BY GLORIA BUTLER BALDWIN

According to the Pharmaceutical Research and Manufacturers of America (PhRMA ), the gathering of prescribing information is not just needed for research but is also a mandate by the FDA which requires companies to monitor and relay medication information to physicians.

Drug recall
FDA regulations require that pharmaceutical companies notify physicians if a drug is recalled and then monitor the effectiveness of the recall.

"Dear Healthcare Provider" letters
These letters are used to alert physicians of risks and other needed information associated with a particular drug.

Adverse health reporting
Federal law requires pharmaceutical companies to report to FDA any adverse event associated with an approved drug. Prescribing information is the key to discovering and communicating those events.

Labeling changes
Targeted communications represent one way that pharmaceutical companies notify physicians of new safety information, including black box warnings, drug-drug interactions and emerging adverse events.

Risk management plan
FDA may also require the manufacturer to implement a risk management plan
to address a safety issue. These plans may require the pharmaceutical company to monitor prescribing practices and to ensure that individual physicians are communicating critical safety information to patients.

SOURCE: Pharmaceutical Research and Manufacturers of America.

January 2007