Compounding I
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Questions and Answers

Which organization sets the standards for compounding preparations?

  • Food and Drug Administration (FDA)
  • State boards of pharmacy
  • Joint Commission
  • U.S. Pharmacopeia (USP) (correct)

    • What determines if a compounded drug is non-sterile or sterile?

  • The drug being used (correct)
  • The dose of the medication
  • The pharmacist's discretion
  • The patient's condition

    • What is the purpose of USP 800?

  • Determine which drugs are hazardous
  • Approve compounded drugs
  • Set the requirements for safe handling of hazardous drugs (correct)
  • Regulate non-sterile compounding

    • What distinguishes a traditional compounded drug from commercially available medications?

    <p>Prepared by a pharmacist for an individual patient based on a prescription</p> Signup and view all the answers

    Which chapter of USP sets standards for non-sterile compounding?

    <p>USP 795</p> Signup and view all the answers

    What are the categories for non-sterile compounding based on the level of complexity involved?

    <p>Simple, moderate, and complex</p> Signup and view all the answers

    Which organization do hospital pharmacists rely on for detailed guidance on implementing USP standards?

    <p>American Society of Health-System Pharmacists (ASHP)</p> Signup and view all the answers

    What is the purpose of non-sterile compounding?

    <p>Prepare doses or formulations that are not commercially available</p> Signup and view all the answers

    What is the primary requirement for the physical space for non-sterile compounding?

    <p>Specifically designated, well-organized, and separated from the dispensing part of the pharmacy</p> Signup and view all the answers

    What is the primary purpose of sterile compounding?

    <p>Prepare drugs free from contamination, particularly for injection or specific body sites</p> Signup and view all the answers

    Which of the following is an example of a product prepared using sterile compounding?

    <p>Intravenous drugs</p> Signup and view all the answers

    What are BSC and CSTD examples of in USP standards?

    <p>Essential terms and acronyms related to compounding</p> Signup and view all the answers

    What do terms like C-PEC, CACI, and C-SEC refer to in USP standards?

    <p>Specific meanings related to compounding</p> Signup and view all the answers

    What is the primary requirement for facilities used in compounding?

    <p>Biological safety cabinets, containment ventilated enclosures, and personal protective equipment</p> Signup and view all the answers

    What is the minimum air quality required in critical areas according to ISO standards?

    <p>ISO 5, with no more than 3,520 particles per cubic meter</p> Signup and view all the answers

    What is the efficiency of High-efficiency particulate air (HEPA) filters in removing particles?

    <p>&gt;99.97%</p> Signup and view all the answers

    How often must the HEPA filter be recertified?

    <p>Every 6 months and anytime a Primary Engineering Control (PEC) has been moved</p> Signup and view all the answers

    What type of air quality does the Primary Engineering Control (PEC) provide for sterile compounding?

    <p>ISO 5</p> Signup and view all the answers

    What are the requirements for surfaces in the compounding area?

    <p>Smooth, impervious, and free from cracks and crevices</p> Signup and view all the answers

    What contributes largely to contamination in sterile compounding?

    <p>Inadequate hand hygiene and garbing by compounding staff</p> Signup and view all the answers

    What organization sets the standards for air quality?

    <p>International Standards Organization (ISO)</p> Signup and view all the answers

    What is the minimum air quality required in the buffer area according to ISO standards?

    <p>ISO 7</p> Signup and view all the answers

    What type of compounding area requires an anteroom of at least ISO 8?

    <p>Certain type of compounding</p> Signup and view all the answers

    What is the air quality requirement for the anteroom in some types of compounding?

    <p>ISO 8 or 7</p> Signup and view all the answers

    What are the types of sterile compounding areas mentioned in the text?

    <p>Cleanroom suites and segregated compounding areas (SCA) with an ISO 5 PEC</p> Signup and view all the answers

    What is the recommended frequency for recertifying the HEPA filter?

    <p>Every 6 months</p> Signup and view all the answers

    What type of environment does the Primary Engineering Control (PEC) provide for sterile compounding?

    <p>ISO 5 environment</p> Signup and view all the answers

    What is the maximum beyond-use date (BUD) for IV drugs prepared under suboptimal conditions for sterility?

    <p>1 hour</p> Signup and view all the answers

    What type of air pressure does the PEC for non-hazardous sterile preparations have?

    <p>Positive air pressure</p> Signup and view all the answers

    What does the Segregated Compounding Area (SCA) provide for low-risk CSPs without a buffer area or anteroom?

    <p>Maximum BUD of 12 hours</p> Signup and view all the answers

    What is the purpose of the Secondary Engineering Control (SEC) in the sterile compounding environment?

    <p>Provides a buffer of relatively clean air (ISO 7) around the PEC</p> Signup and view all the answers

    What is the purpose of the Laminar Airflow Workbench (LAFW) in sterile compounding?

    <p>Maintains ISO 5 environment by keeping cleaner air from mixing with dirtier air</p> Signup and view all the answers

    Where is the Compounding Aseptic Isolator (CAI) located in the sterile compounding environment?

