PTCB PTCE - Pharmacy Technician Certification (CPhT) Exam

📌Reference:USP <797> Sterile Compounding Guidelines.

Apidra (insulin glulisine)is arapid-acting insulinthat must bestored between 36°F and 46°F (2°C to 8°C)in the refrigerator. If frozen,it is no longer usableand shouldnever be thawed or dispensed. The best course of action is toreturn it to the distributorto ensure medication integrity and patient safety.

A. Thawed and stored in a refrigerator→ Incorrect;frozen insulin loses its potencyand shouldnot be used.

B. Sent to the prescriber→ Incorrect; the prescriber does not handle medication storage or replacements.

C. Dispensed to a patient→ Incorrect;frozen insulin is ineffectiveand could harm the patient.

Other Answer Choices Explained:References:

FDA Insulin Storage and Handling Guidelines

USP <797> Sterile Preparations – Storage Conditions

Manufacturer Storage Requirements for Apidra (Sanofi-Aventis)

In prescription terminology,"troche" refers to a dosage form, specifically alozengethat dissolves slowly in the mouth to release medication.

Atroche (or lozenge)is asolid, flavoredmedication thatdissolves in the mouthover time, allowing for gradual drug absorption.

Used for:

Local effects(e.g., sore throat relief with benzocaine troches)

Systemic effects(e.g., hormone replacement therapy troches)

A. Time❌→ Incorrect

"Troche" doesnotindicate when to take the medication.

C. Rate❌→ Incorrect

"Troche" doesnotindicate how fast the drug is absorbed.

D. Route❌→ Incorrect

"Troche"describes the dosage form, whilerouterefers to how a drug is administered (e.g., oral, IV).

USP-NF (United States Pharmacopeia–National Formulary)– Defines dosage forms, including lozenges/troches.

PTCB PTCE Exam Content Outline– Covers pharmaceutical dosage forms and prescription terminology.

ISMP Medication Safety Guidelines– Includes troches in standard medication formulations.

Definition of Troche:Why Not the Other Options?Key References:

NSAIDs (e.g., ibuprofen, naproxen, aspirin) can irritate the gastric mucosa, increase gastric acidity, and worsen GERD symptoms or cause GI adverse effects such as dyspepsia and ulceration. Acetaminophen does not have NSAID gastric effects and is the preferred OTC analgesic/antipyretic for patients with GERD or those at risk for GI complications, when appropriate and within dosing limits.

AMaster Formulation Record (MFR)is adetailed document used in compounding pharmaciesto ensureconsistency, accuracy, and quality controlin preparing compounded medications.

An MFR includes:

Ingredients & amounts required.

Compounding procedures.

Stability and beyond-use dating (BUD).

Storage and labeling instructions.

This ensures that each compounded preparationmeets quality standardsand ismade correctly every time.

B. Prevent drug diversion❌→Incorrect

Drug diversion prevention involves security measures, inventory control, and trackingcontrolled substances, not MFRs.

C. Eliminate patient profiles❌→Incorrect

Patient profiles are essential for tracking medication history; MFRs are unrelated.

D. Guarantee drug availability❌→Incorrect

MFRs do not affect drug supply; they ensure accurate compounding.

USP <795> (Non-Sterile Compounding Guidelines)– RequiresMaster Formulation Records for all compounded preparations.

PTCB PTCE Exam Content Outline– Covers compounding procedures and quality control measures.

Why Not the Other Options?Key References:

Beyond-use dates (BUDs) apply specifically to compounded medicationsand indicate thetime frame in which the medication remains stable and safe to use.

BUDs are different from expiration dates, which are determined by manufacturers through long-term stability testing.

USP <795> BUD Guidelines for Nonsterile Compounds:

Non-aqueous formulations(e.g., capsules, powders) →6 months

Water-containing oral formulations(e.g., suspensions) →14 days (refrigerated)

Water-containing topical formulations(e.g., creams, lotions) →30 days

Why Other Options Are Incorrect:

B. Manufactured preparation expiration dates?❌Expiration dates apply tocommercially manufactured drugs, NOT compounded ones.

