HHS Report on Pain Mgmt Best Practices – part 1

This seems like the first good news in a while: a government agency admitting that most opioid overdoses are from illicit fentanyl. The report also documents the downsides of non-opioid medications and highlights the predicament of pain patients.

Draft Report on Pain Management Best Practices | HHS.gov

This document is so long and detailed that I spent hours picking it over to find the critical pieces and add my own commentary. It’s far from perfect, but still a welcome change from the usual PROPaganda – and I choose to celebrate.

Here’s the first part:  

Draft Report Overview

The Comprehensive Addiction and Recovery Act (CARA) of 2016 led to the creation of the Pain Management Best Practices Inter-Agency Task Force (Task Force), whose mission is to determine whether gaps in or inconsistencies between best practices for acute and chronic pain management exist and to propose updates and recommendations to those best practices. 

The Task Force consists of 29 experts who have significant experience across the disciplines of

• pain management,
• patient advocacy,
• substance use disorders,
• mental health, and
• minority health.

This draft report describes preliminary recommendations of the Task Force that will be finalized and submitted to Congress in 2019, following a 90-day public comment period.

1. Introduction

The experience of pain has been recognized as a national public health problem with profound physical, emotional, and societal costs.

Today, chronic pain affects an estimated 50 million U.S. adults, and as many as 19.6 million of those adults experience high-impact chronic pain that interferes with daily life or work activities

At the same time, our nation is facing an opioid crisis that has seen an unprecedented rise of overdose deaths associated with prescription opioids, heroin, and synthetic opioids in the past two decades

It is imperative to strike a balance between ensuring that patients with painful conditions can work with their health care providers to develop an integrative pain treatment plan that optimizes function, quality of life (QoL), and productivity while also ending the devastating effects of opioid misuse.

The significant public awareness and the pressure for both federal and state regulatory agencies and other stakeholders to address the opioid crisis has in part contributed to health care providers limiting the number of opioid prescriptions they write.

Regulatory oversight has also led to fears of prescribing among some clinicians, with some refusing to prescribe opioids even to established patients on a stable opioid regimen.

This increased vigilance and targeting of the misuse of prescription opioids and the tightening of their availability have in some situations led to unintended consequences, such as patient abandonment and forced tapering.

I make my thoughts on “unintended consequences” clear here: CDC Opioid Prescribing Guideline: Unintentional Consequences?

The Centers for Disease Control and Prevention (CDC) has recently noted that the opioid crisis is quickly moving to a fentanyl crisis.

Illicit fentanyl (manufactured abroad and distinct from medical use in the United States), with an even more potent synthetic form, has sometimes been mixed with other opioids (prescription and illicit opioids, cocaine, and other illegal substances), including heroin, resulting in sentinel outcomes because of its concentrated effect and low costs.

Public comments submitted to the Task Force show growing consideration of suicide resulting from unrelieved pain and in some cases lack of access to treatment.

According to a recent CDC report using data from the National Violent Death Reporting System, the percentage of people who died by suicide who also had evidence of chronic pain increased from 7.4% in 2003 to 10.2% in 2014.

Numbers from this data set beyond 2014 are not yet available. This finding leads to the rising concern that a recent trend of health care professionals opting out of treating pain has contributed to an existing shortage of pain management specialists and is leaving some patients without adequate access to care.

Comprehensive pain management can be a challenge for various reasons. In the current environment, patients with chronic pain, particularly those being treated with opioids, can be stigmatized, a tendency exacerbated when their pain condition is complicated by common mental health co-morbidities such as anxiety and depression or by addiction.

HHS is advancing a comprehensive overview that addresses all issues in the practice of acute and chronic pain management, an effort that is coordinated with the 5-Point Strategy to Combat the Opioid Crisis to recalibrate the role opioid medications play in pain care to reduce opioid harm and improve the QoL for patients living with pain.

The complexity of some pain conditions requires multidisciplinary coordination among health care professionals; in addition to the direct consequences of acute and chronic pain, the experience of pain can exacerbate other health issues, such as delayed recovery from surgery or an activation of behavioral and emotional disorders.

The Task Force reviewed extensive public comments, patient testimonials, and existing best practices; considered relevant medical and scientific literature; and requested information from government and nongovernment experts in pain management and related disciplines

Gaps and recommendations in the report span five major interdisciplinary treatment modalities:

1. medication,
2. restorative therapies,
3. interventional procedures,
4. behavioral health approaches, and
5. complementary and integrative health.