    <p>Buffer room or Segregated Compounding Area (SCA)</p> Signup and view all the answers

    What is the purpose of the Anteroom in the sterile compounding environment?

    <p>Connects the pharmacy to the buffer room (SEC), facilitating garbing and preparation for compounding</p> Signup and view all the answers

    Which organization determines which drugs are hazardous?

    <p>National Institute for Occupational Safety and Health (NIOSH)</p> Signup and view all the answers

    What is the primary requirement for facilities used in compounding hazardous drugs?

    <p>Positive air pressure</p> Signup and view all the answers

    What is the purpose of the National Institute for Occupational Safety and Health (NIOSH) list of hazardous drugs?

    <p>To provide guidance on drug-specific safety information</p> Signup and view all the answers

    Which type of drug is considered hazardous if it is genotoxic?

    <p>Antineoplastics</p> Signup and view all the answers

    What is the purpose of Safety Data Sheets (SDS) for hazardous drugs?

    <p>To provide guidance on drug-specific safety information</p> Signup and view all the answers

    What is the primary responsibility of the designated individual in a compounding facility?

    <p>Creating Standard Operating Procedures (SOPs)</p> Signup and view all the answers

    What is the minimum required frequency for reviewing the list of hazardous drugs stocked?

    <p>Every 12 months</p> Signup and view all the answers

    What must individuals with reproductive capability confirm prior to handling hazardous drugs?

    <p>Confirmation of understanding the risks associated with handling hazardous drugs</p> Signup and view all the answers

    What is the purpose of the Personal Protective Equipment (PPE) for hazardous drug handling?

    <p>To prevent exposure to genotoxic drugs</p> Signup and view all the answers

    What is the primary focus of the Hazard Communication Program for hazardous drug handling?

    <p>Worker safety during all aspects of hazardous drug handling</p> Signup and view all the answers

    What is the purpose of the spill clean-up procedures for hazardous drugs?

    <p>To handle accidental exposure to hazardous drugs</p> Signup and view all the answers

    What is the primary requirement for pharmacies regarding hazardous drugs?

    <p>Maintaining the list of hazardous drugs stocked</p> Signup and view all the answers

    Compounded drugs are always FDA-approved.

    <p>False</p> Signup and view all the answers

    Non-sterile compounded drugs cannot be hazardous.

    <p>False</p> Signup and view all the answers

    USP 795 sets the standards for sterile compounding.

    <p>False</p> Signup and view all the answers

    USP 800 determines which drugs are hazardous.

    <p>False</p> Signup and view all the answers

    Air will flow out of the SEC and into the adjacent anteroom when the door is opened.

    <p>True</p> Signup and view all the answers

    The anteroom for non-hazardous drug compounding must be ISO 7 or 8.

    <p>True</p> Signup and view all the answers

    Positive air pressure in the anteroom means the ISO 8 air will blow into the SEC and risk contaminating the CSPs.

    <p>False</p> Signup and view all the answers

    The National Institute for Occupational Safety and Health (NIOSH) determines which drugs are hazardous.

    <p>True</p> Signup and view all the answers

    NIOSH maintains a list of all hazardous drugs called the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings.

    <p>True</p> Signup and view all the answers

    Each hazardous drug has its own Safety Data Sheet (SDS) providing guidance on drug-specific safety information.

    <p>True</p> Signup and view all the answers

    Facilities must maintain a list of all hazardous drugs stocked and review it every 12 months or whenever a new drug or dosage form is stocked or used.

    <p>True</p> Signup and view all the answers

    Prior to handling any hazardous drugs, individuals with reproductive capability must confirm in writing that they understand the risks associated with handling hazardous drugs.

    <p>True</p> Signup and view all the answers

    High-efficiency particulate air (HEPA) filters must be recertified every 6 months.

    <p>False</p> Signup and view all the answers

    The Hazard Communication Program includes a written plan detailing the implementation of hazardous drug safety procedures and proper training of personnel.

    <p>True</p> Signup and view all the answers

    The purpose of the spill clean-up procedures for hazardous drugs is to prevent contamination of the environment.

    <p>True</p> Signup and view all the answers

    Personal protective equipment (PPE) is not required when handling hazardous drugs.

    <p>False</p> Signup and view all the answers

    HEPA filters are 100% efficient in removing particles as small as 0.3 microns wide or larger.

    <p>False</p> Signup and view all the answers

    The air quality in critical areas must be at least ISO 5, with no more than 3,520 particles per cubic meter.

    <p>True</p> Signup and view all the answers

    The buffer area must be at least ISO 6.

    <p>False</p> Signup and view all the answers

    USP 795 sets standards for non-sterile compounding, while USP 797 sets standards for sterile compounding.

    <p>True</p> Signup and view all the answers

    Compounding should be done in the cleanest air, which is the air coming directly out of the HEPA filter.

    <p>True</p> Signup and view all the answers

    Non-sterile compounding is primarily used to prepare doses or formulations that are commercially available.

    <p>False</p> Signup and view all the answers

    The PEC provides ISO 7 air quality for sterile compounding.

    <p>False</p> Signup and view all the answers

    The revisions to USP 795 and 797 published in June 2019 are currently in effect and have replaced the 2014 and 2008 versions.

