Fundamentals of Sterile Products Preparation for Pharmacy Technicians, Canadian Test Bank

TEST BANK Elaine Magowan

Fundamentals of Sterile Products Preparation for Pharmacy Technicians First Edition Mike Johnston, CPhT Jeff Gricar, CPhT, M.Ed Robin Luke, CPhT George Tsallas Mohawk College

Fundamentals of Sterile Products Preparation for Pharmacy Technicians, Canadian Edition

Chapter 1 Introduction to Sterile Products 1) In Canada, facilities that participate in sterile compounding follow guidelines provided by USP Chapter <797>, NAPRA and this professional association: A) CPTEA B) CSHP C) FDA D) CAPT Answer: B Page Reference: 4 Learning Outcome: 1.1 2) During the late 18th and early 19th century, important advances in aseptic technique practices were developed as well as this breakthrough administration technique.

A) Injection into a large muscle B) Injection directly into a vein C) Injection into the subcutaneous tissue D) Injection into the cardiac muscle Answer: C Page reference: 3 Learning Outcome: 1.1 3) What is the term for a specialized piece of equipment introduced in the late 1960’s and used in sterile compounding facilities today that provides a particle and bacteria free environment when preparing sterile products.

A) Autoclaving B) Laminar Airflow Hood C) Dry Heat Sterilizer D) Sanitation and Contamination control device Answer: B Page reference: 5 Learning Outcome: 1.1 4)Sterile products are generally referred to as: A) pyrogens B) injectables C) infusions d) parenterals Answer: D Page reference: 7 Learning Outcome: 1.2, 1.3

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Fundamentals of Sterile Products Preparation for Pharmacy Technicians, Canadian Edition 5) Which of the following terms is associated with the probability of a preparation not being sterile after it has been exposed to a sterilization process?

A) Optimal Sterilization level B) Sterility Assurance level C) Pyrogen Load level D) Particulate Matter level Answer: B Page reference: 14 Learning outcome: 1.3 6) Sterile products have the same tonicity as what bodily fluid?

A) Blood B) Lacrimal fluid - tears C) Urine D) Saliva Answer: A Page reference: 16 Learning outcome 1.3 7) Which of the following statements would accurately describe Particulate Matter?

A) Can only be introduced during the manipulation process of compounding a sterile product B) It is a micro-organism that is visible to the naked eye C) It could cause blood vessel blockage in the brain and lungs D) It can be removed from a compounded sterile product by heat sterilization Answer: C Page reference: 14 Learning Outcome 1.3 8) A solution with a lower concentration of dissolved substances than that of red blood cells is defined as: A) Isotonic B) Hypotonic C) Hypertonic D) Endotonic Answer: B Page reference: 17 Learning Outcome: 1.4 9) Which of the following ingredients would be considered a common antimicrobial preservative?

A) Benzyl Alcohol B) Benzoyl Peroxide C) Chlorpropamide D) Chlorpheniramine Answer: A Page reference: 17 Learning Outcome: 1.4

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Fundamentals of Sterile Products Preparation for Pharmacy Technicians, Canadian Edition 10) The term “coring” when related to the rubber stopper of a medication vial is a result of: A) the vial accidentally being dropped on the floor B) poor manufacturer’s quality control during production C) poor quality materials resulting in the breakdown of the rubber stopper D) improper technique when inserting a needle into the rubber stopper Answer: D Page reference: 19 Learning Outcome: 1.5 11) Non-Aqueous vehicles are recommended to be injected by which of the following administration routes?

A) Intradermal B) Subcutaneous C) Intravenous D) Intramuscular Answer: D Page reference: 16 Learning Outcome: 1.4 12) The most common tonicity agent used to adjust tonicity of a sterile preparation is: A) Potassium Chloride B) Sodium Chloride C) Calcium Chloride D) Magnesium Chloride Answer: B Page Reference: 16, 18 Learning Outcome: 1.3 13) Which of the following is a technique used to dissolve sterile solid dosage forms?

A) Trituration B) Levigation C) Reconstitution D) Dissolution Answer: C Page Reference: 8 Learning Outcome: 1.2 14) “Potential for increased drug wastage” is a disadvantage of this type of sterile product container: A) Prefilled syringe B) Ampoule C) Vial D) Cartridge Answer: B Page Reference: 20 Learning Outcome: 1.5

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Fundamentals of Sterile Products Preparation for Pharmacy Technicians, Canadian Edition 15) Which of the following containers has a “luer lock opening” which allows the attachment of a luer-lock syringe to the opening?

A) Glass ampoule B) Double chamber vial C) Plastic IV bag D) Plastic ampoule (polyamp) Answer: D Page reference: 20 Learning Outcome: 1.5 16) To maintain the pH of a preparation, phosphate, citrate and acetate could be added to the solution. These are commonly referred to as: A) Buffers B) Tonicity agents C) Emulsifiers D) Chelating agents Answer; A Page reference: 17 Learning Outcome: 1.4 17) Which of the following statements regarding Osmotic pressure is most accurate: A) The less particles, the lower the osmotic pressure B) The more particles, the higher the osmotic pressure C) The more particles, the lower the osmotic pressure D) The number of particles does not determine the osmotic pressure Answer: B Page reference: 16-17 Learning Outcome: 1.4 18) A substance released from the cell wall of gram negative bacteria that could cause serious adverse effects and possibly death if introduced into a sterile product, is called: A) Microbe B) Funghi C) Virus D) Endotoxin Answer: D Page reference: 13 Learning Outcome: 1.3 19) This parenteral vehicle has been purified by either distillation and/or reverse osmosis, has no preservative and has been sterilized.

A) Bacteriostatic water B) Sterile water for injection C) Distilled water D) Water for irrigation Answer: B Page reference: 15 Learning outcome: 1.4

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Fundamentals of Sterile Products Preparation for Pharmacy Technicians, Canadian Edition 20) Plastic containers such as polyamps and IV solution bags are commonly made of PVC or PEC material. What does the acronym PVC stand for?

A) Poly Vascular Container B) Plastic Vinyl Container C) Polyvinyl Chloride D) Polyethylene Vinyl Chloride Answer: C Page reference: 20 Learning outcome: 1.5

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Fundamentals of Sterile Products Preparation for Pharmacy Technicians, Canadian Edition Chapter 2 Standards and Guidelines for Preparing Sterile Products 1. Which of the following statements best describes the preparation and compounding of sterile products in Canada?

A) Regulations are only defined for commercially available products B) Are governed under the jurisdictions of the provincial/territorial regulatory bodies C) Canada and USA both follow USP Chapter <797> regulations D) CSHP has developed the current standards of practice used across all provinces Answer: B Page Reference: 21 Learning Outcome: 2.1 2. The Policy on Manufacturing and Compounding Drug Products in Canada also complies with which of the following federal legislative acts?

