Pharmacy Practice and Healthcare System Review (Lecture Notes)

A comprehensive set of practice flashcards covering professional identity, symbols, standards, drug naming, pharmacology basics, clinical trial processes, drug distribution, safety, law (federal and Kentucky), prescription requirements, and prescriber authorities.

What elements define pharmacy as a profession?

Specialized training, a service orientation, a unique body of knowledge, and societal authority.

What is the primary role of pharmacists?

To prevent, identify, and manage medication therapy problems (MTPs).

What guides the pharmacy profession ethically?

A set of values and ethics with an obligation to serve the best interests of patients and society.

What is the Bowl of Hygeia and what does it symbolize in pharmacy?

A symbol of pharmacy representing healing through medicine, linked to Hygeia, goddess of health.

From which country/mythology does the Bowl of Hygeia originate and when was it associated with pharmacy?

Greek mythology (Hygeia); associated with pharmacy since 1796.

When did the American Pharmacists Association adopt the Bowl of Hygeia as the profession’s symbol?

1964.

What is USP and what does it do?

United States Pharmacopeia; sets national standards for drug quality, purity, strength, and consistency.

When was USP established, and what areas do its standards cover?

Established in 1820; standards apply to medications, foods, and dietary supplements.

Name common types of medication-related problems.

Over-utilization or under-utilization; therapeutic duplication; drug-disease or drug-drug interactions; incorrect dosage or duration; drug-allergy interactions; clinical abuse/misuse.

What is health?

A state of complete physical, mental, and social well-being.

What is health equity?

All people have the opportunity to attain their full health potential, with no one disadvantaged by social position or circumstances.

Define Primary, Secondary, and Tertiary care.

Primary: first contact/general health maintenance; Secondary: specialist care often by referral; Tertiary: advanced, specialized care.

What does Medicare Part A cover?

Hospital insurance (inpatient care).

What does Medicare Part B cover?

Medical insurance (outpatient, doctor visits).

What does Medicare Part C (Medicare Advantage) provide?

Private plans covering A and B, often D.

What does Medicare Part D cover?

Prescription drug coverage.

Name the three major components of the U.S. healthcare system.

Patients (recipients of care), Payors (pay for care), Providers (deliver care).

Define Drug, API, Legend Drug, and Non-Prescription Drug.

Drug: substance for diagnosis/treatment/prevention; API: active ingredient; Legend drug: prescription-only; Non-prescription drug: OTC.

What is an orphan drug?

A drug that treats a rare disease (<200,000 people in the U.S.), eligible for incentives.

What is a limited distribution drug?

A drug available only through select pharmacies, often due to REMS.

What is a specialty drug?

High-cost, complex medications for serious conditions, often requiring special handling.

What are Chemical, Generic (Non-proprietary), and Brand (Proprietary) names?

Chemical name describes molecular structure; generic name is official; brand name is trademarked by the manufacturer.

What is the purpose of prefixes, infixes, and suffixes in drug names?

Prefix: unique identifier; infix: subclassification; suffix: indicates drug class or mechanism.

What are stereoisomer prefixes and what do they indicate?

rac-, ar-, es-, lev-/levo-, dex-/dextro-; indicate different stereoisomers.

Give examples of common drug-name suffixes and what they signify.

-afil (PDE-5 inhibitors); -statin (cholesterol-lowering); -prazole (proton pump inhibitors); -sartan (ARBs); -olol (beta-blockers); -vir (antivirals).

Outline the drug discovery and development process timeline.

Pre-clinical testing (lab/animal); Clinical trials (Phase 1 safety/dosage, Phase 2 efficacy/side effects, Phase 3 large-scale, Phase 4 post-marketing); FDA review and approval before marketing.

What are Phase 1, Phase 2, Phase 3, and Phase 4 trials focused on?

Phase 1: safety/dosage; Phase 2: efficacy/side effects; Phase 3: large-scale effectiveness and adverse reactions; Phase 4: post-marketing surveillance.

Who reviews drugs vs biologics in the FDA?

Drugs are reviewed by CDER; biologics by CBER.

Describe the typical flow of drug distribution from manufacturer to patient.

Manufacturer → Wholesaler → Pharmacy → Patient; money flows from payors/patients to pharmacies, then to wholesalers and manufacturers.

What does REMS stand for?

Risk Evaluation and Mitigation Strategies.

What is a PBM?

Pharmacy Benefit Manager; manages prescription drug benefits for payors.

What is the National Drug Code (NDC)?

A unique identifier for medications.

List the five steps in the medication use process.

Prescribing, Transcribing, Dispensing, Administration, Monitoring.

What is a medication error?

Any preventable event that may cause or lead to inappropriate medication use or patient harm; includes errors in prescribing, transcribing, dispensing, administration, and monitoring.

Name strategies to mitigate medication errors.

Obtain thorough patient history; clear, unambiguous communication; avoid dangerous abbreviations; use technology (electronic prescribing); educate patients.

What is ISMP and what does it do?

Institute for Safe Medication Practices; provides education/resources to prevent errors and publishes safety alerts and best practices.

Describe the three branches of the U.S. government and their roles.

Legislative: makes laws; Executive: enforces laws; Judicial: interprets laws.

Difference between statutes and regulations in pharmacy practice.

Statutes are laws enacted by legislatures; Regulations are rules to implement and interpret statutes.

Identify two federal statutes: the FDA’s main act and the CSA, and where they appear in the U.S. Code.

Food, Drug, and Cosmetic Act (FDCA): Title 21, Chapter 9; Controlled Substances Act (CSA): Title 21, Chapter 13.

Name the Kentucky statutes/regulations mentioned for pharmacy practice.

Kentucky Pharmacy Practice Act: KRS Chapter 315; Kentucky Food Drug and Cosmetic Act: KRS Chapter 217; Kentucky Controlled Substance Act: KRS Chapter 218A.

What other legal sources influence pharmacy practice besides statutes?

Ordinances (local laws) and Common law (court decisions).

What elements must a prescription include?

Date; patient’s name and address; drug name, strength, dosage form; quantity; directions; prescriber’s name, address, phone; DEA number for controlled substances; issued by an authorized practitioner within scope of practice.

Which Kentucky practitioners have full prescribing authority?

MD (Doctor of Medicine) and DO (Doctor of Osteopathy).

Which Kentucky practitioners have prescriptive authority in general (examples)?

DMD/DDS (dentists) for dental conditions; DPM (podiatrist) for foot/ankle; OD (optometrist) limited; APRN (advanced practice) with collaborative agreements; PA (physician assistant) under supervision; DVM (veterinarian) for animals.

What is the role of the Kentucky APRN in prescribing?

Prescribe within collaborative agreements.

What is the key concept of ‘prescription communication and required elements’ in Kentucky practice?

Prescriptions must include all required elements and be issued by an authorized prescriber.

What is the difference between statutes and regulations in practical terms for pharmacy?

Statutes establish broad legal authority; regulations provide the specifics on how to comply with statutes.

Why is the Bowl of Hygeia important to pharmacists today?

It serves as a long-standing symbol linking pharmacy to healing and health.

What is the role of the Institute for Safe Medication Practices (ISMP) in daily practice?

To educate and provide resources to prevent medication errors and to publish safety alerts and best practices.