Administration of Hazardous Drugs via CADD® Ambulatory Infusion Pump
Drugs & Therapeutics Committee
Page: 1 of 16
Medical Advisory Committee
Approval Date: May 3, 2016 Effective Date: June 1, 2016
Registered Nurses on 6 Link and 6 North Clinic, Pharmacy
The administration of cytotoxic agents for oncological purposes is a Beyond Entry Level Competency (BELC) for Hematology/Oncology Registered Nurses (RNs) at the IWK Health Centre and requires initial certification including successful completion of the APHON Chemotherapy and Biotherapy Provider Course, online e-source tracking, and ongoing biennial recertification.
Appendices Appendix A: Definitions Appendix B: CADD-PRIZM VIP Model 6100 & 61010 Ambulatory Infusion Pumps Quick Reference Card for Clinicians Appendix C: CADD-PRIZM VIP Model 6100 and 6101 Ambulatory Infusion Pumps Quick Reference Card for Caregivers Appendix D- Guidelines for the safe disposal of waste and management of a cytotoxic spill in the home. Version History
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This is a CONTROLLED document for internal use only. Any documents appearing in paper form are not controlled and should be checked against the electronic file version prior to use. OP3PO150710
Administration of Hazardous Drugs via CADD Ambulatory Infusion Pump – Policy 7.44 Page 2 of 16
POLICY Select hazardous agents may be candidates for administration via CADD® pump based on clinical trial protocol and/or on the basis of other predetermined criteria. These agents will be administered in a safe and effective manner in the inpatient or outpatient setting via a CADD® Ambulatory Infusion Pump using the following guidelines and protocols. CADD® pumps used for hazardous agents must be programmable and approved for use in the IWK Health Centre. CADD® pumps must have visual and auditory alarms and must be lockable. The bolus function on these pumps must be disabled prior to use. Elastomeric pumps should not be used.
A RN who administers cytotoxic agents must attain and maintain certification in Hematology/Oncology in accordance with Atlantic Provinces Pediatric Hematology/Oncology Network (APPHON/ROHPPA ) pediatric chemotherapy administration standards. See APPHON/ROHPPA Pediatric Chemotherapy Administration Competencies at http://www.apphon-rohppa.com/.
All cytotoxic agents are considered High Alert and must undergo an independent double check prior to initiation of administration. Individuals with appropriate qualifications will perform this verification: for example a RN certified in chemotherapy/biotherapy administration, a clinical hematology/oncology pharmacist, a Hematologist/Oncologist, a hematology/oncology NP, or a hematology/oncology fellow (as approved by the attending oncologist). Refer to Parenteral Administration Of Cytotoxic Agents For Oncological Indications, Medication Management Policy 7.45.
GUIDING PRINCIPLES AND VALUES The occupational risks associated with any hazardous drug depend on the inherent properties of the drug and the level of exposure (quantity being handled, dosage form, how it is manipulated and how often, level of protection employed, etc.). There are no known values regarding the limits of safe exposure to a hazardous drug. For this reason, it is important to recommend measures to minimize exposure to the greatest extent possible. Health care providers should follow the policies and procedures in this document for optimal occupational safety. Refer to Medication Management Policy 4.75 (Identification and Classification of Hazardous Drugs) for a current list of hazardous drugs and safe handling chart.
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Four basic principles must be considered when handling, transporting or administering cytotoxic drugs: 1. Protection of the patient (using good aseptic technique, prevention of extravasation events). 2. Protection of family and visitors (care givers must be educated on how to handle body fluids and potential for chemotherapy spill management at home). 3. Protection of staff (using personal protective equipment (PPE) and specialized techniques). Staff must be educated and knowledgeable about how cytotoxic agents are handled; this applies to pharmacists, nurses, assistive and housekeeping staff. 4. Protection of the environment (drug administration techniques to avoid leakage, aerosolization or spillage, management of waste materials to minimize environmental contamination).
CADD® Administration Set with or without a bag spike OR CADD® Administration Set with bag spike and 0.2 micron filter ( if filter required for specific medications) CADD® Pump and key Batteries (Refer to operator’s manual for specific type and size) CADD® Cassette or IV bag (prepared by pharmacy as deemed appropriate) PPE- as per Medication Management Policy 7.15 Chemotherapy sharps container Absorbent plastic backed pad Cytotoxic spill kit for family Antiseptic swabs 10 mL prefilled 0.9% NaCl syringe Heplock solution if required ( Refer to Clinical Policy CVAD, Heparinization 735 D)
General Refer to specific policy & procedure for the ordered route of administration, i.e. subcutaneous or, intravenous. Refer to Medication Management Policy 7.45 (Parenteral Administration of Cytotoxic Agents for Oncological Indications).
Safety Considerations 2.1. Refer to the equipment manual for the specific CADD® Pump model being used for direction on set-up, operation and troubleshooting for the individual pump.
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2.2. Do not get the pump wet as it is not waterproof. If the pump does get wet, pump must be sent to biomedical engineering for assessment. 2.3. Ensure that the LOCK LEVEL is in the appropriate setting so the patient and family are able to perform only the function on the pump as prescribed by thephysician to avoid risk of receiving more than prescribed dose. 3.
Preparation of the Cassette or Medication Bag 3.1. The IWK Health Centre Pharmacy Department will prepare the medication cassette or infusion bag.
On-going Maintenance 4.1. Medication cassette or infusion bag and tubing changes are done by the RN according to IWK Medication Management Policy 30.05. Tubing is changed every 72-96 hours. Drug stability may necessitate more frequent changes. 4.2.
Assess the infusion site for signs of redness, swelling, hardness or leakage hourly while in hospital and on each ambulatory visit.
Review the pump program with the orders at the beginning of each shift, or on each ambulatory visit, to ensure correct settings including checking: reservoir volume units of delivery concentration of medication rate of infusion the amount of medication given since the pump was last cleared 4.4. Assess the following a minimum of hourly while in hospital, or on each ambulatory visit: no kinks in the tubing pump is working properly 4.5. Any infusion interruptions that occurs as a result of a line occlusion or malfunctions must be investigated by a health care professional.
Patient/Family Education 5.1. Patient and family/caregiver education will be a shared responsibility between the medical staff, nursing and pharmacy. 5.2. In preparing patients to manage the CADD® infusion pump in the home setting, ascertain that the patient/caregiver is deemed competent to learn about and understand basic pump function. 5.2. Include the patient where appropriate when providing teaching. 5.3. Determine that the patient and/or caregiver have an adequate understanding of: desired effect of the medication, adverse effects of the medication, management of adverse effects of the medication at home,
Administration of Hazardous Drugs via CADD Ambulatory Infusion Pump – Policy 7.44 Page 5 of 16
basic operation of the pump and what steps to take if the pump malfunctions, when and how to assess infusion sites, 5.4. Provide Cytotoxic Spill Kit for home use. Review contents and procedures with patient/caregiver. 5.5. Ensure that the patient and caregiver know who to contact if problems arise. 6.
Documentation 6.1. Document the following on the Medication Administration Record (MAR): initiation of a medication via a CADD® Pump, cassette or infusion bag changes, medication and dose changes, and discontinuation of a CADD® Pump infusion 6.2. Complete the Patient Controlled Analgesia Record (PCA) Patient’s Health (FormIWKPACO) at the beginning and end of each shift and with each ambulatory visit. 6.3. Document patient and family education on the permanent health record.
