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Adverse Event Reporting System (AERS) is a database which is designed to support the post-marketing safety surveillance program of the United States Food and Drug Administration (USFDA). The AERS database is a collection of adverse event reports, medication error reports and product quality complaints leading to adverse effects. The structure of AERS is based on the guidelines of international safety reporting guidance published by the International Conference on Harmonization (ICH E2B).

The role of AERS is to help FDA with activities such as observing safety concerns related to any product post marketing, assessing the compliance of manufacturers and replying to the requests for information. The reports of the system are evaluated by clinical reviewers for monitoring the safety of the drugs post-approval in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). In case any safety concerns are observed, additional evaluations are performed, which may include studies using other larger databases. Based on the results of these evaluations, FDA may take necessary steps, like updating labeling information of the product, restricting the use of the drug, or, in rare cases, removal of the product from the market.

Who can send reports to FDA’s AERS?

Healthcare professionals, consumers, and manufacturers can voluntarily send their adverse reports or medication errors to the AERS. The healthcare professionals and consumers can also send their reports directly to the manufacturer of the product. In such case, the manufacturer is required to submit the report to FDA as per the regulations.

Availability of AERS data

The AERS data is available in the following formats for the use of public:

  1. FAERS dashboard – It is a highly interactive web-based tool used for performing queries on data in a user-friendly environment.
  2. FAERS data files – The data files provide raw data in the form of individual case safety reports from the AERS.
  3. A Freedom of Information (FOI) request can also be sent to FDA for retrieving an individual case safety report.

Limitations of AERS

  • Does not ensure that the adverse event was a result of the product
  • Does not contain enough information for the evaluation of a reported event or medication error
  • Not all adverse events or medication errors are reported to the FDA
  • Duplication of report is possible as both, consumers and sponsors, can report the same adverse event to the FDA

Systems like FDA’s AERS have been introduced by agencies to help manufacturers and other healthcare professionals to ensure the safety and efficacy of drug products. Therefore, keeping abreast with them is necessary. To know more about AERS and similar systems, reach out to Freyr experts at sales@freyrsolutions.com.