A) Health Canada Act B) Canada Health Act C) Food and Drugs Act D) Pharmacy Act Answer: C Page Reference: 21 Learning Outcome: 2.1 3. The Policy on Manufacturing and Compounding Drug Products in Canada also defines the Expiration Date as: A) Short with a beyond use date of one month B) The date based on known stability data C) The date that the prescription is no longer valid D) The date which the manufactured product should be returned to the pharmacy for full refund Answer: B Page Reference: 22 Learning Outcome: 2.1 4. The act of compounding does not include: A) Reconstitution of medication according to a manufacturer’s label B) Reformulating a new drug delivery system C) Using 2 or more ingredients – one of which is pharmacologically active D) Altering commercially available products Answer: A Page Reference: 21 Learning Outcome: 2.1

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Fundamentals of Sterile Products Preparation for Pharmacy Technicians, Canadian Edition 5. Hospital pharmacies are allowed to provide sterile product services to other hospitals if: A) There is a financial agreement which outline the cost of services B) Both hospitals are of a bed capacity greater than 100 beds C) They are within the same province and under the same hospital management board D) There are no restrictions, as long as they are located in Canada Answer: C Page Reference: 22 Learning Outcome: 2.1 6. Which of the following principles do Health care professionals who are involved with compounding products need to comply with?

A) Must demonstrate a patient-health care professional relationship B) Must have a manufacturing assembly line process C) Must have legal counsel in place before entering into manufacturing practices D) Must have a minimum of one Pharmacist on site per shift Answer: A Page Reference: 21 Learning Outcome: 2.1 7. Customized medications are: A) Formulations that only contain non-medicinal ingredients B) Formulations that meet a patient’s therapeutic needs C) Formulations that can only be manufactured pursuant to a prescription D) Formulations that contain API’s listed in the CPS Answer: B Page Reference: 22 Learning Outcome: 2.1 8. Risk management processes associated with compounded products would include the following EXCEPT: A) Sterility B) Stability C) Solubility D) Adverse Reactions Answer: C Page Reference: 21 Learning Outcome: 2.1

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Fundamentals of Sterile Products Preparation for Pharmacy Technicians, Canadian Edition 9. According to Health Canada’s policy, a Third Party is: A) An organization who arranges the patient-health care professional relationship B) An organization or individual outside the patient-health care professional relationship C) An organization or individual who acts as a mediator within the patient-health care relationship D) An organization or individual that resolve compliance issues within the patient-healthcare relationship Answer: B Page Reference: 22 Learning Outcome: 2.1 10. What schedule within the Food and Drugs Act would you find reference to USP, BP, NF defining standards of drug materials used for compounding?

A) Schedule D B) Schedule A C) Schedule B D) Schedule C Answer: C Page Reference: 22 Learning Outcome: 2.1 11. Canadian Institutions involved in the preparation of sterile products currently follow guidelines developed by which professional association?

A) Canadian Association of Pharmacy Technicians B) Canadian Society of Hospital Pharmacists C) Canadian Association of Hospital Pharmacy D) Canadian Society of Hospital Pharmacy Answer: B Page Reference: 23 Learning Outcome: 2.2 12. According to Table 2.1 which defines the current practices of each province, which province is currently following the guidelines set by NAPRA, CSHP and Health Canada Guidelines?

A) Ontario B) Alberta C) Manitoba D) British Columbia Answer: C Page Reference: 25 Learning Outcome: 2.2

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Fundamentals of Sterile Products Preparation for Pharmacy Technicians, Canadian Edition 13. According to Table 2.1 which province has implemented policies on risk levels of sterile products?

A) Nova Scotia B) New Brunswick/PEI C) Saskatchewan D) Newfoundland/Labrador Answer: B Page Reference: 25 Learning Outcome: 2.2 14. USP Chapter <797> standards do not apply to: A) Sterile products for inhalation B) Injectable Sterile products C) Clinical administration of Sterile products D) Sterile products for infusion Answer: C Page Reference: 24 Learning Outcome: 2.2 15. USP Chapter <797> ensures personnel involved in sterile compounding are: A) Trained on-the-job on an informal basis B) Assessed according to defined competencies C) Paid according to a pay scale that reflects the number of years of service and error rate D) Trained through an outside government agency before being hired by any manufacturing facility Answer: B Page Reference: 24 Learning Outcome: 2.2 16. Which of the following statements does NOT represent how USP Chapter <797> classifies risk levels?

A) Risk of contamination of a sterile product due to transportation delays B) Risk of professional liability C) Risk of a profession’s credibility and trust D) Risk of contaminated products to the health and life of the patient treated Answer: A Page Reference: 26 Learning Outcome: 2.2 17. What type of sterile product manufacturing does USP Chapter <800> relate to?

A) Hazardous/cytotoxic B) Non sterile compounding – such as creams and ointments C) Veterinary medicine D) Total Parenteral Nutrition Answer: A Page Reference: 26 Learning Outcome: 2.2 .

Fundamentals of Sterile Products Preparation for Pharmacy Technicians, Canadian Edition

18. A Hollow Bore needle is: A) One of the safety engineered needles B) A needle that contains a large space or cavity inside the shaft of the needle C) A needle that does not attach to a syringe D) A needle that will prevent needle stick injuries Answer: B Page Reference: 27 Learning Outcome: 2.3 19. Safety –engineered needles are: A) Needles that meet the Occupational Health and Safety Standards Act of Canada B) Needles that are only used for medication administration and not sterile product preparation C) Needles that have been approved for use to prevent needlestick injuries D) Needles that have a hollow –bore Answer: C Page Reference: 27 Learning Outcome: 2.3 20. Which of the following is NOT a safety engineered needle?

A) Safety Glide needle B) Precision Glide needle C) Blunt Needle D) Safety Eclipse Needle Answer: B Page Reference: 27 Learning Outcome: 2.3

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Fundamentals of Sterile Products Preparation for Pharmacy Technicians, Canadian Edition

Chapter 3 Contamination Control Facilities and Engineering Control Systems 1. Which of the following statements best describes preparing sterile products in a controlled environment?

A) A controlled environment must allow space for dispensing and processing prescriptions B) A controlled environment will increase exposure to hazardous products C) A controlled environment is free of harmful contaminants D) A controlled environment is a large open work area within the main dispensary Answer: C Page Reference: 33 Learning Outcome: 3.1 2. Primary engineering controls include: A) Computer workstations B) Laminar Airflow Hoods C) Housekeeping supplies D) Electrical and Power outlets Answer: B Page Reference: 33 Learning Outcome: 3.1 3. Which of the following activities would be performed within the Anteroom environment?

A) Handwashing B) Inventory storage area for supplies C) Compounding of sterile products D) Preparation of hazardous products Answer: A Page Reference: 33 Learning Outcome: 3.1 4. According to USP Chapter <797> an anteroom that is considered to be a high-level risk of microbial contamination would be separated from the cleanroom by: A) A Strip curtain B) A glass door C) A physical wall D) There is no requirement to separate these spaces Answer: C Page Reference: 35 Learning Outcome: 3.1 5. The cleanroom environment is: A) Used for preparation of the operator such as gowning and gloving B) The area where actual compounding takes place C) Divided into 2 separate areas by a “line of demarcation” D) The main storage area for compounding supplies Answer: B Page Reference: 35 Learning Outcome: 3.1

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Fundamentals of Sterile Products Preparation for Pharmacy Technicians, Canadian Edition

