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Project Information

Project Information


Evidence-based clinical practice guidelines for prescribing opioids for acute pain


Project Scope:

An ad hoc committee under the auspices of the National Academies of Sciences, Engineering, and Medicine will develop a framework to evaluate existing clinical practice guidelines for prescribing opioids for acute pain indications, recommend indications for which new evidence-based guidelines should be developed, and recommend a future research agenda to inform and enable specialty organizations to develop and disseminate evidence-based clinical practice guidelines for prescribing opioids to treat acute pain indications.

In developing its report, the committee will:

  • Identify existing opioid prescribing guidelines for acute pain indications;

  • Identify a list of specific medical procedures and conditions associated with acute pain for which opioids are commonly prescribed and for which evidenced-based clinical practice guidelines would thus help inform prescribing practices;

  • Develop a framework for evaluating the evidence base underpinning clinical practice guidelines for opioid prescribing, to create a threshold level of evidence to support guidelines and ensure consistency among guidelines;

  • Evaluate existing opioid prescribing guidelines for acute pain using this framework to identify specific indications for which prescribing guidelines are not sufficiently evidence-based; and
  • Develop a prioritized research agenda, by specific medical procedure or condition for which no opioid prescribing guidelines exist or for which more evidence is required to support existing guidelines, to enable the development and availability of comprehensive evidence-based opioid prescribing guidelines for acute pain. The committee will establish a statement of needs for a minimum of 5 indications that are abuse-prone and/or commonly prescribed.

In developing its evaluation framework, the committee will consider the standards established in the 2011 IOM report, Clinical Practice Guidelines We Can Trust. The committee will produce recommendations for how to generate easily accessible, evidence-based, trustworthy clinical practice guidelines for effectively managing acute pain with opioid drugs for specific medical procedures and conditions that FDA could use as a reference in its publicly available materials.

Status: Current

PIN: HMD-HCS-18-06

Project Duration (months): 16 month(s)

RSO: Wedge, Roberta

Board(s)/Committee(s):

Board on Health Care Services

Topic(s):

Health and Medicine



Geographic Focus:

