FDA Adverse Events Reporting System Patient Outcome 2016

$395 / year

FAERS database is designed to support the FDA’s post-marketing safety surveillance program for drug and therapeutic biologic products.
The Outcome file contains patient outcomes for the event (0 or more).

Complexity

The FDA Adverse Event Reporting System (FAERS) is a database that contains information on adverse event and medication error reports submitted to FDA. The informatic structure of the FAERS database adheres to the international safety reporting guidance issued by the International Conference on Harmonisation (ICH E2B). Adverse events and medication errors are coded to terms in the Medical Dictionary for Regulatory Activities (MedDRA) terminology.

FAERS is used for the spontaneous reporting of adverse events and medication errors involving human drugs and therapeutic biological products. FAERS began on September 10, 2012, and replaced the Adverse Event Reporting System (also known as Legacy AERS), which was decommissioned on August 27, 2012.

FAERS is a useful tool for FDA for activities such as looking for new safety concerns that might be related to a marketed product, evaluating a manufacturer’s compliance to reporting regulations and responding to outside requests for information. The reports in FAERS are evaluated by clinical reviewers in 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. If a potential safety concern is identified in FAERS, further evaluation is performed. Further evaluation might include conducting studies using other large databases, such as those available in the Sentinel System. Based on an evaluation of the potential safety concern, FDA may take regulatory action(s) to improve product safety and protect the public health, such as updating a product’s labeling information, restricting the use of the drug, communicating new safety information to the public, or, in rare cases, removing a product from the market.

Reporting of adverse events and medication errors by healthcare professionals and consumers is voluntary in the United States. FDA receives some adverse event and medication error reports directly from healthcare professionals (such as physicians, pharmacists, nurses and others) and consumers (such as patients, family members, lawyers and others). Healthcare professionals and consumers may also report adverse events and/or medication errors to the products’ manufacturers. If a manufacturer receives an adverse event report, it is required to send the report to FDA as specified by regulations. The reports received directly and the reports from manufacturers are entered into FAERS.

Date Created

2012-09-10

Last Modified

2017-02-25

Version

2017-02-25

Update Frequency

Quarterly

Temporal Coverage

2016-01-01 to 2016-12-31

Spatial Coverage

United States

Source

John Snow Labs => U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Surveillance and Epidemiology (OSE)

Source License URL

John Snow Labs Standard License

Source License Requirements

N/A

Source Citation

N/A

Keywords

Event Data, FDA Database, Medwatch, Event Reports

Other Titles

FDA Adverse Event Data Reporting System Outcome 2016, FDA Database Adverse Events Reporting System Outcome 2016, FDA Adverse Event Reports System Outcome 2016

NameDescriptionTypeConstraints
YearThe year in which the data was submitteddaterequired : 1
QuarterThe quarter of the year in which the data was submittedstringrequired : 1
Primary_idNumber for identifying a FAERS report. This is the primary link field (primary key) between data files. This is a concatenated key of Case_id and Case Version Number. It is the Identifier for the case sequence (version) number as reported by the manufacturer.integerrequired : 1 level : Nominal
Case_idNumber for identifying a FAERS case.integerrequired : 1 level : Nominal
Patient_Outcome_CodeCode for a patient outcome. Abbreviations: DE means Death, LT means Life-Threatening, HO means Hospitalization - Initial or Prolonged, DS means Disability, CA means Congenital Anomaly, RI means Required Intervention to Prevent Permanent Impairment/Damage, OT means Otherstringrequired : 1
YearQuarterPrimary_idCase_idPatient_Outcome_Code
2016Q1335385823353858LT
2016Q1335686523356865HO
2016Q1336121223361212OT
2016Q1347959723479597OT
2016Q1348350223483502OT
2016Q1348398423483984OT
2016Q1364270223642702OT
2016Q1372167923721679HO
2016Q1375364923753649OT
2016Q1375364923753649LT