Hazardous Drug Handling 2024 PDF

PHAR 145: BPSA II USP Chapter Anna E. Shook, PharmD, BCPS, BCOP Assistant Professor of Pharmacy Practice Drake University College of Pharmacy PGY1 Residency Program Director Mary Greeley Medical Center Learning Objectives oDescribe the scope of USP General Chapter oList the criteria for a hazardous...

PHAR 145: BPSA II USP Chapter Anna E. Shook, PharmD, BCPS, BCOP Assistant Professor of Pharmacy Practice Drake University College of Pharmacy PGY1 Residency Program Director Mary Greeley Medical Center Learning Objectives oDescribe the scope of USP General Chapter oList the criteria for a hazardous drug, according to NIOSH oDescribe the primary and secondary engineering controls required for sterile compounding of hazardous drugs oIdentify appropriate personal protective equipment (PPE) required for sterile compounding of hazardous drugs oDifferentiate between the processes of deactivating, decontaminating, cleaning, and disinfecting 2 Abbreviations ACPH Air changes per hour API Active pharmaceutical ingredient BSC Biological safety cabinet BUD Beyond-use date CACI Compounding aseptic containment isolator CPEC Containment primary engineering control CSEC Containment secondary engineering control CSP Compounded sterile preparation CSTD Closed-system transfer device HD Hazardous drug NIOSH National Institute for Occupational Safety and Health PPE Personal protective equipment 3 USP Chapter oDescribes standards for handling hazardous drugs to ensure safety of patient, worker, and environment oHandling includes receipt, storage, compounding, dispensing, administration, and disposal of hazardous products 4 Hazardous Drugs Chemotherapeutic agents Antivirals Hormonal therapies Meet at least one of the following characteristics in humans or animals: o Carcinogenicity o Teratogenicity or other developmental toxicity o Reproductive toxicity o Organ toxicity at low doses o Genotoxicity o Structure and toxicity profiles of new drugs that mimic existing drugs determined hazardous by the above criteria 5 6 Three Groups of Hazardous Drugs Group 1: Antineoplastic Drugs Group 2: Non-antineoplastic drugs that meet one or more NIOSH criteria for a hazardous drug Group 3: Pose a risk to individuals actively trying to conceive, and/or those who are pregnant or breastfeeding 7 List of Hazardous Drugs o NIOSH maintains a list of hazardous drugs used in healthcare o Entity must also maintain a list of hazardous drugs utilized at the facility o Review at least annually o NIOSH List.pdf 8 Containment Requirements o Drugs on the NIOSH list that must follow requirements of USP include: o Any hazardous drug API o Any antineoplastic requiring manipulation o Some drugs have dosage forms that do not require all the containment requirements of this chapter o Final dosage forms that do not require further manipulation o Tablets or capsules administered whole o Injectable agents that come as pre-filled syringe o For these products, perform an assessment of risk 9 Assessment of Risk Performed when full containment requirements of USP are not met for a medication Working document that outlines the steps taken to reduce risk of exposure Alternative containment strategies Different work practices to protect employees Must contain the following: o Type of HD (antineoplastic, nonantineoplastic, reproductive risk only) o Dosage form o Risk of exposure o Packaging o Manipulation 10 Assessment of Risk: Example 11 Assessment Question A new medication is recently approved by the FDA. This medication has a Black Box Warning for increased risk of congenital abnormalities when taken in the first trimester of pregnancy. According to NIOSH, in which Group of Hazardous Drugs should this new medication be listed? a) Group 1 b) Group 2 c) It was 3! Group 3 12 Inhalation Routes of Exposure to Hazardous Drugs Dermal or mucosal absorption Ingestion Injection 13 Examples of Exposure Activity Potential Opportunity of Exposure Receipt HD residue on containers Dispensing Counting or repackaging tablets or capsules Compounding or other manipulations Administration Generating aerosols during administration Priming an IV set Patient-care activities Handling bodily fluids Spills Spill generation, management, or disposal Waste Disposal or hazardous waste Crushing or splitting tablets Pouring liquids from one container to another Reconstituting powdered HDs Expelling air or HDs from syringes 14 Handling Hazardous Drugs o HDs must be handled in a way that promotes safety of the patient, worker, and environment o Signs designating an area as “Hazardous” must be displayed before the entrance to HD handling areas o Designated areas must be available for: o Receipt and unpacking of HDs o Storage of HDs o Sterile compounding of HDs 15 Receipt and Storage of HDs o Antineoplastic HDs and all HD APIs must be unpacked in neutral or negative pressure o HDs must be stored