POLICIES/PROCEDURES TITLE: Safe Handling of Hazardous Medications SCOPE All pharmacy and nursing staff must have proper knowledge and training in handling techniques for hazardous medications as described in this policy including proper receiving, storage, preparation, distribution, administration, cleanup, and disposal. Employees must be informed if they will handle hazardous medications while performing their duties. All personnel must be informed that the procedures and expectations governing the handling of hazardous medications in the institution must be followed. PURPOSE 1. To create protective measures for health care workers, patients, and the environment from the potentially harmful effects of hazardous medications and their associated waste. 2. To provide a safe, consistent method for the handling (receiving, storage, preparation, distribution, administration, cleanup, and disposal) of hazardous medications. 3. To strive for compliance set forth by the United States Pharmacopeia (USP) Chapters <797> and <800> based on current facility layout, budget, and staffing model. BACKGROUND and DEFINITIONS 1. Medications considered hazardous include those that exhibit one or more of the following six characteristics in humans or animals: Carcinogenicity Teratogenicity or other developmental toxicity Reproductive toxicity Organ toxicity at low doses Genotoxicity Structure and toxicity profiles of new medications that are similar to existing medications determined hazardous by the above criteria 2. Evaluation of hazardous medications is an on-going process, and determination of hazardous characteristics must be performed for medications encountered at the institution. A master hazardous medication list will be available to ensure employee safety. Biological Safety Cabinet (BSC) a ventilated cabinet having an open front with inward airflow for personnel protection and a downward HEPA filtered airflow for product protection. BSCs are located in the Cancer Center Pharmacy and Inpatient Hospital Pharmacy within negative pressure environments, and are used for the compounding of all hazardous medications. 1 of 10
Closed System Transfer Device (CSTD) a drug transfer device that mechanically prohibits the transfer of environmental contaminants into the system and the escape of hazardous drug or vapor concentrations outside the system. Chemotherapy Spill Kit These kits are specifically designed to provide worker and environmental safety in the event of a spill containing hazardous medications. Chemotherapy spill kits must contain: disposable chemotherapy gown, safety goggles, face-mask, 2 pairs of ASTM-6978 certified chemotherapy gloves, utility gloves, absorbent mats, shoe covers, yellow hazardous waste bags, caution sign/labels, dust pan, brush, spill containment pillows, and documentation card. Hazardous Medications - oral and injectable medications that pose a significant hazardous risk to health care workers and patients due to their carcinogenic, mutagenic, or teratogenic potential. o High-Risk Hazardous Medications medications that have been determined to exhibit a high degree of risk to the safety of health care workers if exposure occurs. This includes, but not limited to all injectable chemotherapy and antineoplastic medications. o Low-Risk Hazardous Medications medications that have been determined to exhibit a lower degree of risk to the safety of health care workers if exposure occurs. This includes, but not limited to solid dosage forms not requiring further manipulation following dispensing. Hazardous Medication List A master hazardous medication list will be maintained for the entire healthcare facility. This list will include all medications deemed as hazardous by the most current NIOSH Hazardous Drug List, as well as additional medications deemed necessary based on individual risk assessments. This list will be reviewed at least every 12 months, and when new hazardous medications are stored or administered within the facility. Personal Protective Equipment (PPE) Disposable garb worn by health care workers to minimize risk of exposure to hazardous medications. This includes, but not limited to shoe covers, gowns, chemo-rated gloves facemasks, and hair covers. o Hand Hygiene Hands must be washed with soap and water according to hospital policy prior to donning and after doffing (taking off) the second pair of shoe covers, gown, and gloves worn for hazardous drug compounding. This also applies to all personnel handling and administering hazardous medications. o Shoe Covers - Personnel must don two pairs of shoe covers before entering the C-SEC (hazardous compounding room), along with all required garb for entering an ISO 7 buffer room. o Gowns - Disposable chemotherapy gowns of lint-free, low permeable fabric with a closed front, long sleeves, and knit-cuffs must be worn for the preparation of hazardous medications. Gowns used for chemotherapy will be considered single use and cannot be reused once removed. o Gloves Personnel compounding hazardous medications must don two pairs of powder-free chemotherapy gloves that have been tested to ASTM standard 6978. One pair of gloves is to be worn under the cuff of the chemo gown and the other is to be pulled over the cuff of the chemo gown. Outer gloves should be sterile and latex-free. Gloves used for hazardous compounding must be inspected for physical defects before donning and must be changed when torn, punctured or contaminated. This also applies to all personnel handling and administering hazardous medications. 2 of 10
