SafeHandlingOfCytotoxicDrugsRelatedWastesGuideline-PHCS-120515

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

Version control and change history

Version Date from Date to Amendment 1.0 2/2/2012 Current Original version

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

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

Guidelines for South Australian Health Services 2012

Cytotoxic Drugs and Related Wastes

Safe Handling

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.

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

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 GroupSouth 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 NetworkThe Queen Elizabeth HospitalEric Hofmanis

Clinical Oncological Society of AustraliaBen 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 SAJayne Hallam

SafeWork SA Antonietta Colella Shelley Rowett

Society of Hospital Pharmacists of Australia (SA/NT Branch)Hayley Vasileff

University of AdelaideDr 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.

page 2 Safe Handling | Cytotoxic Drugs and Related Wastes Guidelines for South Australian Health Services 2012

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.


Table of Contents

Table of Contents

1 Introduction 7

1.1 What are cytotoxic drugs? 7

Monoclonal Antibodies (MABs) 8

BCG 8

1.2 Who is at risk? 8

1.3 Potential adverse effects 9

2 Legislation 10

2.1 Occupational Health, Safety and Welfare Act 1986 10

2.2 Occupational Health, Safety and Welfare Regulations 2010 10

2.3 Risk management 10

2.4 Hazardous substances 11

2.5 Duties of manufacturers, importers and suppliers of hazardous substances 11

2.6 Safety data sheets (also known as material safety data sheets – MSDS) 12

2.7 Summary of duties of employers who use hazardous substances 12

2.8 Transport of cytotoxic drugs as dangerous goods 12

2.9 Plant and equipment 13

2.10 Other legislation, policies and measures 13

3 Managing the Risk 16

3.1 Consultation and communication 16

3.2 Hazard identification 17

3.3 Risk assessment 17

3.4 Risk control 21

Develop a risk control plan 21

3.5 Trial and implementation 22

3.6 Monitor and review 23

4 Staff Health 24

4.1 Health surveillance 24

Health monitoring 24

Biological monitoring 24

What type of health surveillance should be implemented? 25

4.2 Special health considerations 28

4.3 Hygiene 29

4.4 Work flow 29

4.5 Emergency procedures 29

4.6 Reporting and keeping records 29

4.7 Model procedures 29

5 Training 30

5.1 Who should be trained? 30

5.2 Identify training requirements 31

Patient training 31

5.3 Evaluate the training program 32

5.4 Training records 32


6 Preparation and Dispensing 35

6.1 Elimination, substitution or replacement 35

6.2 Isolation at the source of the hazard/source containment 35

Closed system drug transfer devices 35

Other devices 36

6.3 Engineering controls/ventilation 37

Cytotoxic drug safety cabinets 37

Pharmaceutical isolator cabinets 37

Biological safety cabinets (BSC) 38

6.4 Administrative controls/organisation measures 39

Parenteral preparations 39

Non-parenteral preparations 39

Non-parenteral preparations – oral tablets and capsules 39

6.5 Personal Protective Equipment 42

6.6 Procedures and model procedures 43


Table of Contents

7 Labelling 44

7.1 All cytotoxic drugs 44

7.2 Supply of a cytotoxic drug to a patient 44

Supply on a medication order 44

Dispensing on a prescription 44

Ancillary labels 45

Australian Commission on Safety and Quality in Health Care 46

7.3 Cytotoxic drugs for transportation 46

7.4 Cytotoxic drugs provided to drug preparation facilities by a supplier for further processing 46


8 Transport 49

8.1 Transportation of cytotoxic drugs 49

External transportation 49

Additional considerations for manufacturers 51

Transportation within a health service 51

8.2 Transport of cytotoxic waste 52

On-site waste transport 52

Off-site waste transport 52

Transport licence 52

Transport certificates 52

Vehicle signage 52


9 Administration 53

9.1 Key risk control measures 53

9.2 Establishing a drug administration area 54

9.3 Cytotoxic drug administration 55

Patient assessment 55

Equipment 55

Intravesical administration 57

Topical administration 57

Oral administration 57


10 Caring for Patients in the Community 58

10.1 Community dispensing 58

10.2 Role of the treating facility 59

10.3 Personnel management 59

10.4 Maintaining controls 60

10.5 Administration of cytotoxic drugs 60

10.6 Managing cytotoxic waste 60

10.7 Safe work procedures 61

10.8 Emergency procedures 61

11 Caring for Patients at Home 62

11.1 Home care by nursing staff 62

Setting up a patient care area 63

Equipment 63

11.2 Home care by relatives and/or patient 64

12 Cleaning 65

12.1 Cleaning agents 65

12.2 Work place monitoring 66

12.3 Cleaning staff 66

13 Personal Protective Equipment (PPE) 67

13.1 Coveralls and gowns 67

13.2 Gloves 68

13.3 Protective eyewear 68

13.4 Shoe covers and overshoes 68

13.5 Respiratory protective equipment (RPE) 69

13.6 Head covering 69

14 Laundry 70


14.2 General recommendations 70

14.3 Other contaminated bedding 70


Table of Contents

15 Spills 71

15.1 Sources of spills 71

15.2 Spill kits 72

15.3 Spill containment 73

15.4 Reporting procedures 74

Notification of incidents 74


16 Contaminated Body Wastes 76

16.1 Assessment of contaminated body waste 76


17 Waste Management 77

17.1 What is cytotoxic waste? 77

17.2 Establishing a waste management strategy 78


17.4 Identification, containment and segregation 79

Identification 79

Containment 79

Segregation 79

17.5 Requirements and licensing for handling or storage of cytotoxic waste 80

17.6 Waste disposal and treatment 80


18 Animal Research Facilities 81

18.1 Establishing an animal care area 81

18.2 Equipment required 82

Animal cages and cleaning 82


Appendices 84

1 Glossary 84

2 Information Sources 89

3 Monoclonal Antibodies (MABs) 93

4 Hazardous Substances (Cytotoxic Drugs) Register 94

5 Risk Assessment Tool for Cytotoxic Drugs and Related Wastes 95

6 Cytotoxic Drug Precautions Alert Proforma 101

7 Model Procedures

1 Health Surveillance for Staff Handling Cytotoxic Drugs and Related Wastes 103

2 Staff Training for the Safe Handling of Cytotoxic Drugs and Related Wastes 112

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 122

5 Transport of Cytotoxic Drugs Within the Health Service 125

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

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1 Introduction


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. 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.

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, community and production facilities

> patients homes

> nursing homes, hostels and other residential care settings

> paramedical or ambulance vehicles

> analytical pathology and research laboratories

> research, 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.

For the purpose of this guide, the scope of the use of cytotoxic drugs includes their preparation, administration, handling, storage, transportation, disposal and spills management.

This document has not been designed for use by:

> the private and commercial sectors

> waste collection and disposal facilities

> funeral homes

> veterinary facilities.

The principles discussed in this guidance document are applicable to these settings and therefore may be used as a reference for the above services.

1.1 What are cytotoxic drugs?Cytotoxic drugs are known to be highly toxic to cells, mainly through their action on cell reproduction. Many have proved to be carcinogenic, mutagenic or teratogenic.

