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 review the existing data pertaining to neuropsychiatric adverse events with montelukast use and will provide an overview of the decision-making framework underlying the recent labeling changes. The FDA has been aware of post-marketing reports of neuropsychiatric adverse events associated with montelukast use for over a decade. In response to continued concerns from the public, FDA recently conducted another comprehensive review and observational study using claims data in the Sentinel Distributed Database, the results of which were presented at an Advisory Committee meeting in September of 2019. After careful consideration of the available data and feedback received during the FDA Advisory Committee meeting, the FDA required a boxed warning and a revision specifically for the allergic rhinitis indication to reserve use of montelukast for patients who have an inadequate response or intolerance to alternative therapies. References: -
U.S. Food and Drug Administration. FDA Briefing Materials for the September 27, 2019 Joint Meeting of the Pediatric and Drug Safety and Risk Management Advisory Committees. -
U.S. Food and Drug Administration. Transcript of the September 27, 2019 Joint Meeting of the Pediatric and Drug Safety and Risk Management Advisory Committees. -
U.S. Food and Drug Administration. "FDA requires Boxed Warning about serious mental health side effects from asthma and allergy drug montelukast (Singulair); advises restricting use for allergic rhinitis." FDA Drug Safety Communication. March 4, 2020. -
Sansing-Foster V, Haug N, Mosholder A, Cocoros NM, Bradley M, Ma Y, et al. Risk of Psychiatric Adverse Events Among Montelukast Users. J Allergy Clin Immunol Pract. 2021;9(1):385-93.e12. -
Chin S, Clarridge K, Eworuke E, Seymour S. A Boxed Warning for Montelukast: The FDA Perspective The Journal of Allergy and Clinical Immunology: In Practice. 2021. In Press. 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 the spectrum of neuropsychiatric adverse events, including serious neuropsychiatric events associated with montelukast use. -
List the different sources of safety data that contributed to the understanding of the risk of neuropsychiatric events with montelukast. -
Describe the revised labeling recommendations for use of montelukast in patients with allergic rhinitis. 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: Safety Labeling Changes for Leukotriene Receptor Antagonists and Decisions Behind a Boxed Warning presented by Katherine Clarridge, MD, Medical Officer, in the Division of Pulmonology, Allergy, and Critical Care within FDA's Office of Immunology and Inflammation, Office of New Drugs. 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 JA0002895-0000-21-053-L01-P, and ACPE Universal Activity Number JA0002895-0000-21-053-L01-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.
Attention Pharmacists and Pharmacy Technicians: 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, 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: -
Clarridge, Katherine, MD, Medical Officer, FDA/CDER/OND/OII/DPACC - nothing to disclose, may reference off-label use -
Chin, Stacy, MD, Medical Officer, FDA/CDER/OND/OII/DPACC - nothing to disclose -
Eworuke, Efe, PhD, Lead Epidemiologist, FDA/CDER/OSE/OPE/DEPIII - 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/CDER/OND/OID/DAI - nothing to disclose -
Nguyen-Chu, Thanh Tam, PharmD, BCPS, Pharmacist, FDA/CDER/OCOMM/DDI - nothing to disclose -
Paraoan, Dianne, MPH, RN, Associate Director for Regulatory Affairs, FDA/CDER/OMP - nothing to disclose CE Consultation and Accreditation Team: -
Bryant, Traci, M.A.T., 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. |
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