Update on COVID 19 at the Opioid Treatment Program

 

 

 

 

Yeah I’ve got nothing new. Same old stuff. Social distancing, extra take homes for patients, everyone wear masks, wash hands every two minutes, wipe down facility periodically…

We’ve had a few COVID positive patients, but not as many recently as a month or so ago. We car-dose anyone who is medically fragile or who has any symptoms of COVID. Confirmed cases are usually given two weeks of take homes, unless they are terribly unstable.

Financial stress on patients has been worse. Our state grants for treatment that are administrated by area LMEs (local management entities, a frustratingly vague term) dried up at the end of June. More money from the State Opioid Response (SOR) grants has become available, but prospective grant recipients must qualify for them. In order to qualify for this grant money that pays for treatment, the patients must first apply for, and be turned down for, Medicaid coverage.

In the past, patients could go to our local department of social services, be interviewed, and get a letter saying they didn’t qualify for Medicaid within a day or two. Now, for some reason, our local department of social services says it will take at least a month to process applications for Medicaid.

I hate red tape.

Many of our patients, out of work due to COVID, have no money to pay for treatment. They have great difficulty hanging on for a week, let alone for a month. As a result, we’ve had a higher-than-normal number of patients drop out of treatment last month, mostly because their grant that paid for treatment ended. Our OTP, owned by a for-profit company, has allowed people to charge, especially for extra take home doses, for the last four months and that’s been great. But there’s an end to all charity in such companies, and now our clerical personnel have been instructed to ask for payment on balances.

Lest any person think our for-profit company is unfeeling for asking to be paid, allow me to remind readers that in our country, healthcare is not a right. It is a privilege. People with no money and no insurance are denied medical care every day of the week, in all areas of medicine. If you don’t like that arrangement, be sure you vote this fall. I know I will.

Some readers will surely point out that prospective patients spend more each day for illicit drugs than they would for treatment, but it’s different. When using drugs, people often resort to illegal activities to finance their addiction, and in treatment of course we don’t want them to do this.

Overall, I sense a downward slide in the overall wellness of our patients. More patients have tested positive for benzodiazepines, and judging from my conversation with these patients, it appears driven by the stress and uncertainly of present-day life.

Patients with school-age children must decide how to manage the every-other-day schedule our local school system announced. The schools are doing this to reduce the number of children in school at the same time, to promote distancing. But parents, if they work, have to find child care on the off days from school, adding to their anxiety burden.

Many more patients are testing positive for methamphetamines. From what I hear from other doctors, this seems to be a statewide trend. It’s a cheap and widely available drug, with effects that last for days.

At first, this liking for methamphetamine puzzled me. If a patient prefers sedating effects of opioids, why would he like the speedy effects of methamphetamine? But I was thinking too simplistically. Some patients with opioid use disorder say they like the energy it temporarily brings, or they enjoy feeling different for a short time, to forget about their problems.

We have no medication that’s been proven to help treat stimulant use disorder, so counseling is the mainstay of treatment. Often it must be provided in an inpatient setting, where the patient is removed from the source of methamphetamine, before patients make progress in recovery.

I used to taper patients on methadone or buprenorphine out of treatment for intractable methamphetamine use. Now, with overdose deaths from fentanyl rising in our state, I keep these patients in treatment while we try to increase their “dose” of counseling, either with us or to go to inpatient treatment at a facility where they can stay on their methadone or buprenorphine.

Overall, it feels like our opioid treatment program is in limbo, waiting for the end of COVID, waiting for more grant money for patients with no means to pay for treatment.

Yet some patients have thrived over the past months. Unexpectedly, some patients are making progress in their recovery despite difficult and stressful times. Some people are like that – fires that burn brighter against the wind. Watching those patients, I remember how resilient people can be. Many, if not most of our patients are survivors of one disaster or another: suboptimal parenting, physical/sexual/emotional trauma, terrible auto accidents, major health issues at a young age, or other calamities.

These are the people who inspire me to remain positive. It’s easy to give in to pessimism and cynicism, but watching these patients reminds me there’s another way, a better way to conduct myself in the world. I lean on these people for inspiration and hope I can reflect it back to others.

 

Pregnant Women with Opioid Use Disorder: Treatment with Combination Buprenorphine/naloxone versus Buprenorphine Monoproduct

 

 

 

 

 

 

 

 

Browsing through my copy of the May/June 2020 issue of the Journal of Addiction Medicine, I started reading an article titled, “Buprenorphine and Naloxone Versus Buprenorphine for Opioid Use Disorder in Pregnancy: A Cohort Study.” Then I happened to read the authors’ names and discovered it was written by physicians and scientists from Asheville, NC. I was pleased to see a submission in this major journal by people I knew in my state and read it with interest.

In their introduction, the authors of this article gave some basic facts about opioid use disorder and pregnancy. They quoted statistics from the 2017 NSDUH report, saying 8.5% of pregnant women reported that they had used an illicit substance within the past month, and 1.4% reported the use of some sort of opioid, either heroin or prescription opioid pain medications.

In our nation, opioid use disorder during pregnancy quadrupled between 1999 and 2014, at a rate of 6.5 per 1000 pregnant women. In North Carolina, our rate was 7.8 per 1000 pregnant women. Along with this increased use of opioids, the U.S. has seen a five-fold increase in neonatal abstinence syndrome between 2009 and 2012.

The authors point out that medication (methadone and buprenorphine products) for stabilization of opioid use disorder during pregnancy is the recommended standard of care, endorsed by the World Health Organization, The American College of Obstetrics and Gynecology, the American Society of Addiction Medicine, and the Substance Abuse and Mental Health Services Administration.

Prior to DATA 2000, these pregnant women could only get this treatment at opioid treatment programs, with methadone. Since DATA 2000, these patients also can get treatment with buprenorphine products at office-based practices as well as at opioid treatment programs. All of the patients in this study received buprenorphine product prescriptions from office-based practices, either at the community-based OB/GYN residency program or community-based providers.

Past studies (MOTHER trial, 2010, Jones et al –  another great scientist from North Carolina, at University of North Carolina) showed buprenorphine worked as well as methadone for pregnant patients with opioid use disorders, and over the past ten years, more moms-to-be have chosen buprenorphine over methadone.

This present study was done in order to compare outcomes of moms (and their babies) treated with buprenorphine monoproduct compared to those treated with the combination product, buprenorphine/naloxone.

In the past, pregnant women were usually treated with buprenorphine monoproduct because of fears the fetus could be exposed to naloxone if the combination product was used. However, over the past ten years, more physicians have prescribed the combination product for pregnant women, after some small studies reported no adverse effects. Prescribers were hesitant to prescribe the monoproduct buprenorphine because it is more often misused, and can be injected. The monoproduct has a higher street value than the combination product in most areas, underlining its popularity on the black market.

