Clinical Guidelines (Nursing)

Cytotoxic Drugs - The Management Of

    1. Introduction
    2. Definition of Terms
    3. Training of Personnel
    4. Health Monitoring
    5. Preparing and Dispensing Cytotoxic Agents
    6. Patient Care
    7. Personal Contamination
    8. Spill Management
    9. Waste Management

    1. Introduction

    The handling, preparation, administration and disposal of cytotoxic agents may constitute an occupational hazard. While it has not been established that handling cytotoxic agents is consistently linked with adverse health risks, handlers must be aware of the possibility. The implementation of suitable safety precautions reduces the possibility of adverse health effects to hospital employees.

    This guideline is for use within the Royal Children's Hospital by all medical, nursing, pharmacy and ancillary staff handling cytotoxic agents and/or involved in the management of patients treated with cytotoxic agents.  It recommends basic safety procedures to promote an awareness of the potential hazards involved and ensure appropriate practice. These include the use of specialised facilities, equipment, handling, administration and waste disposal techniques to protect staff, patients and the environment.

    For more information about dealing with hazardous substances go to RCH Policy and Procedure 'Dangerous Goods and Hazardous Substances'

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    2.  Definition of Terms

    Cytotoxic Agents - substances used in the treatment of malignant and other diseases.  They are designed to destroys rapidly growing cancer cells. They have been shown to be mutagenic, carcinogenic and/or teratogenic, either in treatment doses or animal and bacterial assays

    Cytotoxic - an agent or process that is toxic to cells

    Chemotherapy - The use of any chemical agents to treat or control disease.  Most often used to describe treatment of malignant and other diseases with cytotoxic agent.

    Mutagenic - capable of causing alterations/damage to genes

    Carcinogenic - capable of causing cancer

    Teratogenic - capable of causing foetal defects, either anatomic or functional

    cytosticker

    Cytotoxic materials are identified by a purple symbol representing a cell in late telophase.

    Refer to Commonly Used Cytotoxic agents at RCH

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    3. Training of Personnel

    All medical, nursing and pharmacy personnel must ensure they are familiar with these guidelines. No person must be involved in the handling, transport, preparation, administration or disposal of waste of any cytotoxic substance, without appropriate training to ensure the protection of the operator, the environment and the patient. This must involve specific training courses as follows with regular update/refresher courses and internal evaluations/reviews of methods and equipment. 

    What course currently exist eg. current RCH requirements?

    Pharmacy staff

    As outlined by the Society of Hospital Pharmacists of Australia (SHPA) Standards of Practice.

    Nursing Staff

    To be accredited to administer cytotoxic agents, nursing staff must

    • attend a chemotherapy accreditation study day
    • complete a written test
    • complete a practical assessment

    Each nurse is to be reaccredited each year. 

    Medical Staff

    Training as recommended by professional bodies.

    Ancillary Staff

    Before commencement of duty in areas where cytotoxic agents are handled, ancillary staff are required to refer to  Instruction Guide for Ancillary Staff

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    4. Health Monitoring

    Health monitoring refers to the process of assessing and counselling individuals to identify changes to health status caused by occupational exposure to a substance. Health monitoring may include the collection of demographic data, occupational and medical history, physical examination and biological monitoring.

    Biological monitoring refers to the measurement and evaluation of a substance or its metabolites in the body tissue, fluids or exhaled air of an exposed person. The value of routine biological testing in monitoring the health of employees handling cytotoxic agents and related waste is inconclusive. Therefore biological testing is not recommended as part of routine health monitoring.

