HOST: Captain Mary Kremzner
Pharmacist: Dr. Sonia Kim
Captain Kremzner: The “FDA Adverse Event Reporting System” or FAERS is the database that houses reports submitted to FDA on adverse events and medication errors. This database is used by the FDA’s drug and biologic post-marketing safety surveillance program.
Hi, I’m Captain Mary Kremzner and this is Drug Info Rounds, brought to you by the pharmacists in the FDA’s Division of Drug Information.
Today, I’m joined by my colleague, Dr. Sonia Kim. Can you provide some background information about the FAERS database?
Dr. Kim: Pharmaceutical companies submit reports of adverse events that they receive to FDA. Adverse event reports are also submitted to the FDA through Medwatch, by consumers and healthcare professionals. This information is used by FDA to identify safety concerns that might be related to a marketed drug or biologic product. FAERS, which was formerly known as AERS, is the system used to hold all of these reports. This database permits the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) to monitor the safety of products after they are approved by FDA.
Captain Kremzner: Will you describe how data is collected for the FAERS database?
Dr. Kim: Reporting of adverse events and medication errors by healthcare professionals and consumers is voluntary in the United States. FDA may receive these adverse event and medication error reports directly or, from the manufacturer who made the drug or biologic product. If a manufacturer receives an adverse event report, they are, in most cases, required to send the report to FDA. The reports received directly from healthcare professionals or consumers, and the reports received from manufacturers are both entered into FAERS.
Captain Kremzner: Will you review how pharmacists may obtain the data stored in the FAERS database?
Dr. Kim: There are three ways FAERS data is made available:
The first is FAERS Statistics, which provides the historical numbers of reports that FDA has received for drug and biologic products over the past ten years. For example if we choose the “Reports Received and Reports Entered into FAERS by Year” we can see all of the reports received and entered into the database for certain time periods.
The second is the FAERS Data Files, which provide raw data consisting of individual case safety reports extracted from the FAERS database. The latest quarterly data files are published on this page for public view. It should be noted that a simple search of FAERS data cannot be performed with these files without a good working knowledge of relational databases.
Third, individual case safety reports from the FAERS database can also be obtained by submitting a Freedom of Information Act request to FDA. FOIA requests must be made in writing and can now be submitted online. A fee may be required for processing and a separate request should be submitted for each product.
If a potential safety concern is identified in FAERS, further evaluation is performed, such as conducting studies using other large databases. Based on an evaluation of the potential safety concern, FDA may take regulatory action to improve product safety and protect the public health, such as requiring changes to the drug’s labeling. Drug safety labeling changes are published on the FDA website.
Captain Kremzner: The FAERS database is a valuable resource. The reporting of adverse events is important to ensure we at the FDA have accurate data to use to analyze adverse events and to monitor drug safety through a drug’s life cycle. If you have questions about FAERS, please call or email FDA’s Division of Drug Information.