PHRM 591 Pharmacy Law & Ethics: California Regulations & Practice - Flashcards

Flashcards covering California regulatory bodies, licensure, scope of practice, key terms, and essential laws from the provided lecture notes.

What are the stakeholders in pharamcy

California State Board of Pharmacy, DEA, FDA, Prescribers, Pharmacists, Patients, Wholesalers, Vendors, Payers, Legislators, Joint Commission

What is CA Business & Professional Code (B&P 4000+)

A law enacted by the California State Legislature

What is Title 16 CA Code of Regulations (CCR 1700+)?

A body of state regulations, not laws, within the California Code of Regulations (CCR) that governs various professional and vocational fields. These regulations are established by specific state boards

What is the CA Health & Safety Code (H&S 11000+)?

A statutory law that codifies laws related to public health, safety, environmental law, and healthcare in California

What is the CA Civil Code (56–56.37)?

A collection of laws (statutes), not a regulation, that governs the general rights and obligations of individuals in California

Does the CA Civil Code (56–56.37) contain regulations?

No

Does the CA Civil Code (56–56.37) contain laws?

Yes

What is Title 22 CCR?

A collection of state regulations, not a law itself. It contains detailed rules and standards for health and safety. These regulations are enforced by various California government agencies, such as the Department of Public Health

Does Title 22 CCR contain laws?

Yes

Does Title 22 CCR contain regulations?

No

What is the U.S. Code & 21 CFR (Controlled Substances)?

Set of federal regulations, not a law, which provides the specific rules and requirements for industries regulated by the FDA. The regulations have the “force of law”

Does the U.S. Code & 21 CFR (Controlled Substances) contain laws?

No

Does the U.S. Code & 21 CFR (Controlled Substances) contain regulations?

Yes

What is Joint Commission Standards?

Neither a law nor a regulation itself, but rather a private, nonprofit organization that accredits healthcare organizations

What are the key organizations of standards of Practice?

State Boards of Pharmacy, NABP, APhA, ASHP, ACCP

What is the role of State Board of Pharmacy?

Governmental agency that set and enforces state-specific standards

What is the role of NABP?

National Association of Boards of Pharmacy; private coalition of all US Boards of Pharmacy; works toward a Model State Pharmacy Act.

What does NABP stand for?

National Association of Boards of Pharmacy

What is the role of APhA?

Professional association for pharmacists that advocates for the profession, provides education, and develops practice standards

What does APhA stand for?

American Pharmacists Association

What is the role of ASHP?

Professional association that supports pharmacists and pharmacy technicians, promotes patient care, and advances pharmacy practice.

What does ASHP stand for?

American Society of Health-System Pharmacists

What is the role of ACCP?

Professional association that focuses on clinical pharmacy practice, education, and research, supporting pharmacists in providing optimal patient care

What does ACCP stand for?

American College of Clinical Pharmacy

Name two professional associations and their general roles in pharmacy standards.

APhA (advocacy and policy influence) and ASHP (medication-use standards and clinical medication management).

What are the core principles for Pharmacy Standards of Care?

Patient-centered care, professional competence & lifelong learning, judgement & communication, safety & effectiveness, professionalism & ethics (beneficence, non-maleficence, confidentiality, and compliance with laws/regulations

What is Patient-centered care?

Delivers care for each patient’s needs and values

What is Professional competence & lifelong learning?

Maintains and enhances professional knowledge and skills through education and professional development activities

What is Judgment & communication?

Applies sound and inform judgement across all areas of practice

What is Safety & effectiveness?

Ensures safe and affection provision in medication and services

What is Professionalism & ethics (beneficence, non-maleficence, confidentiality)?

Demonstrates professional behavior, safeguarding patient confidentiality and privacy, and adheres to ethical principles like beneficence and non-maleficence

What is Compliance with laws/regulations?

Follows all applicable federal, state, and local laws and regulations in pharmacy practice

What is the primary regulator of pharmacy practice in California?

California State Board of Pharmacy (CABOP) - the main regulatory authority

When was California State Board of Pharmacy established?

1891

What is the California State Board of Pharmacy under?

Department of Consumer Affairs

When was the California State Board of Pharmacy became under Department of Consumer Affairs?

1971

How many people are part of the California State Board of Pharmacy?

13

How many pharmacists are part of the California State Board of Pharmacy?

7

How many non-pharmacists are part of the California State Board of Pharmacy?

6

What is the function of the California State Board of Pharmacy?

Adopt/enforces rules, licenses pharmacies and individuals; develop licensure exams, investigations & disciplinary actions against licensees who violated laws

What are the major California laws and codes that govern pharmacy practice?

CA Business & Professions Code (B&P 4000+); Title 16 CCR (Regulations); CA Health & Safety Code (H&S 11000+); CA Civil Code (56–56.37); Title 22 CCR; U.S. Code & 21 CFR; Joint Commission standards; Attorney General opinions & practice standards.

