The Tangled Mess of Prescription Opioid Guidelines

By Roger Chriss, PNN Columnist

The opioid overdose crisis has impacted medical practice in unanticipated and unfortunate ways. A recent JAMA study warned that efforts to reduce opioid prescribing through tapering raises the risk of overdose and mental health crises in pain patients on stable, long-term opioid therapy.

This study is the latest to find that opioid tapering is fraught with risks. Amid this, the American Medical Association has issued a call to revamp the CDC’s problematic 2016 opioid prescribing guideline because of its “devastating” impact on pain patients.

“The CDC should remove arbitrary thresholds, restore balance and support comprehensive, compassionate care as it revises the guideline,” wrote AMA news editor Kevin O’Reilly.

But revising the CDC guideline may not have much effect. The guideline is voluntary and doesn’t have the force of law, but many states have implemented their own guidelines in ways that make them enforceable. They are often paired with requirements and regulations covering everything from daily dose and prescription duration to drug testing, pain management agreements, and tapering. These state guidelines do not necessarily follow the CDC guideline on even basic issues of dose, duration or recommended use.

Some states, including Minnesota and Oregon, have adopted the CDC’s recommended threshold of 90 morphine milligram equivalents (MME) as a maximum daily dose not requiring consultation with a pain management specialist or a special exemption. Other states make their own rules. Washington has kept to 120 MME in its latest guideline update, as has Tennessee.

State policies also differ on the merits of using opioids for chronic pain. The Medical Board of California recommends that physicians and patients “develop treatment goals together” for long-term use of opioids, while Arizona’s opioid guideline flatly warns physicians: “Do not initiate long-term opioid therapy for most patients with chronic pain.”

On tapering, states do not agree much at all and generally do not follow federal HHS guidelines that tapering be individualized and “slow enough to minimize opioid withdrawal symptoms.”

Minnesota’s opioid guideline recommends that physicians “routinely discuss tapering with patients at every face to face visit” and allows for forced, rapid tapers or discontinuation under some circumstances.

Tennessee’s guideline notes that there are “many reasons to discontinue chronic opiate therapy” and “several different weaning protocols outlined by various sources.” It does not recommend any specific one, leaving it up to individual doctors to decide how to taper their patients.

The VA and Department of Defense have their own guideline, which contains a complex set of treatment algorithms that span several pages and effectively exclude almost all patients from long-term opioid use. Further, according to a separate algorithm, the VA is clearly aiming to taper or discontinue opioids in as many patients as possible. The guideline states "If prescribing opioid therapy for patients with chronic pain, we recommend a short duration.”

The Trouble With Algorithms

Many of the state guidelines are paired with a prescription drug monitoring programs (PDMPs) and use NarxCare, a private analytics system that gives individual risk scores to every patient based on their medical and prescription drug history. PNN first covered NarxCare in 2018, noting that patients can be automatically “red flagged” by the system for seeing too many doctors or using multiple pharmacies.

Maia Szalavitz recently wrote about Narxcare in Wired, noting that legitimate patients were being denied medications or abandoned by doctors because of their Narxcare scores.

“A growing number of researchers believe that NarxCare and other screening tools like it are profoundly flawed,” Szalavitz wrote. “None of the algorithms that are widely used to guide physicians’ clinical decisions — including NarxCare — have been validated as safe and effective by peer-reviewed research.”

A similar problem exists for data from PDMPs. A well-documented analysis by Terri Lewis, PhD, found that “machine learning” algorithms are often based on untested assumptions and financial incentives for providers, not on patient care.

“The worst part of machine learning (ML) snake-oil isn’t that it’s useless or harmful — it’s that ML-based statistical conclusions have the veneer of mathematics, the empirical facewash that makes otherwise suspect conclusions seem neutral, factual and scientific,” wrote Lewis. “What the PDMP is NOT designed to do, is detect patients who are using their opioids correctly from patients who are misusing their medications.”

All of the above imposes a significant risk and burden on patients, in particular if they relocate for work or school, or seek medical care outside of their state of residence.

In essence, patients are subjected to a set of federal recommendations from the CDC that may inform some state laws or regulations that are then implemented in a privatized process with little transparency or accountability. Patients simply cannot tell what is happening at the time of implementation, and if they see a problem after the fact, it is usually too late to fix it.

The AMA’s current effort to improve the CDC guideline for opioids is a laudable step forward. But the mess is far larger and more complex, and the role of the CDC is smaller than is generally appreciated amid an abundance of contradictory guidelines and regulations.

Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society. Roger is a technical consultant in Washington state, where he specializes in mathematics and research. 

Opioid Guidelines Leave Some Surgery Patients in Pain

By Pat Anson, PNN Editor

In recent years, many U.S. hospitals have adopted policies that reduce or eliminate the use of opioids during and after surgery.

Patients at Houston Methodist Hospital, for example, are getting acetaminophen (Tylenol) for post-operative pain after hernia repairs and other minimally invasive surgeries. And dozens of hospitals in Michigan have adopted guidelines for post-operative pain that have significantly reduced the use of opioids.

But a new study presented at the annual meeting of the American College of Surgeons suggests that policies that discourage the use of opioids for post-operative pain may be neglecting patients that need opioids for better pain control.

“The key findings of our study are that we were able to successfully reduce how many opioids we were prescribing for patients after operations using evidence-based guidelines,” said lead author Cornelius Thiels, DO, a surgical oncology fellow at Memorial Sloan Kettering Cancer Center and a researcher at the Mayo Clinic.

“However, the other finding of our research is that there’s still additional room to improve in terms of making sure all patients after surgery have their pain well controlled.”

The researchers evaluated 138 patients who had one of 12 elective surgeries after the Mayo Clinic adopted guidelines in 2018 that call for “multimodal pain control,” a combination of opioids with non-opioid pain relievers such as ibuprofen, naproxen and acetaminophen. Those patients were compared with 603 patients who had the same procedures before the guidelines, when opioids were used more widely.

While most patients in the post-guideline group were satisfied with their pain control after discharge, a significant number were not.

In telephone surveys conducted about four weeks after discharge, the percentage of patients in the post-guideline group who were dissatisfied with their pain control was more than double that of the pre-guideline group (9.4% vs. 4.2%). The percentage who said they were not prescribed enough pain medication was also higher (12.5% vs. 4.9%).

“There is a small subset of patients who we’re not optimally managing yet, and this study confirmed that this is a small number,” Thiels said. “However, I think that’s a critically important subset of patients.”

Thiel says about half of patients need opioid medication after major surgeries, and doctors need to do a better job identifying who they are.

“Our goal is to give them the exact right amount so that we limit the number of un-used opioids in our community while also making sure we don’t reduce it down too far and then leave them in pain,” he said. “The right answer may be more non-opioid based pain medications, better patient education and setting of expectations, or in some cases patients may actually require slightly more opioid medications, and that is OK.”  

Opioid addiction is actually rare after surgery.  A large 2016 Canadian study found only 0.4% of older adults were still taking opioids a year after major elective surgery.  Another large study in the British Medical Journal found only 0.2% of patients who were prescribed opioids for post-surgical pain were later diagnosed with opioid dependence, abuse or had a non-fatal overdose.

Panel Recommends Opioid Guidelines for Acute Pain Conditions

By Pat Anson, PNN Editor 

The National Academies of Sciences, Engineering and Medicine (NASEM) is recommending that new clinical guidelines be developed for the treatment of short-term acute pain to reduce the risk of excess opioid prescribing.  

A 247-page report released by NASEM cites a lack of guidance on the appropriate type, strength and amount of opioid medication that should be prescribed to patients in acute pain, and claims that many patients are sent home with more pills than they need, which can later be misused. 

“Clinicians who prescribe opioids have to balance two distinct goals: relieving a patient’s severe pain, while minimizing the potential public health harms of opioid misuse and the resulting emotional distress to families and communities,” said Bernard Lo, president of the Greenwall Foundation and chair of a NASEM committee that wrote the report.  

The 15-member panel is composed primarily of academic, government and medical professionals. No pain sufferers or patient advocates served on the committee and the report gives no indication they were consulted with.    

NASEM is a private, nonprofit institution that was contracted by the FDA in 2018 to study the treatment of acute pain and develop a framework for new clinical guidelines.

Unlike the CDC’s controversial 2016 opioid guideline, which applies to a broad range of chronic pain conditions, NASEM is recommending that guidelines be developed for specific medical conditions or procedures that result in acute pain lasting less than 90 days. 

High-priority surgical procedures include cesarean (C-section) delivery, total knee replacement and wisdom tooth removal. Acute pain conditions such as low back pain, sickle cell disease, migraines and kidney stones are also considered top priorities for opioid guidelines.  

“There are still too many prescriptions written for opioid analgesics for durations of use longer than are appropriate for the medical need being addressed,” Janet Woodcock MD, Director  of the FDA Center for Drug Evaluation and Research, said in a statement.  

