Adverse Event Reporting for better quality of drugs | Medicine
Most drugs that are on the market have side-effects. Most are minor and do little harm to the users. But sometimes, the adverse reaction to certain drugs can be more pronounced and in certain cases, may even lead to death. If such a situation occurs, it’s important for the drug user or his health practitioner to report it to the FDA or the drug manufacturer.
All the drugs that enter the market have been rigorously tested for adverse events according to stringent global norms and approved by
adverse event reporting for better quality of drugs medicine
Post-marketing surveillance of drugs undertaken by regulatory authorities help manage risks from drugs over a long period of time. However, the chief drawback of this system is that either the affected patient or the med
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ical practitioner must report the adverse reaction or else it goes unnoticed. So it’s important to have an effective Adverse Event Reporting System in place to make reporting, monitoring and analyzing adverse reactions easy.
Adverse Event Reporting System or AERS is a computerized information database that helps drug regulatory authorities monitor and manage information on adverse drug reactions. The system uses information technology to track, report and access adverse effects.
AERS helps
Category › Medicine
Title › Adverse Event Reporting for better quality of drugs | Medicine
post-marketing surveillance of drugs by:
›› Helping drug companies identify warning signals soon after product launch
›› Aiding drug companies to monitor adverse effects happening over many years
›› Allowing greater transparency in marketing drugs
›› Working to protect public health by watching out for adverse reactions
›› Providing drug manufacturers with information to make better drugs and biological products.
An effective Adverse Event Reporting System helps monitor and even minimize adverse reactions during the drug manufacturing process and also during the post-marketing surveillance of drugs.