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, multiple sclerosis and auto-immune disorders.

Generally, cytotoxic materials are identified by a purple symbol that depicts a cell in late telophase.


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.

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. These agents differ from conventional cytotoxic agents in that they do not directly or indirectly damage DNA or RNA and therefore would not, as a class, be expected to be carcinogenic, mutagenic or teratogenic in the patient themselves or in the staff handling the drugs. These drugs differ chemically and pharmacologically from conventional cytotoxic drugs, however lack of understanding of the science behind these drugs has caused concerns among healthcare professionals.

Some limited information and references for health services dealing with monoclonal antibodies are provided in Appendix 3.

BCGThe 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. Each drug should be risk assessed based on current information, safety data sheets, investigator brochures and other relevant information sources, taking into account molecular and cellular level mechanisms of action as well as published toxicity data.

Depending on the individual agent and clinical setting, similar handling precautions to those used for cytotoxic drugs may be required.

1.2 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.

Exposure may occur through skin contact, skin absorption, inhalation of aerosols and drug particles, ingestion and sharps injuries.

1 Introduction


1.3 Potential adverse effectsWhere control measures have been inadequate, 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, hair loss, nasal sores and vomiting

> liver damage

> contact dermatitis.

Where a high standard of risk control is in place and adhered to, threats to health are greatly reduced.

1 Introduction


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. Employers have obligations to ensure staff and other individuals are not exposed to risks which may affect their health and safety.

Occupational health and safety requirements are to be implemented when using and handling cytotoxic drugs and related waste.

2.1 Occupational Health, Safety and Welfare Act 1986 In South Australia, there is a legal obligation to provide a healthy and safe workplace. Under the Occupational Health, Safety and Welfare Act 1986 (OHSW Act), 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, instruction and training

> monitoring of the workplace and the health of employees.

Self-employed people, employees, manufacturers, importers and suppliers of plant, equipment and substances also have an obligation to ensure workplace health and safety.

A person who designs, manufactures or supplies any plant or substance for use by people at work must provide, or arrange for the provision of, adequate information about the plant or substance to the persons to whom it is supplied to ensure its safe use.

2.2 Occupational Health, Safety and Welfare Regulations 2010 The Occupational Health, Safety and Welfare Regulations 2010 (OHSW Regs) make specific provisions for hazardous substances. But, even when a substance is not classified as a hazardous substance (see below), information must be provided in accordance with OHSW Reg 22 to ensure it is safe and without risks to health when properly used. Product information, including adverse effects, is often provided with packaged drugs and provides an additional source of information about safe use. Requirements for storage of Class 6 toxic substances are also covered under Dangerous Substances Regulations 2002.

Work involving the handling and transport of cytotoxic drugs falls within the scope of the OHSW Regs and Dangerous Substances (Dangerous Goods Transport) Regulations, specifically Part 5 which covers hazardous substances and the Australian Code for the Transport of Dangerous Goods by Road and Rail, respectively.

A limited number of substances are exempt from the OHSW Regs, including therapeutic goods that are brought into the workplace for personal use. However, exemption does not apply when the substances are used for a work-related activity.

2.3 Risk managementEven when a substance, including a cytotoxic drug, is not classified as a hazardous substance by the manufacturer or importer, the employer must still comply with OHSW Regs Part 1 Division 3 with respect to that substance, and the employer must ensure that each substance does not pose a health or safety risk to those at work. This obligation extends to not harming visitors or employees, for example contract waste collection personnel who enter the workplace.

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, including training drills, must be provided

> information and supervision must be provided

> first aid and emergency procedures must be developed.

2.4 Hazardous substancesOHSW Regs Part 5 Division 1 aims to protect people against risks to their health and safety when hazardous substances are used at work.

For a substance used at a workplace to be classified as hazardous, 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, Approved criteria for classifying hazardous substances.

Most cytotoxic drugs will be classifiable as hazardous substances in accordance with the Approved criteria for classifying hazardous substances. The SafeWork SA Approved code of practice for the control of workplace hazardous substances provides practical guidance on complying with the OHSW Regs.

When cytotoxic drugs are classified as hazardous substances, any waste they generate is also likely to be classified as a hazardous substance and the OHSW Regs apply.

The SA Environmental Protection Authority (EPA) regulates the transport of cytotoxic waste, particularly bulk transport. Refer to Section 8 – Transport and Section 17 – Waste Management for additional information.

2.5 Duties of manufacturers, importers and suppliers of hazardous substances In addition to the general duties of the OHSW Act, the OHSW Regs require manufacturers and importers who supply hazardous substances to workplaces to provide certain information about their product.

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. 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, or to other facilities or services, they are considered to be suppliers.

2 Legislation


2.6 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. 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.

Legal obligations in relation to safety data sheets are specified in the OHSW Regs. Manufacturers are required to classify chemicals and prepare safety data sheets. Importers must ensure that the manufacturer’s responsibilities are met.

Suppliers are required to provide safety data sheets for those chemicals classified as hazardous substances if they supply to workplaces. If a supplier fails to provide adequate information to develop a safe work method, 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.

For more specific guidance and advice on safety data sheets, refer to the National code of practice for the preparation of material safety data sheets, 2nd edition (NOHSC: 2011 (2003)), Safe Work Australia or the Code of practice for the control of workplace hazardous substances 2006.

2.7 Summary of duties of employers who use hazardous substances Employers, in consultation with employees, must use information provided by manufacturers, importers or suppliers to identify the hazardous substances used in the workplace, assess the risk to health, and control hazards to health associated with their use.

In summary, 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, instruction and training.

2.8 Transport of cytotoxic drugs as dangerous goods SafeWork SA is the authority responsible for dangerous substances and transport of dangerous goods in South Australia. However, the South Australian Environmental Protection Authority is responsible for regulating the transport of hazardous waste in SA.

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


2.9 Plant and equipment Part 3 of the OHSW Regs outlines specific obligations with respect to plant, as well as the general obligation to ensure workplace health and safety. Plant includes any machinery, equipment or appliance. With respect to cytotoxic drugs and related waste, plant may include cytotoxic drug safety cabinets, trolleys for carrying cytotoxic drugs, administration equipment, drug delivery services, washing machines, other laundry equipment, needles and syringes.

Employers, self-employed persons, designers, manufacturers, suppliers and installers of plant have obligations under Part 3 Division 2. Obligations include:

> installing, erecting and commissioning plant

> using plant

> maintaining and repairing plant

> keeping records

> providing information.

2.10 Other legislation, policies and measuresOther 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.

2 Legislation

Employers must identify the hazardous substances used in the workplace, assess the risk to health and control hazards

to health associated with their use.


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. 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. For this reason, 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, during implementation, monitoring and review

> assess policies and procedures on a regular basis.

The risk management approach is integral to the South Australian OHSW legislation and is essential for every day sound management practice, and good corporate and clinical governance (Figure 1).

3 Managing the Risk

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

The aim of a risk management approach is to eliminate or minimise the risk of illness or injury associated with work. The process is outlined in OHSW Regs Part 1 Division 3.