6. Which of the following generate particulate matter and must never be opened inside controlled areas?

A) Glass ampoules B) Cardboard boxes and cartons C) Plastic ziplock bags D) Packaging of sterile gloves Answer: B Page Reference: 35 Learning Outcome: 3.1 7. The type of airflow that will pick up particles and carry them in one direction away from the critical areas of potential contamination is called: A) Laminar airflow B) Linear airflow C) Parallel airflow D) Circular airflow Answer: A Page Reference: 38 Learning Outcome: 3.2 8. The HEPA filter of a horizontal Laminar Airflow Hood (LAFH) is located: A) At the top of the LAFH B) At the back of the LAFH C) On the work surface of the LAFH D) On each side of the LAFH Answer: B Page Reference: 39 Learning Outcome: 3.3 9. Biological Safety Cabinets are: A) Primarily horizontal airflow hoods B) Used only for non-hazardous sterile preparation C) Classified into 3 categories depending on their ability to protect personnel from hazardous products D) Located in the anteroom to protect all staff Answer: C Page Reference: 40 Learning Outcome: 3.3

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Fundamentals of Sterile Products Preparation for Pharmacy Technicians, Canadian Edition

10. If the Laminar Airflow Hood has been turned off, it must run for how long before using: A) For 1 hour B) For a minimum of 30 minutes C) For a maximum of 10 minutes D) For 5 minutes Answer: B Page Reference: 40 Learning Outcome: 3.3 11. A compounding isolator is classified as a: A) Class I Biological Safety Cabinet B) Class II Biological Safety Cabinet C) Class III Biological Safety Cabinet D) Class IV Biological Safety Cabinet Answer: C Page Reference: 41 Learning Outcome: 3.3 12. Which of the following is a recommended ergonomic feature of chairs used in the cleanroom?

A) Adjustable seat height B) Flat, non-contour seating C) Neck rest D) Permeable material seat coverings Answer: A Page Reference: 42 Learning Outcome: 3.3 13. Which of the following areas would be part of the monthly cleaning routine within the sterile compounding area?

A) Walls B) Stainless steel carts C) Floors D) Laminar Airflow Hoods Answer: A Page Reference: 44 Learning Outcome: 3.4 14. By-products of bacteria are referred to as “toxins” or: A) Fungus B) Pyrogens C) Microbes D) Micro-organisms Answer: B Page Reference: 45 Learning Outcome: 3.5

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Fundamentals of Sterile Products Preparation for Pharmacy Technicians, Canadian Edition

15. According to USP Chapter <797> preparations involving simple aseptic manipulations using a sterile needle and syringe are considered: A) High risk level B) Medium risk level C) Low risk level D) An exemption from specific contamination risk levels Answer: C Page Reference: 46 Learning Outcome: 3.6 16. According to USP Chapter <797> which of the following situations would be considered an immediate-use provision?

A) Injectable syringe prepared for resuscitation purposes B) A sterile product stored in the refrigerator for 14 days C) A hazardous or cytotoxic sterile product D) An IV infusion fluid that will be infused over 12 hours Answer: A Page Reference: 46 Learning Outcome: 3.6 17. Which of the following sterilization methods will kill all vegetative, bacterial, fungal and viral organisms?

A) Dry Heat sterilization B) Membrane filtration C) Non-porous membrane filtration D) Steam sterilization Answer: D Page Reference: 48 Learning Outcome: 3.5 18. A chemical used to disinfect inanimate objects such as the Laminar Airflow Hood is called: A) An antiseptic B) A disinfectant C) A sanitizer D) A sterile cleanser Answer: B Page Reference: 49 Learning Outcome: 3.5 19. Which of the following would be considered a high level chemical disinfectant?

A) Isopropyl alcohol B) Chlorhexidine C) Phenol D) Hydrogen peroxide Answer: D Page Reference: 51 Learning Outcome: 3.5

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Fundamentals of Sterile Products Preparation for Pharmacy Technicians, Canadian Edition

20. It is recommended to rotate the use of chemical disinfectants to reduce: A) The risk of increased resistance B) The costs associated with specialized disinfectants C) The hazards to the staff in the compounding area D) The damage to work surfaces Answer: A Page Reference: 52 Learning Outcome: 3.5

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Fundamentals of Sterile Products Preparation for Pharmacy Technicians, Canadian Edition

Chapter 4 Aseptic Compounding of Sterile Parenteral Preparations 1. According to steps of the IV order cycle, select from the following statements to represent how the IV order would be processed.

1.

2.

3.

4.

5.

The pharmacy technician completes a final product release before sending it to the nursing unit The order is entered into the patient’s profile in the computer system The nurse notes the order in the patient’s MAR The pharmacy Technician completes the proper documentation and attaches label The pharmacy technician aseptically prepares the product

A) 5, 4, 2, 3, 1 B) 4, 5, 2, 3, 1 C) 3, 2, 5, 4, 1 D) 2, 3, 5, 4, 1 Answer: C Page Reference: 59 Learning Outcome: 4.3, 4.4 2. The term that refers to the process of adding a diluent to lyophilized sterile powder is: A) Displacement B) Reconstitution C) Dissolution D) Trituration Answer: B Page Reference: 62 Learning Outcome: 4.4 3. Ketorolac injection is available as a concentration of 30 mg/mL. If a physician has ordered a dose of 45 mg, how much volume will be required for this dose?

A) 0.67 mL B) 1.5 mL C) 0.15 mL D) 6.7 mL Answer: B Page Reference: 61 Learning Outcome: 4.5

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Fundamentals of Sterile Products Preparation for Pharmacy Technicians, Canadian Edition

4. A sterile powder vial label indicates to add 3.4 mL of sterile water which will produce a final volume of 4 mL. The increased volume is the result of: A) Displacement of the powder B) Incorrect calculation C) The type of diluent D) The powder inside the vial was not lyophilized Answer: A Page Reference: 62 Learning Outcome: 4.5 5. Cloxacillin 500 mg vial is to be reconstituted with 3.8 mL of sterile water which when dissolved the vial will contain a final volume of 5 mL. Calculate the concentration of the solution in the vial. Represent your answer as __ mg/1 mL. A) 50 mg/1 mL B) 500 mg/1 mL C) 100 mg/1 mL D) 10 mg/1 mL Answer: C Page Reference: 62 Learning Outcome: 4.5 6. Using the calculation from Question 4, a pediatric patient is to receive a dose of 75 mg.

What volume would be withdrawn from the vial to prepare this dose?

A) 7.5 mL B) 0.75 mL C) 6.7 mL D) 0.67 mL Answer: B Page Reference: 61 Learning Outcome: 4.5 7. If a 2 g vial is reconstituted with 6.8 mL of sterile water which provides a final concentration of 250 mg/mL. What is the total volume of the reconstituted solution?

A) 4 mL B) 8 mL C) 2 mL D) 7 mL Answer: B Page Reference: 64 Learning Outcome: 4.5

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Fundamentals of Sterile Products Preparation for Pharmacy Technicians, Canadian Edition

8. A physician has ordered 30 mmol of Potassium Chloride to be added to 1000 mL IV fluid.

The Potassium Chloride is available in a 20 mL vial with a concentration of 2 mEq/mL. How much volume will be injected into the IV bag?

A) 15 mL B) 30 mL C) 10 mL D) 5 mL Answer: A Page Reference: 65 Learning Outcome: 4.5 9. What is the molecular weight of Sodium Chloride (NaCl)?

Atomic weights: Na+ = 23 g Cl- = 35.5 g A) 12.5 g B) 58.5 g C) 0.585 g D) 816.5 g Answer: B Page Reference: 65 Learning Outcome: 4.5 10. What is the Milliequivalent weight of Sodium Chloride?

