Free PTCB PTCE Practice Exam with Questions & Answers | Set: 2

Risk Evaluation and Mitigation Strategies (REMS)areFDA-required programsto ensure that thebenefits of certain medications outweigh their risks. REMS programsrestrict prescribing, dispensing, and monitoringdue to the potential for serious side effects or misuse.

Suboxoneis used foropioid dependenceand containsbuprenorphine, apartial opioid agonist, which can causeaddiction, misuse, and respiratory depressionif used improperly.

REMS Requirements for Suboxone:

Prescriber Certification:Only specially certified providers can prescribe Suboxone.

Patient Education:Patients must be informed about the risks of misuse, overdose, and dependence.

Limited Dispensing:Pharmacists must ensure prescriptions meet REMS criteria before dispensing.

A. Xarelto (Rivaroxaban).→ Incorrect. While Xarelto is an anticoagulant, it isnot under REMS.

C. Warfarin.→ Incorrect. Warfarin requires monitoring butdoes not have a REMS program.

D. Haloperidol.→ Incorrect. Haloperidol is an antipsychotic, but itdoes not have a REMS program.

FDA REMS Program List (www.accessdata.fda.gov).

Suboxone REMS Guidelines (www.suboxonerems.com).

PTCB PTCE Exam Content Outline – REMS and Medication Safety.

Mosby’s Pharmacy Technician: Principles and Practice – REMS Regulations.

Why Is Suboxone (Buprenorphine/Naloxone) Under REMS?Why the Other Answer Choices Are Incorrect:Pharmacy Technician References:

During pregnancy, medication safety is classified by theFDA Pregnancy Categories(prior to 2015) or thePregnancy and Lactation Labeling Rule (PLLR)(current system).

Acetaminophen (Tylenol) is considered the safest analgesic for pregnant women, especially for treating mild to moderate pain or fever.

It hasno known teratogenic effectswhen used at recommended doses.

A. Isotretinoin❌→Severe risk in pregnancy (Category X / Contraindicated)

Causes severe birth defects(craniofacial, cardiac, and central nervous system malformations).

Requires enrollment in theiPLEDGE programto prevent pregnancy exposure.

C. Lovastatin❌→Not safe in pregnancy (Category X / Contraindicated)

Cholesterol-lowering statins are teratogenic, as fetal development requires cholesterol.

D. Triazolam❌→Not safe in pregnancy (Category X / Contraindicated)

A benzodiazepine that can cause birth defects, neonatal withdrawal syndrome, and CNS depression in the fetus.

FDA Pregnancy and Lactation Labeling Rule (PLLR)– Discusses medication risks in pregnancy.

American College of Obstetricians and Gynecologists (ACOG) Guidelines– Listsacetaminophen as the preferred pain reliever during pregnancy.

PTCB PTCE Exam Content Outline– Covers drug safety in special populations, including pregnancy.

Why Not the Other Options?Key References:

TheFDA classifies recalls into three levels, withClass III being the least severe:

Class I Recall→Most severe→ Issued when a drugmay cause serious harm or death.

Class II Recall→Moderate severity→ The drug may causetemporary or medically reversible adverse effects.

Class III Recall→Least severe→ The productis unlikely to cause harm but violates FDA regulations(e.g., labeling errors, minor packaging issues).

A. Is issued when there is a reasonable probability that the product will cause serious adverse health consequences or death.❌→Incorrect

Describes a Class I recall, not Class III.

B. Is initiated by the FDA if a manufacturer has violated the adulteration provisions of the Food, Drug, and Cosmetic Act (FDCA).❌→Incorrect

FDA action due to adulteration typically leads to Class I or Class II recalls, depending on severity.

C. Occurs when a product may cause temporary or medically reversible adverse health consequences.❌→Incorrect

Describes a Class II recall, not Class III.

FDA Drug Recall Guidelines– Defines Class I, II, and III recalls.

PTCB PTCE Exam Content Outline– Covers recall classifications and pharmacy responsibilities.

FDA Enforcement Report– Lists real-world examples of Class III recalls (e.g.,mislabeling, incorrect expiration dates).

Why Not the Other Options?Key References:

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:

Comprehensive and Detailed Step-by-Step Explanation:

TheInstitute for Safe Medication Practices (ISMP)is anon-profit organizationdedicated tomedication safetyanderror preventionthrougheducation, research, and advocacy.