    All personnel involved in the handling, preparation, administration and disposal of cytotoxic agents have access to health monitoring via staff clinic or after hours via the emergency department. Health monitoring is provided at the request of staff and may include

    • pre-employment/baseline health monitoring
    • during employment
      • annually or as requested by the employee
      • after a reportable spill or sharps injury occurs
      • if an employee advises she is pregnant, or is breast-feeding
    • on termination of employment

    For more information on Health Monitoring go to:

    The Victorian Work Cover Authority - ' Guidelines for Practitioners in Health Monitoring for Cytotoxic agents'(PDF 702KB)

    Note: It is recommended that employees planning parenthood, or those who are pregnant or breast-feeding should avoid exposure to cytotoxic agents and related waste. The employer will provide alternative employment to the satisfaction of the employer and the employee where necessary.

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    5. Preparing and Dispensing Cytotoxic Agents

    Preparing

    All cytotoxic agent preparations shall be prepared by the RCH Oncology Pharmacy.

    RCH Oncology Pharmacy's preparation and dispensing of cytotoxic agents is in accordance with the Society of Hospital Pharmacists of Australia (SHPA) and the Victorian Work Cover Authority - ' Guidelines for Practitioners in Health Monitoring for Cytotoxic agents'(PDF 702KB).

    Dispensing

    All cytotoxic agent preparations shall be supplied by the RCH Oncology Pharmacy. Preparations will be packaged as required for direct administration to the patient and should not be further modified.  All cytotoxic agents should be labelled with purple cytotoxic warning labels.

    Packaging

    Cytotoxic agents should be packaged in a sealed, leak-proof container, with outer bags heat-sealed where possible. The container should protect the agents from breakage in transit, contain leakage if breakage occurs and have a childproof lid.  All cytotoxic agents should be labelled with purple cytotoxic warning labels.

    Transport

    Cytotoxic agents should be transported in sealed impervious containers resistant to breakage. The containers should be labelled with purple cytotoxic warning  labels and used for no other purpose. Containers should be returned to pharmacy after use. For inter hospital transport or transport to the patient's home, a contact telephone number (RCH Oncology Pharmacy 9345 6290)  and instructions in the event of a spill should be included.

    Storage

    Clearly marked storage areas must be available for all cytotoxic agents. Safe storage areas must be designed to minimise the risk of breakage and to contain spills. Cytotoxic agents must not be stored in food storage and preparation areas. 

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    6. Administering Cytotoxic Agents

    Nursing and medical personnel must be aware of specific control measures and safe work practices recommended to administer cytotoxic agents to the patient.

    In general

    • only Division 1 Registered Nurses that have completed the RCH Cytotoxic agent Administration Course may administer chemotherapy
    • 2 Registered Nurses must check all cytotoxic agents (at least 1 Registered Nurse must be accredited to administer cytotoxic agents)
    • a consultant/fellow must countersign the cytotoxic agent medication order 
    • a pharmacist must sign that the order has been processed by oncology pharmacy 

    Establishing a Cytotoxic agent Administration Area

    When preparing a cytotoxic agent administration area, consider a quiet environment with minimal patient/visitor activity. Preferably use a treatment room for the administration of cytotoxic agents via intramuscular and subcutaneous routes, the administration of IV push doses of cytotoxic agents and for connecting IV bags containing cytotoxic agents to existing lines. All patients receiving cytotoxic agent infusions should remain in the treatment area for the duration of the infusion. 

    Administration Equipment

    Prepare all equipment required prior to approaching the patient area with a cytotoxic agent.

    The use of the following equipment is recommended:

    • needleless administration systems: use of a 3-way tap and luer lock syringes
    • portable trolleys
    • disposable injection trays, dressing packs and medication cups
    • disposable gauze squares around the injection site 
    • disposable gauze squares around syringe and bag connection sites
    • plastic-backed absorbent sheets/pads under the injection site
    • purple cytotoxic sharps waste containers for disposal of contaminated sharps
    • purple cytotoxic waste buckets for disposal of all other contaminated waste

    Use disposable equipment where possible.

