A recently published article by Schatz et al offers new clarity around the use of prescription opioids in pain management for people with a diagnosis or history of cancer and chronic pain. The joint publication, which appeared in both JNCCN—Journal of the National Comprehensive Cancer Network and JCO Oncology Practice, includes authors from ASCO, the National Comprehensive Cancer Network® (NCCN®), the American Society of Hematology (ASH), and the Centers for Disease Control and Prevention (CDC). The article describes the results of a meeting among the aforementioned groups, along with then-U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD. The organizations are working together to align information for prescribers, payers, and policymakers on how best to utilize guidelines when balancing the benefits and harms of any pain management strategy involving opioids.
Scott Gottlieb, MD
Robert W. Carlson, MD
“We all have the same goal: to help patients have the best quality of life possible,” said Robert W. Carlson, MD, NCCN Chief Executive Officer. “That means ensuring access to appropriate, safe pain management, while not contributing to inappropriate opioid use and addiction. In recent years, the rise of opioid addiction and overdose in the United States has rightly led to increased scrutiny of opioid prescribing practices. However, multiple reports indicate that well-meaning regulatory and coverage policies have created significant barriers for many patients with cancer and sickle cell disease where careful opioid use may be clinically indicated for pain management. This is especially challenging for cancer survivors. Clinical practice guidelines can serve as a tool for policymakers to account for special populations and mitigate harm in policymaking.”
“Gaining clarification from 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 determinations—inappropriately—for that exact population,” said ASCO Chief Executive Officer Clifford A. Hudis, MD, FACP, FASCO. “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.”
Clifford A. Hudis, MD, FACP, FASCO
Stephanie Lee, MD, MPH
“Debilitating, chronic pain that often starts in childhood is a hallmark symptom of sickle cell disease. At times that pain becomes so severe that clinically prescribed opioids are medically necessary for daily functioning, and in some cases opioid use at home under the supervision of a doctor can prevent hospitalization,” said ASH President Stephanie Lee, MD, MPH, of Fred Hutchinson Cancer Research Center, Seattle. “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. We appreciate the efforts of the CDC to clarify clinical guidelines and look forward to a continued partnership with the agency, NCCN, and ASCO as advocates for the necessary use of opioids for pain management to protect access for those who need it most.”
Letter of Clarification
Following the initial meeting, which took place in November of 2018, the CDC issued a letter of clarification, explaining that the agency’s 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. The letter conveys that the CDC’s guideline is not intended to deny clinically appropriate opioid therapy, 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 letter also notes that clinical practice guidelines for cancer treatment, palliative care, and end-of-life care should be used for these special populations and provide useful guidance on the unique considerations for the use of opioids for pain control in cancer survivors.
Dr. Gottlieb also spoke during the initial meeting, and a summary of his remarks is included in the article. He clarified the agency’s position against a one-size-fits-all approach to opioid restriction policies and stressed the importance of science-based prescribing criteria that took specific clinical situations into consideration. Dr. Gottlieb also noted 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 appropriate pain management tool.
Guidelines
The article delves deeper into the different pain management guidelines and provided tools for determining how and why they differ. One key area of divergence was with regard to intended recipients, which included chronic pain sufferers, people in active cancer treatment, cancer survivors, and people with sickle cell disease. The article also highlights the following constants across guidelines:
- Use of nonpharmacologic therapy and nonopioid 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
- Gradual opioid dose reduction, when indicated, to prevent withdrawal symptoms.
The article also calls for additional coverage across payers for nonopioid pain management therapies and additional training for prescribers on how to appropriately transition patients with substance use issues off of opioids. It concludes by stating that “pain management is a complex and multifactorial challenge,” and suggests further utilization of clinical practice guidelines as a resource to help inform policy, coverage determinations, and treatment decisions for safe, appropriate pain management.
Judith Paice, PhD, RN
“As an oncology nurse, I regularly see patients experiencing major challenges accessing appropriate pain management, including opioids,” said Judith Paice, PhD, RN, Director of the Cancer Pain Program in the Division of Hematology-Oncology at the Feinberg School of Medicine and 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 (NCCN Guidelines®) 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. We hope this clarification will facilitate better use of guidelines for payers, policymakers, and prescribers.”
Disclosures: For full disclosures of the study authors, visit jnccn.org or ascopubs.org.