    <p>False</p> Signup and view all the answers

    Surfaces in the compounding area must be rough, impervious, and free from cracks and crevices.

    <p>False</p> Signup and view all the answers

    Sterile compounding is used to prepare intravenous drugs, intramuscular and subcutaneous drugs, radiopharmaceuticals, eye drops, and oral inhalations.

    <p>False</p> Signup and view all the answers

    Compounding staff largely contribute to contamination through inadequate hand hygiene and garbing.

    <p>True</p> Signup and view all the answers

    The types of sterile compounding areas include cleanroom suites and segregated compounding areas (SCA) with an ISO 6 PEC.

    <p>False</p> Signup and view all the answers

    Non-sterile compounding is categorized into simple, moderate, and complex based on the level of sterility involved.

    <p>False</p> Signup and view all the answers

    The HEPA filter must be recertified every 1 year and anytime a Primary Engineering Control (PEC) has been moved.

    <p>False</p> Signup and view all the answers

    The physical space for non-sterile compounding should be well-organized and separated from the dispensing part of the pharmacy, but it does not need to be specifically designated.

    <p>False</p> Signup and view all the answers

    Sterile compounding must be carried out using strict procedures to keep products free from contamination, particularly for drugs administered into certain body sites, but not necessarily for drugs injected into the blood.

    <p>False</p> Signup and view all the answers

    The PEC provides ISO 6 air quality for sterile compounding.

    <p>False</p> Signup and view all the answers

    The anteroom must be at least ISO 9.

    <p>False</p> Signup and view all the answers

    Biological Safety Cabinet (BSC) and Closed System Transfer Device (CSTD) are not essential terms to understand for compliance with USP standards.

    <p>False</p> Signup and view all the answers

    The air quality in critical areas must be at least ISO 4, with no more than 3,000 particles per cubic meter.

    <p>False</p> Signup and view all the answers

    The terminology used by USP includes terms like C-PEC, CACI, CAI, C-SCA, C-SEC, CSPs, CSTD, CVE, LAFW, and lVP, each with specific meanings related to compounding.

    <p>True</p> Signup and view all the answers

    Non-sterile compounding is not used to prepare specific ointment concentrations.

    <p>False</p> Signup and view all the answers

    USP 795 and 797 standards for compounding apply only to hospital pharmacists, not to pharmacy staff, nurses, and physicians in various practice settings.

    <p>False</p> Signup and view all the answers

    Sterile compounding is primarily used to prepare doses or formulations that are not commercially available.

    <p>True</p> Signup and view all the answers

    Positive air pressure in PEC and SEC protects compounded sterile products (CSPs) from contamination

    <p>True</p> Signup and view all the answers

    Emergency use of IV drugs prepared under suboptimal conditions for sterility has a very short beyond-use date (BUD) of 1 hour

    <p>True</p> Signup and view all the answers

    Segregated Compounding Area (SCA) is an option for low-risk CSPs without a buffer area or anteroom, with a maximum BUD of 12 hours

    <p>True</p> Signup and view all the answers

    Secondary Engineering Control (SEC) contains the PEC, providing a buffer of relatively clean air (ISO 7) around the PEC

    <p>True</p> Signup and view all the answers

    Anteroom connects the pharmacy to the buffer room (SEC), facilitating garbing and preparation for compounding

    <p>True</p> Signup and view all the answers

    Laminar airflow workbench (LAFW) is an open-front PEC that keeps cleaner air from mixing with dirtier air, maintaining ISO 5 environment

    <p>True</p> Signup and view all the answers

    Compounding aseptic isolator (CAI) is a closed-front PEC located in a buffer room or segregated compounding area (SCA), keeping unclassified room air from mixing with clean air inside

    <p>True</p> Signup and view all the answers

    SCA is useful for satellite pharmacies, infusion centers, clinics, and small hospitals

    <p>True</p> Signup and view all the answers

    Types of PECs include horizontal laminar airflow workbench (LAFW) and compounding aseptic isolator (CAI)

    <p>True</p> Signup and view all the answers

    First air into the direct compounding area (DCA) is the cleanest, and positive air pressure in the PEC and SEC protects CSPs from contamination

    <p>True</p> Signup and view all the answers

    Positive air pressure in PEC and SEC prevents CSPs from contamination

    <p>True</p> Signup and view all the answers

    Emergency use of IV drugs prepared under suboptimal conditions for sterility has a very short beyond-use date (BUD) of 1 hour

    <p>True</p> Signup and view all the answers

    What is the primary difference between risk assessment in USP 797 and USP 800?

    <p>USP 797 assesses risk of contamination of sterile product, while USP 800 assesses risk of harm to workers exposed to hazardous drugs</p> Signup and view all the answers

    What is the purpose of an Assessment of Risk (AoR) for drugs with lower risk in USP 800?

    <p>To avoid following all USP 800 requirements for drugs that will be dispensed without manipulation</p> Signup and view all the answers

    What type of airflow does a Biological Safety Cabinet (BSC) have according to USP 800?