in a manner that prevents spilling or breakage o Do not store on the floor o Use shelves with raised front lips o HDs requiring manipulation must be stored separately from non-HDs o Externally-ventilated, negative-pressure room o At least 12 ACPH 16 Storage of HDs (Continued) May be stored with other inventory: o Non-antineoplastic HDs (Group 2) o Reproductive risk only HDs (Group 3) o Final dosage forms of antineoplastics Refrigerated antineoplastic HDs o Dedicated refrigerator o Negative pressure area o At least 12 ACPH 17 Assessment Question You are a pharmacist in a small hospital pharmacy and are trying to best utilize your space while also adhering to USP. Which of the following medications cannot be stored with other inventory and requires a separate storage space? a) Cyclosporine capsules, a non-antineoplastic HD b) Trastuzumab multi-use vial, a refrigerated antineoplastic HD c) Testosterone gel, a Group 3 HD d) Fulvestrant pre-filled syringe, an antineoplastic HD 18 Engineering Controls Primary Example: C-PEC o Ventilated device designed to minimize worker and environmental HD exposure Secondary Example: C-SEC o Room in which C-PEC is placed Supplemental Example: CSTD 19 Example Primary Engineering Controls Class II or III BSC CACI 20 Closed-System Transfer Devices o Adjunct controls that offer additional levels of protection when compounding HDs o Limit potential of generating aerosols during compounding o Should not be used as a substitute for a C-PEC o CSTDs should be used when compounding HDs if dosage form allows o CSTDs must be used when administering HDs if dosage form allows 21 Closed-System Transfer Devices 22 Sterile Compounding Requirements Configuration C-PEC ISO Class 7 buffer room Externally vented with ISO Class 7 ante-room ISO Class 5 or better C-SEC Externally vented 30 ACPH Negative pressure (0.010.03 inches of water column relative to adjacent areas) 23 Personal Protective Equipment oProvides worker protection to reduce exposure to HD aerosols and residues oRequired PPE for compounding: o Gowns o Head/hair covering o Facial hair covering o Shoe covers o Two pairs of chemotherapy gloves 24 When to Wear PPE PPE must be worn when handling HDs o Receipt o Storage o Transport o Compounding o Administration o Deactivation/decontamination/cleaning/disinfecting o Spill control o Waste disposal 25 Gowns 2 pairs of chemotherapy gloves Outer glove must be sterile during compounding Changed every 30 minutes during compounding or when torn, punctured, or contaminated Disposable Resist permeability Close in the back Long-sleeved Closed cuffs No seams Must be changed at least every 2-3 hours or after spill/splash Must not be worn to other areas Head/Hair/Shoe/Sleeve Covers Eye and Face Protection Second pair of shoe covers donned while compounding Must be worn when risk for spills or splashes when working outside C-PEC Eyeglasses alone do not protect eyes from splashes Best practice: goggles plus face shields Gloves PPE Requirements Respiratory Protection Only worn if attending HD spills larger than can be managed with spill kit, deep cleaning under work surface of C-PEC, or known airborne exposure 26 Chemotherapy Spill Kit 27 Cleaning Steps All areas where HDs are handled, and all reusable equipment must be: Deactivated Decontaminated Cleaned Sterile compounding areas and devices must also be disinfected All personnel performing these activities must wear appropriate PPE, including two pairs of chemotherapy gloves 28 Cleaning Steps (Continued) Cleaning Step Purpose Deactivation Render compound inert or inactive Decontamination Remove HD residue Cleaning Remove organic and inorganic material Disinfection Destroy microorganisms 29 Example Designs for Hazardous Drug Compounding C-PEC BSC or CACI ISO Class 5 C-PEC BSC or CACI ISO Class 5 30 ACPH Buffer Room Ante-Room Buffer Room ISO Class 7 Negative for HDs ISO Class 7 Positive ISO Class 7 Positive 30 Example Designs for Hazardous Drug Compounding C-PEC BSC or CACI ISO Class 5 Ante-Room Buffer Room ISO Class 7 Negative 30 ACPH ISO Class 7 Positive 31 Assessment Question You are working overnights in your hospital pharmacy when you receive a call from the Oncology Unit that the nurse forgot to close the roller clamp on the bag of chemotherapy and there was a spill on the floor in a patient’s room. The spill is approximately 15 mL and the nurse believes it can be managed with a spill kit. Which of the following PPE items is not required when cleaning this hazardous spill? a) Chemotherapy gloves b) Chemotherapy gown c) Shoe covers d) PAPR with respiratory protection 32 Hazardous Compounding Lab Plan oEHR Go Quiz oPrepare Label and Compound “Chemotherapy”: Cyclophosphamide o Prepare the same way we have been oPrepare Label and Compound “Chemotherapy”: Doxorubicin o Will utilize CSTDs o CSTDs and prepared solution medications will NOT be on the lab practical 33 Questions? 34