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What pharmacovigilance can do for you!
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relationship assessment is a better concept
24 Nov 2009 3Dar es Salaam
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Outline
Background
Data requirements
Relationship / causality assessment
TEST
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I’m not going to say much
Background
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Causality assessment
Two questions
How close is the relationship between medicine and event? relationship
Was the event caused by the medicine? causality
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Causality assessment
Two approaches
Individual case safety reports (ICSRs) Single reports of suspected reactions (spontaneous reporting)
Epidemiological Large numbers of reports of events Includes CEM
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Causality Assessment
Two definitions Adverse reaction: “a response to a
medicine which is noxious and unintended, and which occurs at doses normally used in man”
Adverse event: any new clinical experience that occurs after commencing a medicine, not necessarily a response to a medicine, and is recorded without judgement on its causality.
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Understanding events & reactions
Events = reactions + incidents
(incidents are those events thought not to be reactions
–’non-reactions’)
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I’ll say a little bit more
Data requirements
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What data are needed?
All medicines near the time of the event dates doses indications
The event description date of onset duration to onset event dictionary term
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What data are needed?
Results of dechallenge & rechallenge
Outcome of the event Patient medical history
past diseases of importance eg hepatitis 0ther current diseases (co-morbidities)
eg tuberculosis diabetes
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Two more definitions
Dechallenge: the outcome of the event after withdrawal of the medicine resolved, resolving, resolved with sequelae,
not resolved, worse, death, unknown Rechallenge: following dechallenge and
recovery from the event, the medicines are tried again, one at a time, under the same conditions as before and the outcome is recorded recurrence , no recurrence, unknown, (no
rechallenge)24 Nov 2009 13Dar es Salaam
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Where are the data? (CEM)
Medicine details: follow-up Q Section C ARV medicines Other medicines
Event details: follow-up Q Section E Dechallenge & rechallenge: follow-up Q
dechallenge Section C rechallenge Section E
Event outcome: follow-up Q Section E Medical history
Baseline E Treatment initiation C Any new diseases
Handbook pages 99-10124 Nov 2009 14Dar es Salaam
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The data elements and more We use all the information available on
the report, and Our pharmacological knowledge, and Our knowledge of previous reports
received, and Our search of the WHO database
(VigiSearch) and Our knowledge of any literature reports
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I’m going to say quite a bit
Assessment of relationship and causality
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Assessmentof each event 1
Initially, what we are really doing is assessing the strength of the relationship between the drug and the event
We can seldom say without any doubt that a specific drug caused a specific reaction
We work with imperfect data and our conclusions are those of probability
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Assessmentof each event 2
Relationship assessment is an essential discipline. It ensures:careful review of report details standardised assessmentan in-depth understanding of the datastandardised data for later evaluationthe ability to sort reports by quality
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Relationship categories
1. CERTAIN Event with plausible time
relationship No other explanation -disease or
drugs Event definitive -specific problem Positive dechallenge Response to withdrawal plausible Key feature: Positive rechallenge
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Relationship categories
2. PROBABLE Event with plausible time
relationship to drug intake No other explanation Response to withdrawal
(dechallenge) clinically reasonable No rechallenge, or result unknown Key feature: Positive dechallenge
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Relationship categories
3. POSSIBLE Event with plausible time
relationship to drug intake Could also be explained by disease
or other medicines Information on drug withdrawal
lacking or unclear Key feature: other explanations for
the event are possible24 Nov 2009 21Dar es Salaam
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Relationship categories
4. UNLIKELY Event with a duration to onset that
makes a relationship improbable Diseases or other drugs provide
plausible explanations Event does not improve after
dechallenge Key feature: several factors indicate
strongly that the event is not a reaction
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Relationship categories
5. UNCLASSIFIED (conditional) An adverse event has occurred, but there is
insufficient data for adequate assessment and
Additional data is awaited or under examination
Nature of event makes it impossible to attribute causality (needs epidemiological studies)
Key feature: Can’t assess with the information available
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Relationship categories
6. UNASSESSABLE (unclassifiable) A report with an event Cannot be judged because of
insufficient or contradictory information Report cannot be supplemented or
verified Key feature: Data elements concerning
the event are inadequate and will not be available
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The process of assessment 1Apply a standard event
term Apply a standard term that fits the clinical details For ICSRs use a reaction dictionary
(WHOART / MedDRA) -VigiFlow For use with Individual Case Safety Reports
(spontaneous reports) Suspected adverse reaction
For event monitoring use the event dictionary -accessible in CemFlow For use with a CEM programme (event
monitoring) If a suitable term cannot be found, use free text
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The process of assessment 2Establishing the
relationshipObjective evaluation (ICSRs & CEM) Dates of use of all medicine(s) Date of onset of event Response to dechallenge Response to rechallenge Outcome Disease being treated Other diseases
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The process of assessment 3Establishing causality
Subjective evaluation (ICSRs& CEM) Is a reaction plausible? Consider
indication for use background or past disease pharmacology prior knowledge of similar reports with
the suspect drug or related drugs Is there a possible mechanism?