REFERENCES (APPHON/ROHPPA )pediatric chemotherapy administration standards http://www.apphonrohppa.com/en/system/files/documents/Pediatric%20Chemotherapy%20Administration%20St andards%20and%20Competencies%20for%20Practice%20and%20Education2015%20MJH%20revisions.pdf Association of Pediatric Hematology/Oncology Nurses (2011). APHON Pediatric Chemotherapy/Biotherapy Provider Course, 3rd edition. Association of Pediatric Hematology/Oncology Nurses (2008). Essentials in Pediatric Hematology/Oncology Nursing. 3rd edition Atlantic Provinces Pediatric Hematology/Oncology Network. Standards of Nursing Practice Atlantic Provinces Pediatric Hematology/Oncology Network. Supportive Care Guidelines CADD-Prizm® VIP Ambulatory Infusion Pump Model 6100 and 6101 Manual http://www.smiths-medical.com/Upload/products/PDF/CADD_Prizm_VIP_System/IN19822.pdf National Institute for Occupational Safety and Health. NIOSH Alert: Preventing Occupational Exposures to Anti-neoplastic and Other Hazardous Drugs in Health Care Settings. www.cec.gov/niosh/docs/2004-165.com Patient Controlled Analgesia Smiths Medical Online Training Portal module for CADD® Solis can be found at https://www.smiths-medical-education.com/ IWK Access code # 2014-22
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RELATED DOCUMENTS Policies Medication Management Policy/ Procedure: 7.40 Cytotoxic Spill Policy/ Procedure: 7.45 Parenteral Administration of Cytotoxic Agents for Oncological Indication Medication Management Policy/ Procedure: 7.12 Employee Awareness/Monitoring Medication Management Policy/ Procedure: 7.15 Personal Protective Equipment(When Handling Cytotoxic Agents/Waste) Medication Management Policy/ Procedure: 7.30 Patient Cytotoxic Excreta/Soft Waste, Disposal of Medication Management Policy/ Procedure: 7.35 Sharps(Needles, IV sets, Syringes,ETC) Contaminated by Cytotoxic Agents, Disposal of Medication Management Policy/ Procedure: 7.41 Accidental Exposure to Cytotoxic Agents Medication Management Policy/ Procedure: 10.11 Medication Administration Record(s) (cMAR) Collaborative Practice Agreement: 10.07 Orders Written By Clinical Pharmacy Specialist Hematology-Oncology Medication Management Policy 25.05 High Alert Medications Medication Management Policy 30.05 Intravenous Infusions Medication Management Policy 20.10, Injectable Medications Medication Management Policy 4.75, Identification and Classification of Hazardous Drugs Clinical Policy 735V CVAD, Administration of Medication Clinical Policy 1140 Intravenous Therapy, Administration of IV Meds Administrative Policy 124 Consent to Treatment IWK Administrative Policy 324.0B, Beyond Entry Level Competency (BELC): Performance of Beyond Entry Level Competency (BELC) by Nurses at the IWK Health Centre
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Forms Assessment/Intervention Flow Sheet Children’s Health (IWKASINFL) Patient Controlled Analgesia (PCA) Record Children’s Health (IWPACO) Vital Signs Record Children’s Health (IWKVISI)
Appendices Appendix A –Definitions Appendix B - CADD-PRIZM VIP Model 6100 and 6101 Ambulatory Infusion Pumps Quick Reference Card for Clinicians Appendix C- CADD-PRIZM VIP Model 6100 and 6101 Ambulatory Infusion Pumps Quick Reference Card for Caregivers Appendix D- Guidelines for the safe disposal of waste and management of a cytotoxic spill in the home.