2. Clinical Best Practices

CPGs that only promote and prioritize minimizing opioid administration run the risk of undertreating pain, especially when the cause of the pain is uncertain or cannot be reduced by non-opioid approaches.

This sounds like a rebuke of the CDC, which slapped together some virulent anti-opioid materials written by PROP, which has been used to demonize all opioids for all long-term conditions.

A recent review of clinical opioid prescribing guidelines by Barth et al. notes several needs — including the development of postoperative pain management guidelines for different surgical procedures, with the understanding of patient variability in physiology, drug metabolism and other medical underlying disease processes.  

This further emphasizes the need for an individualized patient-centered approach.

In light of these gaps, there are potential limitations to evidence-based clinical recommendations that should be considered by pain management providers

A systematic review of CPGs for neuropathic pain identified shortcomings across four evaluation domains:

1) stakeholder involvement (i.e., the extent to which the guideline was developed by the appropriate stakeholders and represents the views of its intended users);
2) the rigor of development (i.e., the process used to gather and synthesize the evidence and the methods used to formulate the recommendations);
3) applicability (i.e., likely barriers and facilitators to implementation of the guideline, strategies to improve its uptake, and resource implications of applying it); and
4) editorial independence (i.e., bias in the formulation of the recommendations), not to mention the knowledge and skill set of the clinician.

Gaps and Recommendations

Gap 1: Current inconsistencies and fragmentation of pain care limit best practices and patient outcomes. A coherent policy for pain management within health systems is needed.

Recommendation 1a: Encourage coordinated and collaborative care that allows for best practices and improved patient outcomes whenever possible. One of many examples is the collaborative stepped model of pain care, as adopted by the VA and DoD health systems.

2.1 Approaches to Pain Management

A multimodal approach to pain management consists of using more than one treatment modality from one or more medical disciplines to be incorporated into a pain treatment plan.

Such modalities allow for different approaches to address the pain condition (acute and chronic) from a variety of mechanisms, often allowing for a synergistic approach that addresses the different aspects of the pain condition, including addressing improved symptoms and functionality.

HHS has developed a National Pain Strategy that

“recommends a population-based, biopsychosocial approach to pain care that is grounded in scientific evidence, integrated, multimodal, and interdisciplinary, while tailored to an individual patient’s needs.

Again, here is that error of applying population statistics to individual patients. This is a gross statistical error and has caused untold damage to patients who aren’t exactly like the “average” yet are treated as though they were.

• Population Statistics do NOT Apply to Individuals
• Population Risk Does Not Equal Individual Risk
• ‘Population-Based,’ Meet ‘Patient-Centered’

Specialty interdisciplinary pain medicine team consultation, collaborative care, and (when indicated) mental health and addiction services should be readily available in the course of treatment of pain to help ensure the best patient outcomes.

Gaps and Recommendations

Gap 1: Current inconsistencies and fragmentation of pain care limit best practices and patient outcomes. A coherent policy for pain management within health systems is needed.

Recommendation 1a: Encourage coordinated and collaborative care that allows for best practices and improved patient outcomes whenever possible. One of many examples is the collaborative stepped model of pain care, as adopted by the VA and DoD health systems.

2.1.1 Acute Pain

Acute pain is a ubiquitous human experience that is classified as a physiologic response to noxious stimuli that is sudden in onset and time limited.

Acute pain flares may recur periodically in common and complex chronic medical problems, including as examples, but not limited to arthritis, neuropathies, spinal conditions, low-back pain, sickle cell disease (SCD), migraine, multiple sclerosis (MS), trigeminal pain or neuralgia, and complex regional pain syndrome (CRPS).

Reevaluation of patient is critical in this setting because the use of medications to control acute pain should be for the shortest time necessary while also ensuring that the patient is able to mobilize and function to optimize outcome following surgery or injury.

As one large study illustrated, among a population of opioid-naive patients who were given a course of opioids to treat pain following surgery, about 6% became new chronic users.

I’m disgusted that they always, always ignore the most obvious reason for this. Continued pain, either because the surgery didn’t “fix” the problem or iatrogenic to the surgery itself, is a valid reason to continue needing opioids.

