| It is a known fact that despite all the efforts on | | | | causes a permanent disability person or causes death. |
| research and development, adverse drug reactions | | | | Under such circumstances, the patient is taken to be |
| still exist and accidents still happen. In the wake of | | | | a subject. Various laboratory and clinical tests are |
| this, adverse event reporting system was started | | | | conducted to deduce the exact cause of trouble. |
| with the motive of recording, analyzing and binding | | | | The findings are then elaborately analyzed to |
| drugs against subsequent adverse drug mishaps. This | | | | accumulate all the necessary data. The available data |
| method is a contributing factor in making clinical | | | | is then categorically organized and is sent to a |
| safety more effective and foolproof. | | | | regulatory body for quality assurance and to ensure |
| It was not until the disaster caused by thalidomide in | | | | appropriate management of the data. |
| 1961, that the first systematic international efforts | | | | The findings of the data may be an adverse case of |
| were made to address safety issues of drugs. This | | | | drug mishap which may or may not be previously |
| led to the creation of WHO Pilot Research Project | | | | regulated. If it is previously detected case of drug |
| for International Drug Monitoring in 1968. The | | | | adversity, it means that there has been a lapse in the |
| intention behind this program was to develop a | | | | drug regulation system which needs to be worked on |
| system applicable internationally to monitor previously | | | | and made more stringent. If it is a fresh care of |
| known or unknown adverse drug reactions. This | | | | adverse drug experience, the case needs to be |
| subsequently led to the science of pharmacovigilance. | | | | recorded, monitored and measure to curb |
| An adverse event is an untoward medical experience | | | | subsequent cases of drug adversity should be taken. |
| in a patient who is administered a pharmaceutical | | | | Either way, adverse event reporting system, helps |
| product and which does not necessarily have to have | | | | take notice of mishaps caused by poor drug safety |
| a casual relationship with this treatment. In serious | | | | measures and ensure s a more stringent and safe |
| events of adverse drug effect, the administration of | | | | drug regulatory system. |
| a particular drug results in prolonged hospital stay, | | | | |