North American Pharmacist Licensure Examination (NAPLEX) Pharmacy Practice, Law, and Patient Care Flashcards

24 sample cards from the Pharmacy Practice, Law, and Patient Care deck

Sampled from the end of the deck, so these are different cards from the ones shown on the syllabus page.

1. What is tall man lettering and how does it reduce errors?

   Tall man lettering uses mixed-case letters to highlight the differing portions of LASA drug names (e.g., predniSONE vs prednisoLONE), making visual differences more salient to reduce selection errors.

2. What are the five steps of a root cause analysis (RCA)?

   1) Identify and form a team after an event, 2) gather data and reconstruct the timeline, 3) identify contributing factors and the root cause(s) by asking 'why' repeatedly, 4) develop and implement corrective actions, 5) measure and monitor effectiveness.

3. What is the difference between a sentinel event, an adverse drug event, and a near miss?

   A sentinel event causes death or serious harm and triggers mandatory review. An adverse drug event is harm from a medication. A near miss (close call) is an error caught before reaching the patient or before causing harm.

4. What is the PDSA cycle in continuous quality improvement?

   Plan (define objective and change), Do (test the change on a small scale), Study (analyze results against predictions), Act (adopt, adapt, or abandon). It is iterated rapidly for continuous improvement.

5. What is the difference between common-cause and special-cause variation in CQI?

   Common-cause variation is inherent random fluctuation within a stable process. Special-cause variation arises from a specific, identifiable, non-random source and signals the process is out of control, requiring investigation.

6. Define pharmacovigilance and the purpose of post-marketing (Phase IV) surveillance.

   Pharmacovigilance is the science of detecting, assessing, and preventing adverse drug effects. Phase IV surveillance monitors approved drugs in real-world use to detect rare, long-term, or population-specific adverse events not seen in trials.

7. What is the FDA MedWatch program, and is reporting mandatory for pharmacists?

   MedWatch is the FDA's voluntary reporting system for adverse events, product problems, and medication errors. Reporting is voluntary for healthcare professionals but mandatory for manufacturers.

8. Rank these study designs by strength of evidence: case report, cohort study, randomized controlled trial, systematic review/meta-analysis.

   From strongest to weakest: systematic review/meta-analysis of RCTs > randomized controlled trial > cohort study > case-control study > case series/case report > expert opinion.

9. What distinguishes a cohort study from a case-control study in direction and outcome measure?

   A cohort study follows exposed vs unexposed forward in time and yields relative risk (incidence). A case-control study starts with diseased vs non-diseased and looks backward at exposure, yielding an odds ratio.

10. What does a p-value represent, and what does $p < 0.05$ conventionally indicate?

    The p-value is the probability of observing results as extreme as those obtained if the null hypothesis were true. $p < 0.05$ means there is less than a $5\%$ chance the result is due to random chance, conventionally deemed statistically significant.

11. How do you interpret a 95% confidence interval for a relative risk or odds ratio?

    If the $95\%$ CI for a ratio (RR or OR) crosses $1.0$, the result is not statistically significant. For a difference in means, significance is lost if the CI crosses $0$.

12. Which statistical test is appropriate for comparing means of two independent groups versus three or more groups?

    Two independent group means: independent (unpaired) Student's t-test. Three or more group means: ANOVA. Paired/repeated measurements on the same subjects: paired t-test.

13. Define Type I and Type II errors in hypothesis testing.

    Type I error ($\alpha$): rejecting a true null hypothesis (false positive). Type II error ($\beta$): failing to reject a false null hypothesis (false negative). Power $= 1 - \beta$.

14. How are absolute risk reduction (ARR) and number needed to treat (NNT) calculated?

    $$ARR = \text{control event rate} - \text{treatment event rate}$$ $$NNT = \frac{1}{ARR}$$ NNT is rounded up to the next whole number; lower NNT means greater treatment benefit.

15. How is relative risk (RR) calculated and interpreted?

    $$RR = \frac{\text{incidence in exposed}}{\text{incidence in unexposed}}$$ $RR = 1$ means no effect, $RR > 1$ indicates increased risk, and $RR < 1$ indicates a protective effect. Relative risk reduction $= 1 - RR$.

16. What is the difference between relative risk reduction and absolute risk reduction, and why does it matter?

    Relative risk reduction expresses the proportional decrease and can appear large even when baseline risk is small. Absolute risk reduction reflects the actual difference in event rates, giving a truer sense of clinical benefit (e.g., $50\%$ RRR from $2\%$ to $1\%$ is only $1\%$ ARR, $NNT=100$).

17. In critical appraisal, what does intention-to-treat (ITT) analysis mean and why is it preferred?

    ITT analyzes participants in the groups to which they were randomized regardless of adherence or dropout. It preserves randomization, prevents bias, and gives a conservative, real-world estimate of effect, unlike per-protocol analysis.

18. What is the difference between statistical significance and clinical significance?

    Statistical significance ($p<0.05$) indicates a result is unlikely due to chance, but with large samples even trivial effects can be significant. Clinical significance asks whether the effect size is large enough to meaningfully change patient care.

19. According to the CDC adult immunization schedule, who should receive the herpes zoster (Shingrix) and pneumococcal vaccines?

    Recombinant zoster (Shingrix) is recommended as 2 doses for adults $\geq 50$ years. Pneumococcal vaccination (PCV15/PCV20/PCV23) is recommended for all adults $\geq 65$ years and younger adults with risk conditions.

20. What are the standard intramuscular injection sites and needle considerations for adult vaccine administration?

    Adult IM vaccines are given in the deltoid using a $22\text{–}25$ gauge, $1\text{–}1.5$ inch needle at a $90^{\circ}$ angle. Subcutaneous vaccines (e.g., MMR, varicella) use a $23\text{–}25$ gauge $5/8$ inch needle at a $45^{\circ}$ angle in the upper arm fat.

21. What is the recommended childhood DTaP and MMR vaccination schedule timing?

    DTaP is given at 2, 4, 6, and 15–18 months and 4–6 years (5 doses). MMR is given at 12–15 months and 4–6 years (2 doses).

22. What are the 5 A's framework for smoking cessation counseling?

    Ask (about tobacco use), Advise (to quit), Assess (willingness to quit), Assist (with a quit plan/pharmacotherapy), and Arrange (follow-up). For unwilling patients, the 5 R's (Relevance, Risks, Rewards, Roadblocks, Repetition) are used.

23. Which first-line pharmacotherapies are used for smoking cessation, and what is a key contraindication of bupropion?

    First-line: nicotine replacement therapy (patch, gum, lozenge), varenicline (Chantix), and bupropion SR. Bupropion is contraindicated in patients with seizure disorders or eating disorders due to lowered seizure threshold.

24. What validated screening tools are used for alcohol and substance use, and what does a positive CAGE score suggest?

    AUDIT and CAGE screen for alcohol use; DAST and the single-item NIDA screen for drugs. A CAGE score $\geq 2$ (out of 4: Cut down, Annoyed, Guilty, Eye-opener) suggests problematic drinking warranting further assessment.

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Pharmacy Practice, Law, and Patient Care flashcards FAQ