    <p>Vertical laminar airflow and negative air pressure</p> Signup and view all the answers

    What is the primary requirement for facilities used in compounding hazardous drugs according to USP 800?

    <p>Compounding must be carried out in a C-PEC located in a C-SEC or C-SCA</p> Signup and view all the answers

    Which type of Biological Safety Cabinets (BSC) is used for sterile hazardous drug compounding?

    <p>Class II BSC</p> Signup and view all the answers

    What type of containment ventilated enclosures (CVEs) are used for non-sterile compounding?

    <p>Class I Biological Safety Cabinets (BSC)</p> Signup and view all the answers

    Where are Compounding Aseptic Containment Isolators (CACIs) located?

    <p>In a buffer room (C-SEC) or a C-SCA</p> Signup and view all the answers

    What does a Compounding Aseptic Containment Isolator (CACI) for compounding hazardous drugs contain?

    <p>Hazardous fumes/particles</p> Signup and view all the answers

    What is necessary for manipulation of low-risk hazardous drugs?

    <p>Compliance with USP 800 requirements</p> Signup and view all the answers

    How often must the review of compounding documents occur?

    <p>At least every 12 months</p> Signup and view all the answers

    Where are containment hoods and buffer rooms required for compounding hazardous drugs?

    <p>In specific space requirements</p> Signup and view all the answers

    Under what conditions can non-sterile and sterile hazardous drug compounding occur in the same space?

    <p>Under specific conditions</p> Signup and view all the answers

    What is used for removing hazardous contaminants in non-sterile hazardous drug compounding?

    <p>External exhaust</p> Signup and view all the answers

    What type of air pressure is essential in the C-PEC and C-SEC for removing hazardous contaminants?

    <p>Negative air pressure</p> Signup and view all the answers

    What are the air changes per hour (ACPH) requirements for spaces used for hazardous drug compounding?

    <p>6-12 ACPH</p> Signup and view all the answers

    How must hazardous drugs be stored?

    <p>In a negatively pressurized room</p> Signup and view all the answers

    USP 800 risk categories are based on risk of contamination of the sterile product.

    <p>False</p> Signup and view all the answers

    Biological safety cabinets (BSCs) have vertical laminar airflow and positive air pressure.

    <p>False</p> Signup and view all the answers

    The anteroom for non-hazardous drug compounding must be ISO 7 or 8.

    <p>False</p> Signup and view all the answers

    Non-sterile compounded drugs cannot be hazardous.

    <p>False</p> Signup and view all the answers

    Class II or Class III Biological Safety Cabinets (BSC) are used for sterile hazardous drug compounding

    <p>True</p> Signup and view all the answers

    Containment Ventilated Enclosures (CVEs) with HEPA-filtered air and negative air pressure are used for non-sterile compounding

    <p>True</p> Signup and view all the answers

    Compounding Aseptic Containment Isolators (CACIs) are closed-front gloveboxes located in a buffer room (C-SEC) or a C-SCA

    <p>True</p> Signup and view all the answers

    Compounding Aseptic Containment Isolator (CACI) for compounding HDs contains hazardous fumes/particles and is externally vented

    <p>False</p> Signup and view all the answers

    Compliance with USP 800 requirements is necessary for manipulation of low-risk hazardous drugs

    <p>False</p> Signup and view all the answers

    Review of compounding documents must occur at least every 12 months

    <p>True</p> Signup and view all the answers

    Specific space requirements include containment hoods and buffer rooms for compounding hazardous drugs

    <p>True</p> Signup and view all the answers

    Non-sterile and sterile hazardous drug compounding can occur in the same space under certain conditions

    <p>True</p> Signup and view all the answers

    External exhaust or redundant HEPA filters are used for non-sterile hazardous drug compounding

    <p>True</p> Signup and view all the answers

    Negative air pressure in the C-PEC and C-SEC is essential for removing hazardous contaminants

    <p>True</p> Signup and view all the answers

    Air changes per hour (ACPH) requirements for spaces used for hazardous drug compounding

    <p>True</p> Signup and view all the answers

    Hazardous drugs must be stored separately in a negatively pressurized room with specific air changes per hour (ACPH) requirements

    <p>True</p> Signup and view all the answers

    What is the most urgent action to take when a staff member has a hazardous drug (HD) exposure?

    <p>Get the drug or chemical off the person as soon as possible</p> Signup and view all the answers

    What is the minimal action to take for an exposure to gloves or gown contaminated with a hazardous drug?

    <p>Deactivate the contaminated gloves or gown</p> Signup and view all the answers

    When is respiratory protection needed in hazardous drug (HD) compounding?

    <p>When cleaning up spills that need more supplies to clean up than provided by a spill kit</p> Signup and view all the answers

    What is the recommended action for an eye exposure to a hazardous drug?

    <p>Flood the affected eye at an eyewash fountain or with water for at least 15 minutes</p> Signup and view all the answers

    What is the primary purpose of the face mask when garbing for hazardous drug compounding?

    <p>To prevent inhalation of hazardous drug particles</p> Signup and view all the answers

    What is the requirement for the Chemotherapy Gloves when handling hazardous drugs?

