REGIONAL Applicable to all sites and facilities where the intended WRHA program services are delivered Level: 1A Policy Name: Cytotoxic Agents, Safe Handling of Approval Signature: Policy Number: Section: 110.160.010 Page 1 of 8 POLICY Date: Original signed by B. Postl October 2007 CLINICAL / PROGRAM SERVICES Supercedes: New 1.0 PURPOSE: 1.1 To provide direction for the preparation, transport, administration, spill clean up and waste management at point of care for Cytotoxic Agents within WRHA and CCMB sites. 1.2 To prevent inadvertent exposure to Cytotoxic Agents. 1.3 To monitor risk of exposure for staff directly involved in the preparation of Cytotoxic Agents. 1.4 To describe safety measures for the handling of Cytotoxic Agents. 2.0 DEFINITIONS: 2.1 Chemotherapy (Chemo) Gloves: Chemotherapy resistant cuff length powder free gloves that are 7 9 mils thick made of latex, nitrile, polyurethane, neoprene or other materials that meet American Standard Testing Material (ASTM 6978-05) standards for chemotherapy administration. 2.2 Cytotoxic Agent: Substances that are potentially detrimental or destructive to cells within the body. Cytotoxic Agents (Refer to: http://home.wrha.mb.ca/prog/pharmacy/druginfo.php ) are a category of Hazardous drugs deemed to have maximal risk from occupational exposure The term is commonly, but not limited to use when referring to antineoplastic drugs that nonselectively damage or destroy dividing cells. 2.3 Cytotoxic Spill, Contained: Cytotoxic Agents in an unintended location that are confined in such a manner that they cannot be spread or dispersed e.g. liquid Cytotoxic Agent absorbed into bed linen. 2.4 Cytotoxic Spill, Uncontained: Cytotoxic Agents in an unintended location not confined within a container or absorbent material, and which exist in a manner which can be spread or dispersed e.g. liquid Cytotoxic Agent on a non-absorbent surface, solid or powdered Cytotoxic Agent on any open surface.
Cytotoxic Agents, Safe Handling of 110.160.010 2 of 8 2.5 Cytotoxic Waste: Bulk: Items considered as bulk Cytotoxic Waste include the original manufacturer s vial containing cytotoxic drug equal to more than 3% of the total container, as well as prepared admixtures that contain full or partial doses of oncology medications. 2.6 Cytotoxic Waste: Trace: Trace chemotherapy waste includes empty Cytotoxic containers, needles, syringes, gloves, pads, empty IV sets and any other supplies used in the preparation or administration of the final product. Any container used in the preparation or administration of Cytotoxic Agents that contains no measurable amount of drug or no more than 3% by weight of the total capacity of the container are considered empty. 2.7 Cytotoxic Waste Container: Specifically designated plastic, leak proof, puncture resistant container labeled with Cytotoxic hazard symbols. 2.8 Direct Contact: Primary direct physical contact with a Cytotoxic Agent during preparation and/or spill management. 2.9 Exposure/Contact: Direct contact with a Cytotoxic Agent in any form via skin, inhalation, injection, or with equipment or material contaminated with a Cytotoxic Agent, e.g. needle stick or ingestion. 2.10 Handling: Any manipulation in which staff can be exposed to a Cytotoxic Agent e.g. preparation, transport, administration, disposal or cleanup. 2.11 Indirect Contact: Secondary contact with a Cytotoxic Agent, i.e. body fluids, bed linens, contaminated gloves, objects in patients bed space or environment, medical equipment, contaminated instruments, etc. 2.12 Personal Protective Equipment: Devices and clothing designed to be worn or used for the protection or safety of an individual while in a potentially hazardous area or performing potentially hazardous operations. 2.13 Spill Kit: Spill kits contents include: instructions, absorbents, reactants, and protective equipment required to clean up contained and/or uncontained hazardous material spills greater than 25 ml. 3.0 POLICY: 3.1 Staff shall be informed of the potential hazards related to Exposure to Cytotoxic Agents, e.g. use of Cytotoxic signage at point of use. 3.2 Staff involved in the Handling of Cytotoxic Agents shall receive orientation to Safe Handling of Cytotoxic Agents. 3.3 Chemotherapy Gloves shall be worn during the Handling of all Cytotoxic Agents. 3.4 Additional Personal Protective Equipment shall be worn as appropriate during Handling of any Cytotoxic Agents (Refer to 5.0 Personal Protective Equipment chart). 3.5 Each site shall have written policies and procedures related to waste disposal and exposure to body fluids from patients undergoing treatment with Cytotoxic Agents.
