SlideShare a Scribd company logo
1 of 22
GUIDELINES FOR ADR REPORTING
AND STATISTICAL METHODS FOR
SAFETY DATA ANALYSIS
By Tanushree Karmakar
M.Pharm Pharmacology 1st Year
Adverse Drug Reaction
• ADR can be defined as 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.
• Whereas, Adverse event is any untoward medical
occurrence in a patient or clinical investigation
subject administered a pharmaceutical product and
which does not necessarily have a causal relationship
with this treatment.
• Therefore, an adverse drug reaction is an adverse
event with a causal link to a drug.
Adverse drug reaction (ADR)
monitoring
• Identifying Adverse Drug Reaction
• Assessing Causality (Relationship between
drug and suspected reaction)
• Documentation of ADR
• Reporting Serious ADRs to Pharmacovigilance
centres /ADR Regulating Authorities
OBJECTIVE OF ADR REPORTING
• To detect the nature and frequency of ADRs including periodic re-
evaluation of the benefit-risk ratio of medicinal products,
• Assist the drug regulatory authority, public health programs,
scientists and consumer society take appropriate action to minimise
risks of ADR
• Providing updated drug safety information to health care
professionals
• Upgrading package insert, design appropriate package insert
information and dissemination of information which may constitute
withdrawal of the product in the market or restrictions for
marketing
• Prevention of relapse or study of new indication, overuse, possible
mechanism underlying the adverse reaction observed or misuse.
• To identify risk factors that may predispose, induce or influence the
development, severity and incidence of adverse reactions in the
population .
REPORTING of ADR
• Spontaneous reporting: Clinician's normal diagnosis of a patient.
Relies on vigilant physicians and other healthcare professionals,
generate a suspicion of an ADR, but also report it.
• Expedited reporting: Involve a serious and unlisted event. The
timeframe for reporting expedited cases is 7 to 15 calendar days.
• Clinical trial reporting: Also known as SAE (serious adverse event)
reporting .It is the key component that drug regulatory authorities
consider in the decision-making - to grant or deny market
authorization for a drug. SAE reporting occurs as a result of study
patients (subjects) who experience serious adverse events during the
conducting of clinical trials.
• Aggregate reporting: Also known as periodic reporting. Performs
the key role in the safety assessment of drugs .Includes compilation
of safety data for a drug over a prolonged period of time (months or
years)
Pharmacovigilance methods Of
Reporting ADR
 Passive Surveillance
• Spontaneous reporting
• Case Series
 Stimulated Reporting
 Active Surveillance
• Sentinel Sites
• Drug Event Monitoring
• Registries
 Comparative Observational Studies
• Cross-sectional Study (Survey)
• Case-control Study
• Cohort Study
 Targeted Clinical Investigations
• Descriptive Studies
• Natural History of Disease
Adverse drug reaction and causality
assessment scales
• Naranjo’s Algorithm
• Kartch Lasagna’s Algorithm
• WHO-UMC probability scale
• Spanish quantitative imputation scale
• Kramer’s scale
• Jones scale
• European ABO system
• Bayesian System
Hartwig ADR Severity assessment scale
Regulatory actions on the basis of ADR
reports
• Summary of Product Characteristics (SPC) – basis of
information for Healthcare Professionals on how to use
the medicinal product safely and effectively
• Patient Information Leaflets (PIL) – drawn up in
accordance with the SPC
• Changes in classification:
– From Over the counter to Prescription only Medicine
– From renewable prescription to non-renewable
– Special medical prescription
– Restricted prescription
• Marketing Authorization withdrawal
• Batch recall based on clustering of ADRs
ADR Reporting through Vigiflow
• VigiFlow is a web-based Individual Case Safety Report
(ICSR) management system that is specially designed for use
by national centres in the WHO Programme for International
Drug Monitoring.
• Can be used by both national authorities and companies for
management of their own reports
– Data entry
– Assessment
– Storage – Retrieval (e.g. for follow-ups)
– Communication with other parties
• It is web-based
• It is E2B compatible
• Other tools:
 ARISg : ARISg is a leading pharmacovigilance and
clinical safety system that helps companies efficiently
process all safety cases and generate appropriate global
reports for distribution to regulatory authorities and
partners.
 Argus : Argus is a scalable end-to-end safety process
providing automated global case processing, periodic
reporting, E2B intake and submission, comprehensive
reporting, detailed analytics, and Japanese safety
operations from within a single system.
 Vigibase: It is a World Health Organization’s (WHO)
global Individual Case Safety Report (ICSR) database
that contains ICSRs submitted by the participating
member states enrolled under WHO’s international
drug monitoring programme. It is the single largest
drug safety data repository in the world.
Statistical Methods for Data Analysis
• Statistics in relation to biological experiments deals with
collection,presentation,analysis of data , interpretation of results with
an aim to draw meaningful inference.
• Categories:
1. Central Tendency: Arithmetic Mean,Median,Mode.
2. Variability : Standard Deviation, Variance
3. Tests of Significance: Parametric tests
Non- Parametric tests
• Parametric Tests: Student’s t-test, Paired t-test, Analysis of
Variance Test (ANOVA),Chi Square test, Fisher's Exact test.
• Non-Parametric test: Kruskal-Wallis H test, Wilcoxon’s Signed rank
test
Central Tendency
• The goal of central tendency is to identify the value
that is most typical or most representative of the
entire group.
• The arithmetic mean is the arithmetic average. It is
calculated by adding up individual observation
divided by number of observation.
• Median is the central value of all observations
arranged from lowest to highest.
• Mode is the most frequently occurring value in a
series of observations.
Variability
Variability is a measure of the spread of scores in a distribution.
• Standard deviation describes the average distance from the
mean.
• Where X= Observation , X = mean ,n = no of observation.
• Variance measures variability by computing the average
squared distance from the mean.
Variance =
Tests of Significance: Parametric
Test
• Parametric test are performed if the parent population
from which the samples are drawn follows a normal
distribution or the sampling distribution approaches to
normal distribution as the sample size is made increase
indefinitely.
1. Student’s t- test : This test is applied to assess the
statistical significance of the difference between two
independently drawn sample means (unpaired means)
obtained from two series of data.
2. Paired t- test : used for analysis of paired data.
3. Analysis of variance test (ANOVA) : Applied when
there is a comparison between more than two samples.
4. Chi square test : generally applied in analysis
of quantal or all or none responses.
5. Fisher’s Exact test : Applied to verify all or
none response to determine the significance.
Non-Parametric tests
Applied if the distribution is not known regarding the
parent population or if it is not possible to make the
distribution to follow normal distribution.
Also known as distribution free statistics
1. Kruskal- Wallis H test : Used to compare
groups.
2. Wilcoxon’s Signed Rank Test : Applied when
the measurements are continuous and have
the strength of only the ordinal scale.
Adr ppt

