FDA Reporting
 

 

 

 

MedWatch Online Voluntary Reporting Form (3500)


Why Should I Report? The testing that helps to establish the safety of products, such as drugs and medical devices, is typically conducted on small groups before FDA approves the products for sale. Some problems can remain unknown, only to be discovered when a product is used by a large number of people.

When problems with FDA-regulated products occur, the agency wants to know about them and has several ways for the public to make reports. Timely reporting by consumers, health professionals, and FDA-regulated companies allows the agency to take prompt action. The agency evaluates each report to determine how serious the problem is, and, if necessary, may request additional information from the person who filed the report before taking action.

How do I report an emergency? If the situation is an emergency that requires immediate action, such as a case of food-borne illness or a drug product that has been tampered with, call the agency's main emergency number, staffed 24 hours a day, 301-443-1240.

You also can report emergencies, as well as non-emergencies, to the FDA consumer complaint coordinator in your geographic area.

What products does FDA regulate? Consumers can play an important public health role by reporting to FDA any adverse reactions or other problems with products the agency regulates. FDA is responsible for ensuring that foods are safe, wholesome, and correctly labeled. It also oversees medicines, medical devices (from bandages to artificial hearts), blood products, vaccines, cosmetics, veterinary drugs, animal feed, and electronic products that emit radiation (such as microwave ovens and video monitors), ensuring that these products are safe and effective.

How do I report non-emergencies about medical products: medicines, medical devices, blood products, biologics, special nutritionals?

FDA's MedWatch program allows healthcare professionals and consumers to voluntarily report serious problems that they suspect are associated with the drugs and medical devices they prescribe, dispense, or use. These problems include serious adverse reactions, product quality problems, and medical errors. Reporting can be done online, by phone, or by submitting the MedWatch 3500 form by mail or fax. Visit the MedWatch site for more details.

How do I report non-emergencies about vaccines? Adverse reactions and other problems related to vaccines should be reported to the Vaccine Adverse Event Reporting System, which is maintained by FDA and the Centers for Disease Control and Prevention. For a copy of the vaccine reporting form, call 1-800-822-7967 or get a copy of the form from the FDA Website.

How do I report non-emergencies about veterinary products? Report any problems with veterinary drugs and animal feed to FDA's Center for Veterinary Medicine at 1-888-FDA-VETS (1-888-332-8387). You can also find the reporting form on the center's Website

How do I report non-emergencies about products sold online? If you find a Website you think is illegally selling human drugs, animal drugs, medical devices, biological products, foods, dietary supplements, or cosmetics over the Web, you may report it to FDA using the form on this Website.

What should I include in my report? Report what happened as soon as possible. Give names, addresses and phone numbers of persons affected. Include your name, address and phone number, as well as that of the doctor or hospital if emergency treatment was provided.
State the problem clearly. Describe the product as completely as possible, including any codes or identifying marks on the label or container. Give the name and address of the store where the product was purchased and the date of purchase.
You also should report the problem to the manufacturer or distributor shown on the label and to the store where you purchased the product
Reports should preferably include a good medical history, all concomitant drugs the animal has been given, any recent surgical procedures, and as much in the way of clinical findings as is possible. Clinical findings would include veterinary exam, clinical chemistries, complete blood counts, urinalysis, fecal exams, radiographic results, and hemodynamic data such as blood pressure, any other pressure measurements in or around the heart, and neurologic assessments.

What kind of information should be included in my complaint?Reports should preferably include a good medical history, all concomitant drugs the animal has been given, any recent surgical procedures, and as much in the way of clinical findings as is possible. Clinical findings would include veterinary exam, clinical chemistries, complete blood counts, urinalysis, fecal exams, radiographic results, and hemodynamic data such as blood pressure, any other pressure measurements in or around the heart, and neurologic assessments.

The ADE scoring system uses a modified Kramer scoring system (Keller et al., Vet Clin North Am, Food Anim Pract, March 1999,15(1):13-30). In this system, each sign is separated from the other signs and scored according to previous experience with the drug, alternative etiologic candidates (other causes), timing of the event, whether there was an overdose, whether the reaction continued or subsided with withdrawal of the drug, and whether a reaction recurred on re-introduction of a drug. The scores are most accurate when there is sound clinical information about an animal. This means that the report should include
** a good medical history,
** all concomittent drugs the animal has been given,
** any recent surgical procedures,
** veterinary exam results,
** clinical chemistries,
** complete blood counts,
** urinalysis,
** fecal exams,
** radiographic results,
** hemodynamic data such as blood pressure, any other pressure measurements ** in or around the heart,
** and neurologic assessments.