To ensure all workers are aware of, and understand the risks associated with the handling and
use of cytotoxic drugs and related waste.
Teaching points:
1.1 Risks associated with occupational exposure to cytotoxic drugs and related waste:
• health risks and toxic effects
• reproductive health risks.
1.2 Rationale for use of cytotoxic drug therapy.
1.3 Legislative requirements for the management of cytotoxic hazards, MSDSs, risk assessment, employer
and worker obligations.
1.4 Institutional policies and procedures.
1.5 Definitions; cell replication; drug classifications, pharmacological actions; rationale for use.
Identification of those drugs which are mutagenic, teratogenic and carcinogenic. Cytotoxic drugs as a
class of drugs:
• define ‘carcinogenic’ ‘mutagenic’ and ‘teratogenic’
• concepts of cell replication
• drug classifications and pharmacological action on cellular reproduction.
1.6 Health surveillance for workers working with cytotoxic drugs;
• health assessment of workers after unprotected exposure to cytotoxic drugs:
° rationale
° health assessment required in response to an unprotected exposure
• principles for initial and ongoing health assessment:
° rationale for personnel management
° the purpose of health assessment
° limitations of current health surveillance methods.
1.7 The importance of accurate record keeping (e.g. an activity log, records of spills and penetrating
injuries). Storage requirements for health surveillance documentation to ensure confidentiality,
perpetual safe keeping and retrieval.
1.8 Incidents and spill management
1.9 Safe disposal methods for cytotoxic drugs and related waste. Safe storage, packaging, consigning and
transport of cytotoxic waste:
• the rationale for the identification, segregation and safe handling of cytotoxic waste
• institution policies and procedures as they apply to:
° segregation of cytotoxic waste
° containment of cytotoxic waste
° transport of cytotoxic waste
° management of cytotoxic drug and related waste spills.
1.10 PPE requirements, including, selection, use, fit, maintenance, storage, cleaning and disposal.
To train workers in the safe preparation of cytotoxic drugs.
Teaching points – to include Module 1, plus:
2.1 Facility requirements:
• minimum requirements for a cytotoxic preparation facility as defined by AS 2567-2002:
Laminar flow cytotoxic drug safety cabinets and AS 2639-1994:Laminar flow cytotoxic drug
safety cabinets - Installation and use
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• principles of clean spaces, their creation and maintenance as described in AS 1386.1-1989:
Cleanrooms and clean workstations - Principles of clean space control:
° essential elements necessary for the preparation of cytotoxic drugs—clean room, air handling
system, peripheral rooms, cytotoxic dispensing facility (e.g. laminar air flow equipment,
isolators, cytotoxic drugs safety cabinet)
° their function and use
• management of the cytotoxic preparation facility:
° operation of the cytotoxic drugs safety cabinet or isolator
° maintenance of the preparation facility
° approved devices/equipment used in preparing cytotoxic drugs
° management of cytotoxic spills
° management of contaminated waste generated in the preparation of cytotoxic drugs
° preparation records
• certification reports
• activity logs
• pressure differential records
• environmental monitoring.
2.2 Aseptic preparation of a cytotoxic product.
• principles of aseptic preparation of parenteral solutions
• specific requirements for aseptic preparation in cytotoxic drug safety cabinets or isolators.
2.3 Quality assurance measures required for preparation cytotoxic drugs.
2.4 Safe techniques for cytotoxic drugs. Health and safety hazards posed by handling cytotoxic drugs in
powder and liquid form:
• routes of absorption associated with occupational exposure
• hazards involved when cytotoxic drug aerosols are liberated into a workplace.
2.5 Packaging requirements for the safe presentation and receipt of prepared cytotoxic drugs in individual
packing:
• labelling and packaging requirements for the presentation of prepared cytotoxic drug doses
• procedure for dealing with broken tablets and capsules
• rationale for the use of primary (e.g. a syringe closure), secondary (e.g. the spill-proof overwrap
containing the syringe) and tertiary (e.g. the spill-proof outer transport container) containers for
the maintenance of product integrity and its safe handling.
2.6 Safe storage and transport of cytotoxic drugs in concentrated from:
• legislative requirements for the storage and transport of cytotoxic drugs
• rationale for specific procedures essential for the storage and transport of cytotoxic drugs
• risks associated with the different presentations of cytotoxic drugs
• institutional policy and procedures as they apply to receipt of goods, storage of goods, transport
of goods, management of cytotoxic drug and related waste spills.
2.7 PPE requirements:
• function and use of PPE—demonstrate appropriate use of PPE:
° selection
° putting on
° concurrent use
• cleaning, laundry and disposal of used PPE.
2.8 Waste management principles of waste containment and segregation:
• contaminated waste disposal
• contaminated patient waste
• cytotoxic waste storage and transport requirements.
2.9 Management in the community.
2.10 Incidents and spill management.
2.11 Record keeping.
To train workers in the safe administration of cytotoxic drugs.
