glossary of terms used in pharmacovigilance -...
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Glossary of terms used in Pharmacovigilance
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• 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
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PharmacovigilanceWHO, 2002
The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem
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Adverse reactionWHO, (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'.
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Adverse event
Medical occurrence temporally associated with the use of a medicinal product, but not necessarily causally related
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Side effect
Unintended effect occurring at normal dose related to the pharmacological properties
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Serious adverse event or reaction
Any untoward medical occurrence that at any dose;
Results in deathRequires inpatient hospitalization or prolongation of existing hospitalizationResults in persistent of significant disability or incapacity
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Unexpected adverse reaction
Not consistent with applicable product information or characteristics of drug.
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Signal
Reported information on possible causal relationship between an adverse event and drugPreviously unknown or incompletely documentedMore than one report is needed.
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AE Types
Adverse Event
Intensity Seriousness Expectedness Causality
•Mild
•Moderate
• Severe
•Non Serious
•Serious•Expected
•Unexpected
•Related
•Un-related
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Adverse event
Serious Not Serious
Serious Adverse event Adverse event
Related to IMP
Not Related to IMP
Related to IMP
Not Related to IMP
Serious Adverse Reaction
Serious Adverse Event
Adverse Reaction
Adverse Event
Expected Not Expected
Serious Adverse Reaction
Suspected Unexpected Serious Adverse Reaction
Seriousness
Causality
Expectedness
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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.
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Methods of causality assessment
WHO assessment scaleNaranjo’s scale European ABO systemKarch and Lasagna’s scaleKramer scaleBayesian networkYale AlgorithmSpanish Imputation System
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WHO Causality categories:Certain ProbablePossibleUnlikely Conditional/Unclassified Unassessable/Unclassifiable
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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.
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Vigibase:The name for the WHO International ADR DatabaseVigiflow: is a sophisticated case report management system created by the UMC, complying with GxP requirements.
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Vigisearch: is a custom search offered by the UMC to third –party inquirers for which several types of standard presentation are available.
Vigimed: E-mail conferencing facility, exclusive to member countries of the WHO Programme for International Drug Monitoring.
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Generic Name?Brand Name?POM OTC
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PEM
Prescription Event MonitoringCohort –event monitoring
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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.
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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.
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HIERARCHIAL STRUCTURE OF PROPOSED CENTRES
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National PVig Programme
ERegional
NRegional
SRegional
WRegional
NEZonal
SWZonal
NationalPVig
Center
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-November’2004-The National Pharmacovigilance CentreOffice 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 110 011.Tel: (11) 23018806 Fax: (11) 23012648Email: [email protected] www.cdsco.nic.in
NATIONAL PHARMACOVIGILANCE ADVISORY COMMITEE
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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 co-ordination with CDSCO
At least one in each state & UT and some other leading medical College
Twenty eight peripheral centers, spread country-wide
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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
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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)
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ZONAL PHARMACOVIGILANCE CENTRES
• ( TERTIARY PHARMACOVIGILANCE CENTRE)
• Large health care facility attached with medical college in metro cities
• Identified by CDSCO
• 3rd level levels
• Also act as Ist ADE data collection centre AIIMS (North & East zone) KEM Mumbai (South and West)
•
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Zonal pharmacovigilance centres
Two zonal pharmacovigilance centres South and West: Seth GS Medical College and KEMhospital, Mumbai North & East zone: AIIMS, New Delhi.
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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
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ADR Flow
Health Care Workers
Pvig Centre
Regional Centre
Zonal Centre
CDSCO
UMC WHO Database
Causality
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The minimum criteria for a valid ADR report*
Identifiable patient
A suspect drug
An adverse event
Identifiable reporter
* ICH / CIOMS
Reporting Forms
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The Data Elements Required by CIOMS I Form
I. Reaction Information
II. Suspect Drug
III.Concomitant
Drugs & History
IV. Mfactur’g Information
Reporting Forms
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The Data Elements Required by CIOMS I Form
IReaction Information Patient’s InitialCountryDOB /AgeSexReaction OnsetDescription of eventSeriousness criteria
Reporting Forms
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The Data Elements Required by CIOMS I Form
II . Suspect Drug Name of drugDoseRouteIndication/sTherapy dates/ durationDe-challenge / Re-challenge
Reporting Forms
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The Data Elements Required by CIOMS I Form
III . Concomitant Drugs & History
Concomitant drugsDatesRelevant history
Reporting Forms