The WHO Programme for International Drug Monitoring has now entered over 7 million adverse drug reaction (ADR) reports from countries contributing to the WHO Global Individual Case Safety Report (ICSR) database, VigiBase. These reports represent the mainly concerns of health professionals around the world about possible harm caused to their patients by medicines, but VigiBase also contains reports sent to national centres from pharmaceutical companies and from patients. After they are processed and entered into VigiBase, the 7 million ADR reports are subject to further analysis. When there are several reports of a specific, suspected new adverse reaction to a particular drug this process may lead to the detection of a ‘signal’ - a notice of a need for increased awareness of a possible hazard communicated to countries in the Programme. This happens after preliminary evaluation and expert review, prior to detailed work on the ground by individual national authorities.
• Press Release - 7 million Reports (pdf)
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