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Project Information

Project Information


Assessment of the Available Scientific Data Regarding the Safety and Effectiveness of Ingredients Used in Compounded Topical Pain Creams


Project Scope:

An ad hoc committee of the National Academies of Sciences, Engineering, and Medicine will conduct a study of the ingredients used in compounded topical pain creams. The committee will identify and analyze the available scientific data relating to the ingredients used in compounded topical pain creams and evaluate how those data translate to the safety and effectiveness of compounded topical pain creams with various combinations of those ingredients. Based on this assessment, the committee will develop a report that summarizes its findings, including addressing the following specific items:

  • Identify the ingredients that the available scientific data suggest may not be safe and/or effective to treat pain topically,
  • Describe the concentrations and combinations of ingredients that may raise significant safety issues, and
  • Comment on the level of benefit expected for the various ingredients given their likelihood of absorption through the skin.

Based on these findings, the report will offer recommendations with respect to how the available evidence of safety and efficacy informs the use of compounded topical pain creams to treat patients.

Status: Current

PIN: HMD-HSP-18-18

Project Duration (months): 16 month(s)

RSO: Jackson, Leigh Miles

Board(s)/Committee(s):

Board on Health Sciences Policy

Topic(s):

Health and Medicine



Geographic Focus:

Committee Membership

Committee Post Date: 02/27/2019

Debra A. Schwinn - (Chair)
Debra A. Schwinn, M.D., is a professor of anesthesiology, pharmacology and biochemistry at the University of Iowa. She served as Dean of the Carver College of Medicine 2012-2016 and is currently Associate Vice President for Medical Affairs (2016-Present). Dr. Schwinn is a member of the Institute of Medicine, Association of American Physicians, past Chair of the Board of Trustees of the International Anesthesiology Research Foundation and Board of Trustees of the Sarnoff Cardiovascular Research Foundation. Her molecular pharmacology laboratory focuses on mechanisms underlying a1-adrenergic receptor regulation and modulation in cardiovascular disease, including the biological effects of genetic variants of these stress receptors. In parallel, over the last few decades, her clinical studies have focused on perioperative genomics, a relatively new field aimed at identifying genetic variants that predict increased risk for perioperative adverse events. Prior to moving to the University of Iowa in 2012, Dr. Schwinn was professor and chair, of anesthesiology and pain medicine, Allan J. Treuer Endowed Professor in Anesthesiology, and adjunct professor of pharmacology and genome sciences at the University of Washington in Seattle. She served for many years on NIH NIGMS advisory council and the external advisory board for the NIH Pharmacogenomics Research Network.
Steven Byrn
Stephen Byrn, Ph. D., is Charles B. Jordan Professor of Medicinal Chemistry in the Department of Industrial and Physical Pharmacy, Purdue University, West Lafayette, Indiana. Dr. Byrn set in motion the development of the field of Solid State Chemistry of Drugs with his books, short courses, and papers on the subject the first of which were first published in the mid-1970’s. He has also educated over 50 Ph. D. students and postdoctoral fellows and taught a wide range of courses at Purdue. Dr. Byrn has had numerous grants including one of the first 13 NIH Centers for AIDS Research. Dr. Byrn is cofounder of Purdue’s graduate programs in regulatory and quality compliance. These programs now constitute the Biotechnology Innovation and Regulatory Science (BIRS) MS program. He is also cofounder of the Purdue-Kilimanjaro School of Pharmacy Sustainable Medicines in Africa project in Moshi, Tanzania. Dr. Byrn has served as chair of the Pharmaceutical Sciences Advisory Committee to the FDA and chaired several USP committees. Dr. Byrn is also cofounder of SSCI, Inc. (Solid State Chemical Information) a cGMP research and information company. SSCI, Inc. is now owned by AMRI. Dr. Byrn has taught a range of courses and short courses involving Medicinal Chemistry, Industrial Pharmacy, Physical Pharmacy, and Solid State Chemistry. Dr. Byrn is an elected Fellow of the AAPS and has received several awards for his research and entrepreneurial activities including the AAPS David Grant Award for Research Achievement and the AAPS Wurster award in pharmaceutics and formulation. Dr. Byrn also received the Purdue University Morrill Award.
Diana D. Cardenas
Diana Cardenas, M.D., M.H.A., is the co-Principal Investigator and co-Project Director of the South Florida Spinal Cord Injury (SCI) Model System. She is Chair Emeritus of the Department of Physical Medicine and Rehabilitation at the University of Miami Miller School of Medicine. She has years of experience with the SCI Model Systems having served as the Principal Investigator of the SCI model system in Seattle from 1990-2006 as well as for the South Florida SCI Model System (2011-2015). Her research focus is pain and other secondary conditions of SCI. She is a board member of the Foundation for Physical Medicine and Rehabilitation which fosters rehabilitation research. She was elected to the Institute of Medicine in 2004. A 1969 graduate of the University of Texas at Austin, Cardenas earned her medical degree at the University of Texas Southwestern Medical School in Dallas in 1973. She completed her internship and residency in physical medicine and rehabilitation medicine at the University of Washington (UW) in 1976, and joined the UW faculty in 1981. She was the clinical director of UWMC’s Spinal Cord Injury Service, and director of the UW Rehabilitation Medicine Spinal Cord Injury Clinic. In 2001 she earned a master’s degree in health administration from the UW.
Barbara I. Crouch
