Buprenorphine: The Pharmacist's View
Sponsored adThis sponsor paid to have this advertisement placed in this section.
Medication-Assisted Treatment has achieved prominence in addiction medicine as the opioid epidemic continues to cause great harm and concern. Recent legislations will make it easier for patients to receive MAT, and new formulations of the medication buprenorphine (the active ingredient in Suboxone, Zubsolv, and Bunavail) will continue to become available. Few people are in a better position to comment on the benefits and risks associated with MAT than Jake Nichols, a pharmacist with a personal history of opioid addiction. Here is Dr. Nichols’ view from the field…Richard Juman, PsyD
On April 9th, 2010, I awoke to find myself lying in bed in a detox facility just outside of Boston. At the age of 34, trained and employed as a pharmacist, married, and a father, this was the last place I imagined I would end up. For over 15 years, I had convinced myself that as a pharmacist, I was educated enough to avoid becoming an addict. Over the next four months, I participated in 12-step meetings, completed an intensive outpatient program, was treated with buprenorphine, and engaged in regular counseling sessions. On July 26th, 2010, I achieved my goal of becoming drug-free, and have been so ever since, largely in part to my involvement in a structured 5-year recovery program administered by the state for health care professionals. From the minute I engaged in treatment, I was absolutely fascinated by the field and quickly decided that I wanted to spend the rest of my professional career working in addiction medicine. I began speaking publicly about my experiences as an addict and educating others on the benefits of treatment. By the grace of God, this blossomed into much-needed employment opportunities. I had begun the process of filing for bankruptcy, and luckily was spared from having to do so. My work in the addiction treatment industry has allowed me to travel around the country and observe how addiction medicine is practiced. Through my own personal involvement with patient and parent support groups, I also have direct interaction with those still struggling with the disease, as well as those being adversely affected by it. I have met thousands of folks in recovery from every walk of life. I am honored to be able to share my observations from the past six years from working in the field. Please note that the following does not represent the opinions of my employer—they are entirely my own.
Sponsored adThis sponsor paid to have this advertisement placed in this section.
There are truly many incredible, caring, and altruistic clinicians working in this field
I have worked in many areas of medicine over the course of my 16-year career. Without question, this field employs some of the most pure, selfless, caring, empathetic, and nonjudgmental individuals on the face of the earth. At a time in our history where most of what we see in the media qualifies as evil and horrific, the culture within the addiction medicine community is the polar opposite. Many folks work for low wages and put up with angry patients and work long hours without a single complaint. They can be regularly yelled and cursed at, argued with, and challenged without wavering from their dedication to helping folks achieve success. This disease frequently causes patients to become something that they are not—and most clinicians that deal with them can usually see that. I recognize that many folks in the field have had a personal experience that has drawn them into practicing addiction medicine, but there are also many others who have not. These individuals in particular intrigue and amaze me. When I first entered the field, I firmly believed that only those with personal experience with this disease could be effective clinicians—I was wrong. There are many who have gravitated to the practice based on their observations that this is truly a disease and that many people are suffering. It’s a public health crisis and epidemic—it should be “all hands on deck.”
There are many misconceptions, opinions, and conflicting viewpoints on Medically-Assisted Treatment
Whether I am dealing with physicians, therapists, patients, or parents—it doesn’t matter—there are an extremely diverse number of opinions on MAT. Let me begin with the prescribers. For the most part, there are two camps—those who are quite liberal with medication and those who are more conservative. The folks who tend to be more liberal (e.g. average higher prescribed doses, no encouragement to reduce dose or taper at some point, less strict on positive urine drug screens) typically invoke harm reduction principles to justify their practices. The more conservative practitioners tend to encourage abstinence as the ultimate endpoint and also discuss the concept of recovery more frequently. They also utilize formal induction protocols to find the appropriate dose for the patient as opposed to just putting everyone on one dose at the higher end of the range. Both approaches have their merits, and until we see more data suggesting that one approach is more clinically effective in maintaining long-term recovery, it is hard to criticize either. The one thing that I do caution against is allowing personal experiences with recovery to dictate how all patients should be treated. I have observed this regularly—many practitioners who have gone through treatment believe that the way they did it is the way that all patients need to do it. This is not a one-size-fits-all treatment algorithm. Patients will benefit from different approaches to treatment, and the ultimate challenge is finding the right individual recipe that is ideal for that patient to maintain their recovery. For the most part, the therapist community exhibits the same viewpoints, although there is a higher percentage of the specialty that still prefers abstinence-based approaches.