OHS Comittee

Employer Health & Safety Representative

System Monitoring and Review

Consultation

Hazard Identification

Trial and Implement Controls

Risk Assessment

Evaluation of Controls

Risk Control

Figure 1: The risk management approach

Elimination/substitution

Isolation

Engineering

Administrative

Personal Protective Equipment


Generally, 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.

3.1 Consultation and communicationThe OHSW Act places a duty of consultation on the employer to consult with employees. This enables employees to contribute to making decisions that affect their health, safety and welfare at work. Adopting a planned, systematic approach to health and safety and applying risk management principles will help identify when to consult.

Employers need to ensure that communication and consultation with external and internal key stakeholders takes place during all stages of the risk management process. Therefore, 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, treat and monitor the risk.

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, work environment, plant, systems of work or substances used for work, including safety data sheets.

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, including risk assessments and control measures

> changes to premises, work environment, plant, systems of work or substances used for work, including safety data sheets (if available)

> records of incidents, illnesses or injuries (in a way that protects the confidentiality of personal information).

Although volunteers are not employees, the duty to consult still applies (as per the OHSW Act).

3 Managing the Risk


3.2 Hazard identificationHazard identification should establish who may be at risk, the cytotoxic drugs being used, the routes of exposure and the specific activities where there is a risk of exposure. Control measures currently in use and their effectiveness should be identified and recorded.

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.

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).

Ways of achieving this include:

> contact the supplier

> if a safety data sheet is not available, safety information about the relevant cytotoxic drug should be obtained from the manufacturer or importer.

Ensure all containers of cytotoxic drugs are labelled with the manufacturer’s or importer’s label.


> check all containers for labels.

Set up and maintain a cytotoxic drugs register. 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 safety data sheet will state whether the product is classified as hazardous

> work place inspection

> indicate which products are classified as hazardous.

Additional useful information may be added to the register in Appendix 4 – Cytotoxic Drugs Register

3.3 Risk assessmentThe purpose for the assessment is to enable decisions to be made about the appropriate control measures, induction and training, monitoring and health surveillance as may be required by legislation.

The assessment process enables a distinction to be made between ‘hazard’ and ‘risk’. If a substance is hazardous, it has the potential to be harmful to health. The risk is the likelihood that harm will be caused in the actual circumstances of use of the substance.

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.

The risk assessment may be done for a work process and may cover more than one cytotoxic drug. The following step-by-step procedure may be used to assist with the risk assessment process.

Risk assessment can be separated into two parts; assessing the hazard and evaluating the risk.

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:

> health hazard information

> precautions for use

> safe handling information.

Determine the chemical properties of the substance. This may include:

> flammable

> toxic

> carcinogen

> corrosive

> oxidising agent.

Determine the form of the substance. This may include:

> liquid

> powder

> solid tablet

> creams, ointments and lotions for topical application.

Determine the routes of exposure. This may include:

> inhalation of aerosols, 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. This may include:

> carcinogenic, 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, hair loss, nasal sores, vomiting

> liver damage

> contact dermatitis, local toxic or allergic reaction, irritation to the skin.

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, transport and disposal of cytotoxic waste on the premises

> patient care after administration.

Examine the work practices and conditions.

(Involve employees who are working with the cytotoxic drugs.)

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.

Review information relating to incidents or symptoms of exposure.

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.

3 Managing the Risk


Evaluate the risks

No likelihood of injury or illness.This means that employers have a high degree of confidence that work practices are sound and that employees are protected.

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, such as a properly operational cleanroom with a laminar-flow cytotoxic drug safety cabinet

> needleless drug administration systems or retractable needles are used.

Likelihood of injury or illness.This means it is apparent that work practices need improvement.

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.

Likelihood of injury or illness is uncertain.This means that employers are not sure whether work practices are adequate to protect employees.

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, for example:

> conduct wipe tests and atmospheric monitoring (if valid and interpretable tests are available) to determine whether there is any contamination. These tests must be individualised to each workplace, according to the drug used

> eliminate or reduce exposure so far as is practicable.

The OHSW Regs requires employers to demonstrate evidence of the risk assessment process. A sample Risk Assessment Tool is located in Appendix 5.

3 Managing the Risk


3.4 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. These controls are in order of greatest effectiveness to least effective as follows:

> elimination

> substitution

> isolation

> engineering control

> administrative controls

> personal protective equipment (PPE).

The hierachy of controls should always be implemented from the most effective to the least effective.

The employer’s primary duty is to eliminate any risk to health arising from the use of hazardous substances. Where elimination of risk is not practicable, employers must reduce the risk, so far as is reasonably practicable.

Employers must first consider whether the risk can be eliminated. This is the most effective way of protecting the health of employees.

Employers need to ensure that all control measures are properly used and maintained. They must not rely exclusively or primarily on administrative controls or personal protective equipment to control the risk, as these measures depend heavily on human behaviour to be effective. The workplace needs to be made safer, rather than placing the onus on employees to work safely in a hazardous environment. 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.

For strategies reflecting the hierarchy of controls refer to Attachment C of the Risk Assessment Tool in Appendix 5.

Develop a risk control planOne way of tracking proposed and implemented controls and treatments is to prepare a risk control plan. This is a strategy that details a logical series of activities involving consultation, implementation and review. The table below gives an indication of the issues that should be covered.

Risk control plan A basic structure for a risk control plan

A risk control plan sets out the actions required to implement controls over time. It also provides a useful tool to effectively manage this process.

A risk control plan should:

> provide a history of health and safety activities for work involving cytotoxic drugs, including any current control measures and their effectiveness

> specify immediate, 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, through consultation

> provide full documentation of activities

> include a process for the regular review of management systems.

3 Managing the Risk


3.5 Trial and implementationOnce appropriate control measures have been selected, they must be put into effect in the workplace. Implementation involves:

> development of work procedures and writing standard operating procedures (SOPs) in relation to the new control measures, to make sure they are effective. Management, 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. It is important to clearly communicate the reasons for the changes

> provision of training and instruction for workers, 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.

3 Managing the Risk


3.6 Monitor and reviewControl measures should be regularly monitored, reviewed and, where necessary, improved, extended or replaced.

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 3.2 Risk Assessment). This will help measure the effectiveness of risk controls and may reveal areas for improvement.

The risk assessment should be reviewed and revised as necessary and preferably every 2 years or at least every 5 years.


> schedule regular reviews/audits to ensure that the assessment is valid and still applies

> establish the circumstances that would trigger a review or revision, such as:

– an incident, or near miss, 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, supervisors, 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, including the outcome, and any action required to be taken, by when and by whom.

Record the documented review process. 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, or nature of risk identified

> why decisions about the risk were made

> any information that assisted in reaching a conclusion.

Update control measures. Ways of achieving this include, but not limited to:

> updating SOPs

> (re)training.

Make the results of the analysis accessible to any employee to which the record relates.


> keep copies of the assessment in accessible/commonly used files.

3 Managing the Risk


4 Staff Health

An essential part of the risk management strategy is dealing with the issues of staff health surveillance, counselling, reporting and record keeping. This section provides a risk management framework to assist in the development of local policies and procedures, and aims to provide practical advice to employers in the matters of staff health.

