Pharmacy Ethics, Management, and Leadership

autonomy

respecting a patient's right to self-determination

beneficiance

acting to do good for patients

Non-malfeasance

do 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

professionalism

adhere to laws, avoid conflicts, maintain integrity

excellence

commitment to lifelong learning

duty

serve and meet patients needs

honor and integrity

upholding honesty and fairness

respect for others

acknowledge others' dignity and beliefs

informed consent

Patient's agreement to treatment after receiving all facts and understanding risks.

requirements for informed consent

- Disclosure: patients must be given adequate info on risks, benefits, and alternatives

- Comprehension: patient must understand the info

- Voluntariness: consent must be given freely without coercion

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

Paternalism

overriding patient decisions for their benefit

can be hard (competent patient) or soft (limited understanding)

Altruism

putting the patient's interests above one's own

centralized vs decentralized pharmacy models

centralized involves a main pharmacy location

decentralized stations are closer to patient care areas

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 & disease state management: enhances adherence, optimizes therapy, and reduces costs

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

inventory turnover rate

measures efficiency; higher rates often reflect optimal inventory use

Just-in-time inventory

reduces waste by receiving goods only when needed

What methods are used as regular checks to help minimize inventory loss and ensure accuracy

Shrinkage, spoilage, and inventory audits

Pharmacy benefit managers

Intermediaries managing prescription drug benefits

they negotiate prices, create formularies, and determine reimbursement to pharmacies

payer contracts exist as a legal agreement between PBMs and pharmacies or insurances

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

Class I Recall

product may cause serious health problems or death

Class II Recall

product may cause temporary or medically reversible health issues

Class III Recall

product not likely to cause harm, but violates labeling/manufacturing standards

How must pharmacies respond to a drug recall

- remove affected products from shelves immediately

- notify patients and prescribers if applicable

- document actions taken

How should a pharmacy manage drug shortages

- MONITOR: monitor FDA & ASHP shortage bulletins regularly

- COMMUNICATE: communicate with providers regarding alternative therapies

- UPDATE: update formulary substitutions and alert staff

Preceptor Feedback Techniques

Feedback should be structured, timely, and actionable. Effective feedback is behavior-focused and private.

Delegation principles for preceptors

- only delegate tasks within legal scope and job descriptions

- for example, technicians may label, count, or fill, but NOT counsel or make clinical decisions

Preceptor responsibilities

- Guide, evaluate, and support student development.

- Address mistakes as opportunities for learning

What biases are prevalent in the trial planning stage

sampling bias and selection bias

Sampling bias

occurs when the participants selected are not representative of the whole population

Selection bias

occurs when there are baseline differences between the study groups that prevent the groups from being comparable and generalizable

can result from lack of randomization or strict exclusion criteria

What types of biases are prevalent in the trial implementation phase

Performance, detection, and attrition bias

Performance bias

occurs when the study groups are not treated equally

ex: treatment group receives a different level of care and attention in an unblinded study

Detection bias

occurs when outcomes are measured differently between the study groups

avoid by blinding researchers

Attrition bias

occurs when study participants with specific characteristics have a higher dropout rate, skewing the results of the study

Reporting bias

occurs when the decision to report on a finding is influenced by the result

ex: reporting positive efficacy results more than adverse event data

Publication bias

occurs when only research with positive results is published

Recall bias

uneven accuracy in recalled data from participants

ex: cases can remember exposure data better than controls

single-blind study

participant blinded, investigator aware

Emergency use authorization

allows temporary use of unapproved drugs in public health emergencies based on early evidence of benefit being greater than risk

fast track designation

accelerates development for drugs treating serious conditions with unmet needs

Phase I Clinical Trial

assesses safety, dosage, and PK in a small amount of healthy volunteers

Phase II clinical trials

evaluate efficacy and further assess safety in 100-300 patients with the targeted condition

Phase III clinical trials

confirm efficacy and monitor for adverse effects in large, diverse populations (hundreds to thousands of patients)

Phase IV clinical trial

post-marketing surveillance for long-term safety or new indications