Response to Dr. Butler’s "Opioid Redux"
Friday, July 20, 2012
Posted by: Joy Ingram
Kevin L. Zacharoff, MD, PainEDU.org
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I just read Dr. Malcolm Butler’s article, Opioid Redux, and thought it was indeed very well written, reflective of many clinicians across the country, and passionate. It is also quite reflective of the "Perfect Storm" that I refer to in one of my current lectures about the climate with regard to chronic opioid therapy. There is quite a major battle going on that even goes a bit deeper than what Dr. Butler describes in his essay.
I recently participated in an FDA 2-day workshop on the "long-term" efficacy of chronic opioid therapy, and quite frankly, it's a bit disappointing to all involved that we don't have more answers at this point in time, 2 years beyond the Decade of Pain Control and Research.
There is much more to this story, as the pendulum swings the other way toward withholding opioids as a component of therapy for chronic noncancer pain. I can also tell your readership that there is much more ahead with regard to this subject. One of the reasons for the NIH funding of our painCAS® project at Inflexxion, Inc., is to develop an outcome measurement tool that could actually help determine chronic opioid therapy outcomes, and outcomes of other treatments and interventions for that matter.
The other (and possibly more relevant) NIH/NIDA grant we are working on is Managing Addiction and Pain in Primary Care,which is an entire curriculum of CMEs devoted to the issues surrounding aberrant drug-related behavior and chronic opioid therapy in a Primary Care setting. This will also hopefully be a likely component of the upcoming REMS education for ER/LA opioids, which was just ratified by FDA last week.
This topic is very much in our focus, and I congratulate your forward thinking in involving us (PainEDU.org) in your QuickNotes. I think that if your organization truly recognizes the significance of this subject, it should be a major topic at your annual meeting – including a meeting of the board of NWRPCA, to realize and understand that this issue is here, it is significant, and it is certainly not going to go away in the near future.
While Dr. Butler does a very good job of making a case for "how we got here," in my opinion he misses some other important gaps in this large, puzzling topic. First of all, the educational deficits are quite large, with a recent article citing the paucity of education about pain management in the North American Medical Education System. This is despite the fact that almost half of all medical visits are for a pain-related complaint. In the medical school where I teach, 1 day of 4 years of medical training is devoted to pain, and 1 hour to opioids (much of which is pharmacology). Secondly, Dr. Butler points out that many of the mortalities in his practice had opioids in their systems; the opioids were present along with other substances in their bloodstreams. What he did not mention is that many of those substances are often obtained by prescriptions as well. It seems that there is often "nobody home" in the Medical Home that is being promoted now to achieve a more coordinated, cohesive, non-paternalistic approach to managing health safely and appropriately, with patients understanding their responsibility in this role. There is nothing in many of today’s healthcare systems to financially enable a framework that supports a true medical home model, let alone an integrated, multidisciplinary management team for chronic pain management.
I think that sometimes people may often confuse the unintended deaths related to opioids (which is at crisis levels), and mix together the deaths related to patients who have comorbities, drug-drug interactions, and addiction with the ones who are taking them totally illicitly. An effective way to categorize this is medical vs. non-medical use, and then look at how many chronic pain patients for whom opioids were appropriately prescribed, that were assessed for risk and monitored appropriately, died, vs. the people who obtained them another way (such as from a family member or friend, which is most common).
Patients are rarely taught to safely store opioids appropriately, or dispose of them. In fact, most of us keep them in the kitchen drawer or cabinet, or the medicine chest. We also have all been taught to silently hold on to them – virtually forever, just in case we (or someone in our household) needs them. My opinion is that this is one major thing needs to change, from the ground up. People actually need to think that they should dispose of unused prescription pain medications when they no longer need them, instead of saving them for a “rainy day.” They need to know that sharing prescription medications with other people is actually against the law in every state.
Nora Volkow (NIDA) published data in the April 6, 2011 JAMA that showed that the three disciplines that prescribed the most opioids in 2009 were (in order) Family Practitioners, Internists, and Dentists. This points to the need for education as at least part of the solution. People need to be taught when (and if) opioids are appropriate components of therapy, and the ethics of prescribing them need to be considered from both the under-treatment angle and the risk angle.
I can tell you that at the FDA Meetings I have attended, for every person who comes to the podium during the public commentary to speak about a loved one who has succumbed to unintended opioid-related death, there is another chronic pain patient who speaks about the fact that without opioids they would be totally disabled, and unable to even perform the most minor daily tasks.
If the argument is going to be put forth that the "spigot" of opioids be turned off, in the absence of education, without alternative treatments (of which Dr. Butler’s essay mentions none), then patients may unfortunately be the ones who suffer from clinicians just saying "No." There needs to be an alternative to opioids if they are not the right choice. Just saying "No" does nothing for the patient, and in my judgment is not morally or ethically correct in the absence of something else that we have taken an oath to do. Keeping the spigot flowing is obviously also not the right thing to do in the absence of education, vigilance, and the societal crisis that exists with respect to aberrant drug-related behavior and the escalating rate of unintended deaths.
It may also be important to consider two other things. One is that for whatever reason, chronic pain is not going away in the U.S.; it is continuing to increase at a steady rate (with 10,000 people turning 65 today, and 10,000 people turning 65 every single day for the next 20 years). Maybe it's because we made pain the 5th vital sign, and look for it, maybe not. No matter what, it's not looking as if its incidence is going to change in the near future. Second is that addiction and aberrant drug-related behavior is not something new; it's just "new" in the medical domain. It has been around for thousands of years, just with different substances such as crack, heroin, etc. Many think that cutting of the flow of opioids will just cause a resurgence of deaths related to those substances, which have taken a back seat to opioid deaths. It's hard to tell at his point, but research may be showing that is exactly what is happening now with the development of abuse-deterrent formulations of opioids.
This is certainly a very complex topic, and one that should definitely be getting significant attention at your organization. Definitely more than a solitary talk on REMS (Risk Evaluation and Mitigation Strategies). It's a major, major subject and growing.
If I have done a good job in writing this, you hopefully have no real idea as to which side of the fence I particularly fall on with respect to the issues, except the fact that patients end up being the most important consideration, and that is most important, as it should be.
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