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Dr. Williams: Welcome to another episode of our podcast series, “Q&A with FDA”, from the FDA’s Division of Drug Information. In this podcast series, we answer some of the most frequently asked questions that we’ve received from the public.

My name is Dr. Celia Williams, and today we will be discussing FDA’s MedWatch program and adverse event reporting. Our Division receives many questions about adverse events and reporting to FDA’s MedWatch program. In the past year alone, we have guided over 11,000 healthcare professionals and consumers through the process of how to report adverse events to FDA, and answered their inquiries about adverse events. Today, I am here with Dr. Gerald Dal Pan, Director of the Office of Surveillance and Epidemiology, to discuss the MedWatch Program and the importance of reporting. Hi Dr. Dal Pan, thank you for joining us today!

Dr. Dal Pan: My pleasure, I’m glad to be here.

Dr. Williams: Dr. Dal Pan, as you know, our Division of Drug Information receives calls and emails from thousands of people each year wanting to report adverse events to FDA, and we in turn provide guidance on how to report to FDA through the MedWatch Program.

Dr. Dal Pan: And thank you for that service! I can’t stress enough the importance of reporting through MedWatch. These reports, along with other data we review, can help to identify important safety concerns. An adverse event can be thought of as any undesirable experience associated with the use of a medical product, and for drug products, can vary from minor problems like a runny nose to life-threatening events, such as heart attack or liver damage. And there are several factors that can affect who may or may not experience an adverse event when taking a drug, such as age, concomitant use of other drugs, vitamins, or dietary supplements, and other underlying diseases or conditions such as diseases that weaken the immune system or affect the function of the kidneys or liver.

Dr. Williams: Can you elaborate on what types of adverse events should be reported to FDA?

Dr. Dal Pan: Well, we're particularly interested in serious adverse events that are not listed in the product labeling. "Serious" here means fatalities, hospitalizations, and medically significant events. For example, if you suspect that a death was the result of an adverse event, this should be reported through MedWatch. Or if the adverse event is life threatening and if the patient was at substantial risk of dying at the time of the adverse event, or if admission to the hospital or a prolonged hospitalization was the result of an adverse event, these should be reported. Other situations in which the adverse event should be reported through MedWatch include if the adverse event resulted in disability or permanent damage which might impact a person’s, uh, physical activities or their quality of life, or if you suspect that exposure to a medical product during pregnancy may have resulted in an adverse outcome in the child, or if you believe that medical or surgical intervention was necessary to prevent permanent impairment or damage.

Dr. Williams: And MedWatch isn’t just for adverse events – it can also be used to report product problems to FDA.

Dr. Dal Pan: That’s correct, for instance, when there is a concern about the quality, authenticity, performance, or safety of any medication. Problems with product quality may occur during manufacturing, shipping, or storage, and may include suspect counterfeit products, product contamination, defective components, poor packaging or product mix-ups, questionable stability, or labeling concerns. Consumers sometimes seek to send us samples of their medications along with their report. We don’t want consumers to send us their medication, but if we do need a sample or additional information, we will reach out to the consumer. Photos are always helpful, and can be attached to the MedWatch report.

For those not familiar with reporting, there are three types of MedWatch forms. Form 3500 should be used by health care professionals, and Form 3500B should be used by patients and consumers. Reporting by health care professionals, patients, and consumers is voluntary. Form 3500A is designed for industry, which has mandatory adverse event reporting requirements.

Dr. Williams: FDA has really made it quite easy to report to MedWatch – online reporting is the quickest and most direct route. When submitting online, there is also an option to save an incomplete report that has been started, and provide an email address to receive instructions on how to complete and submit the report within 3 days. It’s also important to note that reporting through MedWatch is confidential and secure.

Dr. Dal Pan: Yes, we are always working to improve the process. In fact, we recently made some changes to the reporting forms. For example, I mentioned photos - we now allow images to be attached to the report, which is very helpful for FDA staff assessing the reports. In addition, the gender field was recently revised to align more with the Centers for Disease Control and Prevention’s terminology, and the product problem field was also revised to clarify reporting instructions pertaining to adverse events with tobacco products. The consumer-friendly form is also now available in both English and Spanish.

Dr. Williams: Dr. Dal Pan, can you share with our listeners what happens to these reports once they are received by FDA?

