PTCB Comprehensive Pharmacy Practice Review

Vocabulary practice flashcards covering pharmacy laws, DEA regulations, high-alert drugs, compounding standards, and clinical safety concepts from the PTCB review deck.

DEA Form 222

The official Drug Enforcement Administration form required to order or transfer Schedule II controlled substances between registrants.

DEA Form 106

The DEA form required to report the theft or significant loss of controlled substances.

DEA Form 41

The DEA form used to document the destruction of controlled substances with DEA approval.

DEA Form 224

The application form required for a pharmacy or provider to obtain initial registration to dispense controlled substances.

Kefauver-Harris Amendment of 1962

A federal law requiring drug manufacturers to prove both drug safety and effectiveness prior to FDA approval and marketing.

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

Federal legislation requiring proof of drug safety before marketing and mandating patient package inserts for medications such as oral contraceptives.

Durham-Humphrey Amendment of 1951

An amendment that established the formal legal distinction between prescription (legend) drugs and over-the-counter (OTC) medications.

Controlled Substances Act (CSA) of 1970

Federal law that established the DEA, categorized scheduled drugs into five schedules, and authorized prescribers to issue multiple Schedule II prescriptions with future "do not fill until" dates.

Poison Prevention Packaging Act (PPPA)

Federal legislation mandating child-resistant packaging for most prescription drugs to prevent accidental ingestion by children.

OBRA-90

Federal statute requiring pharmacists to perform prospective drug utilization review (DUR) and offer patient counseling for Medicaid patients.

HIPAA

Health Insurance Portability and Accountability Act; protects the privacy and security of protected health information (PHI), mandates breach notification, and requires minimum necessary disclosure.

Drug Supply Chain Security Act (DSCSA)

Federal legislation requiring serialization and tracing of prescription drug products throughout the pharmaceutical supply chain.

USP

The United States Pharmacopeia chapter establishing practice standards for non-sterile compounding, personnel hygiene, facility controls, and default beyond-use dating.

USP

The United States Pharmacopeia chapter governing standards and procedures for sterile compounding facilities, environmental quality, garbing, and personnel technique.

USP

The United States Pharmacopeia chapter establishing safety standards for handling hazardous drugs to protect personnel, patients, and the compounding environment.

First Air

Unidirectional, unobstructed HEPA-filtered air direct from the filter face to critical compounding sites within a laminar airflow workbench or isolator.

ISMP

The Institute for Safe Medication Practices; publishes error-prevention guidelines, look-alike/sound-alike lists, and the official "Do Not Crush" list.

OSHA

The Occupational Safety and Health Administration; enforces workplace safety standards, including hazardous drug handling safety and needle recapping restrictions.

NIOSH

The National Institute for Occupational Safety and Health; issues the official hazardous drug list referenced under USP

Tall-Man Lettering

A visual safety strategy capitalizing unique or distinctive letter segments in look-alike/sound-alike drug names to prevent dispensing mix-ups.

National Drug Code (NDC)

A unique identifier formatted into three segments: labeler/manufacturer (first segment), product strength and dosage form (middle segment), and package size (third segment).

DAW 1

A dispense as written code indicating "no substitution permitted—brand medically necessary" as specified by the prescriber.

Schedule II Refill Restriction

Under federal law, prescriptions written for Schedule II controlled substances are prohibited from receiving any refills ($0\text{ refills}$ allowed).

Schedule III and IV Refill Limits

Under federal law, prescriptions for Schedule III or Schedule IV substances may be refilled up to $5\text{ times}$ within a maximum period of $6\text{ months}$.

Schedule II Partial Fill Rule

If a pharmacy has insufficient stock to dispense a full Schedule II prescription, a partial fill is permitted, but the remaining balance must be filled within $72\text{ hours}$.

High-Alert Medication

A medication that bears a heightened risk of causing significant patient harm when used in error, exemplified by narrow therapeutic index drugs such as warfarin.

Disulfiram-Like Reaction

A severe reaction involving nausea, vomiting, flushing, and abdominal distress resulting from the ingestion of alcohol while taking metronidazole.

Serotonin Syndrome

A life-threatening excess of serotonergic activity caused by combining SSRIs (like sertraline or fluoxetine) with MAOIs, linezolid, St. John's Wort, or dextromethorphan.

Red Man Syndrome

An adverse reaction characterized by flushing, erythema, and hypotension caused by administering intravenous vancomycin too rapidly.

iPLEDGE Program

A mandatory Risk Evaluation and Mitigation Strategy (REMS) program requiring negative pregnancy testing and patient enrollment before dispensing teratogenic isotretinoin.

Clozapine REMS

A mandatory safety registry that monitors absolute neutrophil count (ANC) at regular intervals to mitigate the severe risk of agranulocytosis.