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Appendix A - Definitions Cytotoxic: drugs which are carcinogenic or genotoxic. Drugs classified as antineoplastic are presumed cytotoxic unless evidence supports an alternate classification. Cytotoxic drugs are potentially detrimental or destructive to cells within the body, and typically bind to or damage DNA, interfere with DNA or protein synthesis, or with cell growth or proliferation, often nonselectively. Cytotoxic drugs are subdivided into High Risk (injection) and Medium Risk (oral or topical). Chemotherapy- drug therapy aimed at reducing tumor volume by cytotoxic agents and preventing tumor cell division and spread. Chemotherapy agents are designed to kill cells during different phases of the cell cycle. (Kline 2011) Biotherapy- agents derived from biological sources and/or affecting biological responses to cause anti-tumour activity. Some of these agents have the ability to target cancer cells while sparing normal cells. As a class, monoclonal antibodies are not expected to be carcinogenic, genotoxic or teratogenic in the staff handling the drugs and are not considered hazardous (unless conjugated to a cytotoxic drug). Hazardous drug: drug that exhibits one or more of the following six characteristics in humans or animals: carcinogenicity, genotoxicity, teratogenicity or other developmental toxicity, reproductive toxicity, organ toxicity at low doses, or has a structure and toxicity profile that mimics an existing medication. Hazardous drugs are further classified as high, medium or low risk based on dosage form, pharmacological properties and toxicological profile. Non-cytotoxic: drug which poses lesser potential risk than a cytotoxic hazardous drug in terms of occupational exposure, but which requires special handling precautions. Noncytotoxic drugs may be associated with adverse reproductive effects (teratogenicity, developmental toxicity, early fetal loss, impaired fertility, altered uterine function or classified by the FDA as pregnancy risk category D or X) or cause organ toxicity at low doses. Vesicant: agents that can cause tissue damage and necrosis when extravasated into interstitial tissue. Irritant: agents that induce a local inflammatory reaction with immediate, prolonged or repeated exposure to vascular structures. APPHON: Atlantic Provinces Pediatric Hematology/Oncology Network is an interdisciplinary organization developed to enable care of children/adolescents with cancer and blood disorders. APHON: Association of Pediatric Hematology/Oncology Nurses is an international organization that exemplifies the leading expertise in nursing care for children and adolescents with cancer oncological and hematological diseases.
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Cytotoxic Spill: Any amount of uncontained cytotoxic agent or patient excrement contaminated with cytotoxic agents is considered a cytotoxic spill.
Minor spill: less than or equal to 5 mL • less than 5 mL of cytotoxic agent • less than 5 mL of excreta/soft waste from patients receiving cytotoxic agents for oncologic purposes within 48 hours of administration, • any volume of excreta/soft waste from patients receiving cytotoxic agents for non-oncologic purposes within 48 hours of administration.
Major spill: greater than 5 mL. A spill of a cytotoxic agent does not present a hazard unless one directly contacts the drug or inhales the unreconstituted drug powder. Neither dry drug nor drug solution will produce mobile fumes. However, drug powders may be blown about or solutions may be splashed about during clean-up or by passers-by. • greater than 5 mL of cytotoxic agent, • greater than 5 mL of excreta/soft waste from patients receiving cytotoxic agents for oncologic purposes within 48 hours of administration
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Appendix B - CADD-PRIZM VIP Model 6100 and 6101 Ambulatory Infusion Pumps Quick Reference Card for Clinicians Programming and Setting up the Pump: Pump must be in Lock Level Zero (LL0) see below: Changing the Lock Level 1. 2. 3. 4. 5.
Press Y or N to select desired reservoir volume, press enter. Press Y or N to select the desired units, press enter. Press Y or N to select the desired concentration, press enter. Press Y or N to select desired continuous rate, press enter. Press Y or N to select desired amount of patient demand dose, press enter ( demand dose function would not be used in chemotherapy administration). 6. Press Y or N to select lockout time between demand doses, press enter ( lockout time function would not be used in chemotherapy administration). 7. Press Y or N to select the desired number of demand doses per hour, press enter (number of demand doses function would not be used in chemotherapy administration). 8. To clear the dose counters, press enter.* 9. To clear the units given, press enter.* 10. To review the program entered, press next repeatedly. *It is important to clear the dose counter and the units given each time there is a programming change made. To start clinician bolus: (Would not be used in chemotherapy administration) 1. 2. 3. 4. 5. 6. 7.
Pump must be running. Press LOCK. Clinician activated dose appears Press Y or N until Clinician Bolus Dose code 997 appears. Press LOCK. Press Y or N to select desired bolus dose. Press Enter or Dose to start bolus dose.
To stop clinician bolus or demand dose in progress: 1. Press STOP/START. 2. When stop demand dose or stop clinician dose appears press Y. 3. When stop the pump appears press Y to stop pump or N to remain running.
