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Guideline
Safe Handling of Cytotoxic Drugs and Related Wastes: Guidelines for South Australian Health Services 2012
Guideline developed by: Public Health and Clinical Systems Approved at Portfolio Executive on: 2 February 2012 Next review due: 2 February 2014 Summary This guidance document, deals with the safe handling of cytotoxic drugs and related wastes. It details legal obligations and is a significant review of safe handling practices incorporating evidence based and best practice standards. This guidance document is intended to provide a risk management framework to assist in the development of local policies and procedures for the safe handling cytotoxic drugs. It is primary source of guidance in achieving compliance with the SA Health Directive, The Handling of Hazardous Drugs and Related Wastes in South Australian Health Services.

Keywords

Cytotoxic, cytotoxic drugs, safe handling, cancer drugs, cancer, hazardous, hazardous drugs, MABs, monoclonal antibodies, BCG, guideline, guidance

Guideline history

Is this a new guideline? Y Does this guideline amend or update an existing guideline? N Does this guideline replace an existing guideline? Y If so, which guidelines? South Australian Health Commission ‘Guidelines for the Safe Handling of Cytotoxic Drugs and Related Wastes in Health Units and Services’ (1993)

Applies to

All health units incorporated under the Health Care Act 2008

Staff impact

All staff

PDS reference

G0117

Version control and change history
Version 1.0 Date from 2/2/2012 Date to Current Amendment Original version

© Department for Health and Ageing, Government of South Australia. All rights reserved.

 

Safe Handling

Cytotoxic Drugs and Related Wastes

Guidelines for South Australian Health Services 2012

This document and related resources are available on the SA Health website:

www.sahealth.sa.gov.au/HazardousDrugs

Legislation In July 2008, the Council of Australia Governments formally committed to the harmonisation of work health and safety laws by signing an Intergovernmental Agreement for Regulatory and Operational Reform in Occupational Health and Safety (IGA). The Commonwealth and each jurisdiction will enact laws that reflect the model work health and safety laws. At the time of printing, the South Australian Work Health and Safety (WHS) Bill was before the South Australian Parliament. When reading this publication you should always refer to current laws. Emerging developments will be available on the SA Health Website.

Disclaimer This publication contains information regarding occupational health, safety and welfare requirements. It is intended to provide guidance only and does not constitute legal advice. It includes information about some of your obligations under the occupational health, safety and welfare legislation but is not intended to be a substitute for the official version of any Act, Regulation, Approved Code or other instruments. To ensure you comply with your legal obligations you must refer to the appropriate Acts and Regulations and seek your own independent professional advice. This publication may refer to legislation that has been amended or repealed. When reading this publication you should always refer to the current laws. While every effort has been made to ensure the information contained in this publication is free from error and/or omissions, no claim is made that the information is in fact free from error and/or omissions. By using this information, you acknowledge that the Department for Health and Ageing, the Minister of Health and Ageing, any employees of the Department or any other persons involved in the preparation of this document do not accept liability however arising, for any consequences of anything done or not done by a person in relation to the usage and/or reliance upon (whether in whole or in part) the information contained in this publication.

Acknowledgments

Acknowledgments
This guidance document has been developed from a project funded and managed by the Pharmaceutical Services and Strategy Branch of the South Australian Department for Health and Ageing and was prepared by the Cytotoxics Work Group. The guidelines aim to provide a practical health and safety standard for the handling of cytotoxic drugs and related wastes in SA Health. The Work Group is the primary reference group for the development of the guidelines. Members represent a range of stakeholders dedicated to improving health, safety and welfare in the healthcare sector and to the wellbeing of patients. Without their participation, this project would not have been possible.

Members of the Work Group
South Australian Department for Health and Ageing Dr Merrîcc Edgar-Hughes (Project Manager) Karen Boss Serena Coulls Ro Williams Australian Nurses and Midwifery Federation (SA Branch) Alison Walsh Cancer Nursing Society of Australia (SA Group) Carmel Henderson Alison Walsh Central Adelaide Local Health Network The Queen Elizabeth Hospital Eric Hofmanis Clinical Oncological Society of Australia Ben Stevenson Country Health SA Dr Jacqui Adams Flinders Medical Centre Megumi Ng Lawrie Wu Northern Metropolitan Health Network Lyell McEwin Hospital Lynn Kerr Royal Adelaide Hospital Virginia Sharley Royal District Nursing Service of SA Jayne Hallam SafeWork SA Antonietta Colella Shelley Rowett Society of Hospital Pharmacists of Australia (SA/NT Branch) Hayley Vasileff University of Adelaide Dr Michael Tkaczuk In addition to the Work Group members, various other State Government departments, health care groups and individuals have provided input. Their assistance has been invaluable in developing this document.

Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012

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Acknowledgments

These guidelines were adapted from WorkCover NSW; Cytotoxic Drugs and Related Waste – Risk Management Guide 2008. The following publications also provided invaluable reference during the preparation of these guidelines: >> International Society of Oncology Pharmacy Practitioners (ISOPP); Standards of Practice: Safe Handling of Cytotoxics, J Oncol Pharm Pract;13 Suppl:1-81 2007. >> WorkSafe Victoria; Handling Cytotoxic Drugs in the Workplace: Managing Health and Safety Risks Associated with the Handling of Cytotoxic Drugs in the Healthcare Industry 2003. >> Queensland Department of Industrial Relations; Guide for the Handling of Cytotoxic Drugs and Related Waste 2005.

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Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012

Table of Contents

Table of Contents
1 Introduction
1.1 What are cytotoxic drugs? Monoclonal Antibodies (MABs) BCG 1.2 Who is at risk? 1.3 Potential adverse effects 7 7 8 8 8 9

4 Staff Health
4.1 Health surveillance Health monitoring Biological monitoring What type of health surveillance should be implemented?

24 24 24 24 25 28 29 29 29 29 29

4.2 Special health considerations 4.3 Hygiene 4.4 Work flow

2 Legislation
2.1 Occupational Health, Safety and Welfare Act 1986 2.2 Occupational Health, Safety and Welfare Regulations 2010 2.3 Risk management 2.4 Hazardous substances 2.5 Duties of manufacturers, importers and suppliers of hazardous substances 2.6 Safety data sheets (also known as material safety data sheets – MSDS) 2.7 Summary of duties of employers who use hazardous substances 2.8 Transport of cytotoxic drugs as dangerous goods 2.9 Plant and equipment 2.10 Other legislation, policies and measures

10 10 10 10 11 11 12 12 12 13 13

4.5 Emergency procedures 4.6 Reporting and keeping records 4.7 Model procedures

5 Training
5.1 Who should be trained? 5.2 Identify training requirements Patient training 5.3 Evaluate the training program 5.4 Training records 5.5 Model procedures

30 30 31 31 32 32 32

6 Preparation and Dispensing
6.1 Elimination, substitution or replacement

35 35

3 Managing the Risk
3.1 Consultation and communication 3.2 Hazard identification 3.3 Risk assessment 3.4 Risk control Develop a risk control plan 3.5 Trial and implementation 3.6 Monitor and review

16 16 17 17 21 21 22 23

6.2 Isolation at the source of the hazard/source containment 35 Closed system drug transfer devices Other devices Cytotoxic drug safety cabinets Pharmaceutical isolator cabinets Biological safety cabinets (BSC) 35 36 37 37 37 38

6.3 Engineering controls/ventilation

6.4 Administrative controls/organisation measures 39 Parenteral preparations Non-parenteral preparations Non-parenteral preparations – oral tablets and capsules 39 39 39 42 43

6.5 Personal Protective Equipment 6.6 Procedures and model procedures

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8 Emergency procedures 11 Caring for Patients at Home 62 11.2 Gloves 13.1 Community dispensing 10.2 Work place monitoring 12.1 Home care by nursing staff Setting up a patient care area Equipment 11.2 Supply of a cytotoxic drug to a patient Supply on a medication order Dispensing on a prescription Ancillary labels Australian Commission on Safety and Quality in Health Care 44 44 44 44 44 45 46 46 10  Caring for Patients in the Community 10.3 Protective eyewear 13.2 Role of the treating facility 10.4 Cytotoxic drugs provided to drug preparation facilities by a supplier for  further processing 7.2 Transport of cytotoxic waste 12 Cleaning 12.3 Personnel management 10.1 Key risk control measures 9.7 Safe work procedures 58 58 59 59 60 60 60 61 61 7.3 Other contaminated bedding 70 70 70 70 9.2 Establishing a drug administration area 9.5 Model procedures 46 47 10.1 Key risk control measures 14.Table of Contents 7 Labelling 7.5 Respiratory protective equipment (RPE) 13.3 Model procedures 13 Personal Protective Equipment (PPE) 13.3 Cleaning staff 65 65 66 66 8.3 Cytotoxic drugs for transportation 7.3 Cytotoxic drug administration Patient assessment Equipment Intravesical administration Topical administration Oral administration 53 53 54 55 55 55 57 57 57 57 14 Laundry 14.4 Model procedures page 4 Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 .4 Maintaining controls 10.6 Head covering 67 67 68 68 68 69 69 9 Administration 9.1 Transportation of cytotoxic drugs External transportation Transportation within a health service On-site waste transport Off-site waste transport Transport licence Transport certificates Vehicle signage 49 49 49 51 52 52 52 52 52 52 52 Additional considerations for manufacturers 51 8.1 All cytotoxic drugs 7.4 Shoe covers and overshoes 13.1 Cleaning agents 12.1 Coveralls and gowns 13.5 Administration of cytotoxic drugs 10.2 General recommendations 14.2 Home care by relatives and/or patient 62 63 63 64 8 Transport 8.6 Managing cytotoxic waste 10.

6 Waste disposal and treatment 17.1 Establishing an animal care area 18.2 Spill kits 15. containment and segregation 79 6  Administration of Oral Cytotoxic Drugs in the Health Service 130 7  Accidental Exposure to Cytotoxic Drugs and Related Wastes 135 8 Spill Management of Cytotoxic Drugs 137 9 Managing Cytotoxic Waste 144 17.1 Sources of spills 15.5 Model procedures 71 71 72 73 74 74 74 Appendices 1 Glossary 2 3 4 5 6 7 Information Sources Monoclonal Antibodies (MABs) Hazardous Substances (Cytotoxic Drugs) Register Risk Assessment Tool for Cytotoxic Drugs and Related Wastes 84 84 89 93 94 95 16 Contaminated Body Wastes 16.3 Safe work procedures 81 81 82 82 82 Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 page 5 .3 Spill containment 15.5 Requirements and licensing for handling or storage of cytotoxic waste 17.2 Establishing a waste management strategy 78 17.1 Assessment of contaminated body waste 16.3 Key risk control measures Identification Containment Segregation 78 79 79 79 80 80 80 3  Preparation of Parenteral Cytotoxic Drugs Without a Closed System Transfer Device in the Pharmacy Department 116 4  Transport of Cytotoxic Drugs External to the Health Service 5  Transport of Cytotoxic Drugs Within the Health Service 122 125 17.1 What is cytotoxic waste? 77 77 17.4 Reporting procedures Notification of incidents 15.4 Identification.7 Model procedures 18 Animal Research Facilities 18.2 Safe work procedures 76 76 76 Cytotoxic Drug Precautions Alert Proforma 101 Model Procedures 1  Health Surveillance for Staff Handling Cytotoxic Drugs and Related Wastes 2  Staff Training for the Safe Handling of Cytotoxic Drugs and Related Wastes 103 112 17 Waste Management 17.2 Equipment required Animal cages and cleaning 18.Table of Contents 15 Spills 15.

1 Introduction page 6 Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 .

hostels and other residential care settings >> paramedical or ambulance vehicles >> analytical pathology and research laboratories >> research. mutagenic or teratogenic.1 Introduction 1 Introduction This guide provides practical advice for employers and employees on how to prevent or minimise the health risks associated with handling cytotoxic drugs and related waste within health care related services. cytotoxic materials are identified by a purple symbol that depicts a cell in late telophase. Many have proved to be carcinogenic. Generally. This document has not been designed for use by: >> the private and commercial sectors >> waste collection and disposal facilities >> funeral homes >> veterinary facilities. mainly through their action on cell reproduction. The principles discussed in this guidance document are applicable to these settings and therefore may be used as a reference for the above services. community and production facilities >> patients homes >> nursing homes. handling. transportation. It will assist in the development and implementation of safe work systems that are consistent with the requirements of South Australia’s health and safety laws. disposal and spills management. the scope of the use of cytotoxic drugs includes their preparation. storage. Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 page 7 . pathology or diagnostic services associated with veterinary science >> domiciliary ambulatory clinics >> doctors surgeries and medical practice rooms >> pharmacy courier services >> other transport services >> pathology courier services >> mortuaries. This guide applies primarily to the clinical handling of cytotoxic drugs and related waste in the provision of health care related services: >> hospital settings >> pharmacies – hospital. These drugs are increasingly being used in a variety of health care settings for the treatment of cancer and other medical conditions such as rheumatoid arthritis. 1. administration. For the purpose of this guide.1  What are cytotoxic drugs? Cytotoxic drugs are known to be highly toxic to cells. multiple sclerosis and auto-immune disorders.

Each drug should be risk assessed based on current information. inhalation of aerosols and drug particles. These drugs differ chemically and pharmacologically from conventional cytotoxic drugs. BCG The handling of BCG (the Bacillus of Calmette and Guerin strain of Mycobacterium bovis) and inhibitors of the receptor tyrosine kinases and related drugs are not specifically addressed in this document however the risk management framework outlined in this document can be used in the development of local policies and procedures for these drugs.2  Who is at risk? Occupational exposure to cytotoxic drugs and related waste may occur when: >> preparing drugs >> administering drugs >> transporting drugs >> storing drugs >> handling patient waste >> transporting and disposing of waste >> cleaning up spills. Depending on the individual agent and clinical setting. taking into account molecular and cellular level mechanisms of action as well as published toxicity data. however lack of understanding of the science behind these drugs has caused concerns among healthcare professionals. mutagenic or teratogenic in the patient themselves or in the staff handling the drugs. page 8 Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 . investigator brochures and other relevant information sources. These drugs are prominent among the new types of therapeutic agents currently in clinical practice for the treatment of cancer as well as other medical conditions. skin absorption. safety data sheets. as a class. Some limited information and references for health services dealing with monoclonal antibodies are provided in Appendix 3. similar handling precautions to those used for cytotoxic drugs may be required. 1. ingestion and sharps injuries. These agents differ from conventional cytotoxic agents in that they do not directly or indirectly damage DNA or RNA and therefore would not.1 Introduction Monoclonal Antibodies (MABs) It is becoming more common to see issues relating to the safe handling of monoclonal antibodies (MABs) included in clinical guidelines and documents dealing with the safe handling cytotoxic drugs. be expected to be carcinogenic. Exposure may occur through skin contact.

Where a high standard of risk control is in place and adhered to. nasal sores and vomiting >> liver damage >> contact dermatitis. the health effects on those who prepare and administer cytotoxic drugs have included: >> alterations to normal blood cell count >> foetal loss and possible malformations in offspring >> fertility changes >> abdominal pain.3  Potential adverse effects Where control measures have been inadequate. threats to health are greatly reduced. Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 page 9 .1 Introduction 1. hair loss.

importers and suppliers of plant. employers have a duty to provide: >> a workplace that is safe and without risks to health >> safe system of work >> plant and structures in safe condition >> information.3  Risk management Even when a substance. Under the Occupational Health. Occupational health and safety requirements are to be implemented when using and handling cytotoxic drugs and related waste. Safety and Welfare Regulations 2010 The Occupational Health. Requirements for storage of Class 6 toxic substances are also covered under Dangerous Substances Regulations 2002. is often provided with packaged drugs and provides an additional source of information about safe use. including adverse effects.2  Occupational Health.1  Occupational Health. and the employer must ensure that each substance does not pose a health or safety risk to those at work. Employers have obligations to ensure staff and other individuals are not exposed to risks which may affect their health and safety. This obligation extends to not harming visitors or employees. Product information. Self-employed people. for example contract waste collection personnel who enter the workplace.2 Legislation 2 Legislation This section aims to provide practical advice to employers and employees about the legal requirements that must be met when using and handling cytotoxic drugs and related wastes. there is a legal obligation to provide a healthy and safe workplace. However. employees. respectively. 2. instruction and training >> monitoring of the workplace and the health of employees. including therapeutic goods that are brought into the workplace for personal use. page 10 Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 . Work involving the handling and transport of cytotoxic drugs falls within the scope of the OHSW Regs and Dangerous Substances (Dangerous Goods Transport) Regulations. adequate information about the plant or substance to the persons to whom it is supplied to ensure its safe use. Safety and Welfare Act 1986 (OHSW Act). manufacturers. 2. including a cytotoxic drug. exemption does not apply when the substances are used for a work‑related activity. But. 2. specifically Part 5 which covers hazardous substances and the Australian Code for the Transport of Dangerous Goods by Road and Rail. the employer must still comply with OHSW Regs Part 1 Division 3 with respect to that substance. or arrange for the provision of. even when a substance is not classified as a hazardous substance (see below). is not classified as a hazardous substance by the manufacturer or importer. equipment and substances also have an obligation to ensure workplace health and safety. manufactures or supplies any plant or substance for use by people at work must provide. Safety and Welfare Regulations 2010 (OHSW Regs) make specific provisions for hazardous substances. A person who designs. information must be provided in accordance with OHSW Reg 22 to ensure it is safe and without risks to health when properly used. A limited number of substances are exempt from the OHSW Regs. Safety and Welfare Act 1986 In South Australia.

2. Refer to Section 8 – Transport and Section 17 – Waste Management for additional information. or to other facilities or services. it must either: >> be listed in the Hazardous Substance Information System (HSIS) published by Safe Work Australia >> meet the criteria set out in National Occupational Health and Safety Commission’s (NOHSC) publication. 2. Approved criteria for classifying hazardous substances.4  Hazardous substances OHSW Regs Part 5 Division 1 aims to protect people against risks to their health and safety when hazardous substances are used at work. Most cytotoxic drugs will be classifiable as hazardous substances in accordance with the Approved criteria for classifying hazardous substances. Suppliers (excluding retailers) are required to provide employers with a copy of the manufacturer’s or importer’s safety data sheets >> ensure that containers of hazardous substances are labelled with safety information. When hospital departments supply cytotoxic drugs to other hospitals. including training drills. When cytotoxic drugs are classified as hazardous substances.5  Duties of manufacturers. The SafeWork SA Approved code of practice for the control of workplace hazardous substances provides practical guidance on complying with the OHSW Regs. Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 page 11 . particularly bulk transport.2 Legislation In other words: >> any hazards associated with the cytotoxic drug must be identified >> any risks must be assessed in consultation with employees >> risks must be eliminated or controlled in consultation with employees >> training. importers and suppliers of hazardous substances In addition to the general duties of the OHSW Act. They are required to: >> determine whether a substance is a hazardous substance >> prepare and provide specific information in the form of safety data sheets and labels to employers who use their substances. the OHSW Regs require manufacturers and importers who supply hazardous substances to workplaces to provide certain information about their product. any waste they generate is also likely to be classified as a hazardous substance and the OHSW Regs apply. they are considered to be suppliers. The SA Environmental Protection Authority (EPA) regulates the transport of cytotoxic waste. must be provided >> information and supervision must be provided >> first aid and emergency procedures must be developed. For a substance used at a workplace to be classified as hazardous.

Cytotoxic drugs that are classified as dangerous goods and are being transported must comply with the Australian Dangerous Goods Code and Dangerous Substances (Dangerous Goods Transport) Regulations requirements for road transport and the International Air Transport Association’s (IATA) Dangerous Goods Regulations for air transport.2 Legislation 2. Importers must ensure that the manufacturer’s responsibilities are met. The safety data sheet is a recognised source of information in the workplace and underpins the risk assessment to control exposure to hazardous and dangerous substances. Safe Work Australia or the Code of practice for the control of workplace hazardous substances 2006. 2. the South Australian Environmental Protection Authority is responsible for regulating the transport of hazardous waste in SA. 2nd edition (NOHSC: 2011 (2003)). If a supplier fails to provide adequate information to develop a safe work method. For more specific guidance and advice on safety data sheets. Manufacturers are required to classify chemicals and prepare safety data sheets. instruction and training. assess the risk to health. other sources of information should be used to assist in the development of safe work procedures. Employers must ensure that safety data sheets and other sources of information are accessible to workers who may be exposed to the substances. Suppliers are required to provide safety data sheets for those chemicals classified as hazardous substances if they supply to workplaces. in consultation with employees. refer to the National code of practice for the preparation of material safety data sheets. and control hazards to health associated with their use. 2. However. In summary.7  Summary of duties of employers who use hazardous substances Employers.8  Transport of cytotoxic drugs as dangerous goods SafeWork SA is the authority responsible for dangerous substances and transport of dangerous goods in South Australia.6  Safety data sheets (also known as material safety data sheets – MSDS) The safety data sheet is a document that describes the chemical and physical properties of a substance and provides precautionary advice on safe handling and use. page 12 Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 . the OHSW Regs require employers to: >> obtain a copy of the manufacturer’s or importer’s safety data sheet and ensure that it is accessible to workers >> ensure all containers of hazardous substances are labelled according to legislation >> set-up a hazardous substances register (see Appendix 4) >> in consultation with employees: –– assess employees’ risk to health from exposure to hazardous substances –– eliminate or control the risk associated with the use of hazardous substances –– provide employees with information. must use information provided by manufacturers. importers or suppliers to identify the hazardous substances used in the workplace. Legal obligations in relation to safety data sheets are specified in the OHSW Regs.

Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 page 13 . washing machines. self-employed persons. Employers must identify the hazardous substances used in the workplace. administration equipment. Employers. needles and syringes.9  Plant and equipment Part 3 of the OHSW Regs outlines specific obligations with respect to plant. drug delivery services.10  Other legislation. other laundry equipment. suppliers and installers of plant have obligations under Part 3 Division 2. plant may include cytotoxic drug safety cabinets. With respect to cytotoxic drugs and related waste. manufacturers. Obligations include: >> installing. designers. as well as the general obligation to ensure workplace health and safety. trolleys for carrying cytotoxic drugs.2 Legislation 2. Plant includes any machinery. equipment or appliance. policies and measures Other legislation and standards covering the handling and storage of cytotoxic drugs and related waste that need to be considered when implementing safe work systems include: >> South Australian Controlled Substances Act 1984 >> South Australian Controlled Substances (Poisons) Regulations 1996 >> South Australian Environmental Protection Act 1993 >> South Australian Environment Protection Regulations 2009 >> South Australian Environmental Protection (Waste to Resources) Policy 2010 >> The National Environment Protection (Movement of Controlled Waste between States and Territories) Measures 2010. assess the risk to health and control hazards to health associated with their use. 2. erecting and commissioning plant >> using plant >> maintaining and repairing plant >> keeping records >> providing information.

page 14 Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 . during implementation. The risk management approach is integral to the South Australian OHSW legislation and is essential for every day sound management practice. Employers need to ensure that communication and consultation with external and internal key stakeholders takes place during all stages of the risk management process.3  Managing the Risk 3  Managing the Risk This section outlines the risk management processes based on the hazard identification and risk management approach as outlined in the OHSW legislation. monitoring and review >> assess policies and procedures on a regular basis. and good corporate and clinical governance (Figure 1). It should be noted that this approach is inclusive of the AS/NZS ISO 31000:2009 Risk Management – Principles and Guidelines. Cytotoxic drugs are known to be highly toxic. employers and staff who handle them occupationally have an obligation to: >> work to a risk management plan >> keep up-to-date with current practices and standards >> consult with employees at key stages of risk strategy development – at the planning stage. For this reason.

The process is outlined in OHSW Regs Part 1 Division 3. Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 page 15 .3  Managing the Risk Figure 1: The risk management approach OHS Comittee Employer Consultation Health & Safety Representative Hazard Identification Risk Assessment Risk Control Elimination/substitution Isolation Engineering Administrative Personal Protective Equipment System Monitoring and Review Trial and Implement Controls Evaluation of Controls The aim of a risk management approach is to eliminate or minimise the risk of illness or injury associated with work.

including risk assessments and control measures >> changes to premises. This enables employees to contribute to making decisions that affect their health. safety and welfare at work. 3. including safety data sheets (if available) >> records of incidents. Therefore.1  Consultation and communication The OHSW Act places a duty of consultation on the employer to consult with employees. it is a process of: >> consultation and communication >> hazard identification >> risk assessment >> risk control >> evaluation of control measures >> continuous improvement Effective management of health and safety involves: >> training >> documentation of activities >> regular review of the management system. work environment. Employers need to ensure that communication and consultation with external and internal key stakeholders takes place during all stages of the risk management process. plant. systems of work or substances used for work. work environment. including safety data sheets. treat and monitor the risk. systems of work or substances used for work. plant. systematic approach to health and safety and applying risk management principles will help identify when to consult. plans for communication and consultation need to be developed from an early stage and should address issues related to the risk and the measures to control. illnesses or injuries (in a way that protects the confidentiality of personal information). page 16 Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 . the duty to consult still applies (as per the OHSW Act).3  Managing the Risk Generally. Adopting a planned. Accurate and relevant safety information made available to employees and their health and safety representative(s) should include: >> work processes and procedures >> risks associated with exposure to cytotoxic drugs >> OHSW policies and procedures. Consultation must occur: >> when identifying cytotoxic drugs and associated hazards >> during the risk assessment process >> when determining which control strategies should be applied to eliminate or minimise risks associated with the handling of cytotoxic drugs >> when reviewing the effectiveness of control measures >> prior to changing premises. Although volunteers are not employees.

3  Managing the Risk 3. the routes of exposure and the specific activities where there is a risk of exposure.3  Risk assessment The purpose for the assessment is to enable decisions to be made about the appropriate control measures.2  Hazard identification Hazard identification should establish who may be at risk. monitoring and health surveillance as may be required by legislation. The risk assessment may be done for a work process and may cover more than one cytotoxic drug. Decisions about appropriate action to protect employees will depend on the degree of health risk that arises from the use of cytotoxic drugs and related wastes in particular environments. Ways of achieving this include: >> contact the supplier >> if a safety data sheet is not available. Control measures currently in use and their effectiveness should be identified and recorded. Ways of achieving this include: >> check all containers for labels. the cytotoxic drugs being used. The following step-by-step procedure may be used to assist with the risk assessment process. Set up and maintain a cytotoxic drugs register. Identify which cytotoxic drugs are used and stored at the workplace Obtain a copy of the manufacturer’s or importer’s safety data sheet (or MSDS) for all cytotoxic drugs (where available). The safety data sheet will state whether the product is classified as hazardous >> work place inspection >> indicate which products are classified as hazardous. induction and training. Risk assessment can be separated into two parts. Additional useful information may be added to the register in Appendix 4 – Cytotoxic Drugs Register Ensure all containers of cytotoxic drugs are labelled with the manufacturer’s or importer’s label. The table below provides examples of how you can ascertain if the cytotoxic drugs that are used in your workplace pose a risk to staff health and safety. The risk is the likelihood that harm will be caused in the actual circumstances of use of the substance. it has the potential to be harmful to health. Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 page 17 . If a substance is hazardous. assessing the hazard and evaluating the risk. Ways of achieving this include: >> list the product names of all cytotoxic drugs used at the workplace >> check the safety data sheet and the product label to identify cytotoxic drugs that are classified as hazardous substances. The assessment process enables a distinction to be made between ‘hazard’ and ‘risk’. safety information about the relevant cytotoxic drug should be obtained from the manufacturer or importer. 3.

particulates and droplets >> skin or eye contact through splash of liquid >> ingestion through poor personal hygiene or splash of liquid >> injection resulting from injuries from sharps. Ascertain the potential harmful effects. page 18 Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 . hair loss. This may include: >> carcinogenic. ointments and lotions for topical application. mutagenic or teratogenic potential >> alterations to normal blood cell count >> foetal loss in pregnant women and malformations in the offspring of pregnant women >> abdominal pain. Determine the form of the substance. vomiting >> liver damage >> contact dermatitis. Determine the routes of exposure. This may include: >> health hazard information >> precautions for use >> safe handling information. irritation to the skin. nasal sores. local toxic or allergic reaction. This may include: >> flammable >> toxic >> carcinogen >> corrosive >> oxidising agent. Determine the chemical properties of the substance.3  Managing the Risk Obtain and review information about cytotoxic drugs used Consult the safety data sheet (or other available information for each drug) for details of the properties and hazards associated with the substance. This may include: >> inhalation of aerosols. This may include: >> liquid >> powder >> solid tablet >> creams.

3  Managing the Risk Identify the nature of the work involving cytotoxic drugs Divide up the workplace and determine where cytotoxic drugs are used. For example: >> drug preparation in the pharmacy >> drug administration in the ward or day care centre >> handling. Review information relating to incidents or symptoms of exposure. Examine the work practices and conditions. Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 page 19 . What to do: >> review incident records >> identify any problems associated with storage and transport of cytotoxic drugs >> determine whether employees have suffered any adverse effects >> ascertain whether there have been any spills >> determine if incidents have been reported and followed up.) What to look for: >> how the substance(s) is used in various jobs >> the quantities used >> level of potential exposure >> frequency and duration of use >> the number of employees that may be exposed >> risk control measures already in place and their effectiveness. transport and disposal of cytotoxic waste on the premises >> patient care after administration. (Involve employees who are working with the cytotoxic drugs.

according to the drug used >> eliminate or reduce exposure so far as is practicable. Likelihood of injury or illness is uncertain. This means that employers are not sure whether work practices are adequate to protect employees. such as a properly operational cleanroom with a laminarflow cytotoxic drug safety cabinet >> needleless drug administration systems or retractable needles are used. page 20 Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 . It may be reasonable to make such a conclusion where: >> risks have been eliminated/reduced so far as is practicable >> work methods employ best practice control >> drug packaging features in-built breakage prevention systems >> cytotoxic drugs are handled in an enclosed area. A sample Risk Assessment Tool is located in Appendix 5. It may be reasonable to make such a conclusion where: >> work methods do not employ best practice control >> drug preparation is not conducted within a properly operational cleanroom with a laminar-flow cytotoxic drug safety cabinet >> drug administration does not employ needleless systems >> housekeeping is poor >> some activities involve skin contact >> personal protective equipment such as gloves and skin covering are not worn >> the workforce has not received appropriate training >> control measures are not maintained or serviced >> no spill management system exists. for example: >> conduct wipe tests and atmospheric monitoring (if valid and interpretable tests are available) to determine whether there is any contamination. Likelihood of injury or illness.3  Managing the Risk Evaluate the risks No likelihood of injury or illness. The OHSW Regs requires employers to demonstrate evidence of the risk assessment process. This means that employers have a high degree of confidence that work practices are sound and that employees are protected. These tests must be individualised to each workplace. It may be reasonable to make such a conclusion where employers are not sure if there is a risk to health and may require employers to do more work. This means it is apparent that work practices need improvement.

