Welcome, pharmacy scholars, to this specialized quiz on the critical areas of sterile compounding. As you progress in your PharmD journey, mastering general sterile compounding is just the beginning. The real challenge and reward lie in the specialties, such as the preparation of parenteral nutrition, the handling of hazardous drugs, and the unique considerations for pediatric and neonatal patients. This quiz is designed to test your knowledge on these advanced topics, which are integral to courses like PHA5104 Sterile Compounding and essential for your Hospital Introductory Pharmacy Practice Experience (HIPPE). We will delve into concepts from USP <797> and <800>, exploring the nuances of compatibility, stability, and safety that define excellence in hospital pharmacy practice. Prepare to challenge your understanding and solidify your expertise in these vital areas of patient care.
1. When compounding a Total Parenteral Nutrition (TPN) solution, which two electrolytes have a significant potential for precipitation?
- a. Sodium and potassium
- b. Magnesium and chloride
- c. Calcium and phosphate
- d. Acetate and bicarbonate
Answer: c. Calcium and phosphate
2. What is the primary purpose of using a 0.22-micron filter for a 2-in-1 parenteral nutrition solution?
- a. To remove lipid globules
- b. To sterilize the solution by removing bacteria
- c. To remove air bubbles
- d. To remove vitamin particulates
Answer: b. To sterilize the solution by removing bacteria
3. According to USP Chapter <800>, what type of engineering control is required for compounding hazardous drugs (HDs)?
- a. A Class I Biological Safety Cabinet (BSC)
- b. A Compounding Aseptic Isolator (CAI) with positive pressure
- c. A Compounding Aseptic Containment Isolator (CACI) with negative pressure
- d. A standard laminar airflow workbench
Answer: c. A Compounding Aseptic Containment Isolator (CACI) with negative pressure
4. A major toxicity concern with the excipient benzyl alcohol in neonatal preparations is:
- a. Renal failure
- b. “Gasping Syndrome”
- c. Pulmonary edema
- d. Kernicterus
Answer: b. “Gasping Syndrome”
5. In preparing a TPN, what is the correct order of adding calcium and phosphate to minimize precipitation risk?
- a. Add calcium first, then add phosphate immediately after
- b. Add phosphate early in the mixing process and calcium near the end
- c. Add both electrolytes at the same time
- d. The order does not matter if the solution is agitated well
Answer: b. Add phosphate early in the mixing process and calcium near the end
6. What is the minimum frequency for environmental wipe sampling for hazardous drug residue, as stated by USP <800>?
- a. Monthly
- b. Annually
- c. Every six months
- d. Weekly
Answer: c. Every six months
7. When preparing a chemotherapy agent, which piece of Personal Protective Equipment (PPE) is uniquely required by USP <800> compared to non-hazardous compounding?
- a. A single pair of sterile gloves
- b. A disposable gown that is impermeable
- c. A surgical mask
- d. Shoe covers
Answer: b. A disposable gown that is impermeable
8. What is a primary challenge in preparing IV medications for pediatric patients compared to adults?
- a. Need for larger volumes of fluid
- b. Requirement for non-standard, very small doses requiring dilution
- c. Fewer compatibility concerns
- d. Higher tolerance to excipients
Answer: b. Requirement for non-standard, very small doses requiring dilution
9. A “3-in-1” TPN formulation refers to a solution containing:
- a. Dextrose, Amino Acids, and Water
- b. Dextrose, Amino Acids, and Electrolytes
- c. Dextrose, Amino Acids, and Intravenous Fat Emulsion (IVFE)
- d. Vitamins, Minerals, and Trace Elements
Answer: c. Dextrose, Amino Acids, and Intravenous Fat Emulsion (IVFE)
10. What is the function of a Closed System Drug-Transfer Device (CSTD) in hazardous drug compounding?
- a. To sterilize the final preparation
- b. To prevent the escape of drug vapor or liquid outside the system
- c. To automate the calculation of drug doses
- d. To verify the final concentration of the drug
Answer: b. To prevent the escape of drug vapor or liquid outside the system
11. Why is propylene glycol an excipient of concern in pediatric IV preparations?
- a. It can cause severe hypertension.
