CPDI_RxPrep Book 2022 copy_17-22.pdf

15 I COMPOUNDIN G I: BASICS DRUG EXPOSURE The most urgent action to take when a staff member has an exposure (whether to a non-HD, a chemical in the workplace or a HD) is to get the drug or chemical off the person as soon as possible. The first 10 to 15 seconds after exposure are critical. Delayi...

15 I COMPOUNDIN G I: BASICS DRUG EXPOSURE The most urgent action to take when a staff member has an exposure (whether to a non-HD, a chemical in the workplace or a HD) is to get the drug or chemical off the person as soon as possible. The first 10 to 15 seconds after exposure are critical. Delaying treatment, even for a few seconds, may cause serious injury. Protocols for emergency procedures should be kept in the pharmacy. Minimal actions to take: 1. For an exposure to gloves or gown, immediately the garb that has the drug on it. 2. Immediately cleanse any affected skin with soap and water. 3. For an eye exposure, flood the affected eye at an eyewash fountain (see image above}, or with water or an isotonic eyewash for at least 15 minutes. Depending on the chemical, the time required for flushing can be longer. An N95 respirator is sufficient for most HD compounding, but does not provide adequate protection against gases, vapors or direct liquid splashes. 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. 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 (minimally} trace amounts. When there is a risk of respiratory exposure, one of the following should be worn: A fit-tested respirator mask with attached gas canisters (a "gas mask"}; see picture below on the left. > 0 Cjl u 0 u 4. Obtain medical attention, when warranted. 5. Document the exposure in the employee's record. HAZARDOUS DRUG EXPOSURE & SPILL MANAGEMENT Remove any HD exposed to the skin as soon as possible (see details above}. Emergency medical treatment must be sought with significant skin exposure (see foilowing section on managing a spill) and with mucus membrane and inhalation exposure. Chemotherapeutics and some other HDs can irritate the eyes and mucus membranes in the nose and mouth and cause lung damage. 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 (e.g., when administering the drug to a patient or cleaning up a spill). Goggles are used for eye protection. Eye glasses alone or safety glasses with side shields do not protect the eyes adequately from splashes; face shields in combination with goggles is preferable and provides complete protection against splashes to the face and eyes. RESPIRATORY PROTECTION 248 When HDs are unpacked and they are not contained in plastic, the staff member should wear an elastomeric half-mask, with a multi-gas cartridge and PlO0-.filter, until assessment of the packaging integrity ensures that no breakage or spillage occurred during transport. (Q) Respirator mask with gas canisters L.c...~-----..J II'~ Powered Air-Purifying Respirator (PAPR) A powered air-purifying respirator (PAPR) that blows air through the filter to the user (see picture above on the right). PAPRs are easier to breathe through than the gas mask type but require a fully charged battery to work properly. They use the same filters as gas masks. HAZARDOUS DRUG SPILLS HD spills must be cleaned up immediately. Depending on the facility, all of the compounding staff can be trained to handle HD spills, or the facility can have a trained spill response team. The Safety Data N9 5 Respirator Mask plus Sheet (SDS) should be consulted for Goggles with Side Shields guidance on spill clean-up procedures. Establish the Who, What and When 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. If HD exposure has occurred, emergency medical help will be needed. 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. Rx PREP 202 2 COU RSE BO OK I Rx PREP ©2021. ©2022 Managing the Spill Spill kits for HDs must be kept in areas where HDs are prepared, stored and administered. The spill kits must be available immediately wherever HDs travel, which is where they can 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. The warning sign should state Caution: Hazardous Spill, Proceed with Care! or something similar. Spill Kit Contents Protective gown, latex gloves (minimally), N95 respirator mask p l u s ~ 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 Procedure for Cleaning up a Spill Open the spill kit. The PPE should be donned immediately to protect the staff cleaning up the spill. Put the heavy-duty gloves over the ASTM D6978 (chemotherapy) -rated gloves, which are the type used for HD compounding. The heavy-duty gloves protect the hands from broken glass. Clean up macro amounts (big amounts) of spilled drug and broken glass. D Never use a brush to clean up broken glass and powder that is contaminated with HDs. Brushes can cause particles to become