This is the most effective way of protecting the health of employees. This is a strategy that details a logical series of activities involving consultation.4  Risk control The OHSW Regs set out a hierarchy of control/treatments (or ranking of controls) that incorporates a best practice approach to managing risks. Employers need to ensure that all control measures are properly used and maintained. It is important to remember that a number of risk controls will need to be used in combination to effectively eliminate or reduce the risk. The table below gives an indication of the issues that should be covered. rather than placing the onus on employees to work safely in a hazardous environment. A basic structure for a risk control plan A risk control plan should: >> provide a history of health and safety activities for work involving cytotoxic drugs. The workplace needs to be made safer. Employers must first consider whether the risk can be eliminated. Where elimination of risk is not practicable. interim and long-term control measures >> set priorities for putting controls in place >> indicate when controls are to be implemented >> specify those responsible for overseeing the implementation >> record the date of completion and ’sign off‘ by a person nominated by management >> include or refer to relevant policies and procedures for work involving cytotoxic drugs >> outline plans for the provision of training >> involve employees. so far as is reasonably practicable. Develop a risk control plan One way of tracking proposed and implemented controls and treatments is to prepare a risk control plan.3  Managing the Risk 3. implementation and review. These controls are in order of greatest effectiveness to least effective as follows: >> elimination >> substitution >> isolation >> engineering control >> administrative controls >> personal protective equipment (PPE). as these measures depend heavily on human behaviour to be effective. The employer’s primary duty is to eliminate any risk to health arising from the use of hazardous substances. Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 page 21 . including any current control measures and their effectiveness >> specify immediate. They must not rely exclusively or primarily on administrative controls or personal protective equipment to control the risk. For strategies reflecting the hierarchy of controls refer to Attachment C of the Risk Assessment Tool in Appendix 5. through consultation >> provide full documentation of activities >> include a process for the regular review of management systems. It also provides a useful tool to effectively manage this process. The hierachy of controls should always be implemented from the most effective to the least effective. employers must reduce the risk. Risk control plan A risk control plan sets out the actions required to implement controls over time.

page 22 Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 . supervision and worker responsibilities may need to be clearly defined in the work procedures >> communication to inform workers and others about the control measures to be implemented. they must be put into effect in the workplace.3  Managing the Risk 3.5  Trial and implementation Once appropriate control measures have been selected. Management. It is important to clearly communicate the reasons for the changes >> provision of training and instruction for workers. to make sure they are effective. supervisors and others in relation to the new control measures >> provision of adequate supervision to verify that the new control measures are being used correctly >> maintenance of control measures to ensure their ongoing effectiveness. Implementation involves: >> development of work procedures and writing standard operating procedures (SOPs) in relation to the new control measures.

resulting from the failure of the control measures –– symptoms reported that may relate to the substance used –– a change in the product used (including its form) –– introduction of a new work process or changes to an existing process –– increase in the hours worked or frequency and duration of exposure –– increase in the quantities used –– availability of new information about the health hazards of substances >> ensure that management. such as: –– an incident.2 Risk Assessment). Ways of achieving this include: >> keep copies of the assessment in accessible/commonly used files. or near miss. but not limited to: >> updating SOPs >> (re)training.6  Monitor and review Control measures should be regularly monitored. Update control measures. What to include: >> name of the assessor >> date of the assessment >> the workplace/unit >> the substance for which safety data sheet (or equivalent information) has been reviewed >> the controls in place to prevent a risk to health >> a summary of the process >> hazard information on the substance(s) >> the degree of exposure. Record the documented review process. Make the results of the analysis accessible to any employee to which the record relates. supervisors. including the outcome. health and safety representatives and purchasing officers feed back the outcome of the review into the assessment process >> record the date of the review or revision of the assessment. by when and by whom. reviewed and. Ways of achieving this include: >> schedule regular reviews/audits to ensure that the assessment is valid and still applies >> establish the circumstances that would trigger a review or revision. and any action required to be taken. Ways of achieving this include. improved. or nature of risk identified >> why decisions about the risk were made >> any information that assisted in reaching a conclusion. The following table outlines the strategies to facilitate a robust monitoring and review process: Review and revise the risk analysis Review and revise the risk assessment (see Section 3.3  Managing the Risk 3. Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 page 23 . This will help measure the effectiveness of risk controls and may reveal areas for improvement. extended or replaced. The risk assessment should be reviewed and revised as necessary and preferably every 2 years or at least every 5 years. where necessary.

4. The program must include counselling of employees on the potential risks to health and reproductive risks. Several cytotoxic drugs are known to cause bladder damage and blood in the urine of treated patients leading some international standards to recommend monitoring the urine of workers who handle hazardous drugs with a urine dipstick or a microscopic examination of the urine for blood. rapid.4  Staff Health 4  Staff Health An essential part of the risk management strategy is dealing with the issues of staff health surveillance. Health surveillance includes health and biological monitoring but does not include atmospheric monitoring. Exposure standards for acceptable levels of exposure to cytotoxic drugs have not been developed for pharmaceutical products. Importantly. Many methods have been used to investigate potential health effects of exposure to cytotoxic drugs. The robustness of this testing is unclear. for example pharmacy production/manufacturing staff. quantitative. the procedures for taking a sample should be non-invasive and should not cause unnecessary duress or anxiety to the individual. These methods have given results that are often inconclusive and difficult to interpret. The OHSW Regs require employers to provide health surveillance of employees when the risk assessment identifies substances in the workplace that are hazardous to health. information must be obtained about methods that can detect the early signs of health effects or disease. and aims to provide practical advice to employers in the matters of staff health. In particular. The ideal test should meet several requirements – it should be sensitive. how exposures might occur and control measures in place. The benefits of health surveillance for occupational exposure to cytotoxic drugs and related wastes have not been adequately addressed in the current literature. however health surveillance should be considered in conjunction with environmental monitoring where hazards or incidents have been highlighted in areas where cytotoxic drug preparation and administration is undertaken. National and statewide agreed standard operating procedures with sufficient initial and regular ongoing training in safe handling/administration is paramount to reducing potential for exposure and risk. reproducible and inexpensive. Health monitoring This includes the implementation of a health program which monitors an individual’s health status pre-employment/ pre-placement and on an ongoing basis to determine any adverse affects to health following exposure to cytotoxic drugs. therefore adoption of standard precautions and the principles of ALARA (as low as reasonably achievable) is recommended. Biological monitoring Biological monitoring is the measurement and evaluation of a substance or its metabolites in the body tissue fluids or exhaled air of exposed persons.1  Health surveillance Health surveillance is the monitoring of persons to identify changes (if any) in their health status due to the potential for occupational exposure to a hazardous substance. This section provides a risk management framework to assist in the development of local policies and procedures. Employers have a responsibility to ensure that they remain aware of and apply current developments for monitoring the health of employees involved in the handling of cytotoxic drugs. specific. reporting and record keeping. It is recommended that full blood and lipids are tested at baseline for staff who are assessed to be ‘high risk’ following a risk assessment based on duties performed. page 24 Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 . counselling. The need for biological monitoring to detect exposure to a scheduled carcinogenic substance or tests to detect health effects caused by exposure should be carefully considered when the risk assessment is carried out.

Appointment means that the employer has a formal arrangement with a medical practitioner.4  Staff Health Unfortunately. >> The employer must ensure that the appointed medical practitioner is: –– provided with access to the workplace and information required –– involved in discussions relating to risk exposure to staff including mitigation strategies. What type of health surveillance should be implemented? Any health surveillance program must first and foremost meet the needs of the employees and includes: >> providing security of personal information >> supported care (such as the Employee Assistance Program) >> selecting an authorised medical practitioner in consultation with the employees >> elimination of sex bias >> privacy >> continuation throughout the period of use cytotoxic drugs. Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 page 25 . >> Reporting must comply with all privacy requirements and government policy. oncologist. The need for ongoing monitoring should be determined at scheduled termination health monitoring assessments. General guidance is provided in accordance with NOHSC Competencies for health surveillance 1998 and Guidelines for health surveillance 1995. >> Implementation of the program will involve both relevant staff and health site OHSW representatives. 2 3 4 The health monitoring program is an integrated part of the hazard /risk management program. Guidance is provided to the appointed medical practitioner. Considerations >> The medical practitioner may be an occupational physician. >> Records that are not related to occupational health and safety screening should not be used in relation to records relating to health monitoring. As a consequence. haematologist or local general practitioner. Outcome Staff and the organisation are in agreement on the facilitation of health monitoring. there is currently no test that meets all these requirements – nor is there one test that can be used to detect the presence of all cytotoxic drugs. there is conflicting information and opinion about the value of routine biological tests in monitoring the health of employees handling cytotoxic drugs and related waste. Additional factors to consider in the development and implementation of a health surveillance program are summarised below. Factors in implementing a health monitoring program 1 A medical practitioner is appointed to oversee the program. >> All staff are provided with information and training in relation to the monitoring program. In regard to the issue of privacy in relation to medical practitioners providing reports to employers. >> Employers will undertake regular monitoring of their employees’ health. Guidelines and competencies are followed and made available to all relevant staff. All employees must be made aware of this arrangement (ideally this practitioner would be accessible to staff on site). >> Staff will receive a copy of the health monitoring assessment findings including the timing of the next recommended health monitoring review. >> The medical practitioner should be suitably qualified to provide health surveillance in accordance with NOHSC Competencies for health surveillance (1998).

>> Health monitoring reviews are documented and counter signed by the staff member. 6 Pre-employment/preplacement health monitoring to establish baseline health is conducted by the approved medical practitioner before an employee commences work with cytotoxic drugs. All prospective employees are required to acknowledge this aspect of the role at application.4  Staff Health Factors in implementing a health monitoring program 5 Prospective employees are counselled and provided information about the risks of working with cytotoxic drugs. if appropriate >> health advice and counselling >> a report to the employer and prospective employee. Prospective employees should undertake baseline health monitoring with approved medical practitioner(s) within 2 weeks of employment. Outcome >> Staff orientation handbooks should include orientation to cytotoxic substances. The employee is provided with a copy of any reports with respect to the baseline health assessment and is also to be afforded the opportunity to discuss any adverse outcomes in a timely manner. Baseline health monitoring includes: >> collection of demographic data >> occupational history >> medical history >> physical examination >> investigation. Prior to appointment. Considerations The counselling must include: >> the nature of work to be undertaken >> potential risks to health >> reproductive risks >> how exposure may occur >> the control measures in place. control measures in place and health monitoring programs. Exposure to cytotoxic drugs should form part of the relevant staff position statements. page 26 Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 . prospective staff must agree to and be counselled on the approved health monitoring protocol.

and >> is provided with a copy of the health record within agreed time frames. 8 Any relevant employee may access advice and counselling from any approved medical officer(s) at any time outside of scheduled health monitoring rota. Access to an employee’s medical records can be obtained only with the written consent of the employee. and continuity of service.g. or are unable to. All entitlements must be maintained. Data collection should include details of: >> health advice and counselling >> health issues identified >> medical review after a spill or sharps injury >> review of control measures – e. No employee will be compelled to work with cytotoxic drugs if special health considerations apply (see Section 4. Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 page 27 . Considerations Health monitoring is conducted: >> during the period the employee works with cytotoxic drugs >> as advised following cessation of employment or work with cytotoxic drugs. Information to relevant employees on how to contact approved medical officers is available at all times. 10 An employee’s medical records are confidential. confidentiality of an employee’s medical records must be ensured. Employees will be given access to contact details of approved medical officer(s) and released from duties to attend a consultation.4  Staff Health Factors in implementing a health monitoring program 7 Health monitoring is conducted during the period that the employee works with cytotoxic drugs. needleless injection sets should be in place to eliminate the potential for sharps injuries >> the name of carcinogenic substance(s) involved >> the period of exposure or potential exposure. The employee shall be provided with a copy of all health monitoring reports. A clear process to opt out of work involving cytotoxic drugs should be made available to new and existing staff through establishment of identified communication processes. The employee shall be advised as to the advisability of having periodic health assessments following cessation of employment or work with cytotoxic drugs and details of the types of investigations/ testing that are relevant. >> be provided with copies of any exposure incident reports >> recommendations as to the advisability The results of health monitoring shall be made available within clearly defined time frame with consideration given to delays involving further investigations Outcome Employee attends health monitoring assessment: >> signs off the record. Review of an employee’s health monitoring record may only occur during scheduled health monitoring or to support health care of the employee. 9 Skill matched and appropriate alternative duties should be provided to employees who choose not to.2). Employee health records will be secured separate to their employee human resource records and/or hospital medical records. On termination of placement/ employment the employee must sign the report of the final assessment to acknowledge that they understand the contents of the report and any implications to their health discovered during the scheduled final health monitoring assessment. Where any form of health monitoring is undertaken. Employees will not suffer disadvantage in relation to loss of pay and conditions. work with cytotoxic drugs.

In such cases. Obtain informed consent from employees to do tests. Considerations No one test can be used to detect the presence of all cytotoxic drugs. 4. Employees required to perform duties associated with the preparation or administration of cytotoxic drugs or related waste may elect to not do so in the cases listed in the table below.g.2  Special health considerations All personnel involved in any aspect of the handling of cytotoxic drugs should be informed about the risks of occupational exposure to hazardous drugs. appropriate and suitable alternative duties must be provided. systems of work or substances used for work.4  Staff Health Factors in implementing a health monitoring program 11 Biological monitoring issues. the following requirements should be considered: >> specificity >> sensitivity >> availability >> rapidity >> reproducibility >> cost. Employers to consult with employees including those of non-English speaking backgrounds about consultative arrangements. work environment. pregnant women and immunocompromised individuals. page 28 Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 . Accurate and relevant safety information must be made available to employees and others. when an employee’s circumstances change – e. Outcome 12 Consultation. including safety data sheets >> where appropriate. plant. Consult with employees on appropriate biological monitoring to be carried out. When choosing tests. Consultation should occur: >> when identifying cytotoxic drugs and associated hazards >> during the risk assessment process >> when determining which control strategies should be applied to eliminate or minimise risks associated with the handling of cytotoxic drugs >> when reviewing the effectiveness of control measures >> prior to changing premises.

sufficient breaks must be provided to maintain concentration. 4. In addition. 4.5  Emergency procedures Planning for emergencies is an essential part of risk management. Systems should therefore be in place to manage sharps injuries and personal contamination. or are pregnant or breast feeding and are involved in the preparation or administration of cytotoxic drugs and the handling of cytotoxic contaminated wastes should be informed of the reproductive risks and possible effects on foetal development. As staff often work in isolation. including any training on hazardous substances (these should be kept within the health monitoring record. Staff allocation must be sufficient to allow for adequate breaks for those working in the cytotoxic cleanroom. >> Model Procedure 7 – Accidental Exposure to Cytotoxic Drugs and Related Wastes. It is recommended that no more than two hours be spent working at the cabinet or isolator without a break. Staff with abnormal pathology results should not prepare cytotoxic drugs until the abnormality has been investigated. drinking. and follow-up action taken if required (see Model Procedure 7 – Accidental Exposure to Cytotoxic Drugs and Related Wastes). cutaneous infections etc.3 Hygiene Strict hygiene procedures must be developed and followed when handling cytotoxic drugs. even if a record is also kept with the employees’ human resource training record) >> individual employee records – medical records are to be kept confidential >> details about drug preparation equipment. 4. The following considerations should also be taken into account in cytotoxic drug preparation areas when setting staff levels: >> the workload during the busiest period >> the complexity of products manufactured. sharps injuries and contamination. Staff with infectious diseases such as upper respiratory. Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 page 29 . 4.4  Staff Health Consideration Planning parenthood (male and female). chewing gum and the application of cosmetics must be strictly prohibited. Eating.4  Work flow A sufficient number of qualified staff members must be available to provide for the expected workload. personnel in the preparation facility should not wear jewellery. such as cytotoxic drug safety cabinets >> details about spills. The employee should keep copies of their records. pregnancy and lactation Illness Abnormal pathology results Issue Employees who are planning parenthood.7  Model procedures The following model procedures are associated with this section: >> Model Procedure 1 – Health Surveillance for Staff Handling Cytotoxic Drugs and Related Wastes. Any incident should be reported so that the cause can be investigated and determined. along with the current safety data sheet for each substance listed >> risk assessment reports >> health monitoring records (this record must be kept for at least 30 years) >> training records. 4.6  Reporting and keeping records The employer must keep the following records: >> a register of all hazardous substances (including cytotoxic drugs) that are used in the workplace.

or procedures change >> on an ongoing basis with two yearly review. page 30 Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 .1  Who should be trained? The risk assessment results should be used to identify staff and carers who require specific training. depending on the level of contact to cytotoxic drugs and related waste. handle cytotoxic drugs and related waste. Staff that could be potentially affected are listed in the following table. This section provides a risk management framework to assist in the development of local policies and procedures. Different levels of training are recommended. and aims to provide practical advice on the development of training programs and associated record keeping. training and supervision to staff and other individuals who handle cytotoxic drugs and related waste. A strategy of continuous education should be developed and implemented to keep staff up-to-date with policies and procedures for handling cytotoxic drugs and related waste. 5. Employers should ensure that only employees who have received appropriate training. and have attained the required level of proficiency. High risk >> pharmacy personnel >> nursing and medical personnel >> laboratory staff >> animal handlers (research) Low risk >> supervisors and managers >> maintenance personnel >> stores personnel >> cleaners >> on-site waste transporters >> couriers and porters >> waste handlers >> carers >> ambulance officers >> patient transport personnel Advice on the safe handling of cytotoxic drugs should also be provided to volunteers and contractors who are not staff. instruction. Training should be undertaken: >> at induction >> prior to commencement of duties where cytotoxic drugs or related waste are involved >> when new equipment or substances are introduced.5 Training 5 Training Employers have a duty to provide information.

clinical or technical specialists. the following South Australian training manuals are available: >> Pharmacy –– SA Health Central Training Manual – Clinical Pharmacy Services – Cancer and Chemotherapy –– SA Health Central Training Manual – Production Pharmacy Services – Cytotoxic and Other Hazardous Drugs >> Nursing –– SA Health Statewide Framework for Chemotherapy Education and Assessment. An Integrated Model for South Australia. transport.2  Identify training requirements The training needed should reflect the level of risk of exposure as well as the anticipated exposure. use. Training should be provided by appropriate academic. Additional training resources include: >> The Australian National Cancer Nursing Education Project. Patient training Patients. This requirement will vary depending on the specific training required. cleaning and disposal of personal protective equipment >> procedures to be adopted in the event of accident. General guidance on the possible training and information content is provided in Section 11 – Caring for Patients at Home. including reporting and recording >> access to first aid resources >> storage. Training provided should be tailored to the needs of the individual after consideration of the: >> job description >> previous level of education >> specific responsibilities relating to cytotoxic drugs. Position Statement on the Minimum Education Requirements for Nurses involved in the Administration of Anti-Cancer Drugs within the Oncology and Non-Oncology Setting 2010. family and carers must be provided with education and information relevant to the environment in which the patient is being treated. treatment and disposal of cytotoxic waste >> health surveillance and reporting >> any written safe work procedures. Training Competencies: Handling Cytotoxic Drugs in Health Care Establishments 1997 >> National Occupational Health and Safety Commission.5 Training 5. For health care professionals working in the field of cancer therapy. EdCaN On-line >> Cancer Australia. injury or spill. Consideration should be given to the use of training competencies that exist for cytotoxic drugs or other health industry association training courses. Cancer Learning On-line >> WorkCover Victoria. Competencies for Health Surveillance 1998 >> Cancer Nurses Society of Australia. Training and information in relation to cytotoxic drugs and related waste should cover: >> occupational hazards of exposure to cytotoxic drugs and waste >> legislative requirements for health and safety >> legislative requirements for waste management >> the risk management process >> control measures and work practices to be adopted when handling cytotoxic drugs and related waste >> maintenance of equipment >> correct selection. Any written training competencies on cytotoxic drugs that are available for specialist professions should be reviewed regularly. Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 page 31 .

page 32 Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 . Monitoring performance will determine if further training is required >> ensure the modules and topics required in the training are applicable to the work being carried out – this should be done either: –– each time there is a change of equipment. Training records should include: >> date of the session >> topics dealt with at the session >> name of the person who conducted the session >> names of the employees (and their signatures) who attended the session >> course evaluations >> competencies assessed. 5. The training needed should reflect the level of risk of exposure as well as the anticipated exposure. work practice or control measure –– at least every two years. Following all incidents and accidents.4  Training records Employers must keep records of employees’ training for at least five years after the date the record was created. 5. Oncology and haematology specialists should review any written competencies regularly. substance. by monitoring how work is being performed to determine whether control measures are used correctly >> regularly (at least every two years) monitor employees’ performance to ensure continued competency.3  Evaluate the training program Training programs should be evaluated to: >> assess the effectiveness of the training.5 Training 5. the training program should be reviewed to ensure its adequacy.5  Model procedures The following model procedure is associated with this section: >> Model Procedure 2 – Staff Training for the Safe Handling of Cytotoxic Drugs and Related Wastes.

Exposure may occur through: >> skin. consideration should be given to: >> workplace design. The risk of exposure may be reduced by ensuring that cytotoxic drugs are prepared by trained pharmacists or technicians in approved facilities. utilising the hierarchy of control measures. contamination of personnel and the work environment has been shown to be reduced. Figure 2 summarises the decision making process when applying the hierarchy of control measures to the preparation of cytotoxic drugs.6  Preparation and Dispensing 6  Preparation and Dispensing This section provides a risk management framework to assist in the development of local policies and procedures. To facilitate the safe preparation of cytotoxic drugs. Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 page 33 . This section should be read in conjunction with the following sections: >> Section 5 – Training >> Section 7 – Labelling >> Section 8 – Transport >> Section 12 – Cleaning >> Section 13 – Personal Protective Equipment >> Section 14 – Laundry >> Section 15 – Spills >> Section 16 – Waste Management Cytotoxic drug preparation poses the greatest risk of occupational exposure to personnel. implemented and maintained. Education and training is crucial in ensuring that control measures and safe work practices are developed. understood. equipment and training as specified in this guide should not undertake to provide a cytotoxic drug preparation service. eye or mucous membrane contact with cytotoxic material >> spills >> inhalation of aerosols and powders >> sharps injuries. Applying the hierarchy of control measures outlined in Section 3 – Managing the Risk to the preparation of cytotoxic drugs is essential. Health services that are unable to provide the facilities. With adequate precautions. set-up and maintenance according to Australian Standards >> use of cleanrooms >> cytotoxic drug safety cabinets >> other specialised equipment. and aims to provide practical advice on how to prevent or reduce the risks associated with the preparation and dispensing of cytotoxic drugs.

Level 1 Control Elimination. Substitution or Replacement Has there been a risk assessment? Yes Yes Implement control Yes Perform task Do not perform task No No Can this measure be applied? Is the risk mitigated or controlled? No Level 2 Control Isolation at the Source of the Hazard/Source Containment Can a closed system transfer device be used? Yes Implement control No Can another device be used? No No Is the risk mitigated or controlled? Yes Perform task Yes Implement control Is the risk mitigated or controlled? No Can this measure be applied? No Yes Perform task Yes Implement control Is the risk mitigated or controlled? No Yes Perform task Level 4 Control Administrative Controls/ Organisation Measure Can this measure be applied? No Yes Implement control Is the risk mitigated or controlled? Yes Perform task 6  Preparation and Dispensing No Can this measure be applied? Level 5 Control Personal Protective Equipment Yes Implement control Is the risk mitigated or controlled? Yes Perform task No No page 34 Do not perform task Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 Figure 2: Decision making process for the safe handling of cytotoxic drugs Level 5 Control Engineering Controls/ Ventilation .

Studies over the past 10 years have concluded that closed system drug transfer devices can reduce occupational contamination and exposure to cytotoxic drugs in the hospital work environment. Closed system drug transfer devices The ideal first consideration under this control measure is a closed system device. A closed system drug transfer device prohibits the escape of hazardous drug (regardless of its form. >> When selecting an appropriate closed system drug transfer device. Drug preparation equipment Specific handling techniques and procedures incorporating suitable equipment (designed to reduce the risk of exposure) should be employed. substitution or replacement It is rarely possible to substitute a cytotoxic drug for a less toxic or non toxic drug.1  Elimination. liquid etc) and the transfer of environmental contaminants into the system.6  Preparation and Dispensing 6. the following factors should be taken into consideration: –– does the device cover all steps in the preparation? If not. i. therefore the most practical first level control measure is to identify an alternative supply of cytotoxic drugs. equipment and trained personnel to provide prepared cytotoxic drug doses. source containment should be continuous throughout the entire process of preparation. If possible. vapour. powder.2  Isolation at the source of the hazard/source containment It may be possible to prevent the contamination of staff and the environment by containing the cytotoxic drug at its source. 6. if so. Equipment used for preparing drugs should incorporate closed system drug transfer devices (unless the preparation process does not allow it) and should also minimise the potential for preparing drugs under pressure. then it is important to identify where the closed properties of the device are NOT retained –– does the device retain its closed characteristics when more than one vial is used for a preparation? –– are there any studies available showing that the device fulfils its intended purpose of eliminating or reducing environmental/operator contamination in daily practice and. to what degree? Closed system drug transfer devices should always be used in combination with a cytotoxic drug safety cabinet. Alternative supply arrangements Alternative arrangements could include: >> purchasing and supplying prepared cytotoxic drugs in a single-dose delivery unit from a commercial source – it is not safe for community pharmacies and community workers to reconstitute cytotoxic drugs because adequate risk control measures are not in place >> establishing supply arrangements with a health service that has the required facilities. Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 page 35 .e.

must be clearly marked and identifiable by all staff. to equalise pressures and to prevent the passage of powder aerosols and liquids. but only when the cytotoxic drug has been removed from a glass ampoule or if particulate matter is visible – e.2 mm.g. Damaged packages should be handled with care. 18 G/1. Badly damaged packages should be safely contained and destroyed appropriately. >> All staff involved in the receipt. the quantity of cytotoxic drugs stored in pharmacy departments.6  Preparation and Dispensing Drug preparation equipment continued Other devices The secondary consideration under this control measure. such as intrathecal needles >> syringe-to-syringe connectors when transferring solutions from one syringe to another >> wide-bore needles. clinics and satellite pharmacies should be restricted to those required for short-term use. fitted with a 0. >> In the drug preparation area: –– a worker wearing appropriate PPE (see Section 12) should open damaged packages –– contents should be examined for damage or leakage to determine whether they are safe for repackaging or must be disposed of as cytotoxic contaminated waste –– institutional investigation and reporting should be followed when badly damaged packages are received and subsequent repackaging occurs. leakage from vial stoppers after multiple punctures and aerosol generation resulting from increased pressure inside drug vials have also been observed. Droplets. including refrigeration. risks of exposure and control measures (see Model Procedure 2 – Training). >> A dedicated area should: –– be designed to limit the chance of breakage –– limit the extent of contamination if breakage occurs –– be secured and access limited to authorised staff. The tertiary consideration. Numerous studies have shown that aseptic manipulation using a classic syringe and needle technique almost universally results in contamination. Drug storage >> A dedicated storage area. >> Use of a dedicated area offers quick and efficient containment and management of a spill. wards. >> Generally. Alternative devices which have been employed to protect staff using this classic technique include: >> luer-slip syringes (only if luer-lock connections are incompatible). in the absence of a closed system drug transfer device which covers all steps in preparation. >> A dedicated area should be provided for the unpacking of cytotoxic drugs.2 micron hydrophobic filter. distribution and storage of cytotoxic drugs must receive appropriate instruction and training on the hazards. is the concomitant use of alternative devices with closed system device. to reconstitute and draw-up cytotoxic drugs >> filter needles. if coring of vial rubber has occurred >> air-venting devices. page 36 Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 . is the use of alternative devices. >> Current safety data sheet for each drug should be located in each dedicated storage area. in the absence of any form of closed system device.

it will enter the environment. installation and use of pharmaceutical isolators. Drug preparation facilities Cytotoxic drugs should be prepared in a purpose-designed cleanroom suite that comprises: >> a primary barrier to provide drug containment and aseptic manipulation. The following technical standards are recommended.6  Preparation and Dispensing 6. They describe suitable risk controls for facilities and installation of those facilities: >> AS 1386-1989 Cleanrooms and clean workstations >> PIC/S Guide for Good Manufacturing Practice of Medicinal Products in Healthcare Establishments (PE010-3) 2008. Standards for the provision of drug containment and aseptic manipulation include: >> a separate dedicated cytotoxic drug safety cabinet installed with a carbon filter that complies with AS 2567 – 2002 Laminar flow cytotoxic drug safety cabinets. The ventilation tools discussed here have a number of features. or use of a pharmaceutical isolator that complies with AS 4273-1999 and AS 4273-1999/Amdt1-2000 Guidelines for the design. with the room design directly influenced by which type is used. This should be provided by high efficiency particulate air (HEPA) filters which supply filtered air to the cleanroom and the anteroom. >> Similar to Class II BSCs but have different HEPA filter system. controlled air flow. Horizontal laminar flow hoods must never be used for preparing cytotoxic drugs due to the high risk of exposure to staff. Secondary containment is provided by maintaining the cleanroom at a pressure lower than that of the anteroom. All preparation of cytotoxic drugs should take place in either a cytotoxic drug safety cabinet (CDSC) or a pharmaceutical isolator for drug preparation >> a secondary barrier to prevent cytotoxic drug contamination of the outside environment. Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 page 37 . however none of these features will prevent contamination. Isolator specifications for the preparation of parenteral cytotoxic drugs are as follows: >> located in a room which should have limited access. Cytotoxic drug safety cabinets >> These cabinets are purpose built for the preparation of cytotoxic drugs and must comply with AS 2567 – Laminar Flow Cytotoxic Drug Safety Cabinets – 2002. biohazard cabinets or pharmaceutical isolators should be used for preparing cytotoxic drugs and BCG due to the risk of contamination of the cytotoxic drug preparation. protection shields. Pharmaceutical isolator cabinets An isolator is a completely enclosed system with an airflow which is either turbulent or laminar flow. such as HEPA filters. Installation and use of cytotoxic laminar flow drug safety cabinets should be in accordance with the specifications of AS 2639-1994 Laminar flow cytotoxic drug safety cabinets – installation and use.3  Engineering controls/ventilation Engineering controls use technological means to isolate or remove hazards from the work environment. Note: Separate CDSC. be easily cleaned and well organised >> can be positive or negative. Ventilation tools Any form of dilution will reduce the concentration of contamination. etc. Once contamination has occurred. Cytotoxic drugs should be prepared in either a cytotoxic drug safety cabinet or a pharmaceutical isolator cabinet.

page 38 Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 . such as chairs. Factors to consider in the organisation of the physical environment and design include: >> the level of concentration and visual control required >> precision of movements needed >> design of equipment and availability of adjustable furniture. Further considerations in designing and setting up a cleanroom and anteroom include: >> provision of access for cleaning and replacement of equipment e.6  Preparation and Dispensing Ventilation tools continued Biological safety cabinets (BSC) >> Class I and II – NOT appropriate for the preparation of cytotoxic drugs as they do not safe guard the product and/or the operator from contamination. stools and foot rests >> storage requirements >> potential noise sources.g. cytotoxic drug safety cabinet >> incorporation of seam-free. smooth and durable work surfaces and furniture >> installation of recessed lights >> limitation of the number of surfaces and shelves to minimise particle shedding or the accumulation of particulate matter >> installation of an accessible emergency shower outside the anteroom >> maintenance of an effective airlock between the cytotoxic suite and external environment >> ensuring all equipment used is dedicated to the cytotoxic cleanroom >> temperature control >> ensuring the anteroom provides: –– the only access for personnel to the cleanroom –– access to only one cleanroom –– facilities for donning personal protective equipment and checking that it fits correctly (full length mirror on wall) >> ensuring the pass through hatch has: –– no direct access to the external environment unless an appropriate chemical or HEPA filter is used to control emissions –– interlocking doors and is supplied with HEPA filtered air >> provision of a means of communication between the cleanroom and other areas (preferably a telephone) >> installation of a manometer to monitor the pressure differential within the cytotoxic suite and record daily differential pressure readings >> installation of a manometer alarm in case of inadequate pressure differentials >> installation of a spill switch that reverses the airflow. minimising contamination to the external environment. They have a physical barrier between the drug and the operator. These cabinets are an intermediate between a Class II and an isolator. Organisation of the physical environment and work flow Attention to ergonomic design principles. Class III BSCs may be used for the preparation of cytotoxic drugs but should not be selected in preference to either a cytotoxic drug safety cabinet or a pharmaceutical isolator cabinet. equipment layout and work practices will minimise operator error. >> Class III – These are totally enclosed vented cabinets of gas tight construction.

