Wednesday, March 30, 2016
In case you didn’t notice, the US Centers for Disease Control published their long-awaited (dreaded?) “CDC Guideline for Prescribing Opioids for Chronic Pain.” It made a pretty big splash: Five editorials plus the full Guideline in the online Mar 15 JAMA, front page New York Times feature article, the first hour on NPR’s “Diane Rehm Show,” (Mar 17) and multiple others. It is specifically aimed at primary care prescribers, who write about half of the scripts for opioids in the US. It is intended to “support clinicians caring for patients outside the context of active cancer care or palliative or end-of-life care.” The Guideline was published in the Mar 15 Weekly Morbidity and Mortality Report and is the first US Government guideline to address treatment of chronic pain; it is 52 pages long. A good “Cliff Notes” version of the Guideline is the JAMA piece by CDC Director Thomas Frieden, MD and Debra Houry, MD.
I should point out that the document was prepared by the CDC’s Division of Unintentional Injury Prevention. The Guideline is intended to address the epidemic of opioid-related deaths, not the pandemic of chronic pain. On its face, the Guideline promotes good, standard prescribing practices, especially for potentially high-risk agents: history and diagnosis of the painful disorder, prognosis of the painful state, history of prior interventions, establishing clear treatment goals, careful selection and implementation of treatments based on patient informed consent and risk-benefit discussion, and close follow-up with scheduled re-evaluation of the condition and effects of the intervention. Appropriately, the Guideline states that “nonpharmacologic therapy and nonopioid pharmacologic therapy are preferred for chronic pain.” The Guideline focuses on chronic pain, but points out that many prescriptions begin for acute pain. For acute pain, the lowest effective doses of opioids for the shortest possible course (3 days or less; “more than 7 days will rarely be needed”) should be used.
Additional risk-management strategies for opioids include: using short-acting opioids at the commencement of treatment; avoid concurrent benzodiazepine prescribing; evaluate patient history of substance misuse; use the state prescription drug monitoring program (PDMP); do initial and periodic urine drug screening.
So, what are the implications of all of this?
1. I’ll start with the positives:
a. The Guideline highlights a major public health issue, namely a dramatic increase in the past 20 years in opioid prescribing and a corresponding increase in opioid overdoses and deaths, especially in the past 10 years.
b. About half of all opioid prescriptions are written by nonspecialists, many of whom have asked for a guideline for treating chronic pain with opioids; this Guideline responds to that need.
c. Prescribing practices for potentially high-risk medications are reinforced. One hopes that more thoughtful prescribing will reduce the habitual writing of 30-day prescriptions when 7 or 15 days is more appropriate (this assumes a 1 or 2-week, not one-month, follow-up)
d. Chronic pain is often a complex treatment dilemma—prescribers are reminded that multimodality intervention is the preferred treatment
2. The Guideline does nothing to address (and may make worse) insufficient capacity in our healthcare infrastructure for
a. Nonpharmacologic treatments such as physical and occupational therapy
b. Care by pain management specialists, some of whom limit the number of patients they see for medication management
c. Treatment for substance use disorder including methadone and buprenorphine programs
3. Capacity aside, some insurance will pay for pills but not for physical therapy
4. Many insurance plans will not cover so-called alternative interventions such as therapeutic massage. [I acknowledge a major burden on insurance plans to start covering everything in the “alternative” realm. How could they possibly evaluate them all? Perhaps plans could consider an ‘allowance’ for alternative interventions: massage, acupuncture, yoga, tai chi, etc. The PCP and patient could choose which approach seems most appropriate to the individual situation].
5. Not only is it quick and easy to write a prescription (with some serious attendant risks), but analgesics generally work much faster than other interventions. Sometimes analgesics make it possible for patients to participate in other interventions, such as physical therapy. I fear that some clinicians will interpret the Guideline as requiring physical therapy prior to using “strong analgesics” such as opioids.
6. Alternative analgesics may not be as effective and may has their own serious side effects and contraindications. NSAIDs are an obvious example of those with serious side effects, especially in elders. Acetaminophen has recently been shown to be no more effective than placebo for osteoarthritis patients in a clinical trial.
7. Because of DEA practices it is already difficult for pharmacies to maintain sufficient stock of opioids, so patients commonly must do monthly “pharmacy shopping” to fill their prescriptions. Do prescribers “get” this when the PDMP shows their patient getting their meds at a different pharmacy 4 months in a row?
