Report prepared by Myra Christopher
May 9-10, 2017, the FDA hosted a workshop titled Training Health Care Providers on Pain Management and Safe Use of Opioid Analgesics – Exploring the Path Forward. On the 9th, the FDA also released the Draft Revisions to FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioids in the Federal Register and began the process of seeking public input. Approximately two hundred people concerned about these issues attended.
After opening remarks by Dr. Doug Throckmorton, Deputy Center Director for Regulatory Programs, Janet Woodcock, Director of the Center for Drug Evaluation and Research set the framework for the meeting by articulating FDA’s goals:
- Reducing overall exposure to opioids
- Approving alternatives to opioids
- Sponsoring CME about opioid prescribing
- Decreasing non-medical use of opioids by approving abuse deterrent formulations (ADF)
- Decreasing opioid related deaths by promoting co-prescribing of Naloxone
- Increasing treatment options for substance use disorders (SUD)
Unfortunately, there was no mention of advancing comprehensive/integrative chronic pain care. However, as she proceeded to explain the critical nature of addressing the opioid epidemic, she said that it is “imperative to treat pain” because this public health issue “will not go away” and stressed the need for prescriber education. She and Dr. Throckmorton argued that the Risk Evaluation Mitigation Strategy (REMS) associated with prescribing of long-acting (LA) opioids needs to be updated to include immediate release (IR) opioids and education more broadly about pain management. The meeting focused on whether an expanded version of REMS should be mandated and if so, for whom and who would oversee such.
During the panel which followed, Lisa Robin, Chief Advocacy Officer at the Federation of State Medical Boards, pointed out that 40 states already have mandated CME related to this issue. Melinda Becker at the National Governors’ Association Center for Best Practices said that the opioid epidemic is a top priority for governors across the country and said that the Centers for Disease Control now indicated that 91 people die every day in the U.S. from drug overdoses. Joanna Katzman from the University of New Mexico (NM) and Director of Project ECHO, a tele-mentoring program, provided a ray of hope to the discussion by describing the success of their approach and legislation in NM that mandated 5 hours CME for all those prescribing opioids within 18 months. This year, the NM legislature also mandated that all law enforcement agents must carry Naloxene. Others spoke about successful efforts of Project Lazarus in West Virginia, the VA, and at Kaiser Permanente where 95% of their entire workforce has participated in online training.
Following the panel, there was a public commentary period, and people spoke passionately about the importance of simultaneously addressing the opioid epidemic AND poor treatment of chronic pain in the U.S.
There was no disagreement about the need for CME on chronic pain care and risks associated with opioid prescribing. However, consensus did not emerge about mandating an expanded REMS. The afternoon panel discussed the “pros and cons” of mandated continuing education. Greg Terman and Bob Twillman, both members of PAINS Advisory Committee, spoke. Terman addressed the benefits of mandated CME, and although Twillman agreed that all those who prescribe need to have a core body of knowledge, he argued that education is necessary but not sufficient to address the public health problems we are facing and that there is little evidence that continuing education changes practice. Patrice Harris, President of the AMA, agreed and said the critical issues are not about whether or not education should be provided but rather in “the what and how.” Dr. Harris also pointed out that medicine is regulated at the state level and that, in her opinion, education provided at the state level would be better accepted than programs delivered by federal agencies. She also referenced data from a recent report by the AMA Opioid Task Force showing that although opioid prescribing has declined every year since 2012, addiction and opioid related deaths continue to rise. Nearly 120,000 physician completed opioid prescribing, pain management and addiction courses in 2015 and 2016, and Prescription Drug Monitoring Programs (PDMP) were checked more than 136 million times in 2016.
The second day included a panel of health care providers including Col. Chester (Trip) Buckenmaier with the Defense and Veterans Center for Integrative Pain Management and also a member of PAINS Advisory Committee, Carol Haven, Director of Medical Education at Kaiser Permanente in California, Larry Goldblatt, Professor of Medicine and Community and Family Medicine at Duke University; Joanna Katzman, Project ECHO, and a panel of advocates for those living with chronic pain and those living with substance use disorders. Myra Christopher, Director of PAINS, served on the consumer advocacy panel. She shared information from a research project called Healing Relationships that PAINS recently completed but which has not yet been published. She said that from her perspective, many have blamed the opioid epidemic on people living with chronic pain and those who care for them, especially primary care providers (PCP). She reported that PCPs are practicing pain management in a stressful environment and feel constrained to provide quality care by:
- The healthcare delivery systems in which they practice
- Lack of time necessary to manage complex chronic pain
- Lack of access to and reimbursement for complementary therapies
- Unrealistic patient expectations.
In addition, they reported that they:
- Lack self-confidence and are frustrated by the opioid epidemic
- Feel they lack control of their medical practice which impedes their ability to provide the best care for their patients
- Struggle with conflicting ethical duties and obligations
- Are living with compassion fatigue and burnout.
She said that their research indicates that physicians want to be the solution, NOT the problem.
Others included on the consumer advocacy panel included Jan Chambers, Founder and President of the National Fibromyalgia and Chronic Pain Association (also a member of PAINS Advisory Board); Teresa Carr a writer from Consumer Reports; Penney Cowan, Founder and President of the American Chronic Pain Association; and Greg Williams, Executive Vice President of Facing Addiction. Together these panelists delivered a strong and compelling message that people living with chronic pain and substance use disorders have much to offer in developing curricula and plans and are eager to be of assistance. Christopher also made a special appeal to consider the role of culture and diversity in curriculum development. She pointed to an initiative focused on palliative care that did not consider these important matters and had to be supplemented and revised.
The meeting concluded with Drs. Buckenmaier and Throckmorton facilitating a panel with representatives from prior panels. Although there was not consensus about mandating CME or if so, who should be responsible for such an effort, there was significant agreement among meeting participants:
- All agreed that education on BOTH chronic pain management and opioid prescribing are desperately needed.
- There was consensus that all healthcare professionals should be exposed to a core curriculum on chronic pain management, including opioid prescribing, and that more comprehensive education targeted to the needs of particular providers should also be made available.
- There was agreement that the federal agencies need to be working together on these issues and that collaboration is essential to success.
- There was also agreement that states must play an important role and that patients and their families are essential to developing future plans and bring expertise and experience vital to developing comprehensive educational programs.