The document discusses signal detection in pharmacovigilance, defining a signal as information suggesting a potential causal relationship between an adverse event and a drug that necessitates further investigation. It emphasizes traditional methods like individual case reviews and aggregate analysis, along with data mining algorithms as modern techniques for detecting safety signals from adverse reaction data. The primary goal of signal detection is to identify and describe suspected harms related to medication use, drawing evidence from spontaneous reports and other sources.

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.