    Refer to Waste Management for disposal of agent administration equipment

    Refer to  Equipment List for ordering agent administration equipment

    Personal Protective Equipment

    The following personal protective equipment is recommended during the administration of cytotoxic agents (where there is an assessed exposure risk):

    • closed footwear
    • gown
      • long-sleeved gown of impermeable material, closed front and elasticised cuffs
      • disposable or able to be processed through a laundry facility capable of handling garments contaminated with cytotoxic agents
      • gowns should be dated and changed daily, or if overt contamination results
    • protective eyewear
      • goggles or protective glasses with side shields
    • protective gloves
      • polyvinyl chloride (PVC), surgical latex, or purpose-manufactured gloves
      • operators not wearing special-purpose gloves should be double gloved
      • gloves should be long enough to cover wrist cuffs of the gown
      • gloves should be changed after each procedure, or if overt contamination or perforation occurs 

    Refer to Waste Management for disposal of personal protective equipment

    Refer to  Equipment List for ordering personal protective equipment

    Administration Procedures

    • ascertain administration and management details of specific cytotoxic agents
    • ensure the child and family are involved in the process, encourage them to alert staff of any problems
    • maintain close supervision of the patient

    Intravenous Cytotoxic Agent Administration

    Intravenous Access

    • where available, utilise a central venous access device to administer intravenous cytotoxic agents.

    Central Venous Access Device Management RCH

    • where a central venous access is unavailable, choose veins of normal circulatory dynamics and reasonable diameter, to limit high agent concentrations and the possibility of extravasation
    • select an infusion site in the following order of preference:
      • dorsum of hand>wrist>forearm>antecubital fossa
    • insert a cannula with only one venipuncture into a vein
    • lightly tape the tubing of the jelco distal to the needle, do not obscure the injection site from view
    • test vein integrity and patency by obtaining blood backflow and/or flush the cannula with saline
    • if extravasation of saline is obvious, select another site i.e. the other arm, or lateral or proximal to the initial site 
      • avoid a distal point  on the same vein because of the potential for extravasation 

    Administration

    • put on personal protective equipment
    • double check cytotoxic agent with another registered nurse immediately prior to administration at the point of administration. 
    • check patency of the CVC/IV line by obtaining blood backflow, flushing CVC/IV cannula with saline or infusing hydration
    • commence administration of cytotoxic agent( if multiple agents are prescribed give vesicants first)
      • place an impermeable sheet /dressing pack under the work area to contain any minor spills 
      • use disposable gauze squares around syringe and bag connection sites
      • connect intravenous bags at waist level using a non-touch technique
      • use cytotoxic labels to identify all intravenous bags, infusion syringes and lines contaminated with cytotoxic agents
    • remove personal protective equipment, discard gloves in purple cytotoxic waste container
    • wash hands with soap and water following administration and disposal of cytotoxic agents and related waste 
    • ensure syringes and bag connections are intact and free of leaks throughout administration
    • initiate appropriate observations and nursing care, manage extravasation incidents promptly 

    Extravasation of Chemotherapy Agents Clinical Guideline currently in development 

    Finishing administration

    • put on personal protective equipment 
    • use disposable gauze squares around syringe site
    • remove cytotoxic agent bag at waist level using disposable gauze squares and a non- touch technique
    • flush line with a compatible IV solution ( generally the solution the cytotoxic agent was prepared in; Amsacrine is only compatible with dextrose)
    • discard all equipment into purple cytotoxic waste container
    • remove personal protective equipment, discard gloves in purple cytotoxic waste container
    • wash hands with soap and water following administration and disposal of cytotoxic agents and related waste

    Removing IV lines

    • put on personal protective equipment 
    • using disposable square gauze remove IV lines intact
    • remove IV lines intact
    • dispose empty IV bags/infusion syringes with the administration set still attached, do not cut down IV infusion sets
    • discard all equipment into purple cytotoxic waste container
    • remove personal protective equipment, discard gloves in purple cytotoxic waste container
    • wash hands with soap and water following administration and disposal of cytotoxic agents and related waste 

    Oral Cytotoxic Agent Administration

    Tablets must be handled in a manner which avoids skin contact and liberation of powdered agent into the air. Most tablets containing cytotoxic agents are either pressed or sugar coated, thus preventing exposure.