A) 12.5 mg B) 58.5 mg C) 0.585 mg D) 29.25 mg Answer: B Page Reference: 65 Learning Outcome: 4.5 11. The pharmacy needs to prepare 500 mL of a dextrose 15% solution, using a 50% dextrose solution and further diluting with sterile water. Using the alligation calculation method, calculate the required volumes needed to prepare this solution.

A) 350 mL sterile water, 150 mL dextrose 50% B) 400 mL sterile water, 100 mL dextrose 50% C) 100 mL sterile water, 400 mL dextrose 50% D) 150 mL sterile water, 350 mL dextrose 50% Answer: A Page Reference: 70-72 Learning Outcome: 4.5

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Fundamentals of Sterile Products Preparation for Pharmacy Technicians, Canadian Edition

12. Which of the following needle sizes would have the largest lumen or bore of the needle?

A) 25 g B) 22 g C) 18 g D) 16 g Answer: D Page Reference: 77 Learning Outcome: 4.6 13. A sterile syringe contains 2 critical sites. These are: A) The barrel and the plunger B) The syringe tip and the plunger C) The barrel and syringe tip D) The plunger and the barrel collar Page 91 Answer: B Page Reference: 91 Learning Outcome: 4.6 14. Which of the following is NOT a requirement of personnel involved in compounding sterile products?

A) Removal of make up and nail polish B) Personal Protective Equipment C) Sterile eye glasses D) No jewelry Answer: C Page Reference: 84 Learning Outcome: 4.7 15. When swabbing the rubber stoppers of 10 vials (of the same medication) with an alcohol swab it is important to: A) Allow the alcohol to dry before entering into each vial with a needle B) Leave the swab on top of each vial the entire time until needle entry C) Wipe the rubber stopper of each vial up to 5 times, using a new swab each time D) Use one alcohol swab for all 10 vials Answer: A Page Reference: 91-92 Learning Outcome: 4.9 16. Before cleaning the LAFH, it is important to dissolve any spills or salts with: A) Isopropyl Alcohol 70% B) Chlorhexidine (cetrimide) solution C) Sterile water D) Ethanol (99% alcohol) Answer: C Page Reference: 87-88 Learning Outcome: 4.8 .

Fundamentals of Sterile Products Preparation for Pharmacy Technicians, Canadian Edition

17. Which of the following is NOT considered as Personal Protective Equipment for personnel preparing sterile products?

A) Bonnet (hair cover) B) Shoe covers C) Gown D) Lint free gloves Answer: D Page Reference: 73-75 Learning Outcome: 4.7 18. Improper needle entry into a vial with a rubber stopper may cause rubber particles to enter into solution. This commonly referred to as: A) Particulation B) Coring C) Fragmentation D) Leaching Answer: B Page Reference: 96 Learning Outcome: 4.10 19. When breaking a glass ampoule, it is important to: A) Swab the neck of the ampoule with alcohol before breaking B) Break the ampoule in the direction of the HEPA filter C) Break the ampoule outside of the LAFH D) Swab the glass edge of the ampoule after breaking Answer: A Page Reference: 103 Learning Outcome: 4.10 20. After withdrawing solution from a glass ampoule it is important to: A) remove filter needle and replace with a regular needle to waste excess solution B) waste any extra solution back into the ampoule with attached filter needle C) waste any extra solution into the needle cap of the filter needle D) remove filter needle and attach a new filter needle to waste excess solution Answer: A Page Reference: 104-105 Learning Outcome: 4.10 21. A doctor’s order is a prescription that contains which patient specific number identifier?

A) Patient’s social insurance number B) Patient’s hospital identification number C) Patient’s home phone number D) Patient’s driver’s license number Answer: B Page Reference: 58 Learning Outcome: 4.1, 4.2 .

Fundamentals of Sterile Products Preparation for Pharmacy Technicians, Canadian Edition

22. Which of the following items would a Pharmacy Technician wear to cover street clothes but also protect themselves from a spilled drug substance?

A) Surgical scrubs B) Mask C) Gown D) Hair Cover Answer: B Page Reference: 75 Learning Outcome: 4.6 23. Proper aseptic handwashing includes all of the following EXCEPT: A) Removal of all makeup and jewelry B) Keeping hands pointing downwards to let dirty water run off clean hands C) Using antimicrobial soap D) Drying with lint free paper towels Answer: B Page Reference: 85, 86 Learning Outcome: 4.7 24. Before disinfecting the Laminar Airflow Hoods it is important to: A) Turn the LAFH motor off B) Rinse with sterile water to remove salt, starch, sugar substances C) Remove the horizontal bar and hooks from inside the hood D) Wipe the HEPA filter with sterile water Answer: B Page Reference: 88, 89, 90 Learning Outcome: 4.8 25. After swabbing a vial rubber stopper with an alcohol swab, the operator will verify: A) The alcohol has dried before puncturing B) The alcohol remains thoroughly saturated before puncturing C) The alcohol swab is dry D) The alcohol swab is place on work surface to swab other vials Answer: A Page Reference: 91, 92 Learning Outcome: 4.9 26. Which of the following statements indicate a technique for removing air bubble from a syringe?

A) Hold syringe with needle pointing downward to expel air B) Ensure all manipulations are performed with the needle cap resting on the work surface C) Use a large air bubble to collect smaller bubbles D) Push plunger to expel air and waste excess solution into needle cap Answer: C Page Reference: 92, 93 Learning Outcome: 4.10 .

Fundamentals of Sterile Products Preparation for Pharmacy Technicians, Canadian Edition

27. After injecting medication into an IV solution, the operator must complete the following EXCEPT: A) Squeeze the bag to check for leakage B) Visually check for particulate matter C) Gently mix contents D) Thoroughly agitate and shake contents to mix Answer: D Page Reference: 108 Learning Outcome: 4.11

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Fundamentals of Sterile Products Preparation for Pharmacy Technicians, Canadian Edition Chapter 5 Parenteral Drug Administration 1. Four primary routes of administration are: A) IV, IM, SC, IT B) IT, IM, SC, ID C) ID, SC, IM, IV D) ID, IV, IM, IS Answer: C Page Reference: 116 Learning Outcome: 5.2 2. A drug injected into the space surrounding the dura matter of the spinal cord is an: A) Intra-articular injection B) Epidural injection C) Intrathecal injection D) Intraperitoneal injection Answer: B Page Reference: 116 Learning Outcome: 5.1 3. The maximum injectable volume for intramuscular injections is: A) 1 mL B) 2 mL C) 3 mL D) 5 mL Answer: C Page Reference: 118 Learning Outcome: 5.2 4. One of the recommended needle gauges for subcutaneous injections is: A) 25 g B) 22 g C) 20 g D) 18 g Answer: A Page Reference: 118 Learning Outcome: 5.2

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Fundamentals of Sterile Products Preparation for Pharmacy Technicians, Canadian Edition 5. Which of the following is considered to be an advantage of the intravenous route of administration?

A) Preferred route for diagnostic tests B) Provides immediate delivery into the bloodstream and rapid onset of action C) Drug absorption is slower than IM injections D) Can be administered deep into the skeletal muscle Answer: B Page Reference: 119 Learning Outcome: 5.2 6. Which of the following is considered to be a disadvantage of the intravenous route of administration?

A) Local or systemic infection B) Only applicable for short term therapies C) Paralysis D) Abscesses Answer: A Page Reference: 119 Learning Outcome: 5.2 7. An inpatient is to receive a continuous infusion of 1000 mL 5% Dextrose. What drug delivery system would be the best option for this infusion?

A) Intermittent B) ADD-Vantage C) Minibag Plus D) Primary Answer: D Page Reference: 120 Learning Outcome: 5.3 8. Which of the following statements accurately represents both the ADD-vantage and Minibag Plus delivery systems?

A) Both will accommodate a standard 20 mm vial B) Drug vials are attached to the bag by nursing staff C) Nursing staff will activate vials to dissolve sterile powder before administering to a patient D) Infusions are administered over 2-4 hours Answer: C Page Reference: 121-122 Learning Outcome: 5.3

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Fundamentals of Sterile Products Preparation for Pharmacy Technicians, Canadian Edition 9. Part of the primary administration set that serves to automatically open or close during intermittent administration of a drug preventing backflow is: A) The drip chamber B) The roller clamp C) The connector D) The back-check valve Answer: D Page Reference: 126 Learning Outcome: 5.3 10. One characteristic of a secondary IV administration set is: A) Longer tubing than primary IV sets B) Used to piggyback intermittent IV medications C) A secondary set does not require a back-check valve D) Each set has a luer-lock connection at each end of the tubing Answer: C Page Reference: 126-127 Learning Outcome: 5.3 11. PICC vascular device is: A) Pharmacy Implemented Catheter Concept B) Peripheral Intravenous Catheter Clamp C) Peripherally Inserted Central Catheter D) Peripherally Inserted Control Catheter Answer: C Page Reference: 129 Learning Outcome: 5.5 12. Which of the following vascular devices is inserted percutaneously into a femoral vein?

A) Central Venous Access device B) Tunnelled vascular device C) Midline catheter device D) Non-tunnelled vascular device Answer: D Page Reference: 129 Learning Outcome: 5.5 13. Electronic devices such as positive pressure pumps are: a. Small, inexpensive disposable devices b. Devices that use clamps and a drip chamber to control the flow of solution c. Devices that have a relatively high error rate d. Devices that have an alarm system to detect occlusions and flow rate issues Answer: D Page Reference: 132 Learning Outcome: 5.5

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Fundamentals of Sterile Products Preparation for Pharmacy Technicians, Canadian Edition 14. Expiration date or Beyond-Use-Date is based on: A) The minimum time period in which 90% or greater of the active ingredient is measurable B) The maximum time period in which 10% or greater of the active ingredient is measurable C) The minimum time period in which 90% or less of the active ingredient is measurable D) The maximum time period in which 90% or greater of the active ingredient is measurable Answer: D Page Reference: 133 Learning Outcome: 5.6 15. Which of the following would be considered a chemical incompatibility?

A) Precipitation B) Oxidation C) Viscosity D) Crystallization Answer: B Page Reference: 133 Learning Outcome: 5.6 16. Which of the following stability factors would affect the acidity or alkalinity of an IV solution?

A) Temperature B) Contact time C) pH D) number of additives Answer: C Page Reference: 134 Learning Outcome: 5.6 17. Flow rates are commonly expressed as: A) mg/1 mL B) mL/hour C) drops/day D) mg/L Answer: B Page Reference: 134 Learning Outcome: 5.7 18. Calculate the infusion rate as milliters/hour for the following order.

1000mL Dextrose 5% to be infused over 20 hours A) 20 mL/hour B) 200 mL/hour C) 50 mL/hour D) 5 mL/hour Answer: C Page Reference: 136 Learning Outcome: 5.8

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Fundamentals of Sterile Products Preparation for Pharmacy Technicians, Canadian Edition

19. Calculate the flow rate in drops/minute for the following IV order. (round answer to a whole number) 1000 mL NaCl 0.9% to infused over 8 hours. IV administration set drop factor is 20 drops/mL A) 42 drops/minute B) 21 drops/minute C) 20 drops/minute D) 82 drops/minute Answer: A Page Reference: 136 Learning Outcome: 5.8 20. Calculate the flow rate in drops/minute for the following mg/kg/min dosing guideline.

Gentamicin 0.1 mg/kg/min Gentamicin IV solution: 5 mg/mL Administration set: 10 drops/mL

Patient weight: 15 kg

A) 30 drops/min B) 0.3 drops/min C) 15 drops/min D) 3 drops/min Answer: D Page Reference: 138 Learning Outcome: 5.8 21. Which of the following is NOT a limitation or disadvantage of a Volume Control Set? A) May be used for unstable drugs that have minimum fluid volumes B) Long travel distance before drug enters the body C) More nursing time required D) Risk of contamination during manipulations Answer: B Page Reference: 127 Learning Outcome: 5.4

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Fundamentals of Sterile Products Preparation for Pharmacy Technicians, Canadian Edition Chapter 6 Parenteral Nutrition 1. Each of the following ingredients can be found in Parenteral Nutrition solutions EXCEPT: A) Lactic Acids B) Dextrose C) Lipids D) Vitamins and Minerals Answer: A Page Reference: 146 Learning Outcome: 6.1 2. Patients who are in hypermetabolic states will often require nutritional support. Which of the following conditions would be considered a hypermetabolic state?

A) Liver failure B) Crohn’s disease C) Severe burns D) Chronic vomiting/diarrhea Answer: C Page Reference: 146 Learning Outcome: 6.2 3. Macronutrients include: A) Electrolytes B) Sodium Chloride solutions C) Proteins D) Minerals Answer: C Page Reference: 147 Learning Outcome: 6.3 4. Trace Elements are ingredients within the micronutrient grouping. They include: A) Zinc B) Chloride C) Magnesium D) Sulphate Answer: A Page Reference: 147 Learning Outcome: 6.3

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Fundamentals of Sterile Products Preparation for Pharmacy Technicians, Canadian Edition 5. Which of the following macronutrients provides 40-60% of total calories in a TPN admixture?

A) Proteins B) Carbohydrates C) Fats D) Vitamins and Minerals Answer: B Page Reference: 151 Learning Outcome: 6.3 6. Which of the following electrolytes is essential for muscle and cardiac function?

A) Magnesium B) Potassium C) Sodium D) Calcium Answer: D Page Reference: 152 Learning Outcome: 6.3 7. One indication for the addition of larger doses of potassium beyond the basic requirements is: A) Increased metabolic demands B) Increased levels of Sodium C) Anemia (reduction of red blood cells) D) Hyperlipidemia Answer: A Page Reference: 152 Learning Outcome: 6.3 8. Which of the following is a fat soluble vitamin?

A) Riboflavin B) Thiamin C) Folic Acid D) Vitamin D Answer: D Page Reference: 154 Learning Outcome: 3 9. One role a pharmacy technician would have as part of the Parenteral Nutrition team is: A) Participation in home care programs B) Generation of documentation and labels C) Administers parenteral nutrition solution D) Evaluates and develops nutritional regiments Answer: B Page Reference: 155 Learning Outcome: 6.4

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Fundamentals of Sterile Products Preparation for Pharmacy Technicians, Canadian Edition

10. Standardized parenteral nutrition orders will have standard formulations of varied concentrations of stable ingredients. Unstable ingredients will be added prior to administration. An example of an unstable ingredient is: A) Dextrose B) Proteins C) Electrolytes D) Vitamins Answer: D Page Reference: 156 Learning Outcome: 6.5 11. Manual compounding of a parenteral nutrition solution is: A) More precise and accurate than other methods B) Is the most cost-effective method C) less chance for human error and possible contamination D) can integrate manual compounding with barcode software Answer: B Page Reference: 162 Learning Outcome: 6.7 12. Which 2 ingredients must not be added closely together during the preparation process due to the formation of precipitate?

A) Calcium and Potassium B) Phosphate and Sodium C) Phosphate and Calcium D) Calcium and Acetate Answer: C Page Reference: 164 Learning Outcome: 6.8 13. Parenteral solutions must be refrigerated immediately upon release because: A) Nursing staff need to know where to locate their patient’s solution B) It will reduce the potential for component instability C) The environment of the plastic IV viaflex containers must stay cool D) The solution will infuse into the patient at a faster rate Answer: B Page Reference: 165 Learning Outcome: 6.8

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Fundamentals of Sterile Products Preparation for Pharmacy Technicians, Canadian Edition 14. Which parenteral administration method requires proper site disinfection and aseptic dressing care?

A) Central administration B) Peripheral administration C) Gravity method D) Infusion pump method Answer: A Page Reference: 166 Learning Outcome: 6.9 15. Chemical instabilities within the parenteral solution will often lead to what other instability?

A) Microbial contamination B) Solution consistency C) Toxicity D) Therapeutic instability Answer: D Page Reference: 166 Learning Outcome: 6.10 16. Calculate the volume of Amino Acid solution to be added to a TPN bag.

TPN order requires 80 g of Amino Acid. The manufacturer’s stock solution is 10% A) 800 mL B) 80 mL C) 100 mL D) 180 mL Answer: A Page Reference: 158-159 Learning Outcome: 6.6 17. Calculate the volume of Lipid solution to be added to a TPN bag.

TPN order requires 15 g of Lipids. The manufacturer’s stock solution is 20% A) 150 mL B) 75 mL C) 750 mL D) 300 mL Answer: B Page Reference: 158-159 Learning Outcome: 6.6

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Fundamentals of Sterile Products Preparation for Pharmacy Technicians, Canadian Edition 18. Calculate the volume of Dextrose to be added to a TPN bag.

TPN order requires 42 g of Dextrose. The manufacturer’s stock solution is 70% A) 31.5 mL B) 63 mL C) 60 mL D) 166 mL Answer: C Page Reference: 158-159 Learning Outcome: 6.6 19. Calculate the volume of Potassium Chloride to be added to a TPN bag.

TPN order requires: Potassium 60 mmol Phosphate (K+) 6 mmol Manufacturer’s stock solution: Potassium Chloride 2 mmol/mL A) 54 mL B) 27 mL C) 30 mL D) 15 mL Answer: B Page Reference: 159 Learning Outcome: 6.6 20. Total all the volumes of the answers from question 16, 17, 18, 19.

Also add 2 mL of Potassium Phosphate.

Now calculate the volume of water to provide a final total volume of 1800 mL for the complete TPN bag.

A) 838 mL B) 800 mL C) 836 mL D) 1036 mL Answer: C Page Reference: 160 Learning Outcome: 6

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Fundamentals of Sterile Products Preparation for Pharmacy Technicians, Canadian Edition Chapter 7 Preparation and Safe Handling of Hazardous Drugs 1. Drugs that are classified as hazardous are: A) Drugs that may only cause harm to the patient’s receiving them B) Drugs used for cancer treatment infused intravenously not orally C) Drugs that have the potential to cause cancer, toxicity and/or harm to organs D) Drugs that have the potential to cause cancer, toxicity and/or harm to humans and not animals Answer: C Page Reference: 175 Learning Outcome: 7.1 2. Hazardous drugs include drugs used for cancer treatment as well as: A) Fungal infections B) Psychological disorders C) Insulin D) Antiviral agents Answer: D Page Reference: 176 Learning Outcome: 7.1, 7.2 3. Which of the following malignancies would represent abnormal blood cells?

A) Lymphoma B) Leukemia C) Sarcoma D) Carcinoma Answer: B Page Reference: 177 Learning Outcome: 7.3 4. Personnel handling cytotoxic agents may be exposed by the following methods EXCEPT: A) Ingestion B) Absorption C) Inhalation D) Intravenously Answer: D Page Reference: 179 Learning Outcome: 7.4

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Fundamentals of Sterile Products Preparation for Pharmacy Technicians, Canadian Edition 5. Policies and procedures must be in place for handling and preparing cytotoxic agents. Which documents must be received from the manufacturer of these products?

A) Receiving documents B) Material Safety Data Sheets (MSDS) C) Purchasing orders D) Transportation documents Answer: B Page Reference: 181 Learning Outcome: 7.5 6. Which of the following groups is required to wear personal protective equipment?

A) pharmacy personnel preparing the products B) nursing personnel administering the products C) All personnel who may be potentially exposed to the products D) Only patients who are receiving the products Answer: C Page Reference: 180-181 Learning Outcome: 7.5 7. The Laminar Airflow Hood used for preparation of cytotoxic agents should be: A) Class I Type A BSC B) Class II Type B BSC C) Class I Type B BSC D) Class 5 Type ISO BSC Answer: B Page Reference: 182 Learning Outcome: 7.5 8. A device used to reconstitute sterile powder and transfer cytotoxic agents is called: A) Chemotherapy Transfer Device B) Cytotoxic Transfer Device C) Closed System Transfer Device D) Cytotoxic System Transfer Device Answer: C Page Reference: 182 Learning Outcome: 7.5

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Fundamentals of Sterile Products Preparation for Pharmacy Technicians, Canadian Edition 9. It is important for personnel preparing cytotoxic agents to be double gloved. Double gloving procedure includes: A) Thoroughly wash hands, drying of hands, one pair of gloves under the cuff of the gown and a second pair to be placed under the cuff as well B) Thoroughly wash hands, drying of hands, place 2 pairs of gloves on each hand pulling both gloves over top of the cuff of the gown C) Thoroughly wash hands, drying of hands, one pair of gloves placed under the cuff of the gown and a second pair to be placed over the cuff of the gown D) Thoroughly wash hands, drying of hands, place 2 pairs of gloves on each hand then put gown on. Ensure cuff of gown stays over top of gloves.

Answer: C Page Reference: 187 Learning Outcome: 7.5 10. It is important when withdrawing solution from a vial with a rubber stopper to: A) Create positive pressure within the vial B) Not create positive pressure within the vial C) Not create negative pressure within the vial D) create aerosolisation of the product Answer: B Page Reference 194 Learning Outcome: 7.5 11. Chemo spill kits must be available: A) In all areas that cytotoxic products are stored, prepared and administered B) Only in areas where cytotoxic products are prepared C) Only in areas where cytotoxic products are administered D) Only in the pharmacy Answer: A Page Reference: 195 Learning Outcome: 7.6 12. When a cytotoxic spill has occurred, what action must be completed first?

