ABSTRACT:
Pharmacovigilance is pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long term and short term effects of medicine. Post marketing pharmacovigilance uses tools such as data mining and investigation of case reports to identify the relationships between drugs and ADRs. The WHO Programme for International Drug Monitoring aims to develop a comprehensive global pharmacovigilance strategy that responds to the healthcare needs of low- and middle-income countries. Information science promises to deliver effective e-clinical or e-health solutions to realize several core benefits: time savings, high quality, cost reductions, and increased efficiencies with safer and more efficacious medicines. The development and use of standard-based pharmacovigilance system with integration connection to electronic medical records, electronic health records, and clinical data management system holds promise as a tool for enabling early drug safety detections, data mining, results interpretation, assisting in safety decision making, and clinical collaborations among clinical partners or different functional groups. The present challenge call to pharmacovigilance technology vendors to partner with pharmaceutical firms and health care providers to offer flexible, configurable, scalable, and interoperable pharmacovigilance technology solutions to meet the future pharmacovigilance needs in Increasing globalization, Web-based sales and information, Broader safety concerns linked to the patterns of drug use within society, Collaborative working approach among biopharmaceutical firms, health providers, regulatory agencies, insurance payers, CROs, standards consortiums, and central laboratories.