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8/13/2019 pharmacovigilence-130918140050-phpapp02

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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



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



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



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



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





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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