"qd"

An unsafe abbreviation meaning "every day" that is prohibited because it can be misread as "qid" (four times daily); the word "daily" must be written instead.

"MSO4"

An error-prone abbreviation intended for morphine sulfate that can be dangerously confused with magnesium sulfate; prescribers must be contacted for clarification.

"U"

A prohibited abbreviation for "units" that can be misread as "0" or "4," resulting in potentially fatal ten-fold overdoses; "units" must always be written in full.

"QOD"

An unsafe abbreviation for "every other day" that is prone to misinterpretation; must always be written out in full to avoid dosing errors.

Near-Miss Capture Rate

A Continuous Quality Improvement (CQI) metric measuring dispensing accuracy by quantifying potential medication errors caught before reaching the patient.

BCMA

Bar Code Medication Administration; an electronic bedside verification system designed to ensure the "five rights" by scanning patient wristbands and medication packages.

One-Hand Scoop Method

The only acceptable technique for recapping a contaminated needle when recapping is strictly necessary, utilized to avoid accidental needlestick exposure.

BUD for Non-Aqueous Formulations (USP

The default beyond-use date for non-aqueous oral formulations (such as powders or capsules) prepared without stability data is $6\text{ months}$ at room temperature.

BUD for Water-Containing Oral Formulations (USP

The default beyond-use date for water-containing oral liquids prepared without stability data is $14\text{ days}$ when stored under refrigeration.

BUD for Water-Containing Topical Formulations (USP

The default beyond-use date for water-containing topical gels, creams, or ointments prepared without stability data is $30\text{ days}$ at room temperature.

HEPA Recertification Interval

Laminar airflow workbenches must undergo HEPA filter certification every $6\text{ months}$, or immediately after relocation or repair service.

Sterile Compounding Garbing Sequence

The order of donning protective wear before entering the buffer area: Shoe covers → Hair cover → Face mask → Hand/forearm wash → Gown → Sterile gloves.

C-SEC Pressure Requirements (USP

Containment secondary engineering controls used for compounding hazardous drugs must maintain negative pressure relative to adjacent areas and be externally vented.

Levothyroxine Administration

A thyroid hormone replacement that must be taken in the morning on an empty stomach with water to optimize absorption.

Atorvastatin Administration

An HMG-CoA reductase inhibitor typically taken in the evening or at bedtime to align with nocturnal peaks in hepatic cholesterol synthesis.

Warfarin Dietary Consistency

Patients receiving warfarin must maintain a stable, consistent intake of vitamin K-rich foods (e.g., green leafy vegetables) to preserve stable INR levels.

Warfarin and Amiodarone Interaction

A drug interaction where amiodarone inhibits warfarin metabolism, elevating serum warfarin concentrations and significantly increasing bleeding risk.

Lithium and NSAID Interaction

Concomitant administration of an NSAID (e.g., ibuprofen) reduces renal clearance of lithium, leading to increased serum levels and lithium toxicity.

Fluoroquinolone Warnings

A class of antibiotics (such as ciprofloxacin and levofloxacin) carrying boxed warnings for tendon rupture, requiring caution with polyvalent cations, and causing photosensitivity.

Aminoglycoside Toxicities

Classic adverse effects of aminoglycoside antibiotics (such as gentamicin), notably permanent ototoxicity (hearing loss) and nephrotoxicity (renal impairment).

Phenelzine and Tyramine Interaction

Ingestion of tyramine-rich foods during monoamine oxidase inhibitor (MAOI) therapy prevents tyramine breakdown, precipitating a dangerous hypertensive crisis.

Digoxin Toxicity Sign

A distinctive clinical manifestation of digitalis toxicity characterized by visual disturbances, especially yellow-green halos around lights.

Dose Dumping

The rapid and unintended gastrointestinal release of an entire drug formulation triggered by crushing or chewing extended-release or enteric-coated dosage forms.

Phenytoin and Enteral Feeding Precaution

Enteral tube feeds bind phenytoin suspension and reduce absorption; feeding must be held $1\text{ to }2\text{ hours}$ before and after dosing.

U-500 Regular Insulin

A concentrated regular insulin formulation containing $500\,\text{units/mL}$ (5 times standard U-100), requiring dedicated syringes or volume calculation to prevent severe overdose.

SIG Code: "HS"

A prescription sig abbreviation derived from the Latin phrase "hora somni," directing the patient to take the medication "at bedtime."

Dispensing Error

Any discrepancy during pharmacy fulfillment where an incorrect drug, dosage form, strength, or quantity is supplied to the patient or hospital floor.

Minimum Necessary Disclosure

A HIPAA privacy principle requiring healthcare personnel to disclose only the minimum amount of protected health information needed to fulfill treatment or payment requests.

Hazardous Spill Response Protocol

Under USP