Pharmacovigilance signal and signal detection

PV signal and signal detection & what is the signal detection discus in this slide show.
Kiran Rajput
MSc in clinical Research
3rd Semester 2021

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- TRADITIONAL PHARMACOVIGILANCE METHODS 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.