- b. It is rapidly metabolized by infants.
- c. It can lead to hyperosmolality and lactic acidosis in neonates.
- d. It enhances the risk of phlebitis only.
Answer: c. It can lead to hyperosmolality and lactic acidosis in neonates.
12. When verifying a parenteral nutrition order, what is a critical parameter for the pharmacist to calculate and assess for safety?
- a. The total weight of the bag
- b. The final color of the solution
- c. The osmolarity of the solution for peripheral administration
- d. The expiration date of the base components only
Answer: c. The osmolarity of the solution for peripheral administration
13. According to USP <800>, decontamination of surfaces contaminated with hazardous drugs should be performed with:
- a. 70% Isopropyl Alcohol alone
- b. Sterile water
- c. An agent like sodium hypochlorite followed by a neutralizing agent, then 70% IPA
- d. A sporicidal agent only
Answer: c. An agent like sodium hypochlorite followed by a neutralizing agent, then 70% IPA
14. What is the “hang time” for a lipid-containing (3-in-1) TPN solution at room temperature generally limited to?
- a. 48 hours
- b. 36 hours
- c. 24 hours
- d. 12 hours
Answer: c. 24 hours
15. A common reason for “cracking” of a TPN solution is:
- a. Exposure to light
- b. The separation of the oil and water phases of the lipid emulsion
- c. Bacterial contamination
- d. Precipitation of trace elements
Answer: b. The separation of the oil and water phases of the lipid emulsion
16. Disposal of empty vials that once contained hazardous drugs should be managed by:
- a. Placing them in a regular sharps container
- b. Placing them in a yellow or black hazardous waste container
- c. Rinsing them and placing them in the trash
- d. Returning them to the manufacturer
Answer: b. Placing them in a yellow or black hazardous waste container
17. Why must some pediatric medications be prepared in a more dilute concentration than for adults?
- a. To increase the stability of the drug
- b. To allow for the accurate administration of very small volumes
- c. Because children have faster metabolism
- d. To make the medication taste better
Answer: b. To allow for the accurate administration of very small volumes
18. What is the primary energy source in a standard TPN formulation?
- a. Amino acids
- b. Intravenous fat emulsion
- c. Dextrose
- d. Electrolytes
Answer: c. Dextrose
19. When compounding hazardous drugs, how many pairs of chemotherapy-tested gloves are required?
- a. One pair
- b. Two pairs
- c. Three pairs
- d. One pair, but it must be changed every 30 minutes
Answer: b. Two pairs
20. What is a key consideration for parenteral nutrition in neonates versus adults?
- a. Neonates require a much lower protein (amino acid) intake per kg.
- b. Neonates have a higher risk of aluminum toxicity from contaminated ingredients.
- c. Fat emulsions are contraindicated in all neonatal patients.
- d. Neonatal TPNs are always 2-in-1 solutions.
Answer: b. Neonates have a higher risk of aluminum toxicity from contaminated ingredients.
21. The Beyond Use Date (BUD) for a TPN compounded in an ISO 5 environment and stored in the refrigerator is typically determined by:
- a. USP <797> stability guidelines
- b. The expiration date of the lipid component
- c. The manufacturer’s recommendation for the amino acids
- d. A standard 48-hour rule
Answer: a. USP <797> stability guidelines
22. An automated compounding device (ACD) for TPNs improves:
- a. The sterility of the final product over manual compounding
- b. The accuracy and efficiency of adding multiple base solutions and electrolytes
- c. The final compatibility of calcium and phosphate
- d. The need for a pharmacist’s final verification
Answer: b. The accuracy and efficiency of adding multiple base solutions and electrolytes
23. Medical surveillance for all healthcare workers who handle hazardous drugs is a requirement under which chapter?
- a. USP <795>
- b. USP <797>
- c. USP <800>
- d. USP <825>
Answer: c. USP <800>
24. The maximum osmolarity recommended for a parenteral nutrition solution to be administered peripherally is generally:
- a. 500 mOsm/L
- b. 900 mOsm/L
- c. 1200 mOsm/L
- d. 1800 mOsm/L
Answer: b. 900 mOsm/L
25. A pharmacist is asked to prepare a dose of morphine 0.1 mg for a neonate. The stock vial is 10 mg/mL. What is the most appropriate first step?
