FDA MedWatch Program

The Council encourages health care professionals to report actual and potential medication errors to national (e.g., FDA MedWatch Program and/or the USP Practitioners Reporting Network), internal, and local reporting programs. 

Because nearly 70% of patients who use alternative therapies do not inform their health-care providers about these products, pharmacists and other health-care professionals should question all patients about their use of alternative therapies. Health-care professionals should remain vigilant for potential interactions between alternative therapies and prescription medications, especially medications with a narrow therapeutic index, and should report suspected interactions to the FDA MedWatch program. The FDA recently established the Special Nutritionals Adverse Event Monitoring System, a searchable database including information about... 

USP MEDICATION ERRORS REPORTING PROGRAM Presented in cooperation with the Institute for Safe Medication Practices The USP Practitioners Reporting Network is an FDA medWatch partner... 

MedWatch program. The FDA recently established the Special Nutritionals Adverse Event Monitoring System, a searchable database including information about suspected adverse events associated with dietary supplements or nutritional products. This database includes reports that have been submitted to MedWatch and can be accessed via the Internet (http //vm.cfsan.fda.gov/ dms/ aems.html). Continued efforts by health-care professionals to recognize and report suspected interactions between prescription medications and herbal and other alternative therapies should ultimately increase knowledge and awareness of interactions and improve the quality of patient care (see Heck et al., 2000 Izzo, 2004 Butterweck, 2004 Chan, 2005). 

The director of the FDA s MedWatch program, Dianne Kennedy (Kennedy et al., 1993), wrote ... 

Kennedy, D. L., McGinnis, T. (1993, September). Monitoring adverse drug reactions The FDA s new MedWatch program. Rockville, MD Food and Drug Administration. 

Initially the MEDWatch program was intended to simplify reporting and enroll more physicians and other health professionals in the process of reporting side effects. According to FDA Commissioner David Kessler, "It is not in... 

Kennedy, D.L. McGinnis, T. Monitoring Adverse Rrug Reactions The FDA s New MedWatch Program. Pharmacol. Ther. 1993, 833-834, 839-842. 

Independent review of all errors reported to the USP-ISMP Medication Errors Reporting Program (MERP) and acting partner in the FDA s MedWatch Program. 

In 1993, the FDA introduced a new streamlined SRS, MedWatch. MedWatch allows healthcare providers and patients to report ADEs to the FDA by several mechanisms, including electronic and print media (Table 1). The goals of the MedWatch program are to increase awareness of drug- and device-induced disease, clarify what should be reported to the FDA, simplify the reporting process, and provide regular feedback to the healthcare community about safety issues involving medical products. - ... 

MedWatch program, the FDA runs a program for adverse events related to veterinary products and in conjunction with the Center for Disease Control and Prevention, a program for adverse events with vaccines, the Vaccine Adverse Event Reports System (VAERS). 

More than 50 reports regarding herbal products, including efficacy concerns and serious adverse effects, have been reported to the DPPR (Anonymous, 1999a). Health care professionals may also contact the FDA s MedWatch program at 1-800-FDA-1088 with reports of serious adverse effects involving herbal products, other dietary supplements, or drugs. 

The Institute of Medicine (lOM) estimates that between 44,000 and 98,000 deaths annually in the U.S. result from medical errors. While there is some debate about this estimate, it is clear that medication errors are common and result in significant adverse effects, including death. Databases of anonymously reported errors are maintained jointly by the Institute for Safe Medication Practices (ISMP), the U.S. Pharmacopeia Medication Errors Reporting Program (USP MERP), and the FDA s MedWatch program. Adverse drug events occm in 3% of hospitalizations, and this number is larger for special populations such as those in pediatric and neonatal intensive care units. 

Appendix A contains a MedWatch form, which is used by health care professionals for voluntary reporting of adverse reactions and problems with tiie drag product. Is also contains advice about voluntary reporting. This form is a part of tiie FDA medical products reporting program. 

MedWatch — The FDA Safety Information and Adverse Event Reporting Program... 

MedWatch is an umbrella program developed by the FDA to enhance the reporting of serious adverse events by health professionals, which are suspected to be related to the use of FDA-regulated products (www.fda.gov/... 

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