o Hair Covers (head and beard) Standard hair covers that completely cover all hair on head and face must be utilized by personnel during the preparation of hazardous medications. o Face masks Standard facemasks must be utilized by personnel when preparing hazardous medications. o Respirators - Each employee who handles hazardous medications should be fit-tested for a NIOSHcertified mask (disposable) or respirator (reusable) and instructed in proper use of the equipment. o Eye Shield - Eye protection should be used if there is a splash risk. FACILITY 1. All hazardous medications must be compounded in a BSC that meets or exceeds the American Society of Health-System Pharmacists (ASHP) and USP Chapters <797> and <800> standards for a BSC. The ISO Class 5 BSC must be placed in an ISO Class 7 area that is physically separated (i.e., a different area from other preparation areas) and optimally has between 0.01-0.03-inch water column negative pressure to adjacent positive pressure ISO Class 7 or better ante areas, thus providing inward airflow to contain any airborne contaminant. A pressure indicator with alarm functionality should be installed that can be readily monitored for correct room pressurization. The BSC should be 100% vented to the outside air through HEPA filtration. 2. The BSC should be operated continuously, 24 hours a day, 7 days per week. The cabinet must be inspected routinely and certified according to the NSF Standard 49 and Controlled Environment Testing Association (CETA) Guidelines every 6 months. 3. To aid in efforts of quality control, chemotherapy wipe studies will be performed on a yearly basis that include high-risk areas of potential contamination (within BSCs, IV Rooms, administration areas, and various equipment). If contamination is confirmed, appropriate measures will be taken to address issues with cleaning and/or handling procedures. 4. Chemotherapy spill kits should be placed within the hazardous compounding rooms, and where hazardous medications are stored, transported, and administered. Personnel who handle hazardous medications must be trained in the retrieval, use, and disposal of chemotherapy spill kits. PERSONNEL 1. All personnel who compound hazardous medications must be fully trained in the receiving, storage, handling, preparation, and disposal of these medications. This training must occur prior to preparing or handling hazardous medications. 2. All employees compounding hazardous medications must have an annual competency conducted and documented, including a training review. A document will then be signed by all employees regardless of gender and includes the statement If I am of reproductive capability, actively trying to conceive, or as soon as I am confirmed to be pregnant, I will discuss this with my supervisor. 3. A permanent registry should be maintained of all employees in pharmacy who prepare hazardous medications. A log of all injectable hazardous medications compounded should also be kept with the following information: date, patient name, drug name, drug strength, name of compounding technician, and name of pharmacist that checked the final preparation. 4. Any personnel who are pregnant, breast-feeding, or trying to conceive will not be required to compound, administer, or transport hazardous medications. It is the responsibility of personnel to notify the hospital pharmacy or nursing manager when pregnant, breast-feeding, or trying to conceive. 3 of 10
RECEIVING 1. Inventory received into the pharmacy must be handled in a manner to minimize exposure to residual amounts of hazardous medications that may be found on outer packaging or vials. 2. Receiving or restocking inventory must be done so in a designated low traffic area to minimize contamination. 3. One pair chemotherapy gloves (must be rated ASTM 6978) and a facemask must be worn when unpacking shipping containers and totes containing hazardous medications. This disposable PPE should be disposed of as hazardous waste. 4. Any shipping container that is visibly damaged, leaking, or contains broken vials must be immediately closed, contained within double hazardous waste bags, and stored within a negative pressure hazardous room. Obtain additional PPE and a spill kit if necessary. No items within a shipping container or tote where a broken vial is located will be used. The distributer will be contacted immediately for replacement. The receiver and pharmacist will immediately document the incident according to policy and procedure on spill management. 5. All hazardous medications that are ordered should contain a separate purchasing order number fully distinguishing the shipping container or tote from non-hazardous medications. STORAGE 1. All high-risk hazardous medications should be stored in an ISO 7 negative pressure hazardous room if feasible within budgetary and facility constraints. Low-risk hazardous medications may be stored with other stock throughout the pharmacy, but must be in a container that is clearly marked as a hazardous medication (some low-risk oral medications may be exempt if risk deemed negligible). Injectable hazardous medications in inpatient pharmacy will be stored in sealed chemotherapy bags to limit a spill if a break occurs. 