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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
Engaging Providers to Address Knowledge Gaps on Medication Use in Pregnancy and Lactation -- Enduring Material
November 16, 2022 - October 27, 2024
Zoom virtual webinar

Activity Coordinator:
Erin South (Erin.South@fda.hhs.gov)
Description

As you learned in the previous session, the FDA implemented a new pregnancy and lactation labeling system starting in 2015. Although the new labeling system improved the presentation of information in prescription medication labeling, it highlighted the gaps in human data and the need for adequate human data regarding the use of prescription medication in pregnant and lactating individuals. This presentation will provide an overview of 1.) the types of studies that are enrolling pregnant and lactating individuals, 2.) the work that FDA is doing to advance research in pregnant and lactating individuals, and 3.) information on how providers can become involved in advancing research in pregnant and lactating individuals.

References
  • Bianchi DW, Kaeser L, Cernich AN. Involving Pregnant Individuals in Clinical Research on COVID-19 Vaccines. JAMA. 2021 Mar 16;325(11):1041-1042. doi: 10.1001/jama.2021.1865. PMID: 33566088.
  • Byrne JJ, Spong CY. "Is It Safe?" - The Many Unanswered Questions about Medications and Breast-Feeding. N Engl J Med. 2019 Apr 4;380(14):1296-1297. doi: 10.1056/NEJMp1817420. PMID: 30943334.
  • Roca C, Sahin L, Yao L. Collaboration in Regulatory Science to Facilitate Therapeutic Development for Pregnant Women. Curr Pharm Des. 2019;25(5):609-614. doi: 10.2174/1381612825666190328112202. PMID: 30919771.
  • Dinatale M, Roca C, Sahin L, Johnson T, Mulugeta LY, Fletcher EP, Yao L. The Importance of Clinical Research in Pregnant Women to Inform Prescription Drug Labeling. J Clin Pharmacol. 2020 Dec;60 Suppl 2:S18-S25. doi: 10.1002/jcph.1761. PMID: 33274508.
  • Postapproval Pregnancy Safety Studies – Draft Guidance for Industry. https://www.fda.gov/media/124746/download
  • Pharmacokinetics in Pregnancy — Study Design, Data Analysis, and Impact on Dosing and Labeling – Draft Guidance for Industry. https://www.fda.gov/media/71353/download
Learning Objectives
  • Describe the data gaps that exist regarding the use of medications in pregnant and lactating individuals.
  • Discuss FDA efforts to advance research in pregnant and lactating individuals.
  • Describe types of studies that are currently enrolling pregnant and lactating individuals.
  • Examine how healthcare providers can become involved and have an impact in advancing research in pregnant and lactating individuals.
Target Audience
This activity is intended for physicians, pharmacists, pharmacy technicians, and nurses.
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 enduring material 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 JA0002895-0000-22-086-H04-P, and ACPE Universal Activity Number JA0002895-0000-22-086-H04-T for 1.00 contact hour(s).
CNE
FDA Center for Drug Evaluation and Research designates this activity for 1.00 contact hour(s).
Requirements for Receiving CE Credit

Physicians, pharmacists, nurses, pharmacist techs, and those claiming non-physician CME: participants must attest to their attendance and complete the final activity evaluation via the CE Portal (ceportal.fda.gov). For multi-day activities, participants must attest to their attendance and complete the faculty evaluation each day. Final activity evaluations must be completed within two weeks after the activity - no exceptions.

Attention Pharmacists and Pharmacy Techs: Failure to provide your correct NABP AND Date of Birth information, in the required format, may result in the loss of credit for this activity. NABP profile number should be the 6-7 digit profile number assigned by the CPE Monitor and your birth date should be in the MMDD format (e.g. 0721) Do not provide your pharmacy license number. Please click the "My Account" tab and then navigate to "Edit Contact Information" to verify that your information is correct.

Important Note regarding completion of evaluations and receiving credit
Attendees have 14 days from the last day of the activity to log in, complete the required evaluation(s) and attest to your attendance to claim credit.Physicians and nurses may then view/print statement of credit. Pharmacists should log into the CPE monitor 8 weeks after the last session of the activity to obtain their CE credit.
Disclosure

Faculty
  • Bersoff-Matcha, Susan, MD, Deputy Director, OC - nothing to disclose
  • Dinatale, Miriam, DO, Team Leader, Food and Drug Administration - nothing to disclose
  • Johnson, Tamara, MD, Lead Medical Officer, CDER/OND - nothing to disclose
  • Sahin, Leyla, MD, Deputy Director for Safety (Acting), Division of Pediatrics and Maternal Health - nothing to disclose
  • South, Erin, PharmD, Pharmacist, FDA - nothing to disclose

Planning Committee
  • Bersoff-Matcha, Susan, MD, Deputy Director, OC - nothing to disclose
  • Shahidzadeh, Rokhsareh, RN, MSN, Senior Regulatory Health Education Specialist, FDA - nothing to disclose
  • South, Erin, PharmD, Pharmacist, FDA - nothing to disclose

CE Consultation and Accreditation Team
  • Bueide, Rachel E., MPhil, Training Specialist, FDA/CDER/OEP/DLOD - nothing to disclose
  • Zawalick, Karen, CE Team Leader, 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.
Registration Information
Registration is complimentary; therefore refunds are not applicable.
Requirements for Certificate of Completion (Non CE)
Must attend 100% of the activity.

Initial Release Date
November 16, 2022

Expiration Date
October 27, 2024