MedWatch is the Food and Drug Administration’s reporting system for an adverse event (sometime also called a sentinel event), and was founded in 1993. An adverse event is any undesirable experience temporally associated with the use of a medical product. The MedWatch system collects reports of adverse reactions and quality problems, primarily with drugs and medical devices, but also for other FDA-regulated products (e.g., dietary supplements, cosmetics, medical foods, and infant formulas). Vaccines are not covered by MedWatch, but instead entails the Vaccine Adverse Event Reporting System (VAERS). MedWatch also does not cover veterinary medicine and internet fraud.

Overview

FDA's MedWatch program offers voluntary reporting by healthcare professionals, consumers, and patients. This reporting can be conducted several different ways including a single, one-page reporting form (Form FDA 3500) tha can be mailed to the address on the form or faxed to 1-800-FDA-0178, online reporting is available at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm , or by phone at 1-800-FDA-1088.

The MedWatch system is intended to detect safety hazard signals for medical products. If a signal is detected, the FDA can issue medical product safety alerts or order product recalls, withdrawals, or labeling changes to protect the public health. Important safety information is disseminated to the medical community and the general public via the MedWatch web site at http://www.fda.gov/Safety/MedWatch/default.htm and the MedWatch E-list and texting service that can be subscribed to at https://public.govdelivery.com/accounts/USFDA/subscriber/new?pop=t&topic_id=USFDA_46

Raw data from the MedWatch system, together with adverse drug reaction reports from manufacturers as required by regulation, are part of a public database. Online tools that analyze the database are available for both health care consumers and professionals. The database is open enough that it was even used by journalists to investigate FDA's drug approval practice.

History

Before, David Kessler, former head of the FDA, introduced MedWatch in 1993 there was not a simple mechanism in place for healthcare professionals to report adverse events associated with medications or devices directly to the FDA. Many facilities and drug manufacturers had their own complicated forms creating a patchwork of reporting tools that were largely ignored. This was despite the post marketing surveillance required of all FDA approved medications.

Various studies conducted in the 1980's suggested that 3 to 11% of admissions could be attributed to adverse drug events and yet only about 1% of adveres events were being reported to the FDA. This means that out of 1400 hospital admissions approximately 100 would be related to adverse events and yet only 1 was actually being reported.

MedWatch was intended to simplify this process and the FDA was also trying to actively engage physicians, hospitals, and schools involved in health care education to use this new voluntary system. This new.....

See also

Food and Drug Administration
Drug recalls
Vaccine Adverse Event Reporting System

References

1. Wikipedia, MedWatch, https://en.wikipedia.org/wiki/MedWatch
2. FDA, MedWatch Tutorial Transcript: FDA MedWatch and Patient Safety, http://www.accessdata.fda.gov/videos/MedWatch/tutorial/tutorial_transcript.htm
3. MedWatch Voluntary Reporting Form (3500), view here
4. MedWatch Online Voluntary Reporting Form (3500), https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm
5. MedWatch Home Page, http://www.fda.gov/Safety/MedWatch/default.htm
6. Sign up for MedWatch e-list, https://public.govdelivery.com/accounts/USFDA/subscriber/new?pop=t&topic_id=USFDA_46
7. Adverse Event Reporting System (AERS) Database, http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/default.htm
8. CBS News - Dangerous Drugs, http://www.ire.org/resource-center/stories/17401/