NAPLEX domains 4 and 5 review 2025

selection bias

differences in baseline characteristics from flawed allocation/enrollment

performance bias

care/monitoring differences due to group awareness

detection bias

outcome assessment influenced by treatment knowledge

selection bias example

younger patients placed in treatment group, skewing outcome

performance bias example

experimental group gets more lab monitoring than control group

detection bias example

pain scores rated higher for patients on new drug

attrition bias

unequal dropout rates between groups

attrition bias example

more patients drop out from placebo group, overstating drug effect

reporting bias

selective reporting of positive outcomes

reporting bias example

secondary endpoint published; negative primary result omitted

recall bias

uneven accuracy in recalled data from patients

recall bias example

cancer patients better recall smoking than healthy controls

observer bias

assessor's beliefs influence measurement

observer bias example

researcher notes improvent they expect in treated group

publication bias

positive findings more likely to be published

publication bias example

only trials showing benefit submitted by sponser

autonomy

respecting a patient's right to self determination and informed decision making

Beneficence

acting to do good for patients

Nonmalfeasance

doing no harm; avoiding harm to patients

justice

fair and equitable treatment for all individuals

veracity

telling the truth and ensuring informed consent

fidelity

keeping promises and commitments to patients

bioethics

a study of moral dimensions (decisions, behavior, policies) in life sciences and healthcare

professionalism

adhere to all laws, avoid conflicts, maintain integrity

altruism

putting the patients interests above one's own

accountability

Taking responsibility for ones actions

excellence

commitment to lifelong learning

duty

serve and meet patient needs

honor and integrity

upholding honesty and fairness

respect for others

acknowledge other's dignity and beliefs

informed consent

patient agrees to treatment after receiving all facts

informed consent requirments

- disclosure: patient must be given adequate info on risks benefits and alternatives

- compensation: patient must understand the information

- voluntariness: consent must be given freely, without coercsion

- competency: the patient must have legal and mental capacity to decide

patient confidentiality

protect helath info under HIPAA and state law

disclose only with consent or to authorized personel

use discretion and secure record handling

ethical dilemmas

definition: conflicts between ethical principles

example: autonomy vs beneficence in medication refusal

resolution: use frameworks and consult ethics committees

paternalism

definition: overriding patient decisions for their benefit

types: hard (competent patient), soft (limited understanding)

ethical tip: educate and seek voluntary agreement

cultural competence

understand and interact effectively across cultures

avoid assumptoins and respect beliefs

adapt care to align with culture values and

end of life care

respect directives and DNR orders

promote comfort and deprescribe unneeded meds

support autonomy in treatment refusal

moral distress

definition: discomfort when unable to act ethically

causes: policy, hierarchy, fear of retalitation

hospital pharmacy management

formulary management & P&T committee: develops, reviews, and updates hospital formulary to ensure cost-effective and evidence-based medication use

centralized vs decentralized models: centralized involves a main pharmacy location; decentralized stations are closer to patient care areas

clinical pharmacy services: involves rounds, medication reconciliation, dosing services, and therapeutic drug monitoring

community pharmacy management

Daily operations and staff roles: Includes workflow management, technician oversight, and customer service.

Regulatory compliance (DEA, BoP): Adherence to controlled substances regulations and state board of pharmacy rules

Regulatory compliance (DEA, BoP): Adherence to controlled substances regulations and state board of pharmacy rules

pharmacy business planning

Business plan structure: Includes executive summary, market analysis, organizational plan, and financial projections.

