Pass the PTCB CPhT PTCE Questions and answers with ValidTests

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:

Methadone is a Schedule II controlled substanceunder theControlled Substances Act (CSA).

Pharmacies must useDEA Form 222orCSOS (Controlled Substance Ordering System)to orderSchedule II drugs.

Why Other Options Are Incorrect:

A. Buspirone?❌NOT a controlled substance(used for anxiety).

B. Nortriptyline?❌NOT a controlled substance(an antidepressant).

D. Sildenafil (Viagra)?❌NOT a controlled substance(used for erectile dysfunction).

????Reference:DEA Controlled Substance Ordering Requirements (21 CFR 1305).

TheNational Drug Code (NDC)is a unique 10- or 11-digit number assigned to each drug product in the U.S.Understanding how NDC numbers are structuredis key to answering this question correctly.

The NDC format is as follows:XXXXX-YYYY-ZZ

First segment (XXXXX)→Labeler (Manufacturer or Distributor)

Second segment (YYYY)→Product Code (Specific Drug, Strength, and Formulation)

Third segment (ZZ)→Package Size (Quantity in the Package)

How to Find the Correct Answer?The given NDC:76439-103-10

76439= Manufacturer/Labeler Code

103= Product Code (Specific Drug & Strength)

10= Package Size

To matchthe same medication, theManufacturer (76439) and Product Code (103) must remain the same. Only thepackage size (last segment) can change.

A. 76439-208-10❌→Incorrect

Product Code (208) does not match (103).

B. 76439-103-50✅→Correct

Same manufacturer (76439) and same drug (103), but different package size (50 instead of 10).

C. 74693-103-10❌→Incorrect

Different manufacturer (74693 instead of 76439).

D. 74693-206-50❌→Incorrect

Different manufacturer (74693) and different product code (206).

FDA NDC Directory– Provides details on NDC structure and product identification.

PTCB PTCE Exam Content Outline– Covers NDC interpretation and drug identification.

Drug Supply Chain Security Act (DSCSA)– Reinforces correct medication identification using NDC.

Analyzing the Answer Choices:Key References:

Comprehensive and Detailed Step-by-Step Explanation:

Cephalexin suspension (Keflex)is anantibioticthat must berefrigerated after reconstitutionanddiscarded after 14 daysto maintain stability and potency.

????Explanation of Answer Choices:✅D. Keep refrigerated; Discard after 14 days→Correct.Proper storage is2-8°C (36-46°F), with a 14-day shelf life.❌A. Protect from light; Discard after 7 days→ Incorrect.Refrigeration is required, not just light protection.❌B. Protect from light; Discard after 14 days→ Incorrect.Light protection is not a major concern for cephalexin.❌C. Keep refrigerated; Discard after 7 days→ Incorrect.Cephalexin is stable for 14 days, not just 7.

????Reference:

USP <795>: Beyond-Use Dating for Reconstituted Suspensions

FDA Drug Stability Guidelines

1 pint =473 mL(since 1 pint = 16 fluid ounces, and 1 fluid ounce = 29.5735 mL).A1% suspensionmeans1 g (1000 mg) of rifampin per 100 mLof suspension.

Total dose required:2 tbsp daily =30 mL per day(1 tbsp = 15 mL).

Total volume of the suspension:473 mL

Total rifampin required:(473 mL × 1000 mg) ÷ 100 mL =4730 mg

Each rifampin capsule contains300 mg.So,4730 mg ÷ 300 mg/capsule = 15.77 capsules, which rounds up to16 capsules.

Thus, the correct answer isC. 32 capsules(since the full pint must be compounded).

????Reference:Pharmacy compounding principles; PTCE study materials on dosage calculations.

Pantoprazole (Protonix)is aproton pump inhibitor (PPI)that isonly available by prescriptionfor treatingGERD, Zollinger-Ellison syndrome, and peptic ulcers.

Omeprazole (Prilosec), Lansoprazole (Prevacid), and Esomeprazole (Nexium)are availableOTC and by prescriptionin different strengths.

Prescription PPIsare typically higher strength than OTC versions.

????Reference:FDA Drug Approvals for OTC and Prescription PPIs.

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A medication'sstabilityrefers tohow well it maintains potency, effectiveness, and safety over time. Several factors candegrade medications, includingoxygen, moisture, temperature, and light.

Oxygen exposurecan causeoxidation, leading to drug degradation and loss of potency.

Many medications, especiallyvitamins (e.g., vitamin C), biologics, and certain antibiotics, are susceptible to oxidative damage.

Medications requiring protection from oxygen are often packaged inair-tight containersorblister packs.

A. Allergies→ Incorrect; allergies affect thepatient, not the drug’sstability.

B. Equivalence→ Incorrect; equivalence refers tobioavailabilitybetween generic and brand-name drugs, not drug stability.

D. Indications→ Incorrect; indications refer toapproved uses of a drug, not factors affecting its stability.

Other Answer Choices Explained:References:

USP <797> and <795> Guidelines on Medication Stability

FDA Drug Stability and Shelf Life Guidelines

PTCB PTCE Exam Content Outline (Medication Storage & Stability)

Comprehensive and Detailed Step-by-Step Explanation:

MedWatchis theFDA's Safety Information and Adverse Event Reporting Program, used totrack drug and device safety concerns.Pharmacists and healthcare professionals should report:

Adverse drug reactions (ADRs).

Medical device failures or malfunctions.

Medication errors that lead to harm.

Product quality issues related to safety.

????Explanation of Answer Choices:✅D. Medical device malfunctions→Correct.MedWatch monitors medical device safety, including pacemakers, insulin pumps, and inhalers.❌A. Medication reimbursement complaints→ Incorrect.Billing and insurance issues are not handled by MedWatch.❌B. Damaged medications received from a wholesaler→ Incorrect.These issues should be reported to the wholesaler or manufacturer, not MedWatch.❌C. Complaints about pharmacy staff→ Incorrect.These concerns should be reported to the state board of pharmacy.

????Reference:

FDA MedWatch Program

PTCB Exam: Medication Safety & Reporting

Intradermal (ID) injectionsare deliveredinto the dermis (just below the epidermis).

Used forallergy testing, tuberculosis (TB) testing, and some vaccines.

Theneedle angle is 10–15 degrees, and only asmall volume (0.1 mL – 0.5 mL)is injected.

Why Other Options Are Incorrect:

A. Intraperitoneal?❌Injected into theperitoneal cavity, used in animal research.

B. Intravenous (IV)?❌Injected into aveinfor rapid drug action.

C. Intramuscular (IM)?❌Injecteddeep into the muscle(e.g., vaccines, pain medications).

????Reference:CDC Injection Guidelines, PTCE Exam Study Guide.

Chemotherapy drugs (e.g., methotrexate, cisplatin)arehigh-alertdue to theirtoxicity, risk of overdose, and narrow therapeutic index.

????Reference:ISMP High-Alert Medication List, PTCE Study Materials.