Compounding I Flashcards
What is compounding?
Compounding is the process of combining or altering ingredients to create a medication
What are some unique characteristics about compounded drugs?
A traditional compounded drug is prepared by a pharmacist for an individual patient based on a prescription. Compounded drugs meet unique needs and are not FDA-approved. The dose or formulation cannot be commercially available as a manufactured product
What are the different types of compounding and how can they be divided?
Compounded drugs are either non-sterile or sterile. Both non-sterile and sterile compounded drugs can be further subdivided into non-hazardous and hazardous.
What determines if a drug is non-sterile or sterile?
The formulation of the compounded drug determines if it is non-sterile or sterile; the drug being used determines if the compound is deemed hazardous
What is the US Pharmacopeia (USP)?
The US Pharmacopeia (USP) sets the standards for compounding preparations
What are the USP chapters related to compounding?
USP 795 (non-sterile compounding), USP 797 (sterile compounding), USP 800 (handling hazardous drugs)
*USP 795, 797 and 800 are considered to be minimum acceptable standards for compounding by the FDA, the state boards of pharmacy and the Joint Commission
Which organization do hospital pharmacists rely on for detailed guidance on implementing USP standards?
American Society of Health-System Pharmacists (ASHP)
What is non-sterile compounding primary used for?
Non-sterile compounding is primarily used to prepare a dose or formulation that is not commercially available (e.g. changing a tablet to a liquid, compounding a 10% ointment only available in 5% and 15%), avoid an excipient, add a flavor
What do non-sterile preparations include?
Non-sterile preparations include those administered by mouth, via tube, rectally, vaginally, topically, nasally or in the ear
How does USP 795 divide non-sterile compounding?
USP 795 divides non-sterile compounding into three categories based on complexity: simple, moderate, complex
What is the definition of simple non-sterile compounding?
Requires (simply) following instructions (e.g. following a USP monograph)
What is the definition of moderate non-sterile compounding?
Involves specialized calculations or procedures, or making a preparation that has no established stability data
What is the definition of complex non-sterile compounding?
Requires specialized training, equipment, facilities, or procedures
Describe the physical space basics of the non-sterile compounding space.
- Specifically designated for compounding
- Can be performed in room air but must be separated from the dispensing part of the pharmacy
- Adequate space is needed to avoid mix-ups and should include shelving and storage
- All components, equipment and containers should be stored off the floor
- Heating, ventilations and air conditioning systems must be controlled to avoid drug deterioration
- The sink must be easily accessible, be clean and be emptied of items unrelated to compounding. Soap, detergent and a sanitary method of drying hands should be available
What are the two types of water needed available for non-sterile compounding?
1) Portable (drinkable, such as from the tap), for hand and equipment washing
2) Purified (e.g. distilled), for use in water-containing formulations, and for rinsing equipment and utensils
How must sterile compounding be carried out?
Sterile compounding must be carried out using strict procedures to keep products free from contamination. Drugs injected into the blood or administered into certain other body sites must be free of microorganisms and contaminants
What is sterile compounding used to prepare for?
Intravenous (IV) drugs, intramuscular (IM) and subcutaneous (SC, SQ) drugs, radiopharmaceuticals, eye drops, irrigations, pulmonary inhalations
What is the meaning of BSC?
Biological safety cabinet: chemo hood, a type of C-PEC
What is the meaning of CACI?
Compounding aseptic containment isolator: “glovebox” for HDs, a type of closed-front C-PEC
What is the meaning of CAI?
Compounding aseptic isolator: “glovebox” for non-HDs, a closed-front sterile hood (PEC)
What is the meaning of C-PEC?
Containment primary engineering control: ventilated (negative pressure) chemo hood used for HDs
What is the meaning of C-SCA?
Containment segregated compounding area: ventilated (negative pressure) room used for HDs; not in a cleanroom suit (air is not ISO-rated)
What is the meaning of C-SEC?
Containment secondary engineering control: ventilated (negative pressure) buffer room for HDs (room where the C-PEC is located)
What is the meaning of CSPs?
Compounded sterile products: IVs or other drugs that require sterile manipulation
What is the meaning of CSTD?
Closed system transfer device: device preventing escape of HD/vapors when transferring (e.g. from a vial to a syringe)
What is the meaning of CVE?