“The FDA’s efforts to address the opioid crisis must focus on encouraging ‘right size’ prescribing of opioid pain medication as well as reducing the number of people unnecessarily exposed to opioids, while ensuring appropriate access to address the medical needs of patients experiencing pain severe enough to warrant treatment with opioids.” 

‘Opioids Commonly Overprescribed’

The CDC guideline was only intended for primary care physicians treating chronic pain, but has been widely implemented throughout the healthcare system by other federal agencies, insurers, states and hospitals. Emergency room physicians are reluctant to prescribe opioids for trauma injuries and some patients recovering from surgery are being treated with Tylenol.    

The NASEM report suggests those efforts haven’t gone far enough. 

“Despite widespread efforts over the last five years to reduce opioid prescribing, opioids are commonly overprescribed for acute pain. In addition, the amount of opioids prescribed for acute pain varies by provider, hospital, and geographical region,” NASEM found. 

The report claims that post-surgical patients consume only half of the opioids prescribed to them, and between 6 percent and 14 percent of patients who receive opioids after surgery or in the emergency room continue to use them six to 12 months later. 

Those claims are at odds with a large Mayo Clinic study found that only about 1% of patients given opioids in emergency rooms went on to long term use. Another large study conducted by Harvard Medical School found less than 1% of patients being treated with opioids for post-surgical pain were later diagnosed with opioid misuse.  

Guidance Gaps

The NASEM report identifies several gaps in current guidelines for acute pain and recommends more research on nonopioid alternatives, outcomes of opioid prescribing on different patient populations, and the amount of opioids prescribed and leftover after treatment. 

As PNN has reported, the CDC is already in the initial stages of updating its 2016 guideline to include recommendations for treating acute pain and how to taper patients safely off opioids. The update likely won’t be completed until late 2021. 

An FDA spokesman described the work of the two agencies as complementary and with similar objectives.   

“We acknowledge the work CDC has taken in developing federal guidelines on pain management and the use of opioids, which are based on expert opinion. Our work seeks to build on that work by generating evidence-based guidelines where needed,” Nathan Arnold said in an email to PNN. 

“The guidelines we generate would be distinct from this corresponding effort by the CDC, in that our effort would be indication-specific, and would be based on prospectively gathered evidence drawn from evaluations of clinical practice and the treatment of pain. Our work could potentially inform drug labelling. These two efforts are highly complementary and serve adjacent goals.” 

One of the co-authors of the CDC guideline is involved in both efforts. Roger Chou, MD, a primary care physician and professor at Oregon Health & Science University School of Medicine, served on the NASEM committee.  Chou is also directing research on three CDC-funded studies on opioid and non-opioid treatments for chronic pain, as well as a fourth study on acute pain treatment. Those studies will be used by CDC to update its current guideline.

Chou recently collaborated with Physicians for Responsible Opioid Prescribing (PROP), an influential anti-opioid activist group that seeks drastic reductions in the use of opioid medication. Chou co-authored an article with PROP President Dr. Jane Ballantyne and PROP board member Dr. Anna Lembke that encourages doctors to taper “every patient receiving long term opioid therapy.”

Pain Poem: A Misery Too Great to Bear

"A Misery Too Great to Bear"

By Angelika Byczkowski

People in pain are dying,
a reluctant calculation,  
the only option left to escape
a misery too great to bear.

While we struggle with our pain,  
our government has decided   
to snatch relief from opioids  
away from us for our own good.  

They say one pill begins the end,  
addiction guaranteed.
We say we need a powerful shield
only opioids can provide.  

By policy now unarmed, defenseless,
we are stalked by pain through every moment.  
It hunts us down relentlessly,  
sinks fangs in deep and feasts.

It rips the flesh and breaks the bones,   
cracks the skull and snaps the spine,  
with license to do just as it pleases,  
impunity guaranteed by decree.  

We are sent out naked now  
to battle this rampaging pain  
with methods long disproven, yet  
"believe and it will be" they say.

Denied our armor, medication  
callously denied by guidelines,   
we teeter at the ragged gash  
where soul was ripped from body.  

How much pain and for how long  
can we be asked to bear,  
while experts coin their catchy phrases,  
call our pain "catastrophizing".

A catastrophe indeed is pain:
It traps us in the wreckage,  
wandering the sad remains    
of tortured flesh that cannot heal.

What we know is pain, we feel  
only pain, exploding pain,  
pain so bad it breaks our will
to live like this forever.  

