Assessment of Global And National Pharmacovigilance Systems and A Proposal of Futuristic Approaches

Pharmacovigilance plays an important role in the rational use of medicines information about ADRs in the general population. Knowledge of the adverse effects of drugs is important for effective treatment. Information collected during the pre-marketing phase of drug development may not detect rare ADRs. The use of a drug during a clinical trial is under controlled conditions. Clinical trials generally enroll a selected, limited number of patients and may not include certain sections of the population. Drug use in special situations or drug interactions may not be studied. Therefore, the post-marketing surveillance of drugs is important. The number of Adverse Drug Reactions (ADRs) reported have also resulted in an increase in the volume of data handled and to understand pharmacovigilance a high level of expertise is required to rapidly detect drug risks as well as to defend the product against an inappropriate removal. An increase in drug safety concerns in recent years with some high profile drug withdrawals have led to raising the public concern by various stakeholders more importantly by the Regulatory Authorities. The number of Adverse Drug Reactions (ADRs) reported have also resulted in an increase in the volume of data handled and to understand pharmacovigilance a high level of expertise is required to rapidly detect drug risks as well as to defend the product against an inappropriate removal. The various strategies and proposals are to build and implement a robust Pharmacovigilance system for various levels and eventually make it happen in our national Pharmacovigilance programme. Adding further conceptional inputs to strengthen the programme to improve its usage and maximize the benefits