This retrospective cohort study looked at pregnant patients with opioid use disorder treated from January of 2014 to July 2018. Of the 226 women who met criteria for the study, 108  women taking the buprenorphine monoproduct delivered locally and could be included in the study. Eighty-five women taking the combination product delivered locally and were able to be included in the study.

At the end of the study, the women who had taken the combination product, buprenorphine/naloxone, had outcomes that were not worse than those of the women who had taken the monoproduct. Therefore, this article reassures providers that they can treat pregnant women safely with the combination product.

But hold on…there’s another interesting finding…

The incidence of neonatal abstinence syndrome (NAS) was significantly lower in babies born to moms on the combination product as compared to the monoproduct.

Thirty-five percent of the babies born to moms on the combination product had neonatal abstinence syndrome severe enough to need treatment. However, 55% of babies born to moms on the monoproduct buprenorphine had NAS severe enough to need treatment. That difference was found to be statistically significant.

There were some other differences between the two groups of women that didn’t meet statistical significance, such as age, race, insurance type, presence of chronic pain diagnoses, mental health diagnoses, buprenorphine dose prescribed, and other physical health problems. Interestingly, prescribers working at the residency program were more likely to prescribe the combination buprenorphine/naloxone product than community prescribers.

Intriguing though this finding is, this present study can’t show cause and effect. That is, the most we can say is that the combination buprenorphine is associated with lower neonatal abstinence rates in the babies, but not that the combination buprenorphine product causes lower neonatal abstinence rates. To determine a causal relationship, a different kind of study must be done.

The authors have some ideas about possible factors that could explain these findings. For one thing, there may have been selection bias in which medication was started. This was not the type of study where patients were randomly assigned the monoproduct versus combo product. Selection bias means that perhaps some unknown factor made the study subjects or their prescribers pick one form of medication over the other, and this factor is responsible for the difference in NAS rates.

The authors also suggested that there’s been a trend toward lower NAS rates in recent years compared to earlier years, and that coincided with the trend towards prescribing the combination product instead of the monoproduct. Maybe since both of those things happened at the same same time, it made it appear that the combination product was associated with lower NAS rates.

However, is it possible that the mothers on the combination product actually do absorb more naloxone that we have thought in the past? Is it possible that there’s enough naloxone in those moms’ bloodstream to affect the risk of withdrawal in the newborns?

We know some patients (not necessarily pregnant) complain of low-grade withdrawal symptoms when they take combination products of buprenorphine/naloxone. Some patients report headaches, persistent nausea, and body aches when taking the combination buprenorphine/naloxone sublingual products. These patients’ symptoms resolve on the monoproduct.

Many providers assume such patients are lying, trying to scam them to get monoproduct buprenorphine for some illicit intent. But perhaps sublingual naloxone in the combination product is more active physiologically than we think, causing withdrawal symptoms in susceptible patients, and causing less opioid effect in utero, and reduction of the risk of withdrawal in the newborn.

This issue desperately needs more study, both for pregnant patients with opioid use disorder, and for the patients who describe withdrawal symptoms with the combination product buprenorphine/naloxone.

 

Buprenorphine Can Reverse Methadone Overdose

 

 

 

In the February 2020 issue of Critical Care, Zamani et al. described a trial of the use of buprenorphine to reverse methadone overdose. This was only a pilot study, with a relatively small number of subjects. The study found intravenous buprenorphine appears to be safe and effective for use in people who have had an opioid overdose.

This study randomized 85 patients with respiratory depression from methadone; 56 received buprenorphine and 29 received naloxone. One person out of each group failed to respond to the medication given.

Fewer patients had to be intubated in the buprenorphine group, and fewer had precipitated withdrawal compared to the patients randomized to naloxone. None of the patients in the buprenorphine group died or had serious complications.

This study was done in a busy emergency department of an Iranian hospital that treats up to 28,000 poisonings annually. The protocol was only for patients who had overdosed on methadone, and they had to meet certain criteria, such a low blood oxygen level and low respiratory rate.

The patients in the naloxone group received from .04mg to 2mg intravenously depending on the rate of respirations, and re-dosed at 2-3-minute intervals. Once the patient responded, they were placed on a naloxone intravenous drip.

Patients in the buprenorphine group were further randomized to two doses; one group was given 10micrograms per kilogram intravenously over 6-9 minutes, and the other group was randomized to 15micrograms per kilogram intravenously over the same rate.

For all three groups, if treatment failed to reverse the overdose, the patient was intubated, and the treatment counted as a failure.

This is a fascinating study and lends support for the use of buprenorphine for opioid overdoses.

In this study, the buprenorphine was administered intravenously, but I’ve heard patients tell me it works sublingually. Over the past five years or so I’ve had two patients tell me – and this is third hand information, but still – they know of a person who had overdosed on opioids and someone on site had sublingual buprenorphine. They placed the buprenorphine in the unconscious person’s mouth, under the tongue, and they regained consciousness some minutes later. At the time, I marveled at the creativity of whoever thought to use that buprenorphine. Of course, they also called 911.

If I had both medications available to me, I’d still use the naloxone because of its proven efficacy, but this study hints that buprenorphine could possibly be of use too.

If naloxone can’t be obtained within a few minutes, placing buprenorphine under the tongue of the overdose victim could provide some benefit, in addition to rescue breathing and calling 911.

Just as a reminder to my readers, people who inject heroin or other opioids should use harm reduction ideas to reduce risk. These include:

-Don’t use alone. Use with someone present so that they can call for help or deliver naloxone if needed.

-Alternate dosing times. Someone in the room should remain “straight” while others inject, to be available to render help.

-Use tester doses. This means use a tiny amount of the material before preparing a usual shot. If the drug has more fentanyl than usual, the tester shot may warn the user that it is very potent.

-Don’t mix drugs. Sedatives like alcohol and benzodiazepines can suppress respirations and lead to overdose in people who are also using opioids of any kind, including heroin.

-Use new needles and clean equipment when injecting. Many more sources for free new needles are now available.

-Get a naloxone kit and use if needed. If you can’t get one from a pharmacy, contact your state’s harm reduction coalition.

-Consider enrolling in medication-assisted treatment for opioid use disorder.

 

1. https://ccforum.biomedcentral.com/articles/10.1186/s13054-020-2740-y#Sec1

Lawsuit with a Purpose

 

 

 

(Please note that details have been changed to protect the identity of this patient).

One of my patients made me so proud today. I was beaming with joy as she told me what took place at her last job.

