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Suggested Citation:"Appendix A: Study Approach." National Academies of Sciences, Engineering, and Medicine. 2020. Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25689.
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Appendix A

Study Approach

In response to a request by the U.S. Food and Drug Administration (FDA), the National Academies of Sciences, Engineering, and Medicine’s Committee on the Assessment of the Available Scientific Data Regarding the Safety and Effectiveness of Ingredients Used in Compounded Topical Pain Creams was charged with identifying and analyzing the available scientific data relating to the ingredients used in compounded topical pain creams and evaluating how these data translate to the safety and effectiveness of compounded topical pain creams with various combinations of those ingredients. The committee’s final report will summarize the current evidence on compounded topical pain creams and offer recommendations on their use.

COMMITTEE EXPERTISE

The National Academies appointed an 11-member committee of experts to address objectives in the Statement of Task. The resulting committee included experts in a variety of disciplines and fields, including drug research and development, pharmacology, toxicology, pain management and care, drug evaluation, epidemiology, and pharmaceutical compounding and manufacturing.

MEEETINGS AND INFORMATION-GATHERING ACTIVITIES

The committee deliberated from March 2019 to February 2020, during the course of which it held four in-person meetings (March, May, July, and September) and two half-day virtual meetings. The March, May, and

Suggested Citation:"Appendix A: Study Approach." National Academies of Sciences, Engineering, and Medicine. 2020. Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25689.
×

September meetings included portions open to the public. The committee meeting in July was held in closed session.

In the three open-session meetings, the committee heard presentations from content experts on a wide variety of topics related to the committee’s charge. These open-session meetings also included periods of public comment, to provide stakeholders with an opportunity to present the committee with any additional relevant information. The agendas for the three open-session meetings are presented in the section below.

In addition to the data collection efforts within the open-session meetings, the committee also received and reviewed a number of resources submitted by various stakeholders, including American Association of Poison Control Centers, American Chronic Pain Association, FDA, Massachusetts State Board of Pharmacy, National Association of Boards of Pharmacy, and Professional Compounding Centers of America. These resources include, but are not limited to, data on active pharmaceutical ingredients commonly used in compounded topical pain creams, literature reviews, findings from national surveys related to the cost and use of compounded topical pain creams, adverse event reports, and guidance on the federal and state regulations and oversight for compounded preparations.

First Committee Meeting

Open Session Agenda
March 25, 2019
National Academies Keck Building
500 Fifth Street, NW, Washington, DC 20001

1:15 p.m. Welcome and Introductions
DEBRA A. SCHWINN, Committee Chair
1:20 p.m. Sponsor Perspective on Charge to the Committee
RUEY JU, Study Sponsor
U.S. Food and Drug Administration
CHARLES GANLEY, Study Sponsor
U.S. Food and Drug Administration
2:00 p.m. Discussion with Committee
2:45 p.m. BREAK
Suggested Citation:"Appendix A: Study Approach." National Academies of Sciences, Engineering, and Medicine. 2020. Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25689.
×
3:00 p.m. Key Stakeholder Perspectives
BARBARA EXUM, Director
Center for Compounding Practice and Research Virginia Commonwealth University
CAPT. EDWARD NORTON, MSC, USN, Pharmacy Specialty Leader
Defense Health Headquarters
TIMOTHY MCPHERSON, Professor
Department of Pharmaceutical Sciences
Southern Illinois University, Edwardsville
JEFFERY FUDIN, Clinical Pharmacy Specialist and Director
[Remote]
PGY-2 Pharmacy Pain Residency Programs
Stratton Veterans Affairs Medical Center
4:30 p.m. Discussion with Committee
5:00 p.m. Public Comments
5:45 p.m. ADJOURN

Second Committee Meeting

Open Session Workshop Agenda
May 20, 2019
National Academies Keck Building
500 Fifth Street, NW, Washington, DC 20001