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The process of assessment 4 Establishing causalityEpidemiological evaluation (CEM)
All the subjective evaluations above Compare patients with the event of
interest with those without the event Search for non-random results
age gender dose duration to onset (life table analysis)
Other statistical analyses of the data Disregard events with a relationship of
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The process of assessment 5The end process
Discuss and consult Establish an opinion on causality Publish Be prepared to revise your decision
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Causality Assessment
Two questions
How close is the relationship between medicine and event? relationship
Was the event caused by the medicine? [What could have caused the event?] causality
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Ha Ha!!
TEST
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What relationship? 1
An event with: a plausible time to onset no dechallenge information other medicines could have caused
the event
Relationship = .....................................
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What relationship? 2
An event with: a plausible time to onset no other obvious causes of the event positive dechallenge & rechallenge
Relationship = .....................................
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What relationship? 3
An event with: a plausible time to onset no other obvious causes of the event event resolved on dechallenge a rechallenge was undertaken, but
the result is not known
Relationship = .....................................
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What relationship? 4
An event with: unknown duration to onset positive dechallenge rechallenge not stated no other obvious cause
Relationship = .....................................
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What relationship? 5
An event with: a plausible time to onset no other obvious cause event outcome ‘death’ cause of death was a known reaction
to the medicine
Relationship = .....................................
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What relationship? 6
An event with: a plausible time to onset no other obvious causes of the event a dechallenge was undertaken, but
the event did not resolve
Relationship = .....................................
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Check your logic You should not have causality 1
if there has been no rechallenge, or the outcome of rechallenge is unknown
You should not have causality 2 if there has been no dechallenge or the
result of dechallenge is unknown or, if the outcome is unknown or, if there are other possible causes
You cannot have an event if it started before the medicine!!
The process of assessment 6The very end process
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The very, very, end (maybe)
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Practice 1 Male aged 34 On tenofovir, stavudine, efavirenz from Feb
2003 Events
July 2003 had MI –onset 5 months dyslipidaemia –onset time unknown
Treatment changed (dechallenge) Outcome:
recovery after angioplasty no information on lipids
Relationship = ………………………………………..
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Practice 2 Male aged 45 receiving HAART for 6 years
2 regimens including ritonavir & lopinavir Event:
penile ulcers onset unknown, but after starting ART biopsy – herpes? –unresponsive to treatment
Treatment stopped July 2007 Outcome: resolved completely in 1 month Relationship =
………………………………………..
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Practice 3 Pregnant woman age 24 LFTs normal lamivudine, zidovudine, nelfinavir at 16 w Event -jaundice leading to liver failure
onset after 13 weeks outcome: recovered after liver transplant
Post op: efavirenz, emtricitabine, tenofovir well at 12 months
Relationship = ………………………………………..
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Data Requirements for Reports
James1, while2 sleeping3 on a bank4
was flattened5 by a Sherman6 tank7.
