A few months ago, Dr. Amelia Persico and colleagues authored a small but import study that highlights the flawed premise on which most providers are tapering opioids. That study, listed immediately below, is open access and can be viewed HERE.
Persico AL, Bettinger JJ, Wegrzyn EL, Fudin J, Strassels SA. Opioid Taper Practices Among Clinicians. Journal of Pain Research. 2021;14:3353.
I have asked our current General Practice Resident, Dr. David Roberts, to team up with our graduate PGY2 Pain and Palliative Care Resident who conducted the study and is listed as first author on this publication to comment here on the findings.
Here’s what they had to say…
Currently, there are no consensus guidelines on how to safely and effectively taper or discontinue opioids, and a recent study has indicated that providers may not be as comfortable as they should be when implementing opioid tapers – perhaps through little fault of their own.
“According to the CDC Guidelines…” is a phrase all practitioners have likely heard countless times during their careers. Clinical practice guidelines are incredibly important tools that clinicians around the world rely on to provide optimal care for their patients. They exist for virtually all the most commonly managed disease states and are often followed by teams of experts in a corresponding field. These experts meet together, review the applicable literature, and come to a consensus regarding the various clinical questions surrounding the topic. Each recommendation is assigned a Class of Recommendation (COR) and a Level of Evidence (LOE) signaling the strength of the recommendation. A COR will signify the strength of a recommendation based on the risk: benefit ratio of that recommendation. An LOE will assign a quality of evidence to a specific recommendation with higher levels being based on high quality evidence based on multiple RCTs, to lower levels being based on consensus of expert opinion from clinical experience.1 For more on this and the National Guideline Clearinghouse, see previous post, Seedy Sea or CDC?
The 2016 Center for Disease Control and Prevention (CDC) Guideline for Prescribing Opioids for Chronic Pain sought to describe and clarify many facets of opioid prescribing in the setting of chronic pain. These guidelines also sought to provide broad recommendations to providers. The authors open by describing the opioid crisis and their belief that prescription opioids were fueling the “opioid epidemic”, which we will call a “crisis” rather than an epidemic for purposes of this post. The shortcomings of this argument have been described previously – largely because it does not acknowledge the largest culprit, illicit fentalogues (fentanyl analogues).2 In these guidelines there is a strong overarching theme, which is presented without adequate nuance, urging prescribers to avoid prescribing above 90 MME/day and to taper opioids in many patients, including any patient with a concurrent benzodiazepine prescription. This has translated to providers blindly tapering patients off opioids under inappropriate circumstances, resulting in unnecessary harm to the patients. The risks of forced opioid tapering are well established and have been previously discussed. These include increased risk of withdrawal symptoms, worsening pain and inadequate pain control, and even increased risk of suicide. 3,4
There are several glaring shortcomings of the Guidelines that have little to do with the content presented. Rather, these Guidelines violate multiple central tenets of what makes a set of guidelines credible in the medical community. As previously mentioned, guidelines are based on quality of evidence, strength of recommendations, and the expertise of the authors in corresponding the field. First, many of the authors of the 2016 guidelines were not experts. In fact, of the three primary authors of the original CDC Guidelines, none are specialists in chronic pain management. Next, when it comes to the level of evidence used in the Guidelines, the recommendations made were largely based on expert opinion or case series data. Though this is not desirable for a set of clinical practice guidelines, it is not necessarily compromising. However, these recommendations ultimately received a grade A rating, which is particularly problematic as described here in Seedy Sea or CDC. With this information considered, the quality of the Guidelines is indisputably diminished.
These Guidelines were published on the backdrop of a nation whose media and politicians propagated the previously mentioned notion that the opioid crisis was caused by prescription opioids. However, the data presented by the Guidelines do not address many of the important factors to consider when determining the largest contributors to opioid-related deaths. The first, as previously mentioned, is the lack of mention of synthetic fentalogues as the primary driver in opioid related deaths.5 The second, is the Guideline’s lack of consideration for confounding substances that may contribute to opioid related deaths. This may include concurrent use of benzodiazepines, barbiturates, skeletal muscle relaxants, anticonvulsants, antidepressants, other sedative hypnotics, or alcohol, and perhaps more importantly, it does not separate opioids prescribed for legitimate purposes from those using prescription opioids from illicit sources. In short, the Guidelines fail to make the distinction between how many of these opioid related deaths are actually related to the over-prescription of opioids alone and how many are influenced by other substances and/or illegal use.