    <p>Must be powder-free</p> Signup and view all the answers

    When should the alcohol-sanitized gloves be used during hazardous drug compounding?

    <p>Whenever gloves touch non-sterile surfaces</p> Signup and view all the answers

    What is the requirement for the Shoe Covers when compounding sterile hazardous drugs?

    <p>Two pairs are required</p> Signup and view all the answers

    What is the primary purpose of the Chemical Cartridge-type Respirator when handling hazardous drugs?

    <p>To prevent skin exposure</p> Signup and view all the answers

    What is the requirement for the Chemotherapy Gown when handling hazardous drugs?

    <p>Must be disposable</p> Signup and view all the answers

    What is the requirement for the Eye/Face Protection when working with hazardous drugs?

    <p>A face shield with goggles</p> Signup and view all the answers

    What is the requirement for the Chemotherapy Gloves when handling higher-risk non-sterile hazardous drugs?

    <p>Disposable sleeve covers must be used</p> Signup and view all the answers

    What is the purpose of the Compounding Aseptic Containment Isolator (CACI) for compounding hazardous drugs?

    <p>To prevent inhalation of hazardous drug particles</p> Signup and view all the answers

    What is the requirement for the Chemotherapy Gloves when handling low-risk non-sterile hazardous drugs?

    <p>One pair is acceptable</p> Signup and view all the answers

    What is the requirement for the Chemotherapy Gown when handling hazardous drugs?

    <p>Must be impermeable</p> Signup and view all the answers

    What is the primary purpose of the Respirator when handling hazardous drugs?

    <p>To prevent skin exposure</p> Signup and view all the answers

    What type of respiratory protection is necessary when there is a risk of respiratory exposure to hazardous drugs?

    <p>Elastomeric half-mask with a multi-gas cartridge and P100 filter</p> Signup and view all the answers

    What is the primary purpose of using closed-system drug transfer devices (CSTDs) for drug administration?

    <p>To contain HDs and prevent leaks and spills</p> Signup and view all the answers

    What should be done immediately after hazardous drug spills are cleaned?

    <p>PPE should be removed, and hand hygiene should be performed</p> Signup and view all the answers

    When should pregnant women leave the area in case of a hazardous drug spill?

    <p>Immediately</p> Signup and view all the answers

    What should be readily available in areas where hazardous drugs are handled?

    <p>Spill kits containing protective gear, waste bags, and spill cleanup procedures</p> Signup and view all the answers

    What is the purpose of a powered air-purifying respirator (PAPR) when handling hazardous drugs?

    <p>To provide respiratory protection by blowing air through a filter to the user</p> Signup and view all the answers

    What type of personal protective equipment (PPE) must be worn when administering hazardous drugs?

    <p>Chemotherapy gloves and gowns</p> Signup and view all the answers

    What is the primary purpose of using eye and face protection, including goggles and face shields, when handling hazardous drugs?

    <p>To be worn when there is a risk of HD spills or splashes</p> Signup and view all the answers

    What is the purpose of immediate cleanup for hazardous drug spills?

    <p>To prevent contamination of the environment</p> Signup and view all the answers

    What should be avoided for cleaning up hazardous drug spills?

    <p>The use of brushes for cleanup</p> Signup and view all the answers

    What is the purpose of using elastomeric half-mask with a multi-gas cartridge and P100 filter when handling unpacked hazardous drugs?

    <p>To ensure packaging integrity</p> Signup and view all the answers

    What should be used for respiratory protection when there is a risk of respiratory exposure to hazardous drugs?

    <p>Elastomeric half-mask with a multi-gas cartridge and P100 filter</p> Signup and view all the answers

    What should be done when manipulating tablets to handle hazardous drugs?

    <p>Manipulate tablets in a plastic bag to contain dust or particles</p> Signup and view all the answers

    Where are outer chemotherapy gloves worn during compounding hazardous drugs discarded?

    <p>In a yellow trace chemotherapy waste bin located inside the containment primary engineering control (C-PEC)</p> Signup and view all the answers

    What is necessary when transporting hazardous drugs to minimize the risk of spillage or breakage?

    <p>Proper labeling and packaging</p> Signup and view all the answers

    What is required for compounding sterile hazardous drugs in terms of personal protective equipment (PPE)?

    <p>Impermeable gowns and respirators</p> Signup and view all the answers

    What is applied in the buffer area before compounding sterile hazardous drugs?

    <p>An alcohol-based surgical hand scrub with persistent antimicrobial activity</p> Signup and view all the answers

    What must be done to reusable gowns before reuse when compounding hazardous drugs?

    <p>Laundered</p> Signup and view all the answers

    What is the alternative option for hand scrub when allergic reactions to chlorhexidine are a concern?

    <p>Povidone-iodine (Betadine)</p> Signup and view all the answers

    What type of gloves are required for compounding hazardous drugs?

    <p>Two pairs of ASTM D6978 (chemotherapy)-rated gloves</p> Signup and view all the answers

    Where are trace and bulk antineoplastic waste disposed for incineration?

    <p>Yellow and black containers, respectively</p> Signup and view all the answers

    What is considered contaminated with trace amounts when handling hazardous drugs?