2. Hazardous medications requiring refrigeration should be stored in a manner that minimizes contamination or exposure if a spill were to occur. A designated hazardous refrigerator should be utilized within the negative pressure room if budgetary and facility constraints allow. TRANSPORTING and LABELING 1. All high-risk hazardous medications (oral and injectable) must be transported within sealed chemotherapy bags, clearly marked as hazardous. 2. Some low-risk hazardous medications (orals) will be clearly marked as hazardous during transportation if deemed necessary by the institution based on individual risk assessment. 3. All infusions, syringes, bottles, delivery bags, or other devices containing hazardous medications must be labeled with a distinctive warning to alert personnel at all times during the transportation and administration process. 4. No liquid/injectable preparations of hazardous medications or high-risk hazardous medications will be transported via the pneumatic tube system. 5. Chemotherapy spill kits, containment bags, and yellow hazardous waste containers must be available in all areas where hazardous medications are handled. PREPARATION 4 of 10
1. High-Risk Hazardous Medications a. All injectable high-risk hazardous medications may only be compounded by a pharmacist or pharmacy technician who has been properly trained and judged qualified by designated pharmacy personnel. b. All injectable hazardous medications are to be compounded in a BSC using aseptic technique. c. Compounding personnel must wear appropriate garb when preparing injectable hazardous medications (double pair chemotherapy gloves, a non-permeable gown, double shoe covers, hair cover, and face mask) to prevent skin contact. d. An absorbent plastic backed chemo mat will be used on the deck of the BSC during hazardous compounding. e. The BSC will be cleaned, decontaminated/deactivated, and disinfected daily according to policy and procedure. f. CSTDs will be used during compounding. g. Whenever possible, IV tubing will be primed with non-drug containing fluid to decrease exposure risk. 2. Low-Risk Hazardous Medications a. If a medication is manufactured in unit-dosed form, pharmacy will attach a hazardous auxiliary label upon dispensing (based on necessary risk assessment decision). b. Tablets and capsule forms of hazardous medications must not be placed in automated counting or packaging machines. Tablets and capsules that are not available in commercial unit-dose packaging should be manually placed in unit-dose packaging which is then manually sealed and labeled. Adhesive labels will be applied that clearly indicate the medication is a hazardous substance requiring special handling. c. All hazardous medications that are being altered in any way are to be prepared in the BSC only, using aseptic technique, and all necessary PPE when in the buffer room (this includes splitting misoprostol tablets). A plastic backed mat must be placed on the surface of the BSC work area to absorb any spills or contamination during preparation. COMPOUNDING TECHNIQUE 1. Use only syringes and intravenous sets with luer lock type fittings and CSTDs. 2. Rubber-stopper vials: a. The rubber stopper should be swabbed with a saturated alcohol swab and allowed to dry. b. An appropriate syringe should be selected. Care should be taken so that the syringe can accurately measure the dose(s) and yet be no more than 3 4 full when the dose is fully withdrawn. This minimizes the chance of spillage and unnecessary exposure to the hazardous medication. c. Attach the CSTD Injector to the syringe and CTSD Protector to the vial. d. The contents of the medication should be kept under a small amount of negative pressure to prevent blowback of aerosolized contaminants. Never add more air into the vial than the solution being withdrawn. 3. CSTD attachments to finished product for nursing: a. All compounded chemotherapy doses must have a CSTD attachment in order for the nurse to start and discontinue the dose for the patient. b. CSTDs are to be used during administration if the dosage form allows. 4. Priming of administration sets: a. All hazardous medications compounded as an infusion will have the appropriate tubing and filter attached by pharmacy. b. Administration sets should be primed with an appropriate diluent-only IV solution prior to attaching to the final container or adding hazardous medication. IV tubing will be attached (infusion bags spiked) within the C-PEC to avoid contamination risk. 5 of 10
5. Unnecessary movement in or out of the BSC should be avoided. All vials, syringes, swabs, protective mats, containers, and other compounding aids should be placed in the BSC after wiping off with sterile 70% isopropyl alcohol prior to the start of compounding. 6. All work should be performed well inside the BSC and at least 3 inches away from the sidewalls. Place objects in the work zone and position them so that they do not block the downward flow of air. Work at waist level; avoid working above the head or reaching. 7. The final preparation will be placed in a sealable hazardous drug plastic bag within the BSC. 8. Once compounding has been completed, the outer glove should be removed and contained inside the BSC within a hazardous waste container. All other potentially contaminated items will also be discarded in the hazardous waste container. 9. During compounding, the outer gloves should be changed whenever it is necessary to exit and re-enter the BSC. For aseptic protection of sterile preparations, the inner gloves must be sanitized with an appropriate disinfectant when reentering the BSC. Gloves must be changed immediately if torn, punctured, or knowingly contaminated. When removing the gloves, the contaminated gloved fingers must only touch the outer surface of the glove, never the inner surface. If the inner glove becomes contaminated, then both pairs of gloves must be changed. 