SOP - Cytotoxins and Antineoplastic Drugs
Principal Investigator (PI) Approval is Required Prior to Performing this Procedure
Contents
Description
This standard operating procedure outlines the handling and use of cytotoxic chemicals and antineoplastic drugs. Review this document and supply the information required in order to make it specific to your facility. In accordance with this document, laboratories should use appropriate controls, protective equipment, and disposal techniques when handling cytotoxic chemicals and antineoplastic drugs.
Potential Hazards
Although little research has been done on the long-term risk of occupational exposure to cytotoxic drugs, these drugs have been associated with human cancers at high (therapeutic) levels of exposure. These drugs have been shown to be carcinogens, mutagens and teratogens in many animal species. There is evidence that hazardous drugs may cause spontaneous abortions and increase the risk of congenital malformations. In addition, some of these drugs have been shown to cause acute effects in humans, such as localized skin necrosis (death of tissue), damage to normal skin after surface contact, dizziness, lightheadedness.
Antineoplastic drugs are substances used as a cancer chemotherapeutic agent which affect the reproductive capabilities including chromosomal damage (mutagens), effects on the fetus (teratogens), and are carcinogenic in animal models. Most hazardous drugs either bind directly to genetic material in the cell nucleus or affect cellular protein synthesis. Cytotoxic drugs may not distinguish between normal and cancerous cells. The growth and reproduction of the normal cells are often affected during treatment of cancerous cells.
Engineering Controls
All hazardous drug work will be conducted in a chemical fume hood or Class II Biological Safety Cabinet.
Work Practice Controls
Decontamination should consist of surface cleaning with water and detergent followed by thorough rinsing. The use of detergent is recommended because there is no single accepted method of chemical deactivation for all agents involved. A plastic backed absorbent pad should be placed under the work area during the process. This should be changed at the end of each process or when a spill occurs.
All locations within the laboratory where cytotoxic or antineoplastic chemicals are handled should be demarcated with designated area caution tape and/or posted with designated area caution signs. This includes all fume hoods and bench tops where the antineoplastic drugs are handled.
Personal Protective Equipment
Use doubled gloves with nitrile or neoprene gloves. Gloves should be changed frequently. Laboratory coat and safety glasses are required for preparation of material. Laboratory SOP: Cytotoxins 1 Revision Date: 6/12/2014
Waste Disposal
All hazardous drug contaminated waste should be placed in a 5-gallon white pail. The container must be closed except when actively adding waste. The container must be located in the area where hazardous drugs are being used. All items contaminated by hazardous drugs, including gloves, syringes, vials, needles, and solution containers should be disposed according to Environment, Health and Safety (EHS) guidelines. Contact EHS at (810) 766-6763 for waste pick-up. Refer to UM-Flint Hazardous Waste Management Program and EHS webpage http://www.umflint.edu/ehs/environment- health-and-safety for more information. Sharps – place needles, syringes with needles attached and other breakable items into appropriately labeled sharps containers. Empty stock vials, reagent bottles, etc. – triple rinse with copious amounts of water. Deface label with black magic marker or scraper. Place in a cardboard box for disposal. Label the box as uncontaminated glass.
Exposures/Unintended Contact
For an actual chemical exposure/injury: • Flush exposed eyes or skin with water for at least 15 minutes, then seek medical attention (see below).
• Note: In case of inhalation, symptoms may be delayed up to 24 hours. Seek medical attention.
• If swallowed, obtain urgent medical attention.
Contact EHS for advice on symptoms of chemical exposure, or assistance in performing an exposure assessment.
