Free PTCB PTCE Practice Exam with Questions & Answers | Set: 6

Alot numberis a unique identifier assigned to a specific batch of a medication during manufacturing.

TheNational Drug Code (NDC)andserial numberare different from the lot number.

On medication stock bottles, the lot number is often preceded by"(10)", which is present in this case:

(10)ABC123→This represents the lot number.

B. 55555444422→ This appears to be aGTIN (Global Trade Item Number), which identifies the product but is not the lot number.

C. 051526→ This could represent a manufacturer’s internal code or part of the packaging details, but not the lot number.

D. 11262026→ This follows the(21) identifier, which represents theexpiration date (November 26, 2026).

PTCB PTCE Exam Content Outline – Medication Labeling and Lot Numbers

FDA Drug Supply Chain Security Act (DSCSA)– Provides guidance on tracking drug batches.

USP Chapter <1079> Good Storage and Distribution Practices– Covers stock bottle labeling and identification.

Why Other Answers Are Incorrect?Pharmacy Technician References:

Vistaril = Hydroxyzine, anantihistamine used for anxiety, nausea, and allergies.

Meclizine (Antivert) is also an antihistaminebut is used primarily formotion sickness and vertigo.

????Reference:FDA Approved Drug List, PTCE Medication Guide.

Amlodipine (Norvasc)is acalcium channel blocker (CCB)used to treathypertension and angina. A common side effect of amlodipine isdizziness, which occurs due to itsvasodilatory effects, leading tolowered blood pressureandpotential orthostatic hypotension.

B. Photosensitivity→ Incorrect;photosensitivityis more commonly associated with drugs such astetracyclines, sulfonamides, and fluoroquinolones, not amlodipine.

C. Agitation→ Incorrect; amlodipine does not typically causeCNS agitation.

D. Insomnia→ Incorrect;amlodipine does not significantly affect sleep patterns.

Peripheraledema

Flushing

Fatigue

Other Answer Choices Explained:Additional Side Effects of Amlodipine:References:

PTCB PTCE Exam Content Outline (Pharmacology for Technicians – Cardiovascular System Drugs)

Lexicomp Drug Monograph for Amlodipine

Goodman & Gilman’s The Pharmacological Basis of Therapeutics

RCRA categorizes hazardous pharmaceutical waste into P-list, U-list, and D-list.

Cyclophosphamide is a U-listed hazardous waste because it is a chemotherapy drug known to be toxic to the environment.

Proper disposal is required to prevent contamination.

Why Other Options Are Incorrect:

A. Dorzolamide?❌Not hazardous, used for glaucoma.

B. Bicalutamide?❌An anti-androgen, but not U-listed.

C. Acetazolamide?❌A diuretic, not hazardous.

????Reference:EPA RCRA Drug Disposal Guidelines, USP <800> Hazardous Drug List.

ARisk Evaluation and Mitigation Strategy (REMS)program is required by theFDAfor certain medications that have serious safety concerns, ensuring their risks do not outweigh their benefits.Mycophenolateis subject to a REMS program due to its severe teratogenic effects.

(A) Sertraline❌Not Subject to REMS

Sertraline (Zoloft) is aSelective Serotonin Reuptake Inhibitor (SSRI)used to treat depression and anxiety.

While SSRIs can carry arisk of birth defects (such as persistent pulmonary hypertension in newborns - PPHN),sertraline is not included in the REMS program.

(B) Ondansetron❌Not Subject to REMS

Ondansetron (Zofran) is anantiemeticused to prevent nausea and vomiting.

While some studies suggest a possible increased risk of congenital defects, it isnot part of a REMS program.

(C) Montelukast❌Not Subject to REMS

Montelukast (Singulair) is aleukotriene receptor antagonist (LTRA)used forasthma and allergies.

It has aBoxed Warningfor mental health side effects butis not subject to a REMS program for pregnancy risks.

(D) Mycophenolate✅Correct – Subject to REMS

Mycophenolate (CellCept, Myfortic)is animmunosuppressantused to prevent organ rejection in transplant patients.

It carries ahigh risk of birth defects and miscarriage, making pregnancy preventionmandatorywhile taking the medication.

TheMycophenolate REMS Programrequires:

Mandatory counselingon pregnancy risks

Negative pregnancy testsbefore starting therapy

Use of effective contraceptionbefore, during, and after treatment

FDA REMS Program for Mycophenolate:https://www.mycophenolaterems.com/

FDA REMS Program Overview: https://www.fda.gov/drugs/risk-evaluation-and-mitigation-strategies-rems

PTCB Exam Content Outline – Medication Safety & Risk Management

Analysis of Answer Choices:References for Pharmacy Technicians:

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

Comprehensive and Detailed Step-by-Step Explanation:

Methotrexate is a hazardous antineoplastic drug listed by NIOSH (National Institute for Occupational Safety and Health). It requires PPE when handled or cleaned up.

????Explanation of Answer Choices:

✅C. Methotrexate → Correct. Listed as a hazardous drug requiring PPE.

❌A. Amiodarone → Incorrect. Not classified as hazardous.

❌B. Atorvastatin → Incorrect. A statin, not hazardous.

❌D. Midazolam → Incorrect. A benzodiazepine, not hazardous.

????Reference:

NIOSH List of Hazardous Drugs (2020)

USP <800>: PPE Requirements for Hazardous Drugs

Comprehensive and Detailed Step-by-Step Explanation:

Hazardous drugs (HDs)must be handled withpersonal protective equipment (PPE), including:

Gloves (chemotherapy-rated)

Gown (disposable, impermeable material)

Eye protection (if splashing risk exists)

Respirator (if airborne exposure is possible)

????Explanation of Answer Choices:✅B. Wearing personal protective equipment→Correct.USP <800> mandatesPPEfor handling hazardous drugs.❌A. In a chemical safety cabinet→ Incorrect.Only sterile hazardous drugs require a biological safety cabinet.❌C. Using disposable gloves washed between each use→ Incorrect.Disposable gloves should be discarded, not washed.❌D. In a positive-pressure clean room→ Incorrect.Hazardous drugs require negative pressure rooms, not positive pressure.

????Reference:

USP <800>: Hazardous Drug Handling

NIOSH Guidelines on PPE for Hazardous Drugs

Expired medications should first be reported to the wholesaler or manufacturer for return or replacement.

Reverse distributorshandlecontrolled substance disposalbut are not the first point of contact for expired non-controlled medications.

????Reference:DEA Medication Disposal Regulations, PTCE Inventory Management Guide.

Pharmacy staff should always visually inspect nonsterile compounds for signs of incompatibility to ensure medication safety and efficacy. The presence ofprecipitationis a key indicator of an incompatibility issue in nonsterile compounded preparations. Precipitation occurs when a solute (drug) comes out of solution, forming visible solid particles. This can result from changes in pH, solvent composition, or chemical interactions between ingredients.

A. Photolysis:

Decomposition of a drug due to light exposure, leading to color changes or potency loss, but it is not a physical incompatibility visible as precipitation.

B. Hydrolysis:

Chemical breakdown of a drug due to water, common in ester and amide-containing drugs, but not a visual incompatibility like precipitation.

D. Oxidation-Reduction:

A chemical reaction that may change drug color or effectiveness but does not typically lead to visible precipitation in nonsterile compounds.

Other Answer Choices Explained:References:

USP <795> Pharmaceutical Compounding—Nonsterile Preparations

PTCB PTCE Exam Content Outline (Medication Safety & Quality Assurance)

Remington: The Science and Practice of Pharmacy