Drug Lit Exam 3- Adr

Front 1

epidemiology definition

Back 1

study of the distribution and determinants of diseases in populations.

Front 2

pharmacoepidemiology definition

Back 2

he study of the use of and the effects (good and bad) of drugs in populations.

Front 3

PE studies- factor in what? compare to RCT (2)

Back 3

factors in population that allow drug to be effective, or allow for more adverse events.

goes beyond typical RCTs and begins to address some of these effects in a population rather than an individual

Front 4

"type" of research that PE studies are

Back 4

translational between clinical studies and population studies

Front 5

main purpose of a PE study

Back 5

1. Describe, Explain , Control and then Predict the use and effects of drugs in a defined
time, place, and population

Front 6

4 other things a PE study does for a drug

Back 6

Determine how a drug performs in clinical practice (effectiveness, safety)

Identify rare adverse events or events that occur in “special” populations.

Document new uses of approved drugs (use these PE studies to get non-approved uses approved by documenting it)

Determine long term effects of drugs, or effects on ultimate vs intermediate outcomes

Front 7

5 factors to analyze when studying how a drug performs in clinical practice

Back 7

a. socioeconomic effects
b. comorbidity
c. health care system (how can we make drug more readily available)
d. compliance
e. environment

Front 8

PE studies are frequency used for what?

Back 8

Frequently used for post-marketing surveillance- once a drug is on market then you use these studies to look broadly at a population over time

because RCTs rae too expensive for that

Front 9

PE studies are used by the FDA in what 2 manners

Back 9

Used by the FDA to allow approval of priority drugs in shorter time (on condition of
surveillance).

Used by the FDA to modify product labeling or approval status.

Front 10

Methods Used in Pharmacoepidemiology (3 main types)

Back 10

1. Randomized controlled trials- occasionally
2. observational studies (automated databases help a lot with these)-->these studies are cohort (follow up), case control and cross sectional studies
3. Descriptive studies (case reports)- drug use, stats, reports

Front 11

levels of evidence: applicable to PE studies?

Back 11

no, not in the same way as efficacy studies

Front 12

controlled, longitudinal, observational study

Back 12

(cohort/follow up)

Front 13

longitudinal, retrospective observational studies: controlled vs. uncontrolled

Back 13

controlled: cohort/case control

uncontrolled: case report/series

Front 14

cross sectional, snap shot in time, observational studies: controlled vs. uncontrolled

Back 14

controlled: risk factor ...studies? factors influencing incidence of something (adr, disease)

uncontrolled: prevalence studies(like surveys to a population)

Front 15

ADR Observational Studies (2)

Back 15

1. Follow-up (cohort) methodology
2. Case-control methodology

Front 16

when would you use a cohort study for ADR? (2)

Back 16

a. more frequent events, shorter onset of ADR
b. or if less frequent exposure (infrequently used medication, but frequent ADR)

Front 17

when would you use a case control methodology for ADR? (2)

Back 17

a. rare event or long time to develop (outcome)
b. frequent exposure (frequently used medication

Front 18

when would case control and cohort study not be good for an ADR study? (2)
in this case what do you use?

Back 18

a. infrequent event
b. infrequent exposure

so must rely on descriptive reports

Front 19

Limitations of Pre-marketing RCTs to Detect ADR (6) OBJECTIVE

Back 19

1. Short duration- sometimes ADRs take a while
2. Narrow population
3. Narrow indications
4. Limited co-morbidities and co-therapies- usually exclude these things in RCTs so hard to extrapolate to gen pop, and it can also mask AEs
5. Some ADRs have a significant background incidence in population are even more difficult- e.g. headaches. everyone has headaches anyway.
6. Small sample size: remember the “rule of three”; for 95% probability to detect an ADR, the number of subjects needed to be followed is 3 times the incidence of the event.

