Pain management is a complex and multifactorial challenge. Opioids are an established and effective component of pain relief strategies for the management of complex, acute, and/or persistent pain in select disease-specific patient populations, such as patients with cancer and sickle cell disease. The Centers for Disease Control and Prevention (CDC), National Comprehensive Cancer Network (NCCN), American Society of Clinical Oncology (ASCO), and other groups publish clinical practice guidelines for the management of chronic pain.
These guidelines are intended for varying populations and are developed using differing methodologies. Unfortunately, the significant increase of opioid addiction and overdose in the United States has led to growing concerns over opioid prescribing practices.
2016 CDC Opioid Prescribing Guidelines
In March 2016, the CDC released guidelines intended to address when to initiate or continue opioids for chronic pain, opioid selection, dosage, duration, follow-up, and discontinuation, as well as assess risk and harms of opioid use for primary care physicians (JAMA 2016;315(15):1624-1645).
Although the guidelines undoubtedly state they are intended for clinicians prescribing opioids outside of active cancer treatment, leaders at ASCO and NCCN voiced their concerns in a JAMA Oncology publication (2018;4:1323-1324), stating that a patchwork of regulatory and coverage policies, intended to curb inappropriate opioid use, has created significant barriers. These included insurers who were inappropriately applying the recommendations of opioid coverage decisions to active cancer patients and individuals with sickle cell disease when making coverage determinations, and were denying opioid prescriptions or increasing the use of prior authorizations for patients suffering pain stemming from cancer treatment, end-of-life care, and other conditions.
“As an oncology nurse, I regularly see patients experiencing major challenges accessing appropriate pain management, including opioids,” noted Judith Paice, PhD, RN, Director of the Cancer Pain Program in the Division of Hematology-Oncology at the Feinberg School of Medicine and a member of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chair of the ASCO Clinical Practice Guideline for Management of Chronic Pain in Survivors of Adult Cancers, and member of the NCCN Clinical Practice Guidelines in Oncology for Adult Cancer Pain.
“The barriers they experience can include challenges with their insurer or limited supplies in the pharmacy. Additionally, prescriber confusion around recommendations, including misunderstandings about guidelines, can contribute to these challenges.”
In response to these concerns, a collaborative effort representative of the CDC, NCCN, ASCO, American Society of Hematology (ASH), FDA, and the authors of the JAMA Oncology article convened to discuss concordance and variation among current guidelines for chronic pain management, develop a strategy to resolve inconsistencies, and improve communication of existing recommendations. The recent publication, “Bridging the Gap Among Clinical Practice Guidelines for Pain Management in Cancer and Sickle Cell Disease,” outlines the discussion and conclusions from this meeting (J Natl Compr Canc Netw 2020;18(4):392-399).
The latest article provides a more granular explanation of different pain management guidelines. Scott Gottlieb, MD, who was serving as Commissioner of the FDA at the time of the meeting, spoke about the agency's position against a one-size-fits-all approach to opioid restriction policies, and highlighted his support for evidence-based guidelines as a tool to differentiate between clinical situations in which opioids are overprescribed and conditions for which opioids may be the only effective pain management tool.
Presentation of each clinical practice guideline revealed that, although each guideline varies in terms of their intended recipients (including chronic pain sufferers, people in active cancer treatment, cancer survivors, and people with sickle cell disease), methodology, and feedback processes, there is not in fact disagreement among recommendations when applied to the appropriate patient and clinical situation.
The article also called for additional coverage across payers for non-opioid pain management therapies and continued training for prescribers on how to appropriately transition patients with substance use issues of opioids.
The article highlights several common themes and recommendations of pain management endorsed by all guidelines, including:
- use of non-pharmacologic therapy and non-opioid pharmacologic therapy;
- assessment of an individual's likely benefit and risk prior to initiating opioid treatment;
- development and implementation of strategies to maintain patient safety and minimize the risk of opioid misuse based on patient history and risk factors;
- continuous monitoring and regular evaluations of effectiveness and necessity of opioid therapy;
- patient education on goals of treatment and safer use of opioid analgesics;
- optimization of adjuvant analgesics, psychosocial support, and interventional therapies in conjunction with opioid therapy; and
- gradual opioid dose reduction, when indicated, to prevent withdrawal symptoms.
CDC Offers Clarification
Additionally, the CDC issued a clarification stating that their guidelines were developed to provide recommendations for primary care clinicians who prescribe opioids for patients with chronic pain outside of active cancer treatment, palliative care, and end-of-life care. Moreover, it was not intended to deny clinically appropriate opioid therapy to any patients who suffer acute or chronic pain from conditions such as cancer and sickle cell disease, but rather to ensure that physicians and patients consider all safe and effective treatment options for pain management with the goal of reducing inappropriate use.
The CDC further notes that clinical practice guidelines released by bodies such as ASCO and NCCN addressing pain control for survivors of cancer, which were published and/or updated more recently than the CDC's guidelines, provide useful guidance on the unique considerations when using opioids to control pain in cancer survivors without deteriorating the current opioid crisis.
“While curbing opioid abuse is an important public health priority, we must ensure that mitigation efforts do not create further barriers to care for people with sickle cell disease and cancer,” noted ASH President Stephanie Lee, MD, MPH, of Fred Hutchison Cancer Research Center.
Clifford A. Hudis, MD, CEO of ASCO, also praised the clarification, calling it necessary to clear up confusion and prevent inappropriate coverage decisions.
“Gaining clarification from the CDC on its pain management guideline was critically important because, while it clearly states that it is not intended to apply to people with cancer, many payers misinterpreted it and are using it to make opioid coverage determination—inappropriately—for that exact population. Addressing the misuse of opioids will require changes within the health care delivery system that protect the public and limit the potential for abuse, while also ensuring access to medically appropriate medication for individuals who live with severe chronic pain. An evidence-based approach will help make sure that one national crisis does not become two.”
Overall, the hope is that publication of this paper represents a first step toward providing clarity regarding perceived guideline variance and advocating that clinical decision-making should be based on the relationship between the clinician and patient, with an understanding of the patient's clinical situation, functioning, and life context, as well as careful consideration of the benefits and risk of all treatment options, including opioid therapy. The meeting participants agreed that further utilization of clinical practice guidelines as a resource is needed to help inform policy, coverage determinations, and treatment decisions for safe, appropriate pain management.
Dibash Kumar Das is a contributing writer.