C. Shelf-life of manufactured drugs?❌This is determined by themanufacturer’s expiration date.

D. Time to prepare a compound?❌BUDsdo not refer to preparation time.

📌Reference:USP <795> & USP <797> Guidelines, PTCE Compounding Study Materials.

• In medication safety terminology used across pharmacy technician study materials and safety taxonomies, an adverse event (specifically, a preventable adverse drug event) occurs when a medication error reaches the patient and results in harm or has the clear potential for harm (e.g., incorrect patient’s medication taken for several doses).

• By contrast, near misses (or “close calls”) are errors that are intercepted before they reach the patient, such as when a pharmacist catches incorrect directions during counseling (Option A), when a technician detects that a prescription was bagged but not yet verified (Option C), or when a technician finds a prescription placed in the wrong will-call bin before pickup (Option D). These represent process breakdowns with potential for harm but no patient exposure once intercepted.

• Therefore, the scenario most likely to lead to an adverse event is Option B, where the patient has already ingested medication intended for another patient. That constitutes an error that reached the patient, with a meaningful risk of harm, aligning with definitions for preventable adverse drug events.

References (Pharmacy Technician documents/Study Guides):

• NCC MERP (National Coordinating Council for Medication Error Reporting and Prevention) Taxonomy and definitions on medication errors, near misses, and events reaching the patient.

• ISMP (Institute for Safe Medication Practices) medication safety terminology and event classification used in community and institutional pharmacy practice.

• PTCB/ExCPT-aligned Pharmacy Technician Certification study guides: sections on medication safety, event reporting, and error prevention (definitions of “adverse event,” “medication error,” and “near miss/close call”).

• ASHP guidelines on preventing medication errors in community pharmacy workflows (verification steps, counseling interception points, and will-call bin best practices).

Comprehensive and Detailed Step-by-Step Explanation:

Mycophenolateis animmunosuppressantused inorgan transplantsand isteratogenic (causes birth defects).It requiresRisk Evaluation and Mitigation Strategies (REMS).

📌Explanation of Answer Choices:✅B. Mycophenolate→Correct.High risk ofbirth defects, requiring REMS.❌A. Miconazole→ Incorrect.An antifungal with no REMS requirement.❌C. Phentermine→ Incorrect.Used for weight loss, not teratogenic.❌D. Phenytoin→ Incorrect.Has risks but no REMS requirement.

📌Reference:

FDA REMS Program for Mycophenolate

PTCB Exam: Medication Safety & REMS

Prochlorperazine (Compazine suppository)requiresrefrigeration(store at2°C to 8°C / 36°F to 46°F) to maintain stability.

Other suppositories are stored atroom temperatureunless specified.

📌Reference:Manufacturer Storage Guidelines, USP Storage Standards.

To determine theweight/weight (w/w) percentage strength, use the formula:

\text{w/w % strength} = \left( \frac{\text{Mass of Active Ingredient (g)}}{\text{Total Mass of Final Product (g)}} \right) \times 100

Given:

Mass of zinc oxide (active ingredient) = 4.5 g

Total mass of final ointment = 30 g

\text{w/w % strength} = \left( \frac{4.5}{30} \right) \times 100 =0.15×100= 0.15 \times 100=0.15×100 =15%= 15\%=15%

(A) 0.25%❌Incorrect – This is too low.

(B) 10%❌Incorrect – This would be true if 3 g of zinc oxide were used in 30 g total.

(C) 15%✅Correct – The calculation confirms this answer.

(D) 17.5%❌Incorrect – This would be true if 5.25 g of zinc oxide were used in 30 g total.

Pharmaceutical Calculations, 15th Edition– Howard C. Ansel

The United States Pharmacopeia (USP) Chapter <795>– Compounding Non-Sterile Preparations

PTCB Exam Content Outline – Pharmaceutical Calculations

Analysis of Answer Choices:References for Pharmacy Technicians: