Lecture 7 Flashcards
WHO DD coding is composed of?
ATC Classification?
Anatomically therapeutic classification
Minimum number of cases needed to generate a signal
three
Sources of signal detection & Managment?
- Individual case safety reports
- Scientific Literature
- Observational studies
- Clinical studies
- Regulatory authorities
- Internet/media
Importance of signal detection?
- Identify unknown ADRs or other drug-related problems
- Prevent/minimize the risk and promote patient safety
Types of signal detection?
A) Qualitative: Striking cases, ICSR, or cumulative manner ( series of ICSR or PSUR)
B) Quantitative: Data Mining
DEF: systematic detection of signals through “Measure of Disproportionality”
in large databases of individual case safety reports (regulatory agencies or
pharmaceutical companies)
Data Mining
DEF: Measure of disproportionality?
Whether or not more reports were received for a particular drug-adverse event
combination than what was expected as background noise
DEF: (Analytical tool used for signal detection in VigiBase)
VigiLyze
How are signals detected quantitatively?
VigiLyze
Indicators of disproportionality?
- Information Component (IC)
- PRR: Proportional Reporting Ratio
Indicator of disproportionality used by WHO?
Information component (IC)
T/F: Indicators of disproportionality are measures of association NOT causality
TRUE
why are medical reviews needed following signal detection methods?
Indicators of disproportionality are measures of association NOT causality
