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Oregon Cancer Care for Animals 172 Magruder Hall Corvallis, Oregon 97331-4803 Oncology: 541-737-4838 Reception: 541-737-4812 Fax: 541-737-4818 I. Title of Policy: Safe Handling of Cytotoxic Drugs Effective Date: 11-22-2010 PURPOSE: Cytotoxic drugs are the family of drugs used to treat cancer. To ensure that staff exposure to cytotoxic drugs is minimized and to maintain a safe working environment OSU-CVM provides information and resources to staff regarding exposure risks and the safe use of cytotoxic drugs in a work environment. II. FORMS USED: Minimizing Occupational Exposure to Cytotoxic Drugs – Employee Handout (Attached) Accident Report form Cytotoxic Drug Spill Report Form (Attached) III. PROCEDURE: A. Protective Clothing 1. Cover clothes with a protective disposal gown made of material that is protective against chemotherapeutic agents. The gown should have long sleeves and elastic or knit closed cuffs. The cuffs should be tucked under the gloves. The gown should be worn during compounding, administration, and when handling waste from patients. Once gowned, the person must not leave the area where mixing or drug administration is occurring. Gowns must be removed with care to avoid spreading contamination and must be disposed of as contaminated waste. Protective eyeglasses must be worn and powderless chemotherapy-approved gloves. Face shields, hair and shoe covers are recommended but not required. Respirators are available for use during compounding and administration of cytotoxic drugs. Double gloving is recommended if going from mixing directly to administration – the outer glove would be removed before administration. If continuously worn, gloves and gowns should be changed every 30 minutes or immediately if damaged. 2. Preparation of cytotoxic injectable agents should be done in a certified Biological Safety Cabinet (BSC), Class II, Type B. Personnel OSU AAHA Standard PH26.1 preparing cytotoxic prescriptions in the oncology ward should wear protect personal equipment (PPE) as described and work at the BSC. Women who are pregnant, lactating, immunosupressed, or taking immunosupressive medications or trying to conceive should avoid preparation of cytotoxic agents. It is recommended that the hood surface, minus the air vents, be covered with a plastic-backed absorbent paper to reduce the potential for dispersion of droplets and spills and to facilitate cleanup. All manipulations should be done over the pad. All work within the hood shall be six inches from either side of the hood and a minimum of six inches from the front. The outside of the hood and front opening and the floor in front should be wiped down after the last mix of the day with detergent and bleach. It is recommended that the BSC should be decontaminated monthly with appropriate ingredients listed by the BSC manufacturer. B. Agent Administration 1. The area beneath the administration site must be protected with a plastic-lined disposable pad of sufficient size to provide protection. 2. Prepared, or unprepared, chemotherapy comes from the drug room in a clear plastic zip-lock bag with an orange chemotherapy/biohazard sticker affixed or commercial yellow chemotherapy zip-lock container. The removal of chemotherapy items from the zip-lock should be minimized to the immediate period of drug delivery to the patient. All sharps and disposables should be immediately returned to the zip-lock bag after drug administration and the zip-lock bag shall be placed in a gray plastic sharps/chemotherapy disposal container. Sharps may also be immediately placed directly into the gray sharps container. Gray sharps/chemotherapy disposal containers are for cytotoxic materials only. Do not recap needles used for reconstituting cytotoxic agents. The lid of the sharps container should be kept closed. 3. If it is necessary to prime the IV set, use a compatible IV solution. Prime the IV set with the IV solution. Do not use a cytotoxic agent for priming. 4. A gauze pad shall be placed around the luer-lock connection before disconnecting. C. Patient Waste Precautions 1. Gloves must be worn when handling or collecting urine, blood or fecal material from patients that have received cytotoxic drugs, and while handling the linen used with or trash generated from those animals. OSU AAHA Standard PH26.1 2. Linen, overtly soiled with discharge from an animal receiving cytotoxic agents, must be placed in a clear plastic linen bag. An orange chemotherapy/biohazard sticker shall be affixed to this bag and the bag taped shut. In areas where cloth linen bags are routinely used, the cloth bag shall be placed in a clear plastic bag as above. 