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Changing the Lock Level: 1. 2. 3. 4. 5.
Stop the pump. Press LOCK – the pump should be in lock level two (LL2) when infusing. Press Y or N until desired lock level appears (LL0 for programming). Press LOCK. Press Y or N until lock level code 061 appears. 6. Press LOCK, then make necessary change to program. Attaching New Cassette and Prime Tubing: 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14.
Stop the pump and change lock level to LL0 Ensure all air is removed from Cassette or medication bag before starting Close tubing clamp. Insert new cassette or CADD administration set with bag spike hooks into pump’s hinge pins. Place pump with cassette on firm surface and push down on top of pump. Use side of key to latch cassette. Use key to lock cassette. The mark on the latching button must line up with solid dot on the side of the pump. Gently twist and pull on the cassette to make sure it is attached properly. When cassette loaded (Locked) appears, press NEXT. If reset reservoir volume to __ mL appears, press Y if appropriate or change to desired reservoir volume. When prime tubing appears, open tubing clamp and press Y if appropriate. Follow priming instructions on pump’s screen. When primed, close tubing clamp. If AutoLock not in use, change lock level back to LL2 (refer to “Changing the Lock Level”). When start the pump appears, connect new tubing to patient’s access site, open tubing clamp and press Y.
Removing Used Cassette or Administration Set: 1. 2. 3. 4. 5. 6. 7.
Stop the pump. Change Lock Level to LL0 Close all tubing clamps. Use key to unlock used cassette. Use side of key to unlatch used cassette. Disconnect tubing from patient. Remove and discard used cassette or administration set in a cytotoxic waste container
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1. Pump can be in stop mode or running. 2. Clamp all lines. 3. Remove old battery from side of pump by depressing the small white button and slide the cover off. 4. Insert new 9 volt battery. You will hear a beep if battery is inserted in correctly. 5. Unclamp all lines and restart the pump by pressing the stop/start button, when start the pump appears press Y. The pump will review the settings before it starts. Settings should be verified at this time. Auto-locking: When pump is set to Auto-Lock, it automatically changes lock level to LL1 or LL2 when pump is started in LL0. Check to make sure the pump changed to LL2 when it runs through the program review. If it is not set on Auto-lock, please refer to “Changing the Lock Level” and insure the pump is in LL2.
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Appendix C- CADD-PRIZM VIP Model 6100 and 6101 Ambulatory Infusion Pumps Quick Reference Card for Caregivers The pump is programmed to infuse medication continuously at a prescribed rate and should not be stopped unless directed by a Health Care Provider. To Stop/Start the Pump: 1. Press the stop/start button. 2. When start the pump? Appears on the screen, press Y Changing Battery: 1. Pump can be in stop mode or running. 2. Clamp all lines. 3. Remove old battery from side of pump by depressing the small white button and slide the cover off. 4. Insert new 9 volt battery. You will hear a beep if battery is inserted in correctly. 5. Unclamp all lines and restart the pump by pressing the stop/start button, when start the pump appears press Y. The pump will review the settings before it starts. Settings should be verified at this time. High Pressure Alarm: A high pressure alarm may sound if there is a problem with the flow of the medication from the pump to the patient. If this alarm sounds the pump will stop infusing and the problem will need to be corrected by: 1. Check the tubing for kinks or closed clamps on the line. 2. Assess the infusion site for leaking, swelling or redness and if any of these are present notify your health care team. 3. Once you have corrected the cause for the high pressure alarm ie. a kink in the tubing, you can restart the pump. 4. If you get repeated high pressure alarms notify your health care team.
