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METHODS TO STUDY DRUG SAFETY PROBLEMS

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animal experiments clinical trials epidemiological methods spontaneous reporting case reports case series. Post-Marketing Surveillance (PMS) prescription event monitoring cohort studies intensive hospital monitoring case - control studies record-linkage meta -analysis.

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Presentation Transcript
methods to study drug safety problems
animal experiments

clinical trials

epidemiological methods

spontaneous reporting

case reports

case series

Post-Marketing Surveillance (PMS)

prescription event monitoring

cohort studies

intensive hospital monitoring

case - control studies

record-linkage

meta-analysis

METHODS TO STUDY DRUG SAFETY PROBLEMS
spontaneous reporting
Spontaneous reporting

Principle

The alert health professional connects an undesirable medical event with drug exposure

(SUSPICION)

Reports suspicion to information collecting centre

adverse drug reaction
ADVERSE DRUG REACTION
  • A reaction 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 modification of physiological function

WHO definition

adverse event experience
ADVERSE EVENT/EXPERIENCE
  • Any untoward medical occurrence that may present during treatment with a pharmaceutical product but which does not necessarily have a causal relationship with this treatment

WHO definition

spontaneous reporting1
SPONTANEOUS REPORTING
  • Advantages
    • large population
    • all medicines
    • hospital and out-patient care
    • long perspective
    • patient analyses possible
    • inexpensive
spontaneous reporting2
SPONTANEOUS REPORTING
  • Disadvantages
    • underreporting
reporting varies with
Reporting varies with:
  • severity of reaction
  • time from market introduction
  • promotional claims
  • promotion of reporting system
  • publicity of specific association
spontaneous reporting3
SPONTANEOUS REPORTING
  • Disadvantages
    • difficult to detect
      • delayed reactions
      • reactions with high background incidence
    • important details often missing
    • number of exposed unknown
    • bias
  • underreporting
when to report early phase
When to report?Early phase
  • Simple message :
    • Report as soon as you suspect that drug therapy has resulted in a negative, unintended effect.
      • i.e all suspected reactions
  • Speed is essential
what to report
What to report?
  • Adverse reactions
    • Type A
    • Type B
  • Lack of effect
    • counterfeiting
    • resistance
    • interaction
  • Quality problem
  • Dependence and abuse
  • Poisoning (?)
  • Medical error (?)
what to report1
What to report?
  • Allopathic medicines
    • Prescription
    • OTC
  • Traditional medicines
  • Biologicals incl vaccines
what to report alternative approach
What to report?Alternative approach
  • Serious reactions (definitions available)
  • Unexpected reaction (not in product info)
  • Unusually severe reactions
  • New medicines
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