Challenges and Future Consideration for Pharmacovigilance

There is always a trade-off involved between the advantages and the possible risk with the use of pharmaceuticals. The risk is minimized when medicines of good quality, safety and efficacy are used rationally by an informed health professional and by patients. Pharmacovigilance helps in reducing the risk of harm by ensuring good quality medicines are used appropriately and expectations and concerns of patients are considered when therapeutic decisions are made. It ensures that health care providers and consumers have the information they need to make their decision about treatment. Pharmacovigilance has emerged as science to examine the safety and efficacy of drugs and other therapeutic products. The World Health Organization (WHO) defines pharmacovigilance as discipline to identify, review and understand drug adverse effects and taking required precautionary actions to curtail these drug linked problems [1]. Its importance has been critical to public health and has become an integral part of effective clinical practice. The first systemic international efforts to address drug safety were initiated in 1961, following the thalidomide tragedy [2,3]. When thalidomide was introduced, the pharmaceutical industry comprised of number of emerging competing companies and many of them were not dedicated to drug development. Also there were very few or no laws regulating drug development and marketing. Thalidomide use by pregnant mothers resulted in birth of thousands of congenitally deformed infants [2]. In response, efforts were initiated to address the drug safety issues by developing a system for detecting previously unknown or poorly understood adverse effects of medicines. Guidelines were developed to monitor drugs, foods and environmental contaminants for adverse reactions and toxicity. In the beginning these guidelines were to meet local and national needs. With globalization of world economy, free trade, increased communication across borders and increasing use of internet resulted in recognized need of a system, applicable internationally, to ensure safety of medicinal products. These efforts and recognition of system to monitor and promote the safety and effectiveness medicines lead to emergence of practice and science of pharmacovigilance.