The on-line publication of the Center for Disease Control and Prevention's (CDC) new guidelines for prescribing opioids for chronic pain on March 15
th
has generated tremendous emotional responses among our SPS membership. Unfortunately, panic, fear, and confusion appear to be the most predominant responses. This is not surprising given the wide publicity covering the publication of the guideline itself in the
Journal of the American Medical Association
(
JAMA
) [1], and the five accompanying editorial featured in
JAMA
[2,3],
JAMA Internal Medicine
[4],
JAMA Neurology
[5], and
JAMA Pediatrics
[6].
Any member looking at the "comments" section of the March 15th new story announcing the guideline's release will find that we are far from the only ones experiencing an intense response. I read the comments section of the New York Times' article and found hundreds upon hundreds of comments from its readership expressing dread, frustration, and fear. The most heart-wrenching comment posts were from patients themselves as well as from rural prescribers who wondered what their patients would do if they implemented the guidelines' recommendations in an immediate and unyielding manner. The comments were so impassioned and numerous that the Times (and other national news outlets) are doing follow-up stories on these very issues and are seeking input from physicians on what the impact of this new guideline will be on their own practice (see URL http://www.nytimes.com/2016/03/16/health/cdc-opioid-guidelines.html).
Like many major medical publications that are featured widely by the press, some of the most pronounced fears are not supported by the JAMA publications themselves but rather are fanned by some news media's stories about the JAMA publications or by some viewers' comments about the news media's stories, or by some bloggers' pieces about the viewers' comments. Like an alarmist's version of Six Degrees of Kevin Bacon, we get more and more panicked by what we think the guideline states- but haven't read the guideline ourselves. So, 'Step One' in replacing panic with thoughtful and deliberative consideration is to get the guideline (and the main editorials) itself.
To this end, the staff at the CDC and JAMA want to make the guideline and editorial content available to all healthcare providers, whether or not they are subscribers to JAMA and its affiliated journals. Simply by opening the URL http://jamanetwork.com/collection.aspx?categoryid=5816 will take the user to JAMA's "Pain Collection" page where the guidelines, editorials, and very interesting other content on pain management are located.
After finishing reading the guideline, my first thought was "none of this surprises me". And, it should not surprise you too. Or, if you have been to a REMS seminar in the past two years it shouldn't surprise you. Or, it shouldn't surprise you if you have read the Federation of State Medical Boards' Model Policy for the Use of Opioid Analgesics in the Treatment of Chronic Pain [7]. Or, it shouldn't surprise you if you looked at the guideline summary of pocket cards from the 2010 VA/DoD Clinical Practice Guideline for the Management of Opioid Therapy for Chronic Pain [8]. Or, it shouldn't surprise you if you looked at the 2011 Institute of Medicine's report Relieving Pain in America [9]. Or, it shouldn't surprise you if you have perused the opioid guidelines from the states of Washington [10] or Utah [11]. Or, it shouldn't surprise you if you skimmed the 2009 APS/AAPM's Clinical Guideline for the use of Chronic Opioid Therapy in Chronic Noncancer Pain [12] - especially since Dr. Roger Chou was a key author in both the CDC and APS/AAPM guidelines.
Catch my drift? The guideline reflects the advice made by leading pain management publications and presentations made for the past several years - advice that has featured prominently at several SPS meetings as well as other regional and national pain management meetings. Now, there are some different suggestions coming from the guideline and accompanying editorials - but most of the new suggestions appear in the editorials and not the guideline itself. Furthermore, I thought the editorial writers did a good job explaining that they were expressing their opinions in the editorials that were born out of their individual clinical, academic, and administrative experiences.
So, let's take a cleansing breath - count to ten - and look at some of this content. There are twelve major recommendations made by the CDC guideline. The guideline itself expands on the explanation and evidence for each recommendation. Dr. Mitchell Katz has turned these recommendations into a box for his editorial in JAMA Internal Medicine [4]. I will provide my own summary of these recommendations, knowing that the guideline and box is readily available to our membership:
1. Non-opioid therapies should be used first. If opioids are used, it should be in conjunction with non-opioid based treatments and only if benefits of opioid therapy outweigh risks.
2. Realistic treatment goals should be established prior to starting opioids. Treatment should continue if improvements in function outweigh risks of treatment.
3. Before starting opioids and periodically during treatment, prescribers must discuss patients' responsibilities in managing opioid therapy.
4. When starting opioid therapy, clinicians should use immediate release opioids. Dr. Katz later states that he only uses immediate release opioids, period. But, this is not what the guideline itself says. Rather, the guideline is referring to making sure that the patient meets the clinical recommendation for opioid tolerance as emphasized in all REMS trainings; with opioid tolerance defined as at least 60mg per 24 hours of morphine milligram equivalent daily dosing (MME) for at least one week. Furthermore, the REMS trainings emphasize the need to follow dosing and conversation guidelines carefully for each and every extended release-long acting opioid product [13].
5. When opioids are started - use the lowest effective dose. Reassess the benefit versus risk for doses above 50mg MME and particularly when the daily opioid dosage is at or exceeds 90mg MME. Other guidelines have had similar warnings about MME dosing such as 200mg MME for APS/AAPM and 120mg MME for Washington State.
