AERS

Adverse Event Reporting System

Alekhya Bethi

The Adverse Event Reporting System (AERS) is a

computerized information database designed to support the FDA's post-marketing safety surveillance program for all approved drug and therapeutic biologic products. The structure of AERS is in compliance with the international safety reporting guidance issued by the ICH. Adverse events in AERS are coded to terms in the MedDRA (Medical Dictionary Regulatory Activities Terminology).

Voluntary

Reporting to FDA:

Reporting by Consumers
Reporting by Health Professionals

Mandatory Reporting by Drug/Biologics Manufacturers, Distributors, and Packers

AERS reports are evaluated by clinical reviewers in the

Center for Drug Evaluation and Research CDER and

Center for Biologics Evaluation and Research CBER.

If potential safety concern is identified in AERS, then further

evaluation might include Epidemiology Studies. Based on these reports FDA takes regulatory actions.

ACTIONS

LIMITATIONS

Updating

label info Restricting the use of the drug Communicating new safety info Removing a product

No

certainty that the reported event was actually due to the product. Not every event is reported. Duplicate reporting occurs.

MEDWATCH

The FDA Safety Information and Adverse Event Reporting Program. Protecting the public health by assuring the safety, efficacy, and security of human ... drugs, biological products, medical devices, cosmetics, and products that emit radiation.

Helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.

Reporting into MedWatch

What, when, how and why to report

What All clinical medical products When If serious How Online, or mail/fax/phone Why Every report can make a difference

Reporting into MedWatch

What products to report on

Drugs
Prescription Over the Counter

Special Nutritional Products

Dietary supplements Infant formulas Medical foods

Medical Devices Biologics, except vaccines

Cosmetics

Reporting into MedWatch

What to report
Serious Adverse Events Drugs, biologics, devices, cosmetics and special nutritional products Product Quality Problems Suspect counterfeit Contamination, instability Poor packaging, labeling Defective components Therapeutic failures Medication and Device Use Errors

Reporting into MedWatch

What is a serious adverse event

Any event that

Is fatal Is life-threatening Is permanently/significantly disabling Requires or prolongs hospitalization Causes a congenital anomaly Requires intervention to prevent permanent impairment or damage

Reporting into MedWatch

How to report

Online
www.fda.gov/medw atch

Phone
1-800-FDA-1088

Fax
1-800-FDA-0178

Mail

Reporting into MedWatch

How to report

Patient Product Description of Event or Problem Reporter

What Happens to Your Report

When you report a serious adverse event

Report captured in a database Database monitored by an FDA professional Review of a case series Consultation with medical review division and manufacturer Further epidemiological studies as needed

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