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BY…………

DEVENDER,M.Pharm (Pharmacology)

The science and activities relating to the detection, evaluation, understanding and prevention of adverse drug reactions or any other drug-related problems

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To discuss the need for pharmacovigilanceTo present WHO’s role in promoting

pharmacovigilanceIntrouction of PvPI

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To improve patient care and safety; To improve patient care and safety; To promote rational and effective use of medicine;To promote rational and effective use of medicine; Early etection of unknown safety problems;Early etection of unknown safety problems; To promote education and clinical training in To promote education and clinical training in

PharmacovigilancePharmacovigilance Identification of signalIdentification of signal

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Pre-marketing safety data Animal Experiments : Relevant? Clinical Trials: Complete? ,safety & efficacy

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Post-marketing data Unexpected adverse reactions Interactions Dependence Long-term efficacy, Resistance Risk factors

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Adverse Drug Reactions are the 4th to 6th largest cause of mortality in the world

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MedicineMedicine Adverse reactionAdverse reaction

Aminophenazone (amidopyrine) AgranulocytosisChloramphenicol Aplastic anaemiaClioquinol Myelooptic neuropathy (SMON)Erythromycin estolate Cholestatic hepatitisFluothane Hepatocellular hepatitisMethyldopa Haemolytic anaemiaOral contraceptives ThromboembolismReserpine DepressionStatins RhabdomyolysisThalidomide Congenital malformations

Intrinsic factors of the drug;Intrinsic factors of the drug;Pharmacological,Pharmacological, Idiosyncratic,Idiosyncratic, Carcinogenicity, Mutagenicity, Carcinogenicity, Mutagenicity, Teratogenicity, Teratogenicity,

Extrinsic factors;Extrinsic factors;Adulterants,Adulterants,Contamination,Contamination,

Underlying medical conditions;Underlying medical conditions; Interactions;Interactions;Wrong usage;Wrong usage;

Spontaneous ReportingSpontaneous ReportingTargeted SRTargeted SRCohert Event MonitoringCohert Event Monitoring

2004-2005

1.Canada; 2.Egypt 3.European Union ;4.India5.Japan ;6.Kenya7.Uganda;8.Latin America9.United States

2004-2005

The Council for International Organizations of Medical Sciences (CIOMS)

ICHWHO

2004-2005

Exchange of InformationTechnical support to countries Advisory Committee on Safety of Medicinal

Products

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WHO Pharmaceuticals NewsletterWHO Drug AlertsWHO Drug InformationWHO Restricted Pharmaceuticals ListVigimed - electronic exchangeUppsala Reports

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Technical guidelines on all aspects of pharmacovigilance

(Several publications and documents)Training courses on

pharmacovigilance (Regional Training Courses, biennial

course by UMC and HQ)

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MCI ApproveMedical colleges and hospitalsPrivate hospitalsAutonomous Institutes

2004-2005

CDSCO , Ministry of Health & family welfare in collaboration with IPC

PvPI is administered&monoitored by 2 committees1.Steering ,2.Strategic Advisory

2004-2005

2004-2005

2004-2005

VIGIFLOW is provided by WHO-UMC

2004-2005

HOW?HOW? Monitor clinical status of patientsMonitor clinical status of patients Identify the correct ADRs not side effectsIdentify the correct ADRs not side effects Get more informationGet more information Investigate at hospital levelInvestigate at hospital level Help doctors to fill-up the formsHelp doctors to fill-up the forms Keep patient’s record if more information Keep patient’s record if more information

neededneeded

SEND NOT ONLY QUANTITY BUT…SEND NOT ONLY QUANTITY BUT…

QUALITYQUALITY REPORTREPORT

Despite its 40-year history, Pharmacovigilance remains a dynamic clinical and scientific discipline. It continues to play a crucial role in meeting the challenges posed by the ever increasing range and potency of medicines, all of which carry an inevitable and some-times unpredictable potential for harm.

1.Source: The Importance of Pharmacovigilance, WHO 2002

2.WHO Technical Report No 498 (1972) 3.a b Current Challenges in Pharmacovigilance:

Pragmatic Approaches (Report of CIOMS Working Group V), 2001 Geneva.

4.http://www.acrin.org/Portals/0/Administration/Regulatory/CTCAE_4.02_2009-09-15_QuickReference_5x7.pdf

2004-2005

2004-2005

5.Lindquist M. Vigibase, the WHO Global ICSR Database System: Basic Facts. Drug Information Journal, 2008, 42:409-419.6The ICH E2B Standard E2B(R3)Data Elements for Transmission of Individual Case Safety Reports ICH E2B Standard7.http://www.who-umc.org/DynPage.aspx?id=13140&mn=1514, accessed 10 February 2009.8.Pharmacovigilance. Mann RD, Andrews EB, eds. John Wiley & Sons Ltd

‘People who are vigilant do not die;

people who are negligent are as if

dead’. - Shakyamuni Buddha

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