10. When removing any PPE, care must be taken to avoid introducing hazardous contamination into the environment. Both the inner and outer gloves should be considered contaminated, and glove surfaces must never touch the skin or any surface that may be touched by the unprotected skin of others. 11. Care must be taken to avoid contaminating the IV tubing set attached to the final preparation in the BSC. 12. Hands must be washed after removal of gloves and disposal of hazardous PPE worn in the hazardous IV room. CLEANING, DECONTAMINATION, and DISINFECTION 1. Decontamination may be defined as decontaminating or deactivating 2. The BSC must be cleaned, decontaminated and disinfected on a regular basis (no less frequently than once a week for inpatient pharmacy and daily for outpatient) and/or whenever there is a spill, the cabinet is moved, the cabinet is turned off, or the cabinet is serviced. Note: The BSC must always be considered a contaminated environment and appropriate safety precautions as described below must be exercised at all times when cleaning the hood. a. The underneath of the deck must be cleaned, decontaminated, and disinfected at least monthly, and if a spill occurs. 3. The use of alcohol for disinfecting the BSC will not deactivate any hazardous contamination and may result in the spread of contamination rather than any actual cleaning. 4. Decontamination of the BSC should be conducted per manufacturer recommendations. 5. BSC s must be disinfected at the beginning of the workday, at the beginning of each subsequent shift (if compounding takes place over an extended period of time), and routinely during compounding. 6. All 70% alcohol used within the BSC for disinfecting should be sterile. 7. Appropriate preparation of materials used in compounding before introduction into the Class II BSC, including wiping with 70% alcohol or appropriate disinfectant, is also necessary for aseptic compounding. 8. All personnel cleaning within a BSC (when the shield is lifted) or cleaning up a spill should utilize a fit-tested dual chamber respirator if one is available for use. a. Since N95 respirators do not protect against vapors and commonly prescribed antineoplastic agents (e.g., cyclophosphamide and fluorouracil) have been shown to form a gas during normal handling at room temperature, it is best practice to use a dual chamber respirator anytime a C-PEC is opened (BSC front shield is lifted) or when cleaning up a hazardous medication spill. 9. All cleaning, decontamination/deactivation, and disinfection of classified areas by pharmacy personnel and E.S. staff must be documented on forms located within the pharmacy. 6 of 10
ADMINISTRATION 1. For low- and high-risk hazardous drug administration refer to the master Hazardous Medication List for specific handling requirements based on individual risk assessments. 2. High-Risk Hazardous Medications a. All injectable high-risk hazardous medications (and some oral low-risk hazardous medications) may only be administered by licensed and trained staff as appropriate to their individual scope. b. During IV/IM/SQ/IT or intravesical administration, the administering nurse should place an absorbent plastic backed chemo mat under the administration area to prevent leaks and to prevent medication contact with the patient s skin. c. The administering nurse must perform hand hygiene and don appropriate PPE before opening the sealed chemotherapy delivery bag. d. The administering nurse must utilize a CSTD for hazardous medications when the dosage form allows. e. The administering nurse must wear appropriate garb while administering hazardous medications (this should include two pairs of ASTM -6978 certified chemotherapy gloves and a non-permeable gown) to prevent skin contact. Eye protection should be used if there is a splash risk. f. In the event of a spill, follow the chemotherapy spill kit process and don the following additional garb (i.e. shoe covers, hair cover, face mask, and second pair of gloves). g. The administering nurse must dispose of hazardous waste (including PPE) in appropriate hazardous waste containers. h. Yellow hazardous waste containers must be available in all areas where high-risk hazardous medications are administered. i. Hypersensitivity and Anaphylaxis kits and/or medications will be readily available where hazardous medications are administered. 3. Low-Risk Hazardous Medications a. Chemotherapy gloves (certified ASTM-6978) must be worn during administration of low-risk oral hazardous medications. A non-permeable gown and face shield should be worn if there is a risk of splashing. b. If a patient is unable to swallow solid dosage forms of low-risk hazardous medications, the nurse must call pharmacy to determine if the order can be changed to a commercially available suspension, a suspension compounded by pharmacy, or if the dosage form can be cut, crushed, or the capsule opened. HAZARDOUS MEDICATION SPILLS 1. All personnel who would potentially be required to assist in hazardous medication spill cleanup must be fully trained in the in the use of chemotherapy spill kits and disposal of hazardous waste. This training must occur prior to handling hazardous medications. Annual competency will be conducted and documented. Pharmacy will also randomly conduct chemo spill training drills in various departments as necessary. 2. In the event of a spill, locate a chemotherapy spill kit and don appropriate PPE. 3. Chemotherapy spill kits are located in the Inpatient Pharmacy, Cancer Center Pharmacy, and all places that high-risk hazardous medications are stored, transported, or administered. 4. Size of spill should be estimated by personnel. A spill kit is adequate for a volume of 500 ml or less. Pharmacy and nursing will be expected to contain all spills that are managed with up to two spill kits (volumes of 1000 ml or less). After spill containment, cleaned, and disposal of waste, Environmental Services (E.S.) must be contacted for final spill area cleaning. 7 of 10
