Sterile Compounding

Hospital pharmacies, home infusion pharmacies, retail pharmacies, clinic pharmacies, nuclear pharmacies and compounding pharmacies (and the Joint Commission and American Society of Health‑System Pharmacists) follow this set of standards and procedures when preparing compounded sterile products: Answer A USP 71 B USP 795 C USP 797 D USP 1000 E USP 1251

797 USP Chapter 797: Pharmaceutical Compounding--Sterile Preparations.

Compounded sterile products (CSP) must meet each of the following requirements except: Answer A The osmolarity should be hypotonic to human blood. B The pH should be close to 7. C The osmolarity should be close to 285 mOsm/L. D There should be no leaching of compounds in the container (IV bag) into the IV fluid. E There should be no sorption of the drug in the solution into the IV container.

A

Which type of alcohol is used to both clean sterile compounding hoods and clean gloves after they are donned? Answer A 70% isopropyl alcohol B 90% isopropyl alcohol C 70% isopropyl alcohol treated with BAK D 90% isopropyl alcohol treated with BAK E 70% isopropyl alcohol diluted in half (35%) with sterile water

A 70% isopropyl alcohol (IPA) is squirted on gloved hands (after the gloves are donned) and on a regular basis; contamination from the compounding staff is the top source of contamination and this helps reduce the risk.

Which of the following sterile compounding monitoring parameters is correct according to USP 797? Answer A Air sampling is done at least every 6 months. B Surface sampling is done daily. C HEPA filter pressure is checked weekly. D Gloved fingertip testing is done daily. E The clean room air temperature is taken twice daily (minimally).

A Air sampling is done every 6 months. Air sampling can be done by the certifier who also comes every 6 months to certify the area), or by trained compounding personnel. Every 6 months means the same as "semi-annually." USP 797 does not specify a schedule for surface sampling using agar plate tests; it says the sampling should be done "periodically." HEPA filter pressure is checked with each shift (preferably) or at least daily. The only thing taken daily is the temperature

Which CSP risk level does not match its correlating compounding locations? Answer A Low-risk: ISO Class 5 PEC, ISO 8 buffer area, ISO 8 ante area B Low-risk with < 12 hour beyond use date: ISO Class 5 PEC segregated from other areas C Medium-risk: ISO Class 5 PEC, ISO 7 buffer area, ISO 8 ante area D High-risk: ISO Class 5 PEC, ISO 7 buffer area, ISO 7 ante area E Immediate-use: Area should be clean, uncluttered, and functionally separate

A Low-risk: ISO Class 5 PEC, ISO 7 buffer area, ISO 8 ante area.

Which of the following compounds can be safely sterilized using an autoclave? (Select ALL that apply.) Answer A Cephalexin B Insulin glargine C Insulin aspart D Procrit E Levothyroxine

A Steam sterilization (with moist heat) is done in an autoclave. The heat denatures the proteins of microorganisms (heat is lethal to the organism). Heat denatures proteins and can destroy other sensitive drugs. The drugs listed above are heat labile (destroyed by heat; the hormones listed are all proteins, and cannot be heated in any manner without destroying the drug.

Choose the correct statement for items placed between the area in the laminar flow hood where compounding takes place and the HEPA filter: Answer A Nothing must be placed between the HEPA filter and the critical compounding area. B Only bags of sterile water for injection and bacteriostatic water are permitted in this space; these are used often in compounding. C Only the calculator and writing instrument used for the dose calculation can be stored here. D Only particle-free writing paper can be placed here. E Only particle-free syringes and bags can be stored here.

A The air described in the question is called the First Air Zone; this is a critical place for contamination and the HEPA filter must be kept clear. Calculators and writing instruments are never placed or brought into the hood.

Elmer Langley has recently taken a new position as pharmacist compounding supervisor. He notices that the laminar flow hood is kept running at all times, even when the pharmacy is shut down from 12:00 AM - 5:00 AM. Select the correct statement: Answer A This is adequate; the laminar flow hood is kept continuously running all the time. B This is inadequate; the laminar flow hood is kept continuously running only when the pharmacy is open. C This is adequate; the laminar flow hood is kept continuously running only when the pharmacy is open but requires an 8-hour interval daily when the machine is turned off. D This is adequate; the laminar flow hood is kept continuously running only when the pharmacy is open but requires an 9-hour interval daily when the machine is turned off. E This is adequate; the laminar flow hood is kept continuously running only when the pharmacy is open but requires an 12-hour interval daily when the machine is turned off.

A The hood should be left running at all times. When it is shut off contamination will start to collect. If, however, the hood is turned off it must run for a set period of time prior to use (generally at least 30 minutes) and then be adequately cleaned prior to use.

