Pharmacovigilance
What is it?
is drug safety.
detection, collection, assessment, understanding and prevention of adverse effects or any other medicine related problem. under the practical conditions of clinical use in large populations.
Goal of Pharmacovigilance
Monitor the quality of drugs
Identify the health risks involved in administration
of certain drugs
Prevent harm to patients Research and efficacy of drugs
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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 effects of dugs.
Pharmacovigilance keeps track of any drastic This gives information about the hazards caused by the medicines.
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. 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
Pharmacovigilanc e start with the Clinical Trial, from phase-I Collection of drug information get started.
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Glossary of terms
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.
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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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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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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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Conclusion
The 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
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THANKS
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