Containment ventilated enclosure: ventilated “powder hood” for non-sterile products (can be used for HDs if USP 800 standards are met)
What is the meaning of LAFW?
Laminar airflow workbench: type of sterile hood (PEC); parallel air streams flow in one direction
What is the meaning of LVP?
Large volume parenteral: IV bag or container containing > 100 mL
What is the meaning of PEC?
Primary engineering control: sterile hood that provides ISO 5 air for compounding
What is the meaning of PPE?
Personal protective equipment: Garb
What is the meaning of RABS?
Restricted access barrier system: “glovebox”/closed-front sterile hood (includes CAIs and CACIs)
What is the meaning of SCA?
Segregated compounding area: designated space that contains an ISO 5 hood but is not part of a cleanroom suite (air is not ISO-rated)
What is the meaning of SEC?
Secondary engineering control: ISO 7 “buffer room” where the sterile hood is located
What is the meaning of SVP?
Small volume parenteral: IV bag or container containing < 100 mL
What is the International Standards Organization (ISO)?
The International Standards Organization (ISO) sets the standards for air quality, which is determined by the number and size of particles per volume of air. The lower the particle count, the cleaner the air
In critical areas that are closest to exposed sterile drugs and containers, what must the air quality be?
ISO 5
What does ISO 5 mean?
This means that there are no more than 3,520 particles per cubic meter. Particles are included in this count if they are 0.5 microns or larger
What must the air quality of the buffer area (the SEC, which contains PECs) be?
At least ISO 7
What must the air quality be in the anteroom (the room adjacent to the SEC, where handwashing and garbing occurs)?
At least ISO 8 if it opens into a positive-pressure buffer area or at least ISO 7 if it opens into a negative-pressure buffer area
What does ISO 7 mean?
This means that there are no more than 352,000 particles per cubic meter
What does ISO 8 mean?
This means that there are no more than 3,520,000 particles per cubic meter
What are high-efficiency particular air (HEPA) filters?
High-efficiency particular air (HEPA) filters pick up particles when the air runs through the filter. HEPA filters are > 99.97% efficient in removing particles as small as 0.3 microns wide or larger, including bacteria, viruses, fungi and dust
Where is the HEPA filter in a vertical airflow biological safety cabinet (BSC) or C-PEC?
The HEPA filter is at the top of the sterile hood
Where is the HEPA filter in a laminar airflow workbench (LAFW) or PEC?
The HEPA filter is at the back of the sterile hood (horizontal airflow)
How often must a HEPA filter be recertified?
The HEPA filter must be recertified by a specialist every 6 months and anytime a PEC has been moved
What is the first air?
The air coming directly out of the HEPA filter is called the first air, which is cleaner than the rest of the air in the sterile hood
What is the recommendation to prevent contamination when preparing a sterile product?
- To prevent contamination of CSPs during compounding, the injection port of the vial and the syringe needle must be kept in the first air
- Do not obstruct first air, especially the area where the needle enters the vial or ampule
- Do not block airflow from the HEPA filter with hands or supplies
- Place items correctly inside the PEC to avoid creating turbulence, which can lead to contamination of the CSPs
What are the recommendations in keep the air in the PEC clean?
- Wipe off the outside of all materials (e.g. vials, syringes) with 70% IPA before bringing them into the PEC
- Open packages along the designated tear line, if present; do not rip open the packages or punch needles or syringes through the wrappers which contaminates the air with particles
- Compound at least 6 inches inside the sterile hood to prevent exposing CSPs to dirtier ISO 7 air from the SEC
- Move waste of the PEC shortly after it is created; do not let it accumulate inside the sterile hood
What should the air pressure be for non-hazardous compounding?
The air pressure inside the PEC and SEC are both positive since the air will not cause toxicity if it moves into adjacent spaces. Positive air pressure helps protect the compounded sterile products (CSPs) from contamination
What should the air pressure be for hazardous compounding?
With hazardous compounding, the containment PEC (C-PEC) and the containment SEC (C-SEC) must have negative pressure to contain and exhaust the toxic air in the space. Negative air pressure protects the compounding staff
What are the physical space basics of sterile compounding?
- Surfaces of ceilings, walls, floors, fixtures, shelving, counters and cabinets must be smooth, impervious and free from cracks and crevices to make them easy to clean and disinfect
- Stainless steel equipment is often used
What is a cleanroom suite?