Select the correct example of a CSP prepared with a USP rating of immediate-use risk level: Answer A Amiodarone infusion given to a patient who has just been brought to the hospital in ventricular fibrillation. B Claforan injection given to a pediatric patient in the neonatal ICU. C Preparing syringes in a batch. D CSPs that have been sterilized with an autoclave. E CSPs that have been filtered with a 0.22 micron filter.

A The immediate-use provision is intended only for those situations where there is a need for emergency or immediate patient administration of a CSP, such as CPR, emergency department treatment, preparation of diagnostic agents, or critical therapy where the preparation of the CSP under low-risk conditions would put the patient at serious risk of harm. V-fib can cause death from cardiac arrest within minutes and must be treated quickly in the emergency department.

Which of the following requirements applies to sterile IV preparations (except hazardous drugs): (Select ALL that apply.) Answer A Positive pressure hood B Negative pressure hood C ISO 5 PEC or better D ISO 7 PEC or better E Gloves and masks only; gowns are required only for hazardous drug preparation.

A & C Positive pressure means the air in the hood flows out (toward the compounder). If the compounder sneezes in the room it should not contaminate the hood. On the other hand, the compounder must be protected from breathing in hazardous drugs, which is why chemotherapy and other hazardous drugs have negative pressure and are vented to the outside.

Which of the following can be classified as a primary engineering control (PEC)? (Select ALL that apply.) Answer A A device or room that provides an ISO Class 5 environment for compounding which relies on a special type of high-efficiency particle air (HEPA) filter. B A Class II biological safety cabinet. C An ante room to garb before preparing sterile products. D A compounding aseptic isolator device. E A buffer area that provides an ISO Class 7 environment.

A,B,D PECs require a special type of HEPA filter that is not found in ante rooms. PECs provide the ISO Class 5 environment needed for compounding CSPs.

Select the correct requirements for compounding chemotherapy drugs: (Select ALL that apply.) Answer A A negative pressure hood B A positive pressure hood C ISO 5 PEC or better D ISO 7 PEC or better E A hood vented to outside air

A,C,E A negative pressure hood that is vented to the outside. It must be ISO 5 (or better

Which of the following drugs does not have a CSP risk level assigned to it by the USP? (Select ALL that apply.) Answer A Hospira's fluconazole injection in dextrose 400 mg/200 mL ready-to-use IV bag B An order received for vancomycin 1.25 grams in 250 mL NS, prepared by pharmacy C Unasyn 3 grams reconstituted with SWFI in 50 mL NS D Rocephin 1 gram/50 mL 0.45% Sodium Chloride Injection, Add-Vantage E Tobramycin 30 mg in 100 mL RTU IV piggyback

A,D,E Injections that are reconstituted or prepared by pharmacy or at an alternate location have risk levels; the examples checked come in a prepared, enclosed formulation that retains sterility, such as the Vial2Bag and Add-Vantage systems.

Proper labeling and packaging of CSPs are crucial for patient safety. The following must be included on the labeling of CSPs: (Select ALL that apply.) Answer A Generic name and concentrations of active ingredients B Beyond use date (BUD) and date of preparation C Route, administration rate, storage and handling requirements D Identification of responsible compounding personnel E Appropriate auxiliary labels

All

Janitors that clean the clean-room area must provide or have the following: I. Training in the cleaning procedure. II. Cleaning equipment for this area that is separate from other cleaning equipment. III. Documentation of the training completed and documentation of the cleaning.

All Documentation is always required of all procedures that remove contamination risk. The personnel who work in compounding must calibrate the equipment used on a daily basis (and be trained in the calibration). They must have training in the proper use of all equipment. The training and the calibration must be documented

High-risk compounded sterile preparations (CSPs) generally require sterility testing prior to use. Which of the following statement/s are correct: (Select ALL that apply.) Answer A Tryptic soy broth (TSB) can be used for sterility testing. B Fluid thioglycollate medium (FTM) can be used for sterility testing. C Sterility testing should include detection of bacterial endotoxins. D Finished products should be individually inspected immediately after preparation against a dark background for particulates, foreign matter, precipitates, and cloudiness. E Batches of more than 25 identical, single-dose, high-risk CSPs must always be tested for sterility.

All are correct

Select the correct statement/s as it pertains to garbing before compounding sterile preparations: (Select ALL that apply.) Answer A Artificial and long nails are not permitted B Disposable gowns are required C Sterile, powder-free gloves are required D Compounding personnel must completely re-garb if they leave the ante room E Garbing refers to protective gear that is put on before entering a cleanroom

All except B Disposable gowns are preferred but not required. If gowns are reusable, they must be laundered prior to reuse.

Which of following statements regarding the beyond use date (BUD) is correct? (Select ALL that apply.) Answer A Stability testing and expirations of the individual components can override the recommended BUD of the final prepared product. B The BUD is a label requirement only if the product has been prepared in a batch (25 or more units). C The BUDs for nonsterile products are usually longer than those for sterile products. D The BUD for a low-risk level CSP stored at room temperature is 48 hours. E The BUD for a high-risk level CSP stored at room temperature is 24 hours.

