Exam 1

Question 1

What is pharmacoepidemiology?

Answer 1

Study of the use and effects of drugs in the population

Question 2

Pharmacoepidemiology has primarily concerned itself with the study of ________ _________ _________

Answer 2

Adverse drug effects

Question 3

What are 4 reasons to perform pharmacoepidemiologic studies?

Answer 3

. Regulatory
. Marketing: repositioning a drug, documenting safety
. Legal
. Clinical: hypothesis testing/generating

Question 4

Considerations for risk/benefit assessment of medical treatments

Answer 4

Severity, reversibility, frequency, immediate vs. delayed, occurs in certain populations

Question 5

Post-marketing drug surveillance is completed to
a. Increase sample size
b. Continue to evaluate drug efficacy
c. Obtain additional drug indications
d. Identify unknown drug-related adverse effects

Answer 5

d. Identify unknown drug-related adverse effects

Question 6

Which of the statements below BEST describes the different types of measurable drug effects looked at in pharmacoepidemiology?
a. Anticipated beneficial effects
b. Unanticipated harmful effects
c. Anticipated harmful effects
d. Anticipated or unanticipated beneficial or harmful effects
e. Unanticipated beneficial effects

Answer 6

d. Anticipated or unanticipated beneficial or harmful effects

Question 7

What is the difference between an adverse drug reaction and an adverse event?

Answer 7

. ADRs are a subset of AEs
. Causal relationship suspected in ADRs

Question 8

What is REMS?

Answer 8

Risk Evaluation and Mitigation Strategy

Question 9

Who authorizes REMS programs and based on what?

Answer 9

FDA is authorized to require a REMS for certain drugs based on risk/benefit profile

Question 10

What is VAERS?

Answer 10

Vaccine Adverse Event Reporting System

Question 11

Who can submit a report to VAERS?

Answer 11

Anyone; patients, caregivers, vaccine manufacturers, healthcare professionals

Question 12

True or false: Vaccine manufacturers are required to report any adverse event that comes to their attention

Answer 12

True

Question 13

The Joint Commission (TJC) requires hospitals to perform which two (2) surveillance programs?
a. Medication Errors
b. Drug Use Evaluation
c. Adverse Drug Reaction Monitoring
d. Antibiotic Resistance Reporting

Answer 13

b. Drug Use Evaluation
c. Adverse Drug Reaction

Question 14

Which of the following may be a reason to conduct a pharmacoepidemiologic study? SELECT ALL THAT APPLY
a. Regulatory requirement
b. Mitigate future outpatient costs
c. Mitigate liability
d. Obtain a new drug indication
e. Mitigate risk

Answer 14

a. Regulatory requirement
c. Mitigate liability
d. Obtain a new drug indication
e. Mitigate risk

Question 15

Efficacy, effectiveness, or efficiency?
a. In the real-world can a drug achieve its desired effect
b. Whether the drug has ability to bring about intended effect
c. Studied in a Randomized Controlled Trial under perfect conditions
d. Can the drug get the desired effect at an acceptable cost

Answer 15

a - effectiveness
b - efficacy
c - efficacy
d - efficiency

Question 16

Where are pharmacists engaging in population health value-added
services?

Answer 16

. Primary care settings
. Community pharmacy settings
. Inpatient settings
. Managed care settings

Question 17

What is chronic care management?

Answer 17

Coordination of care for Medicare patients outside of regular office visits for patients with two or more chronic conditions expected to las at least 12 months or until the patient’s death

Question 18

In what setting is chronic care management provided?

Answer 18

Primary/Ambulatory care clinics

Question 19

What factors are considered in the value proposition of CCM?

Answer 19

. Quality of care
. Cost avoidance
. Provider efficiency
. Patient adherence

Question 20

Quality measures were developed to ensure access to healthcare that is:
a. Safe
b. Cheap
c. Fast
d. Lucrative

Answer 20

a. Safe

Question 21

Which of the following describes a value-proposition in pharmacists providing chronic care management?
a. Reduction in patient adherence
b. Increasing costs
c. Increasing provider efficiency
d. Compromises quality of care

Answer 21

c. Increasing provider efficiency

Question 22

Who are the stakeholders in healthcare?

Answer 22

. Payers
. Employers
. Providers
. Patients

Question 23

True or false: Waste accounted for 34-50% of healthcare spending in 2007

Answer 23

True

Question 24

What are MTMs?

Answer 24

Medication Therapy Management. Face to face patient assessment and intervention as appropriate, by a pharmacist

Question 25

CPT billing code for initial 15min with new patient

Answer 25

99605

Question 26

CPT billing code for initial 15min with established patient

Answer 26

99606

Question 27

CPT billing code for additional 15min with any patient after initial 15min

Answer 27

99607

Question 28

What does HEDIS stand for?

Answer 28

Healthcare effectiveness data and information set

Question 29

Per diem reimbursement model

Answer 29

The hospital is paid for all services delivered to a patient in 1 day (private insurance, PPOs/HMOs)

Question 30

Fee-for-service reimbursement model

Answer 30

The physician or hospital is paid a fee for each service (for example, medication, IV fluids, ECG, surgical
procedure) provided (uninsured, some private insurance)

Question 31

DRGs (diagnosis related groups)

Answer 31

Physician or hospital is paid one sum for all services delivered during one illness; there is a different set
case price for each of approximately 750 distinct DRGs (Medicare)