Risk Management & Signal Detection Flashcards
7 cards from real PVC practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Risk Management & Signal Detection flashcards as text
Which WHO database is the global reference for spontaneous adverse drug reaction reports used in international signal detection?
Answer: VigiBase
VigiBase, maintained by the Uppsala Monitoring Centre (UMC) on behalf of WHO, is the world's largest database of individual case safety reports from over 130 member countries.
The 'Information Component' (IC) used by the WHO-UMC is based on which statistical approach?
Answer: Bayesian confidence propagation neural network
The IC is derived from a Bayesian Confidence Propagation Neural Network (BCPNN), measuring the statistical association between a drug and an event in VigiBase.
A MAH identifies a new serious risk during routine signal detection. According to GVP Module IX, what is the first action the MAH should take?
Answer: Assess and validate the signal, then notify the competent authority if confirmed
GVP Module IX requires MAHs to assess and validate detected signals; if the signal is confirmed and may impact the benefit-risk balance, the competent authority must be notified.
What is 'missing information' in the context of an EU RMP Safety Specification?
Answer: Gaps in knowledge about product safety in specific populations or situations not studied
Missing information refers to areas where safety data are absent or insufficient, such as use in pregnancy, elderly patients, or patients with renal impairment.
Which of the following describes a 'Medication Error' in pharmacovigilance classification?
Answer: An unintended error in prescribing, dispensing, or administration that may or may not cause harm
A medication error is an unintended failure in the drug treatment process that leads to or has the potential to lead to patient harm, regardless of whether harm actually occurred.
In quantitative signal detection, what does a 'shrinkage' method like the MGPS or BCPNN protect against?
Answer: Inflated disproportionality estimates from drug-event pairs with very few reports
Shrinkage methods dampen extreme disproportionality values that arise from small report counts, reducing false positives caused by sparse data.
A REMS communication plan is required when:
Answer: The FDA determines that healthcare providers or patients need specific safety information to ensure safe use
Under 21 CFR 505-1, the FDA may require a REMS communication plan when targeted outreach to prescribers, pharmacists, or patients is necessary to mitigate a serious risk.