World Journal of
Pharmaceutical and Life Sciences

A STUDY TO EVALUATE INTER INDIVIDUAL VARIATIONS IN CAUSAL ASSESSMENT USING NARANJO AND WORLD HEALTH ORGANIZATION UPPSALLA MONITORING CENTRE (WHO-UMC), CAUSALITY SCALE

Dick B. S. Brashier, Dr. Prashant Mishra*, Neha Akhoon, Htet Wai Moe and Kedar G. Bandekar

ABSTRACT

Pharmacovigilance has come up as an important subject in last few decades. The need for adverse drug reaction reporting and sharing the information came into light after the thalidomide crisis in sixties.[1] Thalidomide was a drug approved in fifties as an antiemetic for morning sickness, in first trimester of pregnancy.[1] By the time teratogenic potential of the drug came into light thousands of newborns were affected by this drug by developing phaecomaelia.[1] Since then, countries all over the world realized importance of adverse drug reaction reporting and further getting causal assessment of the drug reaction relationship.[2] United States of America(USA), European Union(EU) and many other countries developed their own system of reporting and causal assessment.[2] There are different ways of doing a causal assessment for a reported adverse drug reaction (ADR). We have global introspection which is based on clinical judgment, probalistic analysis and algorithms.[2] Different algorithms uses a defined format to draw a conclusion, we have World Health Organization (WHO) method, Naranjo scale, Karsh-lasagna, Roussel-uclaf, Imputability and many more.[2] Many countries are following a common programme conducted by WHO, having its centre in Uppsalla, Sweden called Uppsalla Monitoring Center (UMC).[3]

[Full Text Article]   [Download Certificate]