Chemotherapy safety and handling-Thao's presentation
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This document discusses chemotherapy safety and handling guidelines. It outlines the risks of hazardous drug exposure, engineering controls like ventilation requirements, personal protective equipment, safe storage, compounding and administration practices, decontamination procedures, medical surveillance, and future steps for improving safety in Vietnam. The key points are that chemotherapy drugs pose risks and strict protocols are needed to minimize exposure for healthcare workers handling these agents.
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Chemotherapy safety and handling-Thao's presentation
- 1. Chemotherapy Safety and Handling Thao K. Huynh, PharmD, BCOP Assistant Professor Department of Pharmacy and Therapeutics University of Pittsburgh School of Pharmacy Email: t.huynh@pitt.edu
- 2. Outline • Risks of hazardous drug exposure • Engineering control • Storage • Compounding • Administration • Decontamination • Medical surveillance • Future steps for Vietnam
- 3. Outline • Risks of hazardous drug exposure • Engineering control • Storage • Compounding • Administration • Decontamination • Medical surveillance • Future steps for Hue
- 4. Hazardous Drug Exposure • 8 million US healthcare workers experience potential exposure to hazardous drugs every year • National Institute of Occupational Safety and Health (NIOSH) published Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings • http://www.cdc.gov/niosh/docs/2004-165/pdfs/2004-165.pdf
- 5. Who Potentially Experiences Chemotherapy Exposure? Patients and family members Hospital Staff Nurses Pharmacy Staff PhysiciansOR Personnel
- 6. Hazardous Drug Exposure by Profession CAREX Canada 2006 estimates: http://www.occupationalcancer.ca/wp-content/uploads/2014/07/Antineoplastics-and-cancer-ENG.pdf
- 7. Hazardous Drug Exposure • Manufacturing • Shipping • Handling • Compounding • Dispensing •Administration •Patient care activities •Disposal •Spills
- 8. Potential Routes of Exposure • Inhalation • Fluorouracil and cyclophosphamide detected in air without proper ventilation • Skin contact • Body fluids, contaminated clothing, dressings, linens • Ingestion • Accidental ingestion from dermal contact • Injection • Accidental needle stick
- 9. Effects of Hazardous Exposure Acute Effects Chronic Effects Sore throat Chronic cough Infections Dizziness Eye irritation Headaches Malignancies - 7-50 cancer cases per year per million workers exposed to cyclophosphamide Reproductive abnormalities - Increase in fetal abnormalities - Fetal loss - Fertility impairment Congenital malformation Stillbirths Valanis BG, et al. AAOHN J. 1987; 35:487–92. Valanis BG, et al. Am J Hosp Pharm. 1993; 50:455–62. Ensslin AS, et al. Occup Environ Med. 1994; 51:229–33
- 10. Response to Hazardous Drug Exposure: United States Pharmacopeia (USP) 800 • Goal: promote patient safety, worker safety, and environmental protection • Includes any hazardous drug handling: receipt, storage, compounding, dispensing, administration, and disposal • Applies to all healthcare workers who handle hazardous drug preparations
- 11. Outline • Risks of hazardous drug exposure • Engineering control • Storage • Compounding • Administration • Decontamination • Medical surveillance • Future steps for Hue
- 12. Engineering Control • Compounding clean room must be a negative pressure room • Contain an anteroom for garbing and handwashing ASHP Guidelines on Handling Hazardous Drugs: http://www.ashp.org/DocLibrary/BestPractices/PrepGdlHazDrugs.aspx USP 800: http://www.usp.org/sites/default/files/usp_pdf/EN/m7808.pdf