>> Opened/used vials should not be left in the CDSC for later use. >> Only one drug should be in the CDSC at any one time (or one drug per operator in a 2 person CDSC). Staff numbers and staff contact rotation requires consideration (see also Section 4 – Staff Health). Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 page 39 . liberation of powdered drug into the air.g. onto counting trays and onto other surfaces. If the preparation of mixtures and ophthalmic preparations is required. Additional safe work procedures include: >> using purpose-dedicated equipment >> making mixtures by dispersing tablets in water (preferably inside a cytotoxic drug safety cabinet) >> not crushing tablets in an open mortar >> not counting tablets or capsules by machine. installation and use of pharmaceutical isolators. communications system >> access should be controlled. The preparation of mixtures and ophthalmic products poses slightly less risk of contamination but should be kept to a minimum. duress alarm. >> To minimise the potential for dosing error. Parenteral preparations Safe work procedures should be documented and stress the need to: >> avoid using cytotoxic drugs supplied in glass ampoules – if glass ampoules must be used. vial sizes closest to the actual dose should be selected. they should be prepared under the same conditions as parenteral cytotoxic drugs. open with an ampoule breaker or a low‑linting swab >> contain excess drug solutions and air when priming >> use techniques that avoid the generation of pressure differentials. Non-parenteral preparations The preparation of topical creams should be avoided due to the high risk of staff and environmental contamination. Safe work procedures should be documented and stress the need to: >> use gloves when handling tablet or capsule dosage forms >> clean equipment immediately after use – refer to Section 12 – Cleaning >> use purpose-dedicated equipment >> ensure tablets are not crushed or broken. Non-parenteral preparations – oral tablets and capsules Oral tablets and capsules must be handled in a manner which avoids or minimises skin contact.4  Administrative controls/organisation measures Safe work practices – staff considerations When people are working in isolation: >> working-alone arrangements should be in place – e. Handling techniques and procedures for preparation All preparations must be undertaken in cytotoxic drug safety cabinets or pharmaceutical isolators as specified in AS2567–1994 Laminar flow cytotoxic drug safety cabinets and AS4273-1999/Amdt1-2000 Guidelines for the design. They must also be handled in a manner which avoids chemical crosscontamination with other drugs.6  Preparation and Dispensing 6.

Isolators Pressure differentials across HEPA filters. usually daily. and secondary and tertiary barriers should be assessed and certified by a suitably qualified person as specified in AS 2639 – Laminar flow cytotoxic drug safety cabinets – installation and use. cleaning or repair. fittings that allow controlled movement of the plant must be implemented and safe systems of work employed. Cytotoxic drug safety cabinets and secondary and tertiary barriers should be assessed and certified by a suitably qualified person as specified in AS 2639 – 1994 Laminar flow cytotoxic drug safety cabinets – Installation and use. Visual checks every session. Frequency Before beginning work. Isolator glove integrity. Isolator pressure hold test (glove attached). The following frequency is recommended in the PIC/S Guide to Good Practices for the Preparation of Medicinal Products in Healthcare Establishments for Physical Monitoring. Before beginning work. If access to plant is required for the purpose of maintenance. >> Pressure differentials across HEPA filters (workstations) – note that most cabinets will have built in alarms that will activate if pressure differentials are outside limits. Weekly. >> Defective equipment must not be used. page 40 Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 . usually daily. Equipment Laminar flow cabinets Test Parameter >> Pressure differentials between rooms. If it is not practicable to stop the plant. Cytotoxic drug safety cabinets.6  Preparation and Dispensing Performance testing and inspection of facilities and equipment >> Equipment used to prepare cytotoxic drugs and air-handling facilities should be maintained under a planned maintenance schedule. the plant must be stopped and one or more of the following measures used so as to control risks to health and safety: >> lockout or isolation devices >> danger tags >> permit-to-work systems.

and at least every 12 months >> inspection after relocation. must be informed of the potential hazards associated with cytotoxic drugs and be trained in safe cleaning procedures.6  Preparation and Dispensing Equipment maintenance An equipment maintenance schedule should include: >> inspection of cytotoxic drug safety cabinets. who may be involved in cleaning drug preparation suites and associated equipment. A number of agents and combination of agents appear in the literature (see Section 12 – Cleaning). walls and ceilings. cabinets. >> Vinca alkaloids should be labelled ‘For intravenous use only – fatal if given by other routes’ and be supplied in a mini-bag (50 mL or 100 mL). >> Cytotoxic drugs that are vesicants should have an extravasation warning label. General cleaning staff. >> Containers that carry cytotoxic drugs should identify the contents as cytotoxic drugs >> Cytotoxic drugs should be labelled ‘For Intrathecal Use Only’. not in a syringe. >> Checks by a pharmacist should be made before components enter the cleanroom and when the product is finished. it must be validated for the particular facility based on the recommendations of the manufacturer of the cabinet and the cytotoxic drugs that are being prepared. floors. >> Appropriate advisory labels as per latest edition of Australian Pharmaceutical Formulary and Handbook should be on cytotoxic drug containers.g.g. Primary packaging labels >> Appropriate warning labels should be on cytotoxic drug containers. >> Each step of the checking procedure should be documented. Cleaning drug preparation facilities Daily and weekly routines should be established and all equipment used in the cleaning should be dedicated for the purpose. They should also be educated on the extent of surface contamination involving cytotoxic drugs in areas both inside the preparation area and outside of it. and their important role in primarily the removal of this contamination or in the decontamination of these surfaces. and after mechanical or electrical maintenance >> test records and a summary of results in a place accessible to employees >> identification of faulty cabinets – e. filters. fluorouracil cream should be labelled ‘wear disposable gloves and use spatula to apply’. attach a lock-out tag and do not use until fixed >> repair of faulty cabinet faults. Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 page 41 . grilles. all orders should undergo a full clinical check by a chemotherapy competent pharmacist. >> Topical cytotoxic medication e. including syringes and IV bags. Additional information regarding labelling is included in Section 7 – Labelling. and recertification prior to use >> routine performing and recording of microbial and air-particle testing. >> Oral medications should be labelled ‘do not cut or crush’. Cleaning should include bench tops and surfaces. Whichever cleaning agent is used. Checking procedures >> Before preparation commences. Written procedures should be developed for the cleaning of cytotoxic facilities and equipment and a cleaning log maintained. isolators and suitable filters (as required by the Australian Standards) >> inspection at regular intervals.

liberation of powdered drug into the air. Safe work procedures should be documented and stress the need to: >> use gloves when handling tablet or capsule dosage forms >> clean equipment immediately after use with an appropriate cleaning agent (see Section 12 – Cleaning) and rinse thoroughly with water >> use purpose-dedicated equipment >> ensure tablets are not crushed or broken. They must also be handled in a manner which avoids chemical crosscontamination with other drugs. a log should be kept which includes: >> daily activities of each operator >> if more than one cabinet/isolator is used. In addition. For more information see Section 13 – Personal Protective Equipment.5  Personal Protective Equipment The use of personal protective equipment (PPE) is the lowest control priority in the hierarchy of control measures. All records associated with health surveillance must be retained by the employer for at least 30 years. Additional information regarding health surveillance is located in Section 4 – Staff Health. page 42 Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 . Handling techniques and procedures for dispensing Oral tablets and capsules must be handled in a manner which avoids or minimises skin contact. The employee should keep copies of their records. for all staff preparing cytotoxic drugs. onto counting trays and onto other surfaces. the actual cabinet/isolator that was used. 6. PPE General considerations are that the PPE is: >> appropriate for the individual and the task >> readily available >> clean and functional >> correctly used when fitted >> maintained by appropriately trained staff in keeping with relevant standards. Higher levels of control options should be fully investigated before PPE is selected.6  Preparation and Dispensing Record keeping Employers should keep the following records: >> for all equipment: –– maintenance schedules –– testing dates for all equipment –– test results –– operating times –– repairs and breakdowns –– contamination monitoring –– cabinet relocations.

6  Preparation and Dispensing 6. two illustrative procedures are presented to illustrate how the guidance in this section can be applied: >> Model Procedure 3 – Preparation of Parenteral Cytotoxic Drugs Without a Closed System Device in the Pharmacy Department: –– Bolus injection in syringe requiring reconstitution of drug from powder preparation of parenteral treatments (various) –– Infusion requiring dilution of drug from a concentrated solution preparation The following is a suggested minimum set of standard operating procedures regarding the preparation and dispensing of cytotoxic drugs: >> preparation of cytotoxic drugs. There should be individual procedures for: –– preparation of parenteral treatments (various) –– preparation of topical treatments (various) –– preparation of oral treatments (various) >> operation and maintenance of cleanrooms and ante-rooms used in the production of cytotoxic drugs >> operation and maintenance of cytotoxic drug safety cabinets or pharmaceutical isolators used for the production of cytotoxic drugs >> receipt and storage of cytotoxic drugs >> selection and use of Personal Protective Equipment (see Section 13 – Personal Protective Equipment) >> cytotoxic waste management (see Section 17– Waste Management) >> management of cytotoxic drug spills (see Section 15 – Spills) >> transport of cytotoxic drugs (see Section 8 – Transport) >> staff management (see Section 4 – Health Surveillance) >> staff training (see Section 5 – Training). Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 page 43 .6  Procedures and model procedures Noting that there are many possible parenteral preparation procedures that can be undertaken.

standards and codes as well as pharmacy standards of practice recommendations. primary and secondary packaging as well as transport containers.2  Supply of a cytotoxic drug to a patient Supply of drugs to a patient can be done via a medication order or a prescription.1  All cytotoxic drugs All containers.7 Labelling 7 Labelling This section provides a risk management framework to assist in the development of local policies and procedures. page 44 Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 . 7. and aims to provide practical advice on labelling considerations incorporating state based and national legislation. The mechanism of supply will determine the minimum labelling requirements (see Table 1). should have the purple label with the cell in late teleophase and the warning ‘CYTOTOXIC – HANDLE WITH CARE’ prominently affixed. 7.

The APF recommends that all cytotoxic drugs be labelled with the following ancillary label: Special handling and disposal required – ask your pharmacist The APF also requires addition labelling for commonly used cytotoxic drugs. the word ‘POISON’ or the words ‘FOR EXTERNAL USE ONLY’. Additional requirements if dispensed on a prescription >> A unique identifier that enables the cytotoxic drug to be linked with the prescription. >> Name of the cytotoxic drug. >> Patient’s name. Ancillary labels The Australian Pharmaceutical Formulary and Handbook The Australian Pharmaceutical Formulary and Handbook (APF) lists labelling recommendations (cautionary advisory labels) which apply to medicines dispensed for patients’ use at home to assist in pharmacists’ counselling. >> Name of the cytotoxic drug. South Australian Controlled Substances Poisons Regulations 1996 Reg 19(2). >> If the cytotoxic drug is part of a preparation or admixture – the strength or proportion of cytotoxic drug contained in the preparation or admixture. Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) relevant to cytotoxic drugs. refer to the APF. including (where relevant) the route of administration. address and telephone number of the health service. >> The date on which the cytotoxic drug is sold or supplied. >> The strength and form of the cytotoxic drug. 2. For details about the additional labelling requirements. in red on a white background. Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 page 45 . >> Patient’s name. >> Adequate directions for use. >> The total quantity of the cytotoxic drug in the container.7 Labelling Table 1: Text requirements for cytotoxic drug labels in South Australia Supplying on a medication order1 Health service details Patient details Drug details >> Name. Dispensing on a prescription2 >> Name. The APF labelling recommendations may also used be used for individual patient dispensed/supplied medications in health services as they give information to carers or healthcare staff administering medications to patients. In addition. Warnings >> The words ‘KEEP OUT OF REACH OF CHILDREN’ in red on a white background. >> If the cytotoxic drug is intended for external use only. address and telephone number of the health service. >> Directions for the safe and proper use of the cytotoxic drug. 1. for medicines dispensed on a prescription the requirements of the Guidelines for Dispensing of Medicines Pharmacy Board of Australia also apply.

au/ndpsc/susdp. any additional requirements of the International Air Transport Association (IATA) should be adhered to for labelling requirements 7. especially in a spill or breakage. manufacturing. The provisions in the SUSMP for a poison (drug) are that. the CSP Regs require the label to conform to the requirements of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) www. which: >> are prepared outside of the hospital pharmacy (i.nsf/Content/compubs_MedSafety-38757-LabRec-con). These labelling standards do not apply to manufacturers or hospital pharmacies.health. laboratory or dispensary use are exempt from all labelling requirements’ as they are to be labelled in accordance with the National code of practice for the labelling of workplace substances [NOHSC:2012 (1994)]. 7. There should be clear contact details to source advice should this be required >> if the cytotoxic drug is classified as a Dangerous Good. The labelling of injectable cytotoxic drugs.au/internet/safety/publishing. ‘poisons which are packed and sold solely for industrial. The Commission’s National Recommendations for User-applied Labelling of Injectable Medicines. For specific details about the labelling standards refer to the National Recommendations for User-applied Labelling of Injectable Medicines. including outer wraps.3  Cytotoxic drugs for transportation The following labels should be prominently displayed on the outer packaging/shipper: >> the purple ‘CYTOTOXIC – HANDLE WITH CARE’ label >> appropriate temperature and light conditions >> what to do in case of an emergency.e.4  Cytotoxic drugs provided to drug preparation facilities by a supplier for further processing In this scenario.gov.tga. on the ward) and >> leave the hands of the person preparing the cytotoxic drug should comply with the Commission’s labelling recommendations. should be labelled with a prominent warning label stating: ‘FOR INTRAVENOUS USE ONLY – Fatal if given by other routes’ >> all medicines for intrathecal administration should have a prominent warning label on the syringe and the outer wrap. and the devices used to deliver them. Fluids and Lines (August 2010) (www. then the class 6 diamond label should be attached to the packaging. Fluids and Lines (2011). page 46 Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 . Also refer to the SA Health Policy Directive: User-applied Labelling of Injectable Medicines. Any additional requirements of the Australian Code for the Transport of Dangerous Goods by Road and Rail (ADG) must be adhered to for labelling requirements.7 Labelling Following sentinel events associated with the inadvertent intrathecal administration of vincristine repeatedly reported in Australia and overseas.htm. If transporting by air. Fluids and Lines (August 2010) are a set of labelling standards designed to improve safety in the labelling of injectable medicines and fluids. the Australian Commission on Safety and Quality in Health Care has issued the following recommendations: >> all vincristine products. stating ‘For Intrathecal Use Only’.gov.

Under the OHSW Regs. The National Code is proposed to be revised to meet the GHS (Globally Harmonised System) of labelling from 1 January 2012. For specific practical guidance and advice on labelling requirements. including any relevant risk phrases and safety phrases. 7. the supplier must ensure hazardous substances are appropriately labelled. Table 2: Workplace labelling for hazardous substances Label items Greater than 500 mL (g) Identification information: >> Product name >> Chemical name >> United Nations number. Guide for handling cytotoxic (anti neoplastic) drugs and related waste (2005). The label must: >> clearly identify the hazardous substance >> provide basic health and safety information about the substance. suppliers and employers have specific responsibilities for labelling cytotoxic drugs that are hazardous substances. Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 page 47 . suppliers and employers must first determine whether a cytotoxic drug that is also a scheduled poison is to be used for purposes of work.7 Labelling This code has been adopted by the OHSW Regs as an SA Approved Code of Practice for Labelling Workplace Substances (2006). >> Model Procedure 5 – Transport of Cytotoxic Drugs Within the Health Service. To meet the legal requirements for labelling. veterinary practices or domestic use.5  Model procedures The following model procedures are associated with this section: >> Model Procedure 4 – Transport of Cytotoxic Drugs External to the Health Service. such as healthcare facilities. refer to the SA Code of practice for the labelling of workplace substances. In South Australia. and subsidiary risk (where required by ADG Code) Ingredients and formulation Risk phrases Safety phrases Direction for use First aid procedures Emergency procedure Details of manufacturer or importer Expiry date Reference to the safety data sheet Yes Yes Yes Yes Yes Yes Yes No No Capacity of container 500 mL (g) or less (small containers) Container too small to attach to label Where relevant Yes Yes Where appropriate Yes Yes Yes Where relevant Yes No Yes (at least the most significant phrases) Yes (at least the most significant phrases) No Yes No Yes No Yes No No No No No No Yes No No Source: Queensland Department of Industrial Relations. class.

This section should be read in conjunction with the following sections: >> Section 5 – Training >> Section 7 – Labelling >> Section 12 – Cleaning >> Section 13 – Personal Protective Equipment >> Section 14 – Laundry >> Section 15 – Spills >> Section 16 – Contaminated Body Wastes >> Section 17 – Waste Management Cytotoxic drugs and related waste should be packaged and transported so as to provide adequate physical and chemical protection for the drug and protection to handlers and the environment in the event of a spill. page 48 Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 . and aims to provide practical advice on considerations for the transportation of cytotoxic drugs and related wastes to. from and within a health service. It is the responsibility of drug manufacturers to supply cytotoxics in containers which are free of contamination.8 Transport 8 Transport This section provides a risk management framework to assist in the development of local policies and procedures.

Recommendation Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 page 49 . should ensure that they are current and reflect the actual products used within the institution. Spill kits should be readily available to all personnel involved in the transportation and receipt of cytotoxic drugs. compliance with the IATA’s Dangerous Goods Regulations is required. Cytotoxic drugs packaged for transport outside the health service should be in accordance with state and federal requirements. washing hands and cleaning surfaces should be undertaken. compliance with the AGD is required. Staff involved in the receiving and inventory control should be informed of the possibility of surface contamination. These safety data sheets should be readily available in all areas where hazardous drugs are stored or used. contractors.8 Transport 8. Staff. and should update the Dangerous Substances Register whenever purchased products change. Labelling Transport considerations Spills Receipt of drugs Controls See Section 7 – Labelling. transportation. such as the Australian Code for the Transport of Dangerous Goods by Road and Rail (ADG) and the International Air Transport Association’s (IATA) Dangerous Goods Regulations. safe handling procedures such as wearing gloves. For air transport. for example: >> how to use a spill kit >> what to do with contaminated waste following a spill clean up >> what to do with packages that appear to be damaged >> health monitoring >> due to the potential of surface contamination. The recipient of the drug should retain a compilation of the safety data sheets. etc involved in the packaging.1  Transportation of cytotoxic drugs External transportation General considerations From suppliers Packaging Containers used for transporting the cytotoxic drugs should be: >> hard walled and robust >> made from moulded foam or some other suitable packaging material that is capable of withstanding shock equivalent to a one-metre drop onto a concrete surface >> securely closed. Documentation The following records should be kept by the supplier: >> date of transport >> contents of the package >> destination details >> contact details of recipient >> name and contact details of the courier company used. The safety data sheet should be attached to the packaging. For rail and road transport. receiving and inventory control of the cytotoxic drug should receive appropriate training. Also refer to the Australian Code for the Transport of Dangerous Goods by Road and Rail (ADG) and the IATA’s Dangerous Goods Regulations.

should ensure that they are current and reflect the actual products used within the institution. for example: >> how to use a spill kit >> what to do with contaminated waste following a spill clean up >> what to do with packages that appear to be damaged >> health monitoring >> due to the potential of surface contamination. Documentation The following records should be kept by the health service and the receiver: >> date of transport >> contents of the package >> destination details >> contact details of recipient >> name and contact details of the courier company used. Labelling Transport considerations Spills Receipt of drugs Controls Refer to Section 7 – Labelling. residential care facilities etc). safe handling procedures such as wearing gloves. contractors. and should update the Dangerous Substances Register whenever purchased products change. transportation. Refer to the Australian Code for the Transport of Dangerous Goods by Road and Rail (ADG) and the IATA Dangerous Goods Regulations. Staff involved in the receiving and inventory control should be informed of the possibility of surface contamination. Spill kits should be readily available to all personnel involved in the transportation and receipt of cytotoxic drugs. These safety data sheets should be readily available in all areas where hazardous drugs are stored or used. leak-proof container. Primary packaging: >> package in a sealed. etc involved in the packaging. receiving and inventory control of the cytotoxic drug should receive appropriate training.e. Also refer to the Australian Code for the Transport of Dangerous Goods by Road and Rail (ADG) and IATA’s Dangerous Goods Regulations. washing hands and cleaning surfaces should be undertaken.8 Transport General considerations Recommendation From the health service This section describes the transport of cytotoxic drugs from a pharmacy to off site and to third party organisations (i. page 50 Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 . Also refer to the Australian Code for the Transport of Dangerous Goods by Road and Rail (ADG) and IATA’s Dangerous Goods Regulations. with outer bags heat-sealed where possible >> ensure the container offers protection from light where required >> protect the drugs from breakage in transit >> contain leakage if breakage occurs >> childproof packaging. Packaging Containers used for transporting the cytotoxic drugs must be: >> hard walled and robust >> made from moulded foam or some other suitable packaging material that is capable of withstanding shock equivalent to a one-metre drop onto a concrete surface >> securely closed. The recipient of the drug should retain a compilation of the safety data sheets. Staff.

Labelling >> Tablet containers should be labelled ‘do not cut or crush’ >> Containers should be appropriately labelled for the specified use – e. contractors. It is highly desirable that manufacturers provide some form of certification that vials and primary packaging are not contaminated with cytotoxics. intrathecal. washing hands and cleaning surfaces (refer to Section 13 – Personal Protective Equipment). consideration should be given to using an enclosed trolley or similar enclosed device.8 Transport Additional considerations for manufacturers It is the responsibility of drug manufacturers to supply cytotoxics in containers which are free of contamination. for example: >> how to use a spill kit >> what to do with contaminated waste following a spill clean up >> what to do with packages that appear to be damaged >> health monitoring >> due to the potential of surface contamination. intrathecal. * The use of an enclosed trolley or transportation device is a requirement under the EQUiP standard for security and patient confidentiality considerations. This analysis should preferably be carried out by an independent laboratory. Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 page 51 .g. oral or topical >> Packaging to have contains ‘Cytotoxic’ warning label. Manufacturers must provide safety data sheets (or MSDS) on all of their cytotoxic products with explicit details on decontamination and protection measures to be followed in the case of a spill or other accident. Staff. etc involved in packaging.g. with outer bags heat-sealed where possible >> Ensure the container offers protection from light where required >> Protect the drugs from breakage in transit >> Containers used for transport should be hard walled >> Contain leakage if breakage occurs >> Childproof packaging >> Tablet containers should be labelled ‘do not cut or crush’ >> Containers should be appropriately labelled for the specified use – e. General considerations Packaging Recommendation >> Package in a sealed. Documentation Documenting transportation of the cytotoxic drugs/cytotoxic drug preparations from the pharmacy to the units where these are used should be considered. transporting and receiving the cytotoxic drug should receive appropriate training. Transportation within a health service This section describes recommendations for the transportation of cytotoxic drugs from pharmacy departments to wards and clinics within the hospital grounds for in-house use.* Spill kits should be readily available to all personnel involved in the transportation and receipt of cytotoxic drugs. leak-proof container. Transport considerations Spills Controls If a large quantity of drug needs to be transported. oral or topical >> Outer packaging to have ‘Cytotoxic’ warning label. safe handling procedures such as wearing gloves.

handcarts and trolleys – to move cytotoxic waste around the facility >> ensure such equipment – e. meal times and change of shifts) >> avoid movement of cytotoxic waste through public areas or general staff thoroughfares >> ensure that waste disposal and linen chutes are not used for moving cytotoxic waste >> develop a cytotoxic spill management plan for spills occurring during transport >> where required. the following control measures should be implemented when transporting cytotoxic waste within a facility: >> do not overfill cytotoxic waste containers >> locate cytotoxic waste collection bins as close as practicable to the site of generation and to transport corridors >> use dedicated. The Environment Protection Act 1970 (EP Act) and the Environment Protection Regulations 2009 (EP Regs) regulate the transport of cytotoxic waste.g.g. Waste generators (such as health care facilities) have legal obligations for the cytotoxic waste they generate.g. >> Model Procedure 5 – Transport of Cytotoxic Drugs Within the Health Service. and then to the treatment or disposal facility. keep a record of waste movements. There are three principal statutory requirements for the transport of cytotoxic waste: >> appropriate licences >> transport certificates >> vehicle signage. Transport certificates are to be completed. page 52 Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 . 8. Off-site waste transport South Australian Environmental Protection Agency (EPA) is responsible for ensuring the proper transport of cytotoxic waste in South Australia. These legal obligations extend beyond the on-site handling of the waste. wheelie bins. rigid walled. Vehicle signage Permitted vehicles used to transport any volume of cytotoxic waste are subject to special requirements to display information. as set out as a standard condition of the transport licence and as per placarding requirements of the Australian Code for the Transport of Dangerous Goods by Road and Rail (ADG). even where the transporter is exempt from certificate requirements. wheelie bins. Transport certificates help to ensure obligations are discharged by documenting the transfer of each shipment of cytotoxic waste from the generator to the transporter. visiting hours. Transport certificates Transport certificates are required as a standard condition of the transport licence. handcarts and trolleys – is appropriately labelled and kept clean. The vehicle must display both a ‘dangerous goods’ label and the cytotoxic waste symbol. The waste generator is required to send a copy of the certificate to the EPA. puncture-resistant containers – e. Transport licence If no fee or reward is received for transporting the cytotoxic waste then no licence is required.3  Model procedures The following model procedures are associated with this section: >> Model Procedure 4 – Transport of Cytotoxic Drugs External to the Health Service. in accordance with infection control and other relevant standards >> schedule frequent waste collection rounds – movement should be planned to avoid peak activity times (e. Generators must ensure that: >> any person who transports waste has the required licence as per Schedule 1 of the EP Act >> the waste is disposed at a facility licensed by the EPA to handle cytotoxic waste.2  Transport of cytotoxic waste On-site waste transport To minimise exposure.8 Transport 8.