At her last visit, she said she thought she was about to get fired from a relatively new job because an ex-boyfriend told her co-workers that she had a drug use history and was on Suboxone for treatment. In turn, her boss accused her of taking drugs at work and stealing from the company. He asked her directly if she was taking Suboxone. Caught off-guard, and unsure how it was any of his business, she lied and told him no, she wasn’t taking Suboxone. Coincidentally, she had an appointment with me later that day, and we talked about her dilemma during her visit.

Please note that her job wasn’t safety-sensitive, the employer had no policy relating to drug screening of employees, and no one had seen my patients taking Suboxone or any other medication. There was no allegation that she had been impaired at work or unable to do her job.

At her visit, she told me she hated to lie and felt like she should tell the employer that she was on Suboxone. I told her that of course that’s her choice, but that I didn’t think it was proper for an employer to ask about any medications.

I did offer to write a letter she could give to her employer stating that she’s on Suboxone for the treatment of a medical condition, that she’s been in recovery for many years, and that the medication does not impair her ability to work. She wanted this letter, thinking it could help her keep her job. I also added a paragraph at the end that said patients on medication for treatment of opioid use disorder are protected under the Americans with Disabilities Act.

Because I write so many letters, I was able to type it quickly, printed it on my letterhead and have it ready for her by the end of her visit.

I mentioned in passing that I’ve seen similar cases where an employer fired a patient on Suboxone but then to avoid charges of violating the ADA, claimed the termination was for other reasons, and it becomes difficult to prove.

My patient heard this, because when she met with her employer the next day, she secretly recorded him on her cell phone. At her visit with me today, she played the recording. He bluntly told her he didn’t want anyone on drugs working with him and that it was a small town and people talk and he wanted to keep his good name. My patient didn’t interrupt him, letting him dig his own hole a little deeper with each sentence. She was told she was fired at the end of this meeting, despite giving him my letter stating she was able to do her job without problems from the Suboxone.

Here’s the delicious part: armed with the recording, she went to a lawyer in a local big city, who feels she has an excellent case of discrimination because she’s on Suboxone. He took her case and sent an initial demand letter to the ex-employer asking for a healthy six-figure settlement.

I love this. For too long, people in recovery have endured discrimination of all kinds. Here, it appears, is a winnable case that might make people think twice about firing people for being in recovery.

I’m so proud of my patient for taking the initiative and pursuing action on her own behalf. I don’t know how things will turn out, but I hope she gets a nice settlement for being the target of discriminatory behavior.

I have permission from my patient to discuss this on my blog, so I will keep you posted.

Buprenorphine Regulations

Map is from vox.com

In response to the rise of opioid use disorders in this country, lawmakers in heavily affected states are passing laws they hope will help. But well-intentioned laws may have unintended consequences, requiring re-evaluation of those laws.

Nearly one year ago, The Virginia legislature asked the Virginia Board of Medicine to regulate prescribing of buprenorphine. Legislators were worried about the diversion of prescribed monoproduct buprenorphine to the streets. You can read about this in more detail in my blog entry dated February 24, 2017.

It’s been a year since that blog entry, and I have a little bit of data regarding some of the consequences of Virginia’s new rules.

Initially, the new Virginia Board of Medicine (VBOM) regulations said the buprenorphine monoproduct could only be prescribed for pregnant ladies and nursing mothers. They did this because the monoproduct, containing only buprenorphine and no naloxone, has a higher street value and is more likely to be injected and misused than the combination product.

The VBOM received so many complaint letters that they finally changed the regulations to say that each buprenorphine physician could prescribe buprenorphine monoproduct to up to three percent of their patients. Each of these patients must have documentation of their intolerance in their chart.

It was hoped that this compromise would limit the amount of buprenorphine monoproduct being prescribed, while still making allowances for some patents with intolerance to naloxone in the combination product.

The VBOM didn’t stop there. They passed regulations about care at opioid treatment programs (OTPs), which are already the most heavily regulated medical providers in the nation. The VBOM said if buprenorphine monoproduct was used, the patient had to consume it on site, with observed dosing, and that no take home doses could be allowed for the monoproduct.

To clarify, this meant that OTP patients dosing with buprenorphine monoproduct had to either switch to the combination product, buprenorphine/naloxone, to get their usual take homes, or dose daily at the OTP on the monoproduct and forfeit all the take homes they had earned.

Or they could switch to methadone, where take homes are still allowed, following standard guidelines.

This is the irony – methadone is a heavier and stronger opioid than buprenorphine, and more likely to cause overdose death if taken illicitly or diverted. Virginia patients can get methadone take home doses, after they have a period of stability and meet the guidelines which have been in place for decades.

OTPs must follow both state and federal guidelines, and must obey the stricter of the two. The federal guidelines dropped the time in treatment requirement for buprenorphine, meaning the federal agency decided to allow the admitting physician to decide how many take home doses were appropriate, from day one, for a buprenorphine patient.

Essentially, Virginia went the opposite direction, and eliminated take homes, at least for the monoproduct.

At the time the new regulations were implemented, there were 600 Virginia patients on buprenorphine at OTPs. Monoproduct was used because was about half the price of the combination product, and kept treatment more affordable for patients. Also, because OTPs already followed stricter regulations than office-based programs, the risk of diversion was felt to be lower than at office-based programs.

Of those 600 patients, 384 patients attended one of the four OTPs owned by Acadia Healthcare in Virginia. They collected data on what happened to their Virginia patients after these new regulations were implemented. Since I work for Acadia, that data was released to me for an upcoming presentation, but I’ll give my readers an early view.

Of those 384 patients, 260 made the switch to the combination product so that they could continue to get take home doses. In other words, two-thirds of the patients switched, and one-third did not.

The cost of medication doubled, but rather than pass this on to the patients, Acadia Healthcare absorbed all the extra cost. The patients paid the same as if they were getting the cheaper monoproduct. This was fortunate, since an overnight doubling of costs could have caused hundreds of patients to leave treatment.

To some lawmakers, an extra couple of hundred dollars per month might not seem like much. But to many patients, it’s the difference between being able to stay in treatment or having to leave and go back to illicit drug use.

So, what happened to the patients who didn’t make the switch?

• 15 switched to methadone, and will be able to get take home doses once they meet criteria. It’s takes a while, but at least they can get take homes eventually.
• 21 transferred to out-of-state opioid treatment programs because they had an intolerance to the combination product.
• 24 (6%) patients dropped out of treatment.
• 58 remained on the monoproduct and accepted that they will have to dose every single day that they are in treatment. Since all these clinics are in rural areas of Southwestern Virginia, I suspect some of these people are driving long distances daily, and incurring extra expenses for that travel.
• 6 patients were lost to follow up, and couldn’t be contacted to see what happened.