More Related Content

What's hot

Guidelines on adr reporting
Guidelines on adr reportingGuidelines on adr reporting
Guidelines on adr reportingSaiLakshmi110
 
ICH GCP guidelines
ICH GCP guidelinesICH GCP guidelines
ICH GCP guidelinesrx_sonali
 
STATISTICAL METHODS FOR PHARMACOVIGILANCE
STATISTICAL METHODS FOR PHARMACOVIGILANCESTATISTICAL METHODS FOR PHARMACOVIGILANCE
STATISTICAL METHODS FOR PHARMACOVIGILANCESanju Kaladharan
 
Drug safety evaluation in clinical trial
Drug safety evaluation in clinical trialDrug safety evaluation in clinical trial
Drug safety evaluation in clinical trialVikas Sharma
 
Ppt On National Programmes Related to Pharmacovigilance
Ppt On National Programmes  Related to PharmacovigilancePpt On National Programmes  Related to Pharmacovigilance
Ppt On National Programmes Related to PharmacovigilanceNaveen K L
 
Spontenous adr reporting
Spontenous adr reportingSpontenous adr reporting
Spontenous adr reportingSONALPANDE5
 
List of studies needed for IND submission
List of studies needed for IND submissionList of studies needed for IND submission
List of studies needed for IND submissionShivanshu Bajaj
 
Signal detection and management
Signal detection and managementSignal detection and management
Signal detection and managementsekharbabu41
 
Origin and principles of international conference on harmonization- Good clin...
Origin and principles of international conference on harmonization- Good clin...Origin and principles of international conference on harmonization- Good clin...
Origin and principles of international conference on harmonization- Good clin...AbhishekJoshi312
 
Pharmacovigilance signal and signal detection
Pharmacovigilance signal and signal detectionPharmacovigilance signal and signal detection
Pharmacovigilance signal and signal detectionKiranRajput38
 
Pharmacovigilance overview
Pharmacovigilance overviewPharmacovigilance overview
Pharmacovigilance overviewSunil Boreddy Rx
 
PPT on Vigiflow, Argus-G and Aris For ADR Reporting
PPT on Vigiflow, Argus-G and Aris For ADR ReportingPPT on Vigiflow, Argus-G and Aris For ADR Reporting
PPT on Vigiflow, Argus-G and Aris For ADR ReportingNaveen K L
 
Clinical trial study team
Clinical trial study teamClinical trial study team
Clinical trial study teamBharatPatil42
 
Aris G PHARMACOVIGILANCE AND VIGIFLOW
Aris G PHARMACOVIGILANCE AND VIGIFLOWAris G PHARMACOVIGILANCE AND VIGIFLOW
Aris G PHARMACOVIGILANCE AND VIGIFLOWayanarkumar19
 

What's hot (20)

Pharmacovigilance in India - An Insight
Pharmacovigilance in India - An InsightPharmacovigilance in India - An Insight
Pharmacovigilance in India - An Insight
 
Guidelines on adr reporting
Guidelines on adr reportingGuidelines on adr reporting
Guidelines on adr reporting
 
ICH GCP guidelines
ICH GCP guidelinesICH GCP guidelines
ICH GCP guidelines
 
STATISTICAL METHODS FOR PHARMACOVIGILANCE
STATISTICAL METHODS FOR PHARMACOVIGILANCESTATISTICAL METHODS FOR PHARMACOVIGILANCE
STATISTICAL METHODS FOR PHARMACOVIGILANCE
 
