FDA announced a joint effort with
Medicare to help monitor and
track dangerous prescription drugs and medical devices. This joint
effort is called the Sentinel Initiative, and it utilizes existing
electronic databases to help coordinate safety information between
the government and manufacturers.
will allow the FDA to review electronic
medical records from Medicare, as well as private heath care
facilities who wish to share information about patients. Private
medical information will not be held by the government, rather it
will be accessible by the FDA in order to determine potential
complications related to medications and medical devices. Patient
privacy will be maintained, according to the FDA, through strong
Sentinel Initiative represents a change in how the FDA monitors
potentially deadly drug
interactions or defective
medical devices. Currently, the FDA relies on a drug
manufacturer to report complications. Physicians and patients can
also make complaints to the FDA, but it is only on a voluntary basis.
This will increase the FDA’s awareness of potentially harmful drugs
and products, allowing earlier recall of products. This will
hopefully allow the FDA to identify dangerous
drugs in months, rather than years, and take actions quicker to
remove a drug from the market.