are well maintained and in good working order >> ensure access to emergency equipment (or emergency procedures) is available at all times >> use personal protective equipment. implemented and maintained. 9. The principles discussed here can also be adapted to the community and home environment. The following are examples of ways to ensure risk controls are ‘best practice’: >> only undertake a drug administration service with control measures >> use closed system drug administration devices where possible >> always follow agreed statewide standard procedures for administration where available >> drugs intended for administration should be appropriately packaged. Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 page 53 . It is recommended that policy is developed to ensure that these control measures are included into the ward/day clinic health and safety systems.1  Key risk control measures Applying the hierarchy of control measures outlined in Section 3 – Managing the Risk. use of specially designed equipment. workplace design.9 Administration 9 Administration This section provides a risk management framework to assist in the development of local policies and procedures. to the administration of cytotoxic drugs is essential. education. To ensure that control measures and safe work practices are developed. such as infusion pumps. training and supervision are crucial. understood. labelled and ready to use >> cytotoxic orders should be identified by using a specific cytotoxic medication chart or equivalent electronic order >> provide secure and labelled storage of waste and sharps containers to minimise exposure to cytotoxic waste >> provide training and education about side effects of cytotoxic drugs to the patient and carer >> ensure that equipment used. safe work practices and personal protective equipment are essential. These best practice risk control options should be considered a priority. and aims to provide practical advice on how to prevent or reduce the risks associated with the administration of cytotoxic drugs in the hospital environment. Exposure while administering drugs may occur through: >> handling cytotoxic drugs >> spills >> splashes to the skin or eyes >> inhalation of airborne contaminants (which can be generated by the expulsion of air from a drug-filled syringe) >> sharps injuries. This section should be read in conjunction with the following sections: >> Section 5 – Training >> Section 8 – Transport >> Section 12 – Cleaning >> Section 13 – Personal Protective Equipment >> Section 14 – Laundry >> Section 15 – Spills >> Section 16 – Contaminated Body Wastes >> Section 17 – Waste Management To ensure that cytotoxic drugs are safely administered.

such as safety data sheets. When administering cytotoxic drugs in a community or home setting. page 54 Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 . the following should be considered: >> allow sufficient room for movement of staff around the patient chair/bed during drug administration >> provide secure storage for cytotoxic waste and sharps containers >> provide secure storage for cytotoxic waste ready for disposal >> establish a system for obtaining and updating health and safety information. in a place accessible to employees >> provide washable chairs and other furnishings >> provide liquid resistant mattress covers >> provide hand-washing facilities >> provide facilities for storage and disposal of personal protective equipment >> provide secure storage facilities for cytotoxic medications >> ensure there are pre-administration checklist strategies for nursing and medical staff. A patient care area should have a safety shower.2  Establishing a drug administration area When establishing a designated drug administration area in a health care facility.9 Administration 9. or access to a shower. and appropriate hygienic liquid resistant flooring (instead of carpet). comply with these instructions as closely as possible (see Sections 10 and 11).

at baseline and prior to each cycle. body surface area (BSA). Pre-treatment assessment. should include: >> full blood count. the following equipment is recommended: >> closed administration devices: –– Y infusion line or Y site adaptor –– threaded locked cannula >> other devices: –– needleless administration systems –– luer-lock syringes >> portable trolleys to store administration equipment. If blood parameters are abnormal notify a medical officer >> symptom/side effect toxicity review >> allergy and drug reaction history >> performance status >> weight. it is essential that the patient be deemed fit for treatment. cytotoxics sharps disposal containers that are readily accessible >> personal protective equipment as outlined in Section 13 >> a spill kit as outlined in Section 15.3  Cytotoxic drug administration Patient assessment Prior to administration. and between cycles or recovery phases as recommended. renal and liver function tests prior to each treatment cycle (as per individual treatment protocols). Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 page 55 . height.9 Administration 9. wide-necked. Any changes in weight of more than 10% should be referred to a medical officer >> psychosocial screening. Particular care should be taken when using complex administration lines to ensure that all necessary connections are made and the system remains closed. Equipment To minimise risks. rigid walled. allowing movement from patient to patient >> disposable injection trays to contain and carry syringes >> plastic-backed absorbent sheets or pads under the injection site >> plastic.

or to the source of referral >> discard gloves and other personal protective equipment after use into the cytotoxic waste bin >> wash hands following administration and disposal of cytotoxic drugs and related waste.g. after intrapleural. During drug administration. syringes and pump cartridges >> wear appropriate personal protective equipment at all times >> use lines which are compatible with solutions and the cytotoxic drug >> connect all drug administration bags and bottles at waist level >> avoid contact with fluid from body cavities following administration – e. Safe work standard operating procedures for parenteral administration of cytotoxic drugs should be clearly documented and emphasise the need to: >> cross-check therapy with the pharmacist. doctor or nurse >> preparation of all dose reductions must occur in the pharmacy >> follow recommendations from the suppliers and the pharmacy for administration procedures >> use cytotoxic labels to identify all intravenous infusion bags.e. Applying the decision making process (see page 34) including the hierarchy of control measures to the administration of cytotoxic drugs is essential. page 56 Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 . unopened/unspiked bags) to the pharmacy. do not: >> recap needles >> cut down intravenous infusion sets or contaminated needles >> expel air from a syringe (it contaminates the air) >> expel fluid from a syringe (it contaminates the area). then calculate the required dose and check against the medication order. intravesicular or intraperitoneal administrations >> involve the patient and encourage them to alert administration staff to any problems >> maintain close supervision of the patient >> manage extravasation incidents promptly >> dispose of empty bags and bottles – with the administration set attached – into a sealable bag before placing them into a multi-use cytotoxic waste bin or discard empty cytotoxic bags and bottles at the bedside or patient chair into a dedicated cytotoxic bin and close lid of cytotoxic bin immediately as per Section 17 – Waste Management >> partially used bags/bottles/syringes or spiked but unused bags should be disposed off with other contaminated cytotoxic waste in the administration area >> appropriately seal and return the unused cytotoxic drugs (i.9 Administration Parenteral administration Prior to administration. calculate the body surface area (or other parameters).

5 Respiratory Protective Equipment) due to the high risk of aerosol formation >> to limit environmental contamination: –– advise the patient to sit for each urination for 6 hours after treatment –– if possible. lotions or eye drops. prior to treatment with sodium hypochlorite solution >> advising the patient to wash their genitalia after each urination for 6 hours after treatment to limit patient exposure. Oral administration Oral agents are generally given as tablets and capsules. ointments. the patient may need to (be) voided earlier >> nurses performing this activity may want to consider wearing a face shield as well as a P2 mask (see Section 13. 9. Additional control measures when using oral agents include: >> wearing appropriate gloves >> using a non-touch technique when transferring tablets or capsules from their container into a disposable medication cup. designating a toilet for these patients and double flushing the toilet. Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 page 57 . Additional control measures when using topical agents include: >> avoiding unnecessary contact with the topical agent >> minimising contact with a patient’s clothing >> applying ointments evenly with a disposable spatula >> educating a patient on how to apply medication >> disposing of all contaminated equipment as cytotoxic waste >> wearing appropriate personal protective equipment at all times. and notifying the pharmacy >> contacting the pharmacy if it is necessary to produce a cytotoxic drug mixture >> discarding contaminated medication cups as cytotoxic waste >> providing appropriate education regarding handling and exposure to patients and their carers if receiving oral chemotherapy at home. Topical administration Topical agents may be in the form of creams.g. nasogastric or PEG feed – for any reason outside the pharmacy’s cytotoxic drug preparation area >> isolating and discarding damaged tablets or capsules as cytotoxic waste.4  Model procedures The following model procedures are associated with this section: >> Model Procedure 6 – Administration of Oral Cytotoxic Drugs in the Health Service. >> Model Procedure 7 – Accidental Exposure to Cytotoxic Drugs and Related Wastes. some additional control measures may be considered when preparing standard procedures for intravesical administration such as: >> to limit leakage and ‘explosive’ aerosol spray of unmetabolised cytotoxic drug from the site of insertion of the urinary catheter: –– instruct the patient to limit fluid intake for 4 hours prior to administration –– remind the patient to void prior to catheterisation –– remove the catheter as soon as practicable after instillation –– although treatment regimens require mitomycin C remains in situ for 1 hour after administration.9 Administration Intravesical administration Due to the nature of this route of administration. if the patient feels discomfort or a bladder spasm occurs. oral. to avoid direct handling >> not crushing or breaking tablets or capsules – e.

Nursing and medical staff in community and aged care facilities may be involved in administering cytotoxic drugs. page 58 Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 . Labeling advice for community dispensed cytotoxic drugs is included in Section 7 – Labelling as well as the Guidelines for Dispensing of Medicines (Pharmacy Board of Australia).10  Caring for Patients in the Community 10  Caring for Patients in the Community This section provides a risk management framework to assist in the development of local policies and procedures. however it is recommended that the following precautions be used to avoid exposure if handling loose tablets: >> wear gloves >> use separate counting trays >> use separate. day hospitals and clinics. disposable counting spatulas >> clean equipment immediately after use with an appropriate cleaning agent (see Section 12 – Cleaning) and rinse thoroughly with water >> ensure tablets are not crushed or broken. and aims to provide practical advice on how to prevent or reduce the risks associated with the dispensing and administration of cytotoxic drugs as well as the transportation of patients and dealing with cytotoxic waste in the community environment. This is because a community setting is often an uncontrolled environment where both employer and worker have less influence regarding control measures than in a health care facility. The risk from handling cytotoxic drugs and related waste in community settings is somewhat different to those faced by health care facilities. Most cytotoxic tablets and capsules are provided in blister packs so the pharmacist will not usually need to take extra precautions when dispensing. the number of patients being treated in community or in residential facilities is increasing. It also provides guidance to health services. on community specific considerations. Ambulance officers might also be involved in caring for and transferring patients who have received cytotoxic drug treatments. This section should be read in conjunction with the following sections: >> Section 5 – Training >> Section 8 – Transport >> Section 9 – Administration >> Section 12 – Cleaning >> Section 13 – Personal Protective Equipment >> Section 14 – Laundry >> Section 15 – Spills >> Section 16 – Contaminated Body Wastes >> Section 17 – Waste Management While most patients undergoing cytotoxic drug therapy are treated in health care facilities such as hospitals. Others who may be at risk of exposure include waste collection workers and trades people working around the facility. Nursing. 10. medical staff and other carers might care for patients after cytotoxic drugs have been administered.1  Community dispensing Oral cytotoxic drugs may be dispensed in the community. who supervise treatment in the community.

2  Role of the treating facility The treating facility is the hospital. pharmacy or treating doctor supervising the patient receiving the cytotoxic therapy. where applicable. Health care workers preparing parenteral cytotoxic drugs without adequate precautions have been shown to contaminate themselves and their work environment. general practitioners and. equipment and trained personnel to provide prepared cytotoxic drug doses. The risk of exposure may be eliminated or reduced by ensuring that parenteral cytotoxic drugs are prepared by trained pharmacists or technicians in approved facilities. 10. Written information must be provided to residential care facility staff. Information must include: >> what cytotoxic drugs are administered >> the special care requirements >> the timeframes for excretion of the cytotoxic drugs in the patient’s body waste following administration of a dose (see Cancer Institute of NSW: eviQ Cancer Treatments On-line) >> the safety precautions for those who are pregnant or breast feeding if dealing with cytotoxic drugs and related contaminated body waste >> spills management >> laundering contaminated linen and clothing. Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 page 59 . 10.10  Caring for Patients in the Community It is not safe for community pharmacies and community workers or carers to prepare/reconstitute parenteral cytotoxic drugs as adequate risk control measures are not in place. such as a cytotoxic drug safety cabinet or a pharmaceutical isolator (Section 6 – Preparation and Dispensing).3  Personnel management All workers involved in the administration or transportation of cytotoxic drugs or the transportation of patients receiving cytotoxic drugs should: >> have a risk management program available to them (Section 3 – Managing the Risk) >> receive appropriate training (Section 5 – Training) >> be informed about the risks of occupational exposure to cytotoxic drugs (Section 4 – Staff Health). See Section 6 – Preparation and Dispensing for further information. Parenteral cytotoxic drugs should not be prepared in the community setting. Health and community care organisations and referring doctors who are unable to have parenteral cytotoxic drugs prepared in an approved facility by trained workers should not undertake preparation of these drugs for supply to patients for administration at home. Alternative arrangements could include: >> purchasing and supplying prepared cytotoxic drugs in a single-dose delivery unit from a commercial source >> establishing supply arrangements with a health service that has the required facilities. ambulance officers. community health care workers.

catheters.e. discard soiled cloths into a plastic bag. discard gloves into the bag. The waste should be disposed in a cytotoxic waste bin and taken back to the health care facility. This waste may include dressings. catheter bags and the like. With gloves still on. Cytotoxic waste generated must be disposed of safely to reduce the risk of exposure to waste management workers.10  Caring for Patients in the Community 10. for disposal in a cytotoxic waste bin. care should be taken to comply with the instructions outlined in Section 9 – Administration as closely as possible. the contents of colostomy and urostomy bags >> washing hands >> preventing the generation of aerosols when handling a patient’s body waste by covering vomitus bowls or bed pans with lids >> appropriate administration techniques >> managing suspected personal contamination >> cleaning a splash or spill of cytotoxic contaminated body waste while wearing two pairs of disposable gloves if possible – i.4  Maintaining controls Safe work procedures should be documented and should emphasise the need to: >> clean daily >> use a dedicated mop and bucket >> treat all equipment as potentially contaminated >> use personal protective equipment. urine. page 60 Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 . vomitus. ostomy bags.5  Administration of cytotoxic drugs Nursing and medical personnel may be involved in administering cytotoxic drugs in community settings. seal the bag (preferably with a cable tie or a knot in the top of the bag) and discard it into the household waste. faeces. in the boot of a vehicle. nappies.e. 10. then wash affected area with water and detergent. 10. The treating facility should provide the relevant community workers or ambulance officers with advice about: >> the routes of excretion and how long it takes to excrete the drug (see Cancer Institute of NSW: eviQ Cancer Treatments On-line) >> disposing of cytotoxic contaminated body waste – i. For additional information see Section 16 – Contaminated Body Waste and Section 17 – Waste Management. incontinence aids. When setting up a drug administration in a community setting.6  Managing cytotoxic waste Two types of waste will need to be considered: >> any residual cytotoxic drug that remains following a patient’s treatment and any materials or equipment contaminated with cytotoxic drugs >> contaminated body waste. clean up contaminated waste.

10. The procedures should emphasise the need to: >> advise community workers and ambulance officers that the patient is undergoing cytotoxic drug treatment >> avoid skin contact with the patient’s body substances >> prevent generating aerosols when handling the patient’s body waste >> dispose of waste.7  Safe work procedures With the assistance of the treating facility. ambulance officers. spills and personal contamination. safe work procedures should be developed. Systems should be in place to manage sharps injuries. general practitioners and. faeces. vomitus. the contents of colostomy and urostomy bags.8  Emergency procedures Planning for emergencies is an essential part of risk management. Any incident should be reported so that the cause can be investigated and determined and follow-up action taken if required.10  Caring for Patients in the Community 10. Written information must be provided by the treating facility to residential care facility staff. such as urine. where applicable. community health care workers. Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 page 61 . incontinence aids and disposable nappies as outlined in Section 16 – Contaminated Body Waste >> contain waste generated from drug administration in a dedicated container >> keep waste containers secure and appropriately labelled >> have a documented spill management strategy (see Section 15 – Spills) which includes: –– advice to clean up spills immediately –– written instructions on how to manage a spill in an ambulatory situation –– information on the contents of a spill kit >> provide precautionary information to community workers and ambulance officers who are pregnant or breast feeding.

if undertaking administration activities. page 62 Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 .11  Caring for Patients at Home 11  Caring for Patients at Home This section provides a risk management framework to assist in the development of local policies and procedures. An additional consideration in providing treatment with cytotoxic drugs in the patient’s home is not only the potential presence of children but also for children to be undertaking the role of a carer. 11. Nursing staff should not reconstitute parenteral cytotoxic drugs in the patient’s home. If children are present in the setting or will be undertaking administration activities. All cytotoxic drug therapy used in the home care situation must be prepared under the same conditions as all other cytotoxic drug therapies. cytotoxic safety precautions. and aims to provide practical advice on how to prevent or reduce the risks associated with the administration of cytotoxic drugs and dealing with cytotoxic waste in the home environment. it is strongly recommended that the treating facility undertake a robust risk assessment of the patient’s home and ensure appropriate storage. disposal. is able to understand and comply with safe handling procedures. and that the facilities and equipment meet recommended standards. especially those related to handling contaminated body waste. specifically in the hospital pharmacy department or in a production facility complying with the same requirements. are an ongoing concern in a patient’s home. etc controls are in place and that the child.1  Home care by nursing staff All nurses administering chemotherapy in the patient’s home must be adequately trained and competency assessed for the administration of cytotoxic agents. This section should be read in conjunction with the following sections: >> Section 5 – Training >> Section 8 – Transport >> Section 9 – Administration >> Section 12 – Cleaning >> Section 13 – Personal Protective Equipment >> Section 14 – Laundry >> Section 15 – Spills >> Section 16 – Contaminated Body Wastes >> Section 17 – Waste Management Regardless of where cytotoxic drug therapies are administered. It is the responsibility of the institution providing the home care service to ensure that all cytotoxic drugs taken into the patient’s home are appropriately packaged and labelled.

Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 page 63 .11  Caring for Patients at Home Setting up a patient care area Before proceeding with chemotherapy in the home. The transport of cytotoxic drugs from the site of preparation to the patient’s home must be in accordance with procedures described in Section 9 – Transport. Equipment The nursing staff must also verify that the following equipment is available: >> spill kit (see Section 15 – Spills) >> cleaning agent (see Section 12 – Cleaning) >> approved container for sharps >> cytotoxic waste container >> personal protective equipment >> extravasation kit. Nursing staff should have a spill kit available and details of whom to contact in case of emergency. cytotoxic waste bins >> a patient care area set up in a non-carpeted area of the home.g. the nurse must verify that the following facilities are available: >> hand-washing facilities >> laundry facilities >> access to a flushable toilet >> appropriate waste disposal – e.

Patients.2  Home care by relatives and/or patient If the home care is to be provided by either relatives or by the patient. This will include home care nurses and hospital staff including medical and pharmacy personnel >> precautions to be taken where a care giver is pregnant or breast feeding. catheter care. it is very important that this care is organised and coordinated in advance. Carers of patients receiving the cytotoxic drug treatment should be provided with written information about cytotoxic drugs and the precautions to be taken while caring for patients during the time the drug may be excreted. In this way. Carers should be advised about special requirements of the particular drug used. all aspects of the treatment may be explained and full education and training provided. with close cooperation between hospital staff. This should include information about potential interactions with other medications including complementary therapies and over-the-counter medications >> instructions and training on the use of various types of apparatus which may be used. For example. instructions on how to clean up a spill and treating team’s contact details.11  Caring for Patients at Home 11. contained transfer devices. family and carers must be provided with education. port systems and any other venous access devices likely to be used >> instructions and training in the use of any personal protective equipment (PPE) >> information on how to contain and manage waste (including excreta) that is generated from drug administration in the home including laundry >> the importance of keeping waste containers secure and appropriately labelled >> how to use and dispose of incontinence aids and disposable nappies >> how to deal with a spill or leakage from administration sites and set >> for patients on home ambulatory chemotherapy. with a spill kit provided >> instructions on how to proceed in the event of an emergency or other incident. any hypersensitivity reaction of the patient to the drug being administered or alarm of any electronic device being used >> how to dispose of drugs that are no longer required >> provision of contact details for all staff likely to be of assistance. elastomeric infusion devices or ambulatory electronic pumps >> detailed information on the storage and stability of the prepared drugs >> information and training on the routes of administration which will be utilised >> if applicable. including: >> what constitutes cytotoxic waste >> detailed information about the drugs which will be administered. for example. page 64 Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 . extravasation of any vesicant. training on the care of infusion lines.

and aims to provide practical advice on considerations for the development of cleaning procedures. such as sodium hypochlorite solution >> hygiene. It cannot be assumed that cleaning a surface or piece of equipment with a sodium hypochlorite solution will deactivate all types of cytotoxic drugs and thus remove the hazard. laboratories and in the community setting are increasing as utility of these drugs is expanding beyond the treatment of cancer and into therapeutic areas such as rheumatoid arthritis. Sodium hypochlorite solutions (bleach) of various concentrations have been found to be the most efficient reagents for the chemical degradation of a variety of cytotoxic drugs. A number of other agents and combination of agents appear in the literature. work place monitoring and training of cleaners. such as use of: –– disposable cleaning materials were possible –– low lint materials in the CDSC >> use of decontaminating and deactivating agents. 12. The implementation of effective cleaning practices to decontaminate the work area is recommended.1  Cleaning agents The numbers and classes of cytotoxic drugs in use in health services. choice and assessment of cleaning agents. A number of studies over the past 20 years have evaluated various deactivating and decontaminating agents for use on surfaces contaminated with cytotoxic drugs. such as: –– equipment used in the cleaning areas in which cytotoxic drugs or related waste are present should be segregated from other cleaning materials –– reusable cleaning materials should be decontaminated or discarded if decontamination is not possible >> scheduling of cleaning. Effective cleaning practices include: >> choice of cleaning materials. there is inevitably some risk of environmental contamination. Sodium hypochlorite solutions are therefore often recommended for decontamination purposes. However. it is recognised that. however sodium hypochlorite solutions are not effective with all cytotoxic drugs (including dicarbozide and carmustine (under some conditions)).12 Cleaning 12 Cleaning This section provides a risk management framework to assist in the development of local policies and procedures. including the frequency of cleaning >> cleaning technique. such as: >> alkaline cleaning agents >> 70% sterile alcohol >> sterile water. multiple sclerosis and auto-immune diseases. The prevalence and often presence of many cytotoxic drugs in a single physical location. despite the most robust systems that are put in place. This section should be read in conjunction with the following sections: >> Section 5 – Training Preventing contamination of surfaces and equipment with cytotoxic drugs/drug residues is the best strategy to minimise staff and patient exposure. such as a pharmacy preparation area or ward. Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 page 65 . means that cleaning to remove contaminating cytotoxic drug residues is a complex process.

e.5% concentration. More information on cut-off concentration levels for hazardous substance classification can be located on the Hazardous Substance Information Service web site: http://hsis. Particular attention should be given to ensuring that the cleaning agent that is used does not degrade the cytotoxic drug into more toxic components. it should be validated for the particular cytotoxic drug or combination of drugs that may be present in the environment and for the surface/equipment on which it is being used. carmustine and paclitaxel) would also be done to ensure that the cleaning procedure is efficient for both for lipophilic and hydrophilic drugs. as recommended in international standards. consideration should be given to piloting validation studies with sodium hypochlorite solution at a 0. 12. who may be involved in cleaning areas where cytotoxic drugs are stored.g.2  Work place monitoring The regular and random monitoring of surfaces in areas where there is a risk of contamination with cytotoxic drugs surfaces. sodium hypochlorite solution is classed as a hazardous substance in concentrations of 5% and above). must be informed of the potential hazards associated with cytotoxic drugs and be trained in safe cleaning procedures. cyclophosphamide – by wipe sampling of the surfaces before and after cleaning. prepared or administered. page 66 Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 . investigation of lipophilic drugs (e. ifosfamide. is to investigate the most commonly used cytotoxic drugs – for example 5-fluorouracil. note that they may themselves be considered to be hazardous substance depending on the concentration at which they are prepared at (i. there is also a number of propriety cleaning products which have been developed to decontaminate/ deactivate surfaces contaminated with cytotoxic drugs. is key to provide an assurance of the effectiveness of the cleaning practices. If an analytical procedure is available.ascc.aspx.3  Cleaning staff General cleaning staff. Whichever cleaning agent or combination of agents is used.au/SearchHS. Whichever cleaning reagent(s) is used.12 Cleaning In addition. 12. methotrexate.gov. such as the pharmacy preparation and storage areas and patient administrations areas. Unless otherwise indicated by the manufacturer or in the literature. They should also be educated on the importance of their role in the removal of this contamination or in the decontamination. One approach.

a risk assessment should be performed for each activity within the particular setting and an appropriate PPE selected.1  Coveralls and gowns Selection considerations for coveralls or gowns include: >> should be made of impermeable material. This section should be read in conjunction with the following sections: >> Section 5 – Training >> Section 13 – Laundry >> Section 16 – Waste Management The correct selection and use of personal protective equipment (PPE) is required to both protect those who handle cytotoxic drugs and related waste. Respiratory Protective Equipment (RPE) l l l l l l l Coveralls and gowns Protective eyewear Shoe covers or overshoes Preparation of cytotoxic drugs – inside an isolated cytotoxic drug safety cabinet (CDSC) Cleaning of cytotoxic drug preparation areas and equipment Drug administration and patient care Cleaning spills Laundry – handling cytotoxic contaminated linen bags Handling cytotoxic drug contaminated waste Handling contaminated body waste Receiving and storing cytotoxic drugs l l l l l l l l l l l l l l l l l l l l l l l 13.g. e. Gowns should be used for a maximum of one shift and contaminated garments should be removed immediately and disposed of or laundered as appropriate. bonded polyethylene fibre >> should have a closed front and long sleeves with elastic cuff >> should be disposable or reusable. It should be noted that reusable coveralls and gowns have a limited life span and should be discarded when full protection can no longer be guaranteed by the manufacturer or supplier >> hooded coveralls for drug preparation. and ensure the sterility of the end product. Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 page 67 Head covering l l Gloves . Gowns should not be shared and care should be taken in removal of gowns to minimise the risk of personal contamination. and aims to provide practical advice on the selection of PPE. Before selecting PPE.13  Personal Protective Equipment (PPE) 13  Personal Protective Equipment (PPE) This section provides a risk management framework to assist in the development of local policies and procedures. Listed in the table below are general recommendations.

Selection considerations for gloves include: >> must be long enough to cover wrist cuffs of coveralls or gowns while arm is bent or stretched >> should be purpose manufactured or manufacturer recommended >> disposable >> nitrile gloves are generally recommended >> latex gloves used in drug preparation should be sterile and powder free >> polyvinyl chloride (PVC) industrial gloves can be used for waste management activities. or >> when punctured.4  Shoe covers and overshoes Selection considerations for shoe covers and overshoes include: >> shoe covers must be made of impervious material. non-disposable footwear should be cleaned with a detergent solution and rinsed thoroughly after each use.2 Gloves Glove use is essential and gloves must be chosen to maximise protection by minimising permeability. torn or contaminated. This can be done with two pairs of powder-free latex gloves. do not provide sufficient protection from cytotoxic spills >> overshoes should be high enough to cover the trouser cuff of the coverall and designed so they do not slip down >> the soles should be made of a skid-resistant plastic or other suitable non-shedding material. Paper. Note: With double gloving. Disposable eyewear should be disposed of as cytotoxic waste. and reusable overshoes should be stored for laundering Disposable shoe covers should be disposed of as cytotoxic waste. Gloves should be changed at: >> intervals recommended by the manufacturer.g. Individuals handling cytotoxic drugs and related wastes should be double gloved if they are not wearing purpose manufactured gloves.3  Protective eyewear Protective eyewear should be provided to prevent exposure to the mucous membranes of the eye from liquid splashes. 13. page 68 Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 . A risk assessment should be used to determine whether a worker wearing prescription glasses should use additional protection.13  Personal Protective Equipment (PPE) 13. bonded polyethylene fibre. Contaminated. This should be taken into account in selection and fitting of personal protective equipment. Reusable eyewear should be cleaned with a neutral detergent solution and rinsed thoroughly at the end of the shift or when contaminated. such as used in operating rooms. 13. Eye protection can be provided by: >> goggles or protective eyewear with side shields >> a transparent full-face chemical splash shield >> full eye protection provided by full-face respiratory protective equipment (RPE). disposable shoe covers. or >> intervals of 30 minutes. e. Standard surgical gloves may not provide the required level of protection due to drug and/or carrier permeability in the case of liquid cytotoxic drugs. both gloves must be changed.

