A Study of Pharmacovigilance System Performing Intensive and Monitoring in HIV/AIDS: Improving Drug Safety Surveillance and Data Analysis in HIV/AIDS

Abstract

The objective of the present study is to analyze national and international pharmacovigilancedata for potential signals in the pharmacovigilance data analysis. Vigiflow software was used to assesscausality, seriousness, severity of spontaneous adverse drug reaction reportage formulas as describedin the National Pharmacovigilance Program and to enter the WHO database. WHO experts evaluatedthese data and certification was made by WHO for the entry of data in Vigiflow. In relation to importantinformation, which led to difficulties carrying out the causality assessment, the ADR forms reportedunder the National Pharmacovigilance Program were not complete. This is not only because healthcareprofessionals know about the importance of ADR reporting, but also because there are no columns inthe ADR form itself that provide some important facts necessary to evaluate causality.Pharmacovigilance in India hasn't been very advanced. This may be because the health workers areignorant and the drug safety surveillance is not properly trained. The facts generated in other countries,advisory notes issued and regulatory measures taken by regulators elsewhere depend heavily on India.However, if circumstances differ, information obtained in one country may not be relevant to any otherpart of the world. This requires us to produce indigenous data that would be more significant and havean educational value and could contribute to national decision-making on regulatory matters. It istherefore important to develop a strong system of pharmacovigilance. The pharmacovigilance systeminvolves minimizing existing risks through health care provider training, secured health care provision,assessment of new risk by different pharmacovigilance methods, such as active or passive supervision,analysis of pharmacovigilance-generated safety data, the identification of preventive risks, and riskdevelopment.