All except B The BUD is required on all CSPs.

Which of the following require sterile preparation at the pharmacy when preparing medications for patient use? (Select ALL that apply.) Answer A IV bags containing parenteral nutrition B Tissue soaks for organ transplants C IV bags containing 3 individual components or less D Point-of-care activation systems such as Add-Vantage vial/bag systems and premixed ready-to-use bags E Ophthalmics and inhalations that are not prepackaged and must be prepared

All except D Vial/bag systems and premixed ready-to-use bags are closed systems that only require labeling.

Select the correct statements regarding cleaning and disinfecting the pharmacy's sterile compounding area: I. Clean with a germicidal detergent, followed by sterile 70% IPA. II. Clean from the dirtiest areas (first) to the cleanest areas. III. The buffer area must be cleaned at the beginning of each shift, before each medication batch, after spills or if contamination is suspected, and every 30 minutes of continuous use. IV. Counters, work surfaces and floors are cleaned daily, and the walls, ceiling, and storage shelves are cleaned monthly.

All except II Clean from the cleanest areas (first) to the dirtiest areas. If this is done in reverse, the dirt will contaminate the clean surfaces.

Define the beyond use date (BUD) for a compounded sterile product (CSP): Answer A The date or time at which the CSP should not be used. B The date or time at which the CSP should not be used or started. C The date or time at which the CSP should not be started. D The last permissible date to use the product. E The date or time at which the CSP infusion must be completed.

B

Select the test that confirms that the filter used for sterile filtration has integrity (which includes that the pore is not clogged): Answer A The gloved hands test. B The bubble-point test. C The TSB test. D The FTM test. E The TSB and FTM tests.

B

Leila Chow is a staff pharmacist who is preparing Amphotec for an AIDS patient with invasive aspergillosis. Ms. Chow will need to reconstitute the medication prior to injecting it into the IV bag. Which statement is correct? Answer A The reconstitution must be done with distilled water that has been sterilized with heat. B The reconstitution should be done with sterile water for injection (SWFI or SWI). C The reconstitution should be done with bacteriostatic water only. D The reconstitution should be done with water treated with polysorbate and benzalkonium chloride. E The reconstitution of Amphotec requires using an alcohol-based solution.

B For an intravenous medication reconstitution, sterile water for injection is most commonly used. The best practice to use when reconstituting an oral medication (such as an antibiotic suspension) is to use purified or distilled water since tap water may be contaminated. Bacteriostatic water is also sterile water that is used for injection but contains 0.9% benzyl alcohol that is used so that the medication container can be entered multiple times (still using a sterile needle). The benzyl alcohol is what is bacteriostatic; it suppresses the growth of bacterial contaminants.

Select the correct statement concerning aseptic technique and contamination: Answer A When cleaning sterile preparation areas, always start with the dirtiest areas first and end with the cleanest. B Most contamination arises from compounding personnel violating procedures, such as improper garbing. C Most contamination arises from defective HEPA filters. D It is not recommended for compounding personnel be continuously trained and assessed for aseptic technique, as this is not cost-effective. E Environmental monitoring for the number of colony forming units (CFUs) is not necessary if adequate aseptic technique is demonstrated by all compounding personnel.

B Personnel violating procedures (such as wearing contaminated objects into the cleanroom, touching their face, fixing their hair, or improper garbing) are the leading cause of CSP contamination.

Which of the following statements is correct concerning the sterility level in the primary engineering control (PEC) room? Answer A An ISO Class 7 PEC is required. B The smaller the number, the cleaner the air (such as ISO 5 versus ISO 7). C All PECs rely on 0.22 micron filters for air quality control. D HEPA filters that remove at least 94% of particulate matter are required in clean rooms. E HEPA filters can remove particles as small as 10 microns.

B ISO Class 5 hoods must not have more than 100 particles per cubic foot air. All PECs rely on HEPA filters, which remove > 99.97% of particles as small as 3 microns.

Which of the following does not meet the criteria relating to an immediate-use CSP? Answer A Administration must occur within 1 hour of the prepared product. B Compounding must take place in an ISO Class 5 environment. C Preparation may take place near an accident site where emergent preparation is warranted. D A situation where adhering to low-risk compounding procedures would add additional risk due to delays in patient care. E May take place outside of healthcare facilities, such as home infusion.

B Immediate-use CSPs only require that the area be clean, uncluttered, and functionally separate.

Laminar air flow in a sterile compounding hood means the following: Answer A The air flow is bidirectional. B The airflow is unidirectional. C The airflow is described as turbulent. D The airflow is described as vertical and turbulent. E The airflow is described as horizontal and turbulent.

