Hazardous Drug Acknowledgement Statement
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Hazardous Drug Handling Statement Hazardous Drug Acknowledgement Statement I understand that working with hazardous drugs in a pharmacy healthcare setting might cause health issues such as rashes, infertility, miscarriage, birth defects, and possibly cancer. I understand that the accidental exposure to some of these drugs might additionally cause irritation or damage to skin, eyes, or other exposed body parts. I understand that the handling of bodily fluids (urine, feces, sweat, and vomit) or bodily- fluid- contaminated clothing, dressing, linens, and other materials comes with potential exposure to hazardous drugs. I understand that the pharmacy OneWorld will follow reasonable policies and procedures in order to minimize my exposure to these drugs in accordance with commonly available information and guidance by such entities as the FDA and OSHA. I understand that the pharmacy OneWorld will also provide for safety measures and appropriate personal protective equipment to help limit my exposure to, or limit the results of, accidental exposure to such drugs. I also understand that these policies and procedures will be routinely reviewed and revised as needed in light of new information. I have been provided with training concerning hazardous drugs, and have passed a test verifying my understanding of key information concerning them. I understand that similar training will be repeated at least annually. __________________________________________ __________________________ Printed Employee Name Date __________________________________________ __________________________ Employee Signature Date USP 800 Med List for Clinic (11/20/19) Trade Name Generic Name Preparation & Disposal* Spill ** Administration Amethia, Levonorgestrel In clinic dispense: Return pill package Single use gloves Avaine, no single use back to pharmacy if Camrese gloves expired Cytotec Misoprostol Single use glove Dispose of gloves, Single use gloves med cup, and packaging Delestrogen Estradiol Single use glove Dispose of gloves, Double chemo gloves, needle, vial, & gown, & eye protection syringe Depo Provera Medroxyprogesterone Single use glove Dispose of gloves, Double chemo gloves, needle, vial, & gown, & eye protection syringe Depo Testosterone Single use glove Dispose of gloves, Double chemo gloves, Testosterone needle, vial, & gown, & eye protection syringe Ella Ulipristal In clinic dispense: Return pill package Single use gloves no single use back to pharmacy if gloves expired Femynor Norgestimate In clinic dispense: Return pill package Single use gloves no single use back to pharmacy if gloves expired Introvale, Levonorgestrel In clinic dispense: Return pill package Single use gloves Jolessa no single use back to pharmacy if gloves expired Kyleena Levonorgestrel Single use glove Disposal of Single use gloves packaging & implant Lessina Levonorgestrel In clinic dispense: Return pill package Single use gloves no single use back to pharmacy if gloves expired Liletta Levonorgestrel Single use glove Disposal of Single use gloves packaging & implant Lupron Depot Leuprolide acetate Single use glove Dispose of gloves, Single use gloves needle, vial, & syringe Lutera Levonorgestrel In clinic dispense: Return pill package Single use gloves no single use back to pharmacy if gloves expired Makena Hydroxyprogestrone Single use glove Dispose of gloves, Double chemo gloves, needle, vial, and gown, & eye protection syringe My Way Levonorgestrel In clinic dispense: Return pill package Single use gloves no single use back to pharmacy if gloves expired Nexplanon Etonogestrel Single use glove Disposal of Single use gloves packaging & implant Next Choice Levonorgestrel In clinic dispense: Return pill package Single use gloves One Dose no single use back to pharmacy if gloves expired Nuva Ring Etonogestrel In clinic dispense: Return package Single use gloves no single use back to pharmacy if gloves expired Orsythia Levonorgestrel In clinic dispense: Return pill package Single use gloves no single use back to pharmacy if gloves expired Ortho Cyclen, Norgestimate In clinic dispense: Return pill package Single use gloves Ortho Tri no single use back to pharmacy if Cylen (Lo) gloves expired Ortho Evra Xulane In clinic dispense: Return package Single use gloves no single use back to pharmacy if gloves expired Ortho‐ Norethindrone In clinic dispense: Return pill package Single use gloves Micronor no single use back to pharmacy if gloves expired Plan B Levonorgestrel In clinic dispense: Return pill package Single use gloves no single use back to pharmacy if gloves expired Previfem Norgestimate In clinic dispense: Return pill package Single use gloves no single use back to pharmacy if gloves expired Saxenda Liraglutide Single