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.
Authors
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!
References:
- 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.
Thank you for this well thought out article. As a severe chronic pain patient and a pain patient advocate, I live with, and see first hand the devastation the CDC guidelines have caused. It’s hard to believe that forced suffering of those living in agony is acceptable to physicians. I understand their fear of medical boards, clinic policy, and the DEA, but do not understand them not living up to their Hippocratic Oath. I will use this piece to share with doctors and patients in hopes it helps. Thank you again.
Someone above mentioned that they expected more replies to this blog article? Most CPP’s who fought this hard after the GL’s were drafted (creating a cruel death trap for patients) slowly realized there were too many tentacles of this Opioid War, and too much money changing hands, including this was planned so they could win their lawsuits against opioid manufacturing/big pharma. Funny that they used Andrew Kolodny and others who wrote the GL’s to be expert witnesses (not a pain doctor, but addiction) for the prosecution. And no one gives a crap about intractable pain, a life sentence, unless it’s cancer. So patients who have no hope of a cure are allowed to suffer every minute of the day, potentially suicide themself, and have no ability to work or participate in life….it was stolen from us! We are not ever going to the streets, so now we suffer in silence for this travesty in America. 20-30+ million have been all but religated to their beds bc of mass hysteria and evil people profiting off of our horrific pain. People who are elderly,
(or younger) could be your loved ones who one day will be subjected to this unbelievable bias & discrimination. And for what? OD’s have skyrocketed on the streets! Proving it wasn’t pain pills but illicly manufactured drugs!! Yet no one will admit they were wrong. Now the CDC came out with MORE OPIOID GUIDELINES! Can this be any more criminal? They knew we CPP’s wouldn’t be able to fight this, not without our physicians fighting along side of us bc we’re too weak & in pain now. One cannot even discuss pain in the doctor’s office anymore without risking losing the little we’re prescribed or to be fired by the doctor! How is this okay??? My family has basically lost their Mom bc I cannot do anything anymore bc the pain is unmanageable. This is the real Crisis!!! The real Epidemic. Sadly I’ve given up. God Bless the good ole’ USA
I just want to thank you for ;bringing this subject out of the woodwork , out of hiding still. I hesitated to reply as I am not as educated as most here and have trouble putting my thoughts down at times. After reading , I expected a b>gger response. But find it typical now. At first there were many looking for answers, seems most gave up. The ones left , as myself, still search for some hope. My dr, heard thru the grapevine in 2014, that guidelines were changing, went to state house , but came back defeated ?.! Being a legitimate cpp, tried to deal with my forced taper , from over 500mme , for 15 years to , 30mme in 3 months . By that time, after asking to slow it down, turned down, at next taper appt, was so in pain, upset, my BP was at stroke level . Dr came in, asked why was in such a state ! I told him , be had no compassion, didn’t hear me , He said come in am. I came in only to be fired ! Left with 27 pills of 10mg , said I could self taper, don’t come back. I was .left with black mark on my chart , fired , drug seeking behavior ! Needless to say , I had issues I won’t bore ya”ll with. 3 er visits etc. ….l. After 2 years of nothing as Noone would touch me, I retaliated with xrays ect, thinking , Iman honest Togo legit cpp, surely now I can get help? Lol .in 2017, one more try,,_yay! I’m given 2 5mg hydrocodone a day? I cried ! Any relief from unending pain. It’s 2022 , had to fight to get one more , one ! I’m grateful butstill in pain, but a68fraid to ask again , just to prob get fired . Now have stage 4 ckd, from ibuprofen, waiting for liver next from tylenol. It’s good thing that I’m
68 now , won’t have to suffer too much longer I hope. Chances of finding help , slim to none. I pray that pendulum swings back enuf to help some of my cpp family , as I’ve given up hope for myself . Thank you for letting me vent .
During 2018 when my high dose LA and IR breakthrough opioid dosage was reduced to 1/5 of a static dosage (2003-2018), the effect on my health was negative. I lost weight. I developed upper gastric bleeding in my esophagus and duodendum; it was confirmed by upper gastrointenstinal exam with biopsy samples. I kept losing weight. Became anemic. I asked my pain specialist for my “new” titration to be confirmed in the hospital as it was in early 2003. “We don’t do that any more”. was my specialist’s response.