Studies show the risk of death increases as much as eight-fold for patients who leave treatment, so those 24 people are at high risk. I suspect the 6 people who couldn’t be found are also in that risk group.

I have a little bit of data about what’s happened on the receiving end with patients on buprenorphine at Virginia OTPs. One OTP located in Boone, NC, received 12 patients in transfer from Virginia. Those patients could have been OTP patients or office-based patients; I don’t have that data.

I have my own office-based buprenorphine practice in the Lake Normal area of North Carolina, which is 73 miles from the North Carolina-Virginia border. My practice got around twenty phone calls last year, just after Virginia’s law changed. These patients were willing to drive from Virginia to my office if I would prescribe buprenorphine monoproduct. I declined to accept any of those patients, both because it is unworkable in the long run to come from such a distance, and because I was concerned about regulatory scrutiny in my own state.

You can draw your own conclusions based on this limited data. It appears that roughly two-thirds of patients, if forced to switch to the combination product, can do so and remain in treatment.

But remember, costs weren’t increased for those patients enrolled at Acadia OTPs.

That would not have been the case for office-based self-pay patients, who would have paid roughly double each month for their prescriptions for combo products at the pharmacy. Community pharmacies would not have absorbed the extra cost.

I combed the internet, trying to discover data on what happened to office-based patients in Virginia on the monoproduct. If data is out there, I haven’t found it. Or perhaps it’s still being collected and analyzed. I also looked to see if overdose death data changed much in 2017, but it’s likely too early for this.

The American Society of Addiction Medicine has written a public policy statement addressing regulations on office-based buprenorphine policy. This document outlines the most reasonable approach to assure appropriate care for patients while limiting onerous regulations for providers. State legislators would do well to read this policy and abide by its specific recommendations.

https://www.asam.org/docs/default-source/public-policy-statements/statement-on-regulation-of-obot.pdf?sfvrsn=df8540c2_2

I’m tempted to give a summary of ASAM’s statement, but ASAM warns against this, at least without their permission. They don’t want people to use just a section of their policy to justify a position; they want their statement to be read in full.

I think that’s smart of ASAM. I encourage interested readers to check it out.

Buprenorphine Monthly Injection: Sublocade

 

 

 

 

 

 

 

 

 

 

 

Late last year the FDA approved Sublocade, the brand name of a monthly buprenorphine injection, marketed by Indivior, the same company that sells Suboxone brand sublingual films. Sublocade is expected to be commercially available by February or March of this year.

This medication is indicated for patients with moderate to severe opioid use disorder who have stabilized on transmucosal buprenorphine products for at least seven days. Sublocade comes in a pre-filled syringe, and is injected into the subcutaneous tissue over the abdomen. This viscous liquid forms a solid deposit containing buprenorphine, and the medication is released over a month, giving therapeutic plasma levels of buprenorphine.

Thus far, we have two studies, one a randomized controlled trial and another that was an open-label study, that both show Sublocade, compared with placebo, was significantly more likely to result in fewer positive drug screens for illicit opioids and in fewer self-reports of illicit opioid use.

Of note, the manufacturer warns against attempts to inject this preparation intravenously, because the solid mass that forms can block a blood vessel, or travel in the vessel to the lungs, possibly causing death from a pulmonary embolus. To reduce the risk of this bad outcome, the medication will only be distributed to healthcare professionals, and not to patients.

Sublocade comes in two doses; a 300mg dose and 100mg dose. Patients should receive 300mg per month for the first two months, then drop to 100mg per month. This is the indicated dose for patients on the equivalent of sublingual buprenorphine 8 to 24mg per day. If patients have inadequate response after dropping to 100mg, the dose may be increased to 300mg in some patients, if the physician feels this is indicated. At the manufacturers website, they say Sublocade delivers a dose adequate to block opioid receptors to the degree that if other opioids are used, they will have no effect.

Steady state is established after 4-6 months of treatment. Steady state is a term describing the pharmacokinetic state where the drug’s intake is in dynamic equilibrium with the drug’s elimination from the body. Usually this occurs after four to five times the drug’s half-life. After steady-state has been achieved, buprenorphine may be detected in patients for up to 12 months after dosing stops. It is unknown how long buprenorphine will remain detectable in urine testing.

After this medication is stopped, the patient should be monitored for opioid withdrawal symptoms for several months, since blood levels will drop slowly.

Indivior recommend checking liver function tests at baseline, then monthly.

Because of the possible harm of intravenous use of this product, Indivior created a REMS (Risk Evaluation and Management Strategy) protocol. Healthcare settings seeking to dose Sublocade and pharmacies wishing to dispense Sublocade must be certified by the REMS program for this medication.

I tried to go to the website mentioned on the Indivior website regarding the REMS requirements, but the link wasn’t working for me.

I’m excited about this new option because it can reduce diversion of buprenorphine products. At the opioid treatment program, we have a fair number of patients who attempt to divert or misuse sublingual forms. At present, if I have unmistakable evidence a patient is trying to divert medication, I can no longer prescribe it. I can offer to switch the patient to methadone, but that’s unattractive for several reasons to many patients. But if we can administer subcutaneous buprenorphine, it gives us another option. It would be difficult to divert, and it isn’t as complicated to administer as the Probuphine implants.

I do have some concerns. First, how do the financial aspects work? Since it can only be dispensed to the healthcare provider for administration to the patient, I suspect the facility or physician owner of the practice will need to buy the medication and pay up front. What if a patient’s insurance company refuses to pay? What if a patient refuses to pay, or only pays part of the drug cost? Could the physician lose money treating patients if this happens?

Currently, with sublingual buprenorphine products, the physician isn’t in the middle. The patient pays the pharmacy directly.

I was thrilled to learn that North Carolina’s Medicaid program will pay for this medication, without even requiring a prior authorization. That’s wonderful, but many private buprenorphine practices don’t treat Medicaid patients, due to low reimbursement rates. But this will be good for facilities who do accept Medicaid as payment.

I’m amazed our state can afford this. Perhaps they got a much better deal from the drug company, Indivior, than the quoted priced of $1500 to $1800 per month. One month’s worth of generic monoproduct buprenorphine, dosed at 16mg per day, costs about $105 per month at the cheapest retail pharmacy, according to goodrx.com. That means this new subcutaneous injectable formulation costs fourteen times more than the cheapest form of buprenorphine on the market.

That’s quite a difference. I’m assuming the state’s willingness to pay this expense is based on expectation of a marked decrease in diversion of this medication. Apparently, the lump of buprenorphine can be cut out if it’s done within the first 14 days, but that seems an unlikely extreme for patients. In other words, with the monthly injection, the medication will reach the patient for whom it is prescribed.

