The discussion that follows is excerpted from Empowered Patient Coalition, a valuable Internet resource for patients who want to learn how to take care of their own health care.
Reporting to the Government: FDA Medwatch
MedWatch is the Food and Drug Administration’s (FDA) program for reporting serious reactions, product quality problems, therapeutic failure, and product use errors with human medical products, such as drugs and medical devices.
If patients have experienced a serious reaction to a medical product, they are encouraged to take the reporting form to their doctor. Health care providers can provide clinical information based on the patient’s medical record that can help FDA evaluate a report.
Patients may not wish to have the form filled out by a health care provider, or a health care provider may choose not to complete the form since health care providers are NOT required to report to the FDA. In these situations, patients may complete the Online Reporting Form themselves.
Patients will receive an acknowledgement from FDA after a report is received and will be contacted only if MedWatch needs additional information.
Report Problems with Medical Devices to the FDA
Health professionals and consumers may submit reports of device adverse events or product problems to FDA via the MedWatch program in one of the following ways:
- online at: MedWatch Online Reporting Form 3500
- by telephone at 1-800-FDA-1088
- by fax at 1-800-FDA-0178
- by mail to: MedWatch at The FDA Safety Information and Adverse Event Reporting Program
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20852-9787
Related FDA Reporting Information for Consumers
- If you need information or if you have questions or comments about a medical product, please call the FDA’s toll-free information line, 1-888-INFO-FDA (1-888-463-6332) Press 2, followed by 1 for information, then:
- for dietary supplements, select 2
- for drug products, select 3
- for medical devices, select 4
- for biologics, including human cells, tissues, and cellular and tissue-based products, select 6
Reporting Privately: ISMP-MERP
The ISMP Medication Errors Reporting Program (MERP) is operated by the Institute for Safe Medication Practices. It’s a confidential national voluntary reporting program that provides expert analysis of the causes of medication errors and offers recommendations for error prevention to regulatory agencies and manufacturers.
Without reporting, such events may go unrecognized. Errors include — but are not limited to — administering the wrong drug, strength, or dose of medications; confusing drugs with similar names or labels; misuse of medical equipment; and errors in prescribing, dispensing, and monitoring medications.
Consumers can submit reports and associated materials in confidence. With the patient’s permission, reports will be forwarded to the Food and Drug Administration, and the manufacturer to inform them about improper pharmaceutical labeling, packaging, and other issues that may cause errors. The reporter is never identified in case studies and ISMP always respects reporters’ wishes as to the level of detail included in publications.
Please do not submit any patient identifiable information within the form such as your name, social security number, or address when forwarding medication error reports to ISMP.
The electronic report form on their website is easy to complete. Once a patient completes and submits a report it will be housed in a secure database and ISMP nurse and pharmacist analysts will be notified within 24-48 hours of a submission. They’ll review the form and, if the reporter provides an e-mail address or telephone number, analysts will call or email if any necessary follow up information is needed. Please follow the link below to report to ISMP:
https://www.consumermedsafety.org/merp.asp
Consult with an Experienced Malpractice Attorney
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