    <p>All personal protective equipment (PPE)</p> Signup and view all the answers

    What attire is necessary for compounding, depending on the type of compounding?

    <p>Hair covers, special shoes or shoe covers, gowns, gloves, face masks, eye shields, and aprons</p> Signup and view all the answers

    What is the color of the waste bin for discarding outer chemotherapy gloves during compounding?

    <p>Yellow</p> Signup and view all the answers

    Delaying treatment, even for a few seconds, may cause serious injury.

    <p>True</p> Signup and view all the answers

    An N95 respirator is sufficient for most HD compounding, but does not provide adequate protection against gases, vapors or direct liquid splashes.

    <p>True</p> Signup and view all the answers

    Respiratory protection is needed in situations with direct HD exposure including cleaning up spills that need more supplies to clean up than provided by a spill kit.

    <p>True</p> Signup and view all the answers

    Disposal of PPE used when handling HDs, which will be contaminated with (minimally) trace amounts.

    <p>True</p> Signup and view all the answers

    Face masks are not required when compounding with an isolator (glove box)

    <p>False</p> Signup and view all the answers

    The gown can be taken off and kept on the clean side of the anteroom if it is visibly soiled

    <p>False</p> Signup and view all the answers

    A full-facepiece respirator or a face shield with goggles should be used for unpacking HDs which are not wrapped in plastic

    <p>True</p> Signup and view all the answers

    Chemotherapy gloves must meet the American Society for Testing and Materials (ASTM) standard D6978

    <p>True</p> Signup and view all the answers

    Disposable sleeve covers made of coated materials can be used with higher-risk non-sterile HDs

    <p>True</p> Signup and view all the answers

    Shoe covers are not required when compounding sterile HDs

    <p>False</p> Signup and view all the answers

    Two pairs of gloves must be worn while compounding sterile HDs

    <p>True</p> Signup and view all the answers

    Chemotherapy gown must be disposable and may be reused

    <p>False</p> Signup and view all the answers

    Hand hygiene is not necessary when re-entering the compounding area

    <p>False</p> Signup and view all the answers

    A fit-tested NIOSH-certified respirator is not required for sterile compounding

    <p>False</p> Signup and view all the answers

    Two pairs of gloves are worn with a gown, one pair should go under the cuff of the gown

    <p>True</p> Signup and view all the answers

    A powered air-purifying respirator (PAPR) should be worn for cleaning up large HD spills

    <p>True</p> Signup and view all the answers

    Respiratory protection is necessary when there is a risk of respiratory exposure to hazardous drugs.

    <p>True</p> Signup and view all the answers

    Eye and face protection, including goggles and face shields, must be worn when there is a risk of HD spills or splashes.

    <p>True</p> Signup and view all the answers

    Elastomeric half-mask with a multi-gas cartridge and P100 filter should be worn when handling unpacked HDs until packaging integrity is ensured.

    <p>True</p> Signup and view all the answers

    A powered air-purifying respirator (PAPR) can be used for respiratory protection, blowing air through a filter to the user.

    <p>True</p> Signup and view all the answers

    Immediate cleanup is required for hazardous drug spills, with guidance from the Safety Data Sheet (SDS).

    <p>True</p> Signup and view all the answers

    Spill kits containing protective gear, waste bags, and spill cleanup procedures must be readily available in areas where HDs are handled.

    <p>True</p> Signup and view all the answers

    Pregnant women should not be involved in cleanup activities and should leave the area immediately in case of a spill.

    <p>True</p> Signup and view all the answers

    Spill cleanup involves donning appropriate personal protective equipment (PPE), avoiding the use of brushes for cleanup, and decontaminating affected surfaces.

    <p>True</p> Signup and view all the answers

    After the spill is cleaned, PPE should be removed, and hand hygiene should be performed.

    <p>True</p> Signup and view all the answers

    Appropriate PPE, including chemotherapy gloves and gowns, must be worn when administering hazardous drugs.

    <p>True</p> Signup and view all the answers

    Closed-system drug transfer devices (CSTDs) should be used for drug administration to contain HDs and prevent leaks and spills.

    <p>True</p> Signup and view all the answers

    CSTDs have a built-in valve to equalize air pressure when adding or withdrawing fluid from the vial.

    <p>True</p> Signup and view all the answers

    True or false: Outer chemotherapy gloves worn during compounding are discarded in a yellow trace chemotherapy waste bin located inside the containment primary engineering control (C-PEC).

    <p>True</p> Signup and view all the answers

    True or false: FDA has issued a warning for serious allergic reactions to chlorhexidine, an alternative option for hand scrub is povidone-iodine (Betadine).

    <p>True</p> Signup and view all the answers

    True or false: Compounding sterile hazardous drugs requires strict adherence to garbing procedures, including donning garb in the ante-area and performing hand hygiene with soap and warm water.

    <p>True</p> Signup and view all the answers

    True or false: Reusable gowns must be laundered prior to reuse and two pairs of ASTM D6978 (chemotherapy)-rated gloves are required for compounding HDs.

