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

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:

Pseudoephedrineis regulated under theCombat Methamphetamine Epidemic Act (CMEA)of 2005 due to its potential use in methamphetamine production.

It is availableover-the-counter (OTC) but behind the pharmacy counter, and its sale requires:

Proof of ID

Purchase limits (3.6 g per day, 9 g per month)

A log of purchases maintained by the pharmacy

Loratadine, acetaminophen, and naproxendo not have federal restrictions like pseudoephedrine.

????Reference:U.S.Combat Methamphetamine Epidemic Act (CMEA)of 2005.

Comprehensive and Detailed Step-by-Step Explanation:

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Explanation of Answer Choices:✅B. 10→Correct.❌A. 1→ Incorrect.1 tablet contains 100 mg, not 1000 mg.❌C. 100→ Incorrect.Overdose.❌D. 1000→ Incorrect.Severe overdose.

????Reference:

USP <795> Pharmaceutical Calculations

PTCB Dosage Conversions

USP <800> mandates that hazardous drug exposure requires immediate decontamination.

Flushing the affected area with large amounts of water for at least 15minutes is the first step.

For eye exposure, an eye wash station must be used immediately.

Why Other Options Are Incorrect:

A. Writing a report first?❌Incident reports should be done AFTER flushing the area.

B. Ice bag?❌Ice can worsen chemical burns.

C. Soapy water?❌Soap may react with chemicals, causing further irritation.

????Reference:USP <800> Hazardous Drug Handling, OSHA Chemical Safety Guidelines.

AClass III recallis issued whena drug is unlikely to cause adverse health effects but has a labeling defect, packaging issue, or a minor violation of manufacturing regulations.

Example:A bottle of tablets with a slightly misprinted label.

Pharmacies must remove affected stock but are NOT required to notify patients or physicians.

Why Other Options Are Incorrect:

A. Posting signs?❌Only required for certain urgent recalls.

C. Notifying physicians?❌Required forClass I and some Class II recalls, not Class III.

D. Contacting patients?❌Not needed fornon-health-threatening recalls.

????Reference:FDA Drug Recall Guidelines, PTCE Exam Study Guide.

TheNational Drug Code (NDC)is a10- or 11-digit numberthat uniquely identifies drugs in the U.S.

NDC format:

First set of numbers (Labeler Code):Identifies the manufacturer.

Middle set of numbers (Product Code):Identifies the specificdrug, strength, and dosage form(important for accurate product selection).

Last set of numbers (Package Code):Identifies the package size and type.

Why Other Options Are Incorrect:

A. Identification of therapeutic class?❌NDC codes do not indicate a drug’s therapeutic class.

B. Locating expired medication?❌Expiration dates are printed separately on the packaging.

C. Proper storage of the medication?❌Storage requirements are determined by themanufacturer’s label, not the NDC.

????Reference:FDA NDC Directory Guidelines, PTCE Exam Study Guide.

Comprehensive and Detailed Step-by-Step Explanation:

Corticosteroidsare a class of medications used toreduce inflammation.Fluocinoloneis atopical corticosteroidused foreczema, psoriasis, and allergic reactions.

????Explanation of Answer Choices:✅B. Fluocinolone→Correct.Fluocinolone is a corticosteroidused in skin conditions.❌A. Progesterone→ Incorrect.Progesterone is a hormone, not a corticosteroid.❌C. Methyltestosterone→ Incorrect.Methyltestosterone is an androgen (male hormone).❌D. Spironolactone→ Incorrect.Spironolactone is a potassium-sparing diuretic, not a steroid.

????Reference:

FDA Drug Classification Database

USP Drug Information Handbook

Therapy duration (length of treatment)must be specified, especially forantibiotics, to ensureappropriate treatment completion and prevent antibiotic resistance.

Typical duration for amoxicillin:

7–10 days for infections

5 days for strep throat

????Reference:CDC Antibiotic Prescribing Guidelines, PTCE Prescription Requirements.

Comprehensive and Detailed Step-by-Step Explanation:

Ahazardous drug spill kitisrequiredunderUSP <800>, which outlinessafe handling practices for hazardous drugs (HDs). The kit must contain:

Disposable scoop and scraper(to safely collect broken glass and contaminated material).

Absorbent pads or spill control pillows(for liquid spills).

Chemotherapy-rated gloves, gown, goggles, and mask(for protection).

A hazardous waste disposal bag(to properly dispose of contaminated materials).

????Explanation of Answer Choices:✅D. A disposable scoop for glass fragments→Correct.Adisposable scoop is essentialto safely removehazardous drug spills containing broken glass.❌A. Permeable, disposable protective garments→ Incorrect. PPE for hazardous drug spills must beimpermeable(e.g., coated gowns).❌B. Sufficient supplies to absorb a spill of about 10,000 mL→ Incorrect.Most spill kits are designed for smaller spills (≤1000 mL), not massive industrial spills.❌C. Reusable absorbent sponges or toweling→ Incorrect.All absorbent materials must be disposable to prevent contamination.

????Reference:

USP <800>: Handling Hazardous Drugs in Healthcare Settings

NIOSH List of Hazardous Drugs (2020 Update)

PTCB Exam: Medication Safety & Hazardous Drug Management

Naproxen (Aleve, Naprosyn) is a nonsteroidal anti-inflammatory drug (NSAID) used for pain and inflammation.

????Reference:FDA NSAID Safety Guidelines.