Free 1-hr "Live" CME/AAPA/CNE/CPE/CPT/CPH Webinar on An Overview of Naloxone and FDAs Efforts to Expand Access - Drug Information Update

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

FDA Drug Topics: An Overview of Naloxone and FDA’s Efforts to Expand Access   Will be held on:   September 29, 2020   Time:  1:00 pm to 2:00 pm (EDT)   To register for the online meeting, please visit:  https://collaboration.fda.gov/ddi092920/event/registration.html   After registering, you will receive a calendar invitation with details on how to join the online meeting.   An email will be sent to all participants by the next business day with instructions on how to claim CE and a copy of the presentation slides!

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 is designed to aid healthcare professionals in understanding the forms of naloxone that are available for the emergency treatment of acute opioid overdose and will also increase knowledge of steps that FDA has taken to expand community access to naloxone. References: Naloxone hydrochloride nasal spray (Narcan Nasal Spray) labeling: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208411Orig1s002lbl.pdf. Naloxone hydrochloride injection solution (Evzio) labeling: https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/209862lbl.pdf. New Recommendations for Naloxone: https://www.fda.gov/drugs/drug-safety-and-availability/new-recommendations-naloxone. Cohen BR, Mahoney KM, Baro E, Squire C, Beck M, Travis S, Pike-McCrudden A, Izem R, Woodcock J. FDA Initiative for Drug Facts Label for Over-the-Counter Naloxone. N Engl J Med. 2020 May 28;382(22):2129-2136. doi: 10.1056/NEJMsa1912403: https://www.nejm.org/doi/full/10.1056/NEJMsa1912403. Guidance for Industry Label Comprehension Studies for Nonprescription Drug Products: https://www.fda.gov/media/75626/download.  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: Describe what naloxone is, how it works, and the availability of products for treatment of acute opioid overdose. Identify the steps FDA has taken to encourage prescribers to discuss naloxone with patients. Explain FDA’s work to support the development of an over-the-counter (OTC) naloxone product. 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: An Overview of Naloxone and FDA’s Efforts to Expand Access, presented by Barbara Cohen, MPA, Social Science Analyst in FDA’s Division of Nonprescription Drugs, Division of Nonprescription Drugs II, Mark Liberatore, PharmD, RAC, Deputy Director for Safety for the Division of Anesthesiology, Addiction Medicine and Pain Medicine (DAAP), in FDA’s Center for Drug Evaluation and Research, and Megan Moncur, MS, Associate Director for Opioid Policy for the Division of Anesthesiology, Addiction Medicine and Pain Medicine (DAAP), in FDA’s Center for Drug Evaluation and Research.

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 JA0002895-0000-20-081-L08-P***, and ACPE Universal Activity Number JA0002895-0000-20-081-L08-T*** for 1.00 contact hour(s). ***(New as of Jan 1, 2020) ACPE category “08” for “Pain Management/Opioids” 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: Cohen, Barbara, MPA, Social science analyst, FDA/CDER/OND/ONDP/DNPDII - nothing to disclose Liberatore, Mark, PharmD, RAC, Deputy Director for Safety, HHS/FDA/CDER/OND/ON/DAAP - My spouse received Salary from Wal-Mart, Inc. for a role as Employee. My spouse received Salary from Patient Care Pharmacy for a role as Employee. May reference off-label use. Moncur, Megan, MS, Associate Director for Opioid Policy, 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, 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  Kapoor, Rama, MD, Medical Officer, FDA - nothing to disclose  Navin, Lesley, RN, MSN, Consumer Safety Officer, FDA/CDER/OCOMM/DDI - nothing to disclose  CE Consultation and Accreditation Team: Thompson, Lisa, MSHA, MBA, CE Consultant, 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.