One or more sterile hoods (ISO 5 PECs) inside an ISO 7 buffer room (SEC) that is entered through an adjacent anteroom
What is in a segregated compounding area (SCA)?
Segregated compounding area (SCA) with an ISO 5 PEC: a sterile hood, often an isolator (glovebox) with a closed front located in a segregated space with unclassified air
What is the primary engineering control (PEC)?
The PEC is a device or room that provides an ISO 5 environment for sterile compounding
What must PECs used for non-sterile compounding have?
PECs used for non-hazardous sterile compounding have HEPA-filtered air and positive air pressure, to protect the CSPs from contamination, and are not externally ventilated
What is a laminar airflow workbench?
A laminar airflow workbench (LAFW) is an open-front PEC where air flows out in parallel lines from the HEPA filter, typically from the back of the hood
What does laminar airflow do?
Laminar airflow keeps the cleaner air in the PEC from mixing with the dirtier air in the buffer room and keeps particles from colliding with each other and landing on the DCA surface or CSPs
What is a compounding aseptic isolator (CAI)?
A compounding aseptic isolator is a closed-front PEC that can be located in a buffer room (SEC), but is often located in a segregated compounding area (SCA). The closed front keeps the unclassified room air around it from mixing with the clean air inside the PEC
What is required when compounding in a CAI?
Garb required when compounding in a CAI depends on the manufacturer’s instructions, but minimally hand hygiene must be performed and sterile, powder-free gloves should be used inside the CAI (placed over the long gloves attached to the isolator)
What is the secondary engineering control (SEC)?
The SEC is the room that contains PEC or multiple PECs. The SEC is commonly called the buffer area or buffer room because it provides a “buffer” of relatively clean air (ISO 7) around the PEC (ISO 5)
What is the anteroom?
The anteroom connects the rest of the pharmacy to the buffer room (SEC). It contains a sink, cabinets and benches to facilitate garbing and preparation for garbing
What is the line of demarcation?
Running down the center of the anteroom is a large visible line called the line of demarcation, which separates the room into clean and dirty sections
Which is considered the dirty side of the anteroom and the clean side of the anteroom?
The side closest to the other areas of the pharmacy is considered to be the dirty side of the anteroom. The side of the anteroom closest to the buffer room is considered to be the clean side
When should shoe covers, handwashing and donning be applied?
Shoe covers must be applied one at a time while stepping over the demarcation line, placing the covered shoe on the clean side. Handwashing and donning of the gown occur on the clean side of the anteroom
What happens when a compounded sterile product is needed stat?
If a sterile product is compounded under suboptimal conditions for sterility, the CSP will have a very short BUD of 1 hour, after which the drug can no longer be used and must be discarded
What is a segregated compounding area (SCA)?
An SCA is an option when a cleanroom is not able to be installed. It is a designated area with unclassified air. It does not have a buffer area or anteroom and can only be used for certain (low-risk)
What is the maximum beyond use date for a CSP made in an SCA?
12 hours
When is having a SCA useful?
SCAs are useful for satellite pharmacies that are a distance away from the main pharmacy in a large hospital, for infusion centers, clinics and small hospitals
Where can an SCA NOT be located?
SCAs cannot be located adjacent to food preparation, warehouses, construction sites, or unsealed windows/doors near busy areas
What are hazardous drugs?
Hazardous drugs can cause toxicity to the healthcare workers who handle them in any manner, including unloading the drugs in the receiving dock, stocking the shelves, preparing the drugs in the pharmacy, administering the drugs to a patient and obtaining and cleaning up body fluids that contain hazardous drug residues
What is the National Institute for Occupational Safety and Health (NIOSH)?
NIOSH determines which drugs are hazardous. NIOSH keeps a list of all HDs called the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings
When is a drug considered hazardous?
A drug is considered hazardous if it is carcinogenic, teratogenic, genotoxic, toxic to organs at low doses, labeled by the manufacturer with special handling instructions
What are safety data sheets (SDS)?
SDS are a series of safety documents requires by the Occupational Safety and Health Administration (OSHA) to be accessible to all employees who are working with hazardous materials
What drug-specific safety information is included in the SDS?