Injections with steroid and numbing agent help injured tissue. But their effect only lasts so long.
My reduced dosage was twenty percent of former dosage. Not good. 3000mg of Acetaminophen every 24 hours is not pain management for a person with my multiple diagnosed spinal problems which originated from a motor vehicle accident. Once spinal nerves are damaged from injury, that’s it. An injured patient suffering acute pain fears those episodes.
It is very unfortunate that the CMS/HHS Blue Book for determining Social Security Disability claims was ignored in this mess by the CDC. It is also an insult to responsible physicians who were in the dark while this 2016 “Guideline” was planned. Too many compassionate physicians were targeted by the DOJ/DEA.
I am always compliant as a patient with my Rx prescriptions, especially those classified CII-CV. Medical marijuana is NOT an analgesic, and until it is given a federal NDC number will never be used in a hospital setting.
The relationship between physician and patient is private. One size fitting all for opioid analgesic relief is a myth. The DOJ/DEA has an obligation to respect individuals with regard to pain management.
The private sector made billions with “monitoring” prescription events with software analytics since 2013. In this post I will not name companies, but the damage is done. People suffer needlessly, especially children from untreated pain.
I think those of us who have followed the opioid Prohibition Conspiracy in our country and now others know that CDC guidelines are bullshit. Period. Doctors know the risks of forced tapers and weanings, or they should. We know part of the reason is fear of DEA persecution, but it is high time they stood up to this nonsense, and they don’t in most places. In my area providers don’t care if we die … nobody is even willing to undergo HHS recommended weaning of no more than 10% per month. This is not just from one place, either. I think the AMA would agree even if their recommendations have slight differences. People die from untreated pain. People are not even supposed to undergo medically unnecessary forced weaning. It is out of fear or out of greed that providers ignore “legacy” patients cries for help when they are forced on to suboxone or street drugs. The CDC, DEA, PROP and other entitities responsible for this inhumane and evil program of wiping out lifesaving medications creates a new market for the illegal street Fentanyl which caused the “opioid crisis” in the first place. Prescribing rates way down, overdoses up…its as plain as day. Our own government is killing people, and doctors are helping them do it by saying nothing!
All I will say is, Thank You. Now get your findings in front of Congress and EVERY Judiciary you can find.
The 2016 guidelines were a joke then and still are. Only noone is laughing. However, tens of thousands have died and Many Many more will die soon.
These guidelines and the people that came up with them are Criminals@
It is inhumane the harm of the 2016 CDC guidelines has caused. I have lists of names people on know with debilitating pain who have killed them selves to get out of pain. Others turned to heroine. These were wonderful law abiding citizens who did everything right, jumped through all the hoops to be lumped in with a group of addicts who Lorain used drugs illegally ,abuse them, then the real pain patient can’t get them. Imagine having a painful condition that is intractable meaning it will never get better. Opioids gave them a chance to do simple stuff like shop for groceries, push a child on a swing, attend a wedding. The simple things you take for granted every day is a miracle day for us. It lasts about 2 hours so the other 6 hours I rest, cry, curse & try to distract myself long enough for the next dose. It is a horrible life. When people here I’m on laid meds they automatically think I’m a druggie. I would love to show the world what the true life of a pain patient is like.
Thank you for pointing out the flaws of the 2016 CDC guidelines. I’m a disabled RN, chronic pain patient. I have been forced tapered. 40MME. I’m left to suffer. Apparently to receive adequate pain relief, I must have malignant cancers!! The damage has been done. I fear that I will have to live out the rest of my life suffering because of the 2016 CDC guidelines and the authors, members of PROP. Andrew kolodny, Roger Chou and others. I applaud you and thank you for writing this article.
Similar to the countless millions of innocent chronic pain patients who’ve been needlessly affected due to the untransparent adoption of the CDC’s Guidelines, it appears perfectly clear that the CDC did, in fact, intend for the results of their illegitimate study to become codified into law.
Otherwise, numerous much-warranted revisions/deletions would’ve been pursued almost immediately. Not years later after millions of innocent Americans have been subjected to needless suffering and premature deaths due to suicides.
The criminals ultimately responsible for this massive crime against humanity (PROP, DOJ, CDC, & the DEA) must be held criminally liable for the millions of innocent American’s lives they knowingly destroyed.