airborne. If liquid is present, cover the liquid with an absorbent spill pad. Next, decontaminate the surfaces on which the HD has spilled from the area of lesser contamination to areas of greater contamination to avoid spreading the hazard. If moistened pads are not available, pour the solution on the pads. Do not spray. Put trash into a hazardous waste bag, and seal. This is bulk hazardous waste, which is discarded in the black bulk hazardous waste bin. After the Spill is Cleaned Doff (remove) garb and perform hand hygiene. Decontaminate the respirator and replace the cartridges. ADMINISTRATION OF HAZARDOUS DRUGS Appropriate PPE must be worn when administering HDs. Two pairs of chemotherapy gloves are required when administering all HDs. A chemotherapy gown is required when administering IV HDs and recommended when administering other HDs (e.g., oral). Closed-system drug transfer devices (CSTDs) must be used by for drug administration, if available for the formulation being used. Chemotherapy pins are used to prevent HDs from aerosolizing by reducing air pressure with venting. They can be used during reconstitution and during administration. The pins attach with a luer lock connection, described in the Compounding II chapter. CSTDs 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. 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. Example of a Closed System Transfer Device Pharmacy and nursing should try to avoid manipulating oral HDs, such as crushing tablets and opening capsules. If a liquid formulation of the drug is available, it should be used. If manipulation is required (e.g., crushing tablets) it should be done in a plastic bag to contain any dust or particles. Replace the spill kit. 249 1 5 / CO M PO U N DIN G I: BAS ICS DISPOSAL GARB FOR HAZARDOUS DRUGS All PPE worn when handling HDs are considered contaminated with trace amounts. The outer chemothet•apy 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. Remove the outer glove before handling and labeling the compounded preparation. The chemothel'apy 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. The rest of the garb is removed when leaving the anteroom or C-SCA once the compounding session is complete. Appropriate PPE must be worn with each step involving HDs: receiving, storage, transporting, compounding (sterile and non-sterile}, administration, sanitation and during spill control. Double AS1M D6978 (chemotherapy)-rated gloves are required when compounding or cleaning up spills. Single gloves can be used for HD 1·ece.iving and storage. Trace Chemo Bulk Chemo Waste Bin: Yellow Waste Bin: Black All trace antineoplasUc waste (i.e., empty vials, empty syringes, empty IV bags, IV tubes, used gloves, used gowns, used pads) is thrown away in a yellow container, which will be destroyed by incineration (burning} at a waste facility. 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. TRANSPORTING HAZARDOUS DRUGS When HDs need to be transported, they must be properly labeled and packaged to minimize the risk of spillage or breakage. Pnewna1i l~•b systems cannot be used to transport any liquid HDs or any antineoplastics because of the potential for breakage and contamination. GARBING FOR ALL TYPES OF COMPOUNDING 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. The staff have to be protected from chemical exposure (some drugs are more toxic than others}, and the drug needs to be protected from contamination. Hand hygiene and garbing is more detailed for sterile compounding. 250 Non-Sterile Hazardous Drugs Placing intact tablets or capsules into unit-dose or multidose containers on an occasional basis poses relatively low risk to the healthcare worker. A single pair of gloves may be adequate. When USP 800 is not being followed completely (which requires 2 pairs of gloves), it must be based on anAoR that has identified the drugs which can have less stringent requirements, and the procedures put in place to reduce risk. Repeatedly counting, cutting or crushing tablets poses a higher risk for worker exposure and contamination to the workplace if exposure controls are not in place. If a BSC or CACI is not available, then PPE should be used that includes: Double gloves, a gown, a mask and A disposable pad to protect the work surface Sterile Hazardous Drugs PPE for sterile hazardous drug compounding includes: 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 (chemothe ·apy)-rated gloves A full-facepiece respirator or a face shield with goggles when there is a risk for spills or splashes The following pages illustrate how to don garb for sterile compounding, followed by requirements for sterile hazardous garb. Removing coats, sweaters, makeup and visible jewelry is required before entering the ante-area. Some pharmacies have compounders change into scrubs at work; these