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How to Report an Adverse Event to the FDA

How to Report an Adverse Event to the FDA

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Mr Macklis and Dr Porter have no relevant financial relationships. Dr Feldman has received research, speaking and/or consulting support from a variety of companies including Galderma, GSK/Stiefel, Almirall, Leo Pharma, Boehringer Ingelheim, Mylan, Celgene, Pfizer, Valeant, Abbvie, Samsung, Janssen, Lilly, Menlo, Merck, Novartis, Regeneron, Sanofi, Novan, Qurient, National Bio- logical Corporation, Caremark, Advance Medical, Sun Pharma, Suncare Research, Informa, UpToDate and National Psoriasis Foun- dation. He is founder and majority owner of and founder and part owner of Causa Research, a company dedicated to enhancing patients’ adherence to treatment.

Pract_advReporting medication adverse events (AEs) to the FDA is an important process that can help improve prescribing practices and patient outcomes. However, medical education systems rarely address this process, and consequently many physicians are unfamiliar with how to report AEs to the FDA. This summary highlights the key steps involved in reporting an AE to the FDA.

Step 1: Describe the patient
Go to index.cfm and select health professional to begin completing the MedWatch Voluntary Report. Be prepared to provide basic patient information including date of birth, sex, weight, ethnicity, and race.

Step 2: Describe the problem
After going to the FDA website, you need to determine if the report is due to an AE, product use error, or product malfunction. Describe the AE, including the date it occurred, what happened, and the ultimate consequence of this event: death, disability, hospitalization, birth defects, etc. You will also need to provide any relevant laboratory values and when these were obtained as well as any relevant past medical history.

Step 3: Indicate the product
The form asks if a sample of the suspected product involved in the report is available for evaluation by the FDA. However, note that you are not asked to send a product to the FDA. Instead, you can include a picture of the product with the report.

Important product information to describe in this step include:

  • Name and strength of the product being reported

  • Manufacturer or compounder of the product

  • Duration and dates of treatment

  • Product type (over the counter, compounded, generic, or biosimilar)

You will also need to indicate if the AE abated after treatment cessation and if it reappeared after reintroduction of the treatment. Similarly, you can also indicate if the report involves a medical device. If so, detail information such as the brand name, common name, manufacturer, model number, lot number, catalog number, expiration date, serial number, unique identifier, who operated the device, date of implantation, date of explantation (if applicable), it if was a single-use device, and if it was serviced by a third party.

Step 4: List concomitant medical products

Relevant information regarding other concomitant medical products are necessary to determine the relationship between the AE and the patient. Indicate other medications being used by the patient in question, including product names and therapy dates.

Step 5: Include your own information

In its confidentiality statement, the FDA asserts that the patient identity is always protected. The form, however, includes space to indicate your contact information as the reporter, including name, address, and occupation. Here, you can also specify whether you want your information to be shared with the manufacturer as well as whether you have reported the AE to the manufacturer/compounder, the user facility, or the distributor/importer. 

Mr Macklis is a research fellow at Center for Dermatology Research in the department of dermatology at Wake Forest School of Medicine, Winston-Salem, NC. Dr Porter is a research fellow at Center for Dermatology Research in the department of dermatology at Wake Forest School of Medicine. Dr Feldman is with the Center for Dermatology Research and the departments of dermatology, pathology, and social sciences & health policy at Wake Forest University School of Medicine and the department of dermatology at the University of Southern Denmark in Odense, Denmark.

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