9:00 a.m. Welcome and Opening Remarks
LEIGH MILES JACKSON, Ph.D.
National Academies of Sciences, Engineering, and Medicine
DEBRA A. SCHWINN, M.D., Committee Chair
9:10 a.m. Evidence-Based Pain Medicine and Pain Management
DANIEL B. CARR, M.D.
Tufts University School of Medicine
9:30 a.m. Discussion with Committee
Suggested Citation:"Appendix A: Study Approach." National Academies of Sciences, Engineering, and Medicine. 2020. Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25689.
×
9:45 a.m. Compounding Regulation Overview
SARA ROTHMAN, M.P.H.
U.S. Food and Drug Administration
GREGG JONES, R.Ph.
National Association of Boards of Pharmacy
10:15 a.m. Discussion with Committee
11:00 a.m. Dermal and Transdermal Background
S. NARASIMHA MURTHY, Ph.D.
University of Mississippi
11:15 a.m. Discussion with Committee
11:45 a.m. BREAK
12:00 p.m. Background on the Curriculum and Training for Compounding Pharmacists
ROBERT SHREWSBURY, Ph.D.
University of North Carolina
Pharmacists and Compounders Perspectives
MARK HANUS, R.Ph.
Oakdell Pharmacy
LINDA MCELHINEY, Pharm.D.
Indiana University Health
JOHN VOLIVA, R.Ph.
Hook’s Apothecary
Compounding Pharmacy
A. J. DAY, Pharm.D.
Professional Compounding Centers of America
GUS BASSANI, Pharm.D.
Professional Compounding Centers of America
12:35 p.m. Discussion with Committee
1:15 p.m. LUNCH BREAK
Suggested Citation:"Appendix A: Study Approach." National Academies of Sciences, Engineering, and Medicine. 2020. Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25689.
×
2:15 p.m. Patient-Focused Perspectives
PENNEY COWAN, Founder and Chief Executive Officer
American Chronic Pain Association
2:30 p.m. Discussion with Committee
3:00 p.m. BREAK
3:10 p.m. Provider Perspectives
JEANNINE BRANT, Ph.D., Clinical Nurse Specialist, Oncology
Billings Clinic
WILLIAM ZEMPSKY, M.D.
Pain and Palliative Medicine
Connecticut Children’s Medical Center
ROBERT DIMEFF, M.D.
Texas Orthopaedic Associates
Texas Physician NHL Dallas Stars
Past President American Medical Society for Sports Medicine
3:30 p.m. Discussion with Committee
4:00 p.m. Public Comments
4:30 p.m. ADJOURN

Fourth Committee Meeting

Open Session Agenda
October 1, 2019
National Academies Keck Building
500 Fifth Street, NW, Washington, DC 20001

12:30 p.m. Welcome
DEBRA A. SCHWINN, M.D., Committee Chair
Overview of UMD-CERSI’s Review of 503B Compounding Bulks List Ingredients

ASHLEE MATTINGLY, Pharm.D., BCPS, Assistant Professor of Pharmacy Practice and Science

Suggested Citation:"Appendix A: Study Approach." National Academies of Sciences, Engineering, and Medicine. 2020. Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25689.
×
Brief Review of Sample Costs for Compounded Topical Pain Creams

A. J. DAY, Pharm.D., Vice President of Clinical Services, Professional Compounding Centers of America

1:30 p.m. Public Comments
1:35 p.m. ADJOURN
Suggested Citation:"Appendix A: Study Approach." National Academies of Sciences, Engineering, and Medicine. 2020. Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25689.
×
Page 241
Suggested Citation:"Appendix A: Study Approach." National Academies of Sciences, Engineering, and Medicine. 2020. Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25689.
×
Page 242
Suggested Citation:"Appendix A: Study Approach." National Academies of Sciences, Engineering, and Medicine. 2020. Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25689.
×
Page 243
Suggested Citation:"Appendix A: Study Approach." National Academies of Sciences, Engineering, and Medicine. 2020. Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25689.
×
Page 244
Suggested Citation:"Appendix A: Study Approach." National Academies of Sciences, Engineering, and Medicine. 2020. Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25689.
×
Page 245
Suggested Citation:"Appendix A: Study Approach." National Academies of Sciences, Engineering, and Medicine. 2020. Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25689.
×
Page 246
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Pain is both a symptom and a disease. It manifests in multiple forms and its treatment is complex. Physical, social, economic, and emotional consequences of pain can impair an individual’s overall health, well-being, productivity, and relationships in myriad ways. The impact of pain at a population level is vast and, while estimates differ, the Centers for Disease Control and Prevention reported that 50 million U.S. adults are living in pain. In terms of pain’s global impact, estimates suggest the problem affects approximately 1 in 5 adults across the world, with nearly 1 in 10 adults newly diagnosed with chronic pain each year.

In recent years, the issues surrounding the complexity of pain management have contributed to increased demand for alternative strategies for treating pain. One such strategy is to expand use of topical pain medications—medications applied to intact skin. This nonoral route of administration for pain medication has the potential benefit, in theory, of local activity and fewer systemic side effects. Compounding is an age-old pharmaceutical practice of combining, mixing, or adjusting ingredients to create a tailored medication to meet the needs of a patient. The aim of compounding, historically, has been to provide patients with access to therapeutic alternatives that are safe and effective, especially for people with clinical needs that cannot otherwise be met by commercially available FDA-approved drugs.

Compounded Topical Pain Creams explores issues regarding the safety and effectiveness of the ingredients in these pain creams. This report analyzes the available scientific data relating to the ingredients used in compounded topical pain creams and offers recommendations regarding the treatment of patients.

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