The Comprehensive Addiction and Recovery Act of 2016 (CARA) was introduced in Congress by Senator Sheldon [D-RI] on February 12, 2015, “to authorize the Attorney General to award grants to address the national epidemics of prescription opioid abuse and heroin use.”1
On July 13, 2016, the CARA bill was approved by the US Senate, after being passed by the House of Representatives on July 8. President Obama enacted the CARA bill on July 22, turning it into a law.
Although acknowledging benefits of the CARA bill in addressing the opioid epidemic, several groups have voiced their concern, pointing to gaps in the bill that include a failure to adequately provide access to non-opioid therapies.
Clinical Pain Advisor interviewed Dr Bruce Nicholson, a pain clinician and the medical director for the Division of Pain Management, at Lehigh Valley Hospital and Health Network in Allentown, Pennsylvania.
Q: Dr Nicholson, what are your thoughts on the CARA bill?
A: Overall, the intention of the bill is positive; it comes from the perspective that we have moved into a very different environment when it comes to opioid prescribing in the last 5 years or so, in recognizing that 20 years ago, we had very little understanding of opioids from the standpoint of chronic use.
As pain clinicians, we have realized over the past decade, that there are both risks and benefits associated with chronic opioid use, and it has taken a long time for the general medical community to understand what these risks are. It has taken longer for the regulatory bodies, which need to play a role on multiple different levels, to understand what is going on, and CARA is a step toward that understanding, a step toward being more informed and helping to improve pain care. This has to do with the fact that this bill introduces a sort of mandate to educate on all levels within and outside the medical community about opioids.
But I don’t think it goes far enough to educate and mandate other resources and options that clinicians need, in order to adequately treat patients with chronic pain.
Q: Are you referring to a comprehensive pain management program as the one outlined in the National Pain Strategy?
A: Absolutely. I finished my training in 1992, and at that point in time, the model was a multidisciplinary approach that included cognitive behavioral therapy, medication management, potentially injection and rehabilitation therapies. The model has, for the most part, consisted in doing injections or prescribing medication, based on insurance preferences and demands — there has been a lack of options available to patients, which led to where we are now.
Q: It seems essential to involve insurers, does it not?
A: We, as pain practitioners, want insurers on board and want them to understand that chronic pain is not a one-, but a multi-dimensional condition that requires good management on multiple different levels (medications, possibly interventions, psychosocial as well as physical support approaches).
Q: What other gaps do you see with the bill?
A: I am a little concerned that the bill paints a broad brush picture and makes it look as if all opioids are an issue. If you look at the CDC guideline, there is a lot of fault and of concern about the quality of studies that went into developing those guidelines.2 The bill is a great first start, but if we look at it, in a broad brush approach, they lumped all opioids together and said well, there is very little evidence that would suggest that opioids work well for chronic pain. And CARA will not help that from clinicians’ perspective, who might then be thinking they should not be giving [opioids] to anybody. It should be a more selective process.
It is like saying that every diabetic should be on metformin. We know it is not the case-there are about 30 different drugs for type 2 diabetics-it is about finding the right combination [of drugs]. The same goes with opioids. The studies would certainly suggest that there is a benefit, but they have not taken it further to refine and define what particular molecules may work best for certain patients, what may have a lower risk profile for certain patients, for populations of patients, from the standpoint of misuse and abuse. I think we have a long way to go on the research standpoint. Neither the guideline nor CARA will give the ability to further research.
Q: What about alternative µ-opioid agonists with lesser abuse potential which are being developed?
A: That is the direction from a pharmaceutical standpoint in which we need to go, and I think this brings up an interesting observation with regards to lumping all µ-receptor agonists together. Some agonists do not act like traditional opioids.
A classic example is Tapentadol (Nucynta), which, from a clinical standpoint, has the profile of an analgesic, in that it affects µ-opioid receptors, but also norepinephrine levels in other areas that play a role in analgesia.3 But what is really interesting about this molecule, is that it also has a very low abuse profile from a clinician’s perspective. There does not seem to be physical nor psychological dependency that you see with other molecules, but yet, there is the analgesic profile.
Q: What do you advocate the medical community do to address the opioid epidemic?
A: I would advocate that all sides of the table be brought together — there has to be some discussion about research, [a need to] recognize that chronic pain is not going away by saying we are going to stop prescribing traditional opioids. We have to address the tremendous need, particularly as our population ages. Some patients do not have a robust response on some medicines used for chronic pain. There needs to be some consideration in this bill to articulate and address the need for further research and further development of treatments that can be substituted for our traditional therapies.
Q: Who should get involved in such endeavors?
A: I would hope that the American Pain Society, the American Academy of Pain Medicine, and the American Academy of Pain Management would be able to work together with other societies that have an interest, and with the addiction community groups, to advocate for approaches and more rigorous research into chronic pain and managing it more effectively, with not only medications. But also by bringing the insurers on board, and getting them to recognize that we do have a model that has been abandoned for the most part in the US. The multi-disciplinary model has been around and utilized in many countries except in the US to manage chronic pain.
Q: What is the main issue with insurers?
A: Insurers will not cover safer opioids like abuse-deterrents, particularly opioids with a lower profile for abuse, based on the fact that these are going to be more expensive for them (Embeda for example has a naltrexone core and lower profile for misuse and abuse). Other drugs have a very low signal on the Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS) system data.4 There is enough data out there that suggest that some of these abuse-deterrent formulations, and even non abuse-deterrents, have a low level of preference. Transdermal buprenorphine in the form of the Butrans patch is an example of a drug that does not have abuse-deterrent labeling, but yet does not show up as being used and abused at high rate.
There is a lot of opportunity to improve on what can be offered to patients.
- Text of the Comprehensive Addiction and Recovery Act. Available at: https://www.govtrack.us/congress/bills/114/s524/text. Accessed on July 28, 2016.
- CDC Guideline for Prescribing Opioids for Chronic Pain. Available at: https://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm. Accessed on July 28, 2016.
- Tzschentke TM, Christoph T, Kögel BY. The mu-opioid receptor agonist/noradrenaline reuptake inhibition (MOR-NRI) concept in analgesia: the case of tapentadol. CNS Drugs. 2014;28(4):319-329.
- Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS) System. Available at: http://www.radars.org/. Accessed on July 28, 2016.
Dr. Bruce Nicholson received his medical degree from Eastern Virginia Medical School in Norfolk, Virginia. He performed his residency in anesthesiology and pain management training at the University of Virginia, Health Sciences Center in Charlottesville. Dr. Nicholson is the director of Pain Specialists of Greater Lehigh Valley. He is the medical director for the Division of Pain Management, Lehigh Valley Hospital and Health Network, and is a clinical associate professor at Penn State’s College of Medicine at Hershey Medical Center.
Dr. Nicholson is board-certified in anesthesiology and pain management by the American Board of Anesthesiology. His memberships in professional societies include the American Society of Regional Anesthesia, the International Association for the Study of Pain, and the American Pain Society. Dr. Nicholson has authored numerous journal articles, abstracts and book chapters, and has lectured nationally and internationally on the subject of neuropathic pain.