Teaching points - Module 1, plus
3.1 Risks associated with administration for operator and patient:
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• physical and chemical characteristics of these drugs as they pertain to occupational safety:
° differences in potential risk between lyophilized drugs, powdered and liquid filled preparations
° substances requiring protective containment
• cytotoxic drugs and their rationale for use:
° cure, control, prophylaxis and palliation
° drug dosages, routes of administration, delivery methods, calculation of body surface area
° cytotoxic drug protocols.
3.2 Principles of safe handling for all routes of administration. Safe administration techniques for
cytotoxic drugs:
• health and safety hazards posed by handling cytotoxic drugs in liquid form:
° routes of absorption associated with occupational exposure
° hazards involved when cytotoxic drug aerosols are liberated into a workplace
• packaging requirements for the safe presentation and receipt of prepared cytotoxic drugs in
individual packing:
° labelling and packaging requirements for the presentation of prepared cytotoxic drug doses
° procedure for dealing with broken tablets and capsules
° rationale for the use of primary (e.g. a syringe closure), secondary (e.g. the spill-proof
overwrap containing the syringe) and tertiary (e.g. the spill-proof outer transport container)
° containers for the maintenance of product integrity and its safe handling
• identifying safe routes of administration—principles of safe handling and administration of
cytotoxic drug injections:
° demonstrate correct and safe use of cytotoxic drug injectables
° identify variety of routes by which cytotoxic drugs are administered
° identify appropriate blood values and assessments prior to drug administration
• principles of safe handling and administration of cytotoxic drug infusions:
° identify appropriate equipment for management of infusions of cytotoxic drugs
° demonstrate correct technique for the connection and disconnection of cytotoxic drug
administration equipment
• principles of safe handling and administration of oral and topical cytotoxic drugs:
° demonstrate no-touch technique in the administration of oral cytotoxic drug doses
° no-touch application technique and drug containment procedures when applying topical
cytotoxic drugs
• reasons for the selection of differing vascular access techniques for parenteral cytotoxic drugs:
° demonstrate techniques of vein access appropriate for intravenous administration of various
cytotoxic agents
• selection of a vascular access site for vesicant and irritant cytotoxic drug administration:
° identify appropriate vascular access site for the cytotoxic drug used
° identify drugs that are vesicants and those that are irritants
• principles of safe handling and administration of intrathecal cytotoxic drugs:
° identify cytotoxic drugs that can be safely administered by intrathecal route
° calculate intrathecal drug doses
° identify risks associated with accidental intrathecal administration of vinca alkaloids
° identify strategies to reduce risk of accidental intrathecal administration of vinca alkaloids,
including transport, packaging, labelling, checking and administration
• safe procedures for the emergency cessation of cytotoxic drug administration (e.g. adverse
reaction), demonstrate systematic approach to the containment of cytotoxic drugs during
emergency cessation
• management of extravasation—identify critical steps for the management of extravasation
• packaging requirements when transporting cytotoxic drugs within the treatment unit:
° principles of package containment for cytotoxic drug transport within the treatment unit
° transport requirements following the addition of needles to prepared syringes.
3.3 PPE requirements—function and use of PPE—demonstrate appropriate use of PPE:
• selection
• putting on
• concurrent use
• cleaning, laundry and disposal of used PPE.
3.4 Safe disposal methods for cytotoxic agents and equipment involved in administration:
principles of waste containment and segregation as applied to cytotoxic drugs
• appropriate containers required for cytotoxic waste disposal
• understand the principles of waste containment and procedures for the disposal of cytotoxic
sharps
• procedure for disposal of related cytotoxic drug administration equipment
• safe disposal procedure of PPE.
3.5 Incidents and spill management:
• management of cytotoxic drug spills:
° warning and notification requirements for cytotoxic drug spill management:
- isolation and warning procedures
- remedial action in the event of a spill
- procedure for requesting assistance
° PPE requirements for cytotoxic drug spill management
° principles and procedures for cytotoxic drug spill management:
- equipment necessary to contain the cytotoxic spill
- decontamination solutions or substances for cytotoxic containment
- effective use of cytotoxic spill equipment and decontaminants
- containment and disposal of cytotoxic drug spill materials
° action required when an unprotected exposure to workers occurs (e.g. topical, mucous
membrane, or penetrating injury exposure), identify the appropriate health assessment required
in response to unprotected exposure
° post-spill procedures:
- reporting procedures
- health assessment and follow-up.
3.6 Patient education requirements and ethical considerations.
3.7 Patient handling:
• management of contaminated body substances from patients undergoing and following cytotoxic
drug therapy:
° major pathways of body excretion of unchanged cytotoxic drugs or active drug metabolites
° protective period for safe handing of cytotoxic drug body substances:
- standard excretion times (up to seven days)
- drugs which are excreted over prolonged periods (see appendix 3)
- factors which may delay excretion
° procedures for safe handling of body substances and soiled materials used for patient care:
- use of PPE
- procedures for containment and disposal
- special safety precautions associated with contaminated waste material from catheters,
peritoneal dialysis, colostomies etc.
3.8 Management in the community.
3.9 Record keeping.
3.10 Storage and packaging requirements (for transportation and handling).
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