4.1 Health surveillanceHealth 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.

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. Health surveillance includes health and biological monitoring but does not include atmospheric monitoring.

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.

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.

Exposure standards for acceptable levels of exposure to cytotoxic drugs have not been developed for pharmaceutical products, therefore adoption of standard precautions and the principles of ALARA (as low as reasonably achievable) is recommended. 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.

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. The program must include counselling of employees on the potential risks to health and reproductive risks, how exposures might occur and control measures in place.

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, for example pharmacy production/manufacturing staff.

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. 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. In particular, information must be obtained about methods that can detect the early signs of health effects or disease.

Many methods have been used to investigate potential health effects of exposure to cytotoxic drugs. These methods have given results that are often inconclusive and difficult to interpret. The ideal test should meet several requirements – it should be sensitive, specific, quantitative, rapid, reproducible and inexpensive. Importantly, the procedures for taking a sample should be non-invasive and should not cause unnecessary duress or anxiety to the individual.

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. The robustness of this testing is unclear.

4 Staff Health


Unfortunately, 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. As a consequence, 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.

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.

The need for ongoing monitoring should be determined at scheduled termination health monitoring assessments.

Additional factors to consider in the development and implementation of a health surveillance program are summarised below.

Factors in implementing a health monitoring program

Considerations Outcome

1 A medical practitioner is appointed to oversee the program. Appointment means that the employer has a formal arrangement with a medical practitioner. All employees must be made aware of this arrangement (ideally this practitioner would be accessible to staff on site).

> The medical practitioner may be an occupational physician, oncologist, haematologist or local general practitioner.

> The medical practitioner should be suitably qualified to provide health surveillance in accordance with NOHSC Competencies for health surveillance (1998).

Staff and the organisation are in agreement on the facilitation of health monitoring.

2 Guidance is provided to the appointed medical practitioner.

General guidance is provided in accordance with NOHSC Competencies for health surveillance 1998 and Guidelines for health surveillance 1995.

Guidelines and competencies are followed and made available to all relevant staff.

3 In regard to the issue of privacy in relation to medical practitioners providing reports to employers.

> Reporting must comply with all privacy requirements and government policy.

> Records that are not related to occupational health and safety screening should not be used in relation to records relating to health monitoring.

4 The health monitoring program is an integrated part of the hazard /risk management program.

> Implementation of the program will involve both relevant staff and health site OHSW representatives.

> Employers will undertake regular monitoring of their employees’ health.

> 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.

> All staff are provided with information and training in relation to the monitoring program.

> Staff will receive a copy of the health monitoring assessment findings including the timing of the next recommended health monitoring review.

4 Staff Health




5 Prospective employees are counselled and provided information about the risks of working with cytotoxic drugs.

Exposure to cytotoxic drugs should form part of the relevant staff position statements.

All prospective employees are required to acknowledge this aspect of the role at application.

Prior to appointment, prospective staff must agree to and be counselled on the approved health monitoring protocol.

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.

> Staff orientation handbooks should include orientation to cytotoxic substances, control measures in place and health monitoring programs.

> Health monitoring reviews are documented and counter signed by the staff member.

6 Pre-employment/pre-placement health monitoring to establish baseline health is conducted by the approved medical practitioner before an employee commences work with cytotoxic drugs.

Baseline health monitoring includes:

> collection of demographic data

> occupational history

> medical history

> physical examination

> investigation, 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.

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.

4 Staff Health




7 Health monitoring is conducted during the period that the employee works with cytotoxic drugs.

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.

The employee shall be provided with a copy of all health monitoring reports.

Health monitoring is conducted:

> during the period the employee works with cytotoxic drugs

> as advised following cessation of employment or work with cytotoxic drugs.

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.g. 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.

> 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

Employee attends health monitoring assessment:

> signs off the record, and

> is provided with a copy of the health record within agreed time frames.

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.

8 Any relevant employee may access advice and counselling from any approved medical officer(s) at any time outside of scheduled health monitoring rota.

Employees will be given access to contact details of approved medical officer(s) and released from duties to attend a consultation.

Information to relevant employees on how to contact approved medical officers is available at all times.

9 No employee will be compelled to work with cytotoxic drugs if special health considerations apply (see Section 4.2).

Skill matched and appropriate alternative duties should be provided to employees who choose not to, or are unable to, work with cytotoxic drugs. Employees will not suffer disadvantage in relation to loss of pay and conditions, and continuity of service. All entitlements must be maintained.

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.

10 An employee’s medical records are confidential.

Where any form of health monitoring is undertaken, confidentiality of an employee’s medical records must be ensured. Access to an employee’s medical records can be obtained only with the written consent of the employee.

Employee health records will be secured separate to their employee human resource records and/or hospital medical records.

Review of an employee’s health monitoring record may only occur during scheduled health monitoring or to support health care of the employee.

4 Staff Health




11 Biological monitoring issues. No one test can be used to detect the presence of all cytotoxic drugs.

When choosing tests, the following requirements should be considered:

> specificity

> sensitivity

> availability

> rapidity

> reproducibility

> cost.

Consult with employees on appropriate biological monitoring to be carried out.

Obtain informed consent from employees to do tests.

12 Consultation. Employers to consult with employees including those of non-English speaking backgrounds about consultative arrangements.

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, work environment, plant, systems of work or substances used for work, including safety data sheets

> where appropriate, when an employee’s circumstances change – e.g. pregnant women and immuno-compromised individuals.

Accurate and relevant safety information must be made available to employees and others.

4.2 Special health considerationsAll personnel involved in any aspect of the handling of cytotoxic drugs should be informed about the risks of occupational exposure to hazardous drugs.

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. In such cases, appropriate and suitable alternative duties must be provided.

4 Staff Health


Consideration Issue

Planning parenthood (male and female), pregnancy and lactation

Employees who are planning parenthood, 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.

Illness Staff with infectious diseases such as upper respiratory, cutaneous infections etc.

Abnormal pathology results Staff with abnormal pathology results should not prepare cytotoxic drugs until the abnormality has been investigated.

4.3 HygieneStrict hygiene procedures must be developed and followed when handling cytotoxic drugs. Eating, drinking, chewing gum and the application of cosmetics must be strictly prohibited. In addition, personnel in the preparation facility should not wear jewellery.

4.4 Work flowA sufficient number of qualified staff members must be available to provide for the expected workload.

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.

Staff allocation must be sufficient to allow for adequate breaks for those working in the cytotoxic cleanroom. It is recommended that no more than two hours be spent working at the cabinet or isolator without a break. As staff often work in isolation, sufficient breaks must be provided to maintain concentration.

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. Any incident should be reported so that the cause can be investigated and determined, and follow-up action taken if required (see Model Procedure 7 – Accidental Exposure to Cytotoxic Drugs and Related Wastes).

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, 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, including any training on hazardous substances (these should be kept within the health monitoring record, 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, such as cytotoxic drug safety cabinets

> details about spills, sharps injuries and contamination.

The employee should keep copies of their records.

