What is the purpose of the NAPLEX Clinical Review program?
Educational and informational purposes only
It supports, but does not replace, professional judgment or individualized patient care decisions.
What are the phases of drug development?
- Preclinical Studies
- Phase I
- Phase II
- Phase III
- Phase IV
Each phase evaluates different aspects of drug safety and efficacy.
In Phase I of drug development, how many healthy volunteers are typically involved?
20–100
This phase assesses safety, pharmacokinetics (PK), pharmacodynamics (PD), and maximum tolerated dose (MTD).
What is the main goal of Phase III trials?
Confirm efficacy and monitor adverse effects
These are large trials that provide critical data before a drug can be marketed.
List the types of clinical trial designs.
- Parallel
- Crossover
- Factorial
- Cluster Randomized
- Adaptive
- Non-Inferiority
- Superiority
- Equivalence
- Open-Label
- Pragmatic
Each design serves different research purposes and scenarios.
What is a double-blind study?
Both participant and investigator are blinded
This design minimizes bias in clinical trials.
Define selection bias.
Differences in baseline characteristics from flawed allocation/enrollment
Example: Younger patients placed in treatment group, skewing outcome.
What is the purpose of block randomization?
Ensure balanced allocation of subjects
It maintains equal group sizes during randomization.
What does ANOVA stand for and what is its purpose?
Analysis Of Variance; compare means across 3+ independent groups
Example: Comparing A1c levels among different diabetes medications.
What is a primary outcome in clinical trials?
Main, pre-specified outcome the trial is designed to assess
Example: Time to cardiovascular death in a heart failure trial.
List the core ethical principles in pharmacy.
- Autonomy
- Beneficence
- Nonmalfeasance
- Justice
- Veracity
- Fidelity
These principles guide ethical decision-making in patient care.
What is the definition of informed consent?
Patient agrees to treatment after receiving all facts
Requirements include disclosure, comprehension, voluntariness, and competency.
What does HIPAA stand for?
Health Insurance Portability and Accountability Act
It protects patient health information.
Define moral distress.
Discomfort when unable to act ethically
Causes include policy, hierarchy, and fear of retaliation.
What is the purpose of a SWOT analysis in pharmacy business planning?
Identifies strengths, weaknesses, opportunities, and threats
It helps in strategic planning for pharmacy operations.
What does PBM stand for?
Pharmacy Benefit Manager
They manage prescription drug benefits on behalf of insurers and employers.
What is MAC pricing?
Maximum Allowable Cost; a pricing benchmark for generic drugs
Pharmacies are reimbursed based on MAC values.
What is the definition of adaptive randomization?
Allocation probabilities change based on interim results
More patients may be assigned to a treatment arm showing early benefit.
What does AWP stand for in pharmaceutical pricing?
Average Wholesale Price
A list price published by drug manufacturers, often referred to as a ‘sticker price.’
What does WAC represent in drug pricing?
Wholesale Acquisition Cost
The manufacturer’s list price to wholesalers, excluding discounts.
What are DIR Fees?
Direct and Indirect Remuneration
Post-claim fees charged by PBMs to pharmacies based on performance metrics.
List the three types of drug recalls based on risk.
- Class I Recall
- Class II Recall
- Class III Recall
Recalls are classified based on the potential health risks they pose.
What is a Class I Recall?
Product may cause serious health problems or death
Example: Contaminated injectable drug causing septic shock.
What is a Class II Recall?
Product may cause temporary or medically reversible health issues
Example: Wrong dosage strength on label.
