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PHRM 849 > Intro To Pharmacoepidemiology > Flashcards

Intro To Pharmacoepidemiology Flashcards

1
Q

What is the definition of pharmacoepidemiology?

A

Study of use, risks, and benefits of drugs in populations

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2
Q

What is the definition of pharmacovigilance?

A

Continual monitoring for unwanted effects and other safety related aspects of marketed drugs

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3
Q

What is comparative effectiveness research (CER)?

A

Determines what therapeutic intervention (not just drugs) works best for a given disorder in pts likely to be seen in clinical practice

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4
Q

What is the definition of pragmatic research?

A

Studies (often using randomization) that often test small practical changes that could have an impact on health outcomes

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5
Q

What are experimental studies?

A

RCTs (active tx, usual care, pragmatic, etc)

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6
Q

What are nonexperimental studies?

A
  • Observational
  • Case control, cohort, others
  • Pharmacoepi and pharmacovigilance studies are primarily observational
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7
Q

What does pharmacoepi consist of?

A
  • Pharmacology/pharmacotherapy + epidemiology
  • See beneficial effects and safety concerns in populations
  • Application of epidemiological methods to pharmacology issues
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8
Q

What are general contributions of pharmacoepi?

A
  • Reassurance of drug safety
  • Ethical and legal obligations
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9
Q

What data sources are available for pharmacoepi?

A
  • Adverse drug rxn reports
  • Medical claims data
  • Electronic medical records
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10
Q

How can pharmacoepi allow for identification of new info not available from premarketing studies?

A
  • Previously undetected ADRs/beneficial effects
  • Patterns of drug utilization
  • Effects of varied doses
  • Economic impact of drug use
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11
Q

What is a data resource specific to Indiana that could be used for pharmacoepi?

A

Indiana Network for Patient Care (INPC):
- >100 separate healthcare entities providing data

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12
Q

What is bias?

A

Systematic deviation from truth that distorts the results of research

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13
Q

What is confounding?

A
  • Relationship between tx and response is attributable to another variable
  • Confounder is independently related to BOTH exposure and outcome
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14
Q

What is information bias?

A
  • Bias related to info regarding exposure or outcome
  • Includes measurement and/or classification error
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15
Q

What is detection bias?

A

Specific outcome is diagnosed preferentially in subjects exposed to agent

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16
Q

What is confounding by indication?

A

Indication for a drug or severity of disease predicts use of drug

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17
Q

What is selection bias?

A
  • 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
18
Q

What referral bias?

A

Reason for encounter is related to drug tx

19
Q

What is protopathic bias?

A

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

20
Q

What is prevalence bias?

A

Prevalent cases rather than new cases are selected

21
Q

When does confounding by indication occur?

A

When risk of an event is related to the indication for med use but not use of med itself

22
Q

When does confounding by indication appear?

A

When the reason of prescription is associated with the outcome of interest

23
Q

When does protopathic bias also known as?

A

Reverse causality

24
Q

When does protopathic bias occur?

A

If a particular tx was started, stopped, or otherwise changed BC of baseline manifestation caused by a disease or other outcome event

25
Q

When does protopathic bias occur specifically in pharmacoepi?

A

When drug is initiated in response to first Sx of disease which is, at this point, undiagnosed

26
Q

What is immortal time bias?

A

Period of follow-up when, due to exposure definition, the outcome being studied could never occur

27
Q

What is pharmacovigilance?

A
  • Continual monitoring for unwanted effects and other safety-related aspects of marketed drugs
  • Detection, evaluation, understanding, prevention of ADRs
28
Q

What is pharmacovigilance historically involved with?

A

With collection of spontaneous reports of drug related morbidity or mortality

29
Q

What is the FDA Adverse Event Reporting System (FAERS)?

A

A database that houses postmarketing adverse event reports received by FDA

30
Q

What is the FDA Sentinel System?

A
  • Monitors safety of FDA regulated products
  • Data submitted by a number of resources
31
Q

What is FDA VARES?

A

The vaccine adverse event reporting system

32
Q

What is comparative effectiveness research (CER)?

A

The conduct and synthesis of research comparing the benefits and harms of different interventions and strategies to prevent, diagnose, treat, and monitor health conditions in real world settings

33
Q

What is the purpose of CER?

A

Assist consumers, clinicians, purchasers, and policymakers to make informed decisions that will improve healthcare at both individual and population levels

34
Q

What does CER focus on?

A

Patient centered health research

35
Q

What does efficacy determine?

A

Whether a drug (or other tx) has ability to bring about a given intended effect in controlled settings

36
Q

What does effectiveness determine?

A

Whether, in real world pts and settings, a tx, DOES achieves it’s desired effect

37
Q

What is the goal of CER?

A

To inform decisions on interventions or approaches to health care in real world settings with regard to their intended and unintended outcomes that are relevant to pts

38
Q

What is pragmatic research?

A

Studies (often using randomization) that often test practical changes that could have a big impact on health outcomes

39
Q

What is a pragmatic RCT?

A

A randomized clinical trial with one or more pragmatic elements

40
Q

What does a pragmatic RCT try to overcome?

A

Intended to overcome the limitations of traditional RCTs in order to answer CER questions

41
Q

What is hybrid design pragmatic clinical trial?

A

Combination of RCT and routine care

42
Q

What does pragmatic clinical trial measure?

A

The effectiveness in clinical practice

PHRM 849 (4 decks)

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