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17 Articles in Volume 19, Issue #4
Analgesics of the Future: Inside the Potential of Nerve Growth Factor Antagonists
Best Practices Are Still Largely Undefined in Task Force Report
Brief Behavioral Interventions for Chronic Pain
Cervicogenic Headache: Diagnosis and Management
Chronic Headache and Central Pain Conditions
Considering Comorbidities When Selecting Medications for Pain (Part 4)
For APPs: How to Contribute to Clinical Research
Gabapentin and Suicidal Ideation: Is There a Link?
Intranasal Ketamine for the Relief of Cluster Headache
Letters: Slipping Rib Syndrome; Burning Leg Pain; CGRP Complications
Pain Assessment Tools for Malingering in Patients with Chronic Pain
Refractory Chronic Migraine: Mild, Moderate, or Severe
Should Probuphine be considered for MAT?
Special Report: The Abuse Potential of Gabapentin & Pregabalin
Tension-Type Headache: Evidence for Trigger Points
Treatment Alternatives for Migraine
Trigeminal Neuralgia: Current Diagnosis and Treatment Options

Best Practices Are Still Largely Undefined in Task Force Report

When it comes to pain management - and opioid prescribing - what challenges still lie ahead for HCPs? Inside the HHS Inter-Agency Pain Management Task Force Final Report.
Pages 8-12

The US Department of Health and Human Services (HHS), in concert with the US Departments of Veterans Affairs and Defense, established the Pain Management Best Practices Inter-Agency Task Force in 2016 under the US Comprehensive Addiction and Recovery Act. The goal was to propose best practices and issue recommendations that address gaps or inconsistencies for managing chronic and acute pain. The task force released its draft report1 in December 2018 and allowed 90 days for open comment, for which HHS received more than 6,000 written responses. In early May 2019, the task force gathered for two days of public meetings, wherein they adopted and released a final draft report.2

Overall, we applaud all of the task force committee members and involved federal agencies for working collaboratively across clinical disciplines to create a comprehensive document that addresses many of the clinical, political, and practical issues that, until now, have largely been disregarded. Moreover, we applaud their acknowledgment of the thousands of patients and their advocates who are suffering from chronic non-cancer pain and require long-term opioid therapy. While multidisciplinary, the committee was, however, comprised mostly of physicians; having additional community or industry pharmacists as well as rehabilitation and other complementary specialists may have enriched the report.

Below, we highlight a few areas of importance to pain practitioners, which increasingly includes primary care providers, pharmacists, and clinicians across all disciplines, and we identify where key gaps still remain.

While the inter-agency task force identified several gaps in practice, many questions still remain. (Source: 123RF)

Opioids and the MME Issue

Perhaps one of the most important issues discussed and noted by the task force was the impact of the 2016 CDC guideline3 on prescribing opioids for chronic pain. Specifically, Vanila M. Singh, MD, MACM, chief medical officer of the HHS Office of the Assistant Secretary of Health, and chair of the task force stated: “The CDC Guideline has been misinterpreted and misapplied...[and]...unfortunately, unintended consequences such as forced tapering and patient abandonment contribute to adverse patient outcomes and provider disincentives in treating patients with complex acute and chronic pain.”4

This statement was made just weeks after the CDC and FDA publicly backtracked on endorsing and/or mandating the abrupt dose reduction or discontinuation of opioids that ensued across the country after the guideline’s release.5 We were happy, therefore, to see a statement in the final draft report on the specific issue of capping opioid doses: “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.” This section, however, needs to go further to address more comprehensively the flaws around using a morphine equivalent daily dose and the pseudoscience on which managed care organizations and various governmental agencies have relied. Furthermore, the task force’s final recommendations should point out that the CDC’s online calculator has been scrutinized for “opioid equivalent flaws” and comment on its incorrect calculations, as outlined in the safety concerns of the CDC opioid calculator.6

Opioid Alternatives and Risks Buprenorphine

Other areas of the final task force report focus on opioid-alternative medication options for pain, including buprenorphine. “Because buprenorphine is a partial agonist at the mu opioid receptor, it has a reduced potency for respiratory depression and is thus safer than full agonists such as morphine, hydrocodone, and oxycodone. In addition, buprenorphine acts as an antagonist at the kappa receptor, an effect shown to reduce anxiety, depression, and the unpleasantness of opioid withdrawal.”2 Of note, “reduced potency” is scientifically imprecise here, as potency is a measure of how much drug is needed to elicit an effect. More accurately stated, it should read, “buprenorphine has been shown to have a ceiling effect on CO2 accumulation and associated respiratory depression.” (For more, see last month’s PPM cover story on this very topic: “Burprenorphine: A Promising Yet Overlooked Tool”).

