Pharmaco-vigilance is used for: (LQ)
|A||To Monitor drug toxicity|
|B||To monitor unauthorized drug manufacture|
|C||Control the price of drugs|
a. Pharmacovigilance is a French term that means, “Keeping a watch on side effects of drugs”.
b. This is associated with detection, understanding and prevention of adverse drug reactions.
c. The concept of pharmacovigilance evolved following thalidomide disaster in 1950s.
d. In India, there are 4 main centers associated with pharmacovigilance activities in India: AllMS, Delhi, KEM Mumbai, KGMC Lucknow and JIPMER Pondicherry.
e. It comes in phase-IV of clinical trials and is also known as postmarketing surveillance.
f. Ethical clearance may not be needed. It could be done in two different ways: spontaneous or intensive.
g. In the former, the doctors or other health case professionals send the reports directly to the drug monitoring authority on their own; while in the 2nd, there is a planned search for the adverse drug reactions.
h. Spontaneous monitoring has the advantage of monitoring even those drug reactions, which are rare and may not be detected in the small sample size; while intensive will monitor the drug effects in the study population.
Naranjo’s algorithm is used for causality assessment in adverse drug reaction monitoring