- a. Draw up 0.01 mL in a 1 mL syringe
- b. Perform a serial dilution to create a lower concentration stock
- c. Refuse to make the dose as it is too small
- d. Suggest an oral alternative
Answer: b. Perform a serial dilution to create a lower concentration stock
26. Which type of gown is required for compounding hazardous drugs?
- a. Any cloth gown is acceptable
- b. A gown made of polyethylene-coated polypropylene or other laminate material
- c. A standard sterile gown used for non-hazardous compounding
- d. A fire-retardant gown
Answer: b. A gown made of polyethylene-coated polypropylene or other laminate material
27. What is the purpose of trace elements (e.g., zinc, copper, selenium) in parenteral nutrition?
- a. To provide caloric content
- b. To act as cofactors for essential enzymatic reactions
- c. To adjust the pH of the solution
- d. To improve the stability of the lipid emulsion
Answer: b. To act as cofactors for essential enzymatic reactions
28. In the context of pediatric sterile compounding, “overfill” refers to:
- a. Adding extra drug to the preparation
- b. The volume of solution in IV tubing that must be accounted for
- c. Filling the IV bag beyond its stated capacity
- d. An error in calculation
Answer: b. The volume of solution in IV tubing that must be accounted for
29. When cleaning up a small spill of a hazardous drug, the first step is to:
- a. Immediately evacuate the area
- b. Call the hazardous waste management team
- c. Contain the spill with a spill kit
- d. Document the spill in the incident report
Answer: c. Contain the spill with a spill kit
30. Which vitamin is known to be highly susceptible to photodegradation in TPN solutions?
- a. Vitamin C
- b. Vitamin D
- c. Vitamin A
- d. Vitamin K
Answer: c. Vitamin A
31. The primary risk associated with rapid infusion of a hypertonic TPN solution into a peripheral vein is:
- a. Hyperglycemia
- b. Phlebitis and vein damage
- c. Fluid overload
- d. An allergic reaction
Answer: b. Phlebitis and vein damage
32. What is negative pressure technique in the context of HD compounding?
- a. Ensuring air flows out of the vial to prevent contamination
- b. Withdrawing slightly less air than the volume of drug to be removed from a vial
- c. Compounding in a room with lower pressure than adjacent areas
- d. Using a syringe that creates a vacuum
Answer: b. Withdrawing slightly less air than the volume of drug to be removed from a vial