Barbara Insley Crouch, Pharm.D., is the Executive Director of the Utah Poison Control Center (UPCC). She has been the director of the UPCC since 1992. She holds a bachelors degree in pharmacy from the Philadelphia College of Pharmacy and Science, a doctor of pharmacy degree jointly administered by the University of Texas at Austin and the University of Texas Health Science Center at San Antonio and a Masters of Science in Public Health degree from the University of Utah. She completed a clinical toxicology fellowship at the University of Maryland School of Pharmacy and Maryland Poison Center. She has held faculty positions at the University of California San Francisco School of Pharmacy and the Philadelphia College of Pharmacy and Science prior to joining the University of Utah in 1990. Her primary academic appointment is professor (clinical) in the Department of Pharmacotherapy, College of Pharmacy. She established a two year fellowship in Clinical and Applied Toxicology for doctor of pharmacy graduates. Her research interests include the epidemiology of poisonings and facilitation of communication to improve patient care.
Edmund J. Elder
Edmund J. Elder, Jr., Ph.D., R.Ph., is Director of the Zeeh Pharmaceutical Experiment Station in the School of Pharmacy at the University of Wisconsin-Madison (UW). Dr. Elder obtained sixteen (16) years of experience in the pharmaceutical and drug delivery industry prior to joining the UW in 2006. As Director of the Station, he is responsible for providing pharmaceutical and biopharmaceutical R&D support and educational programs for researchers, both on and off campus. He also serves as scientific advisor to the FDA Regulated Research Oversight Committee in the UW Institute for Clinical and Translation Research (ICTR) and serves as chemistry, manufacturing and controls advisor for the ICTR Investigational New Drug/Investigational Device Exemption Consultation Service, which provide support for campus researchers pursuing regulatory filings related to their clinical research. Dr. Elder also holds appointments as an Affiliate in the Pharmaceutical Sciences Division at the UW School of Pharmacy and is the course director for Biotechnology Operations in the MS in Biotechnology Program at the UW School of Medicine and Public Health.
John T. Farrar
John T. Farrar, M.D., Ph.D., has been involved in clinical research for more than 25 years, with a major focus on the study of the efficacy of pain therapeutics and on novel methodology in the design and execution of clinical trials. As a neurologist and a pharmaco-epidemiologist, he has been involved in numerous studies including randomized trials (RCTs), cohort studies, and methodologic studies of pain and associated symptoms such as fatigue, depression, and quality of life in clinical research and practice; these have been conducted with funding he has received from the National Institutes of Health, the U.S. Food and Drug Administration (FDA), private foundations, and industry sources. Currently, he is the Principal Investigator of an FDA funded contract to study the use of opioids in treating pain, the Principal Investigator of the Center of Excellence for Pain Education, he directs the evaluation component of Penn's current Clinical and Translational Science Award (CTSA), and he is a collaborator with the data coordinating center for the U54 multicenter Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) study. Nationally he has served on advisory boards for the FDA, on the National Academy of Science (NAS) committee on Missing Data in Clinical Trials, and on the Institute of Medicine’s (IOM) committee on Relieving Pain in America. He continues to serve roles as an ad hoc reviewer for NIH and the FDA, and as associate editor for the journal Pharmacoepidemiology and Drug Safety (PDS). His current research is focused on the evaluation of new methodologies for understanding how patients report their pain, studies in a large population of patients with pelvic pain, and functional brain imaging in people with pain. At the University of Pennsylvania Perelman School of Medicine, he has co-directed the Biostatistical Analysis Center and the Master of Science in Clinical Epidemiology (MSCE) program for more than ten years. He directs the Introduction to Epidemiology course for medical students. In addition, he continues to see patients, predominately in a palliative care setting.
Carmen R. Green
Carmen Green, M.D., a tenured professor of anesthesiology, with joint appointments in the Medical School's Department of Obstetrics and Gynecology and the Department of Health Management and Policy in the School of Public Health at the University of Michigan. She is co-director for the Community Liaison Core and director of the Healthier Black Elders Center for the Michigan Center for Urban African American Aging Research at the U-M Institute for Social Research. Her research focuses on pain management outcomes, physician decision-making, and access to care - and has documented disparities due to age, race, gender, and class across the lifespan. She has also found community-based structural barriers to health and pain care, including clear disparities in access to pain medication for blacks, women and low-income individuals with chronic pain. Her leadership in developing and diversifying the health professional pipeline includes service on faculty and advisory boards for programs designed to achieve a critical mass of minorities and women in biomedical science. She has been selected for several fellowships focusing on aging, health care and health policy, including the Robert Wood Johnson Health Policy Fellowship at the Institute of Medicine of the National Academies -- where she worked as a health policy analyst on the U.S. Senate's Health Education, Labor, and Pensions Committee and the Children and Families Subcommittee. She is an elected fellow of the New York Academy of Medicine, the Gerontological Society of America, and the Association of University Anesthesiologists. Her work has informed the policy agenda and she has provided expert testimony to state and federal entities.
Friedhelm Sandbrink