Too often, patients are dictating what aspects of treatment they will participate in as well as what medication and dose they will receive
I have a few theories as to why this happens. The first is that many clinicians want to give their patients the benefit of the doubt. I have had discussions with many docs who struggle with this and strongly feel as though trusting the patient will eventually develop a relationship that will facilitate recovery. My response to that is “trust the patient but never trust the disease.” Especially at the beginning of treatment, patients may not truly be engaged—remnants of past behaviors remain, and deception is still a big part of this disease. It’s impossible to identify who is “gaming” you and who is being honest. I do suggest “going with your gut” on things—if something doesn’t sound right, then it probably isn’t—this is especially true in addiction medicine. The second issue deals with the cash-only practice. Let me be clear that I am not claiming that this is necessarily a negative practice—I am not saying that all cash operations are pill mills—but many are. For that reason, clinicians may feel obliged to cater to patients’ requests. They may be afraid to lose a patient and a portion of their cash flow. My observations, purely anecdotal, are that these types of clinics are much more likely to also be prescribing stimulants and benzodiazepines. Finally, the third segment tends to be the hardcore “harm reduction” followers. They truly feel that by giving their patients what they are requesting, the possibility of purchasing and/or using illicit substances, and possibly overdosing, is reduced. Regardless of the philosophy, I would advise that we utilize a little more “tough love” and “go with our guts” when things don’t seem just right.
Sponsored adThis sponsor paid to have this advertisement placed in this section.
Buprenorphine diversion is out of control and most clinicians are apathetic about it
This is the one issue that I have very strong personal opinions about, but I will try to present them in an objective manner. I have encountered a very small percentage of physicians that are apathetic about buprenorphine diversion. Studies have shown that many physicians feel as though diversion isn’t a problem due to the fact that patients are “self-treating” because they cannot access treatment. First off, we need to clarify—patients that purchase/steal/borrow buprenorphine on the streets are self-medicating, not self-treating—there truly is a difference. I highly doubt that they are engaged in psychosocial programs, attending 12-step meetings, or being monitored with urine drug screens. Patients are using it as a “bridge” when they run out of opiates. They use it when they get dope sick until they can attain their drug of choice. From my unofficial survey of patients over the past few years, it is my opinion that the availability of buprenorphine on the streets keeps folks OUT of treatment. As a recovering addict, I can attest to the fact that “surrendering” and entering treatment is one of the hardest, if not the hardest thing to do in this whole process. If a patient can just purchase or use someone else’s buprenorphine, why would they seek treatment to get a prescription? People who suffer from addiction tend to take the path of least resistance. Some may eventually find their way to treatment because buying it on the street becomes cost prohibitive, but they will fight it as long as they can. The ultimate reason that I have such strong opinions about diversion is simple—it gives the field a bad reputation, which I find appalling. As the fourth most diverted controlled substance, law enforcement sees buprenorphine EVERYDAY. How could they not form a negative opinion about it? Many patients that come before a judge for a drug-related offense find buprenorphine among the drugs they are being charged with illegal possession of. The number one contraband item seized in prison systems is buprenorphine. How could the criminal justice system not see buprenorphine in a negative light?
The question then becomes, “What do we do about it?” I wish I had a solid answer. Until we have truly abuse-deterrent formulations of buprenorphine, we are limited. Luckily, there are several in development. My advice is simple and consistent with previous suggestions: use common sense and go with your gut. Don’t let red flags pass you by. Here are a few that I feel should trigger an alert in the clinician’s mind:
1. Patients insisting that they require 24mg (or the appropriate Zubsolv® or Bunavail® equivalent) or more per day. A small subset of patients may truly require higher doses, but it should be a very small percentage of your panel. Pharmacology, imaging studies, clinical trials, and field experience tell us that the large majority of patients will do well on 16mg daily. In fact, I truly feel as though most patients could also get by with 8-12mg daily—there is a good amount of data that also supports this. The use of formal in-office induction protocols is a rare phenomenon these days. We must remember one of the primary goals of that process: to determine the dose at which physical withdrawal symptoms subside. Many providers seem to have adopted this policy that every patient needs 16mg daily. How would you truly know this unless you conducted a formal induction and observed the patient?
