Emerging from the dark ages of addiction medication dosing.
Years ago, I walked into a music store, also known at the time as a “record store,” to look around at the albums of my favorite music. The time was probably in the 90s when vinyl records were on their way out, and CDs were popular. At that time, there was no iTunes online music store or music streaming services.
In the middle of this particular store was a machine that I had never seen before. It was a customized music machine. It was similar to an ATM, or the ticket machines that spit out your boarding pass at the airport. However, this machine was for creating custom music mix albums. You could pick from a list of available songs and have your custom mixtape created by the device.
The interface of the machine was clunky. The song selection was limited. And, the final product was overpriced. Yet, this machine was ahead of its time. In the following decade, Apple would release iTunes, allowing listeners to purchase individual songs and create their mix playlists. I remember reading a scene from the Steve Jobs biography where Dr. Dre gets excited, sitting in front of a screen, viewing iTunes for the first time before its release, exclaiming how they finally got it right.
What does this have to do with sublingual buprenorphine and tapering?
Tapering off of buprenorphine means to reduce the dosage gradually over time with the intent of working towards taking a minimal amount of the drug or stopping it altogether. After a patient stops taking buprenorphine, they can continue with therapy. And, they have the option to continue with naltrexone, a non-opioid alternative for medication-assisted treatment of opioid use disorder. The problem with tapering is that the pharmaceutical industry resembles the pre-millennial state of the music industry, where there is no interest in providing a customized experience that might reduce their profits.
Suboxone, a brand of buprenorphine, comes in the form of rectangular films that dissolve under the tongue. It is available in 12mg, 8mg, 4mg, and 2mg. The 8mg and 2mg are the ones most readily available at pharmacies. I knew of a patient who drove all over South Florida, arguing with pharmacists because he had a prescription for the 4mg, and no place carried it, and they would not order it for him. Effectively, we have an 8mg and 2mg. Pharmacies typically price the 2mg film at more than half of the price of the 8mg strip, which you can verify for yourself at GoodRx. Cutting an 8mg film into pieces might seem like the right way to taper to lower dosages. However, the manufacturer recommends not cutting the strips. And, the drug may not be distributed equally throughout the film.
Think of an 8mg Suboxone film as an album and each milligram as an individual song. You can see what I am getting at with the comparison to the dark ages of music. Patients who take Suboxone and their doctors are severely limited when it comes to the tapering process. Every patient is different. Some patients will tolerate tapering down in daily dosage by 2mg at a time on a monthly or biweekly basis. Many more will find that this rate of tapering is too fast and uncomfortable. Their functioning in daily life is adversely affected by unreasonably rapid tapering. Going down 1mg or even 0.5mg at a time will work better for the majority of patients. This sort of customization is impossible with FDA-approved manufactured buprenorphine products. Patients may find themselves stuck at 8mg because there is no 7mg film. Or, they taper by cutting off a “1mg piece,” which is not likely to be accurate and not recommended.
What does it mean to take the last dose of Suboxone?
Some people call the very last dose taken of Suboxone or buprenorphine, “The Drop Off.” Why do they call it that? Because, often, even when a person tapers to what seems to be a minimal dose of Suboxone, the ensuing physical withdrawal symptoms can be significant and prolonged. Some people have withdrawal symptoms for months after their last dose of Suboxone. One big problem with the drop-off is that the lowest available dosage of Suboxone is 2mg, and the manufacturer says you are not supposed to cut the film. 2mg may not sound like a lot, but when it comes to stopping Suboxone, it is quite high. Think of the drop off like an actual cliff. Ideally, you would want that cliff to be no more than a few feet off of the ground. Stopping Suboxone at 2mg is more like jumping off of a two-story building. You can survive the drop-off, but it will most likely be very uncomfortable.
So, if Suboxone films are like musical albums and each milligram is like a song, how can we customize individual dosages? We will probably not have much luck going to the big pharmaceutical corporations that make buprenorphine films and tablets. Asking a big drug company to change course is like steering the Titanic away from the iceberg. They move too slowly if they are willing to move at all. There is another solution that is already available.
What if each quarter was a song?
Instead of thinking of the Suboxone film album broken up into 1mg songs, lets now imagine that even 0.25mg can be a song. What if patients could taper down to 0.75mg, 0.50mg, and even 0.25mg. Then, what if they could safely and evenly cut those dosages into halves or quarters. That would mean that a patient could taper to as low as 0.0625 mg. That would be a 1/32 of 2mg! Now, we can bring the discomfort of the drop off way down. And, as SAMHSA discusses on their website, alternate-day dosing can work for many patients. We can make the drop off even easier by getting to the lowest possible dosage and then going to 48-hour dosing.
How is all of this possible?
There exists many compounding pharmacies that make highly accurate compounded and customized patient medications that fit the description above. Where the pharmaceutical industry seems to have the goal to keep patients on their buprenorphine indefinitely, individual doctors and pharmacists can work with motivated patients to help them to reach their goal of reducing and discontinuing treatment medication when they are ready. For example, I have seen patients in the situation of being stable on Suboxone 8mg who would like to start tapering to a lower dose. Dropping to 6mg may seem like too big of a jump, and the solution would involve the more expensive and complicated solution of combining a 4mg with a 2mg or three 2mg films. What if we could go from 8mg one month to 7mg the next month? In my experience, patients who make this gradual reduction do not even notice the change.
Tapering is now a possibility.
Those patients who have switched to customized, compounded medication, where the dosage is adjusted precisely to their needs, and they can even pick flavors. Treatment progress can move forward. Also, if a patient is going to continue with buprenorphine for a long time, it is best to use the lowest effective dose to minimize possible side effects.
How can we make this available for everyone?
The pharmacies I am referring to that can make this customized medication are a little like that music machine I described at the beginning of this article. These pharmacies are ahead of their time, helping patients to follow through with their long-term addiction recovery goals. While an individual pharmacy can serve a limited number of patients, what about the many patients throughout the country would also benefit from a highly customized medication plan for tapering gradually? What is the next step? Possibly, the solution will involve a radical overhaul of the US pharmaceutical industry. Just like the music industry revolution and transformation to better serve the needs of the customers, we need a similar revolution in medical treatment. The precise solution may not be apparent right now because of the obstacles to overcome, but it is possible.