Cytotoxic Agents, Safe Handling of 110.160.010 3 of 8 3.6 Staff shall follow WRHA/site specific/ccmb safe handling of Cytotoxic Agents policies and procedures. 3.7 For health surveillance purposes, records of preparation of Cytotoxic Agents in pharmacy shall be maintained. 3.8 Cytotoxic bulk waste shall be measured and recorded in pharmacy for disposal as hazardous waste according to site-specific procedures. 3.9 Staff handling Cytotoxic Agents shall discuss with their immediate supervisor any desired change in work assignment as a result of pregnancy, breast-feeding or attempt to reproduce in accordance with Manitoba Workplace Safety and Health regulation 217/2006. 3.10 Staff shall report any accidental contact or skin puncture with Cytotoxic Agent /Waste to their immediate supervisor. 3.11 Reports and/or other site-specific forms and documentation shall be completed as required when any accidental contact or skin puncture to Cytotoxic Agent/Waste occurs, e.g. occurrence reports, work related injury near miss forms, etc. 3.12 Spill Kits and appropriate Cytotoxic Waste Disposal Containers shall be available in designated handling areas. 3.13 Areas involved in the preparation and/or administration of Cytotoxic Agents shall have access to an eyewash station. 3.14 Cytotoxic Agents transported off site shall be packaged according to Transportation of Dangerous Goods Regulations (Refer to www.tc.gc.ca). 4.0 PROCEDURE: 4.1 Preparation in Pharmacy: 4.1.1 Staff directly involved in preparing, transporting and/or receiving Cytotoxic Agents shall don appropriate Personal Protective Equipment (Refer to 5.0 Personal Protective Equipment chart). 4.1.2 Cytotoxic drug stock shall be stored separately from other drugs in an area restricted to authorized pharmacy personnel. 4.1.3 All Cytotoxic Agents shall be prepared in a Class II B2 externally vented biological safety cabinet that has airflow-monitoring devices. Each cabinet should be inspected and recertified on an annual basis. 4.1.4 All prepared Cytotoxic Agents shall be labeled and packaged to reflect their hazardous nature.
Cytotoxic Agents, Safe Handling of 110.160.010 4 of 8 4.1 4.1.5 Cytotoxic labels shall contain distinctive CSA standard Cytotoxic wording and symbols. 4.1.6 Intravenous infusion bags containing Cytotoxic Agents shall have tubing sets attached and primed with a solution not containing the Cytotoxic agent, and be sealed with a dead end luer-lock cap (Exception: Pediatrics). 4.1.7 Syringes containing Cytotoxic Agents must be sealed with a dead end luerlock syringe cap. 4.1.8 Prepared admixtures containing Cytotoxic Agents must be placed in a clear sealed zip-lock bag and labelled to identify Cytotoxic contents prior to transport from pharmacy. 4.1.9 Waste products generated from the preparation of cytotoxic admixtures must be handled according to site-specific policies designed to protect against exposure to Hazardous materials. 4.1.10 Cytotoxic Spills within the preparation area must be contained and cleaned immediately according to site-specific polices and procedures on Cytotoxic Spill management. 4.1.11 Staff preparing Cytotoxic Agents must be aware of the hazardous nature of these agents, be trained in containment techniques, and be certified on an annual basis. 4.1.12 Staff directly involved in the preparation of Cytotoxic Agents are required to document exposure on a Daily Exposure Record for Cytotoxic Agents. 4.2 Administration: 4.2.1 Staff directly involved in preparing, transporting and/or receiving Cytotoxic Agents shall don appropriate Personal Protective Equipment (Refer to 5.0 Personal Protective Equipment chart). 4.2.2 Once a Cytotoxic Agent is removed from the zip-lock transport bag, all manipulations of intravenous infusions/tubing/syringes shall take place on a plastic-backed absorbent pad, with the absorbent side up. 4.2.3 All intravenous connections shall be secured with appropriate locking devices. 4.2.4 Prior to the administration of any Cytotoxic Agent, the nurse must ensure the central or peripheral line is patent and blood return is present and adequate. 4.2.5 If the line is not patent, the infusion shall be put on hold and the attending physician contacted for further orders. 4.2.6 When withdrawing the canula from the medication port, a 2X2 inch gauze/ alcohol pad shall be used to absorb any droplets of the Cytotoxic Agent, and then disposed of in an appropriate Cytotoxic Waste Container. 4.2.7 The infusion shall be flushed with a minimum of 50 ml to ensure the infusion line is clear of all Cytotoxic Agents before disconnecting (Exception: Pediatrics).
