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Adverse Events

adverse-events.pngAdverse events are undesirable effects that occur after the use of a medication, medical device, pesticide, vaccine or other biological product. They may, or may not, be caused by the product or device.

Although controlled studies are performed to evaluate the safety and efficacy of these products, these studies might not identify small groups of patients at higher risk of experiencing adverse events. Post-marketing monitoring of adverse events provides the government, manufacturers and physicians with critical information about the safety and efficacy of products. If adverse events occur, reporting them allows the government, and manufacturers to investigate and determine if the product's labeling or use should be changed. Adverse events are rare and the majority of them are minor, but some can be life-threatening.

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 FDA uses AERS to monitor for new adverse events and medication errors that might occur with these marketed products.

Reporting of adverse events from the point of care is voluntary in the United States. 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). Healthcare 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 FDA as specified by regulations.

AERS is a useful tool for 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 AERS 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 AERS, further evaluation might include epidemiological studies. 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.

AERS data do have limitations. First, there is no certainty that the reported event 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 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, AERS cannot be used to calculate the incidence of an adverse event in the U.S. population.

As stated previously, it is required for manufacturers that receive an adverse event to report to the FDA. This is in accordance to the code of federal regulations 21 CFR 310.305[1]. Captured within the regulation is the requirement to report adverse events, but to do so in a pre-defined time frame. Taking into consideration the seriousness of adverse events, coupled with the requirement to report them, and in a pre-defined time frame, it is beneficial for a manufacturer to capture adverse events in an electronic quality system. This is so that the manufacture can demonstrate control and appropriate reaction to such adverse events. Candidly speaking, a manufacturer should take a pro-active role when dealing with adverse events to understand the potential effects their product / device has on consumers.

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