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TREATMENT FACILITIES:
MAJOR INJURIES
Genesys Hospital One Genesys Parkway Grand Blanc, MI 48439 (810) 606-5710
Hurley Medical Center One Hurley Plaza Flint, MI 48503 (810) 262-9000
McLaren Hospital Flint 401 South Ballenger Hwy Flint, MI 48532 (810) 342-2000
MINOR INJURIES –During Business Hours
Genesys Occupational Health Network 1460 Center Rd. Burton, MI 48509 (810) 715-4620 Mon. to Fri. 7:30 am to 10 pm Sat. & Sun. Noon to 8 pm
McLaren Flint-Burton OCC Center 1459 S. Center Rd. Burton, MI 48509 (810) 496-0900 Mon. - Fri. 8 am to 8 pm Sat & Sun 10 am to 2 pm
MINOR INJURIES –After Business Hours
Downtown Flint 420 S. Saginaw St. Flint, MI 48502 (810) 762-1550
Genesys East 1096 S. Belsay Rd, Suite F Burton, MI 48509 (810) 743-3351
Genesys North 4154 W. Vienna Rd Clio, MI 48420 (810) 686-7397
Genesys South 8447 N. Holly Rd Grand Blanc, MI 48439 (810) 603-0856 Mon. - Fri. 6 to 10pm / Sat. & Sun. 1-10pm
Click here for more information on the UM – Flint Emergency Preparedness and Response Plan.
Spill Procedure
• When a spill occurs, personal safety should always come first.
• Alert and clear everyone in the immediate area where the spill occurred.
A minor (small) chemical spill is one of a known chemical that the laboratory staff is capable of handling safely without the assistance of safety and emergency personnel, i.e., less than 1 Gallon or 3.5 Liters. A major/large chemical spill requires active assistance from emergency personnel. Spill Response Steps:
MINOR CHEMICAL SPILL
• Alert people in immediate area of spill.
• If spilled material is flammable, turn off ignition and heat sources. Don’t light Bunsen burners or turn on other switches.
• Open outside windows, if possible.
• Wear protective equipment, including safety goggles, gloves and long-sleeve lab coat.
• Avoid breathing vapors from spill.
• Confine spill to as small an area as possible.
• Do not wash spill down the drain.
•Use appropriate spill kits/sorbents to neutralize corrosives and/or absorb spill. Collect contaminated materials and residues and place in container. For powdered chemicals sweep carefully to avoid generation of dust or, if appropriate, use moist sorbent pads or wet the powder with a suitable solvent and then wipe with a dry cloth.
Contact EHS at (810) 766-6763 for proper disposal.
• Clean spill area with water.
MAJOR CHEMICAL SPILL
• Attend to injured or contaminated persons and remove them from exposure.
• Alert people in the laboratory to evacuate.
• If spilled material is flammable, turn off ignition and heat sources. Don’t light Bunsen burners or turn on other switches.
• Call UM-Flint DPS at 911 from any university telephone or (810) 762-3333 from any cell phone or non- university telephone immediately for assistance.
• Close doors to affected area.
• Post warnings to keep people from entering the area.
• Have person available that has knowledge of incident and laboratory to assist emergency personnel.
Additional Spill Links:
• www.oseh.umich.edu/pdf/chemspil.pdf
• http://www.oseh.umich.edu/emer-chemical.shtml.
Report all emergencies, suspicious activity, injuries, spills, and fires to the UM-Flint Department of Public Safety (DPS) at 911 from any university telephone or (810) 762-3333 from cell phone or non-university telephone. Register with the University of Michigan-Flint Emergency Alert System via Wolverine Access. Also, preprogram the UM-Flint DPS telephone number (810) 762-3333 into your cell phone for quick, easy use.
Training of Personnel
All personnel are required to complete Laboratory Safety Training. Documentation of the training is required. This training can be accomplished by completing the Comprehensive Laboratory Safety session (BLS009 or equivalent) via MyLINC, or UM-Flint EHS on-line training or other equivalent approved by EHS. Furthermore, all personnel shall read and fully adhere to this SOP when handling cytotoxins and antineoplastic drugs.
Certification
I have read and understand the above SOP. I agree to contact my Supervisor or Lab Manager if I plan to modify this procedure.
Principal Investigator Revision Date Laboratory SOP: Cytotoxins 4 Revision Date: 6/12/2014
