openFDA Shiny Applications

Shiny Applications for openFDA Data

Drug Apps

Dashboard- Overview of reports for a drug

PRR for a Drug- Calculate Proportional Reporting Rates for Common Events for a drug
PRR for an Event- Calculate Proportional Reporting Rates for Common Drugs that have a specified event
Dynamic PRR- Calculate Proportional Reporting Rates for a drug-event pair over time
Change Point Analysis- Change point analysis for a drug-event pair over time
Adverse Event Browser- View reports that meet search criteria
Label Browser- View labels that meet search criteria
Likelihood Ratio Test for Drug- Calculate Likelihood Ratio Tests for Common Events for a drug
Likelihood Ratio Test for Event- Calculate Likelihood Ratio Tests for Common Drugs for an event
Drug Enforcement Report Browser- View labels that meet search criteria

Device Apps

Adverse Event Browser- View reports that meet search criteria

Device Enforcement Report Browser- View labels that meet search criteria
Device Classification View labels that meet search criteria
510(k) Viewer- View 510(k) Data
PMA Viewer- View PMA Data
Registration and Listing Browser- View Registration and Listing Data
Recall Browser- View Recall Reports

Food Apps

Food Enforcement Report Browser- View reports that meet search criteria

Data Reference


Background

These applications were built as part of my work on FDA's openFDA project, and are hosted on shinyapps.io.

From the OpenFDA Website

The openFDA drug adverse event API returns data from the FDA Adverse Event Reporting System (FAERS),, a database that contains information on adverse event and medication error reports submitted to FDA. Currently, this data covers publically releasable records submitted to the FDA from 2004-2013. The data is updated quarterly.

An adverse event is submitted to the FDA to report any undesirable experience associated with the use of a medical product in a patient. For drugs, this includes serious drug side effects, product use errors, product quality problems, and therapeutic failures for prescription or over-the-counter medicines and medicines administered to hospital patients or at outpatient infusion centers.

Reporting of adverse events by healthcare professionals and consumers is voluntary in the United States. FDA receives some adverse event 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 to the products’ manufacturers. If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.

FAERS data does have limitations. There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event.

Further, FDA does not receive reports for every adverse event or medication error that occurs with a product. Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.

Submission of a safety report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer or product caused or contributed to the event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.

In 2012, FDA changed from the Adverse Event Reporting System (AERS) to the FDA Adverse Event Reporting System (FAERS). There was a minor shift in terms as part of this transition. If you are using data from before December 2012, you should be aware of this shift.

Responsible use of the data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product.

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. In recent years the FDA has undertaken efforts to increase collection of adverse events. Increases in the total number of adverse events is likely caused by improved reporting.

How adverse events are organized

Adverse events are collected through a series of safety reports. Each is identified by a 8-digit string (for instance, 6176304-1). The first 7 digits (before the hyphen) identify the individual report, and the last digit (after the hyphen) is a checksum. Rather than updating individual records in FAERS, subsequent updates are submitted in seperate reports.


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