B In laminar flow hoods the air flow is in one direction only, in either a horizontal or vertical flow. The air exiting the HEPA filter is called first-air and is nearly particle-free; to keep it that way, only critical compounding manipulations (such as inserting the drug into the IV bag with a syringe) is permitted in the first-air zone.

Select the correct statement/s concerning sterile medication compounding: Answer A If a pharmacist has 1, 3, 5, 7.5 and 10 mL syringes and need to draw up an 8 mL dose, the highest accuracy would be to use the 5 mL and the 1 mL (three times) to equal the dose. B If a pharmacist has 1, 3, 5, 7.5 and 10 mL syringes and need to draw up an 8 mL dose, the highest accuracy would be to use the 10 mL syringe. C If a pharmacist has 1, 3, 5, 7.5 and 10 mL syringes and need to draw up an 8 mL dose, the highest accuracy would be to use the 3 and 5 mL syringes to equal the dose. D Medication vials with rubber tops should be swabbed with SWFI prior to use. E Always work toward the sides of the hood so the HEPA filter flow is not blocked.

B Leave 6 inches clear from the front edge of the hood. For greatest accuracy, use the exact syringe or the next size up. In this question, the 10 mL syringe should be used. Do not use two syringes for one dose. Medication vials with rubber tops should be swabbed with 70% IPA prior to use. Always work in the center of the hood, which has the lowest contamination.

Which of the following is an incorrect statement as it pertains to ISO classification in sterile compounding? Answer A The ISO classification refers to the number of particles that are permitted per volume of air. B All primary engineering controls (PECs) must be ISO Class 7. C The buffer area must be ISO Class 7. D The smaller the ISO number, the cleaner the air. E The ante room can be ISO Class 8 if it opens into a positive pressure ISO Class 7 clean room (buffer area).

B PECs must be ISO 5

Which of the following statements is accurate for low-risk with < 12-hour BUD CSP according to USP? Answer A The BUD at room temperature, refrigerated or frozen is 12 hours. B The BUD at room temperature and refrigerated is 12 hours. C The medication can be stored only at room temperature, and must be used within 12 hours. D It would not be acceptable to prepare the medication in a satellite pharmacy that contained an ISO Class 5 hood because the preparation of CSPs requires a dedicated clean room. E A vial of naloxone pulled from an emergency crash cart for immediate use in the critical care step-down unit is considered low-risk.

B These are often prepared in a satellite pharmacy that contains an ISO Class 5 hood. A satellite pharmacy refers to a pharmacy that is located in a patient care area and where the medications for patients are prepared nearby. It is away from the main (central) pharmacy location in a hospital. It must be staffed by at least 1 pharmacist. These are much smaller and are "decentralized" versus the central pharmacy where most medications are prepared. The advantage is that the pharmacist is able to interact with other healthcare professionals and patients.

Benjamin Glass is the staff pharmacist who has been charged with supervising the clean room. He is going to document that the proper procedure per USP 797 is being used to decontaminate the clean room surfaces. Which procedure is correct? Answer A Tryptic soy agar plates with BET are used to check for surface contamination. B Tryptic soy agar plates with polysorbate 80 and lecithin are used to check for surface contamination. C Tryptic soy agar plates with polyethylene glycol 3350 (PEG 3350) are used to check for surface contamination. D Tryptic soy agar plates with TSB and FTM are used to check for surface contamination. E Tryptic soy agar plates with TSB and LAL are used to check for surface contamination.

B Tryptic (also called Trypticase) soy agar plates (TSA) and lecithin and polysorbate 80 sterile pack plates are used for the detection and enumeration of microorganisms present on surfaces of clean rooms. Lecithin is added to neutralize quaternary ammonium compounds and polysorbate 80 is added to neutralize substituted phenolic disinfectants in the agar-filled plates.

A pharmacist intern is being trained in sterile technique. She asks "which are the correct type of gloves required for use in the buffer area by the compounding technician?" Select the correct response: Answer A Non-sterile, powder-free gloves B Sterile, powder-free gloves C Non-sterile, powdered gloves D Sterile, powdered gloves E Sterile gloves, with double gloves worn at all times

B When the gloves are donned, they are sterile. They become contaminated when the compounder is handling non-sterile objects during the compounding processes. This is why they can be disinfected with sterile 70% IPA (rather than being replaced with new sterile gloves). Two pairs of gloves used at the same time (double gloving) is required for certain toxic drugs only. If a glove tears it is replaced immediately.

CSPs that require sterility testing (for example, if they may be used outside of the beyond use date period) can receive sterility testing using either tryptic soy broth (TSB) or fluid thioglycollate medium (FTM). If bacteria grows the IV medication is contaminated. In addition to either TSB or FTM, the medication must also be tested with the following test: Answer A CSP B BUD C NOA D ASH E BET

BET The two test broths mentioned in the question are used to identify a wide variety of organisms but do not identify the presence of bacterial endotoxins (pyrogens). The bacterial endotoxin test (BET) must also be used.

