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Pharmacovigilance

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Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
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Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...

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Reporting and recording are crucial in data documentation. The timely, thorough, and accurate documentation of facts is essential when recording patient data. Failure to record findings during an assessment or interpretation of a problem will result in loss of information and make the patient document unreliable. The reader is left with general impressions if the information is not specific. A recording is documenting data of the individual's health information in a traceable, secure, and...

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An Incident or Occurrence Report in a healthcare setting is a crucial document used to record any unexpected occurrence that may or may not have affected a patient, employee, or visitor. Such reports are critical to improving patient safety and include all details leading up to and including the event.
Purposes:
In the healthcare industry, reports play a crucial role in documenting incidents within an agency. The primary objective of these reports is to ensure patient safety, uphold the...

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Related Experiment Video

Updated: May 9, 2026

Reduced Procedure Time and Variability with Active Esophageal Cooling During Radiofrequency Ablation for Atrial Fibrillation

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Published on: August 25, 2022

Standardizing drug adverse event reporting data.

Liwei Wang¹, Guoqian Jiang, Dingcheng Li

¹School of Public Health, Jilin University, Changchun, Jilin, China.

Studies in Health Technology and Informatics

|August 8, 2013

Summary

This summary is machine-generated.

Normalizing the Adverse Event Reporting System (AERS) data enhances drug safety signal detection. This study created a publicly available AERS data mining set (AERS-DM) for improved analysis.

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Published on: January 8, 2020

Area of Science:

Pharmacovigilance and Drug Safety
Biomedical Informatics
Data Mining

Background:

The Adverse Event Reporting System (AERS) is a valuable FDA database for drug safety.
Current data normalization limitations hinder its full potential for signal detection.
A standardized approach is needed to enhance AERS data mining capabilities.

Purpose of the Study:

To normalize the AERS database for improved drug safety signal detection.
To create a publicly accessible, normalized Adverse Drug Events (ADE) data source.
To develop an aggregated knowledge-enhanced AERS data mining set (AERS-DM).

Main Methods:

Normalized drug information in AERS to RxNorm, a standard medication terminology.
Integrated drug class information using the National Drug File - Reference Terminology (NDF-RT).
Aggregated Adverse Drug Events (ADE) by mapping to MedDRA Preferred Term (PT) and System Organ Class (SOC) codes.

Main Results:

Successfully created an aggregated knowledge-enhanced AERS data mining set (AERS-DM).
The AERS-DM provides a normalized and enriched dataset for AERS analysis.
Established a foundation for advanced data mining of drug safety signals.

Conclusions:

Normalization of AERS data significantly improves its utility for drug safety signal detection.
The developed AERS-DM offers a valuable resource for the research community.
This work facilitates more comprehensive mining of the AERS database for pharmacovigilance.