Information for Fisheries on How to Report Adverse Drug Events

What is an ADE?

Adverse drug experiences or events (ADEs) can include:

• Side effects in animals, such as vomiting, diarrhea, colic, seizures, and other symptoms.
• Side effects in people exposed to drugs and devices used in animals, such as needle stick injuries, rashes, or headache or nausea secondary to product contact.
• Product defects, such as broken product seals, leaking bottles, and other problems.
• Medication errors, such as giving the wrong drug or dose, giving a drug too frequently, and other scenarios.
• Lack of effectiveness, such as a product not working, a product that stops working, or a product that isn’t working as well as it did.
• Human safety issues associated with the handling of animal drug products.

Pre-approval testing by the manufacturer and review of the data by the FDA do not guarantee absolute safety and effectiveness of approved new animal drugs due to the inherent limitations imposed by testing the product on a limited population of animals. To monitor the safety of approved animal drugs, FDA encourages veterinarians and other fish health specialists, fishery biologists, hatchery managers, researchers, and animal owners to report ADEs.

How Do I Report an ADE?

There are two ways you can report an ADE:

1. Call the drug company if you suspect an ADE with an approved animal drug. Drug company phone numbers are usually listed on the product labeling. Tell the drug company that you want to report an ADE. The company representative should ask a series of questions about the event and complete Form FDA 1932. The company is required by law to submit the report to CVM.
   
   If the drug is not FDA-approved for use in animals, or if it is approved but you do not wish to contact the manufacturer, you may submit FDA Form 1932a directly to FDA (see #2).
   
   Your reports for adverse drug events in fish should include a good medical history, a list of all other drugs the animal has been given at the same time, water quality measurements, any recent changes in water quality, and all clinical findings. Clinical findings can include unexpected death, observation of abnormal behavior or appearance (including increased or decreased appetite), necropsy results, results from bacterial or viral cultures, and histopathology results. If possible, indicate what type of system you are using, such as flow-through, recirculating, pond, etc., and what type of life support, such as ozone or filtration, is on the system.
    
2. Fill out and submit Form FDA 1932a, "Veterinary Adverse Experience, Lack of Effectiveness or Product Defect Report".

   To download the fillable 1932a electronic form, click on the hyperlink. If the PDF form does not open automatically in your browser or you get a “Please Wait…” error message, try downloading it as follows:
   
   Step 1. Right-click the 1932a electronic form link, above.
   
   Step 2. Click your browser’s “Save” option. On most browsers, this is the “Save Link As” option, but on other browsers, this may be “Save Target As” or “Download Linked File” and save the file to your computer. 
   
   Step 3. Open the file, complete the fillable form, and email the complete form to [email protected]. 
   
   You may also need to upgrade your version of Adobe Reader - http://get.adobe.com/reader. 
   (PDF Forms must be opened using a Windows or Mac (Apple) desktop or laptop computer. Currently, NO smartphones or tablets are supported.)
   
   A version of Form FDA 1932a is available for those who use either Assistive Technology or those who use the keyboard only without the use of a pointing device, such as a mouse.
   
   To obtain a hard copy of the form: 
   
   Call the Center for Veterinary Medicine at 1-888-FDA-VETS (1-888-332-8387). Leave your name, address, phone number and the brand name of the drug involved. Ask to have a 1932a form sent or ask for the phone number of the drug company you should call to report the problem.
   
   or 
   
   Write to:  
   Center for Veterinary Medicine
   Food and Drug Administration
   HFV-1
   7500 Standish Place
   Rockville, MD 20855

IMPORTANT: The identities of all persons and animals included in ADE reports are held in strict confidence by FDA and protected to the fullest extent of the law. An ADE reporter's identity may be shared with the manufacturer or distributor unless requested otherwise. FDA will not, however, disclose an ADE reporter's identity to a request for the public, pursuant to the Freedom of Information Act.