What are the California State Board of Pharmacy Inspectors?

Employees of the Board; Most are pharmacists; are authorized as law enforcement officers; May inspect, cite violations, and make arrests

Is the DEA healthcare providers?

No

What is the role of the DEA in pharmacy regulation?

Enforces controlled substances laws, registers and inspects entities handling these substances, prevents drug diversion, and shares drug-related intelligence.

What is Enforces controlled substance laws (Controlled Substances Act)?

Investigates and prepares cases against major drug trafficking organizations

What is Prevents drug diversion?

Registers and inspects businesses and medical professionals that handle these substances

What is Intelligence sharing & interagency coordination?

Collect, analyze, and disseminate drug-related intelligence to support investigations and provide information to policymakers, Works with federal, state, local, tribal, and foreign law enforcement partners on joint drug enforcement efforts

What is Regulates scheduling of drugs?

Uses Controlled Substances Act to add, remove, or change the schedule of a drug

What is Operates forensic labs?

Analyze evidence to support drug-related investigations

What is Demand reduction outreach programs?

Supports non-enforcement initiatives aimed at reducing the demand for illicit drugs, including outreach programs and educational campaigns

What does the FDA regulate and ensure in relation to pharmacy?

Regulates food, drugs, devices, cosmetics, tobacco, and radiation products; ensures safety and efficacy of drugs and vaccines.

What are the key laws under the FDA?

1906 Pure Food & Drug Act, 1938 FD&C Act (drug safety standards), 1962 Kefauver-Harris Amendments (effectiveness requirement), 1976 Medical Device Amendments, 2007 FDA Amendments Act, 2009 Tobacco Control Act

What is the Joint Commission?

A private, nonprofit organization that accredits healthcare organizations; not a government agency; sets quality and safety standards.

Administer

Direct application of a drug or device to a patient.

Furnish

Supply by any means (sale or otherwise) of a drug or device to a patient.

Dispense

Furnishing drugs upon prescription or order.

Pharmacy

A licensed area where pharmacy practice occurs, prescriptions are compounded, and controlled substances stored/dispensed.

Intern Pharmacist

Licensed student trainee.

Pharmacist

Licensed person under §4200.

Pharmacists-in-Charge

Ensures pharmacy compliance

Pharmacy Technician

Assists with nondiscretionary tasks

Dangerous Drug

Unsafe for self-use; “Rx only” legend

Nonprescription Drug

Safe for OTC use

Controlled Substance

Listed in H&S Code §11053+.opioids and abusable drugs

Chart Order

Order written in patient medical record.

Prescription

Oral/written/electronic order with patient & prescriber details

Who are examples of prescribers listed in CABOP's stakeholders?

MD, DDS/DMD, DVM, DPM, OD, ND, NP, PA, CNM (examples listed in notes).

What are the Intern Pharmacist License Terms?

1–6 yrs: whiles enrolled as a pharmacy student.; 2 yrs: graduate or foreign graduate.l 1 yr: exam retake after 4 failures (must re-enroll).; Extensions are possible if unable to complete requirements.

What are the types of Pharmacy Licenses?

Community/Outpatient (PHY); Hospital Pharmacy (4029); Hospital Satellite Compounding (4127.15); Sterile Drug Compounding (4127.1, 4127.2); Centralized Hospital Packaging (4128); Remote Dispensing Site (4130); Mobile Pharmacy Units (4110.5); Correctional Pharmacy (4021.5).

What is the Pharmacist Licensure requirements?

≥18 years of age; US Graduates: Graduate of ACPE-recognized or board approved pharmacy school; Graduates from out of the US: ≥150 semester units total (≥90 in pharmacy school) & ≥Baccalaureate degree in pharmacy; Applies to all 1,500 hours of pharmacy practice experience; Applied to all - Pass NAPLEX + CPJE (CA Practice Standards & Jurisprudence Exam).

What is the role of the Pharmacist-in-Charge (PIC) in CA?

Responsible for compliance with state and federal laws; oversees the pharmacy's operations.

What is the requirements for Intern Pharmacists to take the exams?

complete 1,500 practice hours

What is the Intern Pharmacist License Scope?

May perform all pharmacist functions under direct supervision; Limit: 1 pharmacist may supervise max 2 interns; “Direct supervision”: pharmacist on premises & aware of all activities (4023.5)

What is the CA Health & Safety Code primarily concerned with?

Public health, safety, environmental law, and healthcare in California.

What is an Intern Pharmacist and what are internship terms?

A licensed student trainee; typically 1–6 years; 1 year after graduation or foreign graduation; 1,500 practice hours; max 2 interns per supervising pharmacist; direct supervision; license terms vary.