may be cleaner than street clothes, and are light and comfortable. The scrubs are laundered and kept on site to decrease the flow of microbes from the outside. RxPREP 2022 COURSE BOOK I RxPREP ©2021, ©2022 GARBING FOR STERILE COMPOUNDING Garb is donned in the ante-area. The order in which the garb should be donned is from dirtiest to cleanest. Remove coats, rings, watches, bracelets and makeup before entering the ante-area. Artificial or long nails are. not permitted. No make-up is permitted because it sheds. Perform hand hygiene with soap and warm water. Most contamination of CSPs comes from the hands. Don head and facial hair covers and face masks, then shoe covers while stepping over the line of demarcation that separates the dirty side of the anteroom from the clean side. 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. An eye shield is optional, except if preparing a hazardous drug. Under warm water, clean under fingernails to remove debris. Working from the f ingertips to the elbows, wash vigorously in circular motions for 30 seconds. Dry hands and forearms with lint-free disposable towels. tffi ©RxPrep 251 15 I COMPOUNDING I: BASICS GARBING FOR STERILE COMPOUNDING continued r Don a non-shedding 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. If gowns are reusable, they must be laundered prior to reuse. Enter the buffer area (SEC). Apply an alcohol-based surgical hand scrub with persistent antimicrobial activity for the recommended amount of time (per manufacturer) and allow to dry. The FDA has issued a warning for serious allergic reactions to chlorhexidine, which many compounders use. Another option is povidoneiodine (Betadine), which can be used if there has been an allergic reaction to chlorhexidine. Don s erile. powder-free gloves Two pair ot ASTM D6978 (chemotherapy}-rated gloves are required for compounding HDs. Tuck one pair under the cuffs of the gown. The second pair goes over the cuffs. Sanitize the gloves with 70% IPA routinely during compounding and whenever the gloves touch non-sterile surfaces. Do not resume compounding until the alcohol has dried. Continually inspect gloves for tears. All garb must be used when compounding with an isolator (glove box) unless the isolator's manufacturer provides written documentation that garb is not required. When the compounding is completed and the compounding personnel leaves the cleanroom/compounding area, all garb except for the gown goes into the disposal 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 TO 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. 252 l RxPREP 2022 COURSE BOOK I RxPREP ©2021, ©2022 GARBING FOR HAZARDOUS DRUGS Garb is donned in the ante area. The order in which the garb should be donned is from dirtiest to cleanest. Face Mask Respirator A fit tested NIOSH-certified Re9uired for sterile compounding Head and Hair Covers N95 respirator Is appropriate for most activities that need Eye/Face Protection respiratory protection. Must be worn when there A surgical respirator provides is a risk for HD spills or HD the respiratory protection of an splashes when working N95 respirator, and provides the outside of a C-PEC. protection of a surgical mask. A full·facepiece respirator An elastomeric half-mask with a or a face shield wlth •goggles multi-gas.cartridge and P100-filter is acceptable. should be used for unpacking HDs which are not wrapped In plastic. A fulHa·cepiec:e. chemical cartridge-type res·pirator or powered air-purifying respirator (PAPR) should be worn for cleaning up large HD spills, sanitizing the undertray of a C-PEC, or when Chemotherapy Gown there is a known or suspected Must be disposable (may not be ai rborne exposure to powders reused). or vapors. Must be impermeable; polyethylene-coated polypropylene or other laminate material is best. Chemotherapy Gloves Must meet the American Society for Testing and M aterials (ASTM) standard D6978 (or its successor). Powder-free. Must not have pin holes or weak spots. Must be changed every 30 minutes or Must close in the back, be~ sleeved, and have closed cuffs (elastic or knit). No seams or closures that can trap HD particles. Must be changed per manufacturer's schedule, or if unknown, change every 2-3 hours when torn, punctured or contaminated. or Immediately after a spill or Two pairs must be worn while splash, administering chemotherapy drugs Disposable sleeve covers made of and while compounding sterile and coated materials can be used with higher-risk non-sterile HDs. the gown. For low-risk non-sterile HDs, such as intact tablets, one pair of gloves is acceptable. When two pairs of gloves are worn with a gown, one pair should go under the cuff of the gown and the other pair should go the cuff of the gown. Shoe Covers Two pairs are required when compounding sterile HDs. i!J1 ©RxPrep 253