Drug safety evaluation in clinical trial
Drug safety evaluation in clinical trialDrug safety evaluation in clinical trial
Drug safety evaluation in clinical trial
 
Pharmacoepideiology
PharmacoepideiologyPharmacoepideiology
Pharmacoepideiology
 
Ppt On National Programmes Related to Pharmacovigilance
Ppt On National Programmes  Related to PharmacovigilancePpt On National Programmes  Related to Pharmacovigilance
Ppt On National Programmes Related to Pharmacovigilance
 
Ind enabling studies.
Ind enabling studies.Ind enabling studies.
Ind enabling studies.
 
Pharmacovigilance Basics
Pharmacovigilance BasicsPharmacovigilance Basics
Pharmacovigilance Basics
 
Spontenous adr reporting
Spontenous adr reportingSpontenous adr reporting
Spontenous adr reporting
 
List of studies needed for IND submission
List of studies needed for IND submissionList of studies needed for IND submission
List of studies needed for IND submission
 
Signal detection and management
Signal detection and managementSignal detection and management
Signal detection and management
 
Origin and principles of international conference on harmonization- Good clin...
Origin and principles of international conference on harmonization- Good clin...Origin and principles of international conference on harmonization- Good clin...
Origin and principles of international conference on harmonization- Good clin...
 
Pharmacovigilance signal and signal detection
Pharmacovigilance signal and signal detectionPharmacovigilance signal and signal detection
Pharmacovigilance signal and signal detection
 
Pharmacovigilance overview
Pharmacovigilance overviewPharmacovigilance overview
Pharmacovigilance overview
 
PPT on Vigiflow, Argus-G and Aris For ADR Reporting
PPT on Vigiflow, Argus-G and Aris For ADR ReportingPPT on Vigiflow, Argus-G and Aris For ADR Reporting
PPT on Vigiflow, Argus-G and Aris For ADR Reporting
 
INVESTIGATIONAL NEW DRUG (IND)
INVESTIGATIONAL NEW DRUG (IND) INVESTIGATIONAL NEW DRUG (IND)
INVESTIGATIONAL NEW DRUG (IND)
 
Clinical trial study team
Clinical trial study teamClinical trial study team
Clinical trial study team
 
Aris G PHARMACOVIGILANCE AND VIGIFLOW
Aris G PHARMACOVIGILANCE AND VIGIFLOWAris G PHARMACOVIGILANCE AND VIGIFLOW
Aris G PHARMACOVIGILANCE AND VIGIFLOW
 
Passive and active surveillance
Passive and active surveillancePassive and active surveillance
Passive and active surveillance
 

Similar to Adr ppt

Signifcance of pharmacovigilance & risk management plan
Signifcance of pharmacovigilance & risk management planSignifcance of pharmacovigilance & risk management plan
Signifcance of pharmacovigilance & risk management planAnsuman Parida
 
Methods of Pharmacovigilance.pptx
Methods of Pharmacovigilance.pptxMethods of Pharmacovigilance.pptx
Methods of Pharmacovigilance.pptxPraveen kumar S
 
Webinar pv use case 23 march2016
Webinar pv use case 23 march2016Webinar pv use case 23 march2016
Webinar pv use case 23 march2016Ann-Marie Roche
 
signaldetectionandmanagement-210803014643.pdf
signaldetectionandmanagement-210803014643.pdfsignaldetectionandmanagement-210803014643.pdf
signaldetectionandmanagement-210803014643.pdfdabloosaha
 
passive_serviallance and responsibilities in pharmacovigilance pptx
passive_serviallance and responsibilities in pharmacovigilance pptxpassive_serviallance and responsibilities in pharmacovigilance pptx
passive_serviallance and responsibilities in pharmacovigilance pptxAyodhya Paradhe
 
Reporting and Management of Adverse Drug Reaction
Reporting and Management of Adverse Drug ReactionReporting and Management of Adverse Drug Reaction
Reporting and Management of Adverse Drug ReactionSoniya Sunil
 
Methods and Tools for ADR Reporting.pptx
Methods and Tools for ADR Reporting.pptxMethods and Tools for ADR Reporting.pptx
Methods and Tools for ADR Reporting.pptxPankajKadyan5
 
Causality assessment scale
Causality assessment scaleCausality assessment scale
Causality assessment scaledrarunsingh4
 
Pharmacovigilance reporting methods
Pharmacovigilance  reporting methodsPharmacovigilance  reporting methods
Pharmacovigilance reporting methodsArchana Gawade
 
post marketing –surveillance methods
post marketing –surveillance  methodspost marketing –surveillance  methods
post marketing –surveillance methodsAMRUTHA JOSE
 
Pharmacovigilance-Methods for description..pdf
Pharmacovigilance-Methods for description..pdfPharmacovigilance-Methods for description..pdf
Pharmacovigilance-Methods for description..pdfamishapraja123
 