Chronic pain requires chronic opioids.

Gaps and Recommendations

Gap 1: Multimodal, nonopioid therapies are underutilized in the perioperative setting.

Gap 2: Guidelines for the use of multimodal clinical management of the acute pain associated with common categories of surgical interventions and trauma care are needed.

And still, this task force does not recognize that guidelines proposing any kind of standard doses are inappropriate for the highly individual intensities of both the symptom and its relief.

To reflect multidisciplinary approaches and the biopsychosocial model for management of acute and chronic pain, the following sections are organized by five major approaches to pain management: medication, restorative therapies, interventional procedures, behavioral health approaches, and complementary and integrative health.

The following section focuses on special populations that face unique challenges in acute and chronic pain management.

Public comments from the Task Force noted this concern in regard to treatment access issues and provider disincentives as well as directly noting the CDC guideline.

In November 2018, the American Medical Association issued a statement advocating against the misapplication of the CDC Guideline for Prescribing Opioids for Chronic Pain.

Finally, an acknowledgment of the push-back from *medical* professionals (instead of the self-appointed “experts” who pushed the CDC guideline).

I’ve collected a list of medical professionals who have spoken out against the guidelines here: Doctors Advocating for Pain Patients

2.2 Medication

Effective pain management, particularly for chronic pain, is best achieved using a patient-centered, multidisciplinary, multimodal, integrated approach that may include pharmacotherapy

In general, two broad categories of medications are used for pain management: opioids and a variety of nonopioid classes of medications

For any symptom anyone has, you can always say there are “two broad categories of medications used”: a drug category that is effective and a variety of less-effective ones. 

Nonopioid modalities, including these medications, can mitigate and minimize opioid exposure.

Each medication has its own risks and benefits as well as mechanism of action. Different medications can complement one another, and their effects can be synergistic when used in combination. A risk-benefit analysis is always recommended based on the individual patient’s medical, clinical, and biopsychosocial circumstances.

The following paragraphs briefly describe nonopioid medications, which can be considered singularly or as part of a multimodal approach to the management of chronic and acute pain, depending on the patient and his or her medical conditions.

Acetaminophen can be effective for mild to moderate pain. Risks of acetaminophen can include dose-dependent liver toxicity, especially when taken at high doses or by those with liver disease. This risk further illustrates why patients should be aware of the presence of acetaminophen in both over-the-counter and prescribed combination medications.

NSAIDs such as aspirin, ibuprofen, and naproxen can provide significant pain relief for inflammation, such as arthritis, bone fractures or tumors, muscle pains, headache, and acute pain caused by injury or surgery. The use of certain NSAIDs may be associated with renal insufficiency, hypertension, and cardiac-related events.

Anticonvulsants are medications originally developed to treat seizures but are also commonly used to treat different pain syndromes, including postherpetic neuralgia, peripheral neuropathy, and migraine. They are often used as part of a multimodal approach for the treatment of pain in the perioperative period. Some of these agents can be effective in treating the neuropathic components of pain syndromes. Anticonvulsants, which include gabapentinoids, may cause significant sedation and have recently been associated with a possible risk of misuse.

Antidepressants are commonly used in various chronic pain conditions. Tricyclic antidepressants are effective medications for a variety of chronic pain conditions, including neuropathic pain. As with other medications, they can have risks and adverse effects, including dry mouth, dizziness, sedation, memory impairment, orthostatic hypotension, and cardiac conduction abnormalities.

There have been some reports of withdrawal reactions when these medications are suddenly stopped.

This is a monumental understatement of the violent physical withdrawals triggered by stopping or even reducing these horridly dependency-forming drugs.

If my next dose of my SSRI (venlafaxine) is more than about 6 hours late, I start getting “electric zaps” flashing up the back of my neck and into my head. I hate being so dependent on this drug, but I really do need it to maintain my sanity.

I’m grateful that this kind of dependency is not considered problematic as is the case with opioids.  The distinction seems irrelevant when both medications, opioids and antidepressants, are being used to ease pain, physical or mental.

Overall, the analgesic actions of antidepressants occur even in patients who are not clinically depressed, and their analgesic effect typically occurs sooner and at lower doses than are required for the treatment of depression.

