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    Anonymous whcvnPBeQ
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    Animal experiments and clinical trials provide initial knowledge about potential adverse drug reactions (ADRs) but have limitations in population size, duration, and indications studied. Post-marketing surveillance through spontaneous reporting from healthcare professionals on any suspected ADRs helps identify rare or long-term ADRs through a large population over long time periods, though underreporting remains a challenge. Statistical considerations show minimum patient numbers needed to detect ADRs of varying incidences. Spontaneous reporting remains important for generating hypotheses and providing real-world evidence of potential drug-event relationships.

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    Animal experiments and clinical trials provide initial knowledge about potential adverse drug reactions (ADRs) but have limitations in population size, duration, and indications studied. Post-marketing surveillance through spontaneous reporting from healthcare professionals on any suspected ADRs helps identify rare or long-term ADRs through a large population over long time periods, though underreporting remains a challenge. Statistical considerations show minimum patient numbers needed to detect ADRs of varying incidences. Spontaneous reporting remains important for generating hypotheses and providing real-world evidence of potential drug-event relationships.

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    27 views17 pages

    Spontaneous Case Reports

    Uploaded by

    Anonymous whcvnPBeQ
    Animal experiments and clinical trials provide initial knowledge about potential adverse drug reactions (ADRs) but have limitations in population size, duration, and indications studied. Post-marketing surveillance through spontaneous reporting from healthcare professionals on any suspected ADRs helps identify rare or long-term ADRs through a large population over long time periods, though underreporting remains a challenge. Statistical considerations show minimum patient numbers needed to detect ADRs of varying incidences. Spontaneous reporting remains important for generating hypotheses and providing real-world evidence of potential drug-event relationships.

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    of 17

    HOW KNOWLEDGE ABOUT

    ADRs IS CREATED
    • animal experiments – Post-Marketing
    Surveillance (PMS)
    • clinical trials
    – prescription event
    • epidemiological monitoring
    methods – cohort studies
    – spontaneous • intensive hospital
    reporting monitoring
    • case reports – case - control studies
    • case series – record-linkage
    • meta-analysis
    1
    ANIMAL TESTS
    • acute toxicity
    • organ damage
    • dose dependency
    • metabolism
    • kinetics
    • carcinogenicity
    • mutagenicity
    • teratogenicity
    2
    • species specificity
    CLINICAL TRIALS

    • Phase I - healthy volunteers


    – 20 - 50
    • Phase II - a few patients
    – 150 - 350
    • Phase III - more patients
    – 250 - 1000 (rarely 2000)
    • Total pre-marketing 400 - 3000
    • Phase IV
    – approved indications
    3 after registration
    Statistical considerations
    Incidence of Spontaneous Minimum number
    ADR to be background of patients to be
    detected incidence exposed
    1 in 100 0 360
    1 in 10 000 520
    1 in 1 000 730
    1 in 100 2 000

    1 in 500 0 1 800
    1 in 10 000 3 200
    1 in 1 000 6 700
    1 in 100 35 900

    1 in 1 000 0 3 600
    1 in 10 000 7 300
    1 in 1 000 20 300
    1 in 100 136 400

    1 in 5 000 0 18 200
    1 in 10 000 67 400
    1 in 1 000 4 363 000
    1 in 100 3 255 000
    LIMITATIONS OF CLINICAL
    TRIALS
    • limited size
    • narrow population
    • narrow indications
    • short duration

    5
    Spontaneous reporting
    Principle

    The alert health professional connects an


    undesirable medical event with drug exposure

    (SUSPICION)

    Reports suspicion to information collecting centre


    6
    History
    • Most important single event was
    identification of thalidomide
    embryopathy in 1961

    7
    Early response to thalidomide
    • Establishment of registers of suspected
    adverse reactions to drugs
    • UK requested reports on ‘any untoward
    condition in a patient which might be the
    result of drug treatment’
    • Forty years on, reporting of individual
    cases remains a central element in
    ensuring safety of marketed medicines
    8
    SPONTANEOUS
    REPORTING
    • Advantages
    – large population
    – all medicines
    – hospital and out-patient care
    – long perspective
    – patient analyses possible
    – inexpensive

    9
    SPONTANEOUS
    REPORTING
    • Advantages
    – often first evidence of possible relationship
    • hypothesis generating
    – often only evidence of possible relationship
    between uncommonly used drug and a
    rare event
    – does not interfere with prescribing habits of
    doctors
    – useful and relevant10educational resource
    SPONTANEOUS
    REPORTING
    • Disadvantages
    – underreporting

    11
    Reporting varies with:
    • severity of reaction
    • time from market introduction
    • promotional claims
    • promotion of reporting system
    • publicity of specific association

    12
    Reasons for not reporting
    ‘Seven deadly sins’
    • Complacency
    – mistaken belief that only safe drugs are
    allowed on the market
    • Fear
    – of involvement in litigation
    • Guilt
    – because of harm to patient caused by drug
    prescribed
    13
    Reasons for not reporting
    ‘Seven deadly sins’

    • Ambition
    – collect, publish personal series of cases
    • Ignorance
    – of the requirements for reporting
    • Diffidence
    – about reporting mere suspicions possibly
    leading to ridicule
    • Lethargy
    14
    – lack of interest, time etc
    Reasons for reporting
    • contribution to medical knowledge
    • reaction previously unknown to
    reporter
    • reaction to new drug
    • all significant reactions reported
    • known association
    • severity of reaction
    15
    SPONTANEOUS
    REPORTING
    • Disadvantages
    – underreporting
    – difficult to detect
    • delayed reactions
    • reactions with high background incidence
    – important details often missing
    – number of exposed unknown
    – bias 16
    Spontaneous reporting today
    • Pressures to register new medicines
    earlier
    • Important sub-populations not
    represented in clinical trials
    • Unexpected problems with newer
    medicines
    • Clinically important interactions
    • Unexpected problems with older
    medicines
    • Problems with complementary
    17

    medicines

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