3. Excreta may be disposed of through the sewer system. 4. All contaminated disposable supplies, such as dressings and specimen containers must be placed in clear plastic waste bags as described in C.2. above. 5. All needles and syringes must be placed into the gray sharps/chemotherapy disposal containers. D. Drug Spills Outside of the BSC 1. When a cytotoxic drug spill occurs outside the BSC, the clinician on clinic must be immediately notified to assess the size and scope of the spill. If it appears that the spill cannot be contained with two spill kits then: a) Isolate the area of the spill as much as is possible by preventing other persons and/or animals from entering the area, b) Use available absorbent materials (paper towels) to contain spread as much as possible without placing yourself in danger of unnecessary exposure, c) Call EH&S response phone at 230-0129 or landline at 7372273 (M-F 8-5) or Public Safety at 737-7000. 2. Chemotherapy spill kits are located in the oncology ward. To clean up a cytotoxic drug that is spilled outside the BSC staff must wear double gloves and a chemo block protection gown [These gowns are found in the chemotherapy spill kit]. In no case should an attempt be made to clean up a spill without first donning proper personal protective equipment. Solid materials, such as syringes and broken glass must be placed in a gray plastic sharps/chemotherapy disposal container. 3. Powders must be covered with a paper towel wetted with alcohol and then wiped up. Liquids must be cleaned up with a paper towel. 4. The affected area must then be rinsed with water then cleaned with detergent and bleach solution. The MSDS for the particular spilled agent should be reviewed to determine if a neutralizer is also suggested. MSDS for each cytotoxic drug should be kept in the oncology ward. OSU AAHA Standard PH26.1 5. Spills inside the BSC should be cleaned up immediately. If the spill exceeds 30ml or the entire contents of one vial or ampule a spill kit should be used. 6. All materials used in cleaning must be placed in a gray plastic, sharps/chemotherapy disposal container. 7. All chemo spill kits have an attached Chemo Spill Report Form. These forms must be completed following each chemo spill clean up. A copy of the completed form shall be provided to the oncologist onduty. The original form is given to the pharmacist for the Drug Room. F. Inadvertent Patient or Staff Exposure 1. Exposure or splash in eyes must be flushed with water for 15-20 minutes at the nearest eyewash station or sink. The staff member should be taken to student health or emergency department for further treatment and evaluation. 2. If a cytotoxic drug is inadvertently spilled on a staff member, all PPE should be removed and the affected area must be thoroughly washed with soap and water, the clinician on service notified, and an accident report from completed within 48 hours of the accident. The staff member will be offered the opportunity to go to the student health center or other medical service for further evaluation. If the offer is declined a notation to this effect shall be made on the accident form and be initialed and dated by the staff member. 3. If a cytotoxic drug is inadvertently spilled on a patient, the patient must be thoroughly washed with soap and water, and the attending veterinarian must be informed. 4. In all exposures the MSDS for the particular agent should be consulted. All appropriate accident and incident forms should be completed as required. G. Patient Identification System. 1. An orange chemotherapy/biohazard sticker is placed on the identification card by the cage/run door to identify patients who are receiving or have received cytotoxic drugs within the last 48 hours. The sign should be removed 24 hours after the last dose of chemotherapy or following appropriate cleaning of cage/run after the patient is discharged. 2. The staff technician with the primary responsibility for the patient when chemotherapy is started is responsible for posting the sticker at OSU AAHA Standard PH26.1 the start of chemotherapy, and for removing the sign 48 hours after completion of chemotherapy. H. Employee Information 1. The Oncology Service Head shall distribute this Policy with attachments to all new employees, faculty, and students. 2. Personnel working in the oncology ward who are pregnant or attempting to become pregnant are encouraged to discuss how their exposure to cytotoxic drugs might affect their pregnancy with their supervisor and their personal physician. 