A) Contain the spill with paper towels B) Limit personnel in the immediate vicinity of the spill C) Personnel must put on personal protective equipment D) Neutralize the cytotoxic product with water Answer: B Page Reference: 196 Learning Outcome: 7.6

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Fundamentals of Sterile Products Preparation for Pharmacy Technicians, Canadian Edition 13. Most cytotoxic agents are administered intravenously via: A) A peripheral vein in the arm B) A peripheral vein in the hand C) A central vein directly D) A central vein through a venous catheter Answer: D Page Reference: 198 Learning Outcome: 7.6 14. Catheters must be routinely cleared of blockage by: A) Flushing with water B) Flushing with saline C) Flushing heparin and NS D) Flushing with heparin Answer: C Page Reference: 198 Learning Outcome: 7.6 15. Chemotherapy protocols and dosing are based on which of the following measurements?

A) Body weight (kg) B) Body Surface Area (BSA) C) Body Fat (%) D) Body weight (lbs) Answer: B Page Reference: 199 Learning Outcome: 7.7, 7.8 16. Using the nomogram (page 200), what is the BSA (m2) for a patient that is 140 cm tall and weighs 80 kg.

A) 1.64 m2 B) 2.0 m2 C) 1.68 m2 D) 1.46 m2 Answer: A Page Reference: 199-200 Learning Outcome: 7.7, 7.8

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Fundamentals of Sterile Products Preparation for Pharmacy Technicians, Canadian Edition 17. For the patient in question 16, this patient has been prescribed Ondansetron 0.5 mg/m2. What would the dose be in mg for this order?

A) 1 mg B) 0.84 mg C) 0.82 mg D) 0.73 mg Answer: C Page Reference: 203 Learning Outcome: 7.7, 7.8 18. Using the adult BSA formula (page 199), calculate the BSA (m2) for a patient who is 150 cm tall and weighs 70 kg. (round to one decimal place) A) 1.8 m2 B) 1.7 m2 C) 2.9 m2 D) 3.4 m2 Answer: B Page Reference: 201 Learning Outcome: 7.7, 7.8 19. For the adult patient in question 18, this patient has been prescribed Cisplatin 80 mg/m2/ day. To be given in 2 divided doses each day. What would each dose in mg be for this order?

A) 134 mg B) 144 mg C) 68 mg D) 72 mg Answer: C Page Reference: 203 Learning Outcome: 7.7, 7.8 20. If a patient is to receive Doxorubicin 90 mg daily x 5 days. For a total of 4 weeks.

What is the total accumulated amount of Doxorubicin this patient has received after 4 weeks? Represent your answer in grams.

A) 450 g B) 1.8 g C) 360 g D) 1800 g Answer: B Page Reference: 203 Learning Outcome: 7.7, 7.8

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Fundamentals of Sterile Products Preparation for Pharmacy Technicians, Canadian Edition Chapter 8 Compounding Specialty Parenteral Products 1. Specialty parenteral products include TPN, cytotoxic as well as ONE of the following: A) Cleansing agents B) Sterile water for injection C) Irrigation solutions D) Sodium Chloride IV solutions Answer: C Page Reference: 212 Learning Outcome: 8.1 2. According to USP Chapter <797> which of the following scenarios would indicate that the specialty product prepared has a high risk level of contamination?

A) A specialty product prepared with 2 sterile ingredients B) A specialty product prepared with nonsterile components C) A specialty product prepared with a unique formulation of 2 sterile ingredients D) A specialty product prepared not administered via the intravenous route Answer: B Page Reference: 212 Learning Outcome: 8.1 3. Requirements for preparing specialty parenteral products are the same as any parenteral product. They require: A) ISO class 7 Laminar Airflow Hood and ISO class 5 cleanroom B) Tertiary engineering controls C) Trained personnel and personal protective equipment D) A BSC Class II LAFH Answer: C Page Reference: 212 Learning Outcome: 8.2 4. The process of dialysis filters the blood of waste material when this major body organ is dysfunctional.

A) Liver B) Kidney C) Pancreas D) Gall Bladder Answer: B Page Reference: 212 Learning Outcome: 8.2

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Fundamentals of Sterile Products Preparation for Pharmacy Technicians, Canadian Edition

5. Which of the following statements best describes the difference between hemodialysis and peritoneal dialysis?

A) Peritoneal Dialysis is referred to as the “artificial kidney” : hemodialysis is referred to as the “functional kidney” B) Hemodialysis filters the patient’s blood through a semi-permeable membrane: Peritoneal Dialysis filters the patient’s blood through a sterile micron filter C) Peritoneal Dialysis drains the filtered waste products out of the peritoneal cavity then discarded: Hemodialysis drains the filtered waste products into the dialysate solution then discarded.

D) Hemodialysis and Peritoneal Dialysis both require hypotonic dialysate solutions Answer: C Page Reference: 213 Learning Outcome: 8.2 6. The osmotic component of dialysate solutions is commonly: A) Potassium B) Dextrose C) Sodium Chloride D) Calcium Answer: B Page Reference: 213 Learning Outcome: 8.2 7. Irrigation solutions may be similar to IV solutions but they must not be used: A) As a vehicle for antimicrobial agents to wash wounds and body cavities B) As an antimicrobial vehicle during procedures on open wounds C) As a vehicle for topical procedures of the bladder D) As a vehicle to reconstitute sterile powders for injection Answer: D Page Reference: 213 Learning Outcome: 8.2 8. An irrigation solution that may be used during urologic procedures to wash blood and remove surgical debris is: A) Ringer’s irrigation solution B) Neomycin and polymyxin B irrigation solution C) Sterile water for irrigation D) Acetic Acid solution for irrigation Answer: D Page Reference: 214 Learning Outcome: 8.2

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Fundamentals of Sterile Products Preparation for Pharmacy Technicians, Canadian Edition

9. Radiopharmaceuticals can be administered by the following routes EXCEPT: A) Subcutaneously B) Into a vein C) Orally D) Instilled into a body cavity Answer: A Page Reference: 215 Learning Outcome: 8.3 10. The most common application of radiopharmaceuticals is in diagnostics. This includes: A) Treating cancer of the thyroid B) Localizing tumours C) Treating cerebral blood hemorrhage D) Reducing the size of cancerous tumours Answer: B Page Reference: 215 Learning Outcome: 8.3 11. The Laminar Airflow Hood used for the preparation of Radiopharmaceuticals is: A) A BSC with a lead protection screen to protect the operator B) A BSC with a glass protection screen to protect the operator C) A BSC enforced with a non-reactive metal such as iron D) A BSC with a solid front protection screen to protect the operator Answer: A Page Reference: 215 Learning Outcome: 8.3 12. Each of the following statements describes the role of the Pharmacy Technician in the preparation of radiopharmaceuticals EXCEPT: A) Ability to perform calculations of both Curie and SI units of radioactivity B) Determine the required doses for each patient according to patient’s weight C) Perform precalibration and postcalibration activities D) Transcribe and generate computer labels Answer: B Page Reference: 216 Learning Outcome: 8.3

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Fundamentals of Sterile Products Preparation for Pharmacy Technicians, Canadian Edition 13. Ophthalmic preparations are topical products that are applied to the surface of the conjunctiva of the eye. The conjunctiva is: A) The inner corner of the eye next to the tear duct B) The white of the eyeball C) The coloured part of the eyeball D) The membrane covering the exposed surface of the eyeball Answer: D Page Reference: 216 Learning Outcome: 8.4 14. Which of the following may result in a reduction of the tear-holding capacity of the eye?