Pain dominates, annihilates,
ruthless in its roaring rage, while  
helpless at the feet of the beast,
we lie sacrificed for overdoses not ours.

People in pain are dying,
a reluctant calculation,  
the only option left to escape
a misery too great to bear.

Angelika Byczkowski suffers from Ehlers-Danlos Syndrome and fibromyalgia. Until she was disabled by progressive pain and fatigue, Angelika was a high tech IT maven at Apple and Yahoo. She lives in California’s Santa Cruz Mountains with her husband and various four-legged kids.

When pain isn't keeping her flat on her back, she spends her limited energy researching and blogging about chronic pain, EDS, and fibromyalgia at EDS Info.

Pain News Network invites other readers to share their stories (and poems). Send them to:  editor@PainNewsNetwork.org. 

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

CDC Maintains Secrecy Over Opioid Guidelines

By Pat Anson, Editor

The Centers for Disease Control and Prevention (CDC) is refusing to disclose what outside advisors it consulted with during the drafting of its controversial opioid prescribing guidelines for physicians. The proposed guidelines, which were released this week, have angered many pain patients who think they could lead to sharp reductions in the prescribing of opioids for both acute and chronic pain.

“The anonymity of the reviewers engaged in this process is important during the ongoing development of these guidelines, as it allows reviewers to provide honest and independent comment and feedback,” said Courtney Lenard, a health communication specialist in the CDC’s National Center for Injury Prevention and Control. The panel of advisors is known within the CDC as the Core Expert Group.

“The Core Expert Group includes a limited number of CDC scientific staff, primary care professional society representatives, state agency representatives, experts in guideline development methodology, and other subject experts,” said Lenard.

Pain News Network has learned through a reliable source that about 15 people are in the Core Expert Group, only one of which is a physician with expertise in pain management.

The other members were “physicians and non-physicians, many of whom have been involved in efforts to rein in (opioid) prescribing.”

“Input from the pain management community in developing the guideline was, essentially, non-existent,” said the source, who identified Jane Ballantyne, MD, a professor of Anesthesiology and Pain Medicine at the University of Washington as the sole member with pain management expertise.

“As a member of the Core Expert Group, I have been asked not to comment on the (final) guideline until it is released,” said Ballantyne in an email to Pain News Network.

Ballantyne last year was named President of Physicians for Responsible Opioid Prescribing (PROP), a controversial organization that has lobbied Congress and criticized the Food and Drug Administration for not doing more to limit opioid prescribing.

The CDC and PROP appear to have a close working relationship -- a link to PROP literature recommending “cautious, evidence-based opioid prescribing” can be found -- unedited -- on the CDC’s website.

Asked if he was also a member of the CDC’s Core Expert Group that drafted the guidelines, PROP founder Andrew Kolodny said that he had no comment. Kolodny, who is chief medical officer for Phoenix House, which operates a chain of addiction treatment clinics, also said he would have no comment on the guidelines themselves.

Phoenix House was recently the subject of a highly critical report by Reuters, which claimed that in recent years the publicly funded institution “has consistently failed to provide the quality of care necessary to help addicts kick the habit.”

CDC Guidelines for Prescribing

Now that the draft guidelines have been released, the CDC plans to consult with a “Stakeholder Review Group” that includes over a dozen professional organizations involved in the field of pain management. Only two “stakeholders” – the American Chronic Pain Association and the American Cancer Society – represents pain patients.  A full list of the Stakeholder Review Group will be listed at the end of this article.

Secrecy has surrounded the development of the CDC's guidelines from their inception and continues today. The CDC refused to provide an advance copy of the guidelines before they were released Wednesday during an online “webinar.” Even after their release, only a summary of the guidelines is available on a CDC website and the agency is no longer accepting public comments on the guidelines after a 48-hour window of opportunity.

“Given the public health need to respond to the prescription overdose epidemic, it was critical to identify a public participation method and comment period that was rapid and efficient so that comments could be immediately provided to peer reviewers for their consideration,” explained the CDC’s Lenard in an email.

The first prescribing guideline recommends “non-pharmacological therapy” as the “preferred” treatment for chronic non-cancer pain, and states that opioids should only be prescribed if the benefits of reducing pain outweigh the risk of addiction and overdose.

Other guidelines recommend urine drug testing of all patients who are prescribed opioids, both for illicit drugs and prescribed medications. Smaller doses and quantities of opioids are also recommended – including a “three or fewer days” supply of opioids for most types of acute pain. The guidelines also recommend that benzodiazepines not be prescribed concurrently with opioids. A complete list of the guidelines can be found here.

