The 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.
This 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 security measures.
The 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.
