June 15, 2018
Alicia Richmond Scott
Pain Management Best Practices Inter-Agency Task Force
U.S. Department of Health and Human Services
200 Independence Avenue, SW
Washington, DC 20201
RE: Docket No. HHS-OS-2018-0009-0001
Dear Ms. Scott:
The undersigned members of the Protecting Access to Pain Relief (PAPR) Coalition wish to submit written comments in response to “Meeting of the Pain Management Best Practices Inter-Agency Task Force.” The PAPR Coalition is a multi-stakeholder group of public health organizations whose mission is to support continued access to and choice of appropriate over-the-counter (OTC) pain relief as part of a patient’s comprehensive pain management plan, including for use as alternatives to opioids (www.paprcoalition.com). Collectively, our Coalition reaches millions of medical professionals, people living with pain, patients managing chronic disease, and concerned citizens with public health messages about the safe use of OTC pain relief. Our combined communications and engagement platforms have proven to be a powerful resource with the demonstrated capacity to educate and mobilize Americans on complex and timely public health issues.
Currently, over 100 million Americans suffer from chronic pain, which is more than the number of patients suffering from diabetes, stroke, coronary artery disease, and cancer combined. Because of its near ubiquity nationwide, pain presents a significant public health problem in the U.S. An Institute of Medicine report found that pain costs our society at least $560-$635 billion annually (equal to about $2,000 per person) in lost wages and compensation for disability days. In addition, the costs of care associated with chronic pain, which include diagnostic tests, physical therapy, medications, and medication management, can be extremely burdensome on both patients and the healthcare system as a whole. A 2015 study of a large U.S. health integrated delivery system indicated that treating chronic pain costs approximately $32,000 per patient per year, with an annual average of nearly 19 outpatient visits and five imaging tests per patient.
We agree with the statement by HHS Secretary Alex Azar and Assistant Secretary Adm. Brett Giroir that “[A]s we combat the opioid crisis, we cannot forget that pain is a real problem…We must do a better job of securing for them safe, effective options for managing pain.” Recent research has shown that non-opioid pharmacologic alternatives have been shown to be as, if not more, effective than opioids in treating chronic pain over time. The Coalition believes policy makers should take additional steps to educate health care providers and patients about the important role of OTC pain medication as part of a safe and responsible pain management plan.
OTC pain relief is often a medically necessary and cost effective way for patients to manage pain. In addition to lower costs, for many patients, such as those suffering from osteoporosis and end stage renal disease, OTC pain relief represents the safest medically recommended means of alleviating pain. It is important for Americans to have access to and choice of the appropriate OTC pain relief to match their pain profile and comorbidities.
Moreover, while we know that there are numerous safe and effective pharmacologic – including OTC medicines – and non-pharmacologic pain relief options on the market and available to patients, the incorporation of these therapies into a comprehensive pain management policy is not universal. In fact, comprehensive training in the development and execution of pain management plans for patients is frequently left out of graduate medical education curricula and current practice. In large part, these issues stem from inconsistent and disparate federal guidelines for pain management despite a large body of evidence that can inform a series universal best practices within the U.S. health care system.
The PAPR Coalition strongly supports efforts by federal policy makers, including the Pain Management Best Practices Inter-Agency Task Force, to ensure Americans have access to and choice of appropriate OTC pain relief and that providers help their patients develop pain management plans that address the potential for misuse and abuse associated with opioids. More specifically, the PAPR Coalition looks forward to working with stakeholders to pursue specific policy principles, including:
- Improving public health outcomes by ensuring patients have access to and choice of OTC pain relief therapies chosen with their health care provider as part of a comprehensive pain management plan that addresses potential risks of addiction to opioids;
- Ensuring that the Food and Drug Administration (FDA) does not unnecessarily limit access to OTC acetaminophen in the United States, including the 120 million Americans that have a health condition for which non-steroidal anti-inflammatory drugs (NSAIDs) are contraindicated;
- Incorporating the patient experience and patient preference information into the FDA’s decision-making regarding policies related to current and future OTC pain relief therapies.
The PAPR Coalition, with our substantial combined audience and communications and engagement capacities, is dedicated to working with the HHS Pain Management Best Practices Inter-Agency Task Force, Congress, and other allied stakeholders to help support the millions of Americans living in persistent pain with access to and choice of appropriate OTC pain relief within tailored pain management plans for the millions of Americans who suffer from chronic pain.
Alliance for Aging Research
American Association of Kidney Patients
American Gastroenterological Association
American Society of Nephrology
Convenient Care Association
The Gerontological Society of America
National Minority Quality Forum
Renal Physicians Association
Veterans Transplantation Association
 AAPM Facts and Figures on Pain. The American Academy of Pain Medicine. http://www.painmed.org/patientcenter/facts_on_pain.aspx#incidence.
 Institute of Medicine Report from the Committee on Advancing Pain Research, Care, and Education: Relieving Pain in America, A Blueprint for Transforming Prevention, Care, Education and Research. The National Academies Press, 2011.
 Park PW et al. Cost burden of chronic pain patients in a large integrated delivery system in the United States. Pain Practice. November 2016. 16(8):1001-1011.
 Krebs EE et al. Effect opioid vs. nonopioid medications on pain-related function in patients with chronic back pain or hip or knee osteoarthritis pain: The SPACE randomized clinical trial. Journal of the American Medical Association. 2018. 319(9):872-882.
 Mezei L and BB Murinson. Pain education in North American medical schools. J Pain. December 2011. 12(12):1199-1208.