Keeping medical product labeling/package inserts up to date is an ongoing, dynamic process that depends on new information gleaned from spontaneous adverse event reports. Remaining current with changes in medical product information can be an imposing task for the busy health professional. As a result, an important public health aspect of postmarketing surveillance is the dissemination of safety-related information to the clinical community.
The FDA, in concert with the product's manufacturer, informs health professionals of the most serious and pressing safety issues through such mechanisms as:
The population of health professionals to whom individual notifications are distributed is not always universal, and is dependent on the medical product and the provider specialties most likely to be involved. As a result, other methods are used to reach the broadest possible health professional audience. The MedWatch column in the FDA Medical Bulletin, which is distributed to 1.2 million health professionals nationwide, seeks to enhance general awareness by summarizing the most recent notifications.
In addition, MedWatch uses its Partner program to disseminate new safety-related information. To date, over 100 health professional organizations have joined FDA as Partners and work with MedWatch to increase awareness of, and participation in, postmarketing surveillance. Notifications like Safety Alerts are provided to the Partners as they are released, with the information in turn distributed by the Partners to their members.
It is important for health professionals to be aware that not all changes in medical product information necessitate use of mechanisms such as a "Dear Health Professional" letter. These are reserved for only the most serious and pressing adverse events. While the Physicians' Desk Reference® contains official labeling for most drugs and can be reviewed periodically for changes, FDA is currently looking at other ways, including the Internet, by which new safety-related information can be made more readily available to health professionals.
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