Dr. Friedhelm Sandbrink, M.D., is the National Program Director for Pain Management, within the Office of Specialty Care Services in VHA. Dr. Sandbrink completed his residency in Neurology at Georgetown University in Washington DC, and fellowship in Clinical Neurophysiology at the NIH. He is board-certified in Neurology, Clinical Neurophysiology and Pain Medicine. He is Clinical Associate Professor in Neurology at the Uniformed Services University in Bethesda, MD and Assistant Clinical Professor of Neurology at George Washington University in Washington DC. Dr. Sandbrink joined the Department of Veterans Affairs in 2001 and since then has been leading the comprehensive interdisciplinary Pain Management Program within the Neurology Department at the Washington VA Medical Center. He was appointed Deputy National Program Director in VHA in 2014. After serving in Acting capacity (since Oct. 2016), he became the National Program Director for Pain Management in September 2018. He participates in many VHA and national Pain Management initiatives including the Pain Management Best Practices Federal Inter-Agency Task Force (by the Department of Health and Human Services) and the National Pain Strategy Implementation Workgroups. He also participated in the writing of the VA/DoD Clinical Practice Guidelines for Opioid Therapy and for Low Back Pain.
Vinod Shah
Vinod P. Shah, Ph.D., joined NDA Partners as an Expert Consultant in 2016. He has thirty years of experience at the FDA, working in different Divisions, until he retired as a Senior Research Scientist in the Office of Pharmaceutical Sciences in 2005. During his career at FDA, he developed several regulatory guidances for Industry in areas such as dissolution, SUPAC, bioanalysis, bioequivalence, biopharmaceutics, and topical drugs. In addition to his career at FDA, Dr. Shah worked at Sarabhai Chemicals, Baroda, India. He served as Scientific Secretary of the International Pharmaceutical Federation (FIP), as Adjunct faculty at JSS University, India, and Adjunct Professor at College of Pharmacy, University of Kentucky. Dr. Shah is a former Biopharmaceutics Expert Committee member of USP. He was Co-Chair of USP’s Advisory Panel on Dosage Form Performance – Topical/Dermal, and Distinguished Pharmaceutical Scientist/Consultant at USP in Biopharmaceutics. He is a member of the Steering Committee of Non-Biological Complex Drugs (hosted at Lygature, The Netherlands), and Founder and Chairman of the Society of Pharmaceutical Dissolution Science (SPDS) International. In addition, Dr. Shah was a Board Member of the Product Quality Research Institute (PQRI) from 2013-2017 and holds two Honorary Doctorates from Semmelweis University, Hungary and the University of Medicine and Pharmacy “Carol Davila” Bucharest, Romania.
Joyce S. Tsuji
Joyce S. Tsuji, Ph.D., DABT, is a board-certified toxicologist and a Fellow of the Academy of Toxicological Sciences. She specializes in assessing exposure and risks associated with chemicals, and in communication of scientific issues. Dr. Tsuji has worked on projects in the United States and internationally for industry, trade associations, U.S. EPA and state agencies, the U.S. Department of Justice, the Australian EPA, municipalities, and private citizens. Her experience includes toxicology and risk assessment related to a wide variety of chemicals in the environment, work place, food, consumer and personal care products, pharmaceuticals, and medical devices. She has designed and directed dietary and environmental exposure studies and community programs involving health education and biomonitoring for populations potentially exposed to chemicals in the environment, including soil, water, and food-chain exposures. She has served on expert panels on toxicology and health risks issues for the National Academy of Sciences/National Research Council (including their Board on Environmental Studies and Toxicology), Institute of Medicine, and federal and state agencies. Dr. Tsuji earned her BS in Biological Sciences from Stanford University and PhD focused in Environmental Physiology from the Department of Zoology, University of Washington.
Carol S. Wood
Carol S. Wood, Ph.D., is a distinguished staff scientist in the Environmental Science Division of Oak Ridge National Laboratory. She has over 20 years of experience as a toxicologist, with extensive work performing risk assessments of inhalation/pulmonary and oral toxicity from exposure to a variety of chemicals. Her past work has included developing acute exposure guideline levels and provisional advisory levels, in which health-based exposure levels are developed for priority toxic chemicals. These projects often used toxicokinetic data and physiologically based pharmacokinetic models for extrapolating animal toxicology data to humans. Dr. Wood is a past-president of the American Board of Toxicology. She is certified in general toxicology by the American Board of Toxicology. She served on the National Academies Committee on the Review of Clinical Guidance for the Care of Health Conditions Identified by the Camp Lejeune Legislation, and the Committee on Spacecraft Exposure Guidelines, and currently serves on the Committee on Gulf War and Health, Volume 11 (Generational Health Effects of Serving in the Gulf War); she current serves on the Committee on Toxicology. Dr. Wood received her MS in toxicology from Mississippi State University and her PhD in toxicology from Oregon State University.
Leigh Jackson - (Staff Officer)
Leigh Miles Jackson, PhD, (Study Director) is a Senior Program Officer on the Board on Health Sciences Policy (HSP) and serves as the study director for two FDA-sponsored consensus studies related to compounded drug product —one that focuses on the utility of treating patients with compounded bioidentical hormone therapy, and another that focuses on the safety and effectiveness of compounded topical pain creams. Prior to her work on HSP, Leigh served on the Board on Higher Education and Workforce where she directed the consensus study, Minority Serving Institutions: America's Underutilized Resource for Strengthening the STEM Workforce. Prior to this, Leigh worked in the Health and Medicine Division and directed the reports, The Health Effects of Cannabis and Cannabinoids: The Current State of Evidence and Recommendations for Research and Advancing the Power of Economic Evidence to Inform Investments in Children, Youth, and Families. Prior to joining the National Academies, she was a developmental psychopathology and neurogenomics research fellow at Vanderbilt University, where she investigated the role of chronic sleep disturbance and specific epigenetic modifications on the health outcomes of adolescents. Leigh has a bachelor’s degree in chemistry from Wake Forest University and a Ph.D. in molecular and systems pharmacology from Emory University.