5. Open spill kit, and don two pair of gloves, a disposable gown, shoe covers, hair cover, and dual chamber respirator (if available) or N95 surgical mask included in the spill kit. Utility gloves should be worn for cleanup of broken glass. 6. Access to the spill area should be immediately restricted with included sign from the chemotherapy spill kit. 7. Cleanup should proceed from area of lesser concentration to greater concentration utilizing the appropriate supplies in the kit. 8. Liquids should be absorbed with a spill pad; powder should be removed with damp disposable gauze pads or lint-free wipe. 9. The hazardous material(s) must be completely removed and all cleanup material placed into sealed, disposable bags and placed into the hazardous waste container for disposal as hazardous waste. 10. The area should be rinsed with water then cleaned with an appropriate detergent and decontamination/deactivation agent. Consult the Safety Data Sheet for specific cleaning instructions for the hazardous medication that was spilled. 11. All waste generated from the cleaning of the spill must be considered hazardous waste and placed in the provided yellow waste bags. These bags must then be placed in yellow hazardous waste containers for disposal. 12. Final cleaning of the spill area should be completed by E.S. according to their normal cleaning procedure using an approved disinfectant (i.e. bleach followed by detergent). 13. In the case of skin contact, the affected area should be washed thoroughly with soap and water, followed by rinsing with copious amounts of water. Affected eyes should be flushed with copious amounts of water at an eye wash station and refer to Maxcom for specific exposure information/instructions. 14. Any puncture wounds or medication spills on personnel must be documented and reported to Employee Health Services, or to the Emergency Room. 15. Circumstances that led to the spill and spill cleanup must be documented in Midas 16. If the spill occurred within the BSC: a. All non-contaminated materials and supplies used to complete compounding should be placed off to the side in the hood. b. The person compounding/cleaning up the spill should then remove both sets of gloves and dispose of them with the other hazardous materials. c. Two new sets of ASTM -6978 certified chemotherapy gloves should be donned and the hood cleaned, decontaminated/deactivated, and disinfected. d. Following the three-step decontamination within the hood, the outer gloves should be removed and replaced. Hands should be washed with antimicrobial detergent prior to donning new gloves and resuming compounding. WASTE MANAGEMENT and DISPOSAL 1. The pharmacy, nursing departments, operating rooms, radiology, and various clinics (including Urology and Downtown Day Surgery) must appropriately dispose of hazardous medications, disposable equipment associated with the preparation/administration of these medications, and any hazardous waste produced. 2. All waste materials, including vials, ampules, syringes, needles, and gloves that come in contact with hazardous medications during compounding must be placed in a plastic zip-lock bag before removing them from the BSC and then discarded in a separate chemotherapy waste container. 3. Any hazardous material spills must be cleaned up immediately and material disposed of in the appropriate manner. All waste generated from a spill and its associated cleanup must be considered hazardous waste. 4. Environmental Services should wear one pair of ASTM -6978 certified chemotherapy gloves when collecting hazardous waste for disposal. 5. Hazardous waste (yellow sharps container) 8 of 10
a. Chemotherapy/hazardous waste examples include vials, syringes, IV bags, IV tubing, gloves, mats and closed-system transfer devices used during the compounding of hazardous medications. b. Containers must be kept closed when not in use. 6. Each facility handling hazardous medications should be contracted with an authorized and licensed company for the pickup and proper disposal of all hazardous pharmaceutical waste. 7. Routine waste collection and disposal will be in accordance with E.S. policies and procedures. All hazardous waste will be placed in yellow hazardous waste containers marked with the words, CAUTION: Chemotherapy Waste. TRAINING and OVERSIGHT 1. The institution (hazardous medication committee) must perform a yearly review of the current NIOSH Hazardous Drug List and master Hazardous Medication List every 12 months. 