t pay for methadone treatment during pregnancy, which is the standard of care as noted by experts in the Addiction Medicine field.

The Amnesty International report tells of one woman in Tennessee who tried for three months to access treatment but was turned down repeatedly. She was charged under the Fetal Assault Law.

According to calculations, even if all available treatment beds were set aside for pregnant women with substance use disorders, those resources wouldn’t cover even half of the existing need.

I hope Tennessee doesn’t go backward and re-enact this Fetal Assault law. Since substance use disorders are illnesses, it makes more sense for these women to get treatment, not jail time.

After all, that’s how we treat alcohol abuse and cigarette smoking during pregnancy. We have far more data about harm done to the fetus from maternal smoking and drinking alcohol. But because these substances are legal, they are dealt with as a public health issue. Obesity also affects the outcome of pregnancies. In one article, the dangers of maternal obesity were outlined, and the authors concluded, “Even modest increases in maternal BMI were associated with increased risk of fetal death, stillbirth, and neonatal, perinatal, and infant death.” [3]

I doubt lawmakers would be comfortable setting laws around how much weight a pregnant woman can gain. But if their main concern is fetal well-being, and if they think criminalizing behavior is a way to fix problems, who knows? Maybe next year Tennessee will be patrolling obstetricians’ office for obese pregnant ladies.

1. http://www.wmcactionnews5.com/2019/02/12/tennessee-bill-revive-fetal-assault-law-would-prosecute-women-who-use-drugs-during-pregnancy/
2. https://www.npr.org/2016/03/23/471622159/tennessee-lawmakers-discontinue-controversial-fetal-assault-law
3. Aune, et al, “Maternal Body Mass Index and the Risk of Fetal Death, Stillbirth, and Infant Death: a Systematic Review and Meta-analysis,” JAMA, 2014; 311(15):1536-1546.

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.