At this point we could launch into a discussion about whether diversion of buprenorphine – possibly the safest opioid available – is a good or bad thing. Law enforcement types see diversion as bad, but arguing a pure harm reduction viewpoint, one could say that diverted, black market buprenorphine might be saving lives by giving people with untreated opioid use disorder a safer option. Note that I said safer, not safe. But that whole debate is an entire blog post so I’ll keep the focus on this new way of delivering buprenorphine.

About half of my office-based patients are self-pay, with no Medicaid or private insurance. They pay out of their own pocket for my office charges, and pay for their medication at their pharmacy. I think Sublocade’s price will make it an unworkable alternative for these people. About half my patient have private insurance, and most have Blue Cross/Blue Shield. I plan to make some phone calls, to get information about their payment policy for Sublocade.

I’m eager to try this new preparation at the opioid treatment program. It sounds like this will be workable for Medicaid patients.

But that brings up my second concern: how can I get patients to come for weekly counseling sessions if they only get medication once per month? I was pondering this idea in a group Email yesterday when I was informed (by someone who knows these things) that soon, a competitor of Indivior will be releasing a weekly injection form of buprenorphine. He envisioned weekly injections for new patients, with gradual decreasing of frequency of visits as the patient stabilizes, eventually moving to monthly treatment and counseling sessions, when clinically appropriate.

I like this idea. This sounds workable. And as I emailed him…let’s hope there’s a price war, with both companies lowering their prices to attract patients.

I’m happy about any new options for patients, and I’m eager to use this product. I just hope cost won’t be a deal-breaker for patients and their insurers.

 

Subcutaneous Buprenorphine Injections for Treatment of Opioid Use Disorders

 

 

 

 

 

I’ve blogged in the past about studies conducted on CAM2038, a new preparation of buprenorphine that can be given in a subcutaneous injection weekly or monthly. I think this delivery system holds great promise for the treatment of opioid use disorder.

Earlier this year, pharmacokinetic data from healthy volunteers showed that blood levels with the subcutaneous injections equaled the levels provided by sublingual means. This data supports the idea that the injections should provide therapeutic levels in patients with opioid use disorder. [1]

Later this year, a Phase II study was published in JAMA Psychiatry. Weekly subcutaneous preparation of buprenorphine was administered to 47 subjects with opioid use disorder. These patients were not seeking treatment, but had agreed to take part in this study, and all were diagnosed with opioid use disorder, either moderate or severe.

These subjects were given dose of either 24mg or 32mg one week apart, and had complete suppression of opioid withdrawal at both doses. The subjects were then challenged with varying doses of hydromorphone, and had sustained blockade of response to the hydromorphone. [2]

The six-month implant, brand name Probuphine, hasn’t been widely prescribed. As I predicted, the confusion over cost, insurance coverage, and implantation regulations have so complicated Probuphine’s use that mainstream medical providers aren’t considering its use. Also, it’s only indicated for patients on 8mg or less of sublingual buprenorphine, and patients have concerns about what will happen if it doesn’t work well. They ask if their insurance companies would pay for supplemental buprenorphine if the implant doesn’t work as well for them. I don’t know for sure, but I’m guessing they would not pay for supplemental medication.                                                                                                                                                                                                                                                                                                                                                                                                                 My biggest concern with Probuphine was that patients may be less inclined to come for counseling sessions if they have had a six-month implant that keeps them feeling normal. They have no monthly incentive to see their physicians. Many physicians require counseling as a condition for ongoing monthly prescription for sublingual buprenorphine.

I like the idea of injections for weekly or monthly buprenorphine. If it works as well or better than sublingual buprenorphine, it could be the solution to some difficult problems.

• It would save time for my patients on buprenorphine at the opioid treatment program. One of the complaints we hear is of the regulations surrounding treatment in our setting. Unlike in the office-based setting, buprenorphine prescribing at the opioid treatment program demands we follow the sometimes onerous rules of both state and federal laws governing opioid treatment programs.
• It would resolve our diversion dilemma.But injections can’t be diverted, so far as I’m aware.
• Because buprenorphine has a high street value in my community, patients are sometimes tempted to spit out their medication to sell it, or even to inject it into themselves. We don’t want this, given the high rates of complications with intravenous use. We don’t want patients to sell medication because it hurts our reputation in the community. We don’t want to be known as suppliers of illicit buprenorphine.
• It would be a godsend for patients who have to go to jail unexpectedly.
• Most of the time, jails won’t bring incarcerated patients to the OTP for their daily dose of buprenorphine (or methadone), so they suffer opioid withdrawal and are at risk for relapse upon being released, with increased risk of overdose death. But if we can give them a monthly or even weekly shot, it will keep them feeling better, and serve as a blocker if they do leave jail and use illicit opioids like Opana or oxycodone or heroin.
• Patients wouldn’t have to think about taking medication each day; with the injections they wouldn’t have to take a dose of anything each day, just show up for weekly or monthly injections given to them by a medical professional
• Subcutaneous injections are much less complicated to administer than Probuphine, with rods that require a minor surgical procedure to implant, then explant six months later.The FDA plans to discuss this new preparation of buprenorphine at their advisory committee meeting November 1, 2017. Several days prior to this meeting, data to be discussed at this meeting should be available online for interested readers. [3]If this new option is approved by the FDA, it can give us yet another tool with which to treat patients, always a good thing.
• 1. Albayaty et al., Advanced Therapeutics, 2017, Feb; 34 (2)

 

• 2.Walsh et al., JAMA Psychiatry, 2017;74(9):894-902.

• https://www.fda.gov/AdvisoryCommittees/Calendar/ucm578594.htm 

 

Suboxone Manufacturer Sued for Anticompetitive Practices

 

 

 

I read a brief news item online about the drug manufacturer getting sued, but I didn’t get detailed information until I read last week’s issue of Alcoholism and Drug Abuse Weekly (ADAW).

Here’s the scoop: the Attorneys General for thirty-six states are suing Reckitt-Benckiser (RB, now called Indivior), because the company attempted to block generics from entering the market after RB’s patent for sublingual buprenorphine products expired.

Reckitt-Benckiser manufactured Suboxone and Subutex, which were the initial buprenorphine products that came to market in 2002, after the DATA 2000 law was passed.

As a reminder, before DATA 2000 was passed, it was illegal to treat opioid use disorder in an office setting with an opioid prescription. Doctors have gone to jail for this. Before DATA 2000, opioid treatment programs (OTP) were the only setting where prescribing (methadone was the only approved medication) for opioid addiction was permitted, and these OTPs have always been strictly regulated by multiple governmental agencies.