17 action plan
17 action plan17 action plan
17 action planvamsykoram
 
Adverse drug reaction bpharm 7th sem notes
Adverse drug reaction bpharm 7th sem notesAdverse drug reaction bpharm 7th sem notes
Adverse drug reaction bpharm 7th sem notesPrathikshakotari
 
Pharmacovigilance organisation
Pharmacovigilance organisationPharmacovigilance organisation
Pharmacovigilance organisationSomya Solanki
 
Adr reporting ppt
Adr reporting pptAdr reporting ppt
Adr reporting pptRimaSingh14
 

Similar to Adr ppt (20)

Signifcance of pharmacovigilance & risk management plan
Signifcance of pharmacovigilance & risk management planSignifcance of pharmacovigilance & risk management plan
Signifcance of pharmacovigilance & risk management plan
 
Methods of Pharmacovigilance.pptx
Methods of Pharmacovigilance.pptxMethods of Pharmacovigilance.pptx
Methods of Pharmacovigilance.pptx
 
Webinar pv use case 23 march2016
Webinar pv use case 23 march2016Webinar pv use case 23 march2016
Webinar pv use case 23 march2016
 
Pharmacovigilance
PharmacovigilancePharmacovigilance
Pharmacovigilance
 
signaldetectionandmanagement-210803014643.pdf
signaldetectionandmanagement-210803014643.pdfsignaldetectionandmanagement-210803014643.pdf
signaldetectionandmanagement-210803014643.pdf
 
Pharmacovigilance methods
Pharmacovigilance methodsPharmacovigilance methods
Pharmacovigilance methods
 
passive_serviallance and responsibilities in pharmacovigilance pptx
passive_serviallance and responsibilities in pharmacovigilance pptxpassive_serviallance and responsibilities in pharmacovigilance pptx
passive_serviallance and responsibilities in pharmacovigilance pptx
 
Reporting and Management of Adverse Drug Reaction
Reporting and Management of Adverse Drug ReactionReporting and Management of Adverse Drug Reaction
Reporting and Management of Adverse Drug Reaction
 
Methods and Tools for ADR Reporting.pptx
Methods and Tools for ADR Reporting.pptxMethods and Tools for ADR Reporting.pptx
Methods and Tools for ADR Reporting.pptx
 
Causality assessment scale
Causality assessment scaleCausality assessment scale
Causality assessment scale
 
Pharmacovigilance
PharmacovigilancePharmacovigilance
Pharmacovigilance
 
Pharmacovigilance reporting methods
Pharmacovigilance  reporting methodsPharmacovigilance  reporting methods
Pharmacovigilance reporting methods
 
post marketing –surveillance methods
post marketing –surveillance  methodspost marketing –surveillance  methods
post marketing –surveillance methods
 
Pharmacovigilance
PharmacovigilancePharmacovigilance
Pharmacovigilance
 
Pharmacovigilance-Methods for description..pdf
Pharmacovigilance-Methods for description..pdfPharmacovigilance-Methods for description..pdf
Pharmacovigilance-Methods for description..pdf
 
17 action plan
17 action plan17 action plan
17 action plan
 
Pharmacovigilance
PharmacovigilancePharmacovigilance
Pharmacovigilance
 
Adverse drug reaction bpharm 7th sem notes
Adverse drug reaction bpharm 7th sem notesAdverse drug reaction bpharm 7th sem notes
Adverse drug reaction bpharm 7th sem notes
 
Pharmacovigilance organisation
Pharmacovigilance organisationPharmacovigilance organisation
Pharmacovigilance organisation
 
Adr reporting ppt
Adr reporting pptAdr reporting ppt
Adr reporting ppt
 

Recently uploaded

Low Rate Call Girls Patna Anika 8250192130 Independent Escort Service Patna
Low Rate Call Girls Patna Anika 8250192130 Independent Escort Service PatnaLow Rate Call Girls Patna Anika 8250192130 Independent Escort Service Patna
Low Rate Call Girls Patna Anika 8250192130 Independent Escort Service Patnamakika9823
 
Russian Call Girls in Pune Riya 9907093804 Short 1500 Night 6000 Best call gi...
Russian Call Girls in Pune Riya 9907093804 Short 1500 Night 6000 Best call gi...Russian Call Girls in Pune Riya 9907093804 Short 1500 Night 6000 Best call gi...
Russian Call Girls in Pune Riya 9907093804 Short 1500 Night 6000 Best call gi...Miss joya
 
Call Girls Colaba Mumbai ❤️ 9920874524 👈 Cash on Delivery
Call Girls Colaba Mumbai ❤️ 9920874524 👈 Cash on DeliveryCall Girls Colaba Mumbai ❤️ 9920874524 👈 Cash on Delivery
Call Girls Colaba Mumbai ❤️ 9920874524 👈 Cash on Deliverynehamumbai
 
Lucknow Call girls - 8800925952 - 24x7 service with hotel room
Lucknow Call girls - 8800925952 - 24x7 service with hotel roomLucknow Call girls - 8800925952 - 24x7 service with hotel room
Lucknow Call girls - 8800925952 - 24x7 service with hotel roomdiscovermytutordmt
 