- 13. Engineering Control: Ventilation • Designed to eliminate or reduce worker exposure • Sterile compounding MUST be performed in class II biological safety cabinet or compounding aseptic containment isolators ASHP Guidelines on Handling Hazardous Drugs: http://www.ashp.org/DocLibrary/BestPractices/PrepGdlHazDrugs.aspx USP 800: http://www.usp.org/sites/default/files/usp_pdf/EN/m7808.pdf
- 14. Outline • Risks of hazardous drug exposure • Engineering control • Storage • Compounding • Administration • Decontamination • Medical surveillance • Future steps for Hue
- 15. Storage of Hazardous Drugs • Antineoplastic hazardous drugs must be unpacked in separate area than compounding areas under neutral/normal or negative pressure room • Must be stored separately from non-hazardous drugs • Restricted-access storage room must be under negative pressure, externally vented, and have at least 12 air changes per hour • Refrigerated antineoplastics must be stored in a hazardous drug dedicated refrigerator USP 800: http://www.usp.org/sites/default/files/usp_pdf/EN/m7808.pdf
- 16. Outline • Risks of hazardous drug exposure • Engineering control • Storage • Compounding • Administration • Decontamination • Medical surveillance • Future steps for Hue
- 17. Personal Protective Equipment for Compounding: Gloves • Nitrile or neoprene rubber and polyurethane gloves approved by the American Society of Testing and Materials (ASTM) • Use when handling drug packaging, cartons, vials • Use double gloves • Change gloves: • Every 30 min (maximum time) • Upon exit and re-entry of biologic safety cabinet • Damage occurs (puncture, tear) ASHP Guidelines on Handling Hazardous Drugs: http://www.ashp.org/DocLibrary/BestPractices/PrepGdlHazDrugs.aspx
- 18. Personal Protective Equipment for Compounding: Gowns and Other • Dedicated gowns for hazardous drug • Change • Every time inner pair of gloves changed • Contamination • Maximum 2-3 hours • Shoe and hair covers • Eye and face protection required • NIOSH-certified N96 respirators required for compounding ASHP Guidelines on Handling Hazardous Drugs: http://www.ashp.org/DocLibrary/BestPractices/PrepGdlHazDrugs.aspx
- 19. Compounding • Spiking or priming an IV set with in a biological safety cabinet BEFORE adding hazardous drug is added to the solution • Use of closed-system drug transfer devices • PhaSeal shown to decrease environmental exposure • Luer-Lok syringes and connections ASHP Guidelines on Handling Hazardous Drugs: http://www.ashp.org/DocLibrary/BestPractices/PrepGdlHazDrugs.aspx
- 20. Outline • Risks of hazardous drug exposure • Engineering control • Storage • Compounding • Administration • Decontamination • Medical surveillance • Future steps for Hue
- 21. Administration • Chemotherapy gown and gloves should be worn by nursing • Chemotherapy should be transported in hazardous bag to prevent contamination and never be placed in the biological safety cabinet
- 22. Outline • Risks of hazardous drug exposure • Engineering control • Storage • Compounding • Administration • Decontamination • Medical surveillance • Future steps for Hue
- 23. Chemotherapy Spill Kit • 2 caution spill signs • 1 chemotherapy gown • 1 pair overshoes • 1 Plastic safety glasses • 1 Respirator mask • 2 pairs heavy duty rubber gloves • 2 absorbent pads • 4 absorbent towels • 1 waste bag • 2 cable ties • 1 small scoop to collect glass fragments • 1 bottle of water
- 24. Hazardous Waste Disposal • Stored in labeled, leakproof, spill-proof containers of nonreactive plastic • Can be initially contained in thick sealable plastic bags before being placed in containers
- 25. Decontamination • Sodium hypochlorite 0.5% • 98% effectively removed contamination • Wait 1 hour before using cleaned surface • Isopropyl alcohol • Best for hydrophilic compounds (cytarabine, anthracyclines) • ~80.7% effective Queruau Lamerie T, et al. Ann Occup Hyg. 2013 May;57(4):456-69.