6  Head covering Head coverings should be worn to contain hair and minimise contamination. stored and maintained as recommended in AS/NZS1715: 1994 – Selection.5  Respiratory protective equipment (RPE) Suitable RPE should be selected. use and maintenance of respiratory protective devices or comparable internationally accepted standard. Staff required to wear RPE must be fit tested. an effective storage and regular maintenance program should be implemented with procedures covering: >> cleaning and disinfection. It should be noted that surgical respirators do not offer sufficient respiratory protection against exposure to powders. Selection considerations for RPE include: >> a particulate filter P2 (N95) mask is recommended when dealing with situations in which aerosols may be generated. liquids or aerosols (particulates). noting that reusable face piece RPE should have the face piece washed after each daily use or following any contaminating incident >> replacement of filter >> inspection for defects >> repair of equipment. >> a requirement for a worker to wear prescription glasses should be taken into account in selection and fitting of RPE. They should cover exposed hair. Other considerations should include: >> hoods should fit snugly around the face (hooded coveralls are recommended for drug preparation) >> caps should fit snugly around the head >> facial enclosures or covers should be designed in conjunction with hoods and other coverings >> hoods. Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 page 69 . caps and facial enclosures should not interfere with respiratory protection. Disposable RPE are to be disposed of as cytotoxic waste after each use or following any contamination incident. Replaceable filters are to be disposed of as cytotoxic waste at the end of service life. used. 13. including beards and moustaches.13  Personal Protective Equipment (PPE) 13. When using reusable RPE.

these procedures should continue for several days after a patient has completed treatment with the cytotoxic agent. no water will be spilled. previously contaminated personal protective equipment.14 Laundry 14 Laundry This section provides a risk management framework to assist in the development of local policies and procedures. the community and home environments. This section should be read in conjunction with the following sections: >> Section 5 – Training >> Section 12 – Personal Protective Equipment Contaminated laundry can potentially come from three sources: >> linen of a patient receiving cytotoxic therapy >> clothing of a patient receiving cytotoxic therapy >> personal protective equipment. disposable personal protective equipment and linen should be used >> in order to reduce or contain contamination of linen. Once laundered. >> The washing process should be at a maximum cycle and in either hot or cold water. In the case of linen and patient clothing. wear two pairs of disposable gloves. Systems should be established to: >> protect laundry personnel from cytotoxic residues >> prevent contamination of other materials being laundered >> ensure personal protective equipment. >> The laundry can be dried on a line or in a dryer. 14.2  General recommendations When handling contaminated laundry. do not stir up the linen. 14. >> Store the contaminated laundry separate from other laundry prior to washing. page 70 Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 . and aims to provide practical advice on dealing with contaminated laundry in the health service. >> Wash the contaminated laundry separately from other laundry. general recommendations should be followed for up to 7 days (see Cancer Institute of NSW: eviQ Cancer Treatments On‑line). patients who need to be washed in bed should be washed with disposable moist tissues. 14. >> Domestic washing powder is suitable.1  Key risk control measures The following key risk controls should be considered a priority: >> if possible. >> Contaminated laundry should be labelled as ‘Hazardous’ if transporting the laundry to a laundering facility. When using this technique.3  Other contaminated bedding Bed mattresses should be cleaned with decontaminating solution (see Section 12 – Cleaning). linen and clothing can be reused. In the absence of any specific detailed information. linen and clothing is decontaminated prior to sterilisation or reuse. >> To avoid the generation of dust.

storage or transport of packaged drugs >> cytotoxic drugs spilt during administration or disposal >> cytotoxic drugs leaking following disposal >> cytotoxic drugs spilt or leaking during the transport of a patient receiving drug therapy >> cytotoxic contaminated body substances >> cytotoxic contaminated waste. and aims to provide practical advice on setting up a spill management strategy. transported or disposed. Spills may involve: >> cytotoxic drugs in all forms – liquid. Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 page 71 . Ancillary workers should assist only in the containment of a spill while alerting trained personnel. powder.1  Sources of spills A risk assessment should identify all likely areas where there is a risk of a cytotoxic spill. Key to dealing with a spill is the removal of as much of the spilt material as possible with an absorbent prior to decontamination/degradation of the surface with a cleaning agent. This section should be read in conjunction with the following sections: >> Section 5 – Training >> Section 12 – Personal Protective Equipment >> Section 13 – Laundry >> Section 16 – Waste Management Spills of cytotoxic drugs and waste must be contained immediately as they may present a high risk of exposure. with the area being isolated. broken tablets. equipment.15 Spills 15 Spills This section provides a risk management framework to assist in the development of local policies and procedures. work surfaces. Employers should develop a spill management strategy which includes a cytotoxic spills register. bedding and clothing as well as the patient and carer/staff member. tablets or creams >> cytotoxic drugs spilt (or leaking) during preparation. 15. Spills may result in the contamination of floors. Spills may occur wherever cytotoxic drugs and waste are handled. People in the immediate vicinity of a spill should be alerted of the incident immediately and told to stay clear. stored.

chemical absorbent pads. Prior to purchase. safe work procedures for the management of a cytotoxic spill. bonded polyethylene fibre.g. such as used in operating rooms. disposable shoe covers. A cytotoxic drug spill kits contents must be reviewed regularly to ensure its contents have not deteriorated.g.g. Strong alkaline cleaning agent. Spill kits should be co-located with a selection of P2 masks. 150 mL water in bottle.2  Spill kits A risk assessment should be completed for each area to determine the contents of the cytotoxic drug spill kit. Bag ties. dedicated dustpan or disposable scoop. The minimum contents of cytotoxic drug spill kit should include: Item 1 2 3 Documented and laminated instructions/procedure – e. 2 1 1 1 1 1 As required 1 2 2 As required 1 Quantity 1 2 * Shoe covers must be made of impervious material. Locations for storing a cytotoxic drug spill kit should be selected and clearly sign-posted. 4 5 6 7 8 9 Adequate quantities of absorbent materials – e. A small scoop to collect any glass fragments e. Plastic waste bags. do not provide sufficient protection from cytotoxic spills. It is not recommended that P2 masks be included in the cytotoxic drug spill kits. protective mats (bluey or ‘chemomat’). or a ‘P2 mask station’. clearly identified as cytotoxic. with the minimum content requirements listed in the table below.15 Spills 15. these kits should be assessed for applicability to your particular environment and validated before use. P2 masks must be fit tested to each individual. Paper. page 72 Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 .g. Signs to identify and isolate the spill (caution tape can be used to quarantine an area). Note that there are commercially available cytotoxic spill kits. Personal protective equipment: >> latex and/or nitrile gloves >> head cover >> gown or coveralls >> overshoes* >> safety glasses >> full-face chemical splash shield. have been restocked upon use and that it remains appropriate to the designated area. swabs. absorbent towels. spill pillow. Each brand has different fit characteristics and it is the particular brand and size that needs to be identified with an individual after being fit tested. e.

If personnel exposure has occurred.3  Spill containment Key to dealing with spills is to absorb most of the spill onto an absorbent and then deal with any residual cytotoxic agent. Location of spill Health care facilities In the community How to manage See Model Procedure 8 – Spill Management of Cytotoxic Drugs Home and community care patients must be provided with a cytotoxic spill kit with contents appropriate to community care and easy-to-understand instructions. Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 page 73 . Cytotoxic Drug Safety Cabinets or cleanrooms >> See Model Procedure 8 – Spill Management of Cytotoxic Drugs. seek medical ATTENTION AS DEEMED NECESSARY. Instructions should be based on the Model Protocol – Spills. >> Appendix C of AS 2639-1994 Laminar flow cytotoxic drug safety cabinets – installation and use.15 Spills 15. Responsibility for managing the cytotoxic drug spill clean up MUST be allocated to a person that has NOT been exposed. Refer to Section 4 – Staff Health (Emergency Procedures).

5  Model procedures The following model procedures are associated with this section: >> Model Procedure 1 – Health Surveillance of Staff Handling Cytotoxic Drugs and Related Wastes. page 74 Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 . >> Model Procedure 8 – Spill Management of Cytotoxic Drugs.6).4  Reporting procedures Employers should have a system in place for employees to report spills or personnel contamination to management as  soon as possible. Notification of incidents It is a legal requirement of the employer of a workplace to notify SafeWork SA of any work related incident involving hazardous substances. >> Model Procedure 7 – Accidental Exposure to Cytotoxic Drugs and Related Wastes. 15. Part 6. including cytotoxic drugs (OHSW Regs. Employers must notify SafeWork SA of any work related incident involving cytotoxic drugs.15 Spills 15. The following information should be included in an incident report: >> the type of incident >> action taken to manage the spill >> action taken to prevent future occurrences. Division 6.

medical and pathology staff and others may care for patients. and aims to provide practical advice on dealing with contaminated body wastes in the health service. wet nappies and incontinence pads. understood. All body substances may be contaminated with the unchanged drug or with active drug metabolites. The period during which body substances may be contaminated with cytotoxic drugs will differ for individual drugs and patients (see Cancer Institute of NSW: eviQ Cancer Treatments On-line). implemented and maintained. community and home environment. Exposure to cytotoxic waste may occur through: >> removing or inserting catheters >> handling vomitus. and wet dressing materials >> handling bed linen or clothing soiled with a patient’s waste. Ambulance officers. education. To ensure that safe work practices are developed. colostomy or urostomy bags. emptying urinary catheter bags.16  Contaminated Body Wastes 16  Contaminated Body Wastes This section provides a risk management framework to assist in the development of local policies and procedures. nursing. or vomitus bowls. or potentially contaminated with the drug or active drug metabolites >> cleaning spills and surfaces potentially contaminated with a patient’s waste including equipment >> tracheal suctioning. blood. use of appropriate equipment and resources. Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 page 75 . Cytotoxic drugs are primarily eliminated from the patient by renal and hepatic excretion. training and supervision are crucial. safe work practices and personal protective equipment are required to ensure that the risks associated with handling patients are adequately controlled. too. excreta or fluid drained from body cavities >> handling bedpans. urinals. This section should be read in conjunction with the following sections: >> Section 5 – Training >> Section 8 – Transport >> Section 9 – Administration >> Section 12 – Cleaning >> Section 13 – Personal Protective Equipment >> Section 14 – Laundry >> Section 15 – Spills >> Section 17 – Waste Management After cytotoxic drugs have been administered. may be involved in caring for and transporting patients after they have received cytotoxic drug treatment. Workplace design and set-up.

1  Assessment of contaminated body waste To assist in determining whether body wastes are potentially contaminated. excreta or fluid drained from their body cavities >> contain and clean up spills immediately >> use urine hats to avoid sprays and aerosols >> dispose of waste. the patient care sheet should include: >> the name of the drugs >> the route of administration >> the time the drugs were administered >> how the drugs were administered >> the dosage >> the duration of exposure. 16. use equipment to prevent generating aerosols when handling a patient’s vomitus.16  Contaminated Body Wastes 16. such as urine. and heavily exuding dressing materials should be placed into bags and in a cytotoxic waste bin >> take precautions when handling body waste during drug excretion (all staff and carers should be informed) >> use indwelling catheters for incontinent patients >> label all specimens sent to the laboratory as ‘contaminated with cytotoxics’ >> wear personal protective equipment when handling body waste or cytotoxic contaminated equipment. Disposable nappies. page 76 Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 . empty but used colostomy and urostomy bags. vomitus and the contents of colostomy and urostomy bags and incontinence aids into a hot pan flusher or a toilet with a lid. faeces.2  Safe work procedures Safe work procedures should be adopted and emphasise the need to: >> avoid skin contact with a patient’s body substances >> where possible. blood.

disposable gowns.g. gloves.17  Waste Management 17  Waste Management This section identifies the key elements for setting up a waste management strategy. and the materials or equipment associated with the preparation. the requirements of The National Environment Protection (Movement of Controlled Waste between States and Territories) Measures (2010) apply. In the situation where cytotoxic waste may be transported between South Australia and another state or territory. storage and transportation of waste that is pre-classified as a listed waste. taking into consideration the requirements of the environmental protection legislation and the industry standards from the Waste Management Association of Australia and Standards Australia. As cytotoxic waste is hazardous to human health and the environment.1  What is cytotoxic waste? Cytotoxic waste includes any residual cytotoxic drug following a patient’s treatment. These requirements cover the generation. etc >> contaminated personal protective equipment – e. It includes: >> unused cytotoxic pharmaceuticals >> contaminated waste from preparation processes >> sharps and syringes. disposable vomit bags >> dressings and bandages >> linen >> contaminated specimens from the laboratory. shoe covers. Effective separation and segregation of the different waste streams in a clinical setting are essential for compliance with the legal requirements of the EP Act and for protecting the health and safety of workers and the environment. This section should be read in conjunction with the following sections: >> Section 5 – Training >> Section 8 – Transport >> Section 12 – Cleaning >> Section 13 – Personal Protective Equipment >> Section 14 – Laundry 17. Webster packs.g. transport or administration of the drug therapy. it is a listed waste and is subject to the requirements of the South Australian Environmental Protection Act 1993 (EP Act) and gazetted updates and the Environmental Protection (Waste to Resources) Policy (EP Policy) (2010). ampoules and vials >> intravenous infusion sets and containers >> drug bottles and packaging that have been in contact with cytotoxic drugs >> drug administration devices such as dosette boxes. Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 page 77 . respirators >> materials used to clean cytotoxic contaminated equipment or spills >> contaminated body substance receptacles – e.

and involvement of all levels in policy development and implementation >> compliance with legal requirements >> use of an South Australian Environment Protection Authority (EPA) authorised facility able to accept cytotoxic waste >> policies and systems to avoid and minimise waste at the point of generation >> extensive consultation with all those who may be exposed. should also be considered. including those generating the waste. control measures may include: >> elimination. workers and all those who may be exposed to contaminated waste >> maintaining records and tracking cytotoxic waste in accordance with the requirements of the EP Act and Waste Policy >> a transport and disposal flowchart covering internal and external activities from waste generation to treatment and destruction >> appropriate personal protective equipment for identified waste management activities. The strategy should be developed after a comprehensive audit of all sections of the organisation that generate or handle cytotoxic waste. In dealing with cytotoxic waste. Other waste-handling requirements for individual premises may be included in a comprehensive waste management strategy. other related waste derived from clinical settings.17  Waste Management 17. page 78 Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 . Transport and Disposal >> Waste Management Association of Australia’s (WMAA) The Industry Code of Practice for the Management of Clinical and Related Wastes 6th Ed (2010) >> AS/NZ 3816:1998 Management of clinical and related wastes >> HB 202:2000 A management system for clinical and related wastes – guide to application of AS/NZ 3816: 1998. packaging.2  Establishing a waste management strategy Employers should develop and periodically review a comprehensive strategy to safely manage and dispose of cytotoxic waste. 17. storage. administration and disposal >> identification of cytotoxic waste through designated labelling. as cytotoxic waste is often associated with such wastes. Cytotoxic waste should be managed separately from other types of special waste and from other wastes generated in a clinical setting that are not assessed or classified as hazardous waste. Management of clinical and related wastes. waste handlers and waste disposal workers >> appropriate control measures >> regular monitoring and reviewing of strategy. Key references for the management of cytotoxic waste clinical settings are: >> South Australian Environment Protection Authority’s Hazardous Waste Strategy >> South Australian Environment Protection Authority. Key elements of a waste management strategy include: >> designating a person with suitable experience and training to be responsible for ensuring an efficient waste disposal system >> a clear chain of responsibility. EPA Guidelines on Medical Waste – Storage. procedures should be uniform from one organisation to the next.3  Key risk control measures To minimise the risk of exposure to cytotoxic waste. and use of purple bags and containers >> managing cytotoxic waste generated by outpatients and domiciliary services under the direction of the referring health care facility >> training of supervisors. substitution or isolation of identified high risk activities >> engineering or automated methods to minimise the amount of handling >> safe systems of work for identified waste management activities – segregation. To streamline work activities and provide consistent safe practices for all those involved in waste management. transport. such as clinical waste and pharmaceutical waste.

particularly if different waste management contractors are used. containment and segregation Identification To minimise the risk of exposure to cytotoxic materials and to ensure the safe and correct disposal of cytotoxic waste. such as a wheelie bin (of the appropriate colour and labelling). All cytotoxic waste should be placed into compliant bags or containers that are appropriately labelled. Segregation Cytotoxic waste should be segregated from other waste by the development and implementation of the following control measures: >> development of procedures in consultation with those who generate cytotoxic waste and those responsible for the provision of support. Containment The following control measures should be implemented: >> package the waste in a hard walled container for transport to the waste disposal facility >> a leak proof plastic bag will be sufficient for use in the home and should be labelled appropriately >> the storage of sharps in a rigid walled container as per AS 4031-1992 – Non-reusable container for the collection of sharp medical items used in healthcare areas.17  Waste Management 17. the identification of contaminated waste is essential. transport and disposal services >> incorporation of efficient waste disposal >> segregation of waste at the point of generation >> appropriate signage at all collection and storage areas >> separation of cytotoxic waste from general and clinical waste during internal transport and storage >> ensuring that non-rigid receptacles are placed in a rigid walled container.4  Identification. Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 page 79 . Storage areas should be appropriately sign-posted to distinguish cytotoxic waste from general or infectious waste. The following identification of cytotoxic waste is required: >> containers and bags must be purple/lilac >> the container must be marked with the with the cell in late telophase symbol in white     >> the words ‘CYTOTOXIC WASTE’ must be clearly displayed. for transport to a collection area >> containers and bins secured with mobile or fixed stands.

insect and verminproof and leakproof (if only storing medical sharps. All incinerators used for the treatment of cytotoxic waste must be licensed with the EPA and meet the prescribed standards. shatterproof. Patient waste such as urine. Under the EP Act any person who carries on an activity in which medical waste is produced must be licensed. incineration (at 1100°C) is the only approved technology for treating cytotoxic waste. transport and disposal. 17. Requirements for a licensed facility under the EP Policy include: >> storing the medical waste in containers that: –– are weatherproof. but must be leak resistant) –– are cleaned and disinfected immediately after use –– have a label clearly indicating the nature of the contents –– are stored in a secure location >> equipment on hand ready to clean up spills >> storage of medical sharps in containers that comply with Australian Standards >> disposal of medical waste as soon as practicable >> advising the medical waste transporter of the nature and hazards of the medical waste and any precautions to be taken during collection. At the time of writing this guide. page 80 Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 . not being the practice of pathology >> retail pharmacy >> domestic activity >> dental practice >> operation of a nursing home >> veterinary practice >> operation of a hospital with a capacity of less than 40 beds >> operation of an immunisation clinic. faeces. Note: A licence is not required if the medical waste is produced in the course of any of the following activities: >> medical practice. they are classified as clinical waste and must be handled accordingly >> the operation of on-site sewerage treatment systems such as septic tanks might be affected by cytotoxic waste.5  Requirements and licensing for handling or storage of cytotoxic waste Medical waste is a listed waste under the EP Act. the contractor must be a licensed waste transporter authorised to collect and transport medical waste by the EPA or a council. 17.6  Waste disposal and treatment Waste treatment of the cytotoxic waste must render it inactive or no longer hazardous and must meet standards to protect the environment. Further information can be obtained from the relevant sewerage authority >> where materials such as incontinence aids are contaminated with expressible blood. Note: If using a contractor to dispose of cytotoxic waste.7  Model procedures The following model procedure is associated with this section: >> Model Procedure 9 – Managing Cytotoxic Waste. The following limitations should be noted: >> sewerage authorities do not allow disposal of incontinence aids to sewer. Further information should be obtained from the manufacturer or supplier of the system.17  Waste Management 17. or originate from patients with communicable diseases. container does not have to be leakproof. vomitus and the contents of colostomy and urostomy bags may be disposed of in the normal sewage system.

18  Animal Research Facilities 18  Animal Research Facilities Research staff. >> Provide a cytotoxic waste disposal bin. 18. This section should be read in conjunction with the following sections: >> Section 5 – Training >> Section 8 – Transport >> Section 12 – Cleaning >> Section 13 – Personal Protective Equipment >> Section 14 – Laundry >> Section 15 – Spills >> Section 16 – Contaminated Body Wastes >> Section 17 – Waste Management In animal research.1  Establishing an animal care area >> Ensure a secure area accessible by authorised personnel only. veterinary nurses. transported or disposed. Refer to other sections and appendices for related information. >> Provide safety data sheets (or MSDS) for personnel to access. exposure to cytotoxic drugs can occur when cytotoxic drugs and related waste are handled. Many of the procedures and control measures used in human patient management can be applied in these research facilities to ensure the health and safety of personnel. exposure can also occur through contact with animal waste during treatment or cleaning procedures. animal attendants and cleaners may be involved with the handling of cytotoxic drugs and related wastes in dealing with animals held in animal research facilities. administered. The following Information must be provided to research veterinary attendees as a part of their cytotoxic drug handling training session: >> reasons for taking precautions in the handling of cytotoxic drugs and related waste >> how to store cytotoxic drugs >> equipment which might be needed for the animal’s care >> route of excretion of drugs and how to dispose of body waste >> the approximate duration that cytotoxic residues might be excreted after drug administration >> spills and procedures for cleaning up >> laundering contaminated bedding >> emergency procedures for accidental exposure or accidental ingestion of cytotoxic drugs >> how to dispose of drugs that are no longer required. stored. veterinarians. >> Provide a cytotoxic spill clean up kit. Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 page 81 . In addition.

>> Use purpose-designated or disposable equipment. For guidance on cleaning agents refer to Section 12 – Cleaning. >> Dispose of cytotoxic waste as per Section 17 – Waste Management. >> If equipment is non disposable. page 82 Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 .3  Safe work procedures Standard operating procedures should be developed with the assistance of the treating facility and should stress the need to: >> avoid breaking tablets when administering cytotoxic drugs >> monitor and contain the urinating habits of the animal where possible >> dilute animal excretions by gently hosing down affected areas >> keep animals confined to their caged areas/bedding during periods when the drug may be excreted >> clean up faeces by scooping with a disposable shovel and disposing appropriately >> clean or discard soiled articles after use >> wash hands following any contact with cytotoxic drugs. it MUST be cleaned.2  Equipment required Suitable equipment designed to reduce the risk of exposure should be employed. This is to include a cytotoxic spill kit which must be made readily accessible. 18. Further animal care equipment which may be considered to minimise personnel exposure may include: >> animal cages designed to flush excreta directly into the waste sewerage system >> disposable scoops or equivalent for faecal clean up >> disposable bedding material/articles. The contents of the cytotoxic spill kit are outlined in Section 15 – Spills. Animal cages and cleaning >> Animal cages must be signed with “receiving cytotoxic drug therapy“. >> Ensure animals are washed down immediately with water if they become contaminated. animals receiving treatment or related waste products >> dispose of contaminated items (such as gloves) as cytotoxic waste.18  Animal Research Facilities 18.

Appendix 1 – Glossary Appendices Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2011 page 83 .

constructed and used in such a way as to minimise the introduction. An approved industry code of practice is advisory rather than mandatory. formerly known as National Occupational Health and Safety Commission (NOHSC) activity performed so as to exclude micro-organisms work space free from micro-organisms in the working area aseptic manipulation aseptic suite B BCG biological monitoring C carcinogen cleanroom an attenuated. fluids or exhaled air of a person substance or physical agent with the potential to cause cancer in certain circumstances or to make cancer more likely to occur a room with environmental control of particulate contamination. Safety and Welfare Regulations 2010 (OHSW Regs) with respect to occupational health. labelling.g. multiple sclerosis and some ophthalmic conditions a spill of cytotoxic drugs or related wastes page 84 Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 . temperature and humidity. particularly those that reproduce rapidly body fluid/substance that is contaminated with cytotoxic drugs following drug administration drugs that cause the death of certain cells and that are used to treat conditions such as cancer. training Australian code for the transportation of dangerous goods by road and rail. generation and retention of particles inside the room an approved industry code of practice is a practical guide to employers and others who have obligations under the Occupational Health. safety and welfare an approved industry code of practice should be used in conjunction with the requirements of the OHSW Act and the OHSW Regs but does not have the same legal force. live culture preparation of the Bacillus of Calmette and Guerinstrain of Mycobacterium bovis measurement and evaluation of hazardous substances or their metabolites in the body tissue. injury and disease in Australia. However. rheumatoid arthritis. as published by the Commonwealth of Australia and amended from time to time ‘as low as reasonably achievable’ bag made of artificial fibres spun from a constituent of kelp – the fibres become gelatinous when moist and so are biodegradable Australian Safety and Compensation Council – national body that leads and coordinates national efforts to prevent workplace death.Appendix 1 – Glossary Appendix 1 Glossary A administrative control ADG Code ALARA alginate bag ASCC a type of control measure which involves minimising the risk through the use of procedures or instruction e. in legal proceedings under the OHSW Act or OHSW Regs. SOPs. failure to observe a relevant approved industry code of practice is admissible as evidence concerning an offence under the OHSW Act or OHSW Regs code of practice cytogenic cytotoxic cytotoxic contaminated body waste cytotoxic drug cytotoxic spill to do with the formation of cells harmful to cells of the body. Safety and Welfare Act 1986 (OHSW Act) and the Occupational Health.

nor cause undue discomfort to. should neither impair the health of. nearly all workers.Appendix 1 – Glossary cytotoxic waste waste contaminated with cytotoxic drug or metabolites – it includes any residual cytotoxic drug that remains following patient treatment and any materials or equipment potentially contaminated with cytotoxic drug E elimination employer employee engineering control exposure standards a type of control measure in which the hazard is eliminated a person who employs persons under contracts of employment or apprenticeship an individual who works under a contract of employment or apprenticeship a type of control measure which uses technological means to isolate or remove hazards exposure standards are the calculated airborne concentrations of individual chemical substances which. includes biological monitoring. The exposure standards serve as guides only and the control measures selected must ensure that the applicable exposure standard is not exceeded unplanned escape of a liquid from a vessel or tube into surrounding body tissues extravasation H hazard hazardous substance a hazard is the potential for a substance to adversely affect the health and safety of people in the workplace substance listed in the List of designated hazardous substances produced by the Australian Safety and Compensation Council (ASCC). Note: The list and the criteria are now part of the electronic database called the Hazardous substances information system (HSIS) administered by the ASCC regularly maintained list of the product names of all hazardous substances used in a workplace accompanied by an up-to-date safety data sheet for each substance monitoring of individuals for the purpose of identifying changes to health status due to occupational exposure to a substance the monitoring of persons to identify changes (if any) in their health due to exposure to a hazardous substance. although sterile distilled water needs to be added before use M MABs manufacturer see Monoclonal antibodies an obligation holder under the OHSW Act Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 page 85 .97 per cent efficient in removing an aerosol of particles with a diameter of 0. but does not include the monitoring of atmospheric contaminants filter that is made to be at least 99.3 micrometres when tested with a standardised procedure hazardous substances register health monitoring health surveillance HEPA (high efficiency particulate air) filter I intravesical infusion isolation L lyophilised cytotoxic drugs introduction of liquid through a urinary catheter into the bladder a type of control measure that uses barriers to prevent exposure cytotoxic drugs preserved during manufacture by being rapidly frozen and dehydrated in a vacuum – they do not require refrigeration. according to current knowledge. or a substance that meets the criteria for a hazardous substance set out in the Approved criteria for classifying hazardous substances declared by the ASCC.

connections and accessories to plant personal protective equipment under the OHSW Act. A monoclonal antibody therefore consists of a single type of protein (antibody). building or part of any building >> any vehicles. Monoclonal antibodies have been developed for targeting specific tissues and are use in treating certain cancers and other conditions see material safety data sheet substance with the potential to change DNA. includes any place and. and any components. humanised proteins with very specific cell binding properties. includes: >> any land. intraperitoneal. vessel or aircraft >> any installation on land. fittings. implement and tools. They are produced by cloning numerous identical cells from a single parent cell. intravesical percutaneous endoscopic gastostromy a route of exposure – taking in cytotoxic drug or waste through a puncture of the skin clothing. intramuscular. on the bed of any waters or floating on any waters >> any tent or movable structure a legal requirement to take specified action under the OHSW Act or OHSW Regs exposure to cytotoxic drugs during a work activity an occupational health and safety committee or committees established by the employer and employees for the place of work or the employer’s undertaking an occupational health and safety representative/s elected by the employees a surgically created artificial opening. subcutaneous. appliances.Appendix 1 – Glossary material safety data sheet (MSDS) Monoclonal antibodies see safety data sheet laboratory produced. in particular. usually created through the abdominal wall. equipment and substances designed to be worn by a worker to protect them from the risk of injury or illness measure of how strongly acidic or basic a substance is when dissolved in water – acids have a pH less than 7. personal protective equipment. such as intravenous. equipment. to allow the discharge of bodily wastes National Occupational Health and Safety Commission – see ASCC (Australian Safety and Compensation Council) PEG percutaneous injury personal protective equipment pH place of work plant PPE premises page 86 Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 . the part of a body cell that controls its growth and multiplication – being a mutagen also gives a substance the potential to cause cancer MSDS mutagen N NOHSC O obligation occupational exposure OHS committee OHS representative ostomy P parenteral administration of cytotoxic drug by methods other than through alimentary canal. intrapleural. pressure vessels. bases have a pH greater than 7 premises where persons work (under the OHSW Act ) includes machinery.

Appendix 1 – Glossary preparation (of drugs) handling of cytotoxic drugs up to the stage of administration to a patient – includes manufacture. preparing a pre-measured single dose unit (e. the giving of priorities to various risks. the frequency and duration of exposure. and crushing or dissolving tablets or emptying capsules to prepare part doses R respirator respiratory protective equipment risk see respiratory protective equipment equipment designed to prevent inhalation of contaminated air a risk is the likelihood that a substance or hazard will cause illness or injury in the conditions of its use – the risk to health and safety usually increases with the severity of the hazard. administrative or personal protective equipment) and their effectiveness. administrative controls. control measures in use (engineering. ranked from most desirable form of control to least desirable – elimination.g. operational and company or institutional requirements – SOPs should be written for any processes an individual or group performs See safety data sheet free from living organisms a type of control measure that substitutes a hazardous substance or process with a less hazardous one an obligation holder under the OHSW Act SHPA specific test safe work procedure(s) SDS sterile substitution supplier Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 page 87 . personal protective equipment analysis and judgment that uses the results of risk assessments to produce decisions about environmental actions to be initiated – i. health hazard information. forming tablets and capsules. engineering controls (e. drawing liquid cytotoxic drug into a syringe from a vial). and conditions of use control of factors associated with an increase in the probability of a toxic effect occurring – there is an ordered priority for selection of the means to minimise the level of an occupational exposure. isolation.e. precautions for use and safe handling information Society of Hospital Pharmacists of Australia diagnostic or screening test that correctly indicates disease is absent in a high proportion of persons tested that do not have the disease a set of instructions or steps to be followed to complete a job safely and in accordance with legal.g. local exhaust ventilation). substitution. the amount of hazardous substance used and the duration and frequency of exposure evaluation of the probability that an adverse health effect may occur under the conditions that are likely to develop – a risk assessment of the use of a substance will take account of its toxicity. chemical and physical properties. the delivery of risk-averting outcomes and the continuing audit of outcomes and trends see respiratory protective equipment risk assessment risk control risk management RPE S safety data sheet a document that describes the properties and uses of a substance – identity.

a work activity or specified high risk plant the recurrence. a work activity or specified high risk plant workplace incident an incident resulting in a person suffering a work injury or a work-related injury or an incident resulting in a dangerous event cytotoxic drugs that induce tissue damage and necrosis diversion of urine away from a diseased or defective bladder through a surgically created opening in the skin of the abdominal wall includes administration. acceleration. if the injury was caused by work. movement and disposal of cytotoxic drugs and related waste the last of four stages in the division of a single body cell into two identical cells agent capable of causing harm to an embryo or foetus to produce birth defects page 88 Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 .g. a workplace. and it was caused by work. 1998) – e. storage. exacerbation or deterioration of an existing injury in a person if first aid or medical treatment is required for the injury. a workplace. a workplace. aggravation. a work activity or specified high risk plant any serious bodily injury.1 are listed in the ADG code as UN 2810 or UN 2811 urostomy use (of cytotoxic drugs) V vesicants W work workplace work injury work as an employee or as a self-employed person under the OHSW Act see place of work an injury to a person that requires first aid or medical treatment if the injury was caused by work. column 1 of the ADG code (6th edition. handling.Appendix 1 – Glossary T telophase teratogen U UN Number in relation to dangerous goods: >> the number assigned to the dangerous goods by the UN Committee of Experts on the Transport of Dangerous Goods >> the substance identification serial number shown in the list of dangerous goods mentioned in appendix 2. cytotoxic drugs that meet the classification criteria of Class 6. preparation.

