Glossary of terms used in Pharmacovigilance
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1 Glossary of terms used in Pharmacovigilance
2 WHO - World Health Organization CIOMS - Council for International Organizations of Medical Sciences ICH - International Conference on Harmonization PSUR - Periodic Safety Update Report SUSAR- Suspected Unexpected Serious Adverse Reaction
3 Pharmacovigilance WHO, 2002 The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem
4 Adverse reaction WHO, (1972) 'A response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function'.
5 Adverse event Medical occurrence temporally associated with the use of a medicinal product, but not necessarily causally related
6 Side effect Unintended effect occurring at normal dose related to the pharmacological properties
7 Serious adverse event or reaction Any untoward medical occurrence that at any dose; Results in death Requires inpatient hospitalization or prolongation of existing hospitalization Results in persistent of significant disability or incapacity
8 Unexpected adverse reaction Not consistent with applicable product information or characteristics of drug.
9 Signal Reported information on possible causal relationship between an adverse event and drug Previously unknown or incompletely documented More than one report is needed.
10 AE Types Adverse Event Intensity Seriousness Expectedness Causality Mild Moderate Non Serious Serious Expected Unexpected Related Un-related Severe
11 Adverse event Seriousness Serious Not Serious Serious Adverse event Adverse event Causality Related to IMP Not Related to IMP Related to IMP Not Related to IMP Serious Adverse Reaction Serious Adverse Event Adverse Reaction Adverse Event Expectedness Expected Not Expected Serious Adverse Reaction Suspected Unexpected Serious Adverse Reaction
12 Causality assessment The evaluation of the likelihood that a medicine was the causative agent of an observed adverse reaction. Causality assessment is usually made according established algorithms.
13 Methods of causality assessment WHO assessment scale Naranjo s scale European ABO system Karch and Lasagna s scale Kramer scale Bayesian network Yale Algorithm Spanish Imputation System
14 WHO Causality categories: Certain Probable Possible Unlikely Conditional/Unclassified Unassessable/Unclassifiable
15 DeChallenge :the clinical decision to withdraw /discontinue a drug treatment after a possible ADR has occurred Rechallenge: The point at which a drug is again given to a patient after its initial withdrawal.
16 Vigibase: The name for the WHO International ADR Database Vigiflow: is a sophisticated case report management system created by the UMC, complying with GxP requirements.
17 Vigisearch: is a custom search offered by the UMC to third party inquirers for which several types of standard presentation are available. Vigimed: conferencing facility, exclusive to member countries of the WHO Programme for International Drug Monitoring.
18 Generic Name? Brand Name? POM OTC
19 PEM Prescription Event Monitoring Cohort event monitoring
20 FORMULARY A listing of medicinal drugs with their uses, methods of administration, available dose forms, side effects, sometimes including their formulas and methods of preparation.
21 Eudravigilance The European Union data-processing network and management system, established by the European Medicines Agency to support the Electronic exchange,management,and scientific evaluation of Individual Case Safety Reports related to all medicinal products authorized in the European Economic Area.
22 HIERARCHIAL STRUCTURE OF PROPOSED CENTRES
23 National PVig Programme National PVig Center NE Zonal SW Zonal N Regional E Regional S Regional W Regional
24 NATIONAL PHARMACOVIGILANCE ADVISORY COMMITEE -November The National Pharmacovigilance Centre Office of Drugs Controller General of India, Central Drugs Standard Control Organization, Room No. 347-A, D.G.H.S., Ministry of Health & Family Welfare, Nirman Bhawan, New Delhi Tel: (11) Fax: (11)
25 PERIPHERAL PHARMACOVIGILANCE CENTRE ACTIVITIES Primary contact ADR data collection center Small Medical centers nursing homes (Clinics, Private hospitals, Pharmacies) Primary Pharamcovigilance centers Identified & coordinated by RPCs/ZPCs in coordination with CDSCO At least one in each state & UT and some other leading medical College Twenty eight peripheral centers, spread countrywide
26 REGIONAL PHARMACOVIGILANCE CENTRE ACTIVITIES (Secondary Pharmacovigilance Centre) Relatively larger facilities attached with medical college Will act as secondary level centers First contact for ADE data collection Identified and coordinated by Zonal centres in co-ordination with CDSCO Five regional centres
27 Regional pharmacovigilance centers 5 regional pharmacovigilance centers located at Kolkata (IPGMR-SSKM Hospitals) Mumbai (TN Medical College & BYL Nair Charitable Hospital) Nagpur (Indira Gandhi Medical College) New Delhi (Lady Hardinge Medical College) Pondicherry (JIPMER)
28 ZONAL PHARMACOVIGILANCE CENTRES ( TERTIARY PHARMACOVIGILANCE CENTRE) Large health care facility attached with medical college in metro cities Identified by CDSCO 3 rd level levels Also act as I st ADE data collection centre AIIMS (North & East zone) KEM Mumbai (South and West)
29 Zonal pharmacovigilance centres Two zonal pharmacovigilance centres South and West: Seth GS Medical College and KEMhospital, Mumbai North & East zone: AIIMS, New Delhi.
30 ROLE OF CENTRAL DRUG CONTROL STANDARD ORGANISATION (CDSCO) To establish and manage database of ADRs To make regulatory decisions regarding marketing authorization and safety of drugs Possible regulatory measures in coordination with NPAC
31 ADR Flow UMC WHO Database CDSCO Zonal Centre Regional Centre Causality Pvig Centre Health Care Workers
32
33
34 Reporting Forms The minimum criteria for a valid ADR report* Identifiable patient A suspect drug An adverse event Identifiable reporter *ICH/CIOMS
35 Reporting Forms The Data Elements Required by CIOMS I Form I. Reaction Information II. Suspect Drug III. Concomitant Drugs & History IV. Mfactur g Information
36 Reporting Forms The Data Elements Required by CIOMS I Form IReaction Information Patient s Initial Country DOB /Age Sex Reaction Onset Description of event Seriousness criteria
37 Reporting Forms The Data Elements Required by CIOMS I Form II. Suspect Drug Name of drug Dose Route Indication/s Therapy dates/ duration De-challenge / Re-challenge
38 Reporting Forms The Data Elements Required by CIOMS I Form III. Concomitant Drugs & History Concomitant drugs Dates Relevant history
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