Russian Call Girls in Pune Tanvi 9907093804 Short 1500 Night 6000 Best call g...
Russian Call Girls in Pune Tanvi 9907093804 Short 1500 Night 6000 Best call g...Russian Call Girls in Pune Tanvi 9907093804 Short 1500 Night 6000 Best call g...
Russian Call Girls in Pune Tanvi 9907093804 Short 1500 Night 6000 Best call g...Miss joya
 
VIP Call Girls Pune Vani 9907093804 Short 1500 Night 6000 Best call girls Ser...
VIP Call Girls Pune Vani 9907093804 Short 1500 Night 6000 Best call girls Ser...VIP Call Girls Pune Vani 9907093804 Short 1500 Night 6000 Best call girls Ser...
VIP Call Girls Pune Vani 9907093804 Short 1500 Night 6000 Best call girls Ser...Miss joya
 
Call Girls Horamavu WhatsApp Number 7001035870 Meeting With Bangalore Escorts
Call Girls Horamavu WhatsApp Number 7001035870 Meeting With Bangalore EscortsCall Girls Horamavu WhatsApp Number 7001035870 Meeting With Bangalore Escorts
Call Girls Horamavu WhatsApp Number 7001035870 Meeting With Bangalore Escortsvidya singh
 
High Profile Call Girls Coimbatore Saanvi☎️ 8250192130 Independent Escort Se...
High Profile Call Girls Coimbatore Saanvi☎️  8250192130 Independent Escort Se...High Profile Call Girls Coimbatore Saanvi☎️  8250192130 Independent Escort Se...
High Profile Call Girls Coimbatore Saanvi☎️ 8250192130 Independent Escort Se...narwatsonia7
 
VIP Russian Call Girls in Varanasi Samaira 8250192130 Independent Escort Serv...
VIP Russian Call Girls in Varanasi Samaira 8250192130 Independent Escort Serv...VIP Russian Call Girls in Varanasi Samaira 8250192130 Independent Escort Serv...
VIP Russian Call Girls in Varanasi Samaira 8250192130 Independent Escort Serv...Neha Kaur
 
Bangalore Call Girls Hebbal Kempapura Number 7001035870 Meetin With Bangalor...
Bangalore Call Girls Hebbal Kempapura Number 7001035870  Meetin With Bangalor...Bangalore Call Girls Hebbal Kempapura Number 7001035870  Meetin With Bangalor...
Bangalore Call Girls Hebbal Kempapura Number 7001035870 Meetin With Bangalor...narwatsonia7
 
Vip Call Girls Anna Salai Chennai 👉 8250192130 ❣️💯 Top Class Girls Available
Vip Call Girls Anna Salai Chennai 👉 8250192130 ❣️💯 Top Class Girls AvailableVip Call Girls Anna Salai Chennai 👉 8250192130 ❣️💯 Top Class Girls Available
Vip Call Girls Anna Salai Chennai 👉 8250192130 ❣️💯 Top Class Girls AvailableNehru place Escorts
 
Bangalore Call Girls Marathahalli 📞 9907093804 High Profile Service 100% Safe
Bangalore Call Girls Marathahalli 📞 9907093804 High Profile Service 100% SafeBangalore Call Girls Marathahalli 📞 9907093804 High Profile Service 100% Safe
Bangalore Call Girls Marathahalli 📞 9907093804 High Profile Service 100% Safenarwatsonia7
 
College Call Girls Pune Mira 9907093804 Short 1500 Night 6000 Best call girls...
College Call Girls Pune Mira 9907093804 Short 1500 Night 6000 Best call girls...College Call Girls Pune Mira 9907093804 Short 1500 Night 6000 Best call girls...
College Call Girls Pune Mira 9907093804 Short 1500 Night 6000 Best call girls...Miss joya
 
Premium Call Girls Cottonpet Whatsapp 7001035870 Independent Escort Service
Premium Call Girls Cottonpet Whatsapp 7001035870 Independent Escort ServicePremium Call Girls Cottonpet Whatsapp 7001035870 Independent Escort Service
Premium Call Girls Cottonpet Whatsapp 7001035870 Independent Escort Servicevidya singh
 
Call Girls Service Navi Mumbai Samaira 8617697112 Independent Escort Service ...
Call Girls Service Navi Mumbai Samaira 8617697112 Independent Escort Service ...Call Girls Service Navi Mumbai Samaira 8617697112 Independent Escort Service ...
Call Girls Service Navi Mumbai Samaira 8617697112 Independent Escort Service ...Call girls in Ahmedabad High profile
 
♛VVIP Hyderabad Call Girls Chintalkunta🖕7001035870🖕Riya Kappor Top Call Girl ...
♛VVIP Hyderabad Call Girls Chintalkunta🖕7001035870🖕Riya Kappor Top Call Girl ...♛VVIP Hyderabad Call Girls Chintalkunta🖕7001035870🖕Riya Kappor Top Call Girl ...
♛VVIP Hyderabad Call Girls Chintalkunta🖕7001035870🖕Riya Kappor Top Call Girl ...astropune
 