8. It is easy to conjecture that insurance companies will use the Guideline to reinforce pill count limits
9. Some prescribers, already nervous about the DEA and medical and pharmacy boards looking over their shoulders, may stop prescribing opioids or limit them to no more than 50 MME/day (Morphine Milligram Equivalent)
10. The Guideline stresses screening and follow-up practices that are very time consuming. Many medical systems (and insurance companies) will not be supportive
11. The Guideline has the potential to reinforce prejudice against opioids and opioid-users that is already extensive in medicine, nursing, and pharmacy.
13. The Guideline discussion acknowledges that data on the effectiveness of opioids for long-term use is sparse, but lends a lot of weight to research that could be interpreted to suggest that opioids “don’t work” for chronic pain. But the research base is very, very thin.
14. There are many research questions to be addressed, some of which we really haven’t figured out how to ask, much less design an adequate study around. And who will pay for and who will do long-term studies?
a. What are the biological differences between those who become “addicted” vs those who don’t? Is there a continuum? If so, might an individual move in both directions on the continuum?
b. What is the impact of rate of metabolism for certain opioids on safety and effectiveness of pharmacologic treatments? What is the prevalence of the so-called ultrarapid metabolizers vs poor metabolizers?
c. What does “opioids for chronic pain don’t work” really mean? [This clause does not come from the Guideline but is similar to statements made by groups who advocated for the Guideline as a way to reduce opioid prescribing].
d. There seems to be a subset of people who are very functional on long-term opioids—what differentiates them from the “opioids don’t work” population?
e. There has been some interesting work showing persistent changes in the brain after opioids have been discontinued. What is the extent of these changes over large populations? Are there predictors for which changes and what their behavioral effects are?
f. So, really, what is the risk of becoming “addicted?” The varying finding of 0 to 50% just isn’t helpful, and neither the upper nor lower percent seem very credible. How is a clinician to determine, and explain to a patient, what is the risk of addiction?
g. Can we develop better tools for stratifying risk for misuse?
h. Does “high risk” have to translate to “don’t treat?” We need evidence-based models for treating chronic pain in those with a history of and those with current substance use disorder.
i. How effective is urine toxicology monitoring in managing patients? [Will insurance companies cover this cost?]. If the Guideline writers really think urine testing has significant value, the Guideline is weak—“at least annually.”
15. What happens with all the patients who are currently on opioids for chronic pain when their prescriber (or insurance or health system or risk management department) decides that they need to reduce doses based on this Guideline? (This was happening already, even before the CDC Guideline came out)
16. The Guideline specifically does not include care of patients undergoing active cancer treatment and for those in palliative care settings. It remains to be seen what unintended impact the Guideline will have when pain may be part of a serious advanced illness, or may be part of one of several comorbidities.
17. Will professional organizations review their own guidelines, in response to the CDC Guideline? (the American Pain Society and the American Geriatrics Society both published revised guidelines in 2009)
18. Will professional organizations increase pain and chronic pain-related offerings at their annual meetings?
19. Will medical, nursing, dental and pharmacy schools start teaching more about “pain management” rather than just pharmacology and pathophysiology?
20. A major question has to be: can the efficacy and effectiveness of this Guideline be determined on a scale and in a time frame that benefits the most patients and society at large sooner rather than later? Does the government have a commitment beyond issuing a Guideline? Perhaps the CDC and collaborating NIH institutes can work with a couple of major health systems and major insurance companies to implement the Guideline in a study of a comprehensive approach to chronic pain management. The study would have to last a minimum of 2 years. It may make the most sense to start with new patients, not try to cram existing patients into the Guideline (that would be a separate study).
This Guideline puts the prestige of the CDC and US Government behind an approach to prescribing opioids that is intended to help derail the epidemic of opioid-related deaths. CDC-monitored overdose deaths from all classes of drugs (in aggregate and by class) looked like they were leveling off in 2012 and 2013, but spiked again in 2014 (the most recent national data available). The Guideline is an appropriate step, but certainly inadequate to address the enormity, much less the complexity of the issue. In addition, the inadequacies of practice and the knowledge base for treatment of chronic pain remain unaddressed.
Thomas E Quinn, APRN-CNS, AOCN is an oncology and palliative care advanced practice nurse. He has recently accepted a clinical position at Jewish Social Services Hospice in Montgomery County, MD, which will really cut into his pickleball playing at the senior center.
Photo Credit: "lego_head-pain" by Flickr user Mr. Pony via CC
Photo Credit: "Pain!" by Flickr user Harald via CC
Photo Credit: "pain" by Flickr user wallsdontlie via CC