- 26. Outline • Risks of hazardous drug exposure • Engineering control • Storage • Compounding • Administration • Decontamination • Medical surveillance • Future steps for Hue
- 27. Alternative Duty and Medical Surveillance • Attempting to conceive or father a child, pregnant, or breast-feeding should be offered alternative duty • Anyone who handles hazardous drugs should be routinely monitored in a medical surveillance program provided in workplace • Assessment and documentation of symptom complaints • Physical findings • Laboratory values (CBC)
- 28. Outline • Risks of hazardous drug exposure • Engineering control • Storage • Compounding • Administration • Decontamination • Medical surveillance • Future steps for Vietnam
- 29. Small Steps Vietnam Employees Can Take to Ensure Safety • Education and orientation program on hazardous drug handling • Competency assessment • Personal protective equipment • Compounding • Respirator/face shield, gown, double gloves, cap, shoe covers • Receiving, transport, administration • Gown, gloves • Cytotoxic waste should be disposed in hazardous drug containers • Decontamination (cleaning) with bleach (0.5% sodium hypochlorite) for work area • Pharmacy department preparation of chemotherapy
- 30. Chemotherapy Safety and Handling Thao K. Huynh, PharmD, BCOP Assistant Professor Department of Pharmacy and Therapeutics University of Pittsburgh School of Pharmacy Email: t.huynh@pitt.edu
- 31. USP 800 Requirements • Train personnel to utilize related practices • Occupational safety plan • Engineering controls • Safe work practices • Proper use of Personal Protective Equipment (PPE) • Policies for hazardous drug waste segregation and disposal
- 32. Exposure Control • Engineering control • Biological safety cabinet • Administrative control • Procedures and protocols to minimize worker exposure • Ex. Wiping all vials and ampules prior to puncturing and opening • Personal protective equipment (PPE) • Barriers that protect workers from exposure (gloves, gowns)
- 33. History Continued • 2010 Journal of Occupational and Environmental Medicine published 2 key studies • Study of antineoplastic drug exposure of US healthcare workers a 3 university- based healthcare centers showed continued surface contamination in pharmacy and nursing areas despite hazardous drug handling guidelines • Study that reported damage to healthcare workers’ chromosomes that are related to secondary cancers in treated patients • 2011: NIOSH, OSHA, and The Joint Commission sent a letter discussing the safe handling of hazardous drugs
- 34. Airborne Risk and Common Chemotherapy Agents • Fluorouracil concentrations 0.12-82.26 ng/m2 without biological safety cabinets • Cyclophosphamide – detected on HEPA filters • Opportunity for respiratory precautions
- 35. Personal Protective Equipment for Compounding • ASTM-tested chemotherapy gloves required when unpacking, compounding, and administering antineoplastic hazardous drugs • Dedicated gowns for hazardous drug compounding and administering injectable antineoplastic agents • Eye and face protection required for compounding • NIOSH-certified N96 respirators required for compounding • Half mask with multi-gas cartridge and P100 filter required if unpacking hazardous drug not contained in plastic • Dispose of hazardous drug and personal protective equipment • Documented personnel training
Editor's Notes
- Patients Nurses Pharmacists Physicians Operating room personnel Hospital staff Shipping and receiving personnel Custodial workers Laundry workers Waste handlers
- Valanis BG, Hertzberg V, Shortridge L. Antineoplastic drugs: handle with care. AAOHN J. 1987; 35:487–92. Valanis BG, Vollmer WM, Labuhn KT et al. Association of antineoplastic drug handling with acute adverse effects in pharmacy personnel. Am J Hosp Pharm. 1993; 50:455–62. Dranitsaris G, Johnston M, Poirier S, Schueller T, Milliken D, Green E, Zanke B. Are health care providers who work with cancer drugs at an increased risk for toxic events? A systematic review and meta-analysis of the literature. J Oncol Pharm Pract. 2005 Jun;11(2):69-78.
- ajph
- Gloves Handling drug packaging, cartons, vials Nitrile or neoprene rubber and polyurethane gloves approved by the American Society of Testing and Materials (ASTM) Double glove Change gloves: Every 30 min (maximum time) Upon exit and re-entry of biologic safety cabinet Damage occurs (puncture, tear)
- Gowns Compounding in the biologic safety cabinet Administration Spill control Waste management Change Every time inner pair of gloves changed Contamination Maximum 2-3 hours
- Pads to contain liquid spills Towels for clean up after spills
- Queruau Lamerie T, Nussbaumer S, Décaudin B, Fleury-Souverain S, Goossens JF, Bonnabry P, Odou P. Evaluation of decontamination efficacy of cleaning solutions on stainless steel and glass surfaces contaminated by 10 antineoplastic agents. Ann Occup Hyg. 2013 May;57(4):456-69. Gohma H, Inoue Y, Asano M, Sugiura S. Testing the degradation effects of three reagents on various antineoplastic compounds. J Oncol Pharm Pract. 2015 Aug;21(4):268-73.