Committee Membership

Committee Post Date: 11/05/2018

Bernard Lo - (Chair)
Bernard Lo, MD, is President of the Greenwall Foundation, whose mission is supporting bioethics research and young researchers in bioethics. He is also Professor Emeritus of Medicine and Director Emeritus of the Program in Medical Ethics at the University of California San Francisco (UCSF). A member of the National Academy of Medicine (formerly the Institute of Medicine, IOM), Dr. Lo served on the IOM Council and chaired the Board on Health Sciences Policy. He chaired the IOM committees Sharing Clinical Trial Data (2015) and Conflicts of Interest in Medical Research, Education, and Practice (2009). He co-chairs the Standards Working Group of the California Institute for Regenerative Medicine, which recommends ethics standards for publicly funded stem cell research in California. Dr. Lo serves on the Board of Directors of Association for the Accreditation of Human Research Protection Programs (AAHRPP) and on the Medical Advisory Panel of Blue Cross/Blue Shield. Formerly he was a member of the National Bioethics Advisory Commission, the NIH Recombinant DNA Advisory Committee (RAC), and the Ethics Subcommittee of the Centers for Disease Control and Prevention. Dr. Lo and his colleagues have published around 200 peer-reviewed articles on ethical issues concerning decision-making near the end-of-life, oversight of research, the doctor-patient relationship, and conflicts of interest. He is the author of Resolving Ethical Dilemmas: A Guide for Clinicians (6th ed., 2019). He continues to care for a panel of primary care internal medicine patients at UCSF. Dr. Lo received his MD from Stanford University.
Mark C. Bicket
Mark C. Bicket, MD, is an assistant professor of anesthesiology and critical care medicine at the Johns Hopkins University School of Medicine and is the Director of the Multidisciplinary Pain Medicine Fellowship Program and Director of the Divisional Safety and Quality Assurance Program at Johns Hopkins. He also is a core faculty member of the Johns Hopkins Bloomberg Center for Drug Safety and Effectiveness. Dr. Bicket focuses his clinical expertise and research in interventional pain management with the goal of improving treatment options for patients with chronic and persisting pain. His research and work has been published in Journal of the American Medical Association (JAMA), British Medical Journal, JAMA Surgery, Anesthesiology, Regional Anesthesiology and Pain Medicine, and The Spine Journal, among others. He recently published a review in JAMA that indicated the need for more personalized pain management to avoid overprescribing opioids and reduce risks linked to improperly stored opioids in the home. He also attends in the operating rooms, with an emphasis on care under the enhanced recovery after surgery and obstetrical anesthesiology services. He is a member of the American Society of Anesthesiologists, the American Pain Society, and the American Academy of Pain Medicine. Dr. Bicket obtained his MD from the Johns Hopkins University School of Medicine, performed a pain management fellowship at Massachusetts General Hospital, and maintains board certifications in both pain medicine and anesthesiology from the American Board of Anesthesiology.
Nicholas W. Carris
Nicholas W. Carris, PharmD, BCPS, is an Assistant Professor at the University of South Florida in the Department of Pharmacotherapeutics and Clinical Research in the College of Pharmacy and the Department of Family Medicine in the Morsani College of Medicine. As a Board Certified Pharmacotherapy Specialist, Dr. Carris has significant training and expertise in drug therapy. He has completed literature evaluations and has published an evaluation of implementing a new guideline. Presently, Dr. Carris is collaborating with a regional accountable care organization to implement the Centers for Disease Control and Prevention’s (CDC) opioid use guidelines. As part of this effort, he is working with key stakeholders and physicians to emphasize deprescribing. Dr. Carris is a member of the American College of Cardiology, the American College of Clinical Pharmacy (ACCP), and the ACCP Ambulatory Care Practice and Research Network (Ambulatory Care PRN), which connects members from a diverse array of outpatient settings with a particular emphasis on the provision of chronic disease management. Dr. Carris currently serves as a lead for a sub-committee in the Ambulatory Care PRN that awards scholarships to members to attend training programs regarding grant writing or general research. Dr. Carris received his Doctor of Pharmacy Degree from the University of Florida College of Pharmacy.
Roger Chou
