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 professionals 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 le ...
(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 U.S. Food and Drug Administration (FDA), which is a part of the U.S. Department of Health and Human Services. The current Director of CBER is Peter Marks, ...
(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. Fo ...
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.
References
See also
*
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 ...
(VAERS)
External links
FDA Adverse Event Reporting System (FAERS)AdverseEvents.comA summary of the most recently available adverse event data from AERS.
Food and Drug Administration
Government databases in the United States