2. The institution has chosen to perform an assessment of risk for all of the medications eligible for alternative containment and work practice strategies. The assessment of risk considers type of hazardous medication (antineoplastic, non-antineoplastic, reproductive risk only), dosage form carried, risk of exposure, packaging, manipulation requirements, and specific storage requirements. Consideration will also include a review of available literature and safety data sheets. This assessment must be performed to determine the specific handling required of each hazardous medication every 12 months. 3. All personnel that come into contact must confirm in writing that they understand the risks of handling hazardous medications upon hire, and at least every 12 months. a. Employees will sign a document that includes the statement, If I am of reproductive capability, actively trying to conceive, or as soon as I am confirmed to be pregnant, I will discuss this with my supervisor. 4. Competencies for hazardous medication handling have been developed for all pharmacy staff, chemotherapy trained nursing staff, and environmental staff in charge of hazardous waste cleanup and disposal. Each employee must demonstrate competency initially and at least every 12 months. DISCLAIMER Even when recommended precautions are used, the potential for accidental exposure to hazardous medications cannot be eliminated. Alternative duties that do not include exposure to hazardous medication should be made available for both male and female employees who are actively trying to conceive, are pregnant, or are breastfeeding. The employee has the responsibility to notify his or her supervisor of the above situations, or any other medical reasons for avoiding hazardous medications. REFERENCES ASHP Guidelines for handling hazardous drugs, AJHP 2006; 63: 1172-93. NIOSH [2016]. NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings 2016. By Connor TH, MacKenzie BA, DeBord DG, Trout DB, O'Callaghan JP. Cincinnati, OH: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. 2016-161 (Supersedes 2014-138). Oncology Nursing Society. (2014). Chemotherapy and Biotherapy Guidelines and Recommendations for Practice. (4 th ed.). Pittsburgh, PA: Oncology Nursing Society. 9 of 10
Oncology Nursing Society. (2011). Safe Handling of Hazardous Drugs. (2 nd ed.). Pittsburgh, PA: Oncology Nursing Society. NIOSH Publication, Preventing Occupational Exposures to Antineoplastic and other Hazardous Drugs in Healthcare Settings, March 25, 2004. OSHA: Hazard Communication Standard, CFR 29. 1910. 1200. USP Chapter 800. Hazardous Drugs Handling in Healthcare Settings. USP Compounding Compendium. June 2016. 10 of 10
Environmental Services IV Room Cleaning Responsibilities Month Year Cleaning Responsibility Frequency Remove waste products and trash from sterile Twice daily approximately (1000 and 2200) products/ante-room 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 Morning Evening Mop floor of sterile products rooms and ante-room with a cleaning mop and wipes saturated with disinfecting agent (Separate mop heads for CHEMO room and non-chemo room/ante-room) NIGHTLY (Due to requirement that no aseptic operations can be in progress) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 Clean sink with disinfecting agent (ante-room) DAILY 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 Clean ceilings (including air vents and light fixtures), walls, and sliding doors (Non-CHEMO room, Ante-Room, CHEMO room) using 2-step cleaning process= Peridox followed by alcohol MONTHLY CHEMO-Room Non-CHEMO Room Ante-Room Wipe the entire ceiling area with cleaning solution, then the walls starting at the top and moving towards the floor; frequent changes of wiping cloths and cleaning solution will be required when cleaning supplies are visibly dirty. Remove particulate matter from ledges, carts, cabinets, and external surfaces of laminar-air flow hoods with a wiping cloth and cleaning solution; begin all cleaning at the top and finish at the bottom. January February March April May June July August September October November December
Hazardous Drug List Last Reviewed: November 15, 2017 NIOSH TABLE 1 The drugs in Table 1 meet one or more of the NIOSH criteria for a hazardous drug. These drugs represent an occupational hazard to health care workers and should always be handled with use of recommended engineering controls and personal protective equipment (PPE), regardless of their formulation (IV [intravenous], SQ [subcutaneous], topical, tablet, or capsule). Unopened, intact tablets and capsules may not pose the same degree of occupational exposure risk as injectable drugs, which usually require extensive preparation. Cutting, crushing, or otherwise manipulating tablets and capsules will increase the risk of exposure to workers. In addition to many of these drugs being cytotoxic, the majority are hazardous to males or females who are actively trying to conceive, women who are pregnant or may become pregnant, or women who are breast feeding, because they may be present in breast milk. Medication Name (Generic) Medication Name (Brand) Strength Dosage Form Classification Reason Listed Auxiliary Labeling (Chemo/Hazardous) Risk Level Pharmacy Handling (Compounding) Risk Level Nursing Handling (Administration) Require Unit Dosing? Inpatient Cancer Center CC Repository CC Samples HPP Belgrade Clinic BSMC Assessment of Risk (If handling differently than NIOSH) abiraterone Zytiga 250 mg Tablet Antineoplastic FDA Pregnancy X Yes Low (3) Low (9,*) X Conjugated monoclonal ado-trastuzumab Kadcyla 100 mg Vial (powder) Antineoplastic Yes High (1) High (7) X Antibody FDA Pregnancy D anastrozole Arimidex 1 mg Tablet Antineoplastic FDA Pregnancy X Yes Low (3) Low (9,*) YES X X Pharmacy