Personal protective equipment (PPE), first aid procedures, spill clean-up procedures
For the hazard communication program, what is the designated individual in charge of?
Each facility must have a designated individual who is responsible for creating Standard Operating Procedures (SOPs) focused on worker safety during all aspects of hazardous drug handling
What does a hazard communication program include?
This hazard communication program includes a written plan that details implementation of HD safety procedures, proper training of personnel, competency assessment and maintaining all required HD documentation
What paperwork is required for the hazard communication program?
Pharmacies must maintain a list of all hazardous drugs stocked. The list must be reviewed ever 12 months or whenever a new drug or dosage form is stocked or used. Prior to handling any HDs, both men and women with reproductive capability must confirm in writing that they understand the risks associated with handling HDs
How does USP 797 define risk?
USP 797 risk categories are based on risk of contamination of the sterile product
How does USP 800 define risk?
With USP 800, higher risk means a higher change of causing harm to the workers exposed to the drug
What must SOPs include to limit staff exposure to hazardous drugs?
- Putting HDs in distinctive shelf bins to alert staff
- Wearing aSTIM D6978-rated gloves when counting or packaging drugs
- Dedicating a counting tray and spatula for counting HDs and decontaminating both after use
- Placing prepared HD containers into a sealable plastic bag
How often should assessment of risk documents be reviewed?
Every 12 months and the review must be documented
What are the physical space basics for USP 800 space requirements?
Containment is required to keep hazardous drugs, particles and vapors contained within the space due to toxicity risk. Hoods and buffer rooms used for compounding HDs include the word containment (e.g. C-PEC, C-SEC, S-SCA, CACI)
What are biological safety cabinets (BSCs)?
Biological safety cabinets (BSCs) have vertical laminar airflow (air flows down from the HEPA filter at the top of the hood) and negative air pressure, which protects the worker from being exposed to the hazardous drug they are working with
What class must the BSCs be for sterile hazardous compounding?
Class II (most common) or class III
What are containment ventilated enclosures (CVEs)?
Containment ventilated enclosures (CVEs) are powder containment hoods with HEPA-filtered air and negative air pressure used for non-sterile compounding only
What are compounding aseptic containment isolators (CACI)?
Compounding aseptic containment isolators are closed-front C-PECs (globveboxes) that can be located in a buffer room (SEC), but are often located in a C-SCA
What requirements are necessary to prepare a non-sterile hazardous drug in a C-PEC inside a C-SEC?
- The C-SEC must maintain ISO-7 air even when it is being used for non-sterile HD compounding
- If there are separate sterile and non-sterile C-PECs in the same C-SEC, they must be kept at least 1 meter apart
- Particle generating activity, such as working with powders, cannot be performed when any sterile compounding is being performed in the same C-SEC
- Occasional non-sterile HD compounding can be completed in a sterile C-PEC, but it must be properly decontaminated, cleaned and disinfected before using again to compound sterile HDs
What does negative air pressure do?
- Negative air pressure in the C-PEC causes the air to flow into the C-PEC (away from the person who is standing at the front of the hood), and then to flow out of the C-PEC through the external exhaust at the top of the hood
- Negative air pressure in the C-SEC keeps air from flowing into the anteroom. It is removed through the room exhaust
What is the air changes per hour (ACPH)?
The air changes per hour is the number of times (per hour) that the air is replaced in the room
What is the ACPH for non-sterile hazardous drugs?
In a space where non-sterile HDs are compounded there must be at least 12 ACPH
What is the ACPH for a sterile C-SEC?
In a sterile C-SEC, there must be at least 30 ACPH. This requirement also applies to a sterile SEC for non-HDs
What is the required ACPH of the C-SCA?
In a C-SCA, there must be at least 12 ACPH
What does it mean when an HD is externally exhausted?
This means that the air is moved out of the space (from the C-PEC, from the C-SEC or from the non-sterile HD compounding space) and cannot be recirculated and returned to the room. It is sent outside and takes any contamination out with it
What is an alternative option to an external exhaust?
An alternative option to an external exhaust (for non-sterile HD compounding only) is to use redundant HEPA filters. Air is passed through two or more HEPA filters in a series
How must hazardous drugs be stored?