Events



Location:

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

Description :   

The National Academies of Sciences, Engineering, and Medicine is pleased to announce the  Committee on the Assessment of the Available Scientific Data Regarding the Safety and Effectiveness of Ingredients Used in Compounded Topical Pain Creams will hold a fourth meeting in Washington, DC on September 30 and October 1. This meeting will have a open session on Tuesday, October 1 from 12:30 to 1pm in Room 201 of the Keck Center Building (500 5th Street NW, Washington DC, 20001). 

During the public session the Committee will gather input from Dr. Ashlee Mattingly, Assistant Professor of Pharmacy Practice and Science at the University of Maryland School of Pharmacy and Dr. A.J. Day from the Professional Compounding Centers of America. 



Registration for in Person Attendance :   
NA


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:  Leigh Miles Jackson
Contact Email:  LMJackson@nas.edu
Contact Phone:  -

Supporting File(s)
Dr. Day Presentation

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:

Debra A. Schwinn
Steven Byrn
Diana Cardenas
Barbara Insley Crouch
Edmund J. Elder
Carmen Green
Friedhelm Sandbrink
Vinod Shah
Joyce S. Tsuji
Carol S. Wood

The following topics were discussed in the closed sessions:

Statement of Task
Research findings

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

Powerpoint slides from PCCA presentation

Date of posting of Closed Session Summary:
October 02, 2019
Publication(s) resulting from the event:

-

Event Type :  
-

Description :   