4.7 Model proceduresThe following model procedures are associated with this section:

> Model Procedure 1 – Health Surveillance for Staff Handling Cytotoxic Drugs and Related Wastes.

> Model Procedure 7 – Accidental Exposure to Cytotoxic Drugs and Related Wastes.

4 Staff Health


5 Training

Employers have a duty to provide information, instruction, training and supervision to staff and other individuals who handle cytotoxic drugs and related waste. This section provides a risk management framework to assist in the development of local policies and procedures, and aims to provide practical advice on the development of training programs and associated record keeping.

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.

Employers should ensure that only employees who have received appropriate training, and have attained the required level of proficiency, handle cytotoxic drugs and related waste.

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, or procedures change

> on an ongoing basis with two yearly review.

5.1 Who should be trained?The risk assessment results should be used to identify staff and carers who require specific training. Different levels of training are recommended, depending on the level of contact to cytotoxic drugs and related waste. Staff that could be potentially affected are listed in the following table.

High risk Low risk

> pharmacy personnel

> nursing and medical personnel

> laboratory staff

> animal handlers (research)

> 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.

5 Training


5.2 Identify training requirementsThe training needed should reflect the level of risk of exposure as well as the anticipated exposure.

Consideration should be given to the use of training competencies that exist for cytotoxic drugs or other health industry association training courses. Any written training competencies on cytotoxic drugs that are available for specialist professions should be reviewed regularly.

For health care professionals working in the field of cancer therapy, 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.

Additional training resources include:

> The Australian National Cancer Nursing Education Project; EdCaN On-line

> Cancer Australia; Cancer Learning On-line

> WorkCover Victoria; Training Competencies: Handling Cytotoxic Drugs in Health Care Establishments 1997

> National Occupational Health and Safety Commission; Competencies for Health Surveillance 1998

> 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.

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.

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, 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

> any written safe work procedures.

Training should be provided by appropriate academic, clinical or technical specialists. This requirement will vary depending on the specific training required.

Patient trainingPatients, family and carers must be provided with education and information relevant to the environment in which the patient is being treated. General guidance on the possible training and information content is provided in Section 11 – Caring for Patients at Home.

5 Training


5.3 Evaluate the training program Training programs should be evaluated to:

> assess the effectiveness of the training, 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. 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, substance, work practice or control measure

– at least every two years. Oncology and haematology specialists should review any written competencies regularly.

Following all incidents and accidents, the training program should be reviewed to ensure its adequacy.

5.4 Training recordsEmployers must keep records of employees’ training for at least five years after the date the record was created.

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.

5.5 Model proceduresThe following model procedure is associated with this section:

> Model Procedure 2 – Staff Training for the Safe Handling of Cytotoxic Drugs and Related Wastes.

5 Training

The training needed should reflect the level of risk of exposure as well as the anticipated exposure.


6 Preparation and Dispensing

This section provides a risk management framework to assist in the development of local policies and procedures, and aims to provide practical advice on how to prevent or reduce the risks associated with the preparation and dispensing of cytotoxic drugs, utilising the hierarchy of control measures.

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. With adequate precautions, contamination of personnel and the work environment has been shown to be reduced. The risk of exposure may be reduced by ensuring that cytotoxic drugs are prepared by trained pharmacists or technicians in approved facilities.

Health services that are unable to provide the facilities, equipment and training as specified in this guide should not undertake to provide a cytotoxic drug preparation service.

Exposure may occur through:

> skin, eye or mucous membrane contact with cytotoxic material

> spills

> inhalation of aerosols and powders

> sharps injuries.

To facilitate the safe preparation of cytotoxic drugs, consideration should be given to:

> workplace design, set-up and maintenance according to Australian Standards

> use of cleanrooms

> cytotoxic drug safety cabinets

> other specialised equipment.

Education and training is crucial in ensuring that control measures and safe work practices are developed, understood, implemented and maintained.

Applying the hierarchy of control measures outlined in Section 3 – Managing the Risk to the preparation of cytotoxic drugs is essential. Figure 2 summarises the decision making process when applying the hierarchy of control measures to the preparation of cytotoxic drugs.




Level 2 ControlIsolation at the Source of the Hazard/Source

Containment

Level 1 ControlElimination,

Substitution or Replacement

Level 5 ControlPersonal Protective

Equipment

Level 4 ControlAdministrative

Controls/ Organisation Measure

Level 5 ControlEngineering

Controls/ Ventilation

Has there

been a risk assessm

ent?

Can this

measure be applied?

Is the risk m

itigated or controlled?

Is the risk m


Is the risk m


Is the risk m


Is the risk m


Is the risk m


Can a closed

system transfer

device be used?

Can another device be

used?

Can this

measure be applied?

Can this

measure be applied?

Can this

measure be applied?

Do not

perform

task

Do not

perform

task

Perform

task

Perform

task

Perform

task

Implem

ent control

Implem

ent control

Implem

ent control

YesYes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

No

No

No

Figu

re 2: Decisio

n m

aking

pro

cess for th

e safe han

dlin

g o

f cytoto

xic dru

gs

No

No

No

No

No

No

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Perform

task

Perform

task

Perform

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Implem

ent control

Implem

ent control

Implem

ent control


6.1 Elimination, substitution or replacementIt is rarely possible to substitute a cytotoxic drug for a less toxic or non toxic drug, therefore the most practical first level control measure is to identify an alternative supply of cytotoxic drugs.

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, equipment and trained personnel to provide prepared cytotoxic drug doses.

6.2 Isolation at the source of the hazard/source containmentIt may be possible to prevent the contamination of staff and the environment by containing the cytotoxic drug at its source. If possible, source containment should be continuous throughout the entire process of preparation.

Drug preparation equipment

Specific handling techniques and procedures incorporating suitable equipment (designed to reduce the risk of exposure) should be employed.

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.

Closed system drug transfer devicesThe 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, i.e. powder, vapour, liquid etc) and the transfer of environmental contaminants into the system.

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.

> When selecting an appropriate closed system drug transfer device, the following factors should be taken into consideration:

– does the device cover all steps in the preparation? If not, 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, if so, to what degree?

Closed system drug transfer devices should always be used in combination with a cytotoxic drug safety cabinet.



Drug preparation equipment continued

Other devicesThe secondary consideration under this control measure, in the absence of a closed system drug transfer device which covers all steps in preparation, is the concomitant use of alternative devices with closed system device.

The tertiary consideration, in the absence of any form of closed system device, is the use of alternative devices.

Numerous studies have shown that aseptic manipulation using a classic syringe and needle technique almost universally results in contamination. Droplets, leakage from vial stoppers after multiple punctures and aerosol generation resulting from increased pressure inside drug vials have also been observed.

Alternative devices which have been employed to protect staff using this classic technique include:

> luer-slip syringes (only if luer-lock connections are incompatible), such as intrathecal needles

> syringe-to-syringe connectors when transferring solutions from one syringe to another

> wide-bore needles, 18 G/1.2 mm, to reconstitute and draw-up cytotoxic drugs

> filter needles, but only when the cytotoxic drug has been removed from a glass ampoule or if particulate matter is visible – e.g. if coring of vial rubber has occurred

> air-venting devices, fitted with a 0.2 micron hydrophobic filter, to equalise pressures and to prevent the passage of powder aerosols and liquids.

