Scope of Pharmacovigilance

• Improve patient care and safety in relation to the use of medicines, and all medical and paramedical interventions
• Improve public health and safety in relation to the use of medicines.
• Contribute to the assessment of benefit, harm, effectiveness and risk of medicines, encouraging their safe, rational and more effective(including cost effective) use, and
• Promote understanding , education and clinical training in pharmacovigilance and its effective communication to the public
• Humanitarian concerns
• Economical concerns
• At the time of approval, clinical trial data are available on limited numbers of patients treated for relatively short periods
• Once product is marketed, large number of patients may be exposed, including 1.Patients with co-morbid illnesses 2.Patients using concomitant medications 3.Patients with chronic exposure
• After marketing, new safety information may become available 1.Through use of the product domestically or in other countries 2.Through use of other drugs in the same class i)From preclinical studies ii)From pharmacological studies iii)From controlled clinical trials