The National Academies of Sciences, Engineering, and Medicine is holding a closed session meeting for the Committee on the Assessment of the Available Scientific Data Regarding the Safety and Effectiveness of Ingredients Used in Compounded Topical Pain Creams


Registration for Online Attendance :   
NA

Registration for in Person Attendance :   
NA


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:  Leigh Miles Jackson
Contact Email:  LMJackson@nas.edu
Contact Phone:  -

Supporting File(s)
-
Is it a Closed Session Event?
Yes

Closed Session Summary Posted After the Event

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

Debra A. Schwinn
Diana Cardenas
Barbara Insley Crouch
Edmund J. Elder
John T. Farrar
Carmen Green
Friedhelm Sandbrink
Vinod Shah
Joyce S. Tsuji
Carol S. Wood

The following topics were discussed in the closed sessions:

Statement of Task
Initial drafts of the report
Additional data-gathering needs

Date of posting of Closed Session Summary:
August 09, 2019
Publication(s) resulting from the event:

-


Location:


Keck Center
500 5th Street Northwest
Washington, DC, 20001
USA

Event Type :  
Meeting

Description :   

The National Academies of Sciences, Engineering, and Medicine is pleased to announce the second open session meeting for the Committee on the Assessment of the Available Scientific Data Regarding the Safety and Effectiveness of Ingredients Used in Compounded Topical Pain Creams. The public workshop will be held on May 20th, 2019 in the Keck Center Building in Room 100 (500 5th Street NW, Washington DC, 20001) from 9:00am to 4:30pm (ET).

This meeting will provide an opportunity for the committee to gather data and context information from relevant subject matter experts. There will also be a short Q&A session with the viewing public.





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:  Leigh Miles Jackson
Contact Email:  LMJackson@nas.edu
Contact Phone:  -

Agenda
Agenda

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:

Debra A. Schwinn
Steven Byrn
Diana Cardenas
Barbara Insley Crouch
Edmund J. Elder
John T. Farrar
Carmen Green
Friedhelm Sandbrink
Vinod Shah
Joyce S. Tsuji
Carol S. Wood

The following topics were discussed in the closed sessions:

Statement of Task
Outcomes of the public workshop
Additional data-gathering needs

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

Summary of recent materials provided by FDA

Date of posting of Closed Session Summary:
May 23, 2019
Publication(s) resulting from the event:

-

Event Type :  
TeleConference

Description :   

Discussion to plan the agenda for the second committee meeting.


Registration for Online Attendance :   
NA

Registration for in Person Attendance :   
NA


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:  Leigh Miles Jackson
Contact Email:  LMJackson@nas.edu
Contact Phone:  -

Supporting File(s)
-
Is it a Closed Session Event?
Yes

Publication(s) resulting from the event:

-


Location:

Keck Center
500 5th St NW, Washington, DC 20001

500 Fifth Street NW
Keck 101
Washington, DC, 20001
USA

Event Type :  
Meeting

Description :   

The National Academies of Sciences, Engineering, and Medicine is pleased to announce the first open session meeting for the Committee on the Assessment of the Available Scientific Data Regarding the Safety and Effectiveness of Ingredients Used in Compounded Topical Pain Creams. The public meeting will be held on March 25th, 2019 in the Keck Center Building in Room 101 (500 5th Street NW, Washington DC, 20001) from 1:00pm to 5:00pm (ET).

This meeting will provide an opportunity for the committee to discuss their Statement of Task with representatives from the U.S. Food and Drug Administration (the study sponsors) and gather data and context information from relevant subject matter experts. There will also be a short Q&A session with the viewing public.


Registration for Online Attendance :   
https://nasem-paincreams-meeting1.eventbrite.com

Registration for in Person Attendance :   
https://nasem-paincreams-meeting1.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:  Leigh Miles Jackson
Contact Email:  LMJackson@nas.edu
Contact Phone:  -

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:

Debra A. Schwinn
Steven Byrn
Diana Cardenas
Barbara Insley Crouch
Edmund J. Elder
John T. Farrar
Carmen Green
Friedhelm Sandbrink
Vinod Shah
Joyce S. Tsuji
Carol S. Wood

The following topics were discussed in the closed sessions:

• Statement of task (SOT) and the scope of the study discussion with study sponsor and stakeholders
• Discussion of potential biases and conflicts of interest
• Study approach
• Data gathering needs
• Future meeting topics

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

Material from PCCA and FDA

Date of posting of Closed Session Summary:
April 03, 2019
Publication(s) resulting from the event:

-

Publications

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

No data present.