Quiz 5

Question 1

What is the general flow of the drug approval process?

Answer 1

Drug discovery and development
pre-clinical research and development
clinical trial
FDA reviews NDA
manufacturing

Question 2

Investigational New Drug (IND)

Answer 2

drug must be the subject of an approved marketing application before it is transported/distributed across state lines
sponsor has screened molecule for pharmacological activity

Question 3

New Drug Application

Answer 3

sponsor believes enough evidence has been obtained to meet FDAs marketing approval requirements

Question 4

Abbreviated New Drug Application (ANDA)

Answer 4

application process for generic drugs
not required to include preclinical and clinical data
must demonstrate product is bioequivalent

Question 5

Fenfluramine

Answer 5

appetite suppressant
increased risk of pulmonary hypertension
24 cases of valvular heart disease in women
withdrawn from market in 1997

Question 6

Rofecoxib

Answer 6

treated osteoarthritis, acute pain, and dysmenorrhea
4 fold increased risk of acute MI
caused between 88000 and 139000 heart attacks
withdrawn in 2004

Question 7

Dabigatran

Answer 7

prevented stroke in non-valvular atrial fibrillation
risk of bleeding increased

Question 8

pharmacoepidemiology

Answer 8

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

Question 9

What contributes to pharmacoepidemiology?

Answer 9

higher precision studies
new patient groups
comparative effectiveness evaluations
undetected adverse/beneficial effects
allows for a longer follow-up
study in real-world settings
reassurances in drug safety
fulfillment of ethical/legal obligations

Question 10

Exposure types

Answer 10

actual: chemical, microorganism
behavioral: environmental factors
individual attributes: age, sex, race, socioeconomic status

Question 11

outcome types

Answer 11

economic: impacts of intervention on total health resource utilization
clinical: changes in health status
humanistic: patient-centered satisfaction

Question 12

Type 1 error

Answer 12

rejecting the null hypothesis when it was really true
false positive
controlled by setting the significance level

Question 13

Type 2 error

Answer 13

failing to reject the null hypothesis when it is really false
false-negative
reduced by increasing sample size

Question 14

Selection bias

Answer 14

Certain subjects are more likely to be included in the study compared to others, leading to a sample that is non- representative

Question 15

Misclassification bias

Answer 15

Data is incorrectly categorized/recorded, leading to incorrect assumptions and/or conclusions

Question 16

Surveillance bias

Answer 16

Monitoring differs across subjects, leading to measurements of outcomes which may not fully capture the data

Question 17

Recall bias

Answer 17

subjects have different memory of past events leading to incorrect data

Question 18

Interviewer bias

Answer 18

collection methods differ across subjects, leading to incomplete data

Question 19

confounding bias

Answer 19

situation in which a non-casual association between a given exposure and an outcome is observed as a result of the influence of a third variable

Question 20

Type A ADR

Answer 20

augmented; dose related
exaggeration of desired/undesired effect
predictable, usually not serious but relatively common
sedation, diarrhea, nausea

Question 21

Type B ADR

Answer 21

non-dose related; bizarre
idiosyncratic
largely unpredictable, more serious and less common
anaphylaxis, metabolic intolerances

Question 22

Type C ADR

Answer 22

chronic; dose and time related
HPA axis suppression, osteonecrosis

Question 23

Type D ADR

Answer 23

delayed; time related
tardive dyskinesia, teratogenesis

Question 24

Type E ADR

Answer 24

end of use; withdrawal
anxiety after cessation of benzodiazepines

Question 25

Type F ADR

Answer 25

failure; unexpected failure
antibiotic resistance

Question 26

Pure Food and Drug Act (1906)

Answer 26

passed in response to excessive adulteration/misbranding
no requirements for safety/efficacy of marketed drugs

Question 27

Food Drug and Cosmetic Act (1938)

Answer 27

mandated pre-clinical toxicity testing and clinical data on drug safety prior to marketing to the public
response to 100 deaths from sulfanilamide elixir

Question 28

Kefauver-Harris Amendment

Answer 28

strengthened requirements for proof of drug safety in preclinical pharmacological and toxicological testing
required IND before clinical trials and substantial evidence
response to thalidomide disaster

Question 29

Risk Evaluation and Mitigation Strategy (REMS)

Answer 29

required from manufacturers to ensure benefits of a drug outweigh risks
may require based on seriousness of known/potential ADRs, expected benefit of the drug, seriousness of the disease, whether the drug is new, expected duration of treatment, and size of population using drug