Roger Chou, MD, is director of the Pacific Northwest Evidence-based Practice Center, professor of medical informatics and clinical epidemiology and medicine, and a practicing internist at Oregon Health Science University. His primary clinical research areas are screening and prevention, evaluation and management of pain, HIV/Hepatitis C, and diagnostic testing. Dr. Chou has conducted more than 60 systematic reviews used by various organizations to formulate research agendas, to develop clinical practice guidelines, and to inform health care policy and clinical practice. He led a review commissioned by the Agency for Healthcare Research and Quality (AHRQ) on prescribing opioids for chronic pain; the CDC commissioned an update of this review to develop its recently-issued guidelines on prescribing opioids for chronic pain. Dr. Chou serve as the 2016 CDC opioid guidelines GRADE methodologist and was a member of the steering committee. In addition to leading numerous EPC reviews for the AHRQ Effective Health Care Program, Dr. Chou has led OHSU's work supporting the U.S. Preventive Services Task Force (USPSTF) since 2010, and, just this year, was awarded a 3-year contract to conduct seven prevention and counseling systematic reviews for the USPSTF in collaboration with other EPC faculty and staff. Dr. Chou also conducts research on systematic review methods and best practices, and he serves as the GRADE methodologist for the World Health Organization (WHO)'s Division of Reproductive Health, the GRADE methodologist and a member of the WHO Guideline Development Group for the diagnosis and treatment of viral hepatitis, and is a longstanding member of the Cochrane Back Review Editorial Board (currently serving as Coordinating Editor). Previously, Dr. Chou served as Director of the American Pain Society's Clinical Practice Guidelines Development Program and as a member of the American College of Physicians Clinical Practice Guidelines Committee. Dr. Chou received his medical degree from Northwestern University Medical School, and he completed an internal medicine residency at OHSU and a health services research fellowship at the VA Portland Health Care System.
Christine D. Greco
Christine D. Greco, MD, is the Clinical Director of Pain Service at Boston Children’s Hospital and Assistant Professor of Anesthesia at Harvard Medical School. Dr. Greco is also Associate Program Director, Pediatric Pain Medicine Fellowship, at Children’s Hospital. Her clinical practice is focused on the management of pain in children, including pelvic pain and endometriosis. Dr. Greco has made presentations on “Opioid Therapy, Pediatric Pain Management and End of Life Care,” “Opioids in Adolescents; Principles of Pediatric Anesthesia and Critical Care,” and “Managing the Opioid Epidemic in Hospitalized Children.” She is a member of the American Society of Anesthesiologists and the American Academy of Pediatrics. Dr. Greco is certified by the American Board of Anesthesiology in Pediatric Anesthesiology. She received her medical degree from the University of Pittsburgh Medical School, had a pediatric residency at Ohio State University and an anesthesia residency and pediatric anesthesia fellowship at the University of California, San Francisco.
Hillary V. Kunins
Hillary V. Kunins, MD, MPH, is Assistant Commissioner, Bureau of Alcohol and Drug Use – Prevention, Care, and Treatment, of the New York City Department of Health and Mental Hygiene. Dr. Kunins leads work in substance use disorders for the Department and was the driving force behind Implementation of New York City’s guidelines for “judicious prescribing” in emergency departments and primary care; these guidelines and their implementation provided impetus to the CDC Guidelines. Dr. Kunins is the health department lead and architect of HealingNYC, New York City’s 60 million dollar comprehensive opioid strategy. Key to that strategy, Dr. Kunins has scaled up naloxone distribution to more than 100,000 kits to laypeople, established Relay, an emergency department based post-overdose intervention, and overseen provider education around judicious opioid prescribing using academic detailing. She is a frequent speaker on the role of public health in the opioid epidemic and strategies for clinicians to prevent opioid overdose. Dr. Kunins previously was Program Director, Residency in Primary Care/Social Internal Medicine at Montefiore Medical Center/Albert Einstein College of Medicine. She is a Fellow, of the American Society of Addiction Medicine and in 2017 received the Gary S. Spero Memorial Award for leadership in mental health and substance use treatment from Cornell University. Dr. Kunins received her MD and MPH from Columbia University and an MS from the Albert Einstein College of Medicine, Clinical Research Training Program.