SWOT analysis: Identifies strengths, weaknesses, opportunities, and threats

Break-even analysis: Determines when revenues will cover total fixed and variable costs

value-added services in pharmacy

Immunizations: Pharmacist-administered vaccines improve community access and public health

MTM and disease state management: Enhances medication adherence, optimizes therapy, and reduces costs

Home delivery and telepharmacy: Expands reach to underserved populations and improves continuity of care

risk management

Medication errors and mitigation: Includes system safeguards, barcode scanning, and error reporting

Liability insurance and risk assessment: Protects against malpractice and identifies areas for improvement

Documentation and incident reporting: Tracks errors/events to inform training and policy changes.

inventory management

Inventory turnover rate (ITR): Measures efficiency; higher rates often reflect optimal inventory use

Just-in-time (JIT) inventory: Reduces waste by receiving goods only when needed

Shrinkage, spoilage, and inventory audits: Regular checks help minimize loss and ensure accuracy

Third-Party Payers & Reimbursement

PBMs and payer contracts: Influence drug coverage, reimbursement, and formularies

MAC pricing, AWP, and reimbursement models: Determine reimbursement amounts based on cost benchmarks

DIR fees and their impact: Fees charged by PBMs that affect pharmacy reimbursement post-claim

PBMs (Pharmacy Benefit Managers)

Intermediaries that manage prescription drug benefits on behalf of insurers and employers. They negotiate drug prices, create formularies, and determine reimbursement to pharmacies. Contracts with PBMs dictate how much a pharmacy is paid per claim.

Payer Contracts

Legal agreements between pharmacies and PBMs or insurance companies. They set terms for reimbursement, drug coverage, claim submission, and audit compliance.

MAC Pricing (Maximum Allowable Cost)

A pricing benchmark that limits the amount paid for generic drugs. Pharmacies are reimbursed based on MAC values, which can vary between PBMs

AWP (Average Wholesale Price

A list price published by drug manufacturers; often referred to as a "sticker price." Used by payers to calculate reimbursements but typically overestimates true market price

WAC (Wholesale Acquisition Cost)

The manufacturer's list price to wholesalers, not including discounts. Often used as a benchmark for brand name drug reimbursement

DIR Fees (Direct and Indirect Remuneration)

Post-claim fees charged by PBMs to pharmacies based on performance metrics (adherence, cost savings, etc.). Often not disclosed upfront, these fees reduce the final reimbursement a pharmacy receives.

Equal employment opportunity

Prohibits workplace discrimination and ensures fair hiring practices

• Employee rights and safety (OSHA)

Regulations protect workers from hazards and promote safety

Conflict resolution and discipline

Policies for resolving disputes and enforcing professional conduct.

Workflow optimization

Streamlining dispensing processes to improve efficiency and reduce errors

Inventory and technology systems

Use of automation, EHR, and inventory software to manage stock

Legal and compliance oversight

Ensuring adherence to federal/state laws and institutional policies

class I recall

Reason: Product may cause serious health problems or death. Example: Contaminated injectable drug causing septic shock

Class I recall example

Contaminated injectable drug causing septic shock

class II recall

product may cause temporary or medically reversible health issues

Class II recall example

wrong dosage strength on label

class III recall

product not likely to cause harm, violates labeling/manufactuering standards.

class III recall example

minor packaging error or incorrect expiration date

managing drug shortages

monitor: monitor FDA and ASHP shortage bulletins regularly

communicate with providers regarding alternative therapies

update: formulary substitutions and alert staff

ethics

the discipline dealing with what is good and bad and with moral duty and obligation

ethics scenario

a pharmacist refusing to fill an Rx due to suspected misuse, guided by moral duty

bioethics scenario

deciding whether to provide a costly life saving medication under limited insurance coverage

autonomy scenario

honoring a patients to decline a recommended vaccination

Nonmalfeasance scenario

double checkign for drug interactions before dispensing a new prescription

beneficence scenario

recommending an evidence based therapy even if it requires more effort to obtain

justice scenario

ensuring equal access to care for insured and uninsured patients

veracity scenario

explaining potential side effects of a medication honestly before starting treatment

fidelity scenario

following up with a patient about a previously discussed medication issue

professionalism scenario

arriving on time, dressing appropriately, and maintaining respectful communication

Alutrism scenario

staying after hours to help a patient access emergency medciation

accountability scenario

reporting a dispensing error and taking corrective actions

excellence scenario

attending continuing education workshops beyond required credits

duty scenario

helping a confused patient understand how to take their medications correctly

honor and integrity scenario

refusing to alter records to protect a colleague

respect for others scenario

respecting cultural beliefs when discussing treatment options