Pharmacy Law Ch. 1-10

Food, Drug, and Cosmetic (FDC) Act of 1938

Required proof of drug safety before marketing and authorized the FDA to oversee drug approval and labeling.

Food and Drug Administration Modernization Act (FDAMA) of 1997

Modernized the FD&C Act and expanded FDA authority over drugs, biologics, and devices.

Omnibus Budget Reconciliation Act (OBRA-90)

Required prospective drug use review and an offer to counsel Medicaid patients.

Controlled Substances Act of 1970

Established controlled substance schedules I-V and DEA oversight.

Tort

A civil wrong that causes injury or damage.

Malpractice

Professional negligence by a healthcare provider.

Misfeasance

Performing a lawful act improperly.

Misdemeanor

A less serious criminal offense punishable by fines or short jail terms.

Felony

A serious criminal offense punishable by more than one year in prison.

Four Ds of negligence

Duty, Dereliction, Direct cause, Damages.

FDA

Federal agency that ensures drugs are safe and effective.

DEA

Federal agency that enforces controlled substance laws.

Joint Commission

Independent organization that accredits healthcare facilities.

NABP

National Association of Boards of Pharmacy; supports boards and develops uniform standards.

USP

United States Pharmacopeia; sets official standards for medications and compounding.

Laws

Rules passed by legislative bodies.

Regulations

Rules written by agencies to enforce laws.

Standards

Professional expectations set by organizations like USP and Joint Commission.

RX Only

Federal legend indicating the drug requires a prescription.

Pharmacist role

Verifies prescriptions, performs DUR, counsels patients, and is legally responsible for dispensing.

Technician role

Assists with data entry, filling, billing, and inventory under pharmacist supervision.

Prescription requirements

Patient name, drug, strength, directions, quantity, prescriber information, date, and signature.

Prescription label requirements

Pharmacy name/address, Rx number, patient name, prescriber, directions, date, drug information, and cautions.

Medication error documentation

Record what happened, contributing factors, actions taken, and patient outcome.

Recalls

Removal of a product due to safety, efficacy, or quality concerns.

Class I recall

Reasonable probability of serious adverse health consequences or death.

Class II recall

Temporary or medically reversible adverse effects.

Class III recall

Not likely to cause adverse health consequences.

Controlled substance inventory

Complete at least every two years.

Medicare Part A

Hospital insurance.

Medicare Part B

Medical insurance for outpatient services.

Medicare Part C

Medicare Advantage plans.

Medicare Part D

Prescription drug coverage.

Medicare eligibility age

65 years old (or earlier with certain disabilities or ESRD).

Initial Enrollment Period (IEP)

7-month period starting 3 months before the 65th birthday month.

Medicare Open Enrollment

October 15 through December 7.

True out-of-pocket costs (TrOOP)

Costs paid by the patient that count toward Part D catastrophic coverage.

Donut hole

Coverage gap in Medicare Part D.

Medication Therapy Management (MTM)

Comprehensive medication review and interventions for eligible patients.

Formulary

List of covered drugs under an insurance plan.

Drug tiers

Levels of cost-sharing, from lower-cost generics to high-cost specialty drugs.

Six protected classes under Medicare Part D

Anticonvulsants, antidepressants, antineoplastics, antipsychotics, antiretrovirals, immunosuppressants.

Drugs not covered under Medicare Part D

Most OTC drugs, weight-loss drugs, fertility drugs, cosmetic drugs, and some vitamins.

Network pharmacy

Contracted pharmacy with lower member cost-sharing.

Out-of-network pharmacy

Noncontracted pharmacy with higher costs or no coverage.

Medicaid

Joint federal-state program for low-income individuals.

California Medicaid program

Medi-Cal.

Categorically needy

Individuals who qualify based on specific eligibility categories.

Medically needy

Individuals with high medical expenses who qualify after spend-down.

Medically indigent

Individuals unable to afford medical care but not otherwise eligible.

Controlled Schedule I

No accepted medical use and high abuse potential.

Controlled Schedule II

High abuse potential; no refills.

Controlled Schedule III

Moderate abuse potential; up to 5 refills in 6 months.

Controlled Schedule IV

Lower abuse potential; up to 5 refills in 6 months.

Controlled Schedule V

Lowest abuse potential.

Who must register with the DEA

Pharmacies, practitioners, manufacturers, distributors, and narcotic treatment programs.

DEA Form 224

Application for retail pharmacies and practitioners.

DEA Form 225

Application for manufacturers, distributors, importers, exporters, and researchers.

DEA Form 363

Application for narcotic treatment programs.

DEA Form 222

Used to order Schedule I and II controlled substances.

DEA Form 41

Used to document destruction of controlled substances.

DEA Form 106

Used to report theft or significant loss of controlled substances.

Schedule III-V expiration

Valid for 6 months from the date written for refills.

Schedule III-V refills

Up to 5 refills within 6 months.

Schedule V without prescription

Limited quantities may be sold without a prescription in some states.

Controlled drug label

Displays symbol such as C-II, C-III, C-IV, or C-V.

E-prescribing controlled substances

Permitted when DEA security requirements are met.

Protected Health Information (PHI)

Individually identifiable health information.

What PHI includes

Names, addresses, dates, identifiers, and health information.

Notice of Privacy Practices

Document explaining how PHI may be used and disclosed.

When PHI may be disclosed

For treatment, payment, healthcare operations, or as otherwise permitted by law.

EMR

Electronic Medical Record used within one practice or organization.

EHR

Electronic Health Record that can be shared across organizations.

ICD-10 code

Diagnosis code used for billing and documentation.

HCPCS code

Billing code for procedures, supplies, and services.

NDC

National Drug Code identifying labeler, product, and package size.

COBRA

Allows temporary continuation of employer-sponsored health insurance.

HIPAA Title I

Protects health insurance coverage during job changes.

HIPAA Title II

Sets privacy, security, and electronic transaction standards.

CMS

Centers for Medicare & Medicaid Services.

OIG

Office of Inspector General.

Department of Justice

Enforces federal laws including healthcare fraud laws.

Fraud

Intentional deception for unauthorized benefit.

Abuse

Practices resulting in unnecessary costs without intent to deceive.

OSHA

Occupational Safety and Health Administration.

Bloodborne pathogens

Infectious microorganisms in blood, such as HIV, HBV, and HCV.

Exposure to bloodborne pathogens

Wash area, report immediately, document, and seek medical evaluation.

Aseptic technique

Procedures used to prevent contamination.

MSDS/SDS

Safety Data Sheet with hazard information.

NFPA diamond colors

Blue-health, Red-flammability, Yellow-reactivity, White-special hazards.

Medical waste types

Solid, chemical, radioactive, infectious.

Radioactive waste

Waste containing radioactive materials requiring special disposal.

Accident report requirements

Who, what, when, where, witnesses, and actions taken.

Four steps to stop harassment

Tell the person to stop, document incidents, report to supervisor/HR, escalate if unresolved.

USP 795

Standards for nonsterile compounding.

USP 797

Standards for sterile compounding.

USP 800

Standards for handling hazardous drugs.

Minimum clean room classification for sterile compounding

ISO Class 7.

Supervising compounding responsibilities

Ensure training, quality control, documentation, and compliance.

When a pharmacy may not compound

When producing copies of commercially available products without a valid need or prescription.