    • dispense tablets into a disposable medicine cup using a non touch technique or gloves
    • double check cytotoxic agent with another registered nurse immediately prior to administration at the point of administration
    • encourage the child where possible to swallow tablets 
    • avoid crushing and breaking oral cytotoxic agents where appropriate
    • if needed most oral cytotoxic agents used at RCH will dissolve in a sufficient amount of water (remove plunger from a syringe, place tablet into syringe, add 2-3mls of water, cap syringe while dissolving)
    • if patient vomits within 30 minutes to 1 hour following administration, notify oncology pharmacy or the medical team to determine whether the dose must be repeated  (see contaminated linen and clothingpersonal contamination)
    • dispose of gloves and equipment as cytotoxic waste
    • wash hands following administration and disposal of cytotoxic agents and related waste

    Subcutaneous/Intramuscular Cytotoxic Agent Administration

    • wear personal protective equipment
    • double check cytotoxic agent with another registered nurse immediately prior to administration at the point of administration
    • administer SC/IM cytotoxic agent as per medical orders
    • dispose of sharps into purple cytotoxic sharps waste container
    • remove personal protective equipment, dispose gloves in purple cytotoxic waste container
    • wash hands following administration and disposal of cytotoxic agents and related waste

    Intrathecal Cytotoxic Agent Administration

    MethotrexateandCytarabine (Ara-C)are theonly cytotoxicagents which can be administeredintrathecally .

    • Intrathecal cytotoxic agents can only be administered by medical staff competent in the administration of intrathecal cytotoxic agents
    • Intrathecal cytotoxic orders must be confirmed and signed off by a Children's Cancer Centre Consultant or Fellow.
    • All intrathecal cytotoxic agents must also be double checked at the point of administration by the injecting medical doctor and a Div 1 registered nurse, another medical doctor or an RCH pharmacist.
    • All intrathecal cytotoxic agents must be prepared and packaged by the Oncology Pharmacy and stored and transported to point of administration in a purple intrathecal plastic bag in the Intrathecal Cytotoxic Esky provided by pharmacy.
    • Intrathecal cytotoxic agents must be stored separately from other cytotoxic agents.
    • No other (non IT) cytotoxic agents should be present in the area of administration of the intrathecal cytotoxic agent.

    For Intrathecal Cytotoxic Agents given in Day Surgery (>98%) during the Oncology theatre list:

    • All orders are to be written prior to the day of administration
    • The Patients FBE must be checked and the Intrathecal order confirmed and signed by a Children's Cancer Centre Consultant or Fellow prior to the procedure. 
    • The IT esky containing IT cytotoxic agent must be accompanied by pt history containing medication order
    • All IT orders and cytotoxic agent must be double checked in theatre by the injecting doctor and theatre nurse immediately prior to administration of the cytotoxic agent

    For Intrathecal Cytotoxic Agents given in all other Area's :

    • The doctor giving the injection must personally collects the IT agent from Oncology Pharmacy, immediately prior to giving the IT injection and double check the order and medication with an oncology pharmacist.
    • IT orders and cytotoxic agent must be double checked by the injecting doctor and a Div 1 registered nurse, another medical doctor or an RCH pharmacist

    The Doctor handling and administering the Intrathecal Cytotoxic Agent should:

    • wear personal protective equipment
    • administer IT cytotoxic agent as per medical orders
    • dispose of sharps into purple cytotoxic sharps waste container
    • remove personal protective equipment, dispose gloves in purple cytotoxic waste container
    • wash hands following administration and disposal of cytotoxic agents and related waste

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      7. Patient Care

    Caring for Patients

    Cytotoxic agents are primarily eliminated from the patient by renal and hepatic excretion. All body substances may be contaminated with either the unchanged agent or active agent metabolites. The period during which body substances may be contaminated with cytotoxic agents will differ for individual agents and patients.

