Tuesday, September 29, 2009

Adverse Event Reporting Systems For A World With Safer Drugs

by: Vikas S

It is a known fact that despite all the efforts on research and development, adverse drug reactions still exist and accidents still happen. In the wake of this, adverse event reporting system was started with the motive of recording, analyzing and binding drugs against subsequent adverse drug mishaps. This method is a contributing factor in making
clinical safety more effective and foolproof.

It was not until the disaster caused by thalidomide in 1961, that the first systematic international efforts were made to address safety issues of drugs. This led to the creation of WHO Pilot Research Project for International Drug Monitoring
in 1968. The intention behind this program was to develop a system applicable internationally to monitor previously known or unknown adverse drug reactions. This subsequently led to the science of pharmacovigilance.

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 serious events of adverse drug effect, the administration of a particular drug results in prolonged hospital stay, causes a permanent disability person or causes death.

Under such circumstances, the patient is taken to be a subject. Various laboratory and clinical tests are conducted to deduce the exact cause of trouble. The findings are then elaborately analyzed to accumulate all the necessary data. The available data is then categorically organized and is sent to a regulatory body for quality assurance and to ensure appropriate management of the data.

The findings of the data may be an adverse case of drug mishap which may or may not be previously regulated. If it is previously detected case of drug adversity, it means that there has been a lapse in the drug regulation system which needs to be worked on and made more stringent. If it is a fresh care of adverse drug experience, the case needs to be recorded, monitored and measure to curb subsequent cases of drug adversity should be taken.

Either way, adverse event reporting system, helps take notice of mishaps caused by poor drug safety measures and ensure s a more stringent and safe drug regulatory system.


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