Elmer Jack is a technician whose work primarily involves preparing CSPs in the primary engineering control (PEC, in the hood). When he is done adding all the medications and other additives to the bag, he holds the compounded product up against a dark background for inspection. He lightly squeezes the bag. Why does Elmer Jack practice this technique? Answer A He is making sure the label includes the proper drug/s and additives. B He is checking to confirm that the solution is slightly cloudy, which indicates that the drug/s have been added and squeezes the bag to lightly mix the contents. C He is checking the solution for components that are not desired (such as particulates or discoloration) and for leakage. D Mr. Jack should be instructed to hold the bag up to a light background (not dark) and not to squeeze the bag as this can cause breakage. E Mr. Jack should be instructed not to squeeze the bag as this can cause breakage.

C

Which of the following conditions are accurate for storage of a high-risk CSP according to USP? Answer A 24 hour BUD at room temperature, 6 days refrigerated, 60 days frozen. B 30 hour BUD at room temperature, 9 days refrigerated, 45 days frozen. C 24 hour BUD at room temperature, 3 days refrigerated, 45 days frozen. D 12 hour BUD at room temperature, 12 days refrigerated, frozen not applicable due to conditions of use. E 24 hour BUD at room temperature, 3 days refrigerated, 60 days frozen.

C

Select the best method to prevent CSPs from pyrogen contamination: Answer A Filtration using a 0.22 micron filter. B Proper hand washing and garbing technique. C Rinsing glassware with sterile water followed by dry heat sterilization. D Using the BET test with LAL. E Using the CDC's reagent test for pyrogens.

C Bacterial endotoxins usually come from tap water, which is why glassware is rinsed with sterile water and then dry-heat sterilized. The BET test identifies pyrogen presence in the solution.

Which of the following is incorrect regarding bacterial endotoxins (pyrogens)? Answer A The reagent for the bacterial endotoxins test is called Limulus Amebocyte Lysate (LAL). B Pyrogens can arise from using equipment that has been washed with tap water. C Endotoxins from Gram-positive bacteria are the most potent and most lethal. D Glassware and utensils should be rinsed with sterile water and de-pyrogenated using dry-heat oven sterilization. E Endotoxins are produced by Gram-positive and Gram-negative bacteria as well as fungi.

C Gram-negative endotoxins are the most potent and the most lethal.

A hospital pharmacist is attempting to manage a tobramycin shortage. He had prepared tobramycin CSPs for later-use 15 days ago and has stored the CSPs in the refrigerator, with adequate temperature control. He would like to send the tobramycin to the critical care unit to treat a patient who needs the drug. Which of the following statements is correct? Answer A This is permissible because 45 days at controlled refrigerator temperature have not been exceeded. B This is permissible if the pharmacist puts the tobramycin bags into an autoclave to kill off any microorganisms that may now be present. C This is permissible if the pharmacist conducts a sterility test, with adequate results. D This is not permissible; it is beyond the 48-hour time limit. E This is not permissible; it is beyond the 14-day limit.

C In the absence of a passing a sterility test, the USP beyond use dates/storage duration limits will apply. A 45-day limit applies only to CSPs that have been kept frozen. This preparation has a 14-day limit when kept refrigerated unless sterility testing proves otherwise.

Which parameter matches its appropriate monitoring frequency in sterile compounding settings? Answer A Temperature; weekly B HEPA filter pressure; weekly C Qualified outside expert to certify the area; every 6 months D Gloved fingertip sampling; daily E Air sampling by compounding personnel; annually

C Temperature; daily (minimally). HEPA filter pressure; each shift (preferably) or daily (minimally). Gloved fingertip sampling; at initial training, then annually (low-medium risk) or semi-annually (high-risk). Air sampling; every 6 months.

A pharmacy technician is asked to sterilize compounded preparations that are heat labile. She is asked to do a bubble-point test before performing a certain type of sterilization method. What is the purpose of the bubble-point test? Answer A To test if the ethylene oxide gas being used is flammable. B To test the levels of ionized radiation being used. C To test the filter integrity when sterilizing with filtration. D To test the amount of pressurized steam in the autoclave. E To test the melting point of a compounded sterile preparation.

C The bubble-point test uses pressure to force the liquid to "bubble" out of the filter, and is used when sterilizing with filtration, as opposed to autoclaving or dry heat sterilization or gas sterilization. The bubble-point test uses a 0.22 micron filter.

Select the correct reason why IV medications can cause severe infections: Answer A They are often contaminated with microorganisms. B They are often contaminated with microorganisms and pyrogens. C They bypass the skin and gastrointestinal tract. D They are often contaminated due to improper hand cleaning. E IV medications that are contaminated are not likely to cause severe infections.

C The skin is a major protective barrier from infection and other toxicity. Many organisms would not survive through gut passage (neither would most hormones and other proteins, which most commonly cannot be given orally).

