301172
FDA Center for Tobacco Products - Tobacco Adverse Event Reporting Surveillance and Update
Description: CTP established a tobacco product surveillance program to track related complaints and detect potential safety signals. On January 10, 2014, CTP launched the Safety Reporting Portal (https://www.safetyreporting.hhs.gov), a web-based reporting system incorporating tobacco product-specific queries. This system provides a mechanism for consumers, healthcare professionals and other members of the public to report directly to CTP. FDA is interested in receiving reports about tobacco products that are damaged, defective, contaminated or associated with unexpected health or safety consequences. FDA encourages reports of problems associated with new types of tobacco products. FDA evaluates each report and, if appropriate, takes steps to address the issue.
Lessons Learned: Reports received to date pertain to tobacco user and nonuser health, environmental and occupational health. Reports concerning electronic cigarettes (primarily involving adults) have increased, comprising 88% of voluntary reports in calendar year 2013. The live session will summarize reports received through June 30, 2014 and present descriptive statistics by nature of event, tobacco product type, age of affected individuals, and geographic distribution.
Recommendations: Attendees will be equipped to educate all stakeholders about the new Safety Reporting Portal and to encourage appropriate and effective reporting.
Learning Areas:
Public health or related educationPublic health or related public policy
Learning Objectives:
Describe the new tobacco product safety reporting portal (“SRP”) hosted by the USDHHS / FDA / Center for Tobacco Products.
Identify the tobacco product complaint data of interest for reporting via the SRP.
Explain how to request specific adverse health effect data and evaluate data analyzed by CTP’s Office of Science through 6/30/2014.
Keyword(s): Data Collection and Surveillance, Tobacco Use
Qualified on the content I am responsible for because: I am one of the primary analysts of incoming CTP adverse event reports since May, 2012, and have participated in the design and launch of the new safety reporting portal. I am certified as a family nurse practitioner and practicing medicine and nursing at the NIH Clinical Center.
Any relevant financial relationships? No
I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.