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How Adverse Event Reporting System helps reduce drug risks

When a drug is administered to a patient, he may

, at times, experience some unfavorable reactions that may or may not have a causal relationship with that particular drug. Nevertheless, its an adverse event that needs to be reported, monitored, analyzed, accessed and if possible corrected. Thats the logic behind the Adverse Event Reporting System or the AERS. AERS is a computerized information database that helps drug regulatory authorities monitor and manage information on adverse effects of drugs. Its a IT-based surveillance program for drugs and other biological products. Reports of adverse effects are often received from healthcare professionals and patients themselves once the drug hits the market. Regulatory bodies then process the information and urge drug companies to effectively manage risks associated with the product. Using AERS, drug manufacturers and regulatory authorities are able to identify risks, address these risks effectively and manage safety concerns of drugs effectively. AERS helps evaluate the manufacturers compliance to safety standards. Adverse Event Reporting System allows greater transparency in the drug manufacturing process, the pre-marketing and post-marketing phases of the drug. It allows the drug manufacturer to manage volumes of data, look for warning signals at an early stage and saves on time and money. AERS is a great tool that helps protect public health and guards patients against untoward medical experiences due to drugs. It equips pharmaceutical companies with information that can help them make better products. Its a watchdog for the regulatory authorities. AERS is an indispensible tool that benefits the drug manufacturer, the drug regulatory bodies and the drug user, alike.

How Adverse Event Reporting System helps reduce drug risks

By: Vikas Sah
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How Adverse Event Reporting System helps reduce drug risks