    Protective measures

    The following protective measures must be used when handling patients' vomitus, blood, excreta and fluid drained from body cavities which are contaminated with cytotoxic agents.  

    • personal protective equipment
      • closed footwear and protective gloves must be worn
      • a gown (where there is a risk of splash) and protective eyewear (where there is risk of splash to the eye) may be used.
        Refer to Personal Protective Equipment
    • patient waste such as urine, faeces, vomitus and the contents of colostomy and urostomy bags may be disposed of in the normal sewerage system or via a pan flusher. Double flushing is not required 
    • the use of disposable nappies is recommended. Disposable nappies, colostomy and urostomy bags must be disposed of in purple cytotoxic waste containers 
    • wash hands with soap and water immediately after handling cytotoxic excrement.

    Protective measures are required for 72 hours following cytotoxic agentadministration 

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    8. Personal Contamination

    Exposure to cytotoxic agents may occur through skin contact, skin absorption, inhalation of aerosols and agent particles, ingestion and needle stick injuries. Personal contamination may result from the following activities; agent preparation, agent administration, handling patient waste, transport and waste disposal or spills.

    In the event personal contamination occurs

    • immediately remove gloves or gown and any contaminated clothing and dispose of in purple cytotoxic waste container
    • package and launder clothing that is not overtly contaminated

    Refer to Waste Management for management of contaminated clothing

    Procedure for dealing with direct skin, eye and other body contact with cytotoxic agents

    • skin exposure
      • remove contaminated clothing (as above)
      • wash the affected skin and flush thoroughly with running water 
    • eye exposure
      • immediately flood the eye with clean water by continuous irrigation for a period of 15 minutes
    • needlestick injuries
      • wash thoroughly as for skin exposure, refer to RCH Policy and Procedure Manual,  Needlestick Injuries and Blood/Body Fluid Exposure
      • if the needlestick injury results in the injection of agents, it may be necessary to refer to RCH Clinical Guidelines: Extravasation of Chemotherapy Agents
    • do not administer antiseptic or anaesthetic drops or ointments

    Reporting procedures

    • staff
      • notify supervisor responsible for area at time
      • report to staff clinic/emergency department for medical review 
      • complete an incident report
    • patient

    Refer Section 4: Health Monitoring

    Consult the relevant Material Safety Data and Substance Risk Assessment Sheet for details of the properties and hazards associated with each cytotoxic substance (located in Oncology Pharmacy and 6 East)

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    9. Spill Management

    Procedures for dealing with spills

    A cytotoxic spill requires immediate attention and must be effectively controlled so as not to promote unnecessary contamination of the environment. All areas where cytotoxic agents are prepared or administered must have access to :

    • cytotoxic agent spill kit
    • strong alkaline detergent (Det-Sol 5000)
    • one litre container for dilution of strong alkaline detergent specifically used for this purpose

    Cytotoxic agent spill kits are located at RCH in 6 West treatment room, 6 East drug room, Oncology Outpatients treatment room and Oncology Pharmacy.

    Spills during agent administration, patient care and transport

    Minor spills (cytotoxic spills less than 50mls or spills of body fluids containing cytotoxic agents)

    • isolate area and place signs if required
    • allocate responsibility for managing the spill
      • staff contaminated by the agent should refer to Personal Contamination
      • another staff member should be allocated responsibility for managing the spill
    • wear personal protective equipment; gown, gloves and eyewear; refer to Personal Protective Equipment
    • contain and soak up the spill using dry absorbent material
    • wash area with copious amounts of alkaline detergent
    • rinse area thoroughly with water
    • dry area with absorbent material
    • discard all waste into purple cytotoxic waste container
    • remove personal protective equipment, discard into purple cytotoxic waste container
    • wash hands thoroughly with soap and water
    • complete an incident report

    Major spills (cytotoxic spills greater than 50 mls)