Marjorie C. Meyer
Marjorie C. Meyer, MD, is Division Director, Maternal Fetal Medicine and attending physician in Obstetrics and Gynecology at the University of Vermont Medical Center and associate professor (tenured) in the Department of Obstetrics and Gynecology at the University of Vermont. Dr. Meyer’s research interests focus on maternal and newborn sequelae of opioid use in pregnancy: outcomes, opioid use in women, contraception use in opioid dependent women, pain control in labor and delivery. She is a Vermont Child Health Improvement Program grantee to develop a statewide network of care for the treatment of pregnant women with opioid dependence. Dr. Meyer also is engaged in communication and education of OBGYNs across the state regarding public health initiatives, changes in care models (Blueprint), and quality metrics (vital statistics; statewide database data). She received her medical degree from the University of Florida College of Medicine.
Richard Payne
Richard Payne, MD, is the Chair in Bioethics at the Center for Practical Bioethics, and Professor Emeritus in the Duke Divinity School at Duke University. He has published extensively in the areas of chronic pain with cancer, neurology, palliative care, end of life care and the use of hospice, and access for minorities to pain management. Dr. Payne is a past president of the American Pain Society. He has previously given expert testimony to the Congressional Black Caucus National Brain Trust and the President’s Cancer Panel in the area of healthcare access disparities in cancer care, palliative medicine, and end-of-life care. Dr. Payne is currently a member of the NASEM Board on Health Sciences Policy and was previously a member of the National Academies Committee on Physician-Assisted Death: Scanning the Landscape and Potential Approaches and on the Committee on Advancing Pain Research, Care, and Education. He received his MD from Harvard University.
Rosemary C. Polomano
Rosemary C. Polomano, PhD, RN, FAAN, is Associate Dean for Practice and Professor of Pain Practice at the University of Pennsylvania School of Nursing. She holds a secondary appointment as Professor of Anesthesiology and Critical Care at the University of Pennsylvania Perelman School of Medicine and is a Senior Nurse Scientist at the Hospital of the University of Pennsylvania. She is also Adjunct Professor at the Uniformed Services University, Bethesda, MD, in the Graduate School of Nursing. Her research focuses on the impact of pain prevention and treatment strategies on short- and long-term pain outcomes with adult post-surgical patients, military service members and veterans, and cancer patients. Dr. Polomano has led research to develop and test patient-reported outcome measures; for example, the American Pain Society-Patient Outcomes Questionnaire–Revised and the new Defense and Veterans Pain Rating Scale. She has co-authored numerous evidence-based guidelines and consensus reports to advance pain care. She is currently a member of the American Pain Society and American Academy of Pain Medicine, Acute Pain Taxonomy, and the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks Acute Neuropathic Pain expert panels. Dr. Polomano is co-director of the University of Pennsylvania’s NIH-designated Center of Excellence in Pain Education, and leads several pain-related interprofessional education initiatives across the University’s health profession schools. In 2014, in recognition of her career-long work to advance pain science, Dr. Polomano received Penn Nursing’s Norma M. Lang Award for Scholarly Practice and Policy. She has published over 100 peer-reviewed journal articles and more than 30 chapters in nursing and medical textbooks. She received her MSN from the University of Pennsylvania and a PhD from the University of Maryland School of Nursing.
Eric C. Sun
Eric C. Sun, MD, PhD, is an Assistant Professor in the Department of Anesthesiology, Pain and Perioperative Medicine and (by courtesy) the Department of Health Research and Policy at Stanford University. His research examines the economics of policies related to chronic pain and preoperative medicine and how physician practice organization affects outcomes and costs. He is an Associate Editor of Anesthesia and Analgesia. Dr. Sun has conducted studies on regulating pharmaceutical safety and the effect of behind the counter/over the counter switches on drug utilization, prices, and health. He received his PhD in business economics from the University of Chicago Booth Graduate School of Business and a MD from the University of Chicago Pritzker School of Medicine, upon which he then completed his residency in anesthesiology at Stanford University.
Jennifer F. Waljee
Jennifer F. Waljee, MD, is Associate Professor of Surgery, in the Department of Surgery of the University of Michigan Health Systems. She specializes in hand surgery, reconstructive surgery, and burn surgery. Her research interests are the incorporation of patient experiences into measures of surgical quality and treatment effectiveness, and the application of patient-reported outcomes assessment tools into clinical practice. Dr. Waljee is currently an investigator on several federal and state-funded grants including work to explore opioid prescribing and consumption following acute injury and prevention of iatrogenic opioid dependence after surgery. She serves as a co-director of the Michigan Opioid Prescribing Engagement Network, a statewide quality improvement project dedicated to improving pain and opioid-related outcomes following surgical care. Dr. Waljee is a member of the American College of Surgeons, the American Society of Plastic Surgeons, the American Society for Surgery of the Hand, and the Plastic Surgery Research Council. She serves as an associate editor of the Journal of Hand Surgery and Plastic and Reconstructive Surgery Global Open. She is a member of the Centers for Disease Control and Prevention (CDC) Opioid Prescribing Estimates Workgroup. Dr. Waljee received her MD from Emory University School of Medicine and an MPH from the University of Michigan School of Public Health.
Steven J. Weisman
Steven J. Weisman, MD, currently holds the Jane B. Pettit Chair in Pain Management at the Children's Hospital of Wisconsin, where he is the Medical Director of the Jane B. Pettit Pain and Headache Center. In addition, he is Professor of Anesthesiology and Pediatrics at the Medical College of Wisconsin. Dr. Weisman formerly established and directed pain management programs for children at both the University of Connecticut Health Center and Yale University School of Medicine. He has completed residency and fellowship training in Pediatrics, Pediatric Hematology-Oncology and Anesthesiology. His clinical and research interests focus on the management of postoperative pain in children, exploration of the factors mediating chronic pain in children, and the interface of obesity and chronic pain in children. Dr. Weisman is member of the American Pain Society where he serves as the Chair of the Ethics Committee and previously was Liaison Representative from the American Academy of Pediatrics to the FDA Risk Evaluation and Mitigation Strategies on Long-Acting Opioids. Dr. Weismann received his MD from the Albert Einstein College of Medicine.
Charles Widmer
Charles G. Widmer, DDS, MS, is Head, Division of Facial Pain, Department of Orthodontics, at the University of Florida College of Dentistry. Dr. Widmer’s clinical practice includes differential diagnosis of various facial pain conditions with a limited management focus primarily on masticatory musculoskeletal disorders. His research interests include masticatory muscle motor control mechanisms, the biological basis of masticatory muscle pain and mechanisms of masticatory muscle injury and repair. Dr. Widmer is currently the principal investigator for a study on “Assessment of opioid use before and after temporomandibular joint implant surgery.” He has recently chaired an intracollege committee to examine the use of opioids for dental and oral surgery and to bring prescribing practices in line with newer treatment options. Dr. Widmer has served as chair of numerous special emphasis panel for National Institute of Dental and Craniofacial Research. He is a member of the American Dental Association, the American Dental Education Association, the International Association for Dental Research (including the Neuroscience Group), and the American Association for Dental Research (including as board member in 2000). Dr. Widmer received his DDS from Emory University School of Dentistry.

