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The Centers for Disease Control and Prevention (CDC) recently drafted new guidelines on prescribing opioids for chronic pain. Unfortunately, the panel utilized to develop the guidelines did not include any pain experts. Developed without patient or pain expert insight or contribution, the new guidelines could be bad news for pain patients and practitioners. The CDC’s new guidelines have disturbed patients and providers and have created controversy from the moment of their release for a number of reasons which can be read in further detail HERE.

In response, ICA and other impacted groups have jointly signed on to a letter to Sylvia Mathews Burwell, Secretary of the Department of Health and Human Services (HHS) voicing their concern over the manner in which the CDC’s new guidelines were developed and their potential impact on pain patients. The full text of the letter to Secretary Burwell can be read below.

September 8, 2015

Sylvia Mathews Burwell, Secretary
U.S. Department of Health and Human Services
Hubert H. Humphrey Building
200 Independence Ave SW
Washington, DC 20201

Dear Secretary Burwell:

In April, the undersigned members of US chronic pain management professional associations and patient advocacy organizations responded to your call to work with stakeholders on the misuse, abuse, and diversion of; addiction to; and overdose involving prescription opioids. We suggested a meeting to discuss our ideas and interests and, on August 6^th, five representatives of our group met with your designees at FDA. A copy of our follow-up to that meeting is attached.

As articulated in both our original letter to you and the post-meeting communication, the discovery that CDC was engaged in developing opioid prescribing guidelines has been a topic of great curiosity. How the guidelines were being developed, by whom, and what they would address given the woefully inadequate body of clinical evidence supporting prescribing decisions, has not been transparent to our stakeholder community. Since CDC has traditionally not involved itself in developing and disseminating medication prescribing guidelines, these process questions have become less a curiosity and more a concern.

When CDC recommends specific practices be adopted, healthcare providers, administrators, and government agencies nationwide embrace them as the standard of care. They do so with every expectation the guidelines have been developed in a manner consistent with best known evidence or, where there is no evidence, by long-experienced clinical expert consensus opinion. In chronic pain management with opioid medications, we can point to a dozen such expert consensus guidelines that span many years and come from an array of respected organizations. We wonder what the new CDC guidelines will include, and what, if anything, they will add. With respect to existing guidelines:

• Most share common sense recommendations around initial evaluation of pain, function, and confirming diagnosis.
• There are extensive recommended risk assessment processes, including psychosocial and mental health evaluations, along with patient and familial history of substance abuse, use of validated opioid risk instruments, cautions related to concomitant medication use, initial drug testing, and evaluation of medication toxicities.
• When selecting therapeutic approaches, recommendations for setting treatment goals, evaluating and confirming the efficacy and safety of non-opioid medications, as well as non-pharmacologic treatments, are standard. Only when initial therapies do not accomplish the pain, function, and quality of life goals set by the patient and provider do these guidelines move to opioids.
• When opioids are part of the treatment plan, guidelines recommend patient-provider agreements, initiating treatment with short-acting formulations, meticulous dose titration, medication rotation, dose conversion standards, breakthrough pain, and proper storage and medication disposal. Duration and dose considerations are also addressed.
• Many guidelines address the use of opioid medications in special populations including children and adolescents, the elderly, and patients with mental health conditions or active substance abuse disorder.
• With opioids, periodic re-evaluation of function, quality of life, and evidence of aberrant drug behaviors, periodic drug testing, PDMP checks, discontinuation planning and implementation are part of best practices.

While there may be variances among organizations on specific guideline inclusions or recommendations, there is a broad conformity that extends far beyond any of the chronic pain and opioid medication issues that have been addressed by CDC over the past six or seven years.

In fact, it is CDC’s singular focus on prescription opioid diversion, abuse, addiction, and overdose over any improved understanding of chronic pain incidence, prevalence, trends, and optimal interventions that has caused us to reach out to you, to meet with FDA, and prompted us to call on CDC to immediately compile, analyze, and report any and all chronic pain data it possesses, managed with or without opioids. Certainly any health condition that impacts one third of our country’s population should, by definition, have a place of priority in CDC’s mission and mandate. Certainly a better understanding of how to effectively treat chronic pain should be an essential component to any treatment prescribing guideline.

CDC has reported exclusively and extensively on the prescription opioid addiction and unintentional drug poisoning mortalities. Our chronic pain provider and patient advocacy organizations, however, have not seen the same rising adverse trends among their constituents. If CDC only addresses limiting or avoiding opioids and does not address their appropriate use in a range of appropriate chronic pain treatments, the new guidelines will inevitably result in fewer prescriptions overall including those needed by patients with legitimate medical needs. Our chronic pain advocacy organizations do hear daily from increasing numbers of constituents who are not being able to access the opioid medications they’ve relied on to live with their chronic painful conditions. Will CDC be interested in chronic pain when there are more deaths resulting from inability to access essential pain medications?

If the new CDC guidelines reinforce existing recommendations of experts who agree there are tried and true approaches to safely and effectively using opioids to treat chronic pain, it would be a welcomed addition to clinical practices nationwide. Equally important, we need CDC to glean from its prescription opioid addiction and overdose data which cases actually involve chronic pain patients and which involve patients with active substance use disorder so we can help providers better differentiate the two. The unmet challenge in chronic pain management with opioid treatment is to identify the conditions for which, and patients for whom, opioid use is most appropriate; the regimens that are optimal; the alternatives for those who are unlikely to benefit from opioids; and the best approach to ensuring that every patient’s individual needs are met by a patient-centered health care system. We need CDC to provide some context around the incidence and prevalence of undertreated pain and the related adverse consequences of undertreated chronic pain on all body systems. With these insights it may actually be possible to improve pain care rather than restricting one treatment based on perceived, not quantified, harms to legitimate patients.

We learned last week that the new CDC opioid prescribing guidelines will be presented via webinar on September 16 with questions, criticisms, and reactions collected during the session and for a period of just 48 hours afterwards. This is hardly an adequate amount of time to give due consideration to the CDC’s work product and we respectfully request that that period be extended to a customary 30 days.

Additionally, we’ve not seen broad promotion of the webinar so are doing all we can to assure that the chronic pain community registers for it. Coincidentally, there are two long-standing and well-attended pain management professional conferences that occur just before, during, and just after the webinar so large numbers of the pain provider community are likely to be in conference or traveling at the precise time the webinar is being held. We therefore request the webinar be archived and made available on-demand which, along with the extended commentary period, will allow an appropriate amount of expert review and input.

Responses or comment to the group can be sent to Kathleen Strauser, Research Director, Chronic Pain Research Group and Managing Partner, Highwater Partners, Inc. at 215-493-7054 or by email at kstrauser@highwaterpartners.net.

Sincerely,

Original Signers to the April Letter

Alliance for Patient Access*
American Academy of Pain Management*
American Cancer Society*
American Chronic Pain Association
Chronic Pain Research Group at the Clinical Pharmacokinetics Laboratory, University of Buffalo School of Pharmacy and Pharmaceutical Sciences*
Hospice and Palliative Nurses Association
Interstitial Cystitis Association
National Fibromyalgia & Chronic Pain Association
Pain Connection
Project Lazarus
The Pain Community
US Pain Foundation
Virginia Cancer Pain Initiative

* Participant in the FDA August 6 meeting