Jain Deepika*, Rathore Kamal Singh
BN Institute of Pharmaceutical Sciences,
Pharmacovigilance is particularly concerned with adverse drug reactions, or ADRs, which are officially described as: “A response to a drug which is noxious and unintended, and which occurs at doses normally used for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological function”. The mission of Pharmacovigilance is to contribute to the protection of public health in the regulation of the safety; quality and efficacy of medicines for human use and to ensure the healthcare professionals and patients have access to information about the safe and effective use of medicine. The World Health Organization (WHO) defines an adverse drug reaction (ADR) as “Any response to a drug which is noxious and unintended, and which occurs at doses normally used in man for prophylaxis, diagnosis or therapy of disease or for modification of the physiological function”.
The discipline of pharmacovigilance has developed considerably since the 1972 WHO technical report, and it remains a dynamic clinical and scientific discipline. It has been essential to meet the challenges of the increasing range and potency of medicines (including vaccines), which carry with them an inevitable and sometimes unpredictable potential for harm. The following is a summary of some of the serious challenges facing pharmacovigilance programmes in the next ten years & the major challenges are:Globalization, Web-based sales and information, Broader safety concerns, Public health versus pharmaceutical industry economic growth , Monitoring of established products, Developing and emerging countries, Attitudes and perceptions to benefit and harm, Outcomes and Impact.