2. Continuously testing positive for illicit opiates while being prescribed buprenorphine. Let me first say that I truly believe that it takes many patients months, to possibly years, to stabilize. I am not suggesting that an occasional lapse should generate suspicion or lead to discharge from the program. I am talking about the patient who has tested positive for opiates for the past six consecutive months and refuses to go to 12-step meetings or engage in psychosocial treatment. This individual is obviously not ready for recovery and/or they require treatment at a higher level that you are providing.
3. Attaining prescriptions from other providers for controlled substances without discussing with you or your staff. First, let me say that I find it shocking how few providers actually check their states’ prescription drug monitoring program to evaluate this possibility. This is one of the only two objective measures we have to monitor the disease (the other is urine drug screens). Why would you not utilize it? Beyond just providing good patient care, as a physician, I would be worried about liability and malpractice suits. For example, I was involved with a case where a physician was being sued for negligence because a patient died from taking his prescribed buprenorphine along with alprazolam (Xanax®). Once the plaintiff’s attorney asked him if he had checked the patient’s history in the PDMP, the trial was over—obviously he had not. If they are being dishonest about other meds they are taking, then it is a good bet that there are other things that you are not aware of.
4. Insistence on a specific product when you prescribe buprenorphine. Some patients get quite upset when physicians prescribe something other than what they expect or request. There are two sides to this, in my opinion. If the addicted patient has stabilized with a treatment plan that has worked, any sort of change can be a jarring and anxiety-producing phenomenon. Educating the patient on how the products are similar and exactly what their differences are can truly help to ease a transition. Many insurance companies are now notifying prescribers and patients when a formulary change is coming, which allows them to prepare mentally. The second deals with the diverting patient. Some would obviously get upset if their revenue stream were interrupted. The newer formulations have little to no street value, so it should generate concern when a patient gets upset or adamantly insists on one product. Also—I need to break it to you—naloxone allergy is a very rare phenomenon, likely less than 0.1% of the population. Patients will claim this in order to get the plain generic buprenorphine product. The absence of naloxone allows buprenorphine to be injected without the antagonism of the naloxone. Many patients also claim headaches with combination products in order to attain this product. For some reason, clinicians have blamed the naloxone for this side effect. If you actually look at the incidence of headaches with plain buprenorphine vs. the combination product in clinical trials, the incidence actually tends to be higher for the single-agent product.
We have a long way to go before things start to get better
It has truly been amazing to me to observe the tremendous strides that we have made in the treatment of opioid dependence since I have been in the field. As I am sure most of us can attest to, seeing a patient recover from this disease is quite a rewarding experience. You can’t debate the fact that we have saved an innumerable amount of lives. The advent of buprenorphine and Data 2000 revolutionized addiction treatment—it opened up access to many people who would never have considered getting help. It has also highlighted some of the key areas that need to be addressed.
We desperately need true abuse-deterrent buprenorphine formulations. This is a very effective medication and I can attest to the fact that I don’t think I could have entered recovery without it—but we also have to remember that it is a controlled substance with a moderate-high potential for abuse. Regardless of your opinions on buprenorphine abuse and diversion, it gives our industry a bad rap in the eyes of many. It is my hope that the advent of depo-formulations, implants, and FDA-approved abuse-deterrent formulations will curb some of this. We should see these start to hit the market over the next few years.
More companies need to invest in researching novel compounds for the treatment of opioid use disorder. This is a public health crisis that will undoubtedly get worse before we see improvement. The great majority of products in the pipeline are new iterations of buprenorphine. As we learn more about the pathophysiology of the disease, new therapeutic targets will be uncovered. We also have some evidence that agonizing/antagonizing opioid receptors other than mu may have some clinical benefits.
Finally, we need to encourage and train more of the health care system to participate in the treatment of opioid use disorder. We still have tremendous issues with lack of education and judgement as it relates to this disease—that needs to be corrected in the initial phases of schooling/training. This is an epidemic, correct? If this were labeled as an infectious disease epidemic, you would have nurses, pharmacists, physicians, and every other health care provider unselfishly volunteering their time to help those in need. Why should the opioid epidemic be any different?
Jake Nichols, Pharm.D., MBA, is a specialist in medication assisted treatment options for an addiction-focused pharmaceutical company.His email is [email protected]