The FDA Adverse Event Reporting System (FAERS or AERS) is a computerized information database designed to support the U.S.

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...

's (FDA) postmarketing safety surveillance program for all approved

drug A drug is any chemical substance that causes a change in an organism's physiology or psychology when consumed. Drugs are typically distinguished from food and substances that provide nutritional support. Consumption of drugs can be via insuffla ...

and therapeutic biologic products. The FDA uses FAERS to monitor for new

adverse event An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can ther ...

s and

medication errors A medical error is a preventable adverse effect of care ("iatrogenesis"), whether or not it is evident or harmful to the patient. This might include an inaccurate or incomplete diagnosis or treatment of a disease, injury, syndrome A syndrome ...

that might occur with these products. It is a system that measures occasional harms from medications to ascertain whether the

risk–benefit ratio A risk–benefit ratio (or benefit-risk ratio) is the ratio of the risk of an action to its potential benefits. Risk–benefit analysis (or benefit-risk analysis) is analysis that seeks to quantify the risk and benefits and hence their ratio. A ...

is high enough to justify continued use of any particular drug and to identify correctable and preventable problems in health care delivery (such as need for

retraining Retraining or refresher training is the process of learning a new or the same old skill or trade for the same group of personnel. Retraining is required to be provided on a regular basis to avoid personnel obsolescence due to technological change ...

to prevent prescribing errors). The system interacts with several related systems including MedWatch and the

Vaccine Adverse Event Reporting System The Vaccine Adverse Event Reporting System (VAERS) is a United States program for vaccine safety, co-managed by the U.S. Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). VAERS is a postmarketing surveil ...

. FAERS replaced legacy AERS system in Sep 2012.

Background

Reporting of adverse events from the point of care is voluntary in the United States. The FDA receives some adverse event and medication error reports directly from health care professionals (such as physicians, pharmacists, nurses and others) and consumers (such as patients, family members, lawyers and others).

Health professional A health professional, healthcare professional, or healthcare worker (sometimes abbreviated HCW) is a provider of health care treatment and advice based on formal training and experience. The field includes those who work as a nurse, physician (suc ...

s and consumers may also report these events to the products’ manufacturers. If a manufacturer receives an adverse event report, it is required to send the report to the FDA as specified by regulations. The MedWatch site provides information about mandatory reporting.

Structure

The structure of FAERS is in compliance with the international safety reporting guidance (ICH E2B2) issued by the International Conference on Harmonisation. Adverse events in FAERS are coded to terms in the

Medical Dictionary for Regulatory Activities A subscription-based product of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), MedDRA or Medical Dictionary for Regulatory Activities is a clinically validated international medical te ...

terminology (MedDRA)3.

Uses

FAERS is a useful tool for the FDA, which uses it 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 The Center for Drug Evaluation and Research (CDER, pronounced "see'-der") is a division of the U.S. Food and Drug Administration (FDA) that monitors most drugs as defined in the Food, Drug, and Cosmetic Act. Some biological products are also leg ...

(CDER) and the

Center for Biologics Evaluation and Research The Center for Biologics Evaluation and Research (CBER) is one of six main centers for the Food and Drug Administration, U.S. Food and Drug Administration (FDA), which is a part of the U.S. Department of Health and Human Services. The current Dir ...

(CBER) to monitor the safety of products after they are approved by the FDA. If a potential safety concern is identified in AERS, further evaluation might include

Epidemiology Epidemiology is the study and analysis of the distribution (who, when, and where), patterns and determinants of health and disease conditions in a defined population. It is a cornerstone of public health, and shapes policy decisions and evidenc ...

studies. Based on an evaluation of the potential safety concern, The FDA may take

regulatory Regulation is the management of complex systems according to a set of rules and trends. In systems theory, these types of rules exist in various fields of biology and society, but the term has slightly different meanings according to context. For ...

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.

Limitations

AERS data does have limitations. First, there is no certainty that the reported event was actually due to the product. The FDA does not require that a

causal relationship Causality (also referred to as causation, or cause and effect) is influence by which one event, process, state, or object (''a'' ''cause'') contributes to the production of another event, process, state, or object (an ''effect'') where the ca ...

between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. Further, the FDA does not receive all adverse event reports that occur 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. Therefore, FAERS cannot be used to calculate the incidence of an adverse event in the U.S. population. A more reliable medical injury database is kept up-to-date by the Health Resources and Services Administration (HRSA), as claims must first undergo a thorough vetting process before being awarded compensation.{{Cite web , title=Countermeasures Injury Compensation Program (CICP) Data {{! HRSA , url=https://www.hrsa.gov/cicp/cicp-data , access-date=2022-09-07 , website=www.hrsa.gov However, it has limitations as well, being reflective of only the smaller number of people whose injury claims have advanced completely through the adjudication process.

Background

Structure

Uses

Limitations

References

See also

External links