PTCB Updated PTCE Exam Questions and Answers by asa

Risperdal Consta (risperidone long-acting injection) is an antipsychotic medication used to treat schizophrenia and bipolar disorder. It is supplied as a powder that must be reconstituted with a diluent before administration as an intramuscular (IM) injection.

According to the manufacturer’s storage guidelines:

Refrigeration Requirement:Risperdal Consta should be stored in a refrigerator (36°F to 46°F or 2°C to 8°C) to maintain stability.

Room Temperature Stability:If removed from refrigeration, Risperdal Consta can remain stable at room temperature (≤77°F or 25°C)for up to 14 days. After this period, the product should not be used if it has not been administered.

This stability information is critical for pharmacy technicians handling the medication, as it ensures proper storage and prevents medication degradation, which can affect efficacy and safety.

Risperdal Consta (Janssen Pharmaceuticals) Prescribing Information– Official manufacturer guidelines.

PTCB PTCE Exam Content Outline – Medication Storage and Stability– Covers best practices for proper drug storage and handling.

United States Pharmacopeia (USP) Standards– Guidelines on temperature control for pharmaceutical products.

Pharmacy Technician References:This information is essential for pharmacy technicians preparing Risperdal Consta for dispensing or administration, ensuring compliance with manufacturer and regulatory guidelines.

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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)

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:

The NDC number (National Drug Code) is the most effective way to ensure the correct drug is selected.

Hydralazine (blood pressure medication) and hydroxyzine (antihistamine) are Look-Alike, Sound-Alike (LASA) drugsthat can cause serious medication errors if mixed up.

????Reference:ISMP LASA Guidelines, FDA NDC Number Verification.