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PharmacovigilanceBy 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

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 of adverse effects or any other medicine related problem.

Is the study of safety of marketed drug under the practical conditions of clinical use in large populations.

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Monitor the quality of drugs

Identify the health risks involved in administration of certain drugs

Prevent harm to patients

Research and efficacy of drugs

Goal of Pharmacovigilance

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Pharmacovigilance saves thousands of lives each year. By monitoring the adverse effects of drugs right from the lab to the pharmacy and then on for many years

Pharmacovigilance keeps track of any drastic effects of dugs.

This gives information about the hazards caused by the medicines.

By this way, it prevents harm to patients using

those drugs

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Pharmacovigilance: PreambleThalidomide tragedy (1961): The

greatest of all drug disasters.Thalidomide had been introduced and

welcomed as a safe and effective hypnotic and antiemetic. It rapidly became popular for the treatment of nausea and vomiting in early pregnancy.

Tragically the drug proved to be a potent human teratogen that caused major birth defects in an estimated 10,000 children

Phocomelia was a characteristic feature

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The Pharmacovigilance start with the Clinical Trial, from phase-I Collection of drug information get started.

The Pharmacovigilance study of drug or products 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 the time of Clinical Trials.

After knowing this ADRs and ADEs will arranged according to their severity to cause toxicity to maintain the safety profile of the drug.

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Adverse event: Any untoward medical occurrence that may present during treatment with a pharmaceutical product but which does not necessarily have a causal relationship with the treatment.

Adverse reaction: WHO technical report: A response to a drug which is noxious and unintended and which occurs at doses normally used in humans for the prophylaxis, diagnosis or therapy of disease or for the modification of physiological function.

Glossary of terms

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Expected: As opposed to “unexpected”, an event that is noted in the investigators brochure or labeling (package insert or summary of product characteristics).

Unexpected adverse reaction: the nature or severity of which is not consistent with the domestic labeling or market authorization, or expected from characteristics of the drug.

Signal: Reported information on possible causal relationship between an adverse event and a drug, the relationship being unknown or incompletely documented previously. Usually multiple report is required to generate a signal depending upon the seriousness of the event and quality of information.

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Important organizations involved in pharmacovigilance

FDA: The Food and Drug Administration (FDA or USFDA) is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments, responsible for protecting and promoting public health through the regulation 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.

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EMEA: The European Medicines Agency is a decentralised body of the European Union located in London

MHLW: Ministry of Health, Labor and Welfare,Japan

CDSCO: The government of India with the assistance of world bank has initiated the National pharmacovigilance programme. The central drugs standard control organization (CDSCO) is coordinating the country wide pharmacovigilance programme under the aegis of Ministry of health and family welfare, DGHS New Delhi

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Uppsala monitoring centreThe Uppsala monitoring centre(UMC, on

behalf of WHO) has over 3 million AE case reportes from over 75 countries. The data are supplied by national health authorities. Most of the data are from the United states and supplied by the FDA.The UMC does not review or assess the individual cases put into database, but it does pharmacovigilance analyses and signaling.

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ConclusionThe science and activities relating to the

detection, evaluation, understanding and prevention of adverse 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 the mission of EDM

Medicines should be Available, Affordable, Safe and Properly used

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THANKS