3. Clients and their children should not be allowed in the oncology ward during treatment and administration of cytotoxic medications. 4. Children under the age of 18 must be accompanied by an adult to the treatment area. I. Patients being treated with cytotoxic drugs at home. 1. The clinician on service dispensing the drug shall inform clients receiving cytotoxic drugs for in-home injections or infusions of potential hazards to household members. All dispensed medications will be provided in child-resistant containers unless a signed wavier for the removal of child resistant containers is contained within the client’s file. At a minimum, this wavier should be reassessed annually. 2. Any containers of cytotoxic drug solution (ie., syringes, infusion bags) that are not the manufacturer’s container shall be dispensed in a sealed, zip-lock-type bag with an orange, chemotherapy/biohazard sticker affixed. This applies to client transport and common parcel carrier transport. 3. Clients and family members shall be encouraged to wear powder-free latex or nitrile gloves when handling syringes, infusion bags, and drugs. 4. Clients shall be instructed to protect the surface area beneath the preparation and injection sites. 5. Clients shall be instructed to place all materials, including used needles and syringes, and vials into the zip-lock bag and return this to the OSU-CVM Oncology ward or the referring veterinarian’s practice for disposal. 6. Clients shall be advised that in the case of an inadvertent spill, the area will be treated as noted above in Section F. OSU AAHA Standard PH26.1 7. Clients must keep all cytotoxic drugs out of the reach of children. J. Large Animal Policy Staff should wear gloves when handling any large animal patient or any fluid or tissue samples from that patient if it is receiving chemotherapeutic agents until 48 hours after the last dose is administered. Likewise, laboratory staff handling samples from any large animal patient receiving chemotherapeutic agents should be appropriately warned and samples labeled with a biohazard warning sticker where appropriate. A Biohazard sign should be posted on the animal’s stall that it is receiving chemotherapeutic agents until 48 hours after the last dose is administered. If appropriate and practical, cat litter should be placed beneath the area of the large animal receiving cytoxic agents. When administration is complete, this litter should be swept up and put into a chemotherapeutic waste receptacle. Stall cleaners should wear gloves and masks when cleaning the animal’s stall but can dispose of straw, shavings and excreta by traditional means. All waste, such as syringes, needles, urine samples, associated with or potentially affected by administration of a chemotherapeutic agent should be disposed of ONLY in an official chemotherapeutic waste container available from central supply. This container should be left outside the stall of any animal receiving chemotherapeutic treatment at all times until 48 hours after treatment is complete. Staff administering chemotherapeutic agents should wear chemo-rated gloves, and gowns and safety glasses where spill or splashing of the chemotherapeutic agent is possible. A mask should be worn where there is potential for respiratory contamination with the agent (e.g. cyclophosphamide). These items should be disposed of in an official chemotherapeutic waste container. Chemotherapeutic agents should only be administered by a clinician, or under the direct supervision of a clinician of the large animal hospital associated with the case. Visitation by clients should be strictly controlled up until 48 hours after the last dose of chemotherapy is administered with clients either visiting their animals from outside the stall, or only having contact when appropriately clothed with latex gloves and a mask if appropriate. OSU AAHA Standard PH26.1 IV. REFERENCES: ASHP Guidelines on Handling Hazardous Drugs, American Society of Hospital Pharmacists (ASHP), vol. 63, June 15, 2006. OSHA Technical Manual, Section VI: Chapter 2: controlling Occupational Exposure to Hazardous Drugs. National Institute for Occupational Safety and Health (NIOSH). Preventing Occupational Exposure to Antineoplastics and Other Hazardous Drugs in Health Care Settings. NIOSH Publication No. 2004-165. The Office of Health and Safety Information Systems (OHASIS). Primary containment for biohazards. Cancer Chemotherapy Guidelines and Recommendations for Practice – Oncology Nursing Society – Oncology Nursing