staff will utilize bubble packaging when unit dosing from bulk containers. When unit dosing, staff will wear two pairs of chemo certified gloves and a face mask. NIOSH TABLES 2 & 3 The drugs in Tables 2 and 3 meet one or more of the NIOSH criteria for a hazardous drug, OR the criteria for reproductive hazards. Unopened, intact tablets and capsules may not pose the same degree of occupational exposure risk as injectable drugs, which usually require extensive preparation. Cutting, crushing, or otherwise manipulating tablets and capsules will increase the risk of exposure to workers. Some of these drugs may represent an occupational hazard to males or females who are actively trying to conceive, women who are pregnant or may become pregnant, or women who are breast feeding, because they may be present in breast milk. Medication Name Strength Dosage Form Classification Reason Listed Auxiliary Labeling (Chemo/Hazardous) Risk Level Pharmacy Handling (Compounding) Risk Level Nursing Handling (Administration) Group 1 carcinogen azathioprine Imuran 50 mg Tablet Immunosuppressant Pregnancy Category D Tegretol 200 mg YES X Black Box: Aplastic Anemia 100 mg ER Congenital Malformations carbamazepine Tablet Anticonvulsant No Low (5) Minimal (13) Tegretol XR 200 mg ER Rapid transplacental Passage, YES X X FDA Pregnancy D 400 mg ER X Require Unit Dosing? Inpatient Cancer Center CC Repository CC Samples HPP Belgrade Clinic BSMC Assessment of Risk (If handling differently than NIOSH) Yes Low (3) Low (9,*) X X Will follow all handling recommendations suggested by NIOSH 0.5 mg Increased risk of congenital X X clonazepam Klonopin 1 mg Tablet Benzodiazapine abnormalities when taken in first No Low (5) Minimal (13) X X trimester; FDA Pregnancy D 2 mg X Pharmacy staff will utilize bubble packaging when unit dosing from bulk containers. When unit dosing, staff will wear two pairs of chemo certified gloves and a face mask. No special handling requirements for administration because risk judged as minimal. Risk judged as minimal for handling, no special handling requirements. Purchased in unit dose packaging. NON-NIOSH MEDICATIONS Alemtuzumab Campath 30 mg / 1 ml Vial (solution) Monoclonal Antibody Not a NIOSH listed drug No Low (6) Minimal (11) X Atezolizumab Tecentriq 1200 mg / 20 ml Vial (solution) Monoclonal Antibody Not a NIOSH listed drug No Low (6) Minimal (11) X Listed as antineoplastic with special instructions within EPIC. Not classified as HD per SDS. No special handling per SDS. Compound in non-hd hood. Require special handling during administration. Listed as antineoplastic with special instructions within EPIC. Not classified as HD per SDS. No special handling per SDS. Compound in non-hd hood. Require special handling during administration. If any additional drugs are compounded within a BSC in a hazardous clean room, appropriate "cytotoxic handling" procedures will be enforced. Compounding, labeling, and administration will be similar to that of High-Risk (1) compounding and High Risk (7) administration of IV preparations within Table #1. Compounding Administration High-Risk Low-Risk High-Risk Low-Risk High vs. Low-Risk Compounding & Administration Requirements? 1. (IV, IM, SQ, Solution for Irrigation): Double chemo gloves (ASTM -6978 certified), non-permeable gown, face mask, CSTD used, and compounded within an ISO 5 BSC in a ISO 7 negative pressure clean room 2. (Cutting, crushing or otherwise manipulating tablets or capsules): Double chemo gloves (ASTM -6978 certified), non-absorptive protective gown, and compounded within an ISO 5 BSC in an ISO 7 negative pressure clean room 3. (Handling intact tablets or capsules): Single pair of chemo gloves (ASTM -6978 certified) 4. (Handling intact syringes that contain liquid drug): Double chemo gloves (ASTM -6978 certified) 5. No handling restrictions for intact tablets or capsules (loose or unit dosed). Risk judged as minimal 6. Single pair of chemo gloves (ASTM -6978 certified), gown, face mask (NOT N95 or dual chamber respirator), and compounded within an ISO 5 laminar airflow hood within an ISO 7 clean room 7. (IV, IM, SQ): Double chemo gloves (ASTM -6978 certified), non-permeable gown, face mask, CSTD if compatible, and eye protection if splash potential 8. (Solution for Irrigation): Double chemo gloves (ASTM -6978 certified), non-permeable gown, face mask, and eye protection 9. (Handling intact tablets or capsules from unit dose packaging): Double pair of chemo gloves (ASTM -6978 certified) 10. (Handling tablets that have been cut): Double chemo gloves (ASTM -6978 certified), non-absorptive protective gown, and face mask *Nurses should not open capsule, or crush/cut tablets
11. Non-NIOSH Monoclonal Antibodies (MABs) - (IV, IM, SQ): Risk judged as minimal. Will require special handling during administration (i.e. CSTD's and single pair of chemo gloves) Minimal Risk 12. (IV, IM, SQ): No additional precautions, risk judged as minimal 13. (Handling intact tablets or capsules from unit dose packaging, or cutting/crushing tablets or opening capsules): No additional precautions, risk judged as minimal References NIOSH [2016]. NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings 2016. By Connor TH, MacKenzie BA, DeBord DG, Trout DB, O'Callaghan JP. Cincinnati, OH: U.S. Department of Helath and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. 2016-161 (Supersedes 2014-138). USP Chapter 800. Hazardous Drugs Handling in Healthcare Settings. USP Compounding Compendium. June 2016.