    <p>True</p> Signup and view all the answers

    True or false: An alcohol-based surgical hand scrub with persistent antimicrobial activity is applied in the buffer area before compounding sterile hazardous drugs.

    <p>True</p> Signup and view all the answers

    True or false: Proper labeling and packaging are necessary when transporting HDs to minimize the risk of spillage or breakage.

    <p>True</p> Signup and view all the answers

    True or false: Non-sterile hazardous drugs may require a single pair of gloves, while sterile hazardous drugs necessitate a more extensive PPE, including impermeable gowns and respirators.

    <p>True</p> Signup and view all the answers

    True or false: All personal protective equipment (PPE) worn when handling hazardous drugs (HDs) is considered contaminated with trace amounts.

    <p>True</p> Signup and view all the answers

    True or false: Liquid formulations of drugs should be used when available to avoid the need for manipulation.

    <p>True</p> Signup and view all the answers

    True or false: Manipulation, such as crushing tablets, should be done in a plastic bag to contain any dust or particles.

    <p>True</p> Signup and view all the answers

    True or false: Trace and bulk antineoplastic waste are disposed of in yellow and black containers, respectively, for incineration at a waste facility.

    <p>True</p> Signup and view all the answers

    True or false: Garb attire for compounding includes hair covers, special shoes or shoe covers, gowns, gloves, face masks, eye shields, and aprons, depending on the type of compounding.

    <p>True</p> Signup and view all the answers

    Study Notes

    Sterile Compounding Environment and Engineering Controls

    • Primary Engineering Control (PEC) provides ISO 5 environment for sterile compounding, commonly achieved with sterile hoods in pharmacies
    • PECs for non-hazardous sterile preparations have HEPA-filtered air and positive air pressure, preventing contamination and not externally ventilated
    • Laminar airflow workbench (LAFW) is an open-front PEC that keeps cleaner air from mixing with dirtier air, maintaining ISO 5 environment
    • Positive air pressure in PEC and SEC protects compounded sterile products (CSPs) from contamination
    • Compounding aseptic isolator (CAI) is a closed-front PEC located in a buffer room or segregated compounding area (SCA), keeping unclassified room air from mixing with clean air inside
    • Emergency use of IV drugs prepared under suboptimal conditions for sterility has a very short beyond-use date (BUD) of 1 hour
    • Segregated Compounding Area (SCA) is an option for low-risk CSPs without a buffer area or anteroom, with a maximum BUD of 12 hours
    • SCA is useful for satellite pharmacies, infusion centers, clinics, and small hospitals
    • Secondary Engineering Control (SEC) contains the PEC, providing a buffer of relatively clean air (ISO 7) around the PEC
    • Types of PECs include horizontal laminar airflow workbench (LAFW) and compounding aseptic isolator (CAI)
    • "First air" into the direct compounding area (DCA) is the cleanest, and positive air pressure in the PEC and SEC protects CSPs from contamination
    • Anteroom connects the pharmacy to the buffer room (SEC), facilitating garbing and preparation for compounding

    Sterile Compounding Environment and Engineering Controls

    • Primary Engineering Control (PEC) provides ISO 5 environment for sterile compounding, commonly achieved with sterile hoods in pharmacies
    • PECs for non-hazardous sterile preparations have HEPA-filtered air and positive air pressure, preventing contamination and not externally ventilated
    • Laminar airflow workbench (LAFW) is an open-front PEC that keeps cleaner air from mixing with dirtier air, maintaining ISO 5 environment
    • Positive air pressure in PEC and SEC protects compounded sterile products (CSPs) from contamination
    • Compounding aseptic isolator (CAI) is a closed-front PEC located in a buffer room or segregated compounding area (SCA), keeping unclassified room air from mixing with clean air inside
    • Emergency use of IV drugs prepared under suboptimal conditions for sterility has a very short beyond-use date (BUD) of 1 hour
    • Segregated Compounding Area (SCA) is an option for low-risk CSPs without a buffer area or anteroom, with a maximum BUD of 12 hours
    • SCA is useful for satellite pharmacies, infusion centers, clinics, and small hospitals
    • Secondary Engineering Control (SEC) contains the PEC, providing a buffer of relatively clean air (ISO 7) around the PEC
    • Types of PECs include horizontal laminar airflow workbench (LAFW) and compounding aseptic isolator (CAI)
    • "First air" into the direct compounding area (DCA) is the cleanest, and positive air pressure in the PEC and SEC protects CSPs from contamination
    • Anteroom connects the pharmacy to the buffer room (SEC), facilitating garbing and preparation for compounding