Hazardous drugs must be stored separately from non-hazardous drugs in an externally ventilated, negative-pressure room with at least 12 ACPH
What must initial training for personnel include?
Initial training includes didactic training (teaching, with lectures or videos) and hands-on training (compounding), which must be observed by the designated person in charge of compounding or a staff expert
What must continuous training for personnel be done?
Continuous training must also be completed. When work is new or different for any reason, the compounding staff must receive additional training. This can include new drugs, revised drug information, changes in equipment and new or revised procedures
What aseptic procedures must staff follow?
Hand hygiene, garbing and gloving technique, cleaning and disinfecting procedures for the sterile space and equipment, sterile drug preparation
What test demonstrates adequate aseptic technique in hand hygiene, garbing and gloving?
The gloved fingertip test
What test demonstrates adequate aseptic technique in sterile drug preparation?
The media-fill test
How often does staff need a passing sore on the gloved fingertip test?
A passing score on the gloved fingertip test is required initially, then annually (if compounding only low- and medium-risk CSPs) or semi-annually (if compounding high-risk CSPs)
Describe the gloved fingertip test.
The evaluator collects a gloved sample from each hand of the compounder by rolling the pads of the fingers and thumb over a surface which contains tryptic soy agar (TSA). If microorganisms are present, they will use the TSA as a food source and replicate. The plates are incubated for 2-3 days and then inspected for microbial growth, which will be visible as spots on the plates
What are colony-forming units and what do they indicate?
Spots that form are called colony-forming units (CFUs) and indicate contamination was present on the gloves
How do you pass the initial gloved fingertip test?
Passing requires three consecutive gloved fingertip samples, taken after garbing, with zero CFUs for both hands
How do you have ongoing competency for the gloved fingertip test?
At least one sample taken from each hand immediately after completion of the media-fill test, with a goal of < 3 CFUs total for both hands
What is the media-fill test?
The media-fill test is used to determine if a compounder is preparing CSPs in an aseptic manner. The test must be performed initially during training and at least annually for low- and medium-risk
What is tryptic soy broth (TSB) and what is its significance in the media-fill test?
Tryptic soy broth (TSB) takes the place of the drug in the preparation. TSB is a growth medium used by the organisms to replicate. Multiple aseptic manipulations (transfers using the same syringe) are done and then the product is incubated and checked for bacterial growth. Turbidity means contamination is present
What indicates passing in a media-fill test?
If the liquid stays clear after 14 days of incubation, the compounder passed the test
How often should the SEC temperature be checked and at what temperature should it be maintained?
The SEC (buffer room) should be checked once daily and be maintained at 20 degrees celsius or cooler.
How often should the refrigerator and freezer be monitored?
The refrigerator and freezer should be monitored daily unless they contain vaccines, which require twice daily monitoring
What should the refrigerator temperature be?
The refrigerator temperature should be between 2-8 degrees celsius
What should the freezer temperature be?
If a freezer contains only CSPs (no vaccines), then the freezer temperature should be between -25 and -10 degrees celsius according to USP 797. If the freezer also contains vaccines, the required freezer temperature is -50 to -15 degrees celsius, per CDC guidance
What is air sampling and how often should it be performed?
Air sampling identifies contaminants in the air. It should be performed at least every 6 months by a person certified in air sampling, or by a qualified compounding staff member
What is required for surface sampling?
Tryptic soy agar (TSA) provides a good growth medium. Polysorbate 80 and lecithin are added to the TSA to neutralize the effect of any disinfecting agents on the surfaces
When should surface sampling take place and what is the procedure?
The testing should occur at the end of the day when the surface are in the poorest state. All the surfaces that are regularly exposed to staff should be tested. At least one surface sample must be taken from each ISO 5, 7, and 8 area. After the plates have been incubated for 2-3 days, the results should indicate zero CFUs
When should action be taken following a surface sampling?
Action must be taken if > 3 CFUs are identified in the ISO 5 area, > 5 CFUs in the ISO 7 area and > 100 CFUs in the ISO 8 area
What should be done if action is needed following a surface sampling?
If action is needed, polymerase chain reaction (PCR) can be used to identify the microorganisms present, which can help determine the source
What is the purpose of air pressure testing?
Air pressure testing confirms there is the correct differential between two spaces and ensures that the airflow is unidirectional
Where should pressure gauges be installed and how often should they be checked?