Aspirin presentation slides by Dr. Rewas Ali
Aspirin presentation slides by Dr. Rewas AliAspirin presentation slides by Dr. Rewas Ali
Aspirin presentation slides by Dr. Rewas AliRewAs ALI
 
(👑VVIP ISHAAN ) Russian Call Girls Service Navi Mumbai🖕9920874524🖕Independent...
(👑VVIP ISHAAN ) Russian Call Girls Service Navi Mumbai🖕9920874524🖕Independent...(👑VVIP ISHAAN ) Russian Call Girls Service Navi Mumbai🖕9920874524🖕Independent...
(👑VVIP ISHAAN ) Russian Call Girls Service Navi Mumbai🖕9920874524🖕Independent...Taniya Sharma
 

Recently uploaded (20)

Low Rate Call Girls Patna Anika 8250192130 Independent Escort Service Patna
Low Rate Call Girls Patna Anika 8250192130 Independent Escort Service PatnaLow Rate Call Girls Patna Anika 8250192130 Independent Escort Service Patna
Low Rate Call Girls Patna Anika 8250192130 Independent Escort Service Patna
 
Russian Call Girls in Pune Riya 9907093804 Short 1500 Night 6000 Best call gi...
Russian Call Girls in Pune Riya 9907093804 Short 1500 Night 6000 Best call gi...Russian Call Girls in Pune Riya 9907093804 Short 1500 Night 6000 Best call gi...
Russian Call Girls in Pune Riya 9907093804 Short 1500 Night 6000 Best call gi...
 
Call Girls Colaba Mumbai ❤️ 9920874524 👈 Cash on Delivery
Call Girls Colaba Mumbai ❤️ 9920874524 👈 Cash on DeliveryCall Girls Colaba Mumbai ❤️ 9920874524 👈 Cash on Delivery
Call Girls Colaba Mumbai ❤️ 9920874524 👈 Cash on Delivery
 
sauth delhi call girls in Bhajanpura 🔝 9953056974 🔝 escort Service
sauth delhi call girls in Bhajanpura 🔝 9953056974 🔝 escort Servicesauth delhi call girls in Bhajanpura 🔝 9953056974 🔝 escort Service
sauth delhi call girls in Bhajanpura 🔝 9953056974 🔝 escort Service
 
Lucknow Call girls - 8800925952 - 24x7 service with hotel room
Lucknow Call girls - 8800925952 - 24x7 service with hotel roomLucknow Call girls - 8800925952 - 24x7 service with hotel room
Lucknow Call girls - 8800925952 - 24x7 service with hotel room
 
Russian Call Girls in Pune Tanvi 9907093804 Short 1500 Night 6000 Best call g...
Russian Call Girls in Pune Tanvi 9907093804 Short 1500 Night 6000 Best call g...Russian Call Girls in Pune Tanvi 9907093804 Short 1500 Night 6000 Best call g...
Russian Call Girls in Pune Tanvi 9907093804 Short 1500 Night 6000 Best call g...
 
VIP Call Girls Pune Vani 9907093804 Short 1500 Night 6000 Best call girls Ser...
VIP Call Girls Pune Vani 9907093804 Short 1500 Night 6000 Best call girls Ser...VIP Call Girls Pune Vani 9907093804 Short 1500 Night 6000 Best call girls Ser...
VIP Call Girls Pune Vani 9907093804 Short 1500 Night 6000 Best call girls Ser...
 
Call Girls Horamavu WhatsApp Number 7001035870 Meeting With Bangalore Escorts
Call Girls Horamavu WhatsApp Number 7001035870 Meeting With Bangalore EscortsCall Girls Horamavu WhatsApp Number 7001035870 Meeting With Bangalore Escorts
Call Girls Horamavu WhatsApp Number 7001035870 Meeting With Bangalore Escorts
 
High Profile Call Girls Coimbatore Saanvi☎️ 8250192130 Independent Escort Se...
High Profile Call Girls Coimbatore Saanvi☎️  8250192130 Independent Escort Se...High Profile Call Girls Coimbatore Saanvi☎️  8250192130 Independent Escort Se...
High Profile Call Girls Coimbatore Saanvi☎️ 8250192130 Independent Escort Se...
 
VIP Russian Call Girls in Varanasi Samaira 8250192130 Independent Escort Serv...
VIP Russian Call Girls in Varanasi Samaira 8250192130 Independent Escort Serv...VIP Russian Call Girls in Varanasi Samaira 8250192130 Independent Escort Serv...
VIP Russian Call Girls in Varanasi Samaira 8250192130 Independent Escort Serv...
 
Bangalore Call Girls Hebbal Kempapura Number 7001035870 Meetin With Bangalor...
Bangalore Call Girls Hebbal Kempapura Number 7001035870  Meetin With Bangalor...Bangalore Call Girls Hebbal Kempapura Number 7001035870  Meetin With Bangalor...
Bangalore Call Girls Hebbal Kempapura Number 7001035870 Meetin With Bangalor...
 