The FDA has approved only one medication, buprenorphine, to be used under DATA 2000, and only the sublingual form was approved. Then earlier this year, a second form of buprenorphine was approved to treat opioid addiction: the six-month, sustained release implantable rods impregnated with buprenorphine, known as Probuphine.

Buprenorphine taken by other routes of administration aren’t covered by DATA 2000, and therefore can’t be used to treat opioid addiction. These forms include the name brands Butrans patch, Belbucca oral film, and IV/IM buprenorphine used for pain control.

Reckitt-Benckiser’s patent for sublingual buprenorphine tablets was set to expire around 2008. Years before that, RB worked on finding a different delivery system, and the film version of Suboxone came out in mid-2010. This new form had its own patent, so that RB was the only company that could manufacture and sell that form of their medication.

However, since their sublingual tablet had come off patient, other drug companies could make generics, which would bring down the price to consumers of this life-saving medication.

But the Attorneys General allege RB tried to block the release of the generic tablets. RB told their drug salespeople to tell doctors that children were dying from ingesting buprenorphine tablets, and that the risk of prescribing this form of treatment was too great. They said the safest way to treat patients was with the film, which comes individually wrapped in a foil packet. And remember, only RB manufactured this film.

On May 12, 2012, I blogged about Reckitt-Benckiser’s attempt to persuade me to prescribe only the film. In that blog post, I describe how the drug representative told me that sublingual tablets were now suddenly too dangerous to prescribe, due to pediatric overdoses. She also told me it was much better for patients to be prescribed the film, since people addicted to pills could be triggered by tablets.

Her credibility took a big hit that day, because she’d promoted the hell out of her company’s tablet form of Suboxone and Subutex to me for years. I called her out on the inconsistency and disingenuousness of her statements, promulgated by her company, and I blogged about it.

At her next visit, she told me she was “disappointed that I chose such a public forum to describe our conversation.”

It was the first time someone chastised me for something I wrote on my blog, and I was elated. I felt like a real journalist!

She hasn’t visited my office since, and I haven’t missed her. She’s a nice lady, which is the only reason I put up with her in the first place. Right or wrong, I‘ve always found drug reps to be tedious.

I harbor no illusions about what drug reps do. Their job is to sell their product. When I worked in primary care, I was lied to on a regular basis by drug reps. For example, when the drug rep for a company that sold Prempro told me that estrogen replacement therapy reduced the risk of breast cancer. I remember being shocked into silence as I frowned at him, wondering if he thought I was really, really stupid.

Back to the point of this blog. So in 2012, R-B tried to prevent the generic from coming onto the market by saying the pediatric overdose problem was so bad that only the films (still under patent with R-B) should be prescribed

The lawsuit alleges consumers had to pay higher prices due to RB’s efforts to block generic tablets. These states want Indivior, formerly Reckitt-Benckiser, to pay back billions of dollars of profit obtained through unfair practices.

The lawsuit alleges the company manufactured claims of pediatric safety as a way to manipulate doctors into switching their patients over to the film, instead of continuing to prescribe the tablet form of the medication, which would have generic versions coming onto the market soon.

The drug company, as well as the company that developed the film technology, both say they did nothing wrong, and that their product has saved countless lives.

So…what is the price difference for different forms of buprenorphine? I did some current comparisons for my area on www.goodrx.com, recording the lowest price on the site for people with no insurance. Here are the results:

Generic buprenorphine: dose of 16mg per day, #60 tabs: $133

Generic combination product, buprenorphine/naloxone, dose of 16mg per day, #60 tabs: $243

Name brand Suboxone Film, same dose of 16mg per day, #60 films: $455

Name brand Zubsolv, dose of 5.7mg, two per day, #60 tabs: $455

Name brand Bunavail buccal film, 4.2mg, two per day (highest recommended maintenance dose) #60 films: $455

I’m sure readers find it remarkable, as I do, that all three of the name brand forms are the same price. It’s also interesting that the cheapest form, generic buprenorphine monoproduct, is only 28% of what the name brands all cost.

Here’s something more fascinating – BlueCross/Blue Shield of NC requires prior authorization for every one of their covered patients who are prescribed buprenorphine. For years, this insurance company will ONLY authorize payment for the name brand Suboxone in film form. They refuse to pay for the cheaper generic, either mono or combination forms.

I don’t know why BC/BS decided to only cover the name brand Suboxone films.

I could understand if they wouldn’t pay for the monoproduct, due to concerns that it’s more desirable on the black market, and the insurance company may not want to contribute to this problem. But why do they object to the generic combo product? Perhaps they worked out a special, cheaper deal, or perhaps they were swayed by drug manufacturer patter.

It’s hard for me to see that Reckitt-Benckiser/Indivior did anything different than what other drug companies do routinely. Of course their drug salespeople exaggerated the danger of pediatric exposure to buprenorphine tablets in an effort to influence doctors to prescribe only the films. But their claims were so weak and transparent that it would be a gullible doctor indeed who fell for the company line.

And since when do doctors accept what a drug company salesperson tells them at face value? I’m not saying outright lying by drug company representatives should ever be OK, but…it happens.

The drug companies make big bucks, but they counter by saying they spend so much money in research and development of new drugs, and if it weren’t for their work, we wouldn’t have all these new medications that we have that are extending peoples’ lives.

That’s somewhat of a legitimate point, but at what point do we say the drug companies are making adequate profits or excessive profits? And at what point does an exaggeration about a medication become a lie?

 

Celebrity Overdose Deaths

Recently, the overdose death of a beloved celebrity restarted discussion of addiction treatment in the mainstream media. I have mixed feelings about such discussions.

On the one hand, I don’t think it’s appropriate for outsiders to comment on whether the celebrity got the best available treatment. It feels reckless for someone to say he should have had this treatment or that, without being privy to the personal medical history of the celebrity. Those details can make a big difference in deciding the most appropriate treatment. Of course in hindsight we can say the treatment chosen didn’t work… but as I’m painfully aware, even the best evidence-based treatments can have disastrous outcomes in individual patients.

On the other hand, celebrity deaths can focus the public on pertinent addiction issues facing society. For example, the death of 1980’s basketball star Len Bias helped change public perception about the risks of cocaine use. Mr. Bias, the second overall draft pick of the NBA in 1986, was the picture of physical health. When this young man died of a cardiac arrhythmia from cocaine use, people stopped looking at cocaine as a harmless party drug. There was a shift to a more realistic view of cocaine as a potentially addictive drug that can cause serious medical problems, including death, even in young healthy people. It’s possible Len Bias’s death, untimely and tragic, saved some number of young people from experimenting and becoming addicted to cocaine.

