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4 Articles in this Series
Introduction
Forest Tennant, MD, DrPH, Honored for a Lifetime of Achievement in Pain Medicine
PAINWeek 2017 Video Highlights
Time for Pain Practitioners to Take Back Pain Prescribing
Under Scrutiny, What's a Pain Practitioner to Do?

Under Scrutiny, What's a Pain Practitioner to Do?

With presentations by Michael Barnes, JD, Kevin L. Zacharoff, MD, Stephen J. Zeigler, PhD, JD, and commentary by Forest Tennant, MD, DrPH

“Over the past 2 decades, the opioid epidemic has spread throughout the country, leaving no demographic immune,” said Michael Barnes, JD, MIEP, managing partner at DCBA Law & Policy, LLP, and a former Bush staff member, during a PAINWeek 2017 presentation on the impact of federal policy on current pain management.1

Opioids have been demonstrated to help manage pain when other treatments have not offered sufficient pain relief, Mr. Barnes said. Now, there is a need to both expose and push back against the heavy-handedness of insurers who are imposing the Centers for Disease Control and Prevention guideline2 for prescribing opioids for chronic pain as gospel.

Let’s review—this guideline was written as a recommendation for primary care practitioners but instead has become the “law of the land,” levied by insurers and carried out by pharmacists, essentially taking the management of pain out of the hands of pain specialists and prohibiting the ability of patients with diagnosed chronic pain conditions to receive the treatment they need and deserve,1.2 he said.

    Michael C. Barnes, JD, MIEP, speaking to Practical Pain Management at PAINWeek 2017

The issue of unintended consequences must be acknowledged since the political decisions concerning pain prescribing is the root cause of pill-seeking on the street,according to Mr. Barnes.

Furthermore, Mr. Barnes said "while HR. 2063: Opioid PACE Act has been introduced to require educational standards to be eligible for a DEA permit to dispense opioids,3 and S. 892: Opioid Addiction Prevention Act4 was proposed to limit prescribing of opioids to seven days as federal law."

“This kind of legislation won’t guarantee that abusers will not obtain drugs, rather it will only prevent access to patients with chronic pain conditions who really need [prescription strength opioids],”Mr. Barnes said.

These laws fail to address the rogue prescribers, leaving vulnerable individuals at risk and the community still facing avoidable overdoses,” Mr. Barnes told Practical Pain Management.

Clinical Considerations Meet Political Pressures

Regulatory pressures and the sheer number of people involved suggests that we must continue to assess, diagnose, and evaluate risks that are common among patients with chronic pain; and we must communicate more clearly with these patients by getting informed consent,1 said Mr. Barnes.

“We must persist by a willingness, effort, thought, knowledge, persistence, and most importantly documentation,” said Kevin L. Zacharoff, MD, vice president of medical affairs at Inflexxion, in Waltham, Massachusetts.  It is also about dialogue—between the patient and the healthcare provider—so we can face outside forces (ie, regulators at the federal and state levels) to be compliant when we prescribe as appropriate to meet our patients' needs,he said.

“Let’s keep in mind foremost our mission—it's about one thing: the patient,” said Dr. Zacharoff, while we must consider the societal impact and clinical considerations, deliberate and justified, we must do all of this while making sure we are live up to our mission.5

What Now?

"We need to speak up since silence is construed as consent,” said Stephen J. Zeigler, PhD, JD, associate professor emeritus of public policy at Purdue University in Fort Wayne, Indiana, “It is our responsibility to assure that our patients have appropriate access to necessary prescription pain medications.”5

Dr. Zeigler offers a few actions that practitioners were urged to consider:

  • Working with the addiction community, and they with us, rather than being at odds in order to seek ways to permit responsible and reasonable access to opioids while preventing abuse.
  • Insisting that we have a seat at the table on the Pain Management Best Practices Inter-Agency Task Force to assure that best practices rather than politically expedient mandates are part of any future recommendations; this presents a critical opportunity to bring all parties together to work toward a responsible solution.7
  • Supporting efforts such the Narcotics Overdose Prevention & Education (NOPE) Task Force established in Florida to reduce the frequency of deaths due to overuse of opioids and heroin; legislation was passed to require emergency rooms to establish a policy for notifying next of kin and primary care providers of non-fatal overdoses to permit the opportunity for intervention and still protect patient privacy.8 The goal of NOPE is to avoid reviving individuals who are then sent back out into the community only to repeat the risky, drug-seeking (usually street drugs, and cocaine) behavior.
  • Continuing to draw attention to the other issue that remains a societal challenge—mental illness.