Hazardous Learning Module Deployment Decision Tree Policy All employees directly handling hazardous medications, hazardous waste or hazardous lab specimens will be included in this policy. Competency training and documentation will occur during orientation, annually and if exposure occurs. DEFINITIONS Hazardous Medication: A drug which poses a significant risk to a healthcare worker that exhibits characteristics which may include carcinogenicity, teratogenicity, genotoxicity, or organ toxicity. Handling: The process of receiving, unpacking, compounding, storing, compounding, transporting, administering, cleaning, disposing of or other handling of hazardous drugs, waste or specimens from patients to whom hazardous drugs have been administered. Pharmacists Inpatient Pharmacists Outpatient Pharmacists Cancer Center Pharmacists Ambulatory Care Pharmacists Big Sky Pharmacists Technicians Inpatient Technicians Outpatient Technicians Cancer Center Technicians Big Sky Technicians Nursing (Inpatient) ICU SURG MED PCU PostPartum Labor & Delivery Nursery Nursing (Outpatient) OR ER RAD ENDO CATHLAB Cancer Center Providers Urologists Radiologists DTDS Surgeons Ancillary Staff Environmental Services Enginneering Receiving Dock Laboratory Staff Phlebotomy Staff Clinics Urology Clinic Nursing Urology Clinic Transporters Downtown Day Surgery Nursing Belgrade Clinic Nursing WITHIN YOUR JOB, ARE YOU INVOLVED IN Receiving Hazardous Medications (from supplier) Unpacking Hazardous Medications (from supplier) Storing Hazardous Medications (IV and /or Oral) Compounding Hazardous Medications (IV and/or Oral) Working in a sterile Hazardous Compounding Room Administering Hazardous Medications (IV and/or Oral) Disposing of Hazardous Medications and/or Waste Cleaning Hazardous Medication Spills X X X X X X X X X X X X X X X X X X X X X X X X X X X X X Deactivating, Decontaminating, and/or Disinfecting areas where hazardous medications are stored, compounded, and/or administered X X Transporting and/or Handling Hazardous Lab Samples
January February March April May June PHARMACY Daily Cleaning 52 % 71 % 45 % 61 % 82 % 82 % Weekly Decontamination 0 % 50 % 60 % 100 % 87 % 80 % Monthly Decontamination 0 % 0 % 0 % 0 % 0 % 100 % E.S. Trash Removal 38 % 32 % 2% 35 % 33 % 30 % Mopping Floors 61 % 32 % 80 % 56 % 61 % 66 % Cleaning Sink 77 % 71 % 67 % 70 % 67 % 60 % Monthly Clean 100 % 0 % 0 % 0 % 0 % 0 % July August September October November December PHARMACY Daily Cleaning 90 % 80 % 90 % Weekly Decontamination 100 % 100 % 100 % Monthly Decontamination 100 % 100 % 100 % E.S. Trash Removal 33 % 40 % 56 % Mopping Floors 51 % 45 % 70 % Cleaning Sink 61 % 74 % 86 % Monthly Clean 0 % 0 % 100 %
Pharmacy Staff IV Room Cleaning Responsibilities Month Year Cleaning Responsibility Frequency ISO Class 5 work surfaces (Laminar Air-Flow hoods and At the beginning of shift, prior to compounding Biological Safety Cabinet) disinfected with alcohol When compounding activities last > 30 minutes After spills When surface contamination is known or expected Counters and easily cleanable work surfaces disinfected At the beginning of shift with alcohol (areas that come into contact with final After spills product) When surface contamination is known or expected Change tacky floor mat (outside of ante-room) Beginning of each shift When visibly saturated with debris 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 3 step cleaning process (2 Step Surface Safe followed by alcohol) within Biological Safety Cabinet DAILY (When Cytotoxic/Hazardous medications are compounded) WEEKLY (Regardless of compounding within previous week) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 Decontaminate both non-hazardous IV hoods and hard surfaces (counter, top of carts) using 2-step cleaning process = Peridox followed by alcohol WEEKLY Decontaminate HD hood and hard surfaces (top of cart) in HD room using 3-step cleaning process = Bleach, Peridox, followed by alcohol Week January February March April May June July August September October November December 1 2 3 4 5 CHEMO-Room Non-CHEMO Room Ante-Room Decontaminate storage shelves, bins, outside of hoods, refrigerator, rolling carts, chairs, computer, printer and trash bins using 2-step cleaning process= Peridox followed by alcohol. Take both anti-fatigue mats to sterile processing for cleaning. Monthly January February March April May June July August September October November December
BATCHED PRODUCT LABEL INGREDIENTS USED QUANTITY PREPARED Ingredient #1 Ingredient #2 Ingredient #3 Ingredient #4 BATCHED PRODUCT LABEL INGREDIENTS USED QUANTITY PREPARED Ingredient #1 Ingredient #2 Ingredient #3 Ingredient #4 BATCHED PRODUCT LABEL INGREDIENTS USED QUANTITY PREPARED Ingredient #1 Ingredient #2 Ingredient #3 Ingredient #4 BATCHED PRODUCT LABEL INGREDIENTS USED QUANTITY PREPARED Ingredient #1 Ingredient #2 Ingredient #3 Ingredient #4 PHARMACIST INITIALS TECHNICIAN INITIALS PHARMACIST INITIALS TECHNICIAN INITIALS PHARMACIST INITIALS TECHNICIAN INITIALS PHARMACIST INITIALS TECHNICIAN INITIALS