Saudi Prometric Pharmacist Dispensing and Compounding 2 — Questions and Answers
Question 1: What is aseptic technique in sterile compounding?
- Regular hand washing before compounding
- A set of procedures to prevent microbial contamination during preparation of sterile products, including laminar flow hoods and sterile gowning (Correct answer)
- Using clean containers
- Working in any clean area
Correct answer: A set of procedures to prevent microbial contamination during preparation of sterile products, including laminar flow hoods and sterile gowning
Aseptic technique includes: working in a certified laminar airflow hood (ISO 5), proper garbing (sterile gown, gloves, mask, hair cover), surface disinfection with 70% isopropyl alcohol, first-air principles, sterile supply handling, and environmental monitoring.
Question 2: What is the beyond-use date (BUD) for a compounded preparation?
- Same as the manufacturer's expiry date
- The date after which a compounded preparation should not be used, determined by stability data and USP guidelines (Correct answer)
- Always 1 year from compounding
- The date the prescription expires
Correct answer: The date after which a compounded preparation should not be used, determined by stability data and USP guidelines
BUD is assigned based on USP guidelines considering: formulation type, container, storage conditions, and available stability data. For non-sterile preparations: generally not more than 180 days or the shortest remaining expiry of ingredients. For sterile preparations: based on USP <797> risk levels.
Question 3: What are the requirements for handling hazardous drugs during compounding?
- No special requirements
- Use a biological safety cabinet, double gloving, protective gown, closed-system transfer devices, and proper waste disposal (Correct answer)
- Only wear regular gloves
- Handle in a regular pharmacy area
Correct answer: Use a biological safety cabinet, double gloving, protective gown, closed-system transfer devices, and proper waste disposal
Hazardous drug handling (USP <800>, adapted in Saudi hospitals) requires: Class II biological safety cabinet, double chemotherapy gloves, non-permeable gown, eye protection, closed-system transfer devices, designated negative-pressure room, proper waste disposal, and staff health monitoring.
Question 4: What calculations are commonly required in pharmacy compounding?
- Only counting tablets
- Dilution calculations, concentration conversions, alligation, isotonicity adjustments, and dose-weight calculations (Correct answer)
- Only price calculations
- No calculations are needed in modern pharmacy
Correct answer: Dilution calculations, concentration conversions, alligation, isotonicity adjustments, and dose-weight calculations
Compounding calculations include: dilution (C1V1=C2V2), concentration conversions (mg/mL, %, w/w), alligation (mixing different concentrations), isotonicity adjustment (NaCl equivalents), pediatric dose calculations (mg/kg), and proportion/ratio calculations.
Question 5: What quality control measures should be performed on compounded preparations?
- No quality control is needed
- Visual inspection, weight/volume verification, pH testing when applicable, sterility testing for high-risk preparations, and documentation of all results (Correct answer)
- Only visual check for color
- Quality control is only for manufactured drugs
Correct answer: Visual inspection, weight/volume verification, pH testing when applicable, sterility testing for high-risk preparations, and documentation of all results
Quality control includes: visual inspection (clarity, color, particulates), weight/volume verification (within acceptable range), pH testing (for solutions), potency testing (when feasible), sterility and endotoxin testing (for sterile preparations), and complete documentation of all QC results.
Question 6: What is the role of the pharmacist in IV admixture services?
- Only delivering IV bags to nursing units
- Preparing IV medications under aseptic conditions, checking compatibility, calculating concentrations, labeling, and managing workflow (Correct answer)
- IV admixture is a nursing responsibility
- Only checking IV orders
Correct answer: Preparing IV medications under aseptic conditions, checking compatibility, calculating concentrations, labeling, and managing workflow
IV admixture services: verify orders (dose, concentration, compatibility), prepare under aseptic conditions in laminar flow hood, check drug-diluent compatibility, calculate infusion rates, apply proper labeling (drug, concentration, BUD, rate), perform final check, and coordinate timely delivery to nursing units.
What is aseptic technique in sterile compounding?