When patients experience adverse events from prescription drugs, the U.S. Food and Drug Administration (FDA) wants you to report it.
The FDA hosts a database of adverse event reports, medication error reports and product quality complaints resulting in adverse events. The database, called the Adverse Event Reporting System (FAERS), enables providers and the public to report their experiences of adverse events.
“FAERS reports help the FDA to monitor the safety of drug and biologic products once they reach the market,” said Tralisa Colby, a spokesperson for the FDA.
Why adverse event reporting matters
“These reports may provide critical information that prompts a modification in use of the product, improves its safety profile and leads to increased patient safety,” Colby said.
The FDA uses FAERS to:
- Identify and evaluate new safety concerns
- Evaluate manufacturers’ compliance with reporting regulations
- Respond to outside requests for information.
The FDA recently launched a new, user-friendly search tool that makes FAERS easier for providers, consumers and researchers to use. The update should help improve reporting and access to FAERS.
“Improving data access and transparency are core concepts that drove the development of this FAERS Public Dashboard,” Colby said. The FDA said it hopes the increased transparency will help to encourage people and providers to submit better quality reports. “Complete and detailed reports are immensely helpful to the agency when identifying safety signals and choosing particular products for further analysis,” Colby said.
Pharmacies’ role in reporting
Pharmacists play a pivotal role in improving adverse event reporting because of their unique relationship with patients.
“Community pharmacists are very accessible healthcare professionals who are trusted by patients,” Colby said. “They are well-positioned to engage their patients in discussions related to safety concerns that might be related to a marketed product and obtain important adverse event information to report to the FDA.”
Your singular knowledge as a pharmacist also makes you an invaluable resource. “By profession, pharmacists are the experts when it comes to drugs,” Colby said. “They play an important role in drug safety by increasing the number, as well as the quality, of submitted adverse event reports.”
By the numbers
A look at the number of adverse event reports received by the U.S. Food and Drug Administration (FDA) in one year.
1,684,722 – Total reports in 2016
827,346 – Serious reports in 2016 (excluding death)
141,181 – Death reports in 2016
Source: FDA Adverse Event Reporting System (FAERS) Public Dashboard
Want more pharmacy tips and advice? Sign up for our e-newsletter.