What is needed now to inform pain management is a standard of care drawn from evidence-based research and clinical expertise rather than media hype and the winds of special interest groups and ill-informed legislatures,1 said Mr. Barnes.

Getting Back to What Matters—the Patient

 “Pain is a basic human issue,” Forest Tennant, MD, PhD, told Practical Pain Management, “Why should people who have chronic pain be left to suffer, especially when there are affordable, therapeutic treatments available?!”

The conversation should be changed to one that focuses on getting the media to talk about the reality of pain and suffering, rather than continuing to demonize patients who have a chronic pain condition, Dr. Tennant said.

Mr. Barnes suggested that every pain practitioner check out the Healthcare Fraud Prevention Partnership website managed by the Centers for Medicare & Medicaid Services,  which was established by the Office of the Inspector General to identify extreme opioid-prescribing patterns.

“It is good for you to know what your profile for total opioid prescribing claims looks like,” said Mr. Barnes, "While it is safe to say that all of you here have nothing to worry about, it is a good way to see how your prescribing patterns compare to others."  

However, the most important means of protection to afford you "to practice proper pain management is to document, document, document," said Mr. Barnes.

Another Area of Poor Federal Oversight

The Food and Drug Administration skipped a major step in formulating the Risk Evaluation and Mitigation Strategy (REMS),8 which was established to reduce prescribing of immediate-release opioids. Had a product-specific REMS been applied to Opana, for example, it could have remained available for limited use in patients who needed it, rather than pulling it off the market purely as a political decision,said Mr. Barnes.

“Similarly, by creating an expectation that abuse-deterrent opioids are deficient for everyone if even one person finds a way to abuse it, misses the point and is shortsighted,” said Mr. Barnes, “What is really needed is a better definition for abuse-deterrence that reflects the intent behind these products, which is to lessen the abuse but not to withhold their availability from every patient with chronic pain.”

Similar political actions are being made with regard to long-acting prescription opioids with the unintended consequence that more pills will be sought illicitly and obtained on the street with no regulation of what is actually in the pill,1 according to Mr. Barnes. He asked: Who will that help? Where is that benefit to society?

Need a Campaign on Safe Pill Storage & Disposal

From a recent study, “an increasing number of children arrive at the emergency addicted to opioids,” which begs the question of how and why these pills were so readily accessible.  In the current climate, this data could be used as another reason to outlaw access to all opioids, but a more sensible, clinically necessary consideration is needed.

Would these same parents leave their guns out and unlocked, or $1,000 sitting on a dresser? The same rules apply to prescription medications. Lock them up while they are meeting a need, and dispose of them immediately when no longer needed.

The presenters had no financial conflicts of interest to disclose.

References:

  1. Barnes MC.  Making America treatment-friendly again: Federal policy and pain. Presented at PAINWeek 2017. September 4-9, 2017. Las Vegas, Nevada.

  2. Centers for Disease Control and Prevention. CDC guideline for prescribing opioids for chronic pain—United States 2016. MMWR. Recommendations and Reports. 2016;65(1):1-49.  Available at: www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm. Accessed September 13, 2017.

  3. Gov.track.us. H.R. 2063—115th Congress: Opioid PACE Act of 2017. Available at: www.govtrack.us/congress/bills/115/hr2063. Accessed September 13, 2017.

  4. Congress.gov. S.892—Opioid Addiction Prevention Act of 2017. Available at: https://www.congress.gov/bill/115th-congress/senate-bill/892/text. Accessed September 13, 2017.

  5. Schatman ME, Zeigler SJ, Zacharoff KL. Are you now or have you ever been? Saving pain medicine from zealotry. Presented at: PAINWeek 2017. September 4-9, Las Vegas, Nevada.

  6. US Food and Drug Administration. Approved Risk Evaluation and Mitigation Strategies (REMS).  Available at: https://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm. Accessed September 13, 2017.

  7. HHS.gov. HHS establishing pain management task force/seeks member nominations. Available at: www.hhs.gov/about/news/2017/08/25/hhs-establishing-pain-management-task-forceseeks-member-nominations.html. Accessed September 12, 2017.

  8. Narcotics Overdose Prevention & Education (NOPE) Task Force. Available at: http://nopetaskforce.org. Accessed September 12, 2017.

  9. Hannah HA, Arambula K, Ereman R, Harris D, Torres A, Willis M. Using local toxicology data for drug overdose mortality surveillance. Online J Public Health Informatics. 2017;9(1)e143. Available at: http://journals.uic.edu/ojs/index.php/ojphi/article/view/7733. Accessed September 13, 2017.

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