Drug storage > A dedicated storage area, including refrigeration, must be clearly marked and identifiable by all staff.

> Use of a dedicated area offers quick and efficient containment and management of a spill.

> 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.

> Current safety data sheet for each drug should be located in each dedicated storage area.

> Generally, the quantity of cytotoxic drugs stored in pharmacy departments, wards, clinics and satellite pharmacies should be restricted to those required for short-term use.

> A dedicated area should be provided for the unpacking of cytotoxic drugs. Damaged packages should be handled with care. Badly damaged packages should be safely contained and destroyed appropriately.

> 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.

> All staff involved in the receipt, distribution and storage of cytotoxic drugs must receive appropriate instruction and training on the hazards, risks of exposure and control measures (see Model Procedure 2 – Training).



6.3 Engineering controls/ventilationEngineering controls use technological means to isolate or remove hazards from the work environment.

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. 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. This should be provided by high efficiency particulate air (HEPA) filters which supply filtered air to the cleanroom and the anteroom. Secondary containment is provided by maintaining the cleanroom at a pressure lower than that of the anteroom.

Note: Separate CDSC, 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.

The following technical standards are recommended. 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. 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, or use of a pharmaceutical isolator that complies with AS 4273-1999 and AS 4273-1999/Amdt1-2000 Guidelines for the design, installation and use of pharmaceutical isolators.

Ventilation tools Any form of dilution will reduce the concentration of contamination. The ventilation tools discussed here have a number of features, such as HEPA filters, controlled air flow, protection shields, etc, however none of these features will prevent contamination. Once contamination has occurred, it will enter the environment.

Horizontal laminar flow hoods must never be used for preparing cytotoxic drugs due to the high risk of exposure to staff.

Cytotoxic drugs should be prepared in either a cytotoxic drug safety cabinet or a pharmaceutical isolator cabinet.

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.

> Similar to Class II BSCs but have different HEPA filter system.

Pharmaceutical isolator cabinetsAn isolator is a completely enclosed system with an airflow which is either turbulent or laminar flow.

Isolator specifications for the preparation of parenteral cytotoxic drugs are as follows:

> located in a room which should have limited access, be easily cleaned and well organised

> can be positive or negative, with the room design directly influenced by which type is used.



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.

> Class III – These are totally enclosed vented cabinets of gas tight construction. They have a physical barrier between the drug and the operator. These cabinets are an intermediate between a Class II and an isolator. 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.

Organisation of the physical environment and work flow

Attention to ergonomic design principles, equipment layout and work practices will minimise operator error. 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, such as chairs, stools and foot rests

> storage requirements

> potential noise sources.

Further considerations in designing and setting up a cleanroom and anteroom include:

> provision of access for cleaning and replacement of equipment e.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.



6.4 Administrative controls/organisation measures

Safe work practices – staff considerations

When people are working in isolation:

> working-alone arrangements should be in place – e.g. duress alarm, communications system

> access should be controlled.

Staff numbers and staff contact rotation requires consideration (see also Section 4 – Staff Health).

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, installation and use of pharmaceutical isolators.

> To minimise the potential for dosing error, vial sizes closest to the actual dose should be selected.

> Only one drug should be in the CDSC at any one time (or one drug per operator in a 2 person CDSC).

> Opened/used vials should not be left in the CDSC for later use.

Parenteral preparationsSafe work procedures should be documented and stress the need to:

> avoid using cytotoxic drugs supplied in glass ampoules – if glass ampoules must be used, 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. The preparation of mixtures and ophthalmic products poses slightly less risk of contamination but should be kept to a minimum.

If the preparation of mixtures and ophthalmic preparations is required, they should be prepared under the same conditions as parenteral cytotoxic drugs.

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.

Non-parenteral preparations – oral tablets and capsulesOral tablets and capsules must be handled in a manner which avoids or minimises skin contact, liberation of powdered drug into the air, onto counting trays and onto other surfaces. They must also be handled in a manner which avoids chemical cross-contamination with other drugs.

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.



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.

> Defective equipment must not be used.

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.

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.

Equipment Test Parameter Frequency

Laminar flow cabinets > Pressure differentials between rooms.

> Pressure differentials across HEPA filters (workstations) – note that most cabinets will have built in alarms that will activate if pressure differentials are outside limits.

Before beginning work, usually daily.

Isolators Pressure differentials across HEPA filters.

Before beginning work, usually daily.

Isolator glove integrity. Visual checks every session.

Isolator pressure hold test (glove attached).

Weekly.

Cytotoxic drug safety cabinets, 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.

If access to plant is required for the purpose of maintenance, cleaning or repair, 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.

If it is not practicable to stop the plant, fittings that allow controlled movement of the plant must be implemented and safe systems of work employed.



Equipment maintenance An equipment maintenance schedule should include:

> inspection of cytotoxic drug safety cabinets, isolators and suitable filters (as required by the Australian Standards)

> inspection at regular intervals, and at least every 12 months

> inspection after relocation, and after mechanical or electrical maintenance

> test records and a summary of results in a place accessible to employees

> identification of faulty cabinets – e.g. attach a lock-out tag and do not use until fixed

> repair of faulty cabinet faults, and recertification prior to use

> routine performing and recording of microbial and air-particle testing.

Cleaning drug preparation facilities

Daily and weekly routines should be established and all equipment used in the cleaning should be dedicated for the purpose.

Cleaning should include bench tops and surfaces, grilles, filters, cabinets, floors, walls and ceilings.

Written procedures should be developed for the cleaning of cytotoxic facilities and equipment and a cleaning log maintained.

General cleaning staff, who may be involved in cleaning drug preparation suites and associated equipment, must be informed of the potential hazards associated with cytotoxic drugs and be trained in safe cleaning procedures. 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.

A number of agents and combination of agents appear in the literature (see Section 12 – Cleaning).

Whichever cleaning agent is used, 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.

Primary packaging labels > Appropriate warning labels should be on cytotoxic drug containers, including syringes and IV bags.

> Appropriate advisory labels as per latest edition of Australian Pharmaceutical Formulary and Handbook should be on cytotoxic drug containers.

> Containers that carry cytotoxic drugs should identify the contents as cytotoxic drugs

> Cytotoxic drugs should be labelled ‘For Intrathecal Use Only’.

> 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), not in a syringe.

> Oral medications should be labelled ‘do not cut or crush’.

> Topical cytotoxic medication e.g. fluorouracil cream should be labelled ‘wear disposable gloves and use spatula to apply’.

> Cytotoxic drugs that are vesicants should have an extravasation warning label.

Additional information regarding labelling is included in Section 7 – Labelling.

Checking procedures > Before preparation commences, all orders should undergo a full clinical check by a chemotherapy competent pharmacist.

> Checks by a pharmacist should be made before components enter the cleanroom and when the product is finished.

> Each step of the checking procedure should be documented.



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.