Cytotoxic Agents, Safe Handling of 110.160.010 5 of 8 4.2 4.2.8 A CSA approved Cytotoxic" sign shall be posted in the administration area during the procedure and for 48 hours after administration of Cytotoxic Agents. CSA Approved Cytotoxic Sign - 4.2.9 Cytotoxic Agents that are discontinued or temporarily stopped partway through administration shall have the tubing clamped and/or dead end capped. Infusions that are not reused shall be placed in a zip-lock bag and returned to Pharmacy for Bulk Waste disposal. 4.2.10 Trace contaminated materials including empty Cytotoxic IV bags, tubing, gloves, absorbent pads or diapers shall be discarded in the appropriate Cytotoxic Waste Container; 4.3 Waste Disposal at Point of Contact: 4.3.1 The following precautions are advised for staff handling contaminated materials and blood and body fluids of patients who have received Cytotoxic Agents in the previous 48 hours: 4.3.1.1 Chemo gloves shall be worn and discarded after each use. 4.3.1.2 Contaminated personally owned items shall be kept separate from other items of clothing. 4.3.1.3 Contaminated linen shall be placed in waterproof laundry bag that can be closed securely. 4.3.2 Cytotoxic Waste Containers shall be sealed prior to collection, and labelled as Cytotoxic Waste. 4.3.3 Non-disposable items/equipment shall be washed with a detergent solution and copious amounts of water while wearing double gloves, using Chemo gloves as the exterior gloves. 4.4 Spill Management 4.4.1 Any Cytotoxic spill requires immediate attention and must be effectively controlled so as not to promote unnecessary contamination of the environment. Following any accidental exposure or contact during Handling of Cytotoxic Agents, staff shall immediately take the following precautions:
Cytotoxic Agents, Safe Handling of 110.160.010 6 of 8 Eyes Flush affected eye(s) with copious amounts of clean water or normal saline for a minimum of 15 minutes. Skin Remove contaminated clothing immediately. Wash affected area with soap and running water for a minimum of 15 minutes. Skin Puncture Wash puncture site thoroughly with soap and running water for a minimum of 15 minutes. Squeeze puncture site to encourage bleeding. 4.4.2 Small spill or easily contained spill of less than 25 ml: 4.4.2.1 Isolate area and place signs if required. 4.4.2.2 Don gown and two pairs of gloves. 4.4.2.3 Interior gloves shall be worn under the cuffs of the gown. The exterior pair shall be Chemo gloves and worn over the cuffs of the gown. 4.4.2.4 Gently wipe up all contaminated liquids with a plastic backed absorbent pad, absorbent side down. 4.4.2.5 Clean spill area three times using a detergent solution followed by clean water. 4.4.2.6 Place used plastic backed absorbent pads and disposable contaminated items in appropriate Cytotoxic Waste Container. 4.4.2.7 Following spill clean up, hands and any other exposed skin of staff involved shall be washed thoroughly with soap and water. 4.4.3 Large or uncontained spill of greater than 25 ml: 4.4.3.1 Isolate area and place signs if required. 4.4.3.2 Open Spill Kit and follow directions below: 1. Don two pairs of gloves and Personal Protective Equipment provided in Spill Kit. 2. Prevent spill from spreading by gently covering substance with absorbent material, poly-backed side up being careful not to create aerosols. 3. If required, wait for aerosols to settle. 4. Pick up solids (powder) with moistened absorbent material and place in appropriate Cytotoxic Waste Container. 5. Pick up any sharp or broken objects using scoop (do not use hands) and place in appropriate Cytotoxic Waste Container. 6. Rinse spills area three times using a detergent solution followed by equal amounts of clean water. 7. Place used absorbent pads, disposable Spill Kit items and any other contaminated materials and/or apparel in appropriate Cytotoxic Waste Container. 8. Use remaining poly-backed mats to dry area and discard into appropriate Cytotoxic Waste Container. 9. Wash any non-disposable items with detergent solution and water. 10. Place all soiled clothing in a plastic bag and launder separately (Do not dry clean). 11. Following spill clean up, hands and any other exposed skin of staff involved should be washed thoroughly with soap and water. 12. Cytotoxic Waste Containers shall be marked with enclosed labels and sealed for final disposal. 4.4.4 Spill greater than 5 kg or 5 liters: Follow site-specific Code Brown procedures as required.