I am thankful that some light is being shed on the treatment of opioid addiction, even though the cause of this examination is due to a celebrity death. Perhaps something good can come of tragedy.

Realistically, are opioid addicts, including celebrities, being told of all evidence-based treatments for the disease? I don’t have facts or figures, but I’m confident the answer is a resounding “No.”. Most Minnesota model, 12-step based inpatient drug rehabs still discourage patients with opioid addiction from considering methadone or buprenorphine, even though medical evidence proves such treatments to be the most successful. Is this ethical? I don’t think so.

In a recent article from Alcoholism & Drug Abuse Weekly (Feb 10, 2014) on this same topic, even the deputy director of the White House Office of National Drug Control Policy Michael Botticelli says, “For people with opioid dependence, MAT should be the standard of care.”

So how are Minnesota Model facilities, opposed to MAT, able to maintain accreditation if they don’t inform patients of all evidence-based treatments? It’s unethical. Our first obligation is to do the right thing by our patients, based on scientific data.

This wouldn’t be allowed in any other field of medicine.

Combining Medication-Assisted Treatment and 12- Step recovery: One Patient’s Success Story

A few weeks ago, I posted a few articles about 12-step recovery. Several readers became very upset, even saying that if I was pro-12-step, I couldn’t really be an advocate for medicated-assisted treatment of opioid addiction. That’s their opinion, and I honor their views, though I heartily disagree with them.

Now I’d like to present an interview I did with a very successful Suboxone patient who did find help from 12-step meetings.

JB: Please tell me about your experience with pain pill addiction and your experiences with buprenorphine (Suboxone).

XYZ: For me, my opiate addiction got so bad, I was taking two hundred and forty to three hundred and twenty milligrams of OxyContin per day, just to stay normal. It had gotten really, really bad. And it started out with a reason. I had kidney stones, and I was in all this pain, but then it got to the point where it solved some other problems in my life and it got out of hand. I tried a lot of different things. I went to detox, and they helped me, but it was…it was almost like I never came out of withdrawal.

JB: How long were you off pain pills?

XYZ: Even after being clean for thirty or sixty days, I would still feel bad. Bowels, stomach…really all the time.

JB: Did it feel like acute withdrawal or just low grade withdrawal?

XYZ: No…I’d try to fix it myself, sometimes, and I would just put myself back where I was. It got to the point where I was making myself sicker and sicker and sicker. And then I got off of it, and stayed off of it for a hundred and twenty days, I guess…but still just sick. Just miserable, and not feeling right. I was miserable. I wouldn’t eat, I was losing weight…

It [buprenorphine] gave me something that replaced whatever was going on in my head physically, with the receptors. It took that [prolonged withdrawal] away, to the point that I felt well. All that energy I would spend getting pills…and I was going to the doctors almost daily. Because taking that much medicine, nobody would write me for that much, so I had to doctor shop.

My only life was going to the doctors, figuring out what pharmacy I could use. I had a whole system of how many days it could be between prescriptions, what pharmacy to go to. It was sick. I was just trying to not get sick.

JB: And you were working during that time?

XYZ: Yeah! I was working, if you want to call it that. I wasn’t a very good employee, but I held a job. I was a regional vice president for “X” company. I traveled a lot, so I had new states where I could see new doctors. That was bad. When I came off the road, I owed $50,000 in credit card bills.

JB: And your wife didn’t know about it?

XYZ: No. It all came tumbling down. And I had gotten into trouble, because they were company credit cards, and they wanted the money back! So, all of the sudden my wife found out that not only do I have a pain pill problem, but we’re $50,000 short, and I wasn’t very ethical in the way I got the money, because it really wasn’t my credit, it was my company’s credit card.

JB: So addiction made you do things you wouldn’t do otherwise?

XYZ: Absolutely. I lied to people, I took money from people, I ran up credit cards tens of thousands of dollars, and really put my family in serious jeopardy at that time. But buprenorphine took away that whole obsessive-compulsive need for pills, made me feel better, and took away all the withdrawal symptoms at the same time. I didn’t worry about it.
To be honest, I was such a hypochondriac before. I haven’t been sick in years now. I haven’t had a backache or headache that ibuprofen didn’t cure [since starting recovery]. I was fortunate it was all in my head. I would milk any little thing. I had two knee operations that probably could have been healed through physical therapy, but I was all for surgery, because I knew I’d get pain pills.

JB: That’s the power of addiction!

XYZ: Yes. Finally I did some research about buprenorphine, online. Actually, I had some good family members, who did some research and brought it to me, because they were concerned for me, and they brought it to me and said, “Hey, there’s a medicine that can help. Call this number,” and I found places out there that would do it [meaning Suboxone], but my concern was the speed that a lot of them were doing it. A lot of them said, OK come in, and we can evaluate you, and after a week you’ll be down to this, and after a month you’ll be down to this.

This was in 2005. And when I asked them what their success rate is, it wasn’t very high. It was something like twenty percent of the people who were doing it [succeeded]. So when I’d finally gotten a hold of “X,” [receptionist for Dr. H], she saved my life over the phone. Because she said, you can come tomorrow, and she said that whatever it takes, they’ll work with you. And I felt good about going to a place where it wasn’t already determined how long it would take. Because I already knew how I was feeling after I would come off of opiates. I didn’t want to do that again.

I saw Dr. H. and felt better within twenty-four hours, although it took a little while to get the dosage right. I think we started off at a lower dose, then we went up on the dose and it kept me so level. I had no symptoms. It cured my worst withdrawal symptoms, my stomach and my bowels.

There’s always a kind of stigma in the rooms [12-step recovery meetings] because I’d been in NA for a little bit of time then [he’s speaking of stigma against medication-assisted treatment]. You realize who [among addicts in NA] is die-hard, one way to do recovery, and who is willing to be educated about some things and understand that there’s more than one way to skin a cat.
And I was fortunate that I had a sponsor at that time, and still do, who was willing to learn about what exactly it was, and not make me feel guilty about it. It wasn’t necessarily the way he would do it, but he was a cocaine addict, so he didn’t understand that whole part of it.

He said, “Your family’s involved, you’ve got a doctor that’s involved, your doctor knows your history. If all these people, who are intelligent, think this is an OK thing, then who am I to say it’s not going to work?” He was open-minded. And there are not a lot of people I would trust right off the bat [in recovery], that I would tell them. [that he’s taking Suboxone]. I’ve shared it with some people who’ve had a similar problem, and told them, here’s something that might help you. I always preface it with, [don’t do] one thing or another, you’ve got to do them together. You have to have a recovery program and take this medicine, because together it will work. Look at me. I’m a pretty good success story.