In addition, for all staff preparing cytotoxic drugs, a log should be kept which includes:

> daily activities of each operator

> if more than one cabinet/isolator is used, the actual cabinet/isolator that was used.

All records associated with health surveillance must be retained by the employer for at least 30 years. The employee should keep copies of their records.

Additional information regarding health surveillance is located in Section 4 – Staff Health.

Handling techniques and procedures for dispensing

Oral tablets and capsules must be handled in a manner which avoids or minimises skin contact, liberation of powdered drug into the air, onto counting trays and onto other surfaces. They must also be handled in a manner which avoids chemical cross-contamination with other drugs.

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


6.5 Personal Protective EquipmentThe use of personal protective equipment (PPE) is the lowest control priority in the hierarchy of control measures. Higher levels of control options should be fully investigated before PPE is selected.

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.

For more information see Section 13 – Personal Protective Equipment.



6.6 Procedures and model procedures Noting that there are many possible parenteral preparation procedures that can be undertaken, 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).



7 Labelling

This section provides a risk management framework to assist in the development of local policies and procedures, and aims to provide practical advice on labelling considerations incorporating state based and national legislation, standards and codes as well as pharmacy standards of practice recommendations.

7.1 All cytotoxic drugsAll containers, primary and secondary packaging as well as transport containers, should have the purple label with the cell in late teleophase and the warning ‘CYTOTOXIC – HANDLE WITH CARE’ prominently affixed.

7.2 Supply of a cytotoxic drug to a patientSupply of drugs to a patient can be done via a medication order or a prescription. The mechanism of supply will determine the minimum labelling requirements (see Table 1).

7 Labelling


Table 1: Text requirements for cytotoxic drug labels in South Australia

Supplying on a medication order1 Dispensing on a prescription2

Health service details

> Name, address and telephone number of the health service.

> Name, address and telephone number of the health service.

Patient details > Patient’s name. > Patient’s name.

Drug details > Name of the cytotoxic drug.

> The strength and form of the cytotoxic drug.

> The total quantity of the cytotoxic drug in the container.

> Adequate directions for use.

> Name of the cytotoxic drug.

> If the cytotoxic drug is part of a preparation or admixture – the strength or proportion of cytotoxic drug contained in the preparation or admixture.

> Directions for the safe and proper use of the cytotoxic drug, including (where relevant) the route of administration.

> The date on which the cytotoxic drug is sold or supplied.

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, the word ‘POISON’ or the words ‘FOR EXTERNAL USE ONLY’, in red on a white background.

Additional requirements if dispensed on a prescription

> A unique identifier that enables the cytotoxic drug to be linked with the prescription.

1. Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) relevant to cytotoxic drugs.

2. South Australian Controlled Substances Poisons Regulations 1996 Reg 19(2). In addition, for medicines dispensed on a prescription the requirements of the Guidelines for Dispensing of Medicines Pharmacy Board of Australia also apply.

Ancillary labelsThe 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.

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.

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. For details about the additional labelling requirements, refer to the APF.

7 Labelling


Following sentinel events associated with the inadvertent intrathecal administration of vincristine repeatedly reported in Australia and overseas, the Australian Commission on Safety and Quality in Health Care has issued the following recommendations:

> all vincristine products, including outer wraps, 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, stating ‘For Intrathecal Use Only’.

The Commission’s National Recommendations for User-applied Labelling of Injectable Medicines, Fluids and Lines (August 2010) are a set of labelling standards designed to improve safety in the labelling of injectable medicines and fluids, and the devices used to deliver them.

These labelling standards do not apply to manufacturers or hospital pharmacies.

The labelling of injectable cytotoxic drugs, which:

> are prepared outside of the hospital pharmacy (i.e. on the ward) and

> leave the hands of the person preparing the cytotoxic drug

should comply with the Commission’s labelling recommendations.

For specific details about the labelling standards refer to the National Recommendations for User-applied Labelling of Injectable Medicines, Fluids and Lines (August 2010) (www.health.gov.au/internet/safety/publishing.nsf/Content/com-pubs_MedSafety-38757-LabRec-con).

Also refer to the SA Health Policy Directive: User-applied Labelling of Injectable Medicines, Fluids and Lines (2011).

7.3 Cytotoxic drugs for transportationThe 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, especially in a spill or breakage. There should be clear contact details to source advice should this be required

> if the cytotoxic drug is classified as a Dangerous Good, then the class 6 diamond label should be attached to the packaging.

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.

If transporting by air, any additional requirements of the International Air Transport Association (IATA) should be adhered to for labelling requirements

7.4 Cytotoxic drugs provided to drug preparation facilities by a supplier for further processing In this scenario, the CSP Regs require the label to conform to the requirements of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) www.tga.gov.au/ndpsc/susdp.htm.

The provisions in the SUSMP for a poison (drug) are that, ‘poisons which are packed and sold solely for industrial, manufacturing, 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 Labelling


This code has been adopted by the OHSW Regs as an SA Approved Code of Practice for Labelling Workplace Substances (2006). The National Code is proposed to be revised to meet the GHS (Globally Harmonised System) of labelling from 1 January 2012.

To meet the legal requirements for labelling, suppliers and employers must first determine whether a cytotoxic drug that is also a scheduled poison is to be used for purposes of work, such as healthcare facilities, veterinary practices or domestic use.

Under the OHSW Regs, suppliers and employers have specific responsibilities for labelling cytotoxic drugs that are hazardous substances. In South Australia, the supplier must ensure hazardous substances are appropriately labelled.

The label must:

> clearly identify the hazardous substance

> provide basic health and safety information about the substance, including any relevant risk phrases and safety phrases.

For specific practical guidance and advice on labelling requirements, refer to the SA Code of practice for the labelling of workplace substances.

Table 2: Workplace labelling for hazardous substances

Label items Capacity of container

Greater than 500 mL (g)

500 mL (g) or less (small containers)

Container too small to attach to label

Identification information:

> Product name

> Chemical name

> United Nations number, class, and subsidiary risk (where required by ADG Code)

Yes

Yes

Yes

Yes

Yes

Yes

Yes

No

No

Ingredients and formulation Where relevant No No

Risk phrases Yes Yes (at least the most significant phrases)

No

Safety phrases Yes Yes (at least the most significant phrases)

No

Direction for use Where appropriate No No

First aid procedures Yes Yes No

Emergency procedure Yes No No

Details of manufacturer or importer Yes Yes Yes

Expiry date Where relevant No No

Reference to the safety data sheet Yes Yes No

Source: Queensland Department of Industrial Relations; Guide for handling cytotoxic (anti neoplastic) drugs and related waste (2005).


> Model Procedure 4 – Transport of Cytotoxic Drugs External to the Health Service.

> Model Procedure 5 – Transport of Cytotoxic Drugs Within the Health Service.

7 Labelling


8 Transport

This section provides a risk management framework to assist in the development of local policies and procedures, and aims to provide practical advice on considerations for the transportation of cytotoxic drugs and related wastes to, from and within a health service.



> Section 7 – Labelling





> Section 16 – Contaminated Body Wastes


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.