Dr. Dal Pan: Sure. When the FDA receives a MedWatch report, it is entered into a database so that it is available for review and comparison to other reports. Then, an FDA safety evaluator, often a pharmacist, doctor, or nurse, reviews the report and examines the database for similar reports. The FDA monitors the data for trends and, if appropriate, examines other data and conducts additional analyses. The FDA takes necessary action to protect public health, such as adding new information about a drug’s safety to the drug’s label. In order to keep safe and effective medical products available on the market, we rely on the voluntary reporting of these events.

Dr. Williams: I also think it’s important to mention FDA’s Adverse Event Reporting System (or FAERS) database, which contains adverse event reports, medication error reports and product quality complaints resulting in adverse events that have been submitted to FDA.

Dr. Dal Pan: Great point. FAERS is a database that contains over 25 million adverse event reports. Through a variety of techniques, FDA staff use this database to monitor the safety of medicines. If FDA does identify a potential safety concern in FAERS, further evaluation is performed, which might include conducting studies using other large databases, such as those available in the Sentinel System – which is a national electronic system for medical product safety surveillance, primarily containing electronic healthcare and administrative claims data – more to come on this in a future podcast. Or FDA may take regulatory actions such as updating a product’s labeling information, restricting the use of the drug, communicating new safety information to the public, or, in rare cases, removing a product from the market.

The FAERS Public Dashboard is a publicly available form of the FAERS database that really adds a layer of transparency to safety information, providing direct access to certain publicly releasable data from individual case safety reports. And anyone - health care professionals, consumers, manufacturers – can search this dashboard for publicly available data from adverse event reports concerning a drug product. However, the FAERS Public Dashboard is not designed to provide information about the safety or effectiveness of a drug. We encourage patients and consumers to read the FDA-approved labeling and to talk with your healthcare professional is you have questions about your medicine.

Dr. Williams: It’s important to stress that even one report can make a difference. MedWatch reports can result in FDA actions such as updating the product labeling to reflect new warnings or issuing safety alerts with recommendations to monitor a product's use, adjust the way a product is used, or, in some cases, recommend that consumers stop using a product. They may also require development of a Medication Guide which is a consumer-friendly instruction sheet provided to patients each time they fill a prescription to help them use the drug safely.

Dr. Dal Pan: Yes, absolutely, and these reports can also result in requests to change the product’s design, manufacturing process, packaging, or distribution. They can spur inspections of the drug manufacturer, requests for a company to recall a product, or require a manufacturer to conduct further studies to demonstrate the product’s safety prior to allowing the product back on the market.

We also need to remember that MedWatch reports alone rarely confirm a causal relationship between an adverse event and a medical product. It may take a formal epidemiologic study or a controlled clinical trial to do that. Still, MedWatch reports are vital in helping to make sure that medical products are safe, because they provide a rapid signal to FDA that problems may be occurring. MedWatch also ensures that the new safety information is rapidly communicated to the medical community, which ultimately results in improved patient care.

Dr. Williams: Thank you Dr. Dal Pan for speaking with us today! You helped us understand the importance of reporting and how FDA uses these data to ensure safety of these products.

Your report may be the critical action that prompts a change in how a product is used or designed, improving its safety profile and leading to increased patient safety.

We need YOU to be our public health partners by not only submitting MedWatch reports to FDA, but also by spreading the word among your friends and colleagues. We encourage everyone to check out our MedWatch webpage at fda.gov/medwatch, where you can find the forms and additional resources such as MedWatch Learn, which provides training on how to complete the forms. We also urge you to stay up to date with safety information by subscribing to our MedWatch Safety Alerts, which you can do directly from our MedWatch page, or by following MedWatch on Twitter or subscribe to the MedWatch RSS feed.

If you need information or if you have questions or comments about a medical product, please call the FDA's toll-free information line, 1-888-INFO-FDA (that’s 1-888-463-6332) and Press 2 to report to MedWatch or for instructions.

Thanks for tuning in to “Q&A with FDA” podcast series. The full podcast and transcript of this recording is available at fda.gov/QAwithFDA. And if you have drug-related questions, reach out to us at [email protected].

Sources:

• Reporting Serious Problems to FDA
• CDER’s Drug Safety Communications: Ensuring postmarket safety
• Postmarketing Surveillance Programs
• FDA 101: How to Use the Consumer Complaint System and Medwatch
• Finding and Learning about Side Effects (adverse reactions)
• What is a Serious Adverse Event?
• FORM FDA 3500B - MedWatch Consumer Voluntary Reporting