Pharmacoepidemiology Intro

Question 1

Pharmacoepidemiology - Definition

Answer 1

the study of use and the effects of drugs in large numbers of people

applies methods of epidemiology to the content of clinical pharmacology

Question 2

Pharmacology - Definition

Answer 2

the study of effects of drugs

Question 3

Clinical Pharmacology - Definition

Answer 3

the study of effects of drugs in humans

Question 4

Epidemiology - Definition

Answer 4

study of distribution and determinants of diseases in populations

Question 5

Pharmacoepidemiology - Application

Answer 5

post-marketing surveillance

Question 6

Pure Food & Drug Act

Answer 6

1906
allows federal government to remove adulterated or misbranded drugs

Question 7

Food, Drug, & Cosmetic Act

Answer 7

1938
requires preclinical toxicity testing
requires manufacturers to gather clinical data about drug
no proof of efficacy is required yet

Question 8

Clinical Trials - Problems

Answer 8

expensive
small
drugs compared to placebo
exclusions (elderly, children, pregnant women, patients with comorbidities)
sometimes unethical
not timely

Question 9

Study Designs

Answer 9

RCT
cohort
case-control
case series
case reports
analyses of secular trends

Question 10

Case Report - Design

Answer 10

report of an event in a single patient
simple, inexpensive

application: generating hypotheses

Question 11

Case Series - Design

Answer 11

collection of patients all of whom have either a single exposure or a single outcome
no control group

application: quantify an adverse drug event to ensure it is not happening in population larger than that studied prior to drug marketing

Question 12

Analyses of Secular Trends - Design

Answer 12

examine trends in an exposure that is a presumed cause and trends in a disease that is a presumed effect; test whether the trends coincide
lack individual data, no control for confounders

Question 13

Case-Control Study - Design

Answer 13

compare cases with outcome to controls without outcome to look for difference in exposure
quick and inexpensive, potential for bias
OR used for measure of association

application: multiple exposure, uncommon diseases

Question 14

Cohort Study - Design

Answer 14

identifies a cohort of subject and follows them over time to determine outcome
expensive, time-consuming, potential for outcome ascertainment bias
RR and AR used for measure of association

application: rare exposures

Question 15

RCT - Design

Answer 15

participants are randomly assigned between exposure and control groups
the only design that controls for unknown confounders
expensive, logistically difficult, artifical

Question 16

Pragmatic Clinical Trial - Design

Answer 16

the investigator tests the effectiveness of an intervention under “real-world” conditions

not generalizable, evidence paradox

Question 17

P-value

Answer 17

< 0.05 traditionally recognized as statistically significant

Question 18

Confidence Interval

Answer 18

if doesn’t include 1, recognized as statistically significant

Question 19

Pragmatic Clinical Trials vs RCTs

Answer 19

design: test two or more real-world treatments opposed to intervention against placebo

participants: more representative of population due to less strict eligibility criteria

measures: data can be collected in clinical settings

results: relevant and useful in everyday practice

goal: to improve practice opposed to determine causes & effects of treatments

Question 20

Types of Error

Answer 20

random
bias
confounding

Question 21

Types of Bias

Answer 21

information (interviewer, recall)
selection (controls don’t represent the population)