Pressure gauges are installed in the cleanroom space, and check (minimally) once daily or with every work shift
What is the purpose of controlling humidity?
Humidity must be carefully controlled to prevent the presence of excess moisture in the sterile compounding area, which can lead to bacterial growth
What should humidity be and how often should it be checked?
The humidity should be below 60% and should be checked at least once daily
What is the monitoring interval for air sampling?
At least every 6 months
What are the goals of air sampling?
Vary based on ISO level; immediate action required for highly pathogenic organisms
What is the monitoring interval of surface sampling?
Periodically
What is the monitoring interval of air pressure?
Each shift (preferably) or daily (minimally)
What are the goals of air pressure?
- Non-hazardous: positive
- Hazardous: negative
How often is the PECs and C-PECs kept running?
All PECs and C-PECs are preferably kept running at all times to help keep the surface clean
What must be done to PECs and CPECs if there is a power outage?
If there is a power outage, all compounding must stop, and the PECSs will need to be cleaned with a germicidal detergent and then disinfected with sterile 70% isopropyl alcohol (IPA) prior to re-initiation of compounding activity. If the PEC is a C-PEC, sanitization will be needed if the power has been turned off. If the power has been off, in addition to cleaning and disinfecting (or sanitization for C-PECs), the PEC or C-PEC must be on for at least 30 minutes before compounding can begin
How often is the PEC cleaned?
The PEC is cleaned throughout the day and at the end of the day it is cleaned again before cleaning the SEC and the anteroom
What is used to clean the PEC?
Lint-free sterile wipes are used to clean the PEC. First, the PEC is cleaned with a germicidal detergent then disinfected with 70% IPA
What is the process to clean the PEC?
Never spray inside the PEC. Use slightly overlapping, unidirectional strokes rather than circular motions. Use a new side of the wipe for the next area cleaned, and replace used wipes often. PECs are cleaned from top to bottom, back to front which means that the cleanest areas will be cleaned first, and the dirties areas will be cleaned last
What is an example of the order of cleaning for a horizontal laminar airflow PEC?
1) Clean the ceiling of the hood, from back to front
2) Clean the grill over the HEPA filter, from top to bottom
3) Clean the side walls starting from back to front, wiping up and down in a long sweeping motion. Clean the IV bar and hooks. Either the side walls or the bar can be cleaned first
4) Clean anything kept in the hood
5) Clean the bottom surface starting from back to front, with side to side motion
*Do not start compounding until the surfaces have dried
How often do ISO 5 PECs need to be cleaned?
Before each shift, every 30 minutes while working, before and after each batch of CSPs, whenever needed, including after spills
What should be cleaned monthly in a compounding area?
Ceiling, walls, shelving, chains, bins, carts
What does sanitization include for handling HDs?
All areas and equipment used for handling HDs must be sanitized, which includes deactivating, decontaminating and cleaning at least once daily. Sterile compounding areas and equipment must be disinfected as a final step
What is the correct order of sanitizing steps?
1) Deactivation and Decontamination: 2% bleach or peroxide (reduce HD toxicity, then remove HD residues)
2) Cleaning: germicidal detergent (removes dirt and microbial content)
3) Disinfection: sterile 70% IPA (inhibits or destroys microorganisms; required step of sterile compounding)
Why must the deactivation be done before disinfecting?
If disinfecting step is done before deactivating, it will spread the HD residue
What is recommended to be used as a sanitizing agent?
When using the sanitizing agents, wetted wipes should be used instead of using a spray bottle to directly spray onto surfaces and equipment. This is because the spray can cause any HD residue to aerosolize and spread to other areas
What PPE is necessary to be used if the sash of the BSC or the front cover of the CACI is opened?
A NIOSH approved fit-tested respirator
How do you prevent corrosion caused by bleach?
To prevent corrosion, neutralize the bleach by wiping surfaces afterwards with sodium thiosulfate, sterile alcohol, sterile water or a germicidal detergent
How often should a wipe sampling of compounding surfaces be done?
Pharmacies involved in hazardous compounding should perform wipe sampling of all compounding surfaces initially and at least every 6 months to ensure that the hazardous residue is adequately contained
What is the most urgent action to take when a staff member has an exposure?
