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SIGNAL & METHOD OF
SIGNAL DETECTION
CMCR: 606
PHARMACOVIGILANCE
PRESENTED TO PRESENTED BY
Dr. SAURABH KOHLI Kiran Rajput
Assistant Professor M.Sc. C.R.
Department of Pharmacology Sem 3
SIGNAL
• According to WHO signal is “Reported information on a possible casual relationship
between an adverse event and a drug, the relationship being unknown or
incompletely documented previously”.
• A safety signal is information on a new or known adverse event that may be caused
by a medicine and requires further investigation.
• Signals can be detected from a wide range of sources, such as spontaneous reports,
clinical studies and scientific literature.
CONT…
SIGNAL DETECTION
• Pharmacovigilance involves the collection of data on adverse reaction which must
then be analysed and evaluated to create meaningful safety information.
• Signal detection in pharmacovigilance involves looking at the adverse reaction data
for patterns that suggest new safety information.
AIMS OF SIGNAL DETECTION
• Signal detection aims to identify and describe suspected harm to patients, caused by
their use of medicine.
• The evidence comes primarily in the form of spontaneous reports from health
professionals across the world, from pharmaceutical companies and some from
patients.
• Signal detection is a core UMC ( Uppsala Monitoring Centre) activity.
METHOD OF SIGNAL DETECTION
• Commonly signal detection done in two methods are-
1. TRADITIONAL PHARMACOVIGILANCE METHODS
2. DATA MINING ALGORITHMS
TRADITIONAL PHARMACOVIGILANCE
METHODS
• Individual case review
• Aggregate analysis
• Periodic analysis
• Traditionally, signals are detected through the assessment of individual case
safety reports in an individual or cumulative manner.
1. Qualitative review of ICSR
• Critical method of detection for events where the background incidence is
uncommon or rare and should not be replaced by quantitative methods
2. Qualitative review of ICSR
• Periodic review of the aggregate tables displayed in these periodic reports can
provide indication of potential striking events.
• Periodic review of case series.
Quantitative assessment of ICSR
• No of reports of an adverse event or adverse product reaction.
• Absolute counts
Quantitative assessment of ICSR
• No of specific AE reports divided by total no of reports for a given product.
• Proportion
DATA MINING ALGORITHMS
• Once the ICSR database become large enough, statistical techniques can be applied.
• Generally these techniques identify disproportionate reporting ratios.
Pharmacovigilance signal and signal detection

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Pharmacovigilance signal and signal detection

  • 1. SIGNAL & METHOD OF SIGNAL DETECTION CMCR: 606 PHARMACOVIGILANCE PRESENTED TO PRESENTED BY Dr. SAURABH KOHLI Kiran Rajput Assistant Professor M.Sc. C.R. Department of Pharmacology Sem 3
  • 2. SIGNAL • According to WHO signal is “Reported information on a possible casual relationship between an adverse event and a drug, the relationship being unknown or incompletely documented previously”.
  • 3. • A safety signal is information on a new or known adverse event that may be caused by a medicine and requires further investigation. • Signals can be detected from a wide range of sources, such as spontaneous reports, clinical studies and scientific literature. CONT…
  • 4. SIGNAL DETECTION • Pharmacovigilance involves the collection of data on adverse reaction which must then be analysed and evaluated to create meaningful safety information. • Signal detection in pharmacovigilance involves looking at the adverse reaction data for patterns that suggest new safety information.
  • 5. AIMS OF SIGNAL DETECTION • Signal detection aims to identify and describe suspected harm to patients, caused by their use of medicine. • The evidence comes primarily in the form of spontaneous reports from health professionals across the world, from pharmaceutical companies and some from patients. • Signal detection is a core UMC ( Uppsala Monitoring Centre) activity.
  • 6. METHOD OF SIGNAL DETECTION • Commonly signal detection done in two methods are- 1. TRADITIONAL PHARMACOVIGILANCE METHODS 2. DATA MINING ALGORITHMS
  • 7. TRADITIONAL PHARMACOVIGILANCE METHODS • Individual case review • Aggregate analysis • Periodic analysis • Traditionally, signals are detected through the assessment of individual case safety reports in an individual or cumulative manner.
  • 8. 1. Qualitative review of ICSR • Critical method of detection for events where the background incidence is uncommon or rare and should not be replaced by quantitative methods
  • 9. 2. Qualitative review of ICSR • Periodic review of the aggregate tables displayed in these periodic reports can provide indication of potential striking events. • Periodic review of case series.
  • 10. Quantitative assessment of ICSR • No of reports of an adverse event or adverse product reaction. • Absolute counts
  • 11. Quantitative assessment of ICSR • No of specific AE reports divided by total no of reports for a given product. • Proportion
  • 12. DATA MINING ALGORITHMS • Once the ICSR database become large enough, statistical techniques can be applied. • Generally these techniques identify disproportionate reporting ratios.