A) The pH of the eye B) The amount of blinking C) The type of contact lenses a patient wears D) Excessive rubbing of the eye Answer: B Page Reference: 217 Learning Outcome: 8.4 15. An ophthalmic preparation that dilates the pupil of the eye is called: A) Mydriatic B) Myotic C) Cycloplegic D) Vasoconstrictor Answer: A Page Reference: 218 Learning Outcome: 8.4 16. Naphazoline is an example of a product that alleviates eye redness. This product will A) Dilate the blood vessels of the eye B) Increase the amount of tears produced by the conjunctiva C) Constrict the blood vessels of the conjunctiva D) Reduce the intra-ocular pressure of the eye Answer: C Page Reference: 218 Learning Outcome: 8.4

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Fundamentals of Sterile Products Preparation for Pharmacy Technicians, Canadian Edition 17. The tonicity of ophthalmic preparations is commonly adjusted with: A) Sodium Acetate B) Sodium Chloride C) Sodium Phosphate D) Polyvinyl Chloride Answer: B Page Reference: 219 Learning Outcome: 8.4 18. Which of the following is NOT a common preservative used in ophthalmic preparations?

A) Methylcellulose B) Thimerosal C) Chlorobutanol D) Benzalkonium chloride Answer: A Page Reference: 221 Learning Outcome: 8.4 19. Allergenic extracts are prepared either as an aqueous concentrated solution or a solution containing: A) Mineral oil B) Isopropyl alcohol C) Sterile vegetable oils D) Glycerin Answer: D Page Reference: 222 Learning Outcome: 8.1 20. Specialty parenteral solutions used during open heart surgery are called: A) Irrigations solutions B) Non-electrolyte solutions C) Cardioplegic solutions D) Vasodilator solutions Answer: C Page Reference: 222 Learning Outcome: 8.1

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Fundamentals of Sterile Products Preparation for Pharmacy Technicians, Canadian Edition Chapter 9 Quality Assurance 1. Quality Assurance is defined as a system of steps and actions to ensure compliance with: A) Guidelines B) Policies C) Standards D) By-laws Answer: C Page Reference: 229 Learning Outcome: 9.1 2. Quality Assurance processes include each of the following EXCEPT: A) Personnel B) Facilities C) Storage D) Inventory control Answer: D Page Reference: 229 Learning Outcome: 9.1 3. Monitoring of the cleanroom environment includes air sampling. This must be conducted at least: A) Once a year B) Twice a year C) Every month D) Weekly Answer: B Page Reference: 230 Learning Outcome: 9.2 4. Surface sampling includes actively testing: A) Workbench of the Laminar Airflow Hoods B) Ceilings of the anteroom C) Door handles of the external door into the cleanroom D) The inside of containers from specific manufacturers Answer: A Page Reference: 231 Learning Outcome: 9.2

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Fundamentals of Sterile Products Preparation for Pharmacy Technicians, Canadian Edition 5. Temperature and humidity measurements of the cleanroom environment should ideally be: A) Temperature: 25° C Humidity: between 30 and 60% B) Temperature: 15° C Humidity: between 10 and 20% C) Temperature: 20° C Humidity: between 30 and 60% D) Temperature: 25° C Humidity: between 10 and 20% Answer: C Page Reference: 230 Learning Outcome: 9.2 6. Equipment testing of the Laminar Airflow Hood would include each of the following EXCEPT: A) HEPA filter efficiency B) Filter integrity bubble point test C) Air velocity D) Airflow consistency Answer: B Page Reference: 231 Learning Outcome: 9.2 7. According to USP Chapter <797> a 45 day Beyond-Use-Date limitation is applied to: A) All frozen products B) All cold storage temperature products C) All controlled room temperature products D) Only low risk products with the least amount of possible contamination Answer: A Page Reference: 233 Learning Outcome: 9.2 8. Scientific procedures that ensure a preparation meets all specifications of identity, strength, quality and purity is called: A) Quality Control B) Policies and Procedures C) Process Validation D) Quality process Answer: C Page Reference: 235 Learning Outcome: 9.2

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Fundamentals of Sterile Products Preparation for Pharmacy Technicians, Canadian Edition 9. Which of the following products would require either filter sterilization or terminal sterilization to ensure sterility?

A) Level 2 risk product B) Level 3 risk product C) Level 1 risk product D) Only products assigned as exempted from USP Chapter <797> Answer: B Page Reference: 235 Learning Outcome: 9.2 10. Training programs for personnel involved in sterile preparation should include: A) Observation only testing B) Observation and written testing C) Written testing only D) Observation, written and verbal testing Answer: B Page Reference: 234 Learning Outcome: 9.2 11. A chemical test that ensures the active ingredients are within acceptable levels till the end of the product’s shelf life is called: A) Purity B) Stability C) Potency D) Sterility Answer: C Page Reference: 237 Learning Outcome: 9.3 12. These products are usually made from sterile supplies and closed vessel technique using few manipulations.

A) Low and Medium risk level products B) Low risk level products only C) Medium risk level products only D) Medium and High risk level products Answer; A Page Reference: 238 Learning Outcome: 9.3

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Fundamentals of Sterile Products Preparation for Pharmacy Technicians, Canadian Edition 13. The simplest way to check for container integrity of plastic containers is: A) Shake the product B) Drop the product on the workbench C) Squeeze the container D) Inspect the container against a light Answer: C Page Reference: 237 Learning Outcome: 9.3 14. This quality control test ensures essential components meet compendia standards.

A) pH B) purity C) stability D) strength Answer: B Page Reference: 237 Learning Outcome: 9.3 15. A quality control test that involves a media fill procedure should include multiple manipulations using all of the following EXCEPT: A) Glass beakers B) Glass ampoules C) Glass vials D) Empty sterile bags Answer: A Page Reference: 237 Learning Outcome: 9.3 16. Microbiological sterility testing that requires a sample number of units to be tested is often dependant on: A) The number of personnel preparing the products B) The batch size C) The type of medication D) The type of Laminar Airflow Hood that was used in the process Answer: B Page Reference: 239 Learning Outcome: 9.3 17. Which of the following cannot be detected by using the traditional “rabbit test”?

A) Endotoxins of cytotoxic agents B) Endotoxins of dialysate solutions C) Endotoxins of allergenic extracts D) Endotoxins of radiopharmaceuticals Answer: D Page Reference: 240 Learning Outcome: 9.3

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Fundamentals of Sterile Products Preparation for Pharmacy Technicians, Canadian Edition 18. Which of the following best describes the LAL (limulus amoebocyte lysate) test?

A) It is less sensitive than the traditional “rabbit test” B) It detects the presence of bacterial endotoxins C) It uses the blood cells of horses D) The test must be used in containers that have been steam sterilized.

Answer: B Page Reference: 240 Learning Outcome: 9.3 19. Before outsourcing sterile products preparations, a hospital should conduct a: A) Departmental survey B) Patient survey to determine what is important to them C) Cost analysis D) Review of current error rates within the hospital department Answer: C Page Reference: 241 Learning Outcome: 9.4 20. What was the major incident that recently occurred in Canada that changed the licensing and supervision of sterile compounding facilities?

A) Antibiotic formulation error B) Oncology sterile preparation error C) TPN calculation error D) Radiopharmaceutical contamination error Answer: B Page Reference: 241 Learning Outcome: 9.4

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