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Pharmacovigilance & Drug Safety

History of Drug Safety
• In 1848, 15-year old girl died who received chloroform
anesthesia for the removal of ingrown toe-nail
• After a report was published in Lancet, the first committee
set up to monitor drug safety
• In the United States of America in 1950, cases of aplastic
anemia associated with the use of chloramphenicol were
• As a consequence, the Council on Drugs of the American
Medical Association set up a Blood Dyscrasia Registry
History of Drug Safety
• In 1960, Thalidomide marketed in 46 countries (hypnotic,
prevention of nausea in pregnancy)
• In 1960 first reports of deformed infants (phoecomelia)
total more than 20,000 cases
• Food
and Drug Administration (FDA) began the
systematic collection of reports of all types of ADRs in
• Thalidomide, because of its association with congenital
malformation in newborn infants, was withdrawn from the
market in 1961
What is Pharmacovigilance?
• Defined as the science and activities relating to the detection,
assessment, understanding and prevention of adverse effects
or any other drug-related problems
Objectives of PV
• To improve patient care and safety in relation to the use of
medicines, and all medical and paramedical interventions
• To improve public health and safety in relation to the use
of medicines
• To
contribute to the assessment of benefit, harm,
effectiveness and risk of medicines, encouraging their
safe, rational and more effective use
• To promote understanding, education and clinical training
in pharmacovigilance and its effective communication to
health professionals and the public