Canberra. Standard for the uniform scheduling of medicines and poisons. Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 page 89 . EPA Guidelines on Medical Waste – Storage. >> Environmental Protection (Waste to Resources) Policy 2010. >> Dangerous Substances Act 1979. >> Safe Work Australia. Department of Health and Ageing. List of designated hazardous substances in Hazardous Substances Information System (HSIS) (previously available as List of designated hazardous substances [NOHSC: 10005 (1999)]). >> Environment Protection Regulations 2009. >> South Australian Environment Protection Authority. >> Controlled Substances (Poisons) Regulations 1996. standards.Appendix 2 Information Sources Appendix 2 Information Sources The following acts. >> Dangerous Substances Regulations 2002. >> Occupational Health. >> Code of practice for the labelling of workplace substances 2006.aspx (previously available as Adopted national exposure standards for atmospheric contaminants in the occupational environment [NOHSC: 1003 (1995)].gov. >> National Drugs and Poisons Schedule Committee. Hazardous Waste Strategy. >> The National Environment Protection (Movement of Controlled Waste between States and Territories) Measures 2010. >> Safe Work Australia. >> Dangerous Substances (Dangerous Goods Transport) Regulations 2008. Approved criteria for classifying hazardous substances in Hazardous Substances Information System (HSIS) (previously available as Approved criteria for classifying hazardous substances 3rd Edition [NOHSC: 1008 (2004)]). National Code of Practice for the Preparation of Material Safety Data Sheets 2nd Edition [NOHSC: 2011 (2003)]. >> Safe Work Australia. Federal Department of Transport and Communications. Safety and Welfare Regulations 2010. >> South Australian Environment Protection Authority. Australian Government. >> Controlled Substances Act 1984. Codes and Standards >> Code of practice for the control of workplace hazardous substances 2006. >> International Air Transport Association (IATA). South Australian Acts and Regulations >> Occupational Health.ascc. codes of practice and guidance notes apply to work involving handling of cytotoxic drugs and cytotoxic waste.au/Default. Safety and Welfare Act 1986. regulations. >> Federal Office of Road Safety. >> Environment Protection Act 1993. Transport and Disposal. Australian Code for the Transport of Dangerous Goods by Road and Rail (ADG code). Fluids and Lines August 2010. >> Australian Commission on Safety and Quality in Health Care. Dangerous Goods Regulations 51st Edition. Australian Government Publishing Service. National Recommendations for User-applied Labelling of Injectable Medicines. Adopted national exposure standards for atmospheric contaminants in the occupational environment in Hazardous Substances Information System (HSIS) on http://hsis. >> Safe Work Australia.

Central Training Manual – Clinical Pharmacy Services – Cancer and Chemotherapy. >> AS 2243. >> SA Health.2-2006 Safety in laboratories – Chemical aspects. An Integrated Model for South Australia. >> AS 4031-1992 Non-reusable containers for the collection of sharp medical items used in health care areas.10-2004 Safety in laboratories – Storage of chemicals. >> AS 4273-1999 Guidelines for the design. >> AS/NZS 1715-2009 Selection. >> AS 2243. page 90 Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 .6-2010 Safety in laboratories – Plant and equipment aspects. Risk Management. Standards for Chemotherapy Services in South Australia. Performance Review and Development (PR&D) Planning Record http://in. >> SA Health.sa.4-1998 Safety in laboratories – Ionizing radiations.3-2010 Safety in laboratories – Microbiological aspects and containment facilities.5-2004 Safety in laboratories – Non-ionizing radiation – Electromagnetic. Risk Management Policy. >> SA Health. Occupational Health.9-2009 Safety in laboratories – Recirculating fume cabinets. Standards Australia.health. >> AS/NZS 2243. installation and use of pharmaceutical isolators.8:2006 Safety in laboratories – Fume cupboards. >> SA Health.sa. >> AS 4273-1999/Amdt1-2000 Guidelines for the design.7-1991 Safety in laboratories – Electrical aspects. >> AS 2567-2002 Laminar flow cytotoxic drug safety cabinets.health. >> AS 4031-1992/Amdt1-1996 Non-reusable containers for the collection of sharp medical items used in health care areas. >> SA Health.gov. Performance Review and Development (PR&D) Guide Information Sheet 7 http://in. >> HB 436-2005/Amdt 1-2005 Risk management guidelines – Companion to AS/NZS 4360: 2004. Statewide Framework for Chemotherapy Education and Assessment. Central Training Manual – Production Pharmacy Services – Cytotoxic and Other Hazardous Drugs. >> AS 2639-1994 Laminar flow cytotoxic drug safety cabinet – Installation and use. Management of clinical and related wastes.Appendix 2 Information Sources Australian Standards >> AS 1386-1989 Cleanrooms and clean workstations. >> HB 202-2000 A management system for clinical and related wastes – Guide to application of AS/NZS 3816-1998. >> AS/NZS 2243. Safety and Welfare and Injury Management Policy. >> AS 2243. >> AS 2243. >> AS/NZS 1716-2003/Amdt 1-2005 Respiratory protective devices. >> AS/NZS 2982.au/wc.au/wc. >> AS 2243. sound and ultrasound. >> AS 2243. >> AS/NZS 2243. installation and use of pharmaceutical isolators.gov. >> AS/NZS 3831–1998 Waste management – Glossary of terms. SA Health Documents >> SA Health. Standards Australia. >> AS/NZS 2243. >> SA Health.1-2005 Safety in laboratories – Planning and operational aspects.1-2010 Laboratory design and construction – General requirements. >> SA Health. use and maintenance of respiratory protection equipment.

Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 page 91 . >> Cancer Australia. The Industry Code of Practice for the Management of Clinical and Related Wastes 6th Ed 2010. Dispensing and Administration of Cancer Chemotherapy 2008. Safe Management of Wastes from Health Care Activities 1999. Guidelines for the Safe Prescribing. >> Waste Management Association of Australia (WMAA). >> Cancer Institute of NSW: eviQ Cancer Treatments On-Line (accessed Sep – Nov 2010). Standards of practice for the safe handling of cytotoxic drugs in pharmacy departments. >> US CDC/NIOSH. Cytotoxic Drugs and Related Waste – Risk Management Guide 2008. >> Australian Commission on Safety and Quality in Health Care. >> Society of Hospital Pharmacists of Australia. >> PIC/S. Australian Formulary and Handbook 21st Edition 2010. Standards of practice for the transportation of cytotoxic drugs from pharmacy departments. 2 December 2005. >> Clinical Oncology Society of Australia. J Pharm Pract Res 2005 35(1): 44-52. EdCaN On-line. >> Pharmaceutical Society of Australia (PSA). >> Cancer Nurses Society of Australia. Guidelines on Occupational Exposure to Antineoplastic Agents www. >> Queensland Department of Industrial Relations. 13 Suppl:1-81. Standards of Practice: Safe Handling of Cytotoxics. Handling Cytotoxic Drugs in the Workplace: Managing Health and Safety Risks Associated with the Handling of Cytotoxic Drugs in the Healthcare Industry 2003. Guide for Good Manufacturing Practice of Medicinal Products in Healthcare Establishments (PE010-3) 2008. Aust J Hosp Pharm 2000 30(3): 116-17. >> World Health Organisation. Competencies for Health Surveillance 1998. >> The Australian National Cancer Nursing Education Project.html#b accessed 09 Nov 2010. Guide for the Handling of Cytotoxic Drugs and Related Waste 2005. Medication Alert No. >> National Occupational Health and Safety Commission. Position Statement on the Minimum Education Requirements for Nurses involved in the Administration of Anti-Cancer Drugs within the Oncology and Non-Oncology Setting 2010. >> Society of Hospital Pharmacists of Australia.cdc. Training Competencies: Handling Cytotoxic Drugs in Health Care Establishments 1997. Guidelines on Handling Hazardous Drugs Am J HealthSyst Pharm 2006 63. International >> International Society of Oncology Pharmacy Practitioners (ISOPP). >> WorkCover Victoria. Cancer Leaning On-line. J Oncol Pharm Pract 2007. >> WorkSafe Victoria.gov/niosh/topics/ antineoplastic/sampling. >> American Society of Health-System Pharmacists (ASHP).Appendix 2 Information Sources Additional Reference Materials Australian >> WorkCover NSW.

1989. 82:988-991. 2010. Monitoring of exposure of nursing and pharmacy personnel to cytotoxic drugs: Urinary platinum as markers of absorption. >> Lunn G and Sansone EB. Int Arch Occup Environ Health.P et al. 42:259-266. >> Venitt. >> Castegnaro M et al. 1993. >> Siderov J et al. 70:378-384. J Health Saf Environ 2010. 2008. 1997. aclarubicin. Int Arch Occup Environ Health. Ann Occup Hyg.S. Reductive destruction of dacarbazine. ifosfamide and melphalan. Surface contamination of chemotherapy preparation areas with cyclophosphamide in Australian hospital pharmacy departments. Am J Hosp Pharm. 20(4):347-359. et al. 1. the Lancet 2003. 53(3):351-259. >> Lunn G et al. 1998. >> Barek J et al. 1997. >> Sessink. MC et al. >> Touzin K et al. and daunorubicin. doxorubicin. Ann Occup Hyg. J Pharm Sci. 44:2519-2524. procarbazine hydrochloride. Chemical degradation of wastes of antineoplastic agents amsacrine. azathioprine. J Pharm Pract Res 2009. page 92 Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 . isoniazid. >> Hansel S et al. J Infect Dis 2003 188(9): 1332-1335. 1993. 37(4):271-276. asparaginase and thiotepa. pirarubicin. Ann Occup Hyg. >> Roberts S et al. 18:133-137. 12:95-104. Cyclophosphamide contamination observed on the surface of drug vials and the efficacy of cleaning on vial contamination. Drugs hazardous to health workers: Evaluation of methods for monitoring occupational exposure to cytostatic drugs. 69:109-114. 2006. J Pharm Sci. Drug safety 1999. J Oncol Pharm Practice. Nosocomial Mycobacterium bovis-bacille Calmette-Guérin infections due to contamination of chemotherapeutics: case finding and route of transmission. 323:74-77. 1987. Decontamination methods for cytotoxic drugs. Surface contamination from cytotoxic chemotherapy following preparation and administration. Studies on the decontamination of surfaces exposed to cytotoxic drugs in chemotherapy workstations. J Pharm Pract Res 2007. J Clin Pharm and Therap. >> Tkaczuk M et al. Chemical degradation of wastes of antineoplastic agents: cyclophosphamide. >> Benvenuto JA et al. 39:95-9. Chemical degradation of wastes of antineoplastic agents 2: Six anthracyclines: idarubicin. >> Wren AE et al. Surface contamination of cytotoxic drug 5-fluorouracil (5-FU) and decontamination. >> Touzin K et al. 26(2):171-181. and iproniazid. Pilot study comparing the efficacy of two cleaning techniques in reducing environmental contamination with cyclophosphamide. 1-7. epirubicin. Degradation and inactivation of antitumor drugs.Appendix 2 Information Sources Technical Reports >> Vos. >> Lee S-G et al. 78:652-659. Degradation and disposal of some antineoplastic drugs. A. Use of a bioluminescent technique to monitor the inactivation of methotrexate with chlorine-based agents.

especially when external exposure is probable. it should be noted that there are a number of intrinsic difficulties with performing sound risk assessments on MABs. Oncol Pharm Pract. The potential level of occupational exposure is difficult to quantify. There is increasing concern that relatively small numbers of predominantly female nurses of child bearing potential will be handling an increasing range of MABs and increasing numbers of doses over the coming years. 17(1):68-80. MABs acting at molecular level are new agents and their interactions with their cellular targets and the possible cascaded consequences of those interactions down to nuclear level are not clearly understood. 2. These difficulties include:2 >> conventional toxicity tests do not apply to MABs because they are humanised proteins >> criteria for the definition of hazardous drugs are not necessarily adequate for proteinogenic drugs >> mechanisms of action of some MABs are not know in detail >> there is a lack of human data. Assessing the risk to health care staff from long-term exposure to anticancer drugs – the case of monoclonal antibodies. J. In 2010. Exposure during occupational handling is lower but chronic. I.Appendix 3 – Monoclonal Antibodies (MABs) Appendix 3 Monoclonal Antibodies (MABs) There are currently no available Australian guidelines on the safe handling of monoclonal antibodies (MABs) in the clinical setting. predominantly because they are not required to provide this information for licensing purposes. Other jurisdictions have published guidance on the handling of MABs. only pulmonary uptake is supposable which is limited by low-level pulmonary exposure and a maximum of 5% adsorption >> no maximum acceptable levels of internal exposure during long term (occupational) exposure is known as yet >> precautionary measure should be taken to avoid external and internal exposure of workers >> injuries and accidental uptake must be avoided >> prohibitions and restrictions as outlined in the European Directive 2004/37/EC with regards to pregnant staff and nursing mothers must be adhered to. Pan Birmingham Cancer Network Site Specific Groups (UK). NHS Pharmaceutical Quality Assurance Committee (UK). Manufacturers have no formal data on the possible risks to staff of handling monoclonal antibodies. The extrapolation of toxicity data obtained in therapeutic situations can be misleading. there is no appreciable in-use data on the risks of chronic low level exposure.1 As these drugs have only been in clinical use for a relatively short period of time. which are a legal requirement.3 Key considerations recommended in the guidance produced by the British National Health Service in 2008 include: >> given the animal origin of MABs. are available but tend to be geared towards industrial scale handling of raw material and are not easily translated to the clinical setting. Guideline for the preparation or manipulation of Monoclonal Antibodies (MABs) used in the Treatment of Cancer (November 2008). Guidance on the Safe Handling of Monoclonal Antibody (MAB) Products 4th Edition (January 2008). they should be treated as potential biohazards >> consideration should be given to protect the healthcare professional from contamination and the patient from cross contamination >> there is a theoretical risk of the healthcare worker sensitisation. References 1. Safety Data Sheets. G and Krämer. Halsen. Although a risk management/assessment is generally advocated to determine procedures for the safe handling of any drug. 2010. and that they are potentially receiving low level exposure or potentially exposing an unborn foetus to these agents. 3. The results of animal experiments may not be indicative of the effect in humans as MABs are humanised products >> the toxicity of MABs has been assessed according to effect observed after parenteral application of therapeutic doses. It should be noted that cytotoxic drugs were not considered a handling hazard for many years until their mechanisms of action on genetic material were elucidated and epidemiological evidence emerged linking them to late adverse effects. Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 page 93 . a literature review of MABs conducted by Halsen and Krämer2 to assess the risk to health care staff from long-term exposure to MABs concluded that: >> all MABs evaluated were toxic for reproduction with some also exhibiting mutagenic or sensitising activity >> with respect to occupational activity.

refer to Section 2.Hazardous Substances (Cytotoxic Drugs) Register Organisation: Site/area: Person compiling register: Date: Product name Location or process where product is used Notification to SafeWork SA? Yes/No/ Not required Safety Data Sheet* Yes/No Date Risk assessment Yes/No Date Actions/Comments Appendix 4 – Hazardous Substances (Cytotoxic Drugs) Register *Safety Data Sheet should be no more than five years old For information on the Appendix. Date for review of register: page 94 Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 Appendix 4 .

FORM OF THE SUBSTANCE Liquid      Solid tablet     Powder     Creams. Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 page 95 . INCOMPATABILITY WITH VARIOUS SUBSTANCES Comments: 5.Appendix 5 – Risk Assessment Tool for Cytotoxic Drugs and Related Wastes Appendix 5 Risk Assessment Tool for Cytotoxic Drugs and Related Wastes Rationale: This risk assessment is required to be completed. Name of assessor: Date of assessment: Name of HSR (if involved in consultation): Site/location: Department: Product name: Supplier/agent: Safety Data Sheet (SDS/ MSDS) available? Current (Within 5 years of issue): Yes Yes No No Date of SDS:   Describe how and where this cytotoxic substance will be used: Please answer the following questions. in consultation with the work area Health and Safety representative where appropriate. HEALTH EFFECTS – During the preparation and waste disposal phase Can the chemical enter the body via: Ingestion: Yes Comments: No     Inhalation: Yes Yes No No    Skin absorption: Yes No Eyes / Mucus Membrane absorption: IF THIS PRODUCT IS CURRENTLY USED. Refer to the SDS 1. OR IS INTENDED TO BE USED. CHEMICAL PROPERTIES Flammable: Yes Toxic: Comments: Yes No No Corrosive: Yes No No Carcinogen: Yes No Oxidising agent: Yes 4. Dangerous goods classification Yes No Classification: No (*Note: Treat all chemical substances as being hazardous until otherwise defined) 2. PLEASE CONTINUE WITH ASSESSMENT. ointments and lotions for topical application 6. Is it a hazardous substance (according to WorkSafe criteria)? Yes Chemically active ingredient/s: 3. prior to introducing or trialling any cytotoxic drug to: >> determine what precautions are required to make the substance safe for preparation and use >> ensure appropriate processes are in place to manage related waste >> support development of safe work instructions/procedures (SOP).

Appendix 5 – Risk Assessment Tool for Cytotoxic Drugs and Related Wastes

Note that the supplier SDS may provide information for the management of large quantities of the substance. This does not necessarily apply when using small quantities. When completing this assessment, please take into consideration: >> the quantity of the substance kept >> the amount used in one application >> the purpose of substance

Risk Assessment
STEP 1 >> Is the facility required to be licensed under the Environmental Protection Act? >> If ‘yes’, is the facility currently licensed?

Yes Yes Yes Yes Yes Yes Yes

No No No No No No No

     NA  NA  NA    

>> Is a cytotoxic drug safety cabinet available, if drug preparation is required?
(Refer to Section 6.3 – Engineering controls / ventilation) (Refer to Section 6.3 – Engineering controls / ventilation)

>> Is a secondary barrier (high efficiency particulate air – HEPA) filter available? >> Is the use of a closed system drug transfer device, or other similar device available? >> Does the substance require any special storage (bunding/locked cupboard/placarding)? Comments: >> What Personal Protective Equipment (PPE) is required as per manufacturer’s recommendations in SDS? Comments: >> Is there an effective process for managing spills?
(Refer to Section 15 – Spills)

Yes

No No No No No No No

             

>> Can waste products be disposed of safely in accordance with waste management legisaltion? Yes
(Refer to Section 17.4 – Waste Management)

>> Are any special transport requirements required for transporting substance? >> For new substances, will staff need to be trained in the following?  –– Safe and effective use of the product –– Proper, safe and effective use and maintenance of PPE –– First aid and emergency procedures

Yes Yes Yes Yes

>> Has environmental monitoring, where cytotoxic drugs are prepared, been previously conducted? Yes

STEP 2 Complete Job Safety Analysis / Action Plan – Attachment A, in conjunction with the following attachments, to identify actions required, to ensure substance is safe for use: >> Attachment B – Risk Matrix >> Attachment C – Hierarchy of Controls (use this information on safety controls to determine/or review current control measures) >> Attachment D – Decision Making Process for the Safe Handling of Cytotoxic Drugs. STEP 3 – Assessment Outcome From the risk assessment process, is this substance safe to use? If determined to be not safe, can an alternative arrangements be organised?
(Refer to Section 6.1 – Alternative Supply Arrangements).

Yes Yes

No No

STEP 4 – Sign Off Name (Manager): Name (HSR): Signature: Date: Signature: Date: Review Date (Every 2 years with review of SOP, or when SDS is due to be updated i.e. every 5 years): STEP 5 >> Develop safe operating procedure/instruction (SOP), or review established SOP to determine suitability >> Train staff in SOP >> Review Risk Assessment Tool and SOP as per scheduled review date
page 96 Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012

Appendix 5 – Risk Assessment Tool for Cytotoxic Drugs and Related Wastes

Job Safety Analysis/Action Plan
Use of Cytotoxic Drugs and Management of Related Wastes
Refer to the following information: Supplier Safety Data Sheet (SDS); Cytotoxic Drug and Waste Management Risk Assessment Form; Attachment B – Risk Matrix: Attachment C – Safety Controls Management using Cytotoxic Drugs (Hierarchy of Controls); Attachment D – Preparation & Dispensing: Decision Making Process STEP 1: Complete the following analysis to determine if the substance is safe to use for preparation of cytotoxic drugs, and handling of related wastes, and to provide a basis for developing the safe working procedures (SOP). Job/Process/Task: Names – Assessment Team: Site/Location: SUBSTANCE(S) To be used DESCRIPTION OF USE
(Briefly describe tasks or situations where substance is used and/or exposure may occur)

Department: ROUTES OF EXPOSURE/TYPE OF RISK EXISTING SAFETY MEASURES IN PLACE
(Available/ in place e.g. laminar flow cabinet; SOPs, PPE)

Date: RISK SCORE
(Refer Attachment B) Take into consideration existing control measures

CONCLUSION ABOUT RISKS
> Can risks be controlled? > Is there any alternative supply mechanisms? (Refer to attachments C and D)

FURTHER ACTION REQUIRED (Where risk assessment identifies that additional control measures are required): Assessor’s signature: Date of review: STEP 2: If risks can be controlled, and process is considered safe to use, develop SOP and train staff in SOP prior to using products. STEP 3: Attach Job Safety Analysis/Action Plan to Risk Assessment Form – Cytotoxic Drugs and Wastes Management for future review. Date: HSR’s signature: Date:

Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012

page 97

Attachment A

Appendix 5 – Risk Assessment Tool for Cytotoxic Drugs and Related Wastes

Attachment B

Risk Matrix
Complete the RISK MATRIX to determine the severity of the risk and therefore the appropriate control measure from the Hierarchy of Controls. Work through the following 4 tables to determine the RISK SCORE. When determining the risk score, please consider effectiveness of any current control measures, which may contribute to reducing the risk. Table 1: Risk Likelihood (Probability) – how often are people exposed to the hazard? Tick (✔) one.
Almost Certain (Frequent) Likely (Probable) Possible (Occasional) Unlikely (Uncommon) Rare (Remote) Is expected to occur again either immediately or within a short period of time (daily/weekly) Will probably occur in most circumstances (monthly) Probably will recur; might occur at some time (yearly) Possibly will recur; could occur at some time in 2 to 5 years Unlikely to recur; may occur only in exceptional circumstances (may happen every 5 to 30 years)

Table 2: Risk Severity and Consequences – how serious would/might the resulting damage/injury be? Tick (✔) one.
Critical Major Moderate Minor Insignificant Death or total loss of one or more bodily functions i.e. lose use of arm or over 4 months lost time from work Severe injury, permanent partial loss of one or more bodily functions i.e. noise induced hearing loss or major property damage. 2 weeks to 4 months lost time from work Under 2 weeks time lost from work and/or significant property damage Minor injury (first aid/medical treatment) and/or minor property damage Very little effect on employee safety or health

Table 3: Risk Assessment – use the selected Likelihood and Severity to determine the intersection of the relevant row and column.
Risk Severity and Consequences Insignificant Almost Certain 3 3 4 4 4 Minor 3 3 3 4 4 Moderate 2 2 3 3 4 Major 1 2 2 3 3 Critical

1 1 2 2 2

Likelihood

Likely Possible Unlikely Rare

Table 4: Risk Score and Risk Rating Priority. Tick (✔) appropriate score.
1 2 3 4 Extreme risk: take immediate action High risk: senior management responsibility required, utilise temporary control, initiate permanent control as soon as possible Moderate risk: management responsibility must be specified, utilise temporary control, permanent control 3 – 6 months Low risk: manage by routine procedures, monitor situation and action control within 6 –12 months

Risk Control
The objective is to eliminate or minimise the risk of illness or injury. The categories below (Hierarchy of Controls) are the preferred control options, in descending order. Elimination is best outcome. Also refer to Sections 6.1-6.4 of the Guidelines for more information. >> ELIMINATION, SUBSTITUTION OR REPLACEMENT – Complete removal of the hazard or risk OR where total elimination is not possible, exposure should be prevented or minimised by elimination of certain processes. Alternatively, consider substituting or replacing with a less hazardous material, process or equipment >> ISOLATION – Prevention of contamination of staff and/or environment by containing the cytotoxic drug at its source >> ENGINEERING CONTROLS – May include redesigning/re-engineering the workplace e.g. use of laminar-flow cytotoxic drug safety cabinet >> ADMINISTRATIVE CONTROLS – May include: introducing new work practices and development of SOPs, education and training, cytotoxic signs and labels >> PERSONAL PROTECTIVE EQUIPMENT (PPE) – The use of correct PPE which is fitted correctly, properly stored and maintained e.g. sterile coveralls, gloves, safety eye wear, P2 (N95) masks. These are the least effective method of control but are sometimes required to protect employees from cytotoxic related hazards in the workplace

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Examples: Safer substance >> A safer alternative drug is identified Safer form or process >> Can alternative arrangements be made for purchase and supply of prepared cytotoxic drugs in a single dose delivery from a commercial source? >> Outsource cytotoxic drug preparation work to a licensed manufacturer that specialises in this work >> Establishing supply arrangements from a health service that has the required facilities. drinking or smoking in areas where substances are used >> Providing suitable washing facilities >> Providing first aid facilities >> Instructing staff on how to use substances/equipment safely >> Testing competency of work in safe work processes >> Ensuring working-alone processes are in place e.Appendix 5 – Risk Assessment Tool for Cytotoxic Drugs and Related Wastes Attachment C Hierarchy of Control Process Safety Control Measures Involving Cytotoxic Drugs ELIMINATION is the most effective control: apply the highest category possible.g. Examples: >> Designing buildings that are compatible with the intended substances and designed to reduce contamination >> Handling cytotoxic drugs in an enclosed area. Examples: >> Use a closed system transfer device >> Use of an alternative transfer device which is able to provide a closed system for at least some of the steps in preparation. such as a properly operational cleanroom with laminar cytotoxic drug safety cabinet (or closed system) >> Drug packaging features in-built breakage prevention systems >> Using a pharmaceutical isolator for drug preparation >> Using bunding to reduce spillage >> Using high efficiency particulate air (HEPA) filters which supply filtered air to the cleanroom and anteroom. stop or contain substances. reducing the amount of goods stored and used >> Ensuring safe interim storage of wastes >> Effective work organisation layout and design >> Cleaning up spills immediately >> Ensuring no eating. Safety Measure Elimination. Substitution or Replacement Explanation and Examples Eliminate the use of the substance. separate people or property from the substance by distance or barriers. Examples: >> Drugs are stored in dedicated clearly marked storage areas. use of duress alarms >> Controlled access to preparation areas >> Effective management of contaminated laundry Protective clothing and equipment for employees. supervisors. equipment and trained personnel to provide prepared cytotoxic drug doses MOST EFFECTIVE Isolation Isolate the source of the hazard. or limit the area of contamination in the event of spills and leaks and meet recommended technical and safety standards. Examples: >> Coveralls and gowns >> Gloves >> Protective eyewear >> Shoe covers or overshoes >> Respiratory protective equipment (RPE) as recommended in AS/NZS 1715:1994 >> Head covering Engineering Administrative LEAST EFFECTIVE Personal Protective Equipment (PPE) Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 page 99 . Physical controls (such as plant/equipment) that eliminate or reduce substances being produced. Secondary containment is provided by maintaining the cleanroom at a pressure lower than that of the anteroom >> Using needle-less drug administration systems or retractable needles Work methods employ best practice controls. Examples: >> Total elimination of substance >> Prevent exposure or minimise by elimination of certain processes Use a safer substance or a safer form of the substance. volunteers and visitors. including refrigeration >> Correct labelling of decanted solutions (same label as purchased product) >> SDS are available at site of storage and use >> Reducing the number of employees exposed >> Reducing the duration and/or frequency of exposure >> For dangerous goods.

Substitution or Replacement Has there been a risk assessment? Yes Yes Implement control Yes Do not perform task No No Can this measure be applied? Is the risk mitigated or controlled? Perform task No Level 2 Control Isolation at the Source of the Hazard/Source Containment Can a closed system transfer device be used? No Yes Implement control Is the risk mitigated or controlled? No Can another device be used? No Yes Perform task Appendix 5 – Risk Assessment Tool for Cytotoxic Drugs and Related Wastes Yes Implement control Is the risk mitigated or controlled? No Can this measure be applied? No Yes Perform task Yes Implement control Is the risk mitigated or controlled? No Yes Perform task Level 4 Control Administrative Controls/ Organisation Measure Can this measure be applied? No Yes Implement control Is the risk mitigated or controlled? Yes Perform task Attachment D No Can this measure be applied? Level 5 Control Personal Protective Equipment Yes Implement control Is the risk mitigated or controlled? Yes Perform task No Do not perform task No page 100 Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 Level 5 Control Engineering Controls/ Ventilation .Decision Making Process for the Safe Handling of Cytotoxic Drugs Decision making process for the safe handling of cytotoxic drugs Level 1 Control Elimination.

e. wear gloves only – must not crush or cut tablets) >> Drug and equipment disposal >> Disposal of all body fluids (urine/faeces/vomit/wound drainage) >> Drug/body fluid ‘spill’ clean up Disposal issues Place contaminated disposable items. into a cytotoxic drug bin Ensure that a cytotoxic spill kit is available Details of the nurse completing the alert Full name (Please print) Signature Date Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 page 101 MR _________________________ Cytotoxic Drug Precautions Alert Form . dressings. i.Appendix 6 – Cytotoxic Drug Precautions Alert Proforma Appendix 6 Cytotoxic Drug Precautions Alert Proforma Affix Patient Identification Label Here Cytotoxic Precautions Alert (Page 1 of 1) Surname Given Name Address UR Number DOB Sex Suburb/Town Post code This form is to be completed giving due consideration to the (insert policy name) _________________________________ of the (insert health service name) ___________________________________________________________________________________ Precautions to stop 7 days after chemotherapy has completed Therapy details Cytotoxic drug given Date completed Cease cytotoxic precautions on:  Date: Protective measures Personal Protective Equipment (PPE) / / Time: am / pm >> Impermeable long sleeve gown with cuffs >> Safety goggles >> Nitrile long cuffed gloves/double gloves >> Respirator (when dealing with a ‘spill’) PPE to be worn during >> Drug administration (for oral administration.