    Sterile Hazardous Drug Compounding Requirements

    • Class II or Class III Biological Safety Cabinets (BSC) are used for sterile hazardous drug compounding
    • Containment Ventilated Enclosures (CVEs) with HEPA-filtered air and negative air pressure are used for non-sterile compounding
    • Compounding Aseptic Containment Isolators (CACIs) are closed-front gloveboxes located in a buffer room (C-SEC) or a C-SCA
    • Compounding Aseptic Containment Isolator (CACI) for compounding HDs contains hazardous fumes/particles and is externally vented
    • Compliance with USP 800 requirements is necessary for manipulation of low-risk hazardous drugs
    • Review of compounding documents must occur at least every 12 months
    • Specific space requirements include containment hoods and buffer rooms for compounding hazardous drugs
    • Non-sterile and sterile hazardous drug compounding can occur in the same space under certain conditions
    • External exhaust or redundant HEPA filters are used for non-sterile hazardous drug compounding
    • Negative air pressure in the C-PEC and C-SEC is essential for removing hazardous contaminants
    • Air changes per hour (ACPH) requirements for spaces used for hazardous drug compounding
    • Hazardous drugs must be stored separately in a negatively pressurized room with specific air changes per hour (ACPH) requirements

    Sterile Hazardous Drug Compounding Requirements

    • Class II or Class III Biological Safety Cabinets (BSC) are used for sterile hazardous drug compounding
    • Containment Ventilated Enclosures (CVEs) with HEPA-filtered air and negative air pressure are used for non-sterile compounding
    • Compounding Aseptic Containment Isolators (CACIs) are closed-front gloveboxes located in a buffer room (C-SEC) or a C-SCA
    • Compounding Aseptic Containment Isolator (CACI) for compounding HDs contains hazardous fumes/particles and is externally vented
    • Compliance with USP 800 requirements is necessary for manipulation of low-risk hazardous drugs
    • Review of compounding documents must occur at least every 12 months
    • Specific space requirements include containment hoods and buffer rooms for compounding hazardous drugs
    • Non-sterile and sterile hazardous drug compounding can occur in the same space under certain conditions
    • External exhaust or redundant HEPA filters are used for non-sterile hazardous drug compounding
    • Negative air pressure in the C-PEC and C-SEC is essential for removing hazardous contaminants
    • Air changes per hour (ACPH) requirements for spaces used for hazardous drug compounding
    • Hazardous drugs must be stored separately in a negatively pressurized room with specific air changes per hour (ACPH) requirements

    Handling Hazardous Drugs in Pharmacy Settings

    • Liquid formulations of drugs should be used when available to avoid the need for manipulation.
    • Manipulation, such as crushing tablets, should be done in a plastic bag to contain any dust or particles.
    • All personal protective equipment (PPE) worn when handling hazardous drugs (HDs) is considered contaminated with trace amounts.
    • Outer chemotherapy gloves worn during compounding are discarded in a yellow trace chemotherapy waste bin located inside the containment primary engineering control (C-PEC).
    • Trace and bulk antineoplastic waste are disposed of in yellow and black containers, respectively, for incineration at a waste facility.
    • Proper labeling and packaging are necessary when transporting HDs to minimize the risk of spillage or breakage.
    • Garb attire for compounding includes hair covers, special shoes or shoe covers, gowns, gloves, face masks, eye shields, and aprons, depending on the type of compounding.
    • Non-sterile hazardous drugs may require a single pair of gloves, while sterile hazardous drugs necessitate a more extensive PPE, including impermeable gowns and respirators.
    • Compounding sterile hazardous drugs requires strict adherence to garbing procedures, including donning garb in the ante-area and performing hand hygiene with soap and warm water.
    • An alcohol-based surgical hand scrub with persistent antimicrobial activity is applied in the buffer area before compounding sterile hazardous drugs.
    • FDA has issued a warning for serious allergic reactions to chlorhexidine, an alternative option for hand scrub is povidone-iodine (Betadine).
    • Reusable gowns must be laundered prior to reuse and two pairs of ASTM D6978 (chemotherapy)-rated gloves are required for compounding HDs.

    Handling Hazardous Drugs in Pharmacy Settings

    • Liquid formulations of drugs should be used when available to avoid the need for manipulation.
    • Manipulation, such as crushing tablets, should be done in a plastic bag to contain any dust or particles.
    • All personal protective equipment (PPE) worn when handling hazardous drugs (HDs) is considered contaminated with trace amounts.
    • Outer chemotherapy gloves worn during compounding are discarded in a yellow trace chemotherapy waste bin located inside the containment primary engineering control (C-PEC).
    • Trace and bulk antineoplastic waste are disposed of in yellow and black containers, respectively, for incineration at a waste facility.
    • Proper labeling and packaging are necessary when transporting HDs to minimize the risk of spillage or breakage.
    • Garb attire for compounding includes hair covers, special shoes or shoe covers, gowns, gloves, face masks, eye shields, and aprons, depending on the type of compounding.
    • Non-sterile hazardous drugs may require a single pair of gloves, while sterile hazardous drugs necessitate a more extensive PPE, including impermeable gowns and respirators.
    • Compounding sterile hazardous drugs requires strict adherence to garbing procedures, including donning garb in the ante-area and performing hand hygiene with soap and warm water.
    • An alcohol-based surgical hand scrub with persistent antimicrobial activity is applied in the buffer area before compounding sterile hazardous drugs.
    • FDA has issued a warning for serious allergic reactions to chlorhexidine, an alternative option for hand scrub is povidone-iodine (Betadine).
    • Reusable gowns must be laundered prior to reuse and two pairs of ASTM D6978 (chemotherapy)-rated gloves are required for compounding HDs.

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