Vip Call Girls Anna Salai Chennai 👉 8250192130 ❣️💯 Top Class Girls Available
Vip Call Girls Anna Salai Chennai 👉 8250192130 ❣️💯 Top Class Girls AvailableVip Call Girls Anna Salai Chennai 👉 8250192130 ❣️💯 Top Class Girls Available
Vip Call Girls Anna Salai Chennai 👉 8250192130 ❣️💯 Top Class Girls Available
 
Bangalore Call Girls Marathahalli 📞 9907093804 High Profile Service 100% Safe
Bangalore Call Girls Marathahalli 📞 9907093804 High Profile Service 100% SafeBangalore Call Girls Marathahalli 📞 9907093804 High Profile Service 100% Safe
Bangalore Call Girls Marathahalli 📞 9907093804 High Profile Service 100% Safe
 
Russian Call Girls in Delhi Tanvi ➡️ 9711199012 💋📞 Independent Escort Service...
Russian Call Girls in Delhi Tanvi ➡️ 9711199012 💋📞 Independent Escort Service...Russian Call Girls in Delhi Tanvi ➡️ 9711199012 💋📞 Independent Escort Service...
Russian Call Girls in Delhi Tanvi ➡️ 9711199012 💋📞 Independent Escort Service...
 
College Call Girls Pune Mira 9907093804 Short 1500 Night 6000 Best call girls...
College Call Girls Pune Mira 9907093804 Short 1500 Night 6000 Best call girls...College Call Girls Pune Mira 9907093804 Short 1500 Night 6000 Best call girls...
College Call Girls Pune Mira 9907093804 Short 1500 Night 6000 Best call girls...
 
Premium Call Girls Cottonpet Whatsapp 7001035870 Independent Escort Service
Premium Call Girls Cottonpet Whatsapp 7001035870 Independent Escort ServicePremium Call Girls Cottonpet Whatsapp 7001035870 Independent Escort Service
Premium Call Girls Cottonpet Whatsapp 7001035870 Independent Escort Service
 
Call Girls Service Navi Mumbai Samaira 8617697112 Independent Escort Service ...
Call Girls Service Navi Mumbai Samaira 8617697112 Independent Escort Service ...Call Girls Service Navi Mumbai Samaira 8617697112 Independent Escort Service ...
Call Girls Service Navi Mumbai Samaira 8617697112 Independent Escort Service ...
 
♛VVIP Hyderabad Call Girls Chintalkunta🖕7001035870🖕Riya Kappor Top Call Girl ...
♛VVIP Hyderabad Call Girls Chintalkunta🖕7001035870🖕Riya Kappor Top Call Girl ...♛VVIP Hyderabad Call Girls Chintalkunta🖕7001035870🖕Riya Kappor Top Call Girl ...
♛VVIP Hyderabad Call Girls Chintalkunta🖕7001035870🖕Riya Kappor Top Call Girl ...
 
Aspirin presentation slides by Dr. Rewas Ali
Aspirin presentation slides by Dr. Rewas AliAspirin presentation slides by Dr. Rewas Ali
Aspirin presentation slides by Dr. Rewas Ali
 
(👑VVIP ISHAAN ) Russian Call Girls Service Navi Mumbai🖕9920874524🖕Independent...
(👑VVIP ISHAAN ) Russian Call Girls Service Navi Mumbai🖕9920874524🖕Independent...(👑VVIP ISHAAN ) Russian Call Girls Service Navi Mumbai🖕9920874524🖕Independent...
(👑VVIP ISHAAN ) Russian Call Girls Service Navi Mumbai🖕9920874524🖕Independent...
 