Front 20

relative risk =

Back 20

risk of outcome with exposure/risk of outcome without exposure

Front 21

what is absolute risk in terms of RR?

what is the definition

Back 21

RR times the average probability of the event during the same time if
the risk is absent.

It is the probability of an event occurring during a specified period of time

Front 22

how to calculate ARR

Back 22

Risk of outcome with exposure – Risk of outcome without exposure

Front 23

2 flavors of ARR

Back 23

o Absolute Risk Reduction (positive treatment effect) or
o Absolute Risk Increase (adverse event – harm)

Front 24

if RR >1 vs. RR<1 what would your parameters be (3)

Back 24

if RR less than 1
RRR
%RRR
ARR

if RR> 1
RRI (increase)
%RRI
ARI

Front 25

RRR =

RRI =

Back 25

1- RR

RR - 1 (always just want positive)

Front 26

AtR% =

Back 26

[(RR - 1) / (RR)] x 100

Front 27

AtR = (2 ways to calc)

Back 27

AtR = Relative Risk Increase/Relative Risk
or AtR = Absolute Risk Increase/Risk if exposed

Front 28

what is attributable risk %?

Back 28

It is the proportion of the risk increase that is thought to be due to the exposure to the factor.
e.g. A cohort study found lung cancer patients exposed to cigarette smoking

Front 29

NNH =

Back 29

1/absolute risk increase

Front 30

NNH for case control uses what as approximation? what equation?

Back 30

OR as approximation:

PEER (or probability of ctrl group)*(OR-1) + 1

divided by

PEER(OR-1) x (1-PEER)

Front 31

population attributable risk- when can you calc this

Back 31

if you know proportion of population with risk factor for ADR

Front 32

what does the PAR estimate?

Back 32

estimates the proportion of cases that could be prevented by eliminating the risk factor in the total population

Front 33

7 questions to ask about articles about harm (idk if have to know)

Back 33

1. Were there clearly identified comparison groups that were similar with respect to baseline risk of outcome other than the one being studied?
2. Were the outcomes and exposures measured in the same way in the two groups?
3. Was follow-up sufficiently long and complete?
4. Time sequence?
5. Strength of association, dose-response?
6. How precise is the estimate i.e. CI?
7. What are the clinical implications for practice?

Front 34

Patient demographics/med hx for ADR case report (4)

Back 34

a. age, race, gender
b. primary and secondary diagnosis
c. what medications were taken
d. nature of the adverse event, supporting lab data

Front 35

Event development time course info to add in ADR case report (2)

Back 35

a. Clinical course of event, signs, symptoms, intervention.
b. How long was the patient taking the suspected drug?

Front 36

Drug related info for ADR case report (2)

Back 36

a. Why was the drug prescribed?
b. Did the event abate when drug stopped, recur when restarted? (dechallenge, re-challenge)

Front 37

Limitations in Spontaneous Reports (5)

Back 37

1. Causality assessment is difficult.
2. Subject to underreporting.
3. Not possible to calculate an incidence rate; unreliable numerator and very limited ability to estimate the denominator.
4. Reporting rates vary with: the age of the drug, publicity, type of reaction, marketing promotion, local policy, indication for use, frequency of use.
5. Domestic reports should not be lumped with foreign reports or reports from studies.

Front 38

naranjo 10 questions

Back 38

1. Are there previous conclusive reports on this reaction?
2. Did the adverse event appear after the suspected drug was administered?
3. Did the adverse reaction improve when the drug was discontinued or after a specific antagonist was administered?
4. Did the adverse reaction reappear when the drug was readministered?
5. Are there alternative causes (other than the drug) that could have caused the reaction?
6. Did the reaction reappear when a placebo was given?
7. Was the drug detected in the blood (or other fluids) in concentrations known to be toxic?
8. Was the reaction more severe when the dose was decreased?
9. Did the patient have a similar reaction to the same or similar drug in any previous exposure?
10. Was the adverse event confirmed by any objective evidence?