This means that if you’re given a trial of these medications and don’t get relief at the earlier and lower doses, that means it will NOT be effective for your pain. There’s no need to continue escalating the doses to “see if it will work”.

Musculoskeletal agents commonly used for pain treatment include baclofen, tizanidine, and cyclobenzaprine (a TCA). Carisoprodol is metabolized to meprobamate, which is both sedating and possibly addictive, and so the use of carisoprodol is not recommended, particularly because alternatives are available.

Anxiolytics, including benzodiazepines, are often prescribed for anxiety and stress associated with chronic pain. Benzodiazepines do not have independent analgesic effects but can have indirect pain-relieving effects because of other mechanisms of action.
Caution must be used with benzodiazepines because of the potential for substance use disorder. Co-prescription of benzodiazepines and opioids is associated with enhanced risks of overdose, respiratory depression, and death. Combining opioids and benzodiazepines can be unsafe because both types of drugs sedate users and suppress breathing — the cause of overdose fatality — in addition to impairing cognitive function.

Reading this paragraph would make anyone wonder why these drugs are ever prescribed together, yet that is exactly what makes them effective: they have a synergistic pain-relieving effect with opioids.

The following paragraphs briefly describe opioid medications, which can be considered singularly or as part of a multimodal approach to the management of chronic and acute pain, depending on the patient and his or her medical conditions.

Opioids are broad-spectrum analgesics that provide pain relief for a wide variety of conditions.

Yes, these are by far the most effective medications for pain. They are a natural substance of a plant that have been used for thousands of years, so we already know of all their effects and side effects.

With opioids, we don’t have to fear the nasty surprises that so often occur after a “new and improved” pharmaceutical drug is already tested, approved, and widely used.

Opioids bind to opioid receptors in the brain, spinal cord, and other sites, activating analgesic and reward pathways.

I still wonder if the “reward” from these drugs for pain patients isn’t simply the relief from pain.

Illicit fentanyl-related overdoses are now a leading cause of overdose deaths in the United States, often because of its use in combination with illicitly obtained heroin, cocaine, diverted prescription opioids, and other drugs of abuse

Common prescription opioid medications that can be considered for management of acute and chronic pain include hydromorphone, hydrocodone, codeine, oxycodone, methadone, and morphine

There are challenges to completing long-term studies of any therapy for moderate to severe pain, particularly patient drop-out from intolerable pain.

This is how the anti-opioid zealots will forever be able to say that there’s no proof that opioids work long term. Of course, the same is true of any and all other supposed “pain relievers”, but that’s never mentioned.

The point about study participants dropping out due to intolerable pain is important because this limitation will be seen with any study participants that aren’t given sufficient relief from their pain.

Initiation of opioid therapy, when the benefits are deemed by the patient and the clinician to outweigh the risks, should be administered at the lowest dose of medication required to optimally control the pain or improve function and QoL and for the shortest period necessary.

Periodic reevaluation with continued risk assessment and accurate dose adjustment is critical because patients vary widely in the dose required for analgesic efficacy

Comprehensive risk assessments consider patient functionality, QoL, and potential comorbidities

Two of these factors, patient functionality and QoL, are benefits, yet they are listed as part of risk assessment. 

The idea of a ceiling dose of opioids has been put forward, but establishing such a ceiling is difficult, and the precise level for such a ceiling has not been established

The task force is clearly trying to “make nice” with the anti-opioid zealots here. There are obvious problems with establishing a standard dose for many medications.

This is especially true for an opioid, whose effects are so dependent on the individual’s genetic ability to metabolize it, and when it’s used to treat a symptom (pain) that varies so widely in severity, intensity, and duration.

The researchers noted that:

“Dose-dependent opioid overdose risk among patients increased gradually and did not show evidence of a distinct risk threshold.

Much of the risk at higher doses appears to be associated with co-prescribed benzodiazepines. It is critical to account for overlapping prescriptions, and justifies taking a person-time approach to MME calculation with intent-to-treat principles.”

Good grief, what an incomprehensible mumbo-jumbo of jargon just to say doses should be decided on an individual basis.

But what they are saying indirectly, is that there aren’t any fixed numeric “steps” of increasing risk. This is contrary to the CDC guidelines, which created bogus categories of 50MME and 90MME and provoked the forced taper of thousands of patients.

