Agency for Food and Drug Administration continues to strive to make improvements and strengthening of pharmacovigilance systems in Indonesia, among others, with the development of drug side effect reporting system (ESO) electronically.
ESO reporting system that has been running is paper based reporting system by using the yellow form (yellow form) by peer health workers and also CIOMS form by the pharmaceutical industry marketing authorization holder.
Development of reporting ESO electronically is intended to expand outreach and access by health workers and the pharmaceutical industry in reporting ESO as an individual case safety report (ICSR) with timeline reporting more precise, so the National Agency of Drug and Food can immediately detect and identify if ESO there are serious problems (risk identification). In addition, it is expected with the development of this system, of course, good ESO reporting by peer health workers and the pharmaceutical industry marketing authorization holders can be further increased.
In addition, all reports are received electronically ESO will be entered into the database meso, where POM can develop better data management as well. It is very important for POM to be able to do the analysis of the safety profile of the drug circulating in Indonesia, so that the POM can initiate the establishment of appropriate regulatory follow-up proactively with the profile data based on security aspects of the drug in a population of Indonesia itself.
At this time, electronic reporting systems ESO is currently in internal testing phase by the POM as an administrator, so ready and mature during the soft launching implemented. The support of all parties in the form of criticism and suggestions is our motivation for POM to try to develop this system. (Saa)