HOST: Captain Catherine Chew
Pharmacist: Dr. Henry Yu
CAPT Chew: When you report adverse events to FDA’s MedWatch program, you provide a vital source of information to FDA. Today, resources are available to you, the health care professional, to make reporting to MedWatch easier than ever.
Hi, I’m Captain Catherine Chew, and this is Drug Info Rounds, brought to you by the pharmacists in FDA’s Division of Drug Information.
FDA needs to know when a serious problem with a medical product is suspected or identified in clinical use. That’s why FDA’s MedWatch program makes it easy to get important safety information directly from you to us. Dr. Henry Yu joins me today to explain what MedWatch resources are available.
Dr. Yu: Anyone can submit a report to MedWatch online at fda.gov/MedWatch.
On the next page you will read what you should and should not report to MedWatch. If what you are reporting should not go to MedWatch, this site tells you where you shouldreport. Reporting forms can be completed on your computer or printed and completed by hand. You should choose to begin your report as a Health Professional, and refer your patients to the Consumer form. Selecting the Consumer form brings up a new version that was designed specifically for your patients.
If this is your first introduction to MedWatch, or you want a refresher on how to create a well-documented report, I recommend you check out MedWatchLearn.
FDA MedWatchLearn teaches health care professionals, students, and consumers how to complete the forms necessary to report problems to FDA. Here, you have the opportunity to practice filling out FDA Form 3500for health professionals. This tool allows you to complete a MedWatch report using a case study based on an actual report, and offers you an Answer Key at the end so you can compare the quality of your practice report with FDA’s.
MedWatch also provides clinically useful safety information to providers and patients. You can find the latest posts from MedWatch on the homepage under “What’s New”.
You can also sign up for MedWatch email alerts and follow us on Twitter to receive up-to-date safety information on FDA-regulated products.
Finally, if you want to learn even more about MedWatch, a 24-minute tutorial is available. The tutorial covers a range of topics - from how FDA uses post-marketing safety surveillance information - to ways that MedWatch disseminates safety information about FDA-regulated products.
CAPT Chew: We encourage you to tell your colleagues and patients about the tools and resources available to them. Visit fda.gov/medwatch and save it as a favorite website. And please continue sending in those well-documented reports. If you have questions about MedWatch or want help reporting, call or email FDA’s Division of Drug Information or MedWatch.