Adr ppt

  • 1. GUIDELINES FOR ADR REPORTING AND STATISTICAL METHODS FOR SAFETY DATA ANALYSIS By Tanushree Karmakar M.Pharm Pharmacology 1st Year
  • 2. Adverse Drug Reaction • ADR can be defined as 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. • Whereas, Adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. • Therefore, an adverse drug reaction is an adverse event with a causal link to a drug.
  • 3.
  • 4. Adverse drug reaction (ADR) monitoring • Identifying Adverse Drug Reaction • Assessing Causality (Relationship between drug and suspected reaction) • Documentation of ADR • Reporting Serious ADRs to Pharmacovigilance centres /ADR Regulating Authorities
  • 5. OBJECTIVE OF ADR REPORTING • To detect the nature and frequency of ADRs including periodic re- evaluation of the benefit-risk ratio of medicinal products, • Assist the drug regulatory authority, public health programs, scientists and consumer society take appropriate action to minimise risks of ADR • Providing updated drug safety information to health care professionals • Upgrading package insert, design appropriate package insert information and dissemination of information which may constitute withdrawal of the product in the market or restrictions for marketing • Prevention of relapse or study of new indication, overuse, possible mechanism underlying the adverse reaction observed or misuse. • To identify risk factors that may predispose, induce or influence the development, severity and incidence of adverse reactions in the population .
  • 6.
  • 7.
  • 8. REPORTING of ADR • Spontaneous reporting: Clinician's normal diagnosis of a patient. Relies on vigilant physicians and other healthcare professionals, generate a suspicion of an ADR, but also report it. • Expedited reporting: Involve a serious and unlisted event. The timeframe for reporting expedited cases is 7 to 15 calendar days. • Clinical trial reporting: Also known as SAE (serious adverse event) reporting .It is the key component that drug regulatory authorities consider in the decision-making - to grant or deny market authorization for a drug. SAE reporting occurs as a result of study patients (subjects) who experience serious adverse events during the conducting of clinical trials. • Aggregate reporting: Also known as periodic reporting. Performs the key role in the safety assessment of drugs .Includes compilation of safety data for a drug over a prolonged period of time (months or years)
  • 9. Pharmacovigilance methods Of Reporting ADR  Passive Surveillance • Spontaneous reporting • Case Series  Stimulated Reporting  Active Surveillance • Sentinel Sites • Drug Event Monitoring • Registries  Comparative Observational Studies • Cross-sectional Study (Survey) • Case-control Study • Cohort Study  Targeted Clinical Investigations • Descriptive Studies • Natural History of Disease
  • 10. Adverse drug reaction and causality assessment scales • Naranjo’s Algorithm • Kartch Lasagna’s Algorithm • WHO-UMC probability scale • Spanish quantitative imputation scale • Kramer’s scale • Jones scale • European ABO system • Bayesian System
  • 11. Hartwig ADR Severity assessment scale
  • 12. Regulatory actions on the basis of ADR reports • Summary of Product Characteristics (SPC) – basis of information for Healthcare Professionals on how to use the medicinal product safely and effectively • Patient Information Leaflets (PIL) – drawn up in accordance with the SPC • Changes in classification: – From Over the counter to Prescription only Medicine – From renewable prescription to non-renewable – Special medical prescription – Restricted prescription • Marketing Authorization withdrawal • Batch recall based on clustering of ADRs
  • 13. ADR Reporting through Vigiflow • VigiFlow is a web-based Individual Case Safety Report (ICSR) management system that is specially designed for use by national centres in the WHO Programme for International Drug Monitoring. • Can be used by both national authorities and companies for management of their own reports – Data entry – Assessment – Storage – Retrieval (e.g. for follow-ups) – Communication with other parties • It is web-based • It is E2B compatible
  • 14. • Other tools:  ARISg : ARISg is a leading pharmacovigilance and clinical safety system that helps companies efficiently process all safety cases and generate appropriate global reports for distribution to regulatory authorities and partners.  Argus : Argus is a scalable end-to-end safety process providing automated global case processing, periodic reporting, E2B intake and submission, comprehensive reporting, detailed analytics, and Japanese safety operations from within a single system.  Vigibase: It is a World Health Organization’s (WHO) global Individual Case Safety Report (ICSR) database that contains ICSRs submitted by the participating member states enrolled under WHO’s international drug monitoring programme. It is the single largest drug safety data repository in the world.
  • 15.
  • 16. Statistical Methods for Data Analysis • Statistics in relation to biological experiments deals with collection,presentation,analysis of data , interpretation of results with an aim to draw meaningful inference. • Categories: 1. Central Tendency: Arithmetic Mean,Median,Mode. 2. Variability : Standard Deviation, Variance 3. Tests of Significance: Parametric tests Non- Parametric tests • Parametric Tests: Student’s t-test, Paired t-test, Analysis of Variance Test (ANOVA),Chi Square test, Fisher's Exact test. • Non-Parametric test: Kruskal-Wallis H test, Wilcoxon’s Signed rank test
  • 17. Central Tendency • The goal of central tendency is to identify the value that is most typical or most representative of the entire group. • The arithmetic mean is the arithmetic average. It is calculated by adding up individual observation divided by number of observation. • Median is the central value of all observations arranged from lowest to highest. • Mode is the most frequently occurring value in a series of observations.
  • 18. Variability Variability is a measure of the spread of scores in a distribution. • Standard deviation describes the average distance from the mean. • Where X= Observation , X = mean ,n = no of observation. • Variance measures variability by computing the average squared distance from the mean. Variance =
  • 19. Tests of Significance: Parametric Test • Parametric test are performed if the parent population from which the samples are drawn follows a normal distribution or the sampling distribution approaches to normal distribution as the sample size is made increase indefinitely. 1. Student’s t- test : This test is applied to assess the statistical significance of the difference between two independently drawn sample means (unpaired means) obtained from two series of data. 2. Paired t- test : used for analysis of paired data. 3. Analysis of variance test (ANOVA) : Applied when there is a comparison between more than two samples.
  • 20. 4. Chi square test : generally applied in analysis of quantal or all or none responses. 5. Fisher’s Exact test : Applied to verify all or none response to determine the significance. Non-Parametric tests Applied if the distribution is not known regarding the parent population or if it is not possible to make the distribution to follow normal distribution. Also known as distribution free statistics
  • 21. 1. Kruskal- Wallis H test : Used to compare groups. 2. Wilcoxon’s Signed Rank Test : Applied when the measurements are continuous and have the strength of only the ordinal scale.