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U.S. Food & Drug Administration
Continuing Education and Accreditation
Division of Learning and Organizational Development
Center for Drug Evaluation and Research
Activity Outline
FDA Drug Topics: An Update on Transmucosal Buprenorphine and Dental Caries
December 10, 2024
Zoom

Activity Coordinators:
Thanh Nguyen-Chu (Thanh.Nguyen-Chu@fda.hhs.gov),  Kara Burke (Kara.Burke@fda.hhs.gov),  Kimberly De Fronzo (Kimberly.Defronzo@fda.hhs.gov)
Description

In this webinar, we will highlight the regulatory action taken by FDA regarding a post-market safety signal of transmucosal buprenorphine products and dental caries. The audience will gain knowledge on the science behind this action, as well as increase their awareness of the national opioid crisis, treatments for opioid use disorder, and FDA's regulatory authority for addressing safety issues in drug labeling. Upon completion of the activity, healthcare providers will leave with an improved understanding of these adverse events and be better equipped to inform patients.

References
  • Dowell D, Brown S, Gyawali S, et al. Treatment for Opioid Use Disorder: Population Estimates — United States, 2022. MMWR Morb Mortal Wkly Rep 2024;73:567–574. DOI: http://dx.doi.org/10.15585/mmwr.mm7325a1
  • Suzuki, J., L. Mittal, and S. B. Woo. 2013. 'Sublingual buprenorphine and dental problems: a case series', Prim Care Companion CNS Disord, 15.
  • Suzuki, J., and E. M. Park. 2012. 'Buprenorphine/naloxone and dental caries: a case report', Am J Addict, 21: 494-5.
  • Buprenorphine: Drug Safety Communication - FDA warns about dental problems with buprenorphine medicines dissolved in the mouth to treat opioid use disorder and pain, retrieved from: https://www.fda.gov/safety/medical-product-safety-information/buprenorphine-drug-safety-communication-fda-warns-about-dental-problems-buprenorphine-medicines. Posted January 12, 2022.
  • Etminan, Mahyar, Ramin Rezaeianzadeh, Abbas Kezouh, and Kevin Aminzadeh. 2022. 'Association Between Sublingual Buprenorphine-Naloxone Exposure and Dental Disease', JAMA, 328: 2269-71.
  • Barus, R., F. Montastruc, C. de Canecaude, H. Bagheri, A. Sommet, and M. Lapeyre-Mestre. 2023. 'Sublingual/Buccal buprenorphine and dental problems: a pharmacovigilance study', Expert Opin Drug Saf, 22: 1283-87.
Learning Objectives
  • Discuss the national opioid crisis, opioid use disorder, and available treatments.
  • Describe cases of dental caries with the use of transmucosal buprenorphine-containing products.
  • Review FDA’s framework for updating product labeling and explain FDA’s findings and the resulting regulatory action.
  • Summarize how healthcare providers can help mitigate these adverse events.
Target Audience
This activity is intended for physicians, pharmacists, pharmacy technicians, nurses, Certified Public Health (CPH), and physician assistants.
Registration Information
To register for this activity, click here

Registration is complimentary; therefore refunds are not applicable. For information on how to register to attend this activity, please contact the Activity Coordinator(s) listed above.
Agenda
Day 1 December 10, 2024
Time Topic Speaker
1:00 - 2:00 PM EST FDA Drug Topics: An Update on Transmucosal Buprenorphine and Dental Caries Mark Liberatore, PharmD, RAC
Continuing Education Accreditation
Jointly Accredited Provider
In support of improving patient care, FDA Center for Drug Evaluation and Research is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) to provide continuing education for the healthcare team.
ICPE Credit
This activity was planned by and for the healthcare team, and learners will receive 1 Interprofessional Continuing Education (IPCE) credit(s) for learning and change.
CME
FDA Center for Drug Evaluation and Research designates this live activity for a maximum of 1.00 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
CPE
This knowledge-based activity has been assigned ACPE Universal Activity Number JA0002895-0000-24-100-L08-P, and ACPE Universal Activity Number JA0002895-0000-24-100-L08-T for 1.00 contact hour(s).
CNE
FDA Center for Drug Evaluation and Research designates this activity for 1.00 contact hour(s).
AAPA
FDA Center for Drug Evaluation and Research has been authorized by the American Academy of Physician Associates (AAPA) to award AAPA Category 1 CME credit for activities planned in accordance with AAPA CME Criteria. This activity is designated for 1.00 AAPA Category 1 CME credits. PAs should only claim credit commensurate with the extent of their participation.
CPH
Up to 1.00 CPH Recertification Credits may be earned at this event.
Requirements for Receiving CE Credit

All learners claiming credit must attest to their attendance and complete all required activity evaluation(s) in the FDA CE Portal (ceportal.fda.gov) within 14 days after an activity ends. Upon completion, learners may view/print statement of credit.

Attention NABP Pharmacists and Pharmacy Technicians: The FDA CE Team will report your credit to the National Association of Boards of Pharmacy (NABP) provided you add your NABP ID and date of birth to your profile in the FDA CE Portal. The only official Statement of Credit is the one you pull from CPE Monitor®. If you do not see your credit reflected on CPE Monitor®* after 45 days of attestation, please contact FDACETeam@fda.hhs.gov.
*CPE Monitor® sets a strict 60-day limit on uploading credits.

Disclosure

Faculty
  • Liberatore, Mark, PharmD, RAC, Deputy Director for Safety, HHS/FDA/CDER/OND/ON/DAAP - nothing to disclose

Planning Committee
  • Burke, Kara, PharmD, Team Leader/Pharmacist, FDA/CDER/OCOMM/DDI - nothing to disclose
  • Cao, Christian, MPAS, PA-C, Cross-Discipline Safety Advisor, FDA/CDER/OSE/OPE - nothing to disclose
  • De Fronzo, Kimberly, RPh, MS, MBA, Consumer Safety Officer, FDA/CDER/OCOMM/DDI - nothing to disclose
  • Kapoor, Rama, MD, Senior Physician, FDA - nothing to disclose
  • Nguyen-Chu, Thanh, PharmD, Pharmacist, FDA/CDER/OCOMM/DDI - nothing to disclose
  • Paraoan, Dianne, MPH, BSN, RN, Associate Director for Regulatory Affairs, FDA/ CDER/ OMP - nothing to disclose

CE Consultation and Accreditation Team
  • Littlefield, Jr, Kenneth P., Training Specialist, FDA/CDER/OEP/DLOD - nothing to disclose
  • Bryant, Traci, M.A.T., Lead Training Specialist, FDA/CDER/OEP/DLOD - nothing to disclose
  • Wood, Sara, Accreditation Program Administrator, CECAT, FDA/CDER/OEP/DLOD - nothing to disclose
Any relationship shown above in italics has been divested within the last 24 months and is therefore considered mitigated.
All relevant financial relationships have been mitigated.
Requirements for Certificate of Completion (Non CE)
Must attend 100% of the activity.