Adverse Event Reporting System and Its Role in the Pharmaceutical Industry

Although the pharmaceutical industry is becomingAdverse event reporting system (AERS) is a
increasingly vigilant about drug safety, cases ofcomputerized database of adverse events that is
adverse drug reactions are still reported. However,designed to help drug regulation authorities in drug
constant efforts have been made by drug regulationmanufacturing and post-marketing safety surveillance
authorities and pharmaceutical companies in ensuringprogram for all medicines and biological products
that the safe drugs are manufactured and madeproduced. AERS can be used in monitoring activities
available to the consumers. Adverse event reportingsuch as looking for new safety concerns that might
system has been instrumental in helping medicinebe related to a marketed product, evaluating a
manufacturing companies in ensuring its safety.manufacturer's compliance to reporting regulations
An adverse event is an untoward medical experienceand responding to requests for drug information from
in a patient who is administered a pharmaceuticalconsumers, medical practitioners or authorities.
product and which does not necessarily have to haveAERS can be used to compile and enhance the set
a casual relationship with this treatment. In suchof standards set for manufacturing and marketing
cases, though the medicine administered in thedrugs. The pharmaceutical industry will be in turn
patient is the cause of problem, the manufacturernotified about the revised drug standardizations.
cannot be held responsible since the manufacturerBased on this, they can manufacture products that
would have manufactured the medicines in adherencedo not cause any of the reported adverse drug
to standards prescribed by the regulation authorities.reactions. This helps pharmaceutical industries produce
In order to improve the quality of drugs,safer products that in turn generates greater
pharmaceutical companies use the adverse eventdemand and increases sales.
reporting system.