6. For acute pain, use only immediate release opiates, if opiates are even needed. In acute pain, prescribe an amount of opiates to be used for 3 to 7 days and not longer.
7. Clinicians should reevaluate the benefit versus harm of each dose increase within four weeks. Stable patients without dose change should still be seen within every three months. Taper or discontinue opioids if harms outweigh benefits.
8. Before starting and periodically during opioid treatment, clinicians should carefully assess risk factors for overdose and mitigate risks such as pregnancy, elderly patients, hepato-renal insufficiency, patients with mental health and / or substance abuse issues. Risk mitigation can include referral to mental health colleagues as a condition of opioid treatment.
9. Clinicians should review their patients' prescription drug monitoring program report at the onset of treatment and periodically during treatment.
10. Clinicians should order a urine drug screen test when starting opioid therapy for all patients. A follow-up urine drug screen is advised for all patients at least annually.
11. Avoid prescribing benzodiazepines and opioids concurrently whenever possible.
12. Clinicians should refer patients to a credible medication-assisted opioid dependence treatment program for substance abuse treatment should the need arise.
Several discussion points are made in both the guideline and editorials. Including all these topics is not the point of my article, but I do want to mention the following:
* The intended audience for the guideline is primary care providers, not pain management specialists. That is not to say the guideline and editorials are not relevant to pain management specialists, but it is important to note that we are not the chief intended audience. The guideline itself states:
The "CDC Guideline, 2016," is intended for primary care clinicians (eg, family physicians, internists, nurse practitioners, and physician assistants) who are treating patients with chronic pain in outpatient settings. The guideline is intended to apply to patients with chronic pain outside of active cancer treatment, palliative care, and end-of-life care. Some of the recommendations might be relevant for acute care settings or other specialists, such as emergency physicians or dentists, but use in these settings or by other specialists is not the focus of the guideline.
* The evidence supporting eleven of the twelve recommendations was weak to very weak. The CDC uses a four level system of evaluating clinical evidence as the basis for its recommendations (the GRADE system). 'Evidence Type 1' is the best level of evidence and 'Evidence Type 4' is the worse level of evidence. No recommendation was supported by type 1, one recommendation was supported by type 2, four recommendations were supported by type 3 and seven recommendations were supported by type 4 evidence. The CDC acknowledges the major and glaring limitations supporting its recommendations. However, the growing crisis of opioid-related morbidity and mortality demanded that some recommendations (however tenuously supported) emerge from the guideline. The lack of evidence should come as no surprise as this was a major finding of the Institute of Medicine's report. However, the lack of evidence was not a reason for lack of action on the CDC's part. As Dr. Thomas Lee states in his JAMA editorial [3]:
Pain management will never be easy or straightforward, but it is an intrinsic element of any effort to reduce patients' suffering... The CDC guidelines offer important recommendations for addressing that issue. The data will never be perfect. The measures will never be perfect. The guidelines will never be perfect. And neither will clinicians and their performance. But by acknowledging these imperfections and trying to get better with the tools available, physicians can more effectively reduce the suffering of patients.
* Improved communication between clinician and patient is an indispensable part of opioid safety. For there to be a better patient understanding of the acute and long-term risks of opioid treatment, there must be better communication. For there to be a better prescriber understanding of the patient's risk factors and level of overall functioning, there needs to be better communication. For the goals of opioid therapy to be jointly shared and understood by both prescriber and patient, there needs to be better communication. It is only within the framework of better communication that risk mitigation and improved safety and effectiveness can occur. No prescription drug monitoring program report, no urine drug testing result, and no opioid risk tool can take the place of sound & careful doctor-patient communication.
* Both the guideline and editorials recognize that the recommendations made will tax our already limited time and resources. In particular, Dr. William Renthal points out in his editorial that alternatives to opioid therapy in patients who have not adequately responded to NSAIDS and analgesics are often effectively unavailable to most patients [5]. Whether it is the availability or coverage for multi-disciplinary pain management, behavioral pain management, physical therapy, or other forms of pain management treatment - many patients are totally shut out from these options due to lack of coverage or lack of qualified provider available. As unfair as this situation is, it does not permit us to continue "as is". Even if improved prescriber-patient communications lead to only a decrease in the sharing of opioids among friends and family, that one outcome alone will dramatically decrease opioid-related morbidity and mortality.
Although the CDC guideline reflects evidence and recommendations from previous guidelines, its publication is a watershed moment in pain management. It is the beginning of a period of reappraisal by the whole medical community on the problems that our national efforts to bring about better pain control have wrought. For any SPS member who has attended just one of our conferences or read one of our newsletters, these problems should be of no surprise. However, we persist in being advocates for patients with chronic pain, and the providers that try to reduce their suffering, because we know that our work is deeply important - that our patients' well-being and very lives depend on our persistence. At the same time, we must engage in a vigorous and on-going discussion on the problems that have clearly emerged in pain management. We do this to protect the gains that our field have made, as well as to reduce the hazards it has also uncovered. Please join us in future newsletters and conferences as we continue to wrestle with these issues.