use glove Dispose of needle. Single use gloves Dispose of pen when empty (Lo) Levonorgestrel In clinic dispense: Return pill package Single use gloves Seasonique no single use back to pharmacy if gloves expired Skyla Levonorgestrel Single use glove Dispose of Single use gloves packaging, & implant Sprintec, Norgestimate In clinic dispense: Return pill package Single use gloves Trinessa, no single use back to pharmacy if Tri Lo Marzia, gloves expired Tri‐(Lo) Sprintec Trexall Methotrexate Single use chemo Dispose of gloves, Double chemo gloves, gloves needle, vial, & gown, and eye syringe protection Victoza Liraglutide Single use glove Dispose of needle. Single use gloves Dispose of pen when empty Xultophy Insulin degludec + Single use glove Dispose of needle. Single use gloves liraglutide Dispose of pen when empty *Disposal – all equipment in YELLOW hazardous drug container(s) marked Trace Hazardous Drugs **Spill – all used equipment/PPE in RED biohazardous tote in biohazard room *** Chemo gloves‐ Nitrile Exam Gloves Powder Free (blue) USP800 Training: Handling and Disposal Objectives • Review current USP800 guidelines on hazardous medications for safe handling of hazardous drugs to minimize risk of exposure to healthcare personnel, patients, and environment. • Illustrate how clinic demonstrates compliance with USP800 guidelines involving hazardous medication administration & disposal. USP800 – What is it? • The USP chapter that contains guidelines for hazardous drug handling, administration, and disposal. • Since it is below 1000 in the USP chapters it is enforceable by regulatory bodies. • Joint Commission will be surveying for compliance. • Implementation date of December 1, 2019. Who does USP800 affect? • Healthcare settings to include pharmacies, physician offices, clinics, veterinary offices, and other locations that handle hazardous drugs. • The word “entity” in USP800 means your setting if you are handling hazardous medications What medications make “the list”? • NIOSH list of antineoplastic and other hazardous drugs in USP800 that pose hazard to health care workers. ▫ Carcinogens, Teratogens, Reproductive toxicity, Organ toxicity, Genotoxicity, Chemical structure and toxicity that mimic existing drugs that are hazardous Drugs found in the clinic that are on USP800 list (see risk assessment list- this is kept in the Y drive under Nursing??): Methotrexate, all forms of birth control, medication with any type of hormonal component (to include any traces of these medications) Containment strategies for USP800 • Engineering controls • Personal Protective Equipment • Work Practices Work Practices for USP800 • Disposal: Section 11 of USP800 • The entity must establish SOP’s for the labeling, packaging, transport, and disposal of HD’s. • 11.4 Disposal: ….Disposal of all HD waste, including, but not limited to, unused HD’s and trace-contaminated PPE and other materials, must comply with all applicable federal, state, and local regulation. Transportation of HD Pharmacy will place hazardous drug in plastic zip bag (Depo Provera, depo testosterone) or appropriate container indicating contents are hazardous drugs. This excludes items that are already commercially packaged and ready for patient use (ex: birth control pills, patches, rings, IUDs, and any creams or ointments). Disposal – What determines the proper disposal method for a medication? • RCRA (Resource Conservation and Recovery Act) ▫ P-listed – Warfarin, Arsenic, Nicotine ▫ U-listed – all in this category are toxic. Mitomycin, Mercury • NIOSH (National Institute of Occupational Safety and Health) ▫ A part of the CDC ▫ A list of hazardous medications is published and risk categories are assigned. • OSHA (Occupational Safety and Health Administration) ▫ An agency of the US Department of Labor ▫ Responsible for providing a safe and healthful workplace Who regulates and enforces proper medication disposal? • The Resource Conservation and Recovery Act (RCRA) gives EPA the authority to control hazardous waste from the "cradle-to-grave." This includes the generation, transportation, treatment, storage, and disposal of hazardous waste. • NIOSH and CDC may not be actual federal regulations but can be incorporated in state or local law or hospital policies • Joint Commission considers proper disposal of hazardous medication waste as part of their Environment of Care standards • FDA gives guidance • State and federal government can enforce USP Hazardous Medication Waste Trace waste ▫Empty syringes or vials that contained any hazardous medication; and/or gloves used in preparation, administration or clean up. ▫Must be discarded in a YELLOW hazardous waste bin (McKesson stocks these) Yellow Hazardous Waste Bin Chemo Gloves PPE Disposal *Any gowns, masks, goggles, and gloves may be disposed of in the red biohazard