REMINDER! Free 1-hr "Live" CME/AAPA/CNE/CPE/CPT/CPH Webinar on: Drug Shortages - FDA Efforts, Current Challenges and Future Goals sponsored by the Division of Drug Information

FDA’s Division of Drug Information is presenting a series of continuing education webinars targeting the needs of all health care professionals.

FDA Drug Topics: Drug Shortages: FDA Efforts, Current Challenges and Future Goals Will be held on:  November 19, 2019 Time:  1:00 pm to 2:00 pm (EST) To register for the online meeting, please visit: https://collaboration.fda.gov/ddi111919/event/registration.html After registering, you will receive a calendar invitation with details on how to join the online meeting.

Activity Outline Description: This series of educational webinars is designed to aid physicians, physician assistants, nurses, pharmacists, pharmacy technicians, certified public health professionals, other health care professionals, and students, to provide better patient care by knowing how to find relevant FDA regulatory information that will improve drug safety. This webinar will introduce the FDA's Drug shortage program, explain how the agency is addressing drug shortages and speak to the various challenges that lead to drug shortages. References: FDA Sixth Annual Report on Drug Shortages for Calendar Year 2018 FDA Shortages Additional News and Information Federal Food, Drug, and Cosmetic Act (FD&C Act), Section 506C (21 USC 356c) Federal Register Final Rule, 80 FR 38915 (July 8, 2015), Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products. See also 21 CFR 310.306, 314.81, and 600.82. CDER MAPP 4190.1 Rev. 3, Drug Shortage Management (11/1995; Rev. 1, 9/2006; Rev. 2, 9/2014; Rev. 3, 11/2018) Executive Order 13588 (October 31, 2011), Reducing Prescription Drug Shortages Series Objectives: Explain how to utilize FDA’s drug information, medication safety resources, and regulatory guidance, to improve delivery of patient care and optimize outcomes. Describe and inform health care providers of recent labeling changes which would impact prescribing and medication management to optimize patient care. Learning Objectives: After completion of this activity, the participant will be able to: Identify what FDA can and cannot do to prevent and mitigate drug shortages. Describe how to report a drug shortage to the FDA. Summarize the pharmaceutical Industry’s role in drug shortage prevention and mitigation. Target Audience: This activity is intended for physicians, physician assistants, nurses, pharmacists, pharmacy technicians, certified public health professionals, other health care professionals, and students. Schedule: 1:00 pm - 2:00 pm – FDA Drug Topics: Drug Shortages: FDA Efforts, Current Challenges and Future Goals presented by Leo Zadecky, PharmD, Senior Program Management Officer, FDA/CDER/IO/DSS, and Jin Ahn, PharmD, Senior Program Management Officer, FDA/CDER/IO/DSS.

Continuing Education: Accreditation:

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.

This activity was planned by and for the healthcare team, and learners will receive 1.00 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 AMA PRA Category 1 Credit(s)™. Physicians and physician assistants 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 JA0002895-0000-19-020-L04-P, and ACPE Universal Activity Number JA0002895-0000-19-020-L04-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

This activity is designated for 1.00 AAPA Category 1 CME credits. FDA Center for Drug Evaluation and Research has been authorized by the American Academy of PAs (AAPA) to award AAPA Category 1 CME credit for activities planned in accordance with AAPA CME Criteria. 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: Physicians, physician assistants, nurses, pharmacists, pharmacy technicians, and those claiming non-physician CME: participants must attest to their attendance and complete the final activity evaluation survey via the CE Portal (ceportal.fda.gov). Final activity evaluations must be completed within two weeks after the activity - no exceptions. Pharmacy participants: Pharmacists and pharmacy technicians will need their NABP e-profile ID number as well as their DOB in MMDD format in order to claim CE credit.   Important Note regarding completion of evaluations and receiving credit: Attendees have 14 days from the last day of the activity to log in, attest to your attendance, and complete the required evaluation survey, to claim credit. Physicians and nurses may then view/print statement of credit. Pharmacists should log into the CPE monitor 10 weeks after the activity to obtain their CE credit. Disclosure: Faculty: Zadecky, Leo, PharmD, Senior Program Management Officer, FDA/CDER/IO/DSS - may reference off-label use. Ahn, Jin, PharmD, Senior Program Management Officer, FDA/CDER/IO/DSS - nothing to disclose Planning Committee: Burke, Kara, PharmD, Team Leader/Pharmacist, FDA/CDER/OCOMM/DDI - nothing to disclose Cao, Christian, MPAS, PA-C, Safety Evaluator Team Leader, FDA/CDER/OSE/DPV - nothing to disclose DeFronzo, Kimberly, RPh, MS, MBA, Consumer Safety Officer, FDA/CDER/OCOMM/DDI - nothing to disclose Giroux, Virginia, MSN, FNP-BC, Associate Director for Accreditation, FDA/CDER/OEP/DLOD - nothing to disclose Navin, Lesley, RN, MSN, Consumer Safety Officer, FDA/CDER/OCOMM/DDI - nothing to disclose Kapoor, Rama, MD, Medical Officer, FDA - nothing to disclose CE Consultation and Accreditation Team: Thompson, Lisa, MSHA, MBA, CE Consultant, FDA/CDER/OEP/DLOD - nothing to disclose Giroux, Virginia, MSN, FNP-BC, Associate Director for Accreditation, FDA/CDER/OEP/DLOD - nothing to disclose Zawalick, Karen, CE Team Leader, FDA/CDER/OEP/DLOD - nothing to disclose Registration Fees and Refunds: Registration is complimentary therefore refunds are not applicable. Please direct your comments or questions via email to DDIWebinars@fda.hhs.gov. To learn more about future dates and registration, please visit: www.fda.gov/DDIWebinars.