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Adverse Drug Event Reporting and Notification Overview

written by: MandaSpring • edited by: Anurag Ghosh • updated: 12/12/2008

Having a bad reaction to a drug is a horrible thing that happens all the time. So, what can be done to update statistics in an effective manner to save more lives and suffering? The answer is: Adverse Drug Event Reporting and Notification.

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    Whenever a new drug is advertised on TV, there is a list of possible side-effects. That comes from the adverse drug event reporting and notification practice that the FDA insists on. No matter what the intended effects are for a new drug or treatment program, there is always the possibility of someone who uses it having a bad reaction. It could be an allergy to one of the ingredients or a combination of ingredients that produces undesirable and even dangerous reactions. But if there is a chance that the drug can have a bad effect on even a very few patients, it is the FDA policy to notify all those who use the drug that they could be in danger.

    Why Adverse Drug Event Reporting and Notification are Important

    Medical technology is advancing rapidly in the development of new drugs and treatments for everything from the common cold to cancer research. Most of these drugs are tested on a group of volunteers before ever reaching the market. The test group may have no side effects or ill effects from a drug and it is then cleared for the general public, under a doctor’s supervision. The drug may be prescribed for hundreds of patients with no problems at all, but one person might have a serious reaction. Some of these reactions can result in further illness, injury or even death. If the drug, used as prescribed, causes more harm than good to a patient, the FDA alarm bells go off.

    How the System for Reporting and Notification Works

    Every druggist and doctor would be obliged to report the details of any Adverse Drug Event to a main data base, complete with pertinent details about the patient, such as age, weight, race, disabilities known allergies and general health. The doctor, pharmacist or health department would also be obliged to notify all people who are taking the same drug that the possibility of adverse reactions exists. This allows various patients to check with their doctors to see if they are likely to have the same reactions before it happens to them.


    Modern medical technology involves computers, programs and data bases for the protection of patients. Although not all necessary reporting is done, as the technology and programming gets easier and more common in usage the information should be more readily available. Adverse Drug Event Reporting and Notification are essential to keeping patients healthy and free from dangerous reactions to otherwise beneficial drugs.