Intro To Pharmacoepidemiology Flashcards
What is the definition of pharmacoepidemiology?
Study of use, risks, and benefits of drugs in populations
What is the definition of pharmacovigilance?
Continual monitoring for unwanted effects and other safety related aspects of marketed drugs
What is comparative effectiveness research (CER)?
Determines what therapeutic intervention (not just drugs) works best for a given disorder in pts likely to be seen in clinical practice
What is the definition of pragmatic research?
Studies (often using randomization) that often test small practical changes that could have an impact on health outcomes
What are experimental studies?
RCTs (active tx, usual care, pragmatic, etc)
What are nonexperimental studies?
- Observational
- Case control, cohort, others
- Pharmacoepi and pharmacovigilance studies are primarily observational
What does pharmacoepi consist of?
- Pharmacology/pharmacotherapy + epidemiology
- See beneficial effects and safety concerns in populations
- Application of epidemiological methods to pharmacology issues
What are general contributions of pharmacoepi?
- Reassurance of drug safety
- Ethical and legal obligations
What data sources are available for pharmacoepi?
- Adverse drug rxn reports
- Medical claims data
- Electronic medical records
How can pharmacoepi allow for identification of new info not available from premarketing studies?
- Previously undetected ADRs/beneficial effects
- Patterns of drug utilization
- Effects of varied doses
- Economic impact of drug use
What is a data resource specific to Indiana that could be used for pharmacoepi?
Indiana Network for Patient Care (INPC):
- >100 separate healthcare entities providing data
What is bias?
Systematic deviation from truth that distorts the results of research
What is confounding?
- Relationship between tx and response is attributable to another variable
- Confounder is independently related to BOTH exposure and outcome
What is information bias?
- Bias related to info regarding exposure or outcome
- Includes measurement and/or classification error
What is detection bias?
Specific outcome is diagnosed preferentially in subjects exposed to agent
What is confounding by indication?
Indication for a drug or severity of disease predicts use of drug
What is selection bias?
- Bias related to procedures used to select subjects/influence study participation
- Due to systematic differences in characteristics between those who are selected and those aren’t
What referral bias?
Reason for encounter is related to drug tx
What is protopathic bias?
Exposure of interest is used unknowingly to tx adverse event related to outcome/agent is used for early manifestation of disease that has not yet been diagnosed
What is prevalence bias?
Prevalent cases rather than new cases are selected
When does confounding by indication occur?
When risk of an event is related to the indication for med use but not use of med itself
When does confounding by indication appear?
When the reason of prescription is associated with the outcome of interest
When does protopathic bias also known as?
Reverse causality
When does protopathic bias occur?
If a particular tx was started, stopped, or otherwise changed BC of baseline manifestation caused by a disease or other outcome event
