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By Bharti
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Pharmacovigilance
What is it?
What is its role?
How is it helpful?
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Pharmaco = Drug
Vigilance = to keep awake or alert, to
keep watch
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Pharmacovigilance derived from
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Pharmacovigilance (abbreviated PV, PhV )is drug safety.
Is the pharmacological science related to the
detection, collection, assessment,understanding and prevention ofadverse effects or any other medicinerelated problem.
Is the study of safety of marketed drugunder the practical conditions of clinical usein large populations.
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Monitor the quality of drugs
Identify the health risks involved in administrationof certain drugs
Prevent harm to patients
Research and efficacy of drugs
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Goal of Pharmacovigilance
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Pharmacovigilance saves thousands of lives each year. By monitoring the adverse effects of drugsright from the lab to the pharmacy and then on formany years
Pharmacovigilance keeps track of any drasticeffects of dugs.
This gives information about the hazards causedby the medicines.
By this way, it prevents harm to patients usingthose drugs
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Pharmacovigilance: Preamble Thalidomide tragedy (1961): The greatest of all
drug disasters.
Thalidomide had been introduced and welcomed
as a safe and effective hypnotic and antiemetic. Itrapidly became popular for the treatment ofnausea and vomiting in early pregnancy.
Tragically the drug proved to be a potent humanteratogen that caused major birth defects in anestimated 10,000 children
Phocomelia was a characteristic feature
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ThePharmacovigilance start with theClinical Trial,
from phase-ICollection ofdrug informationget started.
The Pharmacovigilance study of drug orproducts until life-cycle is not completed.
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Why do we study
Pharmacovigilance?? Whatever drug we take shows some ADRs which were not knowing at the time of clinical trials, but
come after marketing in the large population which show some events which are not seen at thetime of Clinical Trials.
After knowing this ADRs and ADEs will arranged according to their severity to causetoxicity to maintain the safety profile of the drug.
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Adverse event: Any untoward medical occurrencethat may present during treatment with apharmaceutical product but which does not
necessarily have a causal relationship with thetreatment.
Adverse reaction: WHO technical report: Aresponse to a drug which is noxious and
unintended and which occurs at doses normallyused in humans for the prophylaxis, diagnosis ortherapy of disease or for the modification ofphysiological function.
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Glossary of terms
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Expected: As opposed to “unexpected”, an event thatis noted in the investigators brochure or labeling(package insert or summary of productcharacteristics).
Unexpected adverse reaction: the nature or severity
of which is not consistent with the domestic labelingor market authorization, or expected fromcharacteristics of the drug.
Signal: Reported information on possible causal
relationship between an adverse event and a drug, therelationship being unknown or incompletelydocumented previously. Usually multiple report isrequired to generate a signal depending upon the
seriousness of the event and quality of information. 12
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Important organizations involved
in pharmacovigilanceFDA: The Food and Drug Administration (FDA orUSFDA) is an agency of the United States Department
of Health and Human Services, one of the UnitedStates federal executive departments, responsible forprotecting and promoting public health through theregulation and supervision of food safety, tobacco
products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions,medical devices, electromagnetic radiation emitting
devices (ERED), veterinary products, and cosmetics. 13
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Uppsala monitoring centre
The Uppsala monitoring centre(UMC, on behalf of WHO) has over 3 million AE case reportes fromover 75 countries. The data are supplied by
national health authorities. Most of the data arefrom the United states and supplied by theFDA.The UMC does not review or assess theindividual cases put into database, but it does
pharmacovigilance analyses and signaling.
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Conclusion The science and activities relating to the detection,
evaluation, understanding and prevention ofadverse drug reactions or any other drug-related
problems Pharmacovigilance is used for preventing patients
from being affected unnecessarily
The work of WHO in the area of safety monitoring
of medicines is necessary if we are to achieve themission of EDM
Medicines should be Available, Affordable, Safe
and Properly used 16
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