ADDITIONAL CONSIDERATIONS

Synthetic opioids other than methadone (a category that includes prescribed fentanyl as well as illicit fentanyl) are now the leading opioid involved in overdose deaths in the United States.

The source of illicit fentanyl has been identified as international and rarely from diverted fentanyl pharmaceuticals.

These sources come through the U.S. Postal Service and other means. The illicit fentanyl analog used is not necessarily the same compound used during surgeries, nor in the transdermal fentanyl patches provided for moderate to severe pain

Interaction of multiple medications prescribed to patients (polypharmacy) can have significant clinical and symptomatic effect.

Abuse-deterrent technologies are being developed with the goal of preventing alterations of prescription opioid formulations and the extraction of the active ingredient by users

A challenge to the development of opioid ADFs is the need to maintain the same safety and efficacy profile as the opioid without the ADF for FDA approval.

Many patients, myself included, found that the abuse-deterrent version of OxyContin didn’t give us as much pain relief. The same changes that make a pill abuse-deterrent can also significantly hinder its metabolism and pain-relieving effects.

Gaps and Recommendations

Gap 1: Clinical policies tend to treat the large population of patients with multiple conditions causing chronic pain with simple medication rules.

The lumping of all types of chronic pain into one “symptom” creates a frightening lack of medical specificity and corrupts all the studies and guidelines based on this erroneous assumption.

Chronic pain from a genetic defect, like EDS or sickle cell, is very different from the chronic pain of trigeminal neuralgia, which is very different from visceral pain due to adhesions, which is very different from vague low back pain.

It should be clear that pain must be treated on an individual basis because the variety of pain, patients, medications, and the interactions between all of them create a very specific medical scenario. Only when this whole web of conditions is considered can the pain be treated effectively.

Guidelines for medication use for specific populations of patients (e.g., different ages, genders, medical conditions, comorbidities) with chronic pain need to be developed for each specialty group and setting.

Gap 2: Opioids are often used early in pain treatment. There has been minimal pain education in medical school and residency programs, and little guidance for primary care providers (PCPs) on appropriate pain treatment approaches.

Recommendation 2a: Use of nonopioid medications (e.g., oral and IV acetaminophen, oral and IV NSAIDs, long-acting local anesthetics, dexmedetomidine), with nonpharmacologic treatments, should be used as first-line therapy whenever possible in the in-patient and out-patient settings.

Recommendation 2b: If an opioid is being considered, physicians and other health care providers should use evidence-informed guidelines.
#Wait, there is NO evidence for opioids in the long term, so what evidence do they plan on using?

Recommendation 2c: The type, dose, and duration of opioid therapy should be determined by treating clinicians according to the individual patient’s need and pain condition.

Hurray, at last!

This is actually the only thing that has to be done, but it has to be done right.

Recommendation 2d: Opioid therapy should be initiated only with ongoing nonopioid treatments when the benefits outweigh the risks; the patient is experiencing severe acute or chronic pain that interferes with function; and the patient is willing to continue to engage with the team on a comprehensive multidisciplinary treatment plan, as clinically indicated, with established clear and measurable treatment goals, along with close follow-up and regular risk assessment and reevaluation.

What doctor would initiate any treatment if the benefits did NOT outweigh the risks?

What they are really saying is that the benefits and risks will be decided by outside parties. I suspect that opioid benefits will be minimalized and that opioid risks will be determined by some law enforcement agency, not a doctor.

Recommendation 2e: The Centers for Medicare & Medicaid Services (CMS) and payors should provide reimbursement that aligns with the medication guidelines the Task Force has described.

Gap 3: There is often a lack of understanding and education regarding the clinical indication and effective use of nonopioid medications as part of a multimodal and multidisciplinary approach to acute and chronic pain management. Chronic pain is often ineffectively managed, which can in part be the result of a variety of factors, including physician training, patient access, and other barriers to care:

Gap 4: Barriers, such as lack of coverage and reimbursement and understanding of proper usage, limit access to buprenorphine treatment for chronic pain:

Gap 5: There is currently inadequate education for patients regarding safe medication storage and appropriate disposal of excess medications targeted at reducing outstanding supplies of opioids that may be misused by others or inadvertently accessed by children and other vulnerable members of the household.

That’s all for now. The next post (tomorrow) will continue with section 2.2.1 Risk Assessment.