The U. S. Food and Drug Administration, known as the FDA, is one of the oldest patient protection agencies in the country.
What are FDA’s two big duties?
When it comes to medical products, the FDA has two big jobs:
- Are the medical products we use safe?
- And, are the medical products we use effective, that is, are they doing the job they are supposed to do?
Medical products are drugs, vaccines, or medical devices. For example, aspirin is a drug. A pacemaker is a device for your heart.
What information does FDA want to know?
FDA reviews information about how a particular product was created and tested. If a product is determined to be safe and effective, FDA will approve it. But it is important to know how the product works in the real-world of patients after FDA approves it. FDA wants to know if patients get bad side-effects. It wants to know if they have other problems using these medical products. Some things are discovered after the product has been used for a long time. Other things are discovered when the product is used by many people with different backgrounds or health conditions.
Congress has asked FDA to see when it might use this real-world evidence to help understand these issues. Sentinel makes it easier to gather this kind of real-world evidence. It helps FDA to look at how safe medical products are when different kinds of patients use them in ordinary life. Sentinel might also be able to help FDA see whether medicines are working well for patients.
How does FDA gather real-world evidence?
FDA has been using real-world evidence for a long time. It has used it even more since it created Sentinel in 2008. Here is a link that describes how Sentinel works. Sentinel gets this type of information from insurance claims and electronic health records. Sentinel can also get information from patients themselves.
What kinds of information does FDA get from Sentinel?
Sentinel can look at groups of people who might not have been involved in testing the product before it was approved by FDA. Sentinel can look at groups of people who are using medical products in the real-world, in their everyday lives. With real-world evidence from insurance claims and electronic health records, FDA gets information about things like:
- How are older patients doing on the medication?
- What about patients who take other medications?
- What about patients with other medical conditions?
- What about children, or pregnant women?
What other kinds of questions does FDA use Sentinel to help them answer?
FDA is checking to see if Sentinel can help answer other kinds of questions. FDA wants to know if your medical product is doing its job. They want to know if your medical product interferes with other parts of your life. They want to know if you take your medication the way it is prescribed. FDA is looking into how Sentinel might help them answer these kinds of questions.
- Situation: FDA used Sentinel’s real-world evidence to answer a question about two medications whose names sounded alike. The medications were not meant for the same condition. They were meant to treat different illnesses. Sometimes, doctors got confused because of their similar names.
- Use of Sentinel & Result: FDA used Sentinel to find out more about the problem. FDA asked for a name change for one of the medications.
- Situation: FDA used Sentinel to learn more about a medication for gout. The question was what type of patients were using this medication. It has some risks.
- Use of Sentinel & Result: FDA found out how the medication was being used. FDA also reminded doctors about the risks.
- Situation: FDA is exploring how to use Sentinel in health emergencies. Sentinel may help FDA understand what is happening when many people get sick at the same time.
- Use of Sentinel & Result: For example, FDA is looking into whether Sentinel can help watch over medicines used to treat people with the flu when there is a large outbreak.
- Situation: FDA wants to learn more about how patients are doing with using medical products. FDA worked with Sentinel to develop a new mobile app, called MyStudies.
- Use of Sentinel & Result: FDA might use the app when the specific information needed to answer a question is hard to get from medical records available in the Sentinel System. In such a situation, by using the MyStudies app, patients can volunteer to share information with FDA about how they are doing with a medical product, like if it makes it hard for them to sleep or makes them nauseous. They can also share other information that might make a difference, like: Do they smoke? Do they take other medications? Do they exercise, and how much? Can they walk or climb stairs as well as they want to? Does taking the medicine interfere with their lives? If so, in what ways? This real-world evidence helps FDA learn if medications help patients without causing lots of other problems for them.
- Situation: FDA is working with five health plans to reach out to patients with irregular heartbeats since some of these people may have strokes. The health plans are mailing information to patients. They want patients to talk to their doctors about medications that might keep them from having strokes.
- Use of Sentinel & Result: FDA hopes that patients will have good conversations with their providers. The goal is to get more of them to use medicine to help avoid strokes.
Keeping things private?
No one at Sentinel looks at your personal information. They do not look at your name, address, phone number, etc. Sentinel looks at groups of people, not individuals.
The Future of Sentinel?
FDA will look for new ways that Sentinel can protect your health and safety!
How to report your safety concerns?
If you experience a problem that might be caused by a medical product, contact your doctor. You can also file a report with the FDA to let them know how you are feeling.
Questions or Comments?
The FDA and Sentinel Operations Center welcome comments on this page. Please send all comments to firstname.lastname@example.org.