The CDC stated that the Guideline’s primary target audience is primary care providers.6 This includes physicians, nurse practitioners, and physician assistants practicing family medicine and internal medicine. These are providers who are no strangers to managing pain, however, likely lack the robust experiences and necessary training for managing complex patients on high doses of opioids, behavioral comorbidities, and marginal if any expertise in pharmacogenetics. With a guideline that encourages across-the-board opioid tapering it comes as no surprise that clinicians may choose to implement opioid tapers for the sake of following the Guidelines and without regard for patient specific factors.
A survey of 149 clinicians revealed that when asked “In the past year, if you have tapered opioids, what was the most common reason?” – the most commonly selected answer was “New CDC Guidelines”.4 This data suggests that clinicians, including both pain management specialists and primary care providers alike, have been influenced by a set of guidelines that overlooks the necessity to consider the patient, and not just the patient’s MME. Due to the misapplication of these Guidelines, multiple unintended consequences have occurred extending beyond medical offices and into the courtroom. Since publication of the Guidelines, many states have passed laws establishing maximum daily doses for opioids and some third-party payers, large chain pharmacies and Pharmacy Benefit Managers (PBMs) have placed limits on coverage based on MME. 4
Though the consequences of the CDC’s Guidelines may not have been intended, the results of this study show us that they have had far reaching consequences, including elevated risk of suicidality.3,4 Opioid tapering is certainly warranted and practical in certain cases; however, doing so with a blanket, one-size-fits all approach based on non-expert opinion and low-grade evidence can increase patient harm and suffering. The findings that most clinicians in this small study tapered opioids due to the CDC Guidelines rather than patient-specific factors is eye opening and alarming. It suggests a need for further clarification, revamping and rewriting by pain management experts so that when clinicians seek guidance, they have an evidence-based reference they can trust, written by an interdisciplinary team of pain experts that includes at least one patient advocate.
Dr. David Roberts graduated with his PharmD from Albany College of Pharmacy and Health Sciences in 2021. He is currently a PGY1 Pharmacy Resident Stratton VA Medical Center in Albany, New York and has accepted a PGY2 pharmacy residency position at Stratton in Pain and Palliative Care.
Dr. Amelia Persico, PharmD, MBA, BCACP is a clinical pharmacist at Shields Health Solutions. She completed a PGY2 in pain management and palliative care at the Stratton VA Medical Center and now applies her expertise in pain and palliative care to the specialty pharmacy population.
As always, comments are enthusiastically welcome!
- Atkins D, Best D, Briss PA, et al. Grading quality of evidence and strength of recommendations. BMJ 2004;328;1490-1498. doi:10.1136/bmj.328.7454.1490
- Amarquaye W. Opioid Death and the Real Culprit [Internet]. Paindr.com. 2021 Available from: https://paindr.com/opioid-death-and-the-real-culprit/
- Oliva EM, Bowe T, Manhapra A, et al. Associations between stopping prescriptions for opioids, length of opioid treatment and overdose or suicide deaths in US veterans: an observational evaluation. BMJ. 2020;368:m283. doi:10.1136/bmj.m283
- Persico AL, Bettinger JJ, Wegrzyn EL, et al. Opioid Taper Practices Among Clinicians. J Pain Res. 2021 Oct 20;14:3353–3358.
- Increase in Fatal Drug Overdoses Across the United States Driven by Synthetic Opioids Before and During the COVID-19 Pandemic. Updated March 27, 2020. Available from: https://emergency.cdc.gov/han/2020/han00438.asp
- Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain–United States, 2016. JAMA. 2016 Apr 19;315(15):1624-45. doi: 10.1001/jama.2016.1464.