Press, Inc., 1999. Safe Handling of Cytotoxic Drugs – An Independent Study Module – Oncology Nursing Society – Oncology Nursing Press, Inc. 1997. V. COORDINATION Oncology Service Head, Director VTH, VTH Pharmacist Signed: Stuart C. Helfand, DVM Service Head, Oncology Concurrence: Helen E. Diggs, DVM Director, Veterinary Teaching Hospital Christopher Cebra, DVM Department Head Clinical Services Terry Crowder, RPh, PhD Pharmacist OSU AAHA Standard PH26.1 MINIMIZING OCCUPATIONAL EXPOSURE TO CYTOTOXIC DRUGS AN EMPLOYEE HANDOUT This handout provides information to employees of the Oregon State University College of Veterinary Medicine about potential hazards of occupational exposure to cytotoxic drugs. It also explains the hospital’s policy on handling cytotoxic drugs. Q. What are cytotoxic drugs and how do they work? A. Cytotoxic drugs (CDs) are the family of drugs used to treat cancer. At the OSUCVM, this includes some 40-50 drugs, including experimental study drugs. CDs can inhibit the growth of tumors by disrupting basic cellular processes. This disruption kills cancer cells. Most of these drugs bind directly to DNA or RNA (genetic material or affect other protein synthesis in cells. Normal cells can be damaged, as well as cancer cells. This is one reason why chemotherapy patients often experience debilitating side effects. Staff may also experience effects if they are routinely exposed to these drugs. Q. How does occupational exposure to CDs take place? A. Exposure can occur by ingestion, inhalation, or absorption through the skin or mucous membranes. Although no immediate health effects are usually noticed, rare instances of nausea, headache, dizziness, skin irritation, sores on the mucous lining of the nose, and allergic reactions have been reported. Q. Why is there concern about exposure to health care workers? A. The adverse effects to health care personnel exposed to lower levels of CDs over long periods of time are not known. There are studies that document the presence of small amounts of CDs in the urine of pharmacists who routinely prepare these drugs without proper precautions. There has been no documented connection between occupational exposure and related health problems. The amount of CDs which a patient receives at treatment is considerably greater than staff are exposed to. Yet, the potential adverse side effects of CDs and the concern for the longterm effects of contact with these drugs make it prudent to limit exposure. OSU AAHA Standard PH26.1 Q. Why not measure each individual’s exposure and limit it to a certain safe level? A. At this time, no device or test exists which can satisfactorily monitor the degree of exposure to CDs. The goal is to reduce everyone’s exposure to as close to zero as possible. Q. If exposure cannot be measured and limits cannot be set, how can exposure be controlled? A. A number of studies have demonstrated that exposure can be reduced by the use of gloves, gowns or lab coats, and eye protection and/or face masks. Q. How should employees regard the possible exposure to CDs if they are pregnant or attempting to conceive? A. Employees who are pregnant or attempting to become pregnant are encouraged to discuss how their exposure to CDs might affect their pregnancy with both their supervisor and personal physician. The consensus of OSHA and professional pharmacy, and nursing organizations is that protective measures such as those recommended in the VTH policy are effective in all situations, including possible or actual pregnancy. Because, some CDs are potential teratogens adherence to these safety procedures is strongly encouraged. (03-31-2009) OSU AAHA Standard PH26.1 (03/31/2009) Cytotoxic Drug Spill Report Form (This form is intended to provide documentation of a cytotoxic drug spill. Complete this form and return it to the Drug Room.) Name of drug spilled: ____________________________________________ Spill reported by: (name)______________________________________ (title)________________________________________ Date of spill: Time of spill: Location of spill (Room #): _____________ _____________ _____________ When in relation to administration of the drug did the spill occur? _________Before __________During ________After Cause of spill: ____________________________________________________________ ________________________________________________________________________ ________________________________________________________________________ Approximate volume spilled: (circle one) Less than 10 cc More than 50cc 10cc 20cc 30cc 40cc Who cleaned up the spill? OSU AAHA Standard PH26.1