“We’re concerned about some of the provisions in here, and by the fact that such guidelines issued by CDC are often accepted, sometimes rather uncritically, by state health departments and licensing boards, and thus quickly become standards of practice,” said Bob Twillman, Executive Director of the American Academy of Pain Management, which is one of the stakeholder groups that will be consulted by the CDC.

“I was generally satisfied with the proposed guidelines,” said Pete Jackson, president of Advocates for the Reform of Prescription Opioids, who lost his teenage daughter to a single dose of OxyContin in 2006.

“My main concern at this stage is how the federal government will reconcile these guidelines with the FDA REMS guidelines for long-acting opioids, which were voluntary guidelines issued a few years ago by FDA and have not been effective at deterring the overprescribing,” Jackson told Pain News Network. “Hopefully the CDC's guidelines will supersede the wholly inadequate FDA guidelines.  I would also like to see the CDC implement a very intensive training program to support the implementation of their new guidelines."

Pain Patients Worried

Pain patients – including many who already find it difficult to get opioids for pain relief – are angered and worried by the CDC’s recommendations.

“This terrifies me. I take two Norco per day, it barely keeps my pain at tolerable levels so I can do fun things like shower and get out of bed. I already jump through hoops to get my prescriptions every month.” said Cynthia Mittel. “To arbitrarily take away my only chance to have a life halfway worth living is evil and very short-sighted! Government at its finest. Guess we'll all be getting our drugs off the street now!”

“This is such a slap in the face to the millions of pain sufferers in this country," wrote Sue B. "We are not addicted to opioids! We need them in order to live. Would you think of putting these strict guidelines on insulin? It is not our fault drug abusers use our meds, our lifelines, to sell and get high, yet we are constantly punished.”

“We are not treated properly now. We get drug tested and insulted now. I cannot believe this is even coming up after the last change in guidelines,” wrote Kryste Southwick.  “Why do junkies have more meaning than chronic pain patients? Why are you stripping us of what little lives we can have? Do your research people. If this happens there will be A LOT of suicidal blood on YOUR hands.”

“This is wrong of the CDC to try and force their guidelines in people who live with chronic pain. I am monitored by my rheumatologist for my pain medication. I do not abuse my medication nor am I addicted to them,” said Suzanne Stevenson. “These guidelines the CDC want to impose are wrong and unfair to so many people. What right does the CDC have in this matter? None!”

Many have wondered why the CDC is acting as the lead agency in creating the prescribing guidelines – a role traditionally played by the Food and Drug Administration. The FDA has yet to release a statement about the CDC guidelines or say what role – if any – it had in drafting them.

"CDC and FDA are federal partners and collaborate on many different issues and at many different levels, prescription drug overdose being one of them. FDA has been involved in the review process of the guidelines and we will continue to work with them on this prescription drug overdose epidemic," said the CDC's Lenard.

CDC officials have long been critical of opioid overprescribing and have repeatedly cited a study that claims over 16,000 Americans are killed annual by overdoses linked to pain medications.

"CDC’s top focus in developing these guidelines is improving patient safety and reducing the risk that any more patients will die from an overdose related to mixing medications, using alcohol while on treatment, or taking a dangerous dose of opioids," said Lenard.

"We want to provide tools that primary care physicians can use to help determine when and how to safely initiate, maintain, and discontinue use of opioid therapy for chronic pain outside the setting of end-of-life care.  We understand that pain is a complex problem and that some patients will require treatment with a pain specialist. These guidelines are not intended to guide that care. We want patients currently on opioid therapies to work with their doctors to stay safe while managing their pain."

According to the National Institutes of Health, only about 5% of patients taking opioids as directed for a year end up with an addiction problem.

The CDC said it will now consult with the “stakeholders” group --and will then submit the guidelines to a peer review panel  -- before releasing a final version in January, 2016.

Members of the stakeholders group include the following: American Academy of Neurology; American Academy of Pain Management; American Academy of Pain Medicine; American Academy of Pediatrics; American Academy of Physical Medicine and Rehabilitation; American Cancer Society; American Chronic Pain Association; American College of Medical Toxicology; American College of Obstetrics and Gynecology; American Geriatrics Society; American Hospital Association; American Medical Association; American Pain Society; American Society of Addiction Medicine; American Society of Anesthesiologists; American Society of Hematology; American Society of Interventional Pain Physicians; and Physicians for Responsible Opioid Prescribing.