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Appendix D- Guidelines for the safe disposal of waste and management of a cytotoxic spill at home. Chemotherapy drugs may damage normal cells in the body, so it is important to take precautions to protect yourself and your family from accidental exposure. During chemotherapy treatment and for 48 hours after treatment, patients may eliminate some of the drug in their waste (i.e. urine, vomit, bowel movements). To help prevent caregivers from accidental exposure to chemotherapy, the following precautions should be taken: 1. Have supplies ready in case you need to quickly clean up an accident. You may need paper towel, soap and water, disposable gloves and a disposable container (such as an ice cream container). 2. Wear rubber/disposable gloves while cleaning up waste, changing diapers or handling soiled items Note: a) If reusable rubber gloves are used, wash the outside of the gloves with soap and water prior to taking them off. Rinse. Remove gloves and wash hands then dry. b) If disposable gloves are used they should be discarded after use.
3. Keep a plastic bucket (example - ice cream container) close by in case your child vomits. If you use the container, flush the contents into the toilet and wash the container with soap and water 4. If your child has problems with bowel and/or bladder control, place plastic under the bed sheet to protect the mattress. 5. Avoid splashing and spilling urine or vomit on or around the toilet and flush waste down the toilet with the lid down. 6. Clean soiled surfaces and containers that are washable (i.e. bedpan, vomit basin) after each use. Clean with soapy water, rinse well and wipe dry. Note: Moistened disposable wipes may be used providing that the area cleansed is dried well after cleaning. 7. Sheets and bedding or clothing soiled with waste may be washed separately from regular wash in washing machine or in a sink with soapy water. Wash linens/clothing twice. 8. If waste gets on the skin, immediately wash well with soap and water, rinse and wipe dry. If waste is splashed in the eyes, rinse for 15mins. Seek medical attention if irritated. 9. If a container of water is used in cleaning, laundry and washing then the water may be disposed of in the sink or toilet. 10. Soiled diapers should be placed in plastic bags, sealed and placed in garbage
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How to safely manage a cytotoxic spill at home A Cytotoxic Spill Kit should include but is not limited to the following: respirator mask (N95), as approved by NIOSH chemical splash goggles (Canadian Standards Association approved) 2 pairs of gloves approved for cytotoxic handling disposable, moisture-resistant, long-sleeved gown with cuffs absorbent material (e.g. gauze pads, paper towels) small scoop, spatula, forceps or tweezers to collect sharp objects leak-resistant waste container for sharp or breakable objects or spilled liquid shoe covers Follow instructions on spill kit. • Non-disposable items must be washed with detergent and water by a person wearing double gloves and gown. • Contaminated bedding or clothing should be washed separately from other items and should be washed twice. 1. If a MINOR SPILL(less than or equal to 5mLs) occurs: 1.1 Keep others away from the area. 1.2. Put on personal protective equipment (face shield/mask, gown, and two pairs ofchemotherapy approved gloves). 1.3. If applicable, correct the cause of the spill. 1.4. Dry spill with paper towel or plastic backed absorbent pad. 1.5. Wash exposed area thoroughly with detergent solution and follow with a clean water rinse. Repeat and then wipe dry. Discard all materials used in clean-up process in cytotoxic waste container. 1.6. Contaminated bedding or clothing should be washed separately from other itemsand should be washed twice. 1.7. Wash affected areas of patient or other involved persons with soap and water. 1.8. Remove personal protective equipment and wash hands thoroughly with soap and water. Discard disposable equipment in cytotoxic waste container. Seal bag immediately. 1.9. Notify health care team of spill. 2. If a MAJOR SPILL(greater than 5mLs) occurs: 2.1. Stop the infusion pump. 2.2. Isolate the spill area. Keep other people and pets away from the area. 2.3. Obtain spill kit and follow the instructions on the outside of the spill kit. You will be provided with a spill kit to keep at home. 2.4. Notify health care team of spill.
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IWK Policies Being Replaced (NEW)
Version History (To Be Completed by the Policy Office) Major Revisions (e.g. Standard 4 year review)
Minor Revisions (e.g. spelling correction, wording changes, etc.)
TITLE: Policy Title
MEDICATION MANAGEMENT MANUAL Policy & Procedure TITLE:
Administration of Hazardous Drugs via CADD® Ambulatory Infusion Pump
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