Committee Membership Roster Comments

Note (11/5/18): There was one additional provisional appointment to the committee following the initial posting of the membership on 10/18/18: Hillary V. Kunins was provisionally appointed on 11/5/18.


Comment on Provisional Committee Appointments


Viewers may communicate with the National Academies at any time over the project's duration. In addition, formal comments on the provisional appointments to a committee of the National Academies are solicited during the 20-calendar day period following the posting of the membership and, as described below, these comments will be considered before committee membership is finalized. We welcome your comments (Use the Feedback link below).

Please note that the appointments made to this committee are provisional, and changes may be made. No appointment shall be considered final until we have evaluated relevant information bearing on the committee's composition and balance. This information will include the confidential written disclosures to The National Academies by each member-designate concerning potential sources of bias and conflict of interest pertaining to his or her service on the committee; information from discussion of the committee's composition and balance that is conducted in closed session at its first event and again whenever its membership changes; and any public comments that we have received on the membership during the 20-calendar day formal public comment period. If additional members are appointed to this committee, an additional 20-calendar day formal public comment period will be allowed. It is through this process that we determine whether the committee contains the requisite expertise to address its task and whether the points of views of individual members are adequately balanced such that the committee as a whole can address its charge objectively.


You have 8 day(s) remaining after today to provide comments during the formal comment period.


Events



Location:

Keck Center
500 5th St NW, Washington, DC 20001
Event Type :  
Meeting

Description :   

Through the course of the study, the committee will meet several times. The public session is one of the many processes that the committee will use to gather information and assemble evidence that members will examine and discuss in the course of making the committee’s findings, conclusions, and recommendations. The focus of this public session is for the committee to clarify the scope of the charge with the study sponsor and initiate the process of gathering relevant information related to the study.


Registration for Online Attendance :   
https://opioidrxguidelines-public-session.eventbrite.com

Registration for in Person Attendance :   
https://opioidrxguidelines-public-session.eventbrite.com


If you would like to attend the sessions of this event that are open to the public or need more information please contact

Contact Name:  Ruth Cooper
Contact Email:  rcooper@nas.edu
Contact Phone:  (202) 334-3125

Supporting File(s)
-
Is it a Closed Session Event?
Some sessions are open and some sessions are closed

Closed Session Summary Posted After the Event

The following committee members were present at the closed sessions of the event:

• Bernard Lo
Chair
• Mark Bicket
• Nicholas Carris
• Roger Chou
• Christine Greco
• Hillary Kunins (via teleconference)
• Marjorie Meyer
• Richard Payne
• Rosemary Polomano
• Eric Sun
• Jennifer Waljee
• Steven Weisman
• Charles Widmer

The following topics were discussed in the closed sessions:

• Standard bias or conflict of interest discussion according to NRC procedures
• Scope of study and work plan
• Began development of a draft framework for evidence-based clinical practice guidelines
• Discussed the draft outline for the report
• Generated potential topics/speakers/format for the first public workshop

The following materials (written documents) were made available to the committee in the closed sessions:

• Agenda book
• Journal articles and related literature
• Draft study outline
• Draft workshop agenda
• Presentation slides from speakers

Date of posting of Closed Session Summary:
November 15, 2018
Publication(s) resulting from the event:

-

Publications

  • Publications having no URL can be seen at the Public Access Records Office
Publications

No data present.