The most urgent action to take when a staff member has an exposure is to get the drug or chemical off the person as soon as possible. The first 10 to 15 seconds after exposure are critical
What are minimal actions to take when exposure occurs?
1) For an exposure to gloves or gown, immediately remove the garb that has the drug on it
2) Immediately cleanse any affected skin with soap and water
3) For eye exposure, flood the affected eye at an eyewash fountain or with water or an isotonic eyewash for at least 15 minutes. Depending on the chemical, the time required for flushing can be longer
4) Obtain medical attention, when warranted.
5) Document the exposure in the employee’s record
What must be worn to reduced risk of HD spills and splashes?
Eye and face protection must be worn when there is a risk for HD spills or splashes, including when working in a PEC and when working outside of a PEC. Face shields in combination with goggles is preferable and provides complete protection against splashes to the face and eyes
What should be worn when HDs are unpacked and they are not contained in plastic?
The staff member should wear and elastomeric half-mask, with a multi-gas cartridge and P-100 filter, until assessment of the packaging integrity ensures that no breakage or spillage occurred during transport
What type of mask is sufficient for most HD compounding?
An N95 respirator
What scenarios with direct HD exposure is respiratory protection necessary?
- Cleaning up spills that need more supplies to clean up than provided by a spill kit
- Deactivating, decontaminating and cleaning underneath the work surface of a C-PEC
- When there is a known or suspected airborne exposure to HD powders or vapors
- Disposal of PPE used when handling HDs, which will be contaminated with trace amounts
What should be worn when there is a risk of respiratory exposure?
- A fit-tested respirator mask with attached gas canisters
- A powered air-purifying respirator that blows air through the filter to the use
What does the who, what and when indicate on the SDS in terms of spill-clean up procedures?
- Who refers to the staff who will respond to assist with people exposed to the spill and who will respond to clean up the spill
- What refers to the rapid assessment of the situation to determine if additional help will be needed
- When refers to the urgent need to clean up hazardous spills immediately
Where must spill kits for HDs be located?
Spill kits for HDs must be kept in areas where HDs are prepared, stored and administered
What are steps to manage a spill?
Quickly limit access to the area, and post warning signs around the perimeter of the spill. Multiple signs can be needed if more than one entry opens into the area with the spill. Pregnant women should not be involved with any clean-up activities and should immediately leave the area
What should the warning sign surrounding the spill state?
Caution: Hazardous Spill, Proceed with Care
What should the contents of a spill kit contain?
- Protective gown, latex gloves (minimally), N95 respirator mask plus goggles with side shields
- HD waste bag, scoop and scraper to get spill waste into the waste bag, chemo pads to absorb hazardous liquid
- HD spill report exposure form to document HD exposure
What is the procedure for cleaning up a spill?
1) Put the heavy-duty gloves over the ASTM D6978 rated gloves, which are the type used for HD compounding (protect the hands from broken glass)
2) Clean up macro amounts (big amounts) of spilled drug and broken glass (never use a brush because it can cause particles to become airborne)
3) If liquid is present, cover the liquid with an absorbent spill pad
4) Next, decontaminate the surfaces on which the HD has spilled from the area of lesser contamination to avoid spreading the hazard
5) If moistened pads are not available, pour the solution on the pads. Do not spray
6) Put trash into a hazardous waste bag, and seal. This is bulk hazardous waste bag, which is discarded in the black bulk hazardous waste, which is discarded in the black bulk hazardous waste bin
What is done after a spill has been cleaned?
- Doff (remove) garb and perform hand hygiene
- Decontaminate the respirator and replace the cartridges
- Replace the spill kit
What is required when administering all HDs?
Two pairs of chemotherapy gloves are required when administering all HDs
What is required when administered IV HDs?
A chemotherapy gown is required when administering IV HDs and recommended when administered other HDs
What are chemotherapy pins?
Chemotherapy pins are used to prevent HDs from aerosolizing by reducing air pressure with venting. They can be used during reconstitution and during administration
What are CSTDs and what is its purpose?
Closed-system drug transfer devices should be used to transfer drugs whenever possible to keep the HDs contained within the device. CSTDs reduce leaks and spills when withdrawing solutions from vials, injecting solutions into IV bags, reconstituting dried powders into solutions and for syringe to syringe transfers
When are CSTDs recommended to be used?