33. Why are multi-dose vials often discouraged for use in neonatal and pediatric units?
- a. They are more expensive
- b. They often contain preservatives that can be toxic to neonates
- c. They are difficult to store
- d. They are prone to coring
Answer: b. They often contain preservatives that can be toxic to neonates
34. The final verification of a compounded sterile product for a pediatric patient must include confirming:
- a. The patient’s favorite flavor
- b. The dose calculation, concentration, and total volume
- c. The time of day the dose will be given
- d. The name of the nurse who will administer the dose
Answer: b. The dose calculation, concentration, and total volume
35. What does the term “chemotherapy sequencing” refer to in the context of TPN administration?
- a. Administering chemotherapy before the TPN
- b. The order in which electrolytes are added to the TPN
- c. Not administering certain medications through the same line as a TPN
- d. The specific brand of amino acids used
Answer: c. Not administering certain medications through the same line as a TPN
36. A containment ventilated enclosure (CVE), or powder hood, is used for what activity involving hazardous drugs?
- a. Administering the drug to a patient
- b. Compounding sterile liquids
- c. Handling and manipulating solid or powdered HDs
- d. Storing HDs at room temperature
Answer: c. Handling and manipulating solid or powdered HDs
37. Which of the following is an example of a hazardous drug?
- a. Acetaminophen
- b. Ibuprofen
- c. Methotrexate
- d. Amoxicillin
Answer: c. Methotrexate
38. The use of sterile, empty vials for creating pediatric dilutions helps to:
- a. Reduce the cost of compounding
- b. Maintain sterility and reduce the risk of contamination
- c. Speed up the compounding process
- d. Eliminate the need for a pharmacist’s check
Answer: b. Maintain sterility and reduce the risk of contamination
39. When formulating a parenteral nutrition solution, which component provides the most calories per gram?
- a. Dextrose
- b. Amino Acids
- c. Intravenous Fat Emulsion
- d. Sterile Water
Answer: c. Intravenous Fat Emulsion
40. A key document for handling HDs is the Safety Data Sheet (SDS), which provides information on:
- a. The drug’s therapeutic indications
- b. Spill cleanup procedures, PPE, and first aid measures
- c. The cost of the drug
- d. Patient counseling points
Answer: b. Spill cleanup procedures, PPE, and first aid measures
41. The final step in garbing before entering a buffer area for sterile compounding is:
- a. Donning a hair cover
- b. Performing hand hygiene
- c. Donning sterile gloves
- d. Donning a gown
Answer: c. Donning sterile gloves
42. Which organization publishes the list of antineoplastic and other hazardous drugs used in healthcare settings?
- a. The Food and Drug Administration (FDA)
- b. The Drug Enforcement Administration (DEA)
- c. The National Institute for Occupational Safety and Health (NIOSH)
- d. The Joint Commission (TJC)
Answer: c. The National Institute for Occupational Safety and Health (NIOSH)
43. A pharmacist preparing a vancomycin dose for a neonate must be aware that:
- a. Neonatal renal function is equivalent to adult function.
- b. “Red man syndrome” is not a concern in this population.
- c. Dosing is highly weight-based and requires careful calculation and verification.
- d. Vancomycin is never used in neonates.
Answer: c. Dosing is highly weight-based and requires careful calculation and verification.
44. What is the primary function of amino acids in a TPN solution?
- a. To provide essential fatty acids
- b. To serve as a source of nitrogen for protein synthesis
- c. To provide the main source of energy
- d. To stabilize the emulsion
Answer: b. To serve as a source of nitrogen for protein synthesis
45. According to USP <800>, what must be done with the outer pair of gloves after compounding an HD and before labeling the preparation?
- a. They should be wiped with 70% IPA
- b. They should be removed and discarded inside the C-PEC
- c. They can be worn outside the C-PEC to label the bag
- d. They should be replaced with a new sterile pair
Answer: b. They should be removed and discarded inside the C-PEC
46. A “low-dose” medication for a pediatric patient refers to a dose that is:
- a. Less effective than the standard adult dose
- b. Calculated specifically based on the child’s weight or body surface area
- c. Always administered orally
- d. Only given once a day
Answer: b. Calculated specifically based on the child’s weight or body surface area
47. Refeeding syndrome in a severely malnourished patient starting on TPN is characterized by severe electrolyte shifts, particularly in:
- a. Sodium
- b. Chloride
- c. Calcium
- d. Phosphate
Answer: d. Phosphate
48. Why is it critical to use syringes that are no more than twice the volume being measured for small pediatric doses?
- a. To save money on supplies
- b. To improve the accuracy and precision of the measurement
- c. Because larger syringes are not sterile
- d. To make the process faster
Answer: b. To improve the accuracy and precision of the measurement
49. For a 3-in-1 TPN, what is the required filter size to accommodate the lipid particles?
- a. 0.22 micron
- b. 1.2 micron
- c. 5 micron
- d. No filter is used
Answer: b. 1.2 micron
50. What is a key quality assurance step for compounded hazardous drugs?
- a. Testing the final pH of the solution
- b. Verifying the correct diluent was used and the final volume is correct
- c. Asking the patient if they have any allergies
- d. Ensuring the bag is not leaking before it leaves the pharmacy
Answer: b. Verifying the correct diluent was used and the final volume is correct