What is Advanced Practice Pharmacist (APP) Authority and how is it earned?

Authority to perform advanced patient care activities; requires 2 of: specialty certification, postgraduate residency with 50% patient care, or ≥1 year clinical practice under a collaborative agreement; license valid 2 years with renewal and 10 hours CE.

What is the renewal requirement for CA pharmacists' CE?

Every 2 years; 30 CE hours; at least 2 hours in Law & Ethics (Board-provided); at least 1 hour in cultural competency; specialty CE for patient-care areas; addiction risk CE for Schedule II prescribers every 4 years (1 hour).

How often does a pharmacist need to renew their License for APP?

Every 2 years, with renewal requirements including continuing education.

What are the core duties of a pharmacist (per 1793.1)?

Prescription evaluation, patient counseling, supervising technicians/interns, interpreting patient records, exercising professional judgment.

What is the 'Duty to Consult' requirement?

Required for new prescriptions, different strengths/forms, or upon request; must include directions, precautions, warnings, and adherence importance.

What procedures are included in 'Permitted Procedures' for pharmacists?

Dispensing, compounding, consulting, transmitting prescriptions, furnishing to prescribers, administering drugs/vaccines.

What patient care services might a pharmacist provide?

Immunizations, contraception, opioid antagonists, nicotine replacement, travel medicine, and related services.

What duties do Pharmacy Technicians perform?

Assist with nondiscretionary tasks (counting, pouring, packaging, labeling); may administer vaccines if certified

What training do Pharmacy Technicians require?

240 hours of coursework plus final exam; background check and drug screening

What are the pharmacist-technician supervision ratios?

Base: 1 pharmacist to 1 technician; Expanded: 1 pharmacist to 2 technicians; Hospitals may use tech-check-tech under clinical pharmacy programs.

What are the requirements for Advanced Practice Pharmacist (APP)?

Active RPh license., Must meet 2 of: Specialty certification. & Postgraduate residency & ≥1 year clinical services under collaborative agreement; Recognition valid 2 years, renewable

What are the permitted tasks for Pharmacy Technicians?

Counting, pouring, packaging, labeling; Preparing/administering influenza & COVID-19 vaccines (if certified); Collecting CLIA-waived specimens; May not use professional judgment.

What is the Pharmacists Scope of Practice?

Receive oral prescriptions; Evaluate prescriptions & patient records; Provide consultations (1707.2); Supervise packaging/dispensing; Exercise professional judgment.

What must be included in Patient Consultations?

Directions for use/storage; Compliance importance; Common side effects, interactions, warnings; At Pharmacists discretion: Refill/missed dose information, Name and dosage form of medication

What is included in Expanded Roles for pharmacists (Administer, Furnish, etc.)?

Administer drugs/vaccines; furnish emergency contraception, naloxone, nicotine replacement, PrEP/PEP, COVID-19 meds; order/interpret drug-therapy labs.

What is a Collaborative Practice Agreement (CPA)?

An agreement allowing APP to initiate/manage chronic therapies under a collaborative framework.

What is 4050?

Pharmacy is a profession; pharmacists are health care providers

What is 4051?

Only pharmacists may dispense dangerous drugs

What is 733?

Pharmacists cannot obstruct access to legal prescriptions

What is 1744?

Drug warning label requirements (driving impairment, alcohol interactions)

What is 1261.6?

an “automated drug delivery system” means a mechanical system that performs operations or activities, other than compounding or administration, relative to the storage,
dispensing, or distribution of drugs

What is 4017.3?

An “automated drug delivery system” (ADDS) means a mechanical system that performs operations or activities,
other than compounding or administration, relative to the storage, dispensing, or distribution of drugs, An “automated unit dose system” (AUDS) is an ADDS for storage and retrieval of unit doses of drugs for administration to patients by persons authorized to perform these functions, An “automated patient dispensing system” (APDS) is an ADDS for storage and dispensing of prescribed drugs directly to patients pursuant to prior authorization by a pharmacist.

What is 4017?

"Authorized officers of the law" means inspectors of the California State Board of Pharmacy, inspectors of the Food and Drug Branch of the State Department of Public Health, and investigators of the department's Division of Investigation or peace officers engaged in official investigations.

What is 4023?

"Device" means any instrument, apparatus, machine, implant, in vitro reagent, or contrivance, including its components, parts, products, or the byproducts of a device, and accessories that are used or intended for either of the following

What is 11150?

No person other than a physician, dentist, podiatrist, or veterinarian, or naturopathic doctor acting pursuant to Section 3640.7 of the Business and Professions Code, or pharmacist acting within the scope of a project authorized under Article 1 (commencing with Section 128125) of Chapter 3 of Part 3 of Division 107 or within the scope of Section 4052.1, 4052.2, or 4052.6 of the Business and Professions Code