The model procedures are designed to assist practices in safety and quality improvement.  Review the model procedure(s) to determine changes.sa. you may wish to reformat the sample language to be consistent with existing health service documents. page 102 Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 .sahealth. additions or deletions that may be needed in your health service document(s). If you have a standard format for procedures.Appendix 7 – Model Procedures Appendix 7 Model Procedures How to use the Model Procedures These model procedures are intended to be practical exemplar documents which help translate the Guidelines and which are able to provide utility for health services in implementing the Guidelines.  Save the model procedure(s) to your computer or network. are not comprehensive and do not constitute a complete procedures manual for the safe handling of cytotoxic drugs and related wastes. The model procedures do not represent legal advice. The model procedures are intended to guide health services in the process of creating or updating their own procedures related to the safe handling of cytotoxic drugs and related wastes in a manner that complies with the Guidelines. A Word version of the model procedures is available: www.au/HazardousDrugs Instructions for use: 1. 2.gov.

Any residual cytotoxic drug following patient treatment or any material associated with its preparation or administration which may contain traces of drug. if required. monitored and reviewed regularly. which includes health monitoring and biological monitoring. employers and OHSW employees. how exposures might occur. A health surveillance program may be extended to employees: >> involved in the clean up of spills. The monitoring of an individual’s health status pre-employment/pre-placement and on an ongoing basis to determine any adverse affects to health following exposure to cytotoxic drugs. The monitoring of persons to identify changes (if any) in their health status due to the potential for occupational exposure to a hazardous substance. Organisations shall ensure the health surveillance program is available to employees as detailed in the responsibilities on: >> pre-employment/pre-placement >> an ongoing basis when working with cytotoxic drugs >> termination of employment or transfer to another area not involving work with cytotoxic drugs. Harmful to cells of the body. This procedure would apply to approved medical officers undertaking health surveillance of employees handling cytotoxic drugs. General information Prospective employees shall be counselled at interview. The health surveillance program should be regularly reviewed to include any current developments in health monitoring and/or biological monitoring and changes to legislation. Health surveillance should be implemented and provided to all employees involved in the preparation and administration of cytotoxic drugs. Abbreviations and definitions Biological monitoring Cytotoxic Cytotoxic waste Health surveillance Health monitoring Biological monitoring is the measurement and evaluation of a substance or its metabolites in the body tissue fluids or exhaled air of exposed persons. and the control measures in place. induction and as part of an ongoing health surveillance program on the potential risks to health and reproduction. particularly those that reproduce rapidly. based on risk assessment of the spill and control measures in place at the time >> who are not already identified in this procedure. M A S E L P Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 page 103 .Appendix 7 – Model Procedures Model Procedure 1 Health Surveillance for Staff Handling Cytotoxic Drugs and Related Wastes The purpose of this document is to ensure that a health surveillance program. is implemented.

C Log of Exposure to Cytotoxic Drugs for Nursing Staff.Appendix 7 – Model Procedures Model Procedure 1 Health Surveillance for Staff Handling Cytotoxic Drugs and Related Wastes Organisations shall ensure employees are made aware of the health surveillance/health monitoring program and how to access it. Organisations shall ensure that the medical officer complies with the current competencies for health surveillance. Competencies for Health Surveillance 1998. 4. Occupational Health. 2. Safe Handling of Cytotoxic Drugs and Related Wastes: Guidelines for South Australian Health Services 2012. Safety and Welfare Regulations 2010. B Log of Exposure to Cytotoxic Drugs for Pharmacy Staff. SA Health. 5. 3. M A S E L P page 104 Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 . Appointments with an approved medical practitioner are in work time and at the employer’s expense. Safety and Welfare Act 1986. Reports of health and/or biological monitoring are to be provided to the employee after each consultation in an agreed time frame. Guidelines for Health Surveillance 1995. Appendices A Questionnaire for Staff Handling Cytotoxic Drugs and Related Wastes. Occupational Health. National Occupational Health and Safety Commission. National Occupational Health and Safety Commission. Record keeping/OHSW requirements Health monitoring records must be kept: >> for at least 30 years of date of last entry >> separate from any Human Resource records >> separate from hospital medical records >> confidential. The appointed medical officer shall: >> comply with health surveillance guidelines >> plan. implement and evaluate the health surveillance program >> recognise when it is appropriate to seek advice. References 1.

Appendix 7 – Model Procedures Appendix A Questionnaire for Staff Handling Cytotoxic Drugs and Related Wastes Section A: Personal details Surname Given name Maiden or previous surname (if applicable) Date of birth Position – (e.g. pharmacy production/nurse ) Department Current address Current telephone number Family doctor Doctor’s address Section B: Occupational history Year worked Employer M A S Position held Previous work with cytotoxic drugs Yes/No (Include dates) E L P Exposure to cytotoxic drugs (spills/needlestick Injuries) Current exposure to cytotoxic drugs Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 page 105 .

please provide details Section D: Physical examination Date of medical assessment / / Build Urinalysis M A S Height (cm) Weight (kg) BMI E L P Doctor’s comments Blood pressure Pulse page 106 Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 .Appendix 7 – Model Procedures Section C: Medical history Question 1 Have you ever smoked cigarettes? If yes. how many did you smoke per day? 2 3 4 5 6 7 8 Do you have a personal history of cancer? Do you have a family history of cancer in first relatives? Do you have a history of asthma or other systemic allergic reactions? Are you taking immunosuppressive therapy? Are you pregnant or breast feeding? Are you planning parenthood or considering parenthood at sometime in the future? Do you have any of the following symptoms: a) abdominal pain b) hair loss c) nasal sores d) vomiting e) contact dermatitis f) unplanned weight loss Yes No If yes.

Appendix 7 – Model Procedures Area assessed 1 Skin Normal Abnormal Doctor’s comments 2 Cardiovascular system 3 Respiratory system chest and lung fields 4 Abdomen 5 Lymphatic and endocrine 6 Central nervous system cerebella functions 7 Other Section E: Investigations based on physical examination 1 Blood tests Results M A S E L P 2 Other 3 4 Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 page 107 .

or those who are pregnant or breast feeding M A S E L P page 108 Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 .Appendix 7 – Model Procedures Section F: The following must be reviewed as part of the assessment Yes 1 Exposure log (includes spills) Comments 2 Controls measures in place 3 Any swipe testing for contamination undertaken in the area Section G: Health advice and counselling Provision of the flowing 1 Potential health effects associated with exposure to cytotoxic drugs Normal Abnormal 2 Optimum standard of control measures to expect in the workplace 3 The potential risks of employees planning parenthood.

recommendations and health advice received Other comments M A S E L P Yes No Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 page 109 .Appendix 7 – Model Procedures Section H: Findings and recommendations Re-assessment recommended in ________________________ years Placement recommendations (if required) Report provided to employer advising that the employee has received assessment and health advice/counselling Report provided to employee advising of any test results.

Total hours Cabinet ID Drug name Initials Section C: Documentation spills or accidents involving cytotoxic drugs Note: Staff member and supervisor to initial and date each entry M A S E L P page 110 Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 .m.m. Hours p.Appendix 7 – Model Procedures Appendix B Log of Exposure to Cytotoxic Drugs for Pharmacy Staff Section A: Personal details Surname Given name Department Page Section B: Hours spent handling cytotoxic drugs Date Hours a.

Hours p.Appendix 7 – Model Procedures Appendix C Log of Exposure to Cytotoxic Drugs for Nursing Staff Section A: Personal details Surname Given name Department Page Section B: Hours spent handling cytotoxic drugs Date Hours a.m. Total hours Cabinet ID Drug name Initials Section C: Documentation spills or accidents involving cytotoxic drugs Note: Staff member and supervisor to initial and date each entry M A S E L P Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 page 111 .m.

particularly those that reproduce rapidly. Implementation of this training will minimise risk to the health and safety of staff and patients.  Training needs are identified on ‘Performance Review and Development (PR&D) Planning Record’. 2. administering. An Integrated Model for South Australia 3. other occupants and the environment from contamination with cytotoxic agents. Training needs assessment. Abbreviations and definitions Cytotoxic Harmful to cells of the body. Any residual cytotoxic drug following patient treatment or any material associated with its preparation or administration which may contain traces of drug.  Training needs can also be identified as and when required to enhance the professional capabilities using ‘PR&D Planning Record’. Central Training Manual – Production Pharmacy Services – Cytotoxic and Other Hazardous Drugs >> Nursing: –– SA Health.1 Recommendations for training topics by profession are provided in Appendix A. A competency based training program for nursing and pharmacy staff should be in place in units where cytotoxic drugs are manufactured (pharmacy). and avoid contamination of the environment. Cytotoxic waste TNA General information Staff should not be handling (preparing. The extent of the program (including annual updates and specific instructions relative to changing practice and technology) should be based on measures necessary to protect the operator. Identification of training needs 1. M A S E L P page 112 Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 .  The training needs assessment (TNA) will be conducted for each employee to identify the training needs and to enhance technical skills and professional capabilities of the employee.Appendix 7 – Model Procedures Model Procedure 2 Staff Training for the Safe Handling of Cytotoxic Drugs and Related Wastes The purpose of this document is to ensure that staff members receive the appropriate training about the potential hazards and safe handling requirements of cytotoxic drugs prior to handling cytotoxic drugs and related waste.  Note: For pharmacists and nurses working in the field of cancer therapy. Statewide Framework for Chemotherapy Education and Assessment. handled and administered (nursing staff should not be administering cytotoxic agents unless they have been deemed competent with all elements of this procedure). Central Training Manual – Clinical Pharmacy Services – Cancer and Chemotherapy –– SA Health. training competencies are outlined in the following documents: >> Pharmacy: –– SA Health. transporting and disposing of) cytotoxic agents unless they have been involved in specific skills and work practice training programs. Unit managers are responsible for identifying staff involved (or potentially involved) in cytotoxic drug handling and ensuring that these individuals are recommended for training program entry.

For example.  Revalidation should occur on a regular basis. an ‘Annual Development Plan’2 should be prepared after consultation with the employee’s line manager.  An attendance record will be completed for all training which includes: >> details of the trainer (name. 2. Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 page 113 . although the frequency of revalidation will depend on the training element. which set out the knowledge and skills staff need in order to minimise occupational exposures to cytotoxic drugs and related waste. at a minimum. etc) 2. In case of any change. which is based on the training programs being offered by various providers. 3. the ‘Annual Development Plan’ is updated.Appendix 7 – Model Procedures Model Procedure 2 Staff Training for the Safe Handling of Cytotoxic Drugs and Related Wastes Training plan Based on TNA. 2. 2. keeping in view their market reputation and cost of training. staff regularly reconstituting cytotoxics should undergo a validation test annually.  Line managers need to confirm that staff have a satisfactory level of knowledge or competency for duties. M A S E L P Re-training 1.  Guidance on training competencies.  External trainers can be used. The former ‘Annual Development Plan’ is cancelled by writing ’Cancelled‘. organisation. it is recommended that training be repeated every 2-3 years.  This development plan covers both in-house and external training of staff .  Internal trainers are selected. Validation of training 1.  The impact of the training should be validated by performing competency checks.  Training records will be maintained in a separate ‘Training’ folder or in the personnel file of the particular employee.  To cover the introduction of new drugs or new technical innovations. keeping in view their level of competency in the field of training.  Training should be repeated whenever any major change in practice occurs. 1. 4.4 3. otherwise it will be updated at the end of each year. can be obtained from a number of internal3 and external sources. Training records >> date of training >> name of training >> summary of training content >> signature of trainee. In-house and external training 1.

Appendix 7 – Model Procedures

Model Procedure 2

Staff Training for the Safe Handling of Cytotoxic Drugs and Related Wastes
Appendices
A Training Matrix.

References
1. SA Health; Safe Handling of Cytotoxic Drugs and Related Wastes: Guidelines for South Australian Health Services 2012. 2. SA Health; Performance Review and Development (PR&D) Planning Record http://in.health.sa.gov.au/wc. 3. SA Health; Performance Review and Development (PR&D) Guide Information Sheet 7 http://in.health.sa.gov.au/wc. 4. Internal sources: > > > > > > SA Health; Standards for Chemotherapy Services in South Australia SA Health; Central Training Manual – Clinical Pharmacy Services – Cancer and Chemotherapy SA Health; Central Training Manual – Production Pharmacy Services – Cytotoxic and Other Hazardous Drugs

SA Health; Statewide Framework for Chemotherapy Education and Assessment; An Integrated Model for South Australia WorkCover Victoria; Training Competencies: Handling Cytotoxic Drugs In Health Care Establishments 1997. National Occupational Health and Safety Commission; Competencies for Health Surveillance 1998.

5. External sources:

>  Cancer Nurses Society of Australia; Position Statement on the Minimum Education Requirements for Nurses involved in the Administration of Anti-Cancer Drugs within the Oncology and Non-Oncology Setting 2010. The Australian National Cancer Nursing Education Project; EdCaN On-line Cancer Australia; Cancer Leaning On-line. >

>

M A S

E L P

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Appendix 7 – Model Procedures

Appendix A

Training Matrix
This training matrix provides guidance on the possible training and information content for various staff in relation to the risks of exposure, manipulation and safe handling of cytotoxic drugs and related waste. Patient transport personnel Animal handlers (research)

Pharmacists – production

Staff involved with waste management

Potential risks of exposure to cytotoxic drugs and waste Basic pharmacology of cytotoxic drugs Theory and practice of aseptic technique Legislative requirements for health and safety Legislative requirements for waste management The risk management process

✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔

✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔

✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔

Control measures to be adopted when handling cytotoxic drugs and related waste Maintenance of equipment

Correct selection, use, cleaning and disposal of personal protective equipment

Procedures to be adopted in the event of accident, injury or spill, including reporting and recording Access to first aid resources Storage, transport, treatment and disposal of cytotoxic waste Health surveillance and reporting Working in a cleanroom Any written safe work procedures Correct storage Use of safety cabinet/isolator Extravasation Cleaning procedures

M A S
✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔

✔ ✔ ✔ ✔ ✔

✔ ✔ ✔ ✔ ✔

E L P
✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔

✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔

✔ ✔ ✔ ✔ ✔

✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔

✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔

✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔

✔ ✔

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Maintenance personnel

Pharmacy technicians

Pharmacists – clinical

Couriers and porters

Ambulance officers

Medical personnel

Stores personnel

Laboratory staff

Cleaners

Nurses

Appendix 7 – Model Procedures

Model Procedure 3

Preparation of Parenteral Cytotoxic Drugs Without a Closed System Transfer Device in the Pharmacy Department
The purpose of this document is to ensure that cytotoxic drugs are prepared in a manner that avoids risk to the health and safety of staff and avoids contamination of the environment. This procedure applies to staff preparing cytotoxic drugs in hospital pharmacy departments. It includes the preparation of cytotoxic drugs for parenteral administration: >> Bolus injection in syringe requiring reconstitution of drug from powder. >> Infusion requiring dilution of drug from a concentrated solution.

Abbreviations and definitions
CDSC Cytotoxic Cytotoxic waste Intrathecal ISOPP PIC/S PPE SHPA Cytotoxic drug safety cabinets. Harmful to cells of the body, particularly those that reproduce rapidly.

Any residual cytotoxic drug following patient treatment or any material associated with its preparation or administration which may contain traces of drug. Injection into the fluid-filled space that surrounds the spinal cord.

General information

Personnel shall adopt work procedures that are in accordance with the PIC/S Guide for Good Manufacturing Practice of Medicinal Products in Healthcare Establishments (PE010-3) 2008 and SHPA Standards of Practice for the Safe Handling of Cytotoxic Drugs in Pharmacy Departments 2004. These activities must be performed in the Cytotoxic Drug Safety Cabinet (CDSC) or isolator cabinet. A separate CDSC or isolator cabinet should be used to prepare cytotoxic drugs and BCG due to the risk of contamination of the cytotoxic drug preparation. All staff undertaking the preparation of cytotoxic drugs should wear personal protective equipment. Only one patient’s treatment should be prepared at a time and only one drug should be in the cabinet at any one time (or one drug per operator in a 2 person CDSC). Luer-locking syringes and fittings must be used, both in preparation and handling of these drugs.1 Large bore needles should be selected to ensure that high-pressure syringing of the solutions is avoided.1 Alternatively, 0.2 micron hydrophobic air-venting filter needles may be used to minimise risks associated with the manipulation of aqueous solutions (hydrophobic filters are not suitable for non-aqueous cytotoxic solutions).1 Syringe-to-syringe connectors must be used to minimise the risk of spill when transferring from one syringe to another.1 Other specifically designed closed system devices that prohibit the transfer of environmental contaminants into the system and the escape of hazardous drug or vapour concentrations outside the system should be considered for the preparation of parenteral cytotoxics.6

M A S
Personal Protective Equipment.

International Society of Oncology Pharmacy Practitioners.

Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme – jointly referred to as PIC/S.

Society of Hospital Pharmacists of Australia.

E L P

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Adding diluent solution to the vial >> Withdraw required volume of diluent solution into luer-lock syringe and attach 18 G needle. >> Note: If an air-venting device is used instead of a needle then it is not necessary to use negative pressure technique. an ampoule breaker should be used. Procedures 1. ifosfamide). Vinca alkaloids must be supplied in a mini-bag (50 mL or 100 mL). >> Some vials containing powder are supplied with negative pressure in the vial and so it is not necessary to withdraw air from the vial initially. creating a negative pressure inside vial and then allow solution to flow from syringe into vial until pressure has equalised. Filter needles (5 micron) must be used when dispensing from glass ampoules. Bolus injection in syringe requiring reconstitution of drug from powder The negative pressure technique is used to add or withdraw solutions from a vial using a hypodermic needle. Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 page 117 . >> Discard all cytotoxic waste appropriately. >> Swirl vial gently until drug is dissolved. Repeat until required volume is withdrawn. Excess drug should be returned to the original container or introduced into a closed container to be discarded. Any excess solution should be discarded in a sealed syringe for later safe destruction. Seal syringe with sterile syringe cap. Withdrawing solution from vial >> Check drug is completely dissolved. Note: Syringes must never be sent with a needle attached. Ampoules should be opened away from the operator.1 Opened/used vials should not be left in the cabinet for later use. creating a negative pressure in the vial and then allow air in the syringe to flow back into the vial.  Note: Refer to institution’s specific drug procedure or manufacturer’s product information leaflet for type of diluent and volume to use. M A S E L P >> Draw up air into syringe equivalent to volume of solution to be withdrawn. >> Stand vial on workbench and use forceps to disconnect syringe from needle.g. Care must be exercised when using liquid filled ampoules of cytotoxic drugs. Also use caution to avoid the I needle coming out of the bung which could lead to a needle-stick injury. This may vary from batch to batch (e. Repeat until all of the solution has been added to vial.  t is important to perform this technique carefully to prevent the formation of aerosols. >> Withdraw a few millilitres of air from vial. Note: If the cytotoxic drug is for intrathecal use it must not be prepared during preparation of any other agents. as they produce aerosols of drug solution when opened.Appendix 7 – Model Procedures Model Procedure 3 Preparation of Parenteral Cytotoxic Drugs Without a Closed System Transfer Device in the Pharmacy Department Cytotoxic drugs in glass ampoules should be avoided whenever possible. and to avoid injury or damage to gloves. >> Invert vial and aspirate a few millilitres of solution into syringe. Do not shake vigorously. leaving needle in vial. >> Attach syringe to needle in vial. >> Insert needle into bung of cytotoxic drug vial. not in a syringe.1 Appropriate steps must be taken to contain excess drug or prevent air contamination when priming syringes and other devices.

Labelling The cytotoxic drug must be labelled immediately upon preparation. If more than one syringe is to be added to an infusion container. Note 2: Vinca alkaloids must be labelled ‘for intravenous use only – fatal if given by other routes’. >> Using 21 G needle. all volumes drawn up by a pharmacy assistant must be checked by a pharmacist. cautionary instructions if required. Keep the original ampoules/vials and show to pharmacist at same time. if appropriate >> other supplementary. an injection site cap is attached to a 21 G needle and inserted into the additive port of the infusion container. page 118 Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 . Infusion requiring dilution of drug from a concentrated solution >> Withdraw required volume of cytotoxic drug from vial(s) using luer-lock syringe and 18 G needle(s) and negative pressure technique or air venting device. >> Clean additive port with 70% sterile alcohol and remove from CDSC. >> Prior to addition to infusion bag. if required/appropriate >> intended route of administration >> storage conditions >> expiry date and time. fatal if given intrathecally: Note 1: If the cytotoxic drug is for intrathecal use it must be clearly labelled ’For Intrathecal Use Only‘.  Note: For certain non-PVC bags. DOB) >> prominent cytotoxic warning label >> name and address of the pharmacy Outer container This should be labelled in the same manner as the individual items.g. e. including: Primary container/syringe/bag Labelling should include: >> drug name >> dose and volume >> infusion solution. Refer to manufacturer’s product information.g. make the addition. an 18 G needle can be used to add to the bag. M A S E L P >> patient’s full name and a second patient identifier (e. medical record number. >> Thoroughly clean additive port of infusion bag/bottle with 70% sterile alcohol.Appendix 7 – Model Procedures Model Procedure 3 Preparation of Parenteral Cytotoxic Drugs Without a Closed System Transfer Device in the Pharmacy Department 2. do not extravasate. The additions are made into the bung of the injection site cap. >> Discard all cytotoxic waste appropriately. >> Thoroughly agitate to ensure mixing and check for leakage before removing from CDSC.

ready for transport. Standards of Practice for the Safe Handling of Cytotoxic Drugs. ISOPP. SHPA. Medication Alert No 2. References 1. SA Health. M A S E L P Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 page 119 .Appendix 7 – Model Procedures Model Procedure 3 Preparation of Parenteral Cytotoxic Drugs Without a Closed System Transfer Device in the Pharmacy Department Packaging >> Seal the prepared drug in two layers of plastic (this packaging may also offer protection from light).  Note: If the cytotoxic drug is for intrathecal use it must be packaged and delivered separately from doses to be administered by other routes. Safe Handling of Cytotoxic Drugs and Related Wastes: Guidelines for South Australian Health Services 2012. Guide for Good Manufacturing Practice of Medicinal Products in Healthcare Establishments (PE010-3) 2008. 5.5-2006 Cleanrooms and associated controlled environments Part 5: Operations. December 2005. 2. 3. 4. 7. >> The sealed cytotoxics should then be placed in a dedicated. 6.  Australian Standard AS 2639-1994 Laminar flow cytotoxic drug safety cabinet – installation and use. secure area. Australian Council for Safety and Quality in Health Care.  AS/NZS ISO 14644. Standards for Practice Safe Handling of Cytotoxics. PIC/S.

2. 7. If using a courier. Include a safety data sheet with the packaging.e. Room temperature transport: wrap the drugs in the foil bubble wrap and tape closed. Packaging 2. Tape the foil bubble wrap closed. identify the telephone number. Seal the carton with packaging tape.Appendix 7 – Model Procedures Model Procedure 4 Transport of Cytotoxic Drugs External to the Health Service The purpose of this document is to ensure appropriate procedures for the transport of cytotoxic drugs external to the health service. Verify method of transport to be used. such as courier or staff member. Use an appropriately sized. Note: When regularly transporting drugs to regional and remote areas under cold chain conditions. 3. 6. General information 1. locations and any special requirement of the courier to be used. particularly those that reproduce rapidly. consideration should be given to validating the cold chain measures using a temperature data tracking device wrapped in the foil with the drugs. Note: Room temperature is considered to be 25°C. sample 3) to the bubble wrapped package. M A S E L P page 120 Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 . Place the ice brick inside a folded section of the foil bubble wrap. When there are refrigerate and room temperature drugs for the same patient it is necessary to send two parcels unless the room temperature drugs can safely be refrigerated (see Exceptions). 4. 5. hard walled carton (for example a Baxter brown I. If transporting room temperature drugs during hot summer days or to regional and remote areas (such as Roxby Downs or Ceduna). Abbreviations and definitions Cytotoxic Harmful to cells of the body. room temperature items and refrigerated items. 1. fluids carton). i. Attach the ‘CYTOTOXIC – HANDLE WITH CARE’ label (see Appendix A. Note: Drugs requiring different storage conditions. Cold chain transportation:2 at least one ice pack should be included in the packaging. Include the administration chart with the drugs if the delivery is for the first date of administration on the order. Place sealed luer-lock syringes or infusion containers of prepared cytotoxic solutions into separate plastic bags (double wrapped). 8. then add the drugs ensuring that the drugs are not in direct contact with the ice brick. must be placed into separate cartons. Seal with heat sealer.V. 9. consideration must be give to ambient temperatures exceeding 40°C.

sample 4 for outer wrap label).1  Print a bag label. Also attach calcium folinate label (Appendix A. Labelling >> The outer packaging of cytotoxic drugs will display a clear warning label identifying the product clearly as cytotoxic (Appendix A. >> All vinca alkaloids products. however if it is sent with other drugs not requiring refrigeration it may be sent at room temperature. sample 9). >> Place ‘This Side Up’ labels on two opposite sides of carton (see Appendix A. on the top of the carton (see Appendix A.2 Attach the carboplatin and gemcitabine label (Appendix A. sample 3). sample 5 for outer wrap label). sample 3). send them both in cold chain packaging but attach the label below to the outside of the carton. as well as instructions in the event of spillage (Appendix A. This is in case the consignment note is accidentally removed from the carton in transit. sample 7).Appendix 7 – Model Procedures Model Procedure 4 Transport of Cytotoxic Drugs External to the Health Service Exceptions: >> Calcium folinate injection: Requires cold chain transportation. sample 8). including the outer wraps. >> If the item requires refrigeration. ‘For intravenous use only – fatal if given by other routes’ (Appendix A. >> All cytotoxic drugs for intrathecal use must have a prominent warning label on the syringe and outer wrap stating. must have a prominent warning label stating. Place the calcium folinate into a brown paper bag with bag label attached. sample 6). sample 1). M A S E L P Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 page 121 . >> Carboplatin and gemcitabine: If sending together. >> A separate piece of paper with the receiver’s name and address plus contact telephone number (or pre-printed label) should also be taped to the top of the carton. >> Place the dangerous goods label (diamond with ‘6’). >> A label with the name and address of the health service and a direct contact to the pharmacy department in case of an emergency must be attached to the outer packaging. >> Place the consignment note on top of the box plus a ‘CYTOTOXIC – HANDLE WITH CARE’ label (see Appendix A. place a large ‘Refrigerate’ label on top of the carton (Appendix A. This instructs staff receiving the carton to store the gemcitabine at room temperature and to store the carboplatin in the refrigerator. ‘For Intrathecal Use Only’ label (Appendix A. sample 2).

SA Health. 3. The International Air Transport Association’s (IATA) Dangerous Goods Regulations. December 2005. Logs >> Complete the ‘Log of Chemotherapy Parcels Sent to External Institutions’ (see Appendix B). LA. 5. SHPA. Guidelines on Handling Hazardous Drugs Am J Health-Syst Pharm 2006 63. The Australian Code for the Transport of Dangerous Goods by Road and Rail. 7. 2. 15th Ed (2009).Appendix 7 – Model Procedures Model Procedure 4 Transport of Cytotoxic Drugs External to the Health Service Documentation Consignment note Follow the courier’s procedure for the completion of the consignment note. Australian Council for Safety and Quality in Health Care. Medication Alert No. Standards of Practice for the Transportation of Cytotoxic Drugs from Pharmacy Departments 2007. 8. 6. address and telephone number. 4. Communication with manufacturer. M A S E L P page 122 Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 . Trissel. ASHP. References 1. with the following considerations: >> Sender – the name of the cytotoxic preparation pharmacist and their telephone number >> Receiver – the doctor’s name. 2. Appendices A Sample Labels. Safe Handling of Cytotoxic Drugs and Related Wastes: Guidelines for South Australian Health Services 2012. B Log of Chemotherapy Parcels Sent to External Institutions. Handbook on Injectable Drugs.

immediately > remove any contaminated clothing > contact Jane Smith on (08) 8XXX XXXX during business hours or on Name of Institution Address of Institution wash the area with large amounts of water This Side Up 8 9 Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 page 123 . REFRIGERATE Do not freeze CYTOTOXIC DRUG HANDLE WITH CARE Avoid contact with skin E L P This item has been packaged in accordance with approved guidelines and is safe for transport. On arrival: > Remove the Gemcitabine and store at room te mperature > Store Cartoplatin in the refrigerator PLEASE NOTE: 3 4 For Intravenous Use Only Fatal if given by Other Routes 5 For Intrathecal Use Only 6 7 M A S 04XX XXX XXX after hours.Appendix 7 – Model Procedures Appendix A Sample no. Example PLEASE REFRIGERATE CALCIUM FOLINATE INJECTION ON ARRIVAL 1 2 This package contaiins Gemcitabine which can be stored at room temperature. In the event of accidental breakage or spillage: > do not touch spilt contents or contaminated item > avoid any contact with skin or clothes > if spillage has occurred onto unprotected skin or in the eye.

R. no. note # Appendix 7 – Model Procedures M A S page 124 Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 Appendix B – Log of Cytotoxic Drug Parcels Sent to External Institutions E L P .Month: Year: Date sent Patient name and U. Destination Name and batch number of drug(s) sent Con.

particularly those that reproduce rapidly. Name of fluid in which it is diluted E L P Sample KEEP OUT OF REACH OF CHILDREN CYTOTOXIC INJECTION SOLUTION DOXORUBICIN 100 mg in 50 mL UR: 12345 OWEN.Appendix 7 – Model Procedures Model Procedure 5 Transport of Cytotoxic Drugs Within the Health Service The purpose of this document is to ensure appropriate procedures for the transport of cytotoxic drugs within the health service. Abbreviations and definitions Cytotoxic Harmful to cells of the body. address and phone number of health service >> date of supply. Labelling Primary packaging Cytotoxic drug All Label requirement Primary label has: >> name of the drug >> the dose >> expiry date >> batch number All M A S >> patient name and URN >> ‘protect from light’ if drug is light sensitive >> ‘keep out of reach of children’ warning in red text >> name. DOUGAL Ward: DC ROUTE OF ADMINISTRATION: Intravenous Rate: over 5 minutes B: 11100001 Supplied on: 10/11/10 Exp: 11/11/10 PROTECT FROM LIGHT Name of Institution Address & Phone No of Institution Cytotoxic drugs in solution Intrathecals 0.9% SODIUM CHLORIDE INTRAVENOUS SOLUTION BP For Intrathecal Use Only Vinca alkaloids For Intravenous Use Only Fatal if given by Other Routes Oral medications Do Not Cut or Crush Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 page 125 .

