For the Public

Sentinel System's Story

 

Get to know the FDA

The U. S. Food and Drug Administration, known as the FDA, is one of the oldest patient protection agencies in the country.  One of the FDA’s most important jobs is to make sure medicines, vaccines and medical devices are safe.  The FDA’s scientists and other healthcare professionals learn a lot about medical products.  The FDA lets doctors and patients know about the best way to use medicines and vaccines.  The FDA also lets them know about side effects when they use medicines, vaccines, and devices.

The FDA has systems that allow people to report concerns with medical products.  In the past, it could take a long time to get enough information to learn about these concerns.  FDA created the Sentinel System to make the process easier and faster. 

 

 

 

 

The FDA and Sentinel Operations Center welcome comments on this page. Please send all comments to info@sentinelsystem.org.

 

What makes up the Sentinel System?

The Sentinel System has 3 major parts:  1. Electronic Health Information. The biggest part of this electronic information comes from health insurance bills. A smaller amount comes from medical records.  2. Team of Experts. The Sentinel team is made up of scientists, healthcare professionals, and computer programmers.  3. Special Computer Programs. Computer programs help answer questions about how drugs and vaccines are working.  These programs look for certain groups of patients who might have bad side-effects after taking a drug or getting a vaccine. Remember, these programs do not look at your personal identity and confidential information.   

 

How does the Sentinel System work?

The Sentinel System answers questions like these: How many people are taking the same drug or getting the same vaccine?  How many are having bad side-effects? How many are men and women? How many are young, old, pregnant, or take other drugs?

 

What does the FDA do with all the information?

The FDA gets important answers from the Sentinel System about bad side effects in certain drugs or vaccines. The FDA studies this new information along with other information it gets from doctors and drug companies. The FDA   decides the best way to make doctors and patients aware of side effects. The FDA can send out a warning to doctors and patients. Or the FDA can issue a safety communication to warn the public about taking a medicine or getting a vaccine. 

 

What's so special about the Sentinel System?

The Sentinel System is special in 4 ways: 1. The Sentinel System can get information about a large number of people who take the same medicine or get the same vaccine.  2. The Sentinel System counts how many patients are having the same bad side effects.  3. The Sentinel System finds out about side effects patients are getting by looking at information from medical insurance bills and electronic health records.  4. The Sentinel System protects patient privacy. It doesn’t know your identity.   

 

Sentinel in action

Example 1

In 2012, the FDA got reports from doctors about patients taking a new medicine to help prevent blood clots. The reports were about patients bleeding too much when they took the new medicine.  The Sentinel System looked at a big group of patients on the new medicine.  Then, it looked at a big group of patients on an older medicine.  This information did not suggest the new medicine was less safe than the older medicine. Patients could continue taking the new medicine while additional studies were performed.  

Example 2

In 2013, the FDA used the Sentinel System to look at the safety of a vaccine that was given to about 500,000 babies. The FDA found out that some of the babies who got the vaccine had side effects, but these side effects were very rare.  The vaccine caused the side effect in less than 2 out of every 100,000 babies! With this new information, FDA let doctors and parents know that it was better to get the vaccine. But doctors should be aware of this very rare side effect, so that they can treat it, if it happens.  

 

Protecting your privacy

No one at the FDA looks at your personal information. They do not look at your Name, Address, Phone Number, etc. The Sentinel System learns about big groups of patients taking the same medicine or getting the same vaccine.

 

Reporting Your Safety Concerns

If you get a bad side-effect from taking a drug or getting a vaccine, contact your doctor. You can also file a report with the FDA to let them know how you are feeling. Here are two FDA links: FDA Adverse Event Reporting System (FAERS) and the Vaccine Adverse Event Reporting System (VAERS)