????Explanation of Answer Choices:✅B. ISMP (Institute for Safe Medication Practices)→Correct.The ISMP providesmedication safety guidelines, high-alert drug lists, and error-prevention strategies.❌A. FDA (Food and Drug Administration)→ Incorrect. TheFDA regulates drug safetybut isnot a non-profit organization.❌C. DEA (Drug Enforcement Administration)→ Incorrect. TheDEA enforces controlled substance laws, not medication safety education.❌D. CDC (Centers for Disease Control and Prevention)→ Incorrect. TheCDC focuses on public health, not medication error prevention.

????Reference:

ISMP Official Website

PTCB Exam: Medication Safety & Risk Management

Cytotoxic agents are drugs that kill or damage cells, particularly rapidly dividing cells. They are primarily used in the treatment of cancer (chemotherapy) because cancer cells multiply quickly. These medications interfere with cell division (mitosis), leading to cell death.

According to Mosby’s Pharmacy Technician: Principles and Practice:

“Cytotoxic drugs are most commonly used in oncology. Their use requires special handling and storage protocols to protect healthcare workers and patients.”

Additional Notes:

Diabetes treatments involve insulin or oral antidiabetics, not cytotoxics.

Rosacea and allergies are treated with antimicrobials and antihistamines/steroids, respectively.

Prilosec (omeprazole) is a PPIused to reduce stomach acid forGERD and ulcers.

????Reference:FDA PPI Drug Classification Guide.

Comprehensive and Detailed Step-by-Step Explanation:

TheNational Drug Code (NDC)is a10- or 11-digit numberidentifying a drug'smanufacturer, product, and package size.

????NDC Format:

XXXXX−YYYY−ZZ\text{XXXXX} - \text{YYYY} - \text{ZZ}XXXXX−YYYY−ZZ

First 5 digits= Manufacturer

Middle 4 digits= Drug, strength, and formulation

Last 2 digits=Package size

✅A. Package size→Correct.Since the first two segments(00781-1506)are identical, the difference is in thelast segment, which representspackage size.❌B. Dosage→ Incorrect. Thedosage (mg strength) remains the same.❌C. Manufacturer→ Incorrect. Themanufacturer is the same (first 5 digits are identical).❌D. Strength→ Incorrect. Thestrength is unchanged.

????Reference:

FDA NDC Directory

PTCB Inventory Management Guidelines

Linagliptin is thegeneric name for Tradjenta, a medication used to treattype 2 diabetes mellitus.

Linagliptin is a DPP-4 inhibitor (Dipeptidyl Peptidase-4 Inhibitor).

Works byincreasing incretin levels, which boost insulin secretion and reduce glucagon levels.

Used tolower blood glucose levelsin patients with type 2 diabetes.

(A) Forteo❌Incorrect – Forteo (teriparatide) is for osteoporosis.

(B) Januvia❌Incorrect – Januvia (sitagliptin) is another DPP-4 inhibitor but not the same as Tradjenta.

(C) Tradjenta✅Correct – The brand name for linagliptin.

(D) Xarelto❌Incorrect – Xarelto (rivaroxaban) is an anticoagulant.

Tradjenta Prescribing Information (FDA):https://www.tradjenta.com

American Diabetes Association (ADA) – Pharmacologic Approaches to Diabetes Management:https://diabetesjournals.org

PTCB Exam Content Outline – Brand & Generic Name Drug Recognition

Drug Classification & Mechanism:Analysis of Answer Choices:References for Pharmacy Technicians:

Incompatibility in a nonsterile compound can be identified through various physical, chemical, and therapeutic changes.An unexpected change in odoris a key indicator of chemical instability, contamination, or degradation of a compounded preparation. Some ingredients may break down into volatile compounds, leading to noticeable odor changes.

A. A clear solution→ Incorrect; clarity alone does not indicate incompatibility.Some solutions may be clear but still chemically unstable.

B. The use of a pH buffer system→ Incorrect; buffer systems are used to maintain pH stability and prevent incompatibility rather than indicate it.

D. Suspension particles settling to the bottom of a container→ Incorrect; suspensions naturally settle and require shaking before use.This is not necessarily a sign of incompatibility.

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