The task force report continued: “Oral buprenorphine is widely used for treating patients with [opioid use disorder] OUD but can also be effective and is approved for treatment of pain. There has been a noted challenge, however, by physicians in getting authorization for buprenorphine for pain.” The task force lists gaps in this regard “…as lack of coverage and reimbursement and understanding of proper usage, limit access to buprenorphine treatment for chronic pain.” We have witnessed multiple cases where third-party payors insist on fentanyl transdermal over buprenorphine transdermal (even in cases where the patient was already stable on buprenorphine), and requirement for a failure on a full agonist opioid over transmucosal buprenorphine.

In other words, payors are recommending opioids with potentially lower safety thresholds. The recommendation to “provide coverage and reimbursement for buprenorphine treatment approaches” does not go far enough. It should state that there should be no instance in which an insurer requires a full agonist opioid over buprenorphine and, in no case, should a higher co-pay be used to encourage a more dangerous full agonist opioid with a higher risk for diversion, simply to maximize profit for the insurer.

Scheduled Opioids

Furthermore, in 2016, the CDC’s opioid prescribing guideline outlined 12 recommendations targeted at primary care providers for implementing and continuing patients on long-term opioid therapy. Specifically, the guideline stated that “improving the way opioids are prescribed through clinical practice guidelines can ensure patients have access to safer, more effective chronic pain treatment while reducing the risk of opioid use disorder, overdose, and death.” Neither the CDC nor the task force have since delineated Schedule III from Schedule II opioids, despite the fact that DEA’s definition includes a lower potential for addiction and abuse for drugs classified as Schedule III, IV, and V.

Therefore, we believe that the final task force report should acknowledge that Schedule III opioids have a lesser risk of diversion and that these medications should be considered first-line prior to prescribing a Schedule II opioid, with the caveat that when codeine products are used, consideration be given to the probability of poor or rapid cytochrome (CYP) 2D6 metabolizers, the latter of which could result in harm or death. Notwithstanding, although tramadol is a Schedule IV medication, it comes with significant risk for various toxicities and is pharmacokinetically complex with five Phase I CYP metabolites and a host of potential drug interactions.

NSAIDs

In the HHS’s efforts to expose important warnings against NSAIDs, they failed to delineate in the report that topical NSAIDs are a viable option that may be used in place of oral NSAIDs and/or as adjuvant therapy when prescribing rational polypharmacy with or without opioids. The FDA went a step further, and in fact, demanded the same class-wide warnings regarding heart attack and stroke levied against their oral counterparts7 – but there is no evidence to support that any topical NSAID is as dangerous as any corresponding oral NSAIDS. In fact, the blood levels are so low, more often than not, they are undetectable.

Abuse-Deterrence

The task force took the time to acknowledge the importance of FDA-approved abuse-deterrent formulations (ADFs). There are no specific recommendations for industry, however, of how or when ADFs should be considered. In our experience, most providers are unfamiliar with these products, how they differ from each other, or how they differ from traditional opioid products, other than that they require prior approval and are usually third-tier in terms of availability and co-payment. The task force would benefit from encouraging the development of best practice that incorporates recommendations for when ADFs are most appropriate along with a strategy to make them more readily available and affordable, at the very least, for the most vulnerable patients.

Workforce Training

Within the final draft report, the task force shares gaps across the pain management “workforce,” noting: “There is a lack of multidisciplinary physicians and other health care providers who specialize in pain. These physicians and other health care providers include pain specialists, addiction psychiatrists, psychologists, pharmacists, and others who are trained to be part of the pain management team.” As more pain specialists migrate away from pharmacotherapy and focus more on interventional procedures, alternatives to traditional medicine, and rehabilitation, it is the primary care clinicians that are left with medically complex pain patients that are neither candidates for – or have failed – non-medication options.

A need for education is highlighted in the report, but there is no solution offered on how that might be accomplished or what would/should constitute proficiency. We believe that competency, at least for complex patients, should include:

  • evaluating unique individualized patient medication needs
  • opioid-risk stratification
  • ordering and interpreting toxicology and pharmacogenetic screens when needed, including monitoring for drug interactions that may raise or lower blood opioid (or non-opioid) drug levels
  • pharmacokinetic monitoring and dose adjustment consistent with kidney or liver dysfunction
  • evaluation, education, and prescribing of in-home naloxone when opioids are also prescribed
  • counseling and education to patients and caregivers
  • specific education requirements (including continuing education) within medical, behavioral health, pharmacy, and other post-graduate programs.

Overall, the final draft report has made great headway in a very complicated space with a multitude of players. It is our hope that their next steps will be to consider comments and concerns, such as those presented here, before preparing final guidance.

 

Other perspectives on this topic:

  • Tina L. Doshi, MD, MHS, who attended the public meetings, delves into the report's recommendations, including its take on the CDC guideline for prescribing opioids. Plus: A look at the task force members and history.
  • Perspective and recommendations from Richard A. Lawhern, PhD, Stephen E. Nadeau, MD, and Andrea Trescot, MD
Last updated on: June 21, 2019
Continue Reading:
The Inter-Agency Pain Management Task Force Final Draft Report on Best Practice: What Providers Should Know
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