Role of adverse event reporting system in the pharmaceutical industry
Although the pharmaceutical industry is becoming increasingly vigilant about drug safety, cases of adverse drug reactions are still reported. However, constant efforts have been made by drug regulation authorities and pharmaceutical companies in ensuring that the safe drugs are manufactured and made available to the consumers. Adverse event reporting system has been instrumental in helping medicine manufacturing companies in ensuring its safety.
An adverse event is an untoward medical experience in a patient who is administered a pharmaceutical product and which does not necessarily have to have a casual relationship with this treatment. In such cases, though the medicine administered in the patient is the cause of problem, the manufacturer cannot be held responsible since the manufacturer would have manufactured the medicines in adherence to standards prescribed by the regulation authorities. In order to improve the quality of drugs, pharmaceutical companies use the adverse event reporting system.
Adverse event reporting system (AERS) is a computerized database of adverse events that is designed to help drug regulation authorities in drug manufacturing and post-marketing safety surveillance program for all medicines and biological products produced. AERS can be used in monitoring 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 requests for drug information from consumers, medical practitioners or authorities.
AERS can be used to compile and enhance the set of standards set for manufacturing and marketing drugs. The pharmaceutical industry will be in turn notified about the revised drug standardizations. Based on this, they can manufacture products that do not cause any of the reported adverse drug reactions. This helps pharmaceutical industries produce safer products that in turn generates greater demand and increases sales.