A generic drug manufacturer produces tablets in 2.5 mg, 5 mg and 10 mg strengths. The manufacturer has tested a batch of the 10 mg tablets and finds that the dosage contained is 8 mg with a standard deviation (SD) of 1 mg. The manufacturer should issue this type of recall: Answer A Class I recall B Class II recall C Class III recall D Class IV recall E Class V recall

C There are 3 classes of recalls. Class I recall: a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. Class II recall: a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. Class III recall: a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences

Choose the correct statement/s regarding practices to help ensure the sterility in a laminar flow hood: (Select ALL that apply.) Answer A Do not interrupt the flow of air by placing items in the hood all lined up across the front of the hood; items should be placed in a straight line behind one another. B Use of a mask that covers the nose and mouth is required for regular hoods, but not for laminar flow hoods if the drug is not hazardous. C Preparation should be at least six inches into the hood. D Only the pen and calculator being used in the compounding that is being prepared can be used in the hood. E Laminar flow hoods should be cleaned at least at the start of each shift, but more frequently depending on use.

C & E Items in the hood should be placed side by side, or the smooth flow of air is interrupted and the hood is subject to contamination. Never put items like pens or calculators in the hood. Always use a mask that covers the nose and mouth. Additional garb is required for chemotherapy and other hazardous drugs, such as double gloving.

Contaminated steroid injections sent all over the country by a compounding pharmacy in Massachusetts caused fatalities from fungal meningitis, and many cases of severe illness. What type of recall was required for this event? Answer A The steroid injections were subject to a Class I recall. B The steroid injections were subject to a Class II recall. C The steroid injections were subject to a Class III recall. D The steroid injections should not be subject to a recall of any type. E A recall of the pharmacy staff responsible for preparing the contaminated steroid injections.

Class I Class I recall: a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. Class II recall: a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. Class III recall: a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

Select the incorrect statement as it relates to laminar flow hoods: Answer A Laminar flow hoods are kept running and continuously cleaned. B Chemotherapy preparation should be done in a vertical airflow hood versus a horizontal airflow hood. C All water used for cleaning surfaces must be sterile water and is followed by 70% isopropyl alcohol for disinfecting. D When drawing up medication out of a glass ampule into a syringe, the needle must be changed when inserting the contents of that syringe into an IV bag. E Cleaning the hood with 70% isopropyl alcohol must be done in a circular motion starting from the front of the hood.

Cleaning the hood with 70% isopropyl alcohol must be done in a side-to-side motion starting from the back of the hood.

Drug recalls can include drugs that are often used for sterile compounding. If a drug manufacturer issues a Class II recall, what does this entail? Answer A A situation in which exposure is not likely to cause adverse health consequences. B A situation in which there is a reasonable probability that exposure will cause serious adverse health consequences. C A situation in which there is a reasonable probability that exposure may cause death. D A situation in which exposure can cause temporary or reversible adverse health consequences. E A situation in which only FDA labeling requirements have been violated.

D

Which CSP risk level does not match the corresponding category of preparations? Answer A Low-risk: Only sterile ingredients and equipment limited to transfer, measuring and mixing of three or fewer components. B High-risk: Nonsterile ingredients or equipment that requires terminal sterilization of all preparations. C Medium-risk: Individual or small doses of sterile products are combined with complex aseptic manipulations. D Medium-risk: Nonsterile ingredients or equipment with complex aseptic manipulations that do not require terminal sterilization of preparations. E Immediate-use: Emergency administration of preparations for use within 1 hour.

D Medium-risk CSPs do not use nonsterile ingredients (only high-risk CSPs).

Select the best example of a CSP prepared with a USP rating of high-risk: Answer A An Add-Vantage container of Tazicef. B A CSP stored for 5 days in the pharmacy cold storage refrigeration unit. C A CSP stored for 7 days in the pharmacy cold storage refrigeration unit. D Non-sterile ingredients put into a sterile container. E A CSP that has been sterilized and tested for endotoxins.

D Non-sterile ingredients put into a sterile container or are put into a non-sterile container prior to sterilization, and products exposed to air quality inferior to ISO Class 5 (higher ISO rating, such as ISO Class 7) would be high-risk and would require terminal sterilization (this means the CSP is sterilized in it's "terminal" or final container that will be used to administer the drug to a patient.) High-risk CSPs cannot be stored in the refrigerator for more than 3 days or kept frozen for more than 45 days. At room temperature, high-risk CSPs are good for 24 hours.

Select the correct statement pertaining to contamination and sterile compounding: Answer A Positive pressure keeps contaminated air from exiting the hood. B A biological safety cabinet is where bulk drug containers can be stored for future preparation. C Negative pressure should never be used for hazardous drugs because it can endanger compounding personnel. D If performing high-risk compounding, the buffer area must be in a separate room or done with an aseptic isolator device. E Negative pressure keeps contaminated air from entering the hood.

