Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use (2020)
Chapter: Appendix A: Study Approach
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
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 |
| 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 |
| 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 |
| 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 |
| 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 |
