Labeling Made Simple: The How, What, and Where of Drug Interactions in Prescribing Information (2022)
April 1, 2022 - December 31, 2023
This webinar provided an overview of the evolution of prescribing information (PI) format and content, key regulations impacting drug interaction (DI) content in the PI, and the regulatory science behind, including essential DI information in the PI. In addition, alternative display methods to enhance readability and utility as well as unique DI related content (e.g., in vitro information, modeling and simulation, and complex DI scenarios) was also discussed.
- Grillo, J. & Tran, M. Translation of drug interaction knowledge to actionable labeling. Clin. Pharmacol. Ther. 105, 1292– 1295 (2019).
- Leape, L.L. et al. Systems analysis of adverse drug events. ADE Prevention Study Group. JAMA 274, 35– 43 (1995).
- Raschetti, R. et al. Suspected adverse drug events requiring emergency department visits or hospital admissions. Eur. J. Clin. Pharmacol. 54, 959– 963 (1999).
- McDonnell, P.J., Jacobs, M.R., Monsanto, H.A. & Kaiser, J.M. Hospital admissions resulting from preventable adverse drug reactions. Ann. Pharmacother. 36, 1331– 1336 (2002).
- U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products — Content and Format: Guidance for Industry. December 2016. (2016). Accessed August 20, 2020.
- U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Labeling for Human Prescription Drug and Biological Products - Implementing the PLR Content and Format Requirements: Guidance for Industry. February 2013. (2013). Accessed August 20, 2020.
- Identify key regulations that impact drug interaction content in prescribing information (PI)
- Locate drug interaction content in the PI
- Discuss the content structure of the DRUG INTERACTIONS section in PI
- Identify alternative methods of communicating complex drug interaction content
This activity is intended for physicians, pharmacists, pharmacy technicians, nurses, Certified Public Health (CPH) Professionals, and physician assistants.
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 8 weeks after the last session of the activity to obtain their CE credit.
Faculty
- Grillo, Joseph, PharmD, Associate Director for Labeling and Health Communication, FDA/CDER/OTS/OCP - 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
- Zawalick, Karen, CE Team Leader, FDA/CDER/OEP/DLOD - nothing to disclose
All relevant financial relationships have been mitigated.
Registration is complimentary; therefore refunds are not applicable.
Must attend 100% of the activity.
Initial Release Date
March 15, 2021
Revised Date
April 1, 2022
Expiration Date
December 31, 2023