FDA Drug Topics: An Overview of Naloxone and FDA’s Efforts to Expand Access
September 29, 2020
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.
- Naloxone hydrochloride nasal spray (Narcan Nasal Spray) labeling: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208411Orig1s002lbl.pdf
- Naloxone hydrochloride injection sol. (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
- 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
This activity is intended for physicians, pharmacists, pharmacy technicians, nurses, Certified Public Health Professionals, and physician assistants.
Day 1 September 29, 2020
|1:00 - 2:00 PM||FDA Drug Topics: An Overview of Naloxone and FDA’s Efforts to Expand Access||
Barbara Cohen, MPA
Mark Liberatore, PharmD, RAC
Megan Moncur, MS
Physicians, physician assistants, 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.
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, physician assistants, and nurses may then view/print statement of credit. Pharmacists should log into the CPE monitor 10 weeks after the last session of the activity to obtain their CE credit.
- Cohen, Barbara, MPA, Social science analyst, FDA - 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 - nothing to disclose
- 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
- Kapoor, Rama, MD, Medical Officer, FDA - nothing to disclose
- Navin, Lesley, RN, MSN, Consumer Safety Officer, FDA/CDER/DDI - nothing to disclose
CE Consultation and Accreditation Team
- Lisa Thompson, MSHA, MBA, CE Consultant, FDA/CDER/OEP/DLOD - nothing to disclose
- Zawalick, Karen, CE Team Leader, FDA/CDER/OEP/DLOD - nothing to disclose
Registration is complimentary, therefore refunds are not applicable.
Must attend 80% of the activity.
- This warning banner provides privacy and security notices consistent with applicable federal laws, directives, and other federal guidance for accessing this Government system, which includes (1) this computer network, (2) all computers connected to this network, and (3) all devices and storage media attached to this network or to a computer on this network.
- This system is provided for Government-authorized use only.
- Unauthorized or improper use of this system is prohibited and may result in disciplinary action and/or civil and criminal penalties.
- Personal use of social media and networking sites on this system is limited as to not interfere with official work duties and is subject to monitoring.
- By using this system, you understand and consent to the following:
- The Government may monitor, record, and audit your system usage, including usage of personal devices and email systems for official duties or to conduct HHS business. Therefore, you have no reasonable expectation of privacy regarding any communication or data transiting or stored on this system. At any time, and for any lawful Government purpose, the government may monitor, intercept, and search and seize any communication or data transiting or stored on this system.
- Any communication or data transiting or stored on this system may be disclosed or used for any lawful Government purpose.