    • isolate area and place signs if required
    • allocate responsibility for managing the spill
      • staff contaminated by the agent should refer to Personal Contamination, another staff member should be allocated responsibility for managing the spill
    • access the nearest spill kit
    • put on gown, mask, protective eyewear, shoe coverings and double gloves (inner latex glove and outer heavy utility glove) contained in the spill kit
    • contain and cover the spill using appropriate absorbent material (absorbent side facing down and plastic backed side up) provided in the spill kit
    • use spill towels (in spills kit on ward) to wash area with alkaline detergent
    • use spill towels to rinse area thoroughly with water and to dry area fully
    • discard all waste into large blue poly bag
    • remove shoe coverings and outer utility gloves and discard into blue poly bag
    • wearing inner gloves, seal blue poly bag and place into chemotherapy waste poly bag along with gown, mask and protective eyewear
    • remove inner gloves and seal chemotherapy waste poly bag
    • place entire bag into purple cytotoxic waste bucket
    • wash hands thoroughly with soap and water
    • complete an incident report form

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    10. Waste Management

    Cytotoxic waste includes any residual cytotoxic agent that remains following patient treatment and any materials or equipment potentially contaminated with cytotoxic agents. Relevant regulations concerning the disposal of cytotoxic waste must be followed.

    Equipment

    • sharps contaminated with cytotoxic agents should be disposed of in purple cytotoxic sharps waste containers
    • disposable equipment contaminated with cytotoxic agents should be disposed of in purple cytotoxic waste buckets
    • nondisposable equipment should be washed with copious amounts of hot soapy water 

    Excess agents

    • cytotoxic agents that have not been administered must be returned intact to pharmacy for disposal
    • unused portions of cytotoxic agents should be disposed of in purple cytotoxic waste buckets

    Contaminated linen and clothing

    Clothing and soiled linen may be contaminated with the unchanged agent or an active metabolite. The following is advised when dealing with contaminated linen and clothing:

    • wear personal protective equipment; gown and gloves, when handling soiled linen and clothing
    • place contaminated hospital linen in a alginate bag at the point of contamination, then place in the regular linen skip for subsequent laundering
    • contaminated personal linen and clothing must remain separate from other items of clothing
      • wash soiled items twice using detergent and hot water, rinse well
      • following rinsing the items may be washed with other articles of clothing

    Cytotoxic Waste Disposal

    All cytotoxic waste containers should be sealed prior to collection by domestic services.  Cytotoxic preparations must be transported in sealed designated containers and labelled as cytotoxic waste. Personnel engaged in the routine handling and transport of cytotoxic waste should wear industrial work-wear, polyvinyl chloride (PVC) industrial gloves and safety boots.

    Cytotoxic waste should be segregated from other waste streams. At present incineration is the only acceptable method for treating cytotoxic waste.

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    11. Appendices

    Appendix 1

    Commonly Used Cytotoxic agents at RCH

    Appendix 2

    Instruction Leaflet for Ancillary Staff - Cytotoxic Handling

    Appendix 3

    Equipment List

    Appendix 4

    References

    • Gambrell, j.; Moore, S.  Assessing Workplace Compliance With Handling of Antineoplastic Agents.  Clinical Journal of Oncolgoy Nursing.  August 2006.  Vol. 10, No 4. p473-477
    • Gehan, K.; Willemson-McBride,T.  Safe Handling of Cytotoxic Agents: A Team Approach, AORN Journal.  November 2009, Vol 90 No 5. p731-740
    • WorkSafe Victoria, Healthcare, veterinary clinics and laboritories - Handling Cytotoxic drugs. June 2009, Victorian Government. 
    • Work Cover New South Wales,  Cytotoxic Drugs and Related Waste - Risk Management.  2008, New South Wales Government.
    • New South Wales Health.  Cytotoxic Drugs and Related Waste:  Safe Handling in the NSW Public Health System.  October 2008.  Department of Helath, New South Wales Government.

    Please remember to read the disclaimer.

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