This blog covers the following topics:
- Purpose and benefits of AERS.
- Standard workflow to follow in AERS.
Table of Contents:
Introduction
AERS – Adverse Event Reporting System
It is a comprehensive database dedicated to collecting crucial information on Adverse events (AEs) and Medication Errors associated with marketed drugs and therapeutic biologic products that are marketed.
AERS serves as a sophisticated computerised information repository, specifically designed to support the post-marketing safety surveillance program of the FDA for all approved drugs and therapeutic biologic products.
Several notable reporting systems operate based on the foundation of AERS:
- FAERS (FDA Adverse Event Reporting System)
- VAERS (Vaccine Adverse Event Reporting System)
- The European Medicines Agency’s (EMA) EudraVigilance
- The World Health Organization’s (WHO) VigiBase
📢 We invite you to explore our informative blog, For further insights into difference in between Adverse Events (AE) and Adverse Drug Reactions (ADR) and importance of adverse event reporting.
“Empowering individuals to report Adverse Events is not just a duty, but a collective commitment to ensuring the safety and well-being of us all. Each report is a step towards a safer tomorrow, where every voice contributes to a healthier world.”
Stay vigilant, report with Drugvigil. Your action matters!
Purpose of AERS
Presenting the AERS Public Dashboard, an exceptionally interactive web-based tool designed to facilitate user-friendly querying of AERS data. The primary objective of this tool is to broaden public access to AERS data, empowering individuals to search for information pertaining to human adverse events reported.
Within the FDA, AERS plays a pivotal role in continuously monitoring for any emerging adverse events and medication errors associated with marketed products. It is essential to note that reporting adverse events from the point of care remains voluntary in the United States.
Moreover, it is crucial to understand that the FAERS data, on their own, do not serve as a definitive indicator of the safety profile of a drug or biologic.
Benefits of AERS
Adverse event reporting holds significant importance as it plays a crucial role in safeguarding the well-being of individuals using marketed drugs and therapeutic biologic products. Through reporting AEs, both healthcare professionals and patients contribute to the identification and mitigation of potential safety risks.
The benefits of adverse event reporting are numerous and vital:
- Identification of new safety concerns: Reporting helps in detecting previously unknown or emerging safety issues related to drugs and therapeutic biologic products.
- Assessment of risks and benefits: It allows for a thorough evaluation of the risks and benefits associated with these medical products, aiding in informed decision-making.
- Recommendations on product use: The data obtained from reporting can lead to informed recommendations concerning the appropriate usage of drugs and therapeutic biologic products.
- Patient protection: By reporting adverse events, patients are protected from potential harm, and the overall safety profile of medical products can be improved.
To ensure effective reporting, specific minimum criteria must be met. For detailed insights into these criteria, you can explore the information available in this article.
Typical workflow of AERS
- Reporting
- Data collection
- Database Management
- Signal Detection
- Risk Assessments
- Safety communications
- Pharmacovigilance
Overall, adverse event reporting systems play a crucial role in post-marketing surveillance of medical products, helping to detect, assess, and manage potential safety issues that may not have been evident during pre-market clinical trials. This ongoing monitoring process helps ensure that medical products remain safe and effective for patients.
If you experience an AE after taking a drug or therapeutic biologic product, it is important to report it to your healthcare professional.
Your voice matters in pharmacovigilance. Reporting any Adverse Event you experience is not just a responsibility; it’s a vital step towards enhancing public safety. Together, we can create a safer, healthier future. Don’t hesitate – report today!
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