Modules 1-3 Flashcards
Who can report a potential adverse drug event to the FDA? (4 options)
- physicians
- drug manufacturers
- patients
- pharmacists
TJC requires hospitals to perform which two surveillance programs?
- Adverse Drug Reaction Monitoring
- Drug Use Evaluation
Complete the sentence:
Pharmacoepidemiology is the study of…
The effects of drugs on the population
Post-marketing drug surveillance is completed to…
Identify unknown drug-related adverse effects
What is the BEST way that describes the different types of measurable drug effects looked at in pharmacoepidemiology?
Anticipated or unanticipated beneficial or harmful effects
Epidemiology Principles or Medication Use?
Pharmacokinetics
medication use
- Epidemiology Principles or Medication Use? -
Pharmacology
medication use
- Epidemiology Principles or Medication Use? -
pharmacodynamics
medication use
- Epidemiology Principles or Medication Use? -
Distribution of diseases in populations
epidemiology principles
Post-marketing drug surveillance is completed to:
identify unknown drug-related adverse effects
Efficacy, effectiveness, or efficiency?
Studied in a RCT under perfect conditions
efficacy
Efficacy, effectiveness, or efficiency?
In the real-world can a drug achieve its desire effect?
effectiveness
Efficacy, effectiveness, or efficiency?
Whether the drug has the ability to bring about intended effect
efficacy
Efficacy, effectiveness, or efficiency?
Can the drug get the desired effect at an acceptable cost
efficiency
Who can report a potential adverse drug event (ADE) to the U.S. Food & Drug Administration (FDA)?
- patients
- physicians
- drug manufacturers
- pharmacists
What can be a reason to conduct a pharmacoepidemiologic study?
- mitigate risk
- regulatory requirement
- obtain a new drug indication
- mitigate liability
Pharmacoepidemiology has primarily concerned itself with study of of adverse drug effects
true
Which of the following is a risk evaluation tool for vaccines?
VAERS
Part of the responsibility of clinical pharmacology is to provide a _________ assessment for the effect of drugs in patients
risk-benefit
Which statement is correct about AE and ADR?
- ADRs are a subset of AEs
- AE does not necessarily have to have a causal relationship with the treatment
- ADR generally has a causal relationship associated with the treatment
REMS stands for…
Risk Evaluation and Mitigation Strategy