Cross-check patient’s name and drug with distribution list as: a. as well the procedure to follow in the event of a spill. 6. The pharmacist/assistant will check the distribution book for patient’s name. All personnel involved in the delivery of cytotoxic drugs must be aware of the potential hazards and the care required in handling. 2. first seal inside a clear plastic bag and then seal this package inside a black plastic bag Note: The black bag must have all the same labelling as the primary container. ward and drug(s) ordered. The pharmacy assistant will initial the distribution book next to each patient entry whose items are included in the delivery. page 126 Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 .Appendix 7 – Model Procedures Model Procedure 5 Transport of Cytotoxic Drugs Within the Health Service Cytotoxic drug Topical cytotoxic medications e. 3. First delivery each day 1. fluorouracil cream Vesicants Label requirement Sample Wear Disposable Gloves Use Spatula to Apply Do not extravate Requiring refrigeration Warning Refrigerate Do not freeze Containers Cytotoxic transport plastic eskies that may be used to carry cytotoxic drugs to the wards must identify the contents as cytotoxic drugs (purple ‘CYTOTOXIC – HANDLE WITH CARE’ label as above). The pharmacist will then check all items are correct and initial the distribution book for each patient. 5. 4. If drug requires protection from light. These containers are designed to protect the cytotoxic drugs during delivery and also to contain a spill if it occurs. Packaging 1. a patient may need different drugs delivered on different days. This check may be waived at the discretion of the pharmacist.g. 8. Check the number of containers required (sometimes two or more infusion containers may be required). 7. Place sealed luer-lock syringes or infusion containers of prepared cytotoxic solutions into separate plastic bags (double wrapped) and seal with heat sealer. there may be more than one patient with the same name M A S E L P b. 2. Take appropriate drugs for that date from storage location (refrigerator/room temperature). The pharmacy assistant will assemble the delivery. Place drugs into cytotoxic transport plastic esky or onto cytotoxic transport trolley.

SHPA. On arrival in the ward. Department of Health and Aging. The nurse shall check that all drugs for each patient are correct and still required. If a new order is written on the weekend. Australian Government. Appendices A Cancelled Therapy form. Pharmaceutical Society of Australia.  ensure that the form is attached to drug packaging for return to pharmacy. 3. ASHP.Appendix 7 – Model Procedures 9. Guidelines for the Safe Handling of Cytotoxic Drugs and Related Wastes in South Australian Health Services 2012. B Sample – Distribution Book of Cytotoxic Drug Sent to Wards. Subsequent deliveries The pharmacist/assistant is to complete the documentation and the pharmacy assistant is to proceed as steps 8 and 9 above.  if drugs are not to be given. The pharmacy assistant shall return those not required to the pharmacy b. 5. Australian Formulary and Handbook 21st Edition 2010. 4. Guidelines on Handling Hazardous Drugs Am J Health-Syst Pharm 2006. Medication Alert No. References 1. Standard for the uniform scheduling of medicines and poisons (SUSMP). Australian Council for Safety and Quality in Health Care. Controlled Substances (Poisons) Regulations 1996. 8. 7. National Drugs and Poisons Schedule Committee. 2. the pharmacy assistant shall: a. it is prepared and delivered on the appropriate day(s). Deliveries on weekends and public holidays Drugs for administration during the weekend/public holidays are delivered on Friday afternoon. return them to the Cytotoxic Production Office and notify the pharmacist c.  ask the registered nurse-in-charge (or delegate) to check the chemotherapy being delivered. Documentation Logs Complete the Distribution Book. December 2005. Standards of Practice for the Transportation of Cytotoxic Drugs from Pharmacy Departments 2007. 6. 2. Controlled Substances Act 1984. 63.  check whether there are any ‘Cancelled/Delayed‘ forms to be returned to the pharmacy d. SA Health. M A S E L P Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 page 127 .

Appendix 7 – Model Procedures Appendix A Affix Patient Identification Label Here Cancelled/ Delayed Therapy Form (Page 1 of 1) Surname Given Name Address UR Number DOB Sex Suburb/Town Post code Attach completed form to cytotoxic drug for return to pharmacy. DO NOT RETURN THESE TO PHARMACY Date: / / Time: Name of treatment The treatment has been:          Reason for delay/cancellation: The treatment has been rescheduled:     If yes. date: / / Details of the nurse completing the alert Full name (Please print) M A S   Yes  Time: Signature Delayed        E L P am / pm       Cancelled  No  am / pm Date page 128 Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 . Dispose of all partially used or opened cytotoxic drugs or ‘spiked’ bags in cytotoxic waste bins in the ward.

no.Appendix 7 – Model Procedures Sample – Distribution Book of Cytotoxic Drug Sent to Wards Month: E L P Year: Drug details Dose Batch number Date sent Patient name and U.R. Delivered to ward Name Storage location O = office F = fridge Issued/ delivered by (initials) Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 M A S page 129 Appendix B .

Emergency equipment Prior to administration of therapy with cytotoxic drugs. pre-medications. General information All cytotoxic drugs presented for administration should be marked with a prominent label warning the cytotoxic nature of the drug. administration. patients. and any other information relevant to patient safety. Contaminated waste Contaminated waste such as PPE. including prescribed therapy. Abbreviations and definitions BSA ECOG PPE Body surface area. etc. This procedure applies to staff administering oral cytotoxic drugs for patients in in-patient and out-patient settings. visitors and the environment. ensure emergency equipment is available. No further manipulation of the oral cytotoxic tablet/capsule will occur in the ward area. European Cooperative Oncology Group. Current written information should be provided to the patient/carer. must be place into an approved container for cytotoxic waste. There should also be opportunities made for patients/carers to ask questions. >> emergency equipment. carer/family education should be attended. Prior to any cytotoxic drug being administered to the patient. side effects and management of side effects.Appendix 7 – Model Procedures Model Procedure 6 Administration of Oral Cytotoxic Drugs in the Health Service The purpose of this document is to ensure that oral cytotoxic drugs are administered to patients in a manner that avoids risk to the health and safety of staff. which includes: >> general emergency equipment. including medications to manage anaphylaxis M A S E L P Staff training Cytotoxic drugs must only be administered by doctors or nurses who have undertaken appropriate training and competency assessment in cytotoxic drug administration and who have a complete understanding of the potential hazards associated with cytotoxic drug handling. disposable medicine cups. including oxygen and suction >> access to eye wash facility (eye station). contact details for the treating institution. page 130 Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 . Personal Protective Equipment.

in an appropriately labeled. >> If tablets/capsules are to be counted using a device (e. triangle). Oral administration Most oral cytotoxic drugs are available as capsules or enteric coated tablets which present minimal hazard. M A S E L P Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 page 131 . >> Patient should be deemed fit for treatment by their medical officer. If blood parameters are abnormal. the device should be clearly marked and dedicated for cytotoxic agents only. body surface area (BSA). >> Written information. including a medication profile. >> Put on nitrile gloves or double gloves. sealed container. >> Perform the Time Out Procedure (Appendix A) immediately prior to administration of the drug. should be administered not less than 30 minutes prior to and not more than 90 minutes before the administration of oral therapy unless instructed otherwise in the protocol. Inform the treating physician of the episode for further guidance. forceps. Following education about treatment and procedure. The standard ‘no touch technique’ must be used by personnel administering oral cytotoxic drugs to the patient. The device should be thoroughly washed after each use. renal and liver function tests prior to each treatment cycle (as per approved site treatment protocols). providing breakage has not occurred. Medication should not be left at the bedside. >> Anti-emetic drugs. consent to commence treatment must be obtained. if indicated. >> If the patient experiences emesis immediately after ingestion a further dose must not be administered. between cycles or recovery phases as recommended. >> Return unused cytotoxic tablets/capsules to the pharmacy. >> Staff should wear nitrile gloves or double gloves and use the ‘no touch technique’ when placing cytotoxic medication in a disposable pill container. If necessary.g. ECOG1 scale when undertaking cancer therapy >> weight. >> Medication should be stored as directed by pharmacy. >> Patients should be observed to ensure that they have taken the oral medication.Appendix 7 – Model Procedures Model Procedure 6 Administration of Oral Cytotoxic Drugs in the Health Service Linen and clothing from patients who have received cytotoxic drugs should be considered to be contaminated for a period of 7 days following administration of cytotoxic drugs and should be handled as per contaminated laundry procedures. Assist administration if necessary. Pre-treatment assessment Pre-treatment assessment at baseline and prior to each treatment should be done by the registered nursing staff and should include: >> full blood count. Any changes in weight of more than 10% should be referred to a medical officer. notify medical officer or nurse practitioner >> symptom and side effect review – toxicity grading scale utilised >> allergy and drug reaction history >> performance status – for example. >> Medication should not be broken or crushed. >> Ensure that medications are given in accordance with food precautions and interactions refer to treatment protocols. >> Ensure that the patient can swallow the medication(s) and that there are no risk factors for aspiration. this procedure should only be performed in pharmacy using a cytotoxic safety cabinet. should be provided to the patient and their carer if they are returning home with oral cytotoxics. height.

References 1. M A S page 132 E L P Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 . 4. B Time Out Checklist. Oken. eviQ (www. Am J Clin Oncol 1982. Position Statement on the Minimum Safety Requirements for Nurses involved in the Administration of Anti-Cancer Drugs within the Oncology and Non-Oncology Setting 2010. 2.au) accessed 12 Nov 2010. SA Health. 3. 5:649-655.eviq. Safe Handling of Cytotoxic Drugs and Related Wastes: Guidelines for South Australian Health Services 2012. Toxicity and Response Criteria of the Eastern Cooperative Oncology Group. Cancer Nurses Society of Australia.Appendix 7 – Model Procedures Model Procedure 6 Administration of Oral Cytotoxic Drugs in the Health Service Appendices A Time Out Procedure.org. MM et al.

staff must take a ’time out’ in the presence of another staff member to verify all critical information including: >> the patient’s name and medical record number >> drug >> dose. This is to be checked against the medication order. including BSA check >> volume >> route. the label on chemotherapy syringe and the patient’s armband.Appendix 7 – Model Procedures Appendix A Time Out Procedure Immediately before any medication is administered. M A S E L P Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 page 133 . The Time Out Checklist is located in Appendix B.

If yes. If no. If not within normal limits. refer to medical officer. Details of the registered nurses undertaking procedure. do not proceed. If no. The patient has been identified correctly and the treatment is safe to proceed. do not proceed until medical officer has reviewed and given authority to proceed. seek advice. . Date: / / Time: am / pm Tick (✔) the boxes and initial any changes or information not appropriate. do not proceed. Parameter Patient and family education Consent signed Doctor’s prescription legible and signed FBC / EUC / LFTs checked Yes Toxicities or changes to patient’s ECOG Allergies / previous drug interactions Pre-medication given if indicated Cannual / CVC patient with brisk blood return Patient identity confirmed Correct treatment Correct dose including BSA Correct route Correct time If no. If previous reactions noted to these drugs. Full name (Please print) Signature Date Full name (Please print) Signature Date page 134 Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 MR ___________________________ Time Out Procedure Checklist Medical authority has been given to proceed M A S E L P No Actions If no. This procedure should be undertaken immediately prior to cytotoxic drug administration.Appendix 7 – Model Procedures Appendix B Affix Patient Identification Label Here Time Out Procedure Checklist (Page 1 of 1) Surname Given Name Address UR Number DOB Sex Suburb/Town Post code This form is to be completed giving due consideration to the (insert policy name) _________________________________ of the (insert health service name) ___________________________________________________________________________________ To be completed by 2 registered nurses. refer to medical officer. do not proceed.

Wash the affected skin with soap and clean thoroughly with copious amounts of water. 3. 5. people who are handling. M A S E L P 2. Immediately remove outer gloves. machine washed separately and line dried. refer to the health service’s extravasation procedure. 4. 3. gown and any contaminated clothing. This procedure would apply to all personnel. Remove contaminated clothing as above. 6. 2. Contaminated clothing should be bagged separately. Wash thoroughly as per skin exposure. Refer to the health service’s extravasation procedure where appropriate. Penetrating injuries. Report to supervisor immediately. Clothing and personal protective equipment (PPE) 1. transporting and managing cytotoxic drugs. Seek immediate medical advice and further medical attention as necessary. Abbreviations and definitions Cytotoxic Cytotoxic waste Extravasation Harmful to cells of the body. Remove and dispose of inner gloves into the cytotoxic waste disposal container. 4. 2. Do not administer anaesthetic drops or ointments. administering. skin and other body contact Skin exposure 1. Report to supervisor immediately. particularly those that reproduce rapidly. Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 page 135 . 4. Place disposable personal protective equipment in the cytotoxic waste container. Any residual cytotoxic drug following patient treatment or any material associated with its preparation or administration which may contain traces of drug. Unplanned escape of a liquid from a vessel or tube into surrounding body tissues. 3. If the needle stick injury results in the injection of cytotoxic drug. Needlestick injuries 1. but is not limited to. preparing.Appendix 7 – Model Procedures Model Procedure 7 Accidental Exposure to Cytotoxic Drugs and Related Wastes The purpose of this model procedure is to ensure that individuals exposed to cytotoxic drugs and related wastes are managed and attended to in a manner that minimises the effects of exposure. Seek immediate medical advice and further medical attention as necessary.

Appendix 7 – Model Procedures

Model Procedure 7

Accidental Exposure to Cytotoxic Drugs and Related Wastes
Mucosal exposure, e.g. eyes 1. Immediately flush the affected area – the eyes – with an isotonic saline solution (e.g. Eyestream®) for at least 15 minutes – continuous irrigation may be facilitated with an intravenous infusion set connected to a bag of intravenous normal saline. 2. Report to supervisor immediately. 3. Seek immediate medical advice and further medical attention as necessary.

Record keeping/OHSW requirements
Document occurrence of the incident on the internal OHSW incident report form and provide the form to the manager of the area, following internal OHSW reporting system.

References
1 SHPA; Standards of Practice for the Safe Handling of Cytotoxic Drugs.

2. SA Health; Safe Handling of Cytotoxic Drugs and Related Wastes: Guidelines for South Australian Health Services 2012.

M A S
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Appendix 7 – Model Procedures

Model Procedure 8

Spill Management of Cytotoxic Drugs

The purpose of this model procedure is to ensure that spills involving cytotoxic drugs are managed and attended to in a manner that avoids the risk of exposure to personnel and contamination of the surrounding working environment. This procedure would apply to all personnel, but is not limited to, people who are handling, preparing, administering, transporting and managing cytotoxic drugs.

Abbreviations and definitions
Cytotoxic Cytotoxic waste PPE Harmful to cells of the body, particularly those that reproduce rapidly. Any residual cytotoxic drug following patient treatment or any material associated with its preparation or administration which may contain traces of drug. Person protective equipment.

General information

All spills of cytotoxic drugs during preparation, transport and administration must be segregated, cleaned thoroughly and disposed of in a manner such that personnel and the environment are not contaminated. All personnel handling cytotoxic drugs must be trained in procedures for handling waste generated during the preparation, transportation and administration of cytotoxic drugs. Ancillary workers should assist only in the containment of a spill while alerting trained personnel. Cytotoxic drug spill procedures are to be followed in the event of a cytotoxic spill and must be available to all staff handling cytotoxic drugs. FOR ALL SPILLS

M A S

E L P

DO NOT leave the site of cytotoxic spillage unattended

DO absorb as much of the spill as possible before using decontaminating procedures on residual cytotoxic agent

Spills during preparation within a cytotoxic drug safety cabinet
All personnel handling cytotoxic drugs in cytotoxic drug safety cabinets and cleanrooms must be familiar with the procedures to follow in the event of a spill. They must be familiar with Appendix C of Australian Standard AS 2639‑1994 Laminar flow cytotoxic drug safety cabinets – Installation and use. Note: Within a cleanroom, all personnel should wear personal protective equipment.

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Appendix 7 – Model Procedures

Model Procedure 8

Spill Management of Cytotoxic Drugs

Small drug spills 1. Keep the cabinet operating. 2. Access the nearest spill kit (Appendix A). 3. Clean immediately using available absorbent material. 4. For a spill on a cytotoxic spill mat: >> C ytotoxic solution: Wait for the liquid to be absorbed, then carefully fold the mat containing the spill, avoiding contact with the contaminated area, and dispose in the cytotoxic waste bin. >> C ytotoxic powder: Carefully place a mat over the powder ensuring minimal dust production, then carefully wet the mat so that the powder dissolves and is absorbed by the mat. 5. For a spill on the cabinet floor:

>> Cytotoxic  solution: Mop up the spill with an absorbent wipe or swab and place in the cytotoxic waste bin. Clean the area with a strong alkaline cleaning agent using a circular motion, rinse using sterile water and dry with fresh towlettes. >> C ytotoxic powder: Cover with a dampened sterile wipe, fold absorbent sheet, being careful to collect any broken glass. 6. Discard collected waste into the cytotoxic waste container.

7. Clean the area with strong alkaline cleaning agent using a circular motion. 8. Rinse area thoroughly with purified water.

9. Dry the affected area with absorbent towels or swabs.

10. Wipe the affected area with sterile alcohol (70%) to assist with drying of the surface. 11. Discard the waste into the cytotoxic waste container.

12.  If personal protective equipment is contaminated, discard it into a cytotoxic waste container and don new personal protective equipment. 13. Change gloves.

14. As soon as practicable or at the end of the shift: a. complete an incident report

M A S

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b. enter details into the cytotoxic spills register (Appendix B) c. ensure that the spill kit is replenished and maintained.

Large drug spills 1. Reverse the airflow. 2.  For large spills, a spill pillow to absorb the fluid may be used – this may be placed on the floor of the cabinet or in the sump area as needed. 3. Follow steps 2 to 14 above (i.e. same as for small spills). 4. Return airflow.

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Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012

Appendix 7 – Model Procedures Model Procedure 8 Spill Management of Cytotoxic Drugs Drug spills in a cleanroom but outside a cytotoxic drug safety cabinet Treat as already described with the following additional step: 1. gently pour water onto chemosorb pad so that it saturates (without flooding) the area. Contain the spill by placing towelettes around the spill and gently place a chemosorb pad over the spill. absorb the solution with fresh towelettes and dispose of in the plastic bag.  Cover the area with strong alkaline cleaning agent and leave for 10 minutes. Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 page 139 . 19. and place them in the purple waste bag. 8. 13. start from the spill’s outside edge to carefully wipe towards the spill’s centre and dispose of in the plastic bag. Remove PPE in the following sequence and dispose of in the white bag: > outer gloves > chemogown M A S E L P > safety glasses. disposing of clean up absorbent towels into the white bag.  Put on personal protective clothing (respirator mask. 15. Dry the area with the remaining towelettes and dispose of in the white bag.  Rinse the area thoroughly with water. Do not press down on the bag as broken glass may puncture the bag. 16. 7. If in a cytotoxic suite – reverse airflow. Dry the area with absorbent towels or other suitable material. As soon as practicable or at the end of the shift: > complete an incident report > enter details into the cytotoxic spills register (Appendix B) > ensure that the spill kit is replenished and maintained. mask and hair net. safety glasses. 3. isolating the area and informing people to stay clear. 18. hairnet. Prominently display the “Caution Hazardous Drugs Spill” signs. Use a fresh wipe each time. Wash your hands thoroughly with soap and water.  Use the second cable tie to close the purple bag and dispose of the bag in the cytotoxic bin.  Open white and purple waste bags and roll down the tops so items can be placed inside without contaminating their exteriors. double gloves (second pair over the cuff of the chemo gown). If in cytotoxic suite – return air flow to normal. 17.  Using towelettes moistened with water. > overshoes 14. Scoop up broken glass and/or powder slurry using the plastic scoop and scraper and dispose of in a plastic bag. 5. 9. 2. 4. 12.  Alert others in the immediate vicinity that a cytotoxic spill has occurred. 6.  Clean the spill – if a powder spill.  Place the plastic bag inside the purple waste bag without touching its exterior then remove the second pair of gloves. 10. Wait for the water to soak through to the powder. 11.  Carefully tie the top of the white bag with a cable tie. chemo gown and overshoes).

5. administration and patient care 1. 4. 7. 2. Wash/cover the area with a strong alkaline cleaning agent and leave for 10 minutes. Dry the area with absorbent towels or other suitable material. Remove signs.Appendix 7 – Model Procedures Model Procedure 8 Spill Management of Cytotoxic Drugs Spills during drug transport. 14. 9. Carefully collect the absorbent or mat and place in the labelled plastic waste cytotoxic bag. Don new gloves and seal cytotoxic waste bag. Rinse area thoroughly with water. 6.  Carefully collect any broken glass. M A S E L P page 140 Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 . As soon as practicable or at the end of the shift: > complete an incident report > enter details into the cytotoxic spills register (Appendix B) > ensure that the spill kit is replenished and maintained. The person carrying out the spill clean up MUST be trained in this cytotoxic spill procedure.  Discard outer gloves into cytotoxic waste bag. If powder is spilt. carefully place the mat or absorbent pad over the spill and wet the pad or absorbent with water. discard contaminated PPE and gloves into the cytotoxic waste bag. disposing of clean up absorbent towels into the cytotoxic waste bin. The person MUST don the PPE provided for the cytotoxic drug spill clean up. 12. Isolate and secure the area. 8. Access to the cytotoxic spill kit (Appendix A). Wash hands thoroughly with soap and water. Place the collected waste in the cytotoxic waste bin. placing signs around the area where the spill has occurred. equipment and PPE should be readily available. 15. then cover the spill with absorbent. 11. 3. 10. 13.

 If carpet squares are not removable. Standards of Practice: Safe Handling of Cytotoxics. 3. 8. 4. J Oncol Pharm Pract 2007.Appendix 7 – Model Procedures Model Procedure 8 Spill Management of Cytotoxic Drugs Spills on carpet 1. 7. 2.) 6. International Society of Oncology Pharmacy Practitioners (ISOPP). 9. Decontamination of the carpet cleaning machines is not considered necessary due to the dilution effect. etc) it into a cytotoxic waste container. Discard the waste into the cytotoxic waste container.  Clean the carpet with a strong alkaline cleaning agent. Access the nearest spill kit (Appendix A). Discard personal protective equipment (gloves. 13 Suppl:1-81. The person MUST don the PPE provided for the cytotoxic drug spill clean up. As soon as practicable or at the end of the shift: > complete an incident report > enter details into the cytotoxic spills register (Appendix B) > ensure that the spill kit is replenished and maintained. References 1. 5. If carpet squares are removable: > remove and dispose in the cytotoxic waste container > replace the carpet squares with new ones. Absorb as much fluid as possible using absorbent pads. (Note that the carpet may be bleached if sodium hypochlorite solution is used. minimising the seepage into unaffected areas of the carpet. M A S E L P Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 page 141 . Safe Handling of Cytotoxic Drugs and Related Wastes: Guidelines for South Australian Health Services 2012. 2. SA Health. have the carpet professionally cleaned with a commercial carpet cleaner.

Appendix 7 – Model Procedures Appendix A Cytotoxic Drug Spill Kits Item 1 2 3 Safe work procedures for the management of a cytotoxic spill (laminated) Cytotoxic spill signs and caution tape Personal protective equipment: >> nitrile gloves >> head cover >> gown or coveralls >> bonded polyethylene fibre overshoes >> safety glasses >> full-face chemical splash shield 4 5 6 7 8 9 Swabs. chemical absorbent pads. spill pillow. absorbent towels. ‘chemomat’ Disposable scoop 2 1 1 1 1 1 assorted 1 2 2 1 bottle 1 Quantity 1 2 Plastic waste bags with ‘CYTOTOXIC – HANDLE WITH CARE’ labels affixed Bag ties Strong alkaline cleaning agent 1 L water in bottle M A S page 142 E L P Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 .

Appendix 7 – Model Procedures Cytotoxic Drug Spill Register Organisation: Site/area: Date: Person compiling register: E L P Drug name Location or process where drug product was spilt Notification to SafeWork SA? Yes/No/ Not required Personnel involved Were any personnel contaminated? Yes/No Action taken Comments Date for review of register: / / Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 M A S page 143 Appendix B .

people who are handling. administering. E L P 2. The bins should be identified as ‘Cytotoxic waste – incinerate at 1100ºC’. but is not limited to. particularly those that reproduce rapidly. Purple bin liners should be used * Either purple bins/containers or yellow medical waste bins with appropriate purple stickers. transporting and managing cytotoxic drugs Abbreviations and definitions Cytotoxic Cytotoxic waste Harmful to cells of the body. This procedure would apply to all personnel. Any residual cytotoxic drug following patient treatment or any material associated with its preparation or administration which may contain traces of drug such as: >> cytotoxic pharmaceuticals passed recommended shelf life. etc >> swabs and materials used to clean and contain spills >> contaminated cleaning equipment (mops. expired or contaminated stock Bins and receptacles 1. cloths). disposable gowns and shoe covers. M A S >> dressings and bandages >> HEPA filters >> contaminated PPE – gloves. 3. All cytotoxic wastes must be placed in sharps containers and/or and waste bins readily identifiable* with the telophase cytotoxic symbol. or returned from patients >> sharps and syringes >> IV infusion sets and containers >> ampoules and vials >> the cotton wool from bottles containing cytotoxic drug >> remaining solutions. preparing.Appendix 7 – Model Procedures Model Procedure 9 Managing Cytotoxic Waste The purpose of this document is to ensure that waste contaminated by cytotoxic drugs is managed in a manner that avoids risk to the health and safety of staff. page 144 Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 .

Spills Refer to Model Procedure – Spill Management. Bins should be emptied at least weekly or before the volume in the bin exceeds two thirds the volume of the liner or 6 kilograms. This may be situated within the main waste storage area. 3. try to prolong the disposal time (e.g. Consideration should be given to wrapping glass bottles with liquid waste in bubble wrap and/or absorbent material to avoid breakages. Collection for disposal 1. Health services should ensure that a cytotoxic waste collection area is: >  a dedicated storage area with adequate lighting and ventilation. refrigeration) then transfer to fill a bin for disposal. The bags/bins containing the cytotoxic waste shall be removed from the initial collection containers and sealed before transferring to the contractor supplied. Cytotoxic wastes shall be held for as long as possible (without exceeding the 7 day limit) to fill the bin. 4. Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 page 145 . pharmacy) 1. Cytotoxic waste should be stored in containers. 5. A bin need not be full if the contents of the bin require immediate disposal and the volume cannot be made up. and kept in a secured area. These containers are not to be re-opened on site once they have been secured. that are capable of being secured.Appendix 7 – Model Procedures Model Procedure 9 Managing Cytotoxic Waste Waste at source (i. M A S E L P 2. Sharps containers can be placed inside the bins for disposal. whichever is the lesser. identifiable (see Bins and Receptacles) wheelie bins for collection from a dedicated storage area. identified as being used for cytotoxic waste. provided there is adequate room to separate cytotoxic waste material from the other waste streams > able to be secured > located away from stormwater drains and other sensitive areas > appropriately signed for the type of waste stored. 3. wards. 2. 2. Waste should be put out for collection within 7 days of being generated. For perishable waste. Cytotoxic waste bins should be located as close as practicable to the site of generation to minimise the handling and transport of cytotoxic waste from the site of generation. 4. Storage 1. Cytotoxic waste must be collected in purple liners and transferred to readily identifiable bins (see Bins and Receptacles).e. All bins used to store cytotoxic waste must be placed in such a manner as to reduce the risk of spill and/or contamination. When bins are placed in public areas they must be locked at all times.

7. Occupational Health. 5. 3. The South Australian Environment Protection Regulations 2009. M A S E L P 12. HB 202 A management system for clinical and related wastes – guide to application of AS/NZ 3816-1998.  Waste Management Associate of Australia (WMAA). The South Australian Dangerous Substances (Dangerous Goods) Transport Regulations 2008. 3. 8. Industry Code of Practice for the Management of Clinical and Related Wastes 6th Ed 2010. No government or private vehicle is to be used to transport cytotoxic waste generated by the health service. SA Health.Appendix 7 – Model Procedures Model Procedure 9 Managing Cytotoxic Waste Transporters of cytotoxic waste 1. Safety and Welfare Regulations 2010 (Section 22) specifies that records must be kept for a period of 5 years. 9. page 146 Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012 . The South Australian Environmental Protection (Waste to Resources) Policy 2010. 2. 10. 11. Safety and Welfare Act 1986. Transportation shall be in accordance with: > The Environment Protection Act 1970 > Environment Protection Regulations 2009 > The Dangerous Substances Act 1979 > Dangerous Substances (Dangerous Goods) Transport Regulations 2008 > Australian Code for the Transport of Dangerous Goods by Road and Rail. Record keeping/OHSW requirements The Occupational Health. 2. The South Australian Dangerous Substances Act 1979. Occupational Health. Safe Handling of Cytotoxic Drugs and Related Wastes: Guidelines for South Australian Health Services 2012. Safety and Welfare Act 1986 and Occupational Health. Safety and Welfare Regulations 2010. A copy of the licence cover sheet must be supplied by the contractor to the health service before any waste is removed from site. AS/NZ 3816-1998 Management of clinical and related wastes. 6. The South Australian Environment Protection Act 1970. Australian Code for the Transport of Dangerous Goods by Road and Rail. References 1. Cytotoxic waste shall be collected and transported only by a person or company with a licence for handling regulated wastes (cytotoxics). 4.

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gov. All rights reserved.sahealth. March 2012. Government of South Australia. .gov.For more information Pharmaceutical Services and Strategy Branch SA Health 11 Hindmarsh Square Adelaide SA 5000 Telephone: 08 8204 1944 www.sa.au/HazardousDrugs If you require this information in an alternative language or format please contact SA Health on the details provided above and they will make every effort to assist you. www.ausgoal.ISBN: 978-1-74243-233-5 FIS: 10119.au/creative-commons © Department for Health and Ageing.