Last week, federal health officials announced a new monitoring system called Sentinel Initiative for assessing drugs which have been FDA-approved and then marketed. The plan is to use Medicare claims information to determine how drugs are affecting people’s health.
The current system depends on reports coming in to the FDA from doctors and patients around the country who have problems in connection with specific drugs or medical devices. People are free to report problems or not according to their judgment. This creates uncertainty, since what appears as a problem worth reporting to one person may not appear that way to another. This system also requires a lot more time to pass, for people to notice possible problems and report them.
By using Medicare records, the FDA will be able to quickly learn what percentage of users of a given drug are suffering what specific effects.
Sentinel Initiative has been developing since 2005. Many are delighted with its prospects, but there are potential problems too.
- Medicare only collects data when someone is applying for payment. Actual patient health records would give a lot more detail and be far more accurate.
- Some people experience problems while taking a drug not because of the drug, but just because they are ill people.
- People on Medicare use 28 prescriptions per year on average, whereas that average is only 12 prescriptions among all other Americans. So with 28 medications entering a Medicare recipient’s body, it might be hard to distinguish what one particular drug is causing.
- Government officials have given repeated assurances that the FDA would not have access to personal information about Medicare recipients. However, this possibility worries some.
Perhaps Sentinel Initiative will lead to better drug and device monitoring. Time will tell. Meanwhile, if you have been harmed by a prescription drug and are wondering if you might have a valid legal claim, please give us a call or send an email and we will arrange a free consultation for you.