Monitoring
and Management
MedWatch is the FDA’s Adverse Event Reporting
Program. Drug manufacturers, health care professionals, and consumers
submit reports of adverse events online at www.fda.gov/medwatch/how.htm.
The FDA monitors
and investigates these reports, issues safety alerts, and requires
labeling changes or market withdrawal of a drug if necessary. The
FDA is upgrading the reporting system so reviewers can identify
and track safety issues more efficiently. The agency also is exploring
ways to link private and public sector post-marketing monitoring
systems to improve data collection and risk identification.
A Drug
Safety Oversight Board (DSB) was created in 2005 to provide
advice on managing drug safety issues. It also manages the flow
of emerging safety information to health care professionals and
patients.
To date, the
board has met 11 times to discuss complex drug safety issues, including
actions on the Fentanyl® transdermal patch and Palladone®.
In 2005 and 2006, the DSB published 80 Healthcare Professional Sheets,
79 Patient Information Sheets, and 47 Public Health Advisories.
Communication
Tools
With the benefit of advisory committee expertise, the FDA will be
evaluating its current communication tools. It will also be developing
a comprehensive risk-communication strategic plan.
Current resources
for FDA information on drug safety issues include:
»
MedWatch Alerts – Email notification of
all safety alerts for drugs, biologics, dietary supplements, and
devices, plus monthly labeling changes. Subscribe for free at
www.fda.gov/medwatch.
»
Drug
Safety Podcasts – New from the FDA’s Center
for Drug Evaluation and Research (CDER), the podcasts are produced
in conjunction with the release of Public Health Advisories. They
are available at www.fda.gov/cder/drug/podcast/default.htm
»
News
from CDER at www.fda.gov/cder/index.html,
contains links to information on the FDA’s drug safety initiatives.
»
DailyMed
Web site – Developed in collaboration with the
National Library of Medicine, this new standardized electronic
drug-label library allows physicians and patients to access up-to-date
information at http://dailymed.nlm.nih.gov.