CSTDs are recommended when compounding HDs and required for administering antineoplastics, if available. CSTDs have a built-in valve that equalizes the air pressure when fluid is added or withdrawn from the vial
What is recommended if manipulation of HDs is required?
If manipulation is required, it should be done in a plastic bag to contain any dust or particles
Where are the outer chemotherapy gloves discarded in?
The outer chemotherapy gloves worn during compounding are discarded in a yellow trace chemotherapy waste bin located inside the C-PEC or put in a sealable bag if discarding outside the C-PEC
Where are the chemotherapy gown and outer shoe covers discarded?
The chemotherapy gown and outer shoe covers must be taken off before exiting the negative-pressure area and thrown away in the yellow trace chemotherapy waste bin
Where is the majority of the garb removed?
The rest of the garb is removed when leaving the anteroom or C-SCA once the compounding session is complete
Where are all trace antineoplastic waste disposed of?
All trace antineoplastic waste is thrown away in a yellow container, which will be destroyed by incineration at a waste facility
Where are bulk antineoplastic wasted disposed of?
Bulk antineoplastic waste, which includes unused or partially empty IV bags, syringes and vials, are thrown away in a black container, which will be incinerated at a waste facility
What cannot be used to transport liquid HDs or any antineoplastics and why?
Pneumatic tube systems cannot be used to transport any liquid HDs or any antineoplastics because of the potential for breakage and contamination
What does garb attire include?
Garb attire includes hair covers (bonnets), beard covers, special shoes or shoe covers, gowns, gloves, face masks, eye shields and aprons. The garb attire required depends on the type of compounding performed
What kind of gloves are required when compounding HDs or cleaning up spills?
Double ASTM D6978 (chemotherapy)-rated gloves
What kind of gloves can be used for HD receiving and storage?
Single gloves
For non-sterile compounding of hazardous drugs, if a BSC or CACI is not available, what PPE should be worn?
Double gloves, a gown, a mask and a disposable pad to protect the work surface
For compounding sterile hazardous drugs, what PPE is required?
- Head covers, a face mask and (if applicable) beard covers
- Two pairs of shoe covers
- A gown impermeable to liquids
- Two pairs of ASTM D6978 (chemotherapy)-rated gloves
- A full-facepiece respirator or a face shield with goggles when there is a risk for spills or splashes
What removal is required before entering the ante-area?
Removing coats, sweaters, makeup and visible jewelry is required before entering the ante-area
Where is garb donned?
Garb is donned in the ante-area. The order in which the garb should be donned is from dirtiest to cleanest
Describe the steps to garbing for sterile compounding
1) Remove coats, rings, watches, bracelets, and makeup before entering the ante-area (artificial/long nails and makeup are not permitted)
2) Don head and facial hair covers and face masks, then shoe covers while stepping over the line of demarcation. A second pair of shoe covers are needed for compounding HDs. The ante-area should have a mirror that is used to check that the hair is completely covered
3) Perform hand hygiene with soap and warm water. Under warm water, clean under fingernails to remove debris. Working from the fingertips to the elbows wash vigorously in circular motions for 30 seconds
4) Dry hands and forearms with lint-free disposable towels
5) Don a non-shredding gown that fits snugly around the wrists and has an enclosure at the neck. Disposable gowns are required for HD compounding and preferred for non-HD compounding
6) Enter the buffer area. Apply an alcohol-based surgical hand scrub with persistent antimicrobial activity for the recommended amount of time. Do sterile, powder-free glover. Tuck one pair under the cuffs of the gown. the second pair goes over the cuffs
7) Sanitize the gloves with 70% IPA routinely during compounding and whenever the gloves touch non-sterile surfaces
Describe what should be done when the compounding is completed and the compounding personnel is ready to leave.
All garb except for the gown goes into the disposable container. If the gown is not visibly soiled, it can be taken off and kept on the clean side of the anteroom in order to be re-worn for the current work shift. The gown cannot leave the ante area if it is going to be re-worn. Hand hygiene is repeated, and all other garb is replaced when re-entering the compounding area
When should a compounding personnel re-garb?
- Garb should not be worn outside of the anteroom; if the anteroom has been exited, complete regarbing is required, including hand hygiene
- If working in an SCA and it is left for any reason, regarbing is required
