- June 7 - 8, 2021
9:00 AM - 5:00 PM ET
The public workshop will be held virtually. The Food & Drug Administration (FDA) is announcing a two-day workshop to discuss the topic of Morphine Milligram Equivalents (MMEs).
ABOUT THE PUBLIC WORKSHOP
The Food and Drug Administration (FDA or Agency) is announcing the following public workshop entitled ‘‘Morphine Milligram Equivalents: Current Applications and Knowledge Gaps, Research Opportunities, and Future Directions.’’ The purpose of the workshop is to bring stakeholders together to discuss the scientific basis of morphine milligram equivalents (MMEs) with the goals of providing an understanding of the science and data underlying existing MME calculations for opioid analgesics, discussing the gaps in these data, and discussing future directions to refine and improve the scientific basis of MME applications.
The public workshop will be held virtually and via webcast on June 7 and 8, 2021, from 9 a.m. to 5 p.m. Eastern Time each day. Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone. Registration is free.
To register for this workshop, visit: https://morphinemilligramequivalent.eventbrite.com/
If you need special accommodations due to a disability, please contact Kimberly Compton (see FOR FURTHER INFORMATION CONTACT) no later than May 17, 2021.
REQUEST FOR ORAL PRESENTATIONS
During online registration you may indicate if you wish to present during the public comment session. Submit a brief statement of the topic you wish to address and the names and addresses of proposed participants. We will do our best to accommodate requests to make public comments. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations and request time for a joint presentation.
All requests to make oral presentations must be received by May 24, 2021. We will determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin and will select and notify participants by May 31, 2021. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled public comment session, FDA may conduct a lottery to determine the speakers for the scheduled public comment session.
If selected for presentation, any presentation materials must be emailed to Kimberly Compton (see FOR FURTHER INFORMATION CONTACT) no later than June 3, 2021. No commercial or promotional material will be permitted to be presented or distributed at the public workshop.
- Agenda (PDF - 79 KB)
- Questions for Discussion (PDF - 189 KB)
- Participant List (PDF - 133 KB)
- Biographies and Disclosures (PDF - 205 KB)
- Final Condensed Transcript with Index Day 1
- Introduction: Morphine Milligram Equivalents (MMEs) Current Applications and Knowledge Gaps, Research Opportunities, and Future Directions - Grace Chai, PharmD
- Impact of Science on Real Life Experiences - Penney Cowan
- Overview of Current Applications and Uses of MMEs - Corinne Woods, RPh, MPH
- Calculating Conversations in Opioid Conversions - Mary Lynn McPherson, PharmD, MA, MDE, BCPS
- Individual Patient & Medication Factors that Invalidate Morphine Milligram Equivalents - Jeffrey Fudin, PharmD, FCCP, FASHP, FFSMB
- Opioid Prescribing and the Opioid Safety Initiative in the Veterans Health Administration - Friedhelm Sandbrink MD, Thomas Emmendorfer, PharmD & Francesca Cunningham, PharmD
- Overview of the Opioid NDC and MME Analytical File Compiled by CDC - Kun Zhang, PhD
- MHRA-UK Work in Development of MME Tables - Justin Pittaway-Hay, PhD
- Improving Information for Opioids Prescribers on the Safest Possible Effective Dose of Morphine or Equivalent: A UK Perspective - Maria Luisa Molinari, MD
Public Comment Session
- Final Condensed Transcript with Index Day 2
- Opioid Conversion Information in Approved Labeling - Mary Therese O’Donnell MD, MPH
- Nonclinical Pharmacology and Toxicology Considerations Regarding Opioid Comparisons and Risk Assessments (Basic Opioid Pharmacology 101) - R. Daniel Mellon, PhD & Donna A. Volpe, PhD
- MME Calculations and Abuse Liability Considerations - Chad J. Reissig, PhD
- Oral and Intravenous Oxymorphone: Relative Potency Compared to Other µ Opioid Agonists in Humans - Shanna Babalonis, PhD
- Opioid Potency: Pharmacological and Non-pharmacological Factors - Sandra Comer, PhD
- Inches, Centimeters, and Yards: Overlooked Definition Choices Inhibit Interpretation of Morphine Equivalence - Nabarun Dasgupta, MPH, PhD
- June 7th - https://collaboration.fda.gov/pyxzlz9xddby/
- June 8th - https://collaboration.fda.gov/pbyvk2jfr8x4/
FOR FURTHER INFORMATION CONTACT:
Kimberly Compton, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 3168, Silver Spring, MD 20993–0002, 301– 796–1191, firstname.lastname@example.org