One of my best friends in Florida called me, and I got him to go see a doctor down there, and he’s doing well now. He’s been on it almost eleven months now and no relapses.

To me, it takes away the whole mental part of it, because you don’t feel bad. For me, it was the feeling bad that drove me back to taking something [opioids] again. Obviously, when you’re physically feeling bad, you’re mentally feeling bad, too. It makes you depressed, and all of that, so you avoid doing fun things, because you don’t feel good.

Once I trained myself with NA, how to get that portion of my life together, to use those tools, not having any kind of physical problems made it that much easier to not obsess.

JB: So, how has your life improved, as a result of being on buprenorphine?

XYZ: Well, the most important thing for me is that I’ve regained the trust of my family. I was the best liar and manipulator there was. I’d like to think of myself as a pretty ethical and honest person, in every aspect of my life, other than when it came to taking pills.

JB: So, you regained the trust of your family, felt physically better…

XYZ: I gained my life back! Fortunately, I had enough of a brain left to know it had to stop. Once I started on buprenorphine, it gave me back sixteen hours a day that I was wasting. That’s when I decided I really don’t want to jeopardize my recovery, by going out and looking for a job again [he means a job in corporate America, like he had in the past], because I’ve got this thing, this stigma…they’re going to check a reference and I’m screwed. I’m not going to get a job doing what I was doing for the same amount of money.

My brother had enough faith in me that it was worth the risk of starting this business [that he has now] together. My wife and I started on EBay, making and selling [his product], and slowly grew it to the point that, three years later, I’m going to do over two million dollars in sales this year, I’ve got [large company] as a client, I’ve got [large company] as a client, I’m doing stuff locally, in the community now, and can actually give things back to the community.

JB: And you employ people in recovery?

XYZ: Oh, yeah. I employ other recovering addicts I know I can trust. I’ve helped some people out who have been very, very successful and have stayed clean, and I’ve helped some people out who came and went, but at the same time, I gave them a chance. You can only do so much for somebody. They have to kind of want to do it themselves too, right?

JB: Have you ever had any bad experiences in the rooms of Narcotics Anonymous, as far as being on Suboxone, or do you just not talk to anybody about it?

XYZ: To be honest, I don’t broadcast it, obviously, and the only other people I would talk to about it would be somebody else who was an opioid addict, who was struggling, who was in utter misery. The whole withdrawal process…not only does it take a little while, but all that depression, the body [feels bad]. So I’ve shared with those I’ve known fairly well. I share my experience with them. I won’t necessarily tell people I don’t know well that I’m taking buprenorphine, but I will let them know about the medication. Even though the information is on the internet, a lot of it is contradictory.

It’s been great [speaking of Suboxone] for someone like me, who’s been able to put a life back together in recovery. I’d tell anybody, who’s even considering taking Suboxone, if they’re a true opioid pill addict, (I don’t know about heroin, I haven’t been there), once you get to the right level [meaning dose], it took away all of that withdrawal. And if you combine it with going to meetings, you’ll fix your head at the same time. Really. I didn’t have a job, unemployable, my family was…for a white collar guy, I was about as low as I could go, without being on the street.
Fortunately I came from a family that probably wouldn’t let that happen, at that point, but who knows, down the road… I had gotten to my low. And that’s about it, that’s about as much as I could have taken.

It [Suboxone] truly and honestly gave me my entire life back, because it took that away.

JB: What do you say to treatment centers that say, if you’re still taking methadone or Suboxone, you’re not in “real” recovery? What would you say to those people?

XYZ: To me, I look at taking Suboxone like I look at taking high blood pressure medicine, OK? It’s not mind altering, it’s not giving me a buzz, it’s not making…it’s simply fixing something I broke in my body, by abusing the hell out of it, by taking all those pain pills.

I know it’s hard for an average person, who thinks about addicts, “You did it to yourself, too bad, you shouldn’t have done that in the first place,” to be open minded. But you would think the treatment centers, by now, have seen enough damage that people have done to themselves to say, “Here’s something that we have proof that works…..”

I function normally. I get up early in the morning. I have a relationship with my wife now, after all of this, and she trusts me again. Financially, I’ve fixed all my problems, and have gotten better. I have a relationship with my kids. My wife and I were talking about it the other day. If I had to do it all over again, would I do it the way I did it? And the answer is, absolutely yes. As much as it sucked and as bad as it was, I would have still been a nine to five drone out there in corporate America, and never had the chance to do what I do. I go to work…this is dressy for me [indicating that he’s dressed in shorts and a tee shirt]

JB: So life is better now than it was before the addiction?

XYZ: It really is. Tenfold! I’m home for my kids. I wouldn’t have had the courage to have left a hundred thousand dollar a year job to start up my own business. I had to do something. Fortunately, I was feeling good enough because of it [Suboxone], to work really hard at it, like I would have if I started it as a kid. At forty years old, to go out and do something like that…

JB: Like a second career.

XYZ: It’s almost like two lives for me. And if you’re happy, nothing else matters. I would have been a miserable, full time manager, out there working for other people and reaping the benefits for them and getting my little paycheck every week and traveling, and not seeing my wife and kids, and not living as well as I do now.

I joke, and say that I work part time now, because when I don’t want to work, I don’t have to work. And when I want to work, I do work. And there are weeks that I do a lot. But then, on Saturday, we’re going to the beach. I rented a beach house Monday through Saturday, with just me and my wife and our two kids. I can spend all my time with them. I could never have taken a vacation with them like that before.

JB: Do you have anything you’d like to tell the people who make drug addiction treatment policy decisions in this nation? Anything you want them to know?

XYZ: I think it’s a really good thing they increased the amount of patients you [meaning doctors prescribing Suboxone] can take on. I’d tell the people who make the laws to find out from the doctors…how did you come up with the one hundred patient limit? What should that number be? And get it to that number, so it could help more people. And if there’s a way to get it cheaper, because the average person can’t afford it.

The main thing I’d tell them is I know it works. I’m pretty proud of what I’ve achieved. And I wouldn’t have been able to do that, had I not had the help of Suboxone. It took me a little while to get over thinking it was a crutch. But at this point, knowing that I’ve got everybody in my corner, they’re understanding what’s going on…it’s a non-issue. It’s like I said, it’s like getting up and taking a high blood pressure medicine.

I originally interviewed this patient in 2009, for a book that I wrote. Since that time, he and his family have moved to the west coast, but I’ve stayed in contact with him. He’s been in relapse-free recovery for over eight years, he’s still on Suboxone, and still happy. He has excellent relationships with his wife and children, and his business has thrived and continues to grow.

He’s an excellent example of how a recovering addict’s life can change with the right treatment. For this person, Suboxone plus 12-step recovery worked great.