D Positive pressure keeps contaminated air from entering the hood. Negative pressure keeps contaminated air from exiting the hood, and is required for hazardous drugs. A biological safety cabinet is also referred to as the "hood.

Sterile compounding manipulations, such as inserting medication into an IV bag or preparing an irrigation, are performed in this space (select the best response): Answer A A separate work area in the pharmacy that is not used for non-sterile compounding or other work functions. B The compounding space. C The ante room. D The CSP. E The buffer area.

E

Which of the following statement/s are correct regarding the use of intravenous (IV) medications in the hospital setting? Answer A IV administration of medication carries the lowest risk of infection to the patient because it bypasses the skin barrier and gastrointestinal tract. B IV solutions should be hypotonic so that the osmotic pressure matches to human blood of 285 mOsm/L. C IV solutions should be hypertonic so that the osmotic pressure matches to human blood of 285 mOsm/L. D Less than 10% of medications used in the hospital setting are given IV, so the risk of an adverse reaction occurring via contamination is extremely low. E The pH of IV solutions should be close to neutral (pH of 7), as blood is slightly alkaline at pH of 7.35 - 7.45.

E 50% of medications given in the hospital are IV. They have a higher risk of contamination because they bypass the protective mechanisms of the skin and GI tract. IV solutions should be isotonic to match the osmolarity of blood (285 mOsm/L).

Romeo Langley is a pharmacist who runs the sterile compounding room at a major hospital in New York. He prefers to avoid gas sterilization for the high-risk CSPs whenever possible for this primary reason: Answer A The gas is nitrous oxide and makes the pharmacy staff in the immediate vicinity disoriented and "giggly." B The gas contaminates the compounded sterile products (CSPs). C The gas (ethylene oxide) does not properly sterilize drugs prepared for human use. D The gas contains petroleum distillates. E The gas (ethylene oxide) is toxic when inhaled and flammable if exposed to gas.

E Another sterilization option that has toxicity and is used uncommonly is ionizing radiation. Both ethylene oxide (gas sterilization) and radiation are adequate sterilization techniques if they did not have toxicity concerns (and with gas, flammability concerns).

Select the name of the room where compounding staff perform hand hygiene: Answer A The primary engineering control B The ISO room C The wash and storage area D The biological safety cabinet E The ante room

E Garbing, CSP labeling and other procedures that release a high amount of particulates are done in the ante room, also called the ante-area. The ante room leads into the sterile IV compounding room (where the hood is located).

How often should the laminar flow hood within the buffer area be cleaned when compounding sterile preparations? Select the best answer: Answer A Daily B Twice a day C Every 60 minutes of continuous compounding periods D Every 45 minutes of continuous compounding periods E Every 30 minutes of continuous compounding periods

E The ISO Class 5 PEC area (e.g., laminar flow hood) within the buffer area is where sterile preparations are compounded. It should be cleaned at the beginning of each shift, before and after each batch, after spills, every 30 minutes of continuous compounding periods, and anytime contamination is suspected

Jaycee Jones is a pharmacy technician who is well-known at the hospital for having the highest rating with gloved fingertip sampling. He is the only staff member who continually passes the test. What is required to pass the gloved fingertip test? Answer A Two consecutive samples of the dominant (writing) hand, with < 100 CFUs. B Two consecutive samples of both hands, with < 100 CFUs for both hands. C Two consecutive samples of the dominant (writing) hand, with < 3 CFUs. D Two consecutive samples of both hands, with < 3 CFUs for both hands. E Three consecutive samples of both hands, with zero CFUs for both hands.

E The gloved finger tip sampling is done in the buffer area or ante area after the gloves have been put on and before disinfecting the gloves with 70% IPA. It is taken after the compounding staff member has received their initial training, and semi-annually (every 6 months) if compounding high-risk medications. If low and medium-risk, the testing is required annually.

Select the correct statement concerning garbing for sterile compounding: Answer A Hands are cleaned prior to donning the gown (not after donning the gown). B Do not overlap the gown with the gloves. C Gowns must be low-shedding. D It is acceptable to lean on walls after donning all garb as the garb protects the compounder from contaminants. E Do not hold the door open for staff who are coming into the clean area and are a little further down the hallway.

E The gown must be non-shedding. The gown and the gloves should overlap to avoid exposing skin and hair. Hands are cleaned prior to donning the gown and after donning the gown. It is not the compounder that requires protection from usual contaminants; it is the medication that is being compounded. Avoid leaning on surfaces, and close doors quickly.

Select the sterilization method preferred for CSPs that are heat-sensitive such as antibiotic solutions, radioisotopes, vaccines, carbohydrates, hormones and other proteins, and EtOH solutions: I. Autoclaving II. Heat III. Filtration IV. Moisture

Filtration The preferred method for all heat sensitive liquid preparations is filtration using a 0.22 micron needle. This will remove microorganisms larger than 0.22 microns, including bacteria, viruses, fungi, yeast and particles.