The ground was soft8, the tank was large9
and James was buried10, free of charge11.
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1 James
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1. James
PATIENT IDENTITY
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Data Requirements for Reports
James1, while2 sleeping3 on a bank4
was flattened5 by a Sherman6 tank7.
The ground was soft8, the tank was large9
and James was buried10, free of charge11.
24 Nov 2009 46Dar es Salaam
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2. while
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2. while
TIME / DATE
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Data Requirements for Reports
James1, while2 sleeping3 on a bank4
was flattened5 by a Sherman6 tank7.
The ground was soft8, the tank was large9
and James was buried10, free of charge11.
24 Nov 2009 49Dar es Salaam
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3. sleeping
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3. sleeping
DISEASE
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Data Requirements for Reports
James1, while2 sleeping3 on a bank4
was flattened5 by a Sherman6 tank7.
The ground was soft8, the tank was large9
and James was buried10, free of charge11.
24 Nov 2009 52Dar es Salaam
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4. Bank(where?)
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4. bank
ADDRESS
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Data Requirements for Reports
James1, while2 sleeping3 on a bank4
was flattened5 by a Sherman6 tank7.
The ground was soft8, the tank was large9
and James was buried10, free of charge11.
24 Nov 2009 55Dar es Salaam
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5. flattened
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5. flattened
ADVERSE REACTION
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Data Requirements for Reports
James1, while2 sleeping3 on a bank4
was flattened5 by a Sherman6 tank7.
The ground was soft8, the tank was large9
and James was buried10, free of charge11.
24 Nov 2009 58Dar es Salaam
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6. Sherman
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6. Sherman
PROPRIETARY
NAME
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Data Requirements for Reports
James1, while2 sleeping3 on a bank4
was flattened5 by a Sherman6 tank7.
The ground was soft8, the tank was large9
and James was buried10, free of charge11.
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7. tank
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7. tank
GENERIC NAME
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Data Requirements for Reports
James1, while2 sleeping3 on a bank4
was flattened5 by a Sherman6 tank7.
The ground was soft8, the tank was large9
and James was buried10, free of charge11.
24 Nov 2009 64Dar es Salaam
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8. soft
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8. soft
PREDISPOSING
FACTORS
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Data Requirements for Reports
James1, while2 sleeping3 on a bank4
was flattened5 by a Sherman6 tank7.
The ground was soft8, the tank was large9
and James was buried10, free of charge11.
24 Nov 2009 67Dar es Salaam
![Page 68: What pharmacovigilance can do for you! relationship assessment is a better concept 24 Nov 2009 3 Dar es Salaam.](https://reader035.fdocuments.in/reader035/viewer/2022062315/5697bfa41a28abf838c97590/html5/thumbnails/68.jpg)
9. large
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9. large
DOSE
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Data Requirements for Reports
James1, while2 sleeping3 on a bank4
was flattened5 by a Sherman6 tank7.
The ground was soft8, the tank was large9
and James was buried10, free of charge11.
24 Nov 2009 70Dar es Salaam
![Page 71: What pharmacovigilance can do for you! relationship assessment is a better concept 24 Nov 2009 3 Dar es Salaam.](https://reader035.fdocuments.in/reader035/viewer/2022062315/5697bfa41a28abf838c97590/html5/thumbnails/71.jpg)
10. buried
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10. buried
DIRECT OUTCOME
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Data Requirements for Reports
James1, while2 sleeping3 on a bank4
was flattened5 by a Sherman6 tank7.
The ground was soft8, the tank was large9
and James was buried10, free of charge11.
24 Nov 2009 73Dar es Salaam
![Page 74: What pharmacovigilance can do for you! relationship assessment is a better concept 24 Nov 2009 3 Dar es Salaam.](https://reader035.fdocuments.in/reader035/viewer/2022062315/5697bfa41a28abf838c97590/html5/thumbnails/74.jpg)
11. free of charge
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11. free of charge
INDIRECT
OUTCOME
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