Cytotoxic Agents, Safe Handling of 110.160.010 7 of 8 4.5 Personal Protective Equipment Staff shall use Personal Protective Equipment as indicated in the following circumstances: PERSONAL PROTECTIVE EQUIPMENT CHART TYPE OF PPE GLOVES GOWNS Description Indication For Use Chemotherapy gloves shall be used for 48 hrs post administration For direct contact, change at least every 30 mins. and immediately if contaminated, torn, or punctured Wash hands with soap and water after removal of gloves Impervious longsleeved gown with cuffs and back closure Change immediately if contaminated and/or after spill clean up Should be worn whenever risk for splash occurs ACTIVITY GLOVES GOWNS Preparation in Pharmacy Transport and Storage Transport between Sites Administration Waste Disposal at Point of Use Spill Management Double gloves required Chemo gloves worn as interior gloves under cuffs of gown Sterile powder free gloves worn as exterior gloves over cuffs of gown Recommended when receiving or unpacking stock Not required when agents have been packed by Pharmacy Single gloves required Change between patients Direct Contact Single gloves required Indirect/Trace Contact Single gloves required Blood/Body Fluids Required for 48 hrs post administration Required as per spill management procedure Required FACE PROTECTION Eye/Face Protection e.g. chemical splash goggles Should be worn whenever there is a hazard of eye contact or risk of splash or aerosolization FACE PROTECTION N95 standard mask and safety goggles recommended when decontaminating biological safety cabinet FOOTWEAR PROTECTION Disposable plastic shoe covers Should be worn during preparation of Cytotoxic Agents in pharmacy Should be worn when risk for splash occurs FOOTWEAR PROTECTION Required Not required Not required Not required Not required Not required Not required Recommended Required if waste is uncontained Recommended if danger of face contact Not required if waste is contained Not required Not required if waste contained Not required Not required Not required Recommended Recommended Recommended Small Spill Recommended Large Spill Required Recommended if danger of contact with large uncontained spills Required for large spills
Cytotoxic Agents, Safe Handling of 110.160.010 8 of 8 5.0 REFERENCES: 5.1 A Clinical Quality and Safety initiative to provide RCH Clinicians with a centralized resource of Hospital wide Clinical Guidelines. Royal Children's Hospital, Melbourne http://rch.org.au/rchcpg/index.cfm. 5.2 ASHP Guidelines on Handling Hazardous Drugs, Am J Health-Syst Pharm Vol 63 June 15, 2006. 5.3 British Columbia Cancer Agency V-10, V-30. 5.4 CancerCare Manitoba Department of Pharmaceutical Services Policies and Procedures, 2006 (revised). 5.5 CDC Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings NIOSH ALERT Publication No. 2004-165. 5.6 Cytotoxic Agents, Safe Handling Standards, British Columbia Cancer Agency, August 1, 2000 (revised). 5.7 Evidence Based Series Special Report: Section 1; Safe handling of parenteral Cytotoxics: Recommendations Green, Johnson, Macartney, Milliken, Poirier, Reynolds, Savage, Schwartz, Trudeau. A Quality Initiative of the Program in Evidence-based Care (PEBC), Cancer care Ontario (CCO) April 13, 2007. 5.8 Guidelines for the Handling and Disposal of Hazardous Pharmaceuticals (Including Cytotoxic Drugs), CSHP Official Publications 2000. 5.9 Manitoba Workplace Safety and Health Act W210 Manitoba Workplace Safety and Health regulations 217/2006 Part 2: General Duties: Pregnant or Nursing Workers. 5.10 Practical Guidelines for disposing Cytotoxic Waste, Vijay Roy, Puneet Gupta and MC Joshi Issue dtd. 16th to 30th April 2005. 5.11 Preventing Occupational Exposures to Antineoplastic Drugs in Health Care Settings, Connor, McDiarmid, CA Cancer J Clin 2006; 56:354-365. 5.12 Preventing Occupational Exposures to Antineoplastic and other Hazardous Drugs in Healthcare Settings, NIOSH publications 2004. 5.13 QuapoS 3-Quality Standard for the Oncology Pharmacy Service with Commentary, Published by the Institute for Applied Healthcare Sciences (IFAHS e.v.), for the German Society of Oncology Pharmacy (DGOP e.v.), as the result of the 11th North German Cytotoxics Workshop (NZW), January 2003. 5.14 Safe Handling of Parenteral Cytotoxics: Recommendations, E. Green, M. Johnston, G. Macartney, D. Milliken, S. Poirier, P. Reynolds, T. Savage, L. Schwartz, M. Trudeau A Quality Initiative of the Program in Evidence-based Care (PEBC), Cancer Care Ontario (CCO) Report Date: April 13, 2007. 5.15 Standards of Practice for Oncology Pharmacy in Canada, Canadian Association for Pharmacy in Oncology (CAPHO), Version 1, October 2004. 5.16 Transportation of Dangerous Goods Regulations www.tc.gc.ca. 5.16 United Nations Environment Programme UNEP/CHW.6/20 22 August, 2002 Conference of the parties to the Basel Convention on the Control of Hazardous Waste and their Disposal, Sixth Meeting. Policy Contact: Tanya Benoit, Chief of Professional Practice/Chief Nursing Officer and Quality Management CCMB/Program Director WRHA Oncology Program