USP 797 states: "After completion of hand washing, a non-shedding gown with sleeves that fit snugly around the wrists and enclosed at the neck is donned." Select the correct statement/s concerning gowns: I. The gown should (preferably) be disposable. II. When compounding personnel exit the compounding area during a work shift, the exterior gown can be taken off and kept in the compounding area if not visibly soiled, to be re-donned during that same work shift only. III. When compounding personnel exit the compounding area during a work shift, the exterior gown can be taken off and kept in the compounding area if not visibly soiled, to be re-donned during the following work shift (or day). IV. If the compounding personnel exit the ante area during a work shift, the exterior gown can be worn back into the compounding area if it is sprayed with 70% isopropyl alcohol.

I , IThe gown must be non-shedding. After completion of hand washing, gowns designed for buffer area use are used, and preferably they should be disposable. If reusable gowns are used they must be laundered appropriately for buffer area use. When compounding personnel exit the compounding area during a work shift, the exterior gown can be removed and kept in the compounding area if not visibly soiled, to be re-donned during that same work shift only. When garb is exposed to less than ISO Class 8 conditions (outside the ante room), regarb is required.

Which of the following evaluations is required to ensure a contaminant-free sterile compounding environment? I. Environmental monitoring. II. Competency evaluation of all personnel who enter the clean room area. III. Competency evaluation of aseptic work technique. IV. Documentation of visible tattoos on compounding personnel.

I, II, III Additionally, there must be a competency evaluation of cleaning and disinfection technique. Each of the above correct responses must be documented.

Select the reagent that is used with a bacterial endotoxin test (BET): Answer A BET B USB C TSB D LAL E FTM

LAL Limulus Amebocyte Lysate (LAL) reagent is used with the BET to test for pyrogens.

An IVPB is prepared in and ISO Class 5 environment. The compounding involved only transfer and measurement of the drug into the bag. The CSP can be stored for not more than 48 hours at a controlled room temperature, not more than 14 days at a cold temperature and not more than 45 days frozen. Select the correct USP risk level: Answer A No risk B Low-risk C Medium-risk D High-risk E Immediate-use

Low risk

Compounded sterile preparations that entail single dose vial reconstitution are classified as what CSP risk level by the USP? Answer A Low-risk B Medium-risk C High-risk D Immediate-use E No risk level assigned

Low risk

A female patient, aged 60 years old, is receiving radiation and chemotherapy for a malignant stomach tumor. She is unable to tolerate enteral feeding. Parenteral nutrition will be prepared by the pharmacy department. Select the USP risk level: Answer A No risk is given for parenteral nutrition formulas by USP. B Low-risk C Low-risk with a 12-hour BUD D Medium-risk E High-risk

Medium risk Parenteral nutrition and batched syringes are classified as medium-risk. Opthalmic preparations are medium-risk

Rank the following garb items in the order in which they are donned, from first donned to last donned. Left-click the mouse to highlight, drag, and order the answer options; ALL options must be used. Answer A Don hair and beard covers, face mask, and shoe covers B Perform hand hygiene that includes at least 30 seconds of hand washing with soap, clean the area under the nails cleaned C Don gown D Perform hand cleaning with alcohol based surgical hand scrub with persistent activity E Don gloves

all in order Garbing is done from dirtiest to cleanest. Hair/beard cover, face masks, and shoe covers are donned first. If an eye covering is used, it is also one of the first garb items donned. Nails must be kept cut short and smooth to avoid tearing the gloves. After the gown is donned the hands are cleaned (again) with an alcohol-based surgical hand scrub. Do not put on gloves until the hands are dry.

Which of the following medication containers requires that the drug be filtered using a filter needle or filter straw prior to inserting the medication into the IV container? Answer A PVC ampules B Plastic ampules C Glass ampules D All lipid-based formulations E All lipid-based formulations and ampules

glass ampules Nearly all lipids do require filtration (these use larger filters than are normally used as the lipid globules are > 0.22 microns), but they are not filtered prior to insertion into the IV container. With a glass ampule, when the head of the ampule is snapped open, glass particles can land in the medication liquid.

Which of the following is the most violated of all infection control procedures? Answer A Glassware sterilization B Hand hygiene C Laminar flow hood cleaning (frequency) D Floor and wall cleanings E Contamination in the ambient air

hand hygiene At least a 30-second hand and arm wash is required to perform sterile compounding. Most contamination comes from unclean hands.

Rank the following in the order in which the following compounding sterile preparation areas should be cleaned and disinfected: Left-click the mouse to highlight, drag, and order answer options; ALL options must be used. Answer A General supply area B Ante area C Buffer area (clean room) D ISO Class 5 PEC area

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