8 Transport

It is the responsibility of drug manufacturers to supply cytotoxics in containers which are free of contamination.


8.1 Transportation of cytotoxic drugs

External transportation

General considerations

Recommendation

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.

The safety data sheet should be attached to the packaging.

Cytotoxic drugs packaged for transport outside the health service should be in accordance with state and federal requirements, 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.

Labelling See Section 7 – Labelling.

Transport considerations

For air transport, compliance with the IATA’s Dangerous Goods Regulations is required.

For rail and road transport, compliance with the AGD is required.

Spills Spill kits should be readily available to all personnel involved in the transportation and receipt of cytotoxic drugs.

Receipt of drugs Staff involved in the receiving and inventory control should be informed of the possibility of surface contamination.

Controls Staff, contractors, etc involved in the packaging, transportation, receiving and inventory control of the cytotoxic drug should receive appropriate training, 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, safe handling procedures such as wearing gloves, washing hands and cleaning surfaces should be undertaken.

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 recipient of the drug should retain a compilation of the safety data sheets, should ensure that they are current and reflect the actual products used within the institution, and should update the Dangerous Substances Register whenever purchased products change. These safety data sheets should be readily available in all areas where hazardous drugs are stored or used.

Also refer to the Australian Code for the Transport of Dangerous Goods by Road and Rail (ADG) and the IATA’s Dangerous Goods Regulations.

8 Transport



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.e. residential care facilities etc).

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.

Primary packaging:

> package in a sealed, leak-proof container, 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.

Also refer to the Australian Code for the Transport of Dangerous Goods by Road and Rail (ADG) and IATA’s Dangerous Goods Regulations.

Labelling Refer to Section 7 – Labelling.


Refer to the Australian Code for the Transport of Dangerous Goods by Road and Rail (ADG) and the IATA Dangerous Goods Regulations.


Receipt of drugs Staff involved in the receiving and inventory control should be informed of the possibility of surface contamination.

Controls Staff, contractors, etc involved in the packaging, transportation, receiving and inventory control of the cytotoxic drug should receive appropriate training, for example:




> health monitoring

> due to the potential of surface contamination, safe handling procedures such as wearing gloves, washing hands and cleaning surfaces should be undertaken.

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.

The recipient of the drug should retain a compilation of the safety data sheets, should ensure that they are current and reflect the actual products used within the institution, and should update the Dangerous Substances Register whenever purchased products change. These safety data sheets should be readily available in all areas where hazardous drugs are stored or used.

Also refer to the Australian Code for the Transport of Dangerous Goods by Road and Rail (ADG) and IATA’s Dangerous Goods Regulations.

8 Transport


Additional considerations for manufacturersIt is the responsibility of drug manufacturers to supply cytotoxics in containers which are free of contamination. It is highly desirable that manufacturers provide some form of certification that vials and primary packaging are not contaminated with cytotoxics. This analysis should preferably be carried out by an independent laboratory.

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.

Transportation within a health serviceThis section describes recommendations for the transportation of cytotoxic drugs from pharmacy departments to wards and clinics within the hospital grounds for in-house use.


Recommendation

Packaging > Package in a sealed, leak-proof container, 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.g. intrathecal, oral or topical

> Outer packaging to have ‘Cytotoxic’ warning label.

Labelling > Tablet containers should be labelled ‘do not cut or crush’

> Containers should be appropriately labelled for the specified use – e.g. intrathecal, oral or topical

> Packaging to have contains ‘Cytotoxic’ warning label.


If a large quantity of drug needs to be transported, consideration should be given to using an enclosed trolley or similar enclosed device.*


Controls Staff, contractors, etc involved in packaging, transporting and receiving the cytotoxic drug should receive appropriate training, for example:




> health monitoring

> due to the potential of surface contamination, safe handling procedures such as wearing gloves, washing hands and cleaning surfaces (refer to Section 13 – Personal Protective Equipment).

Documentation Documenting transportation of the cytotoxic drugs/cytotoxic drug preparations from the pharmacy to the units where these are used should be considered.

* The use of an enclosed trolley or transportation device is a requirement under the EQUiP standard for security and patient confidentiality considerations.

8 Transport


8.2 Transport of cytotoxic waste

On-site waste transport To minimise exposure, 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, rigid walled, puncture-resistant containers – e.g. wheelie bins, handcarts and trolleys – to move cytotoxic waste around the facility

> ensure such equipment – e.g. wheelie bins, handcarts and trolleys – is appropriately labelled and kept clean, in accordance with infection control and other relevant standards

> schedule frequent waste collection rounds – movement should be planned to avoid peak activity times (e.g. visiting hours, 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, keep a record of waste movements.

Off-site waste transport South Australian Environmental Protection Agency (EPA) is responsible for ensuring the proper transport of cytotoxic waste in South Australia. The Environment Protection Act 1970 (EP Act) and the Environment Protection Regulations 2009 (EP Regs) regulate the transport of cytotoxic waste.

Waste generators (such as health care facilities) have legal obligations for the cytotoxic waste they generate. These legal obligations extend beyond the on-site handling of the waste. 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.

There are three principal statutory requirements for the transport of cytotoxic waste:

> appropriate licences

> transport certificates

> vehicle signage.

Transport licenceIf no fee or reward is received for transporting the cytotoxic waste then no licence is required.

Transport certificatesTransport certificates are required as a standard condition of the transport licence. Transport certificates help to ensure obligations are discharged by documenting the transfer of each shipment of cytotoxic waste from the generator to the transporter, and then to the treatment or disposal facility. The waste generator is required to send a copy of the certificate to the EPA. Transport certificates are to be completed, even where the transporter is exempt from certificate requirements.

Vehicle signagePermitted 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). The vehicle must display both a ‘dangerous goods’ label and the cytotoxic waste symbol.


> Model Procedure 4 – Transport of Cytotoxic Drugs External to the Health Service.

> Model Procedure 5 – Transport of Cytotoxic Drugs Within the Health Service.

8 Transport


9 Administration

This section provides a risk management framework to assist in the development of local policies and procedures, 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. The principles discussed here can also be adapted to the community and home environment.










To ensure that cytotoxic drugs are safely administered, workplace design, use of specially designed equipment, safe work practices and personal protective equipment are essential. To ensure that control measures and safe work practices are developed, understood, implemented and maintained, education, training and supervision are crucial.

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.

9.1 Key risk control measures Applying the hierarchy of control measures outlined in Section 3 – Managing the Risk, to the administration of cytotoxic drugs is essential.

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, 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, such as infusion pumps, 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.

These best practice risk control options should be considered a priority.

It is recommended that policy is developed to ensure that these control measures are included into the ward/day clinic health and safety systems.

9 Administration


9 Administration

9.2 Establishing a drug administration area When establishing a designated drug administration area in a health care facility, 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, such as safety data sheets, 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, or access to a shower, and appropriate hygienic liquid resistant flooring (instead of carpet).

When administering cytotoxic drugs in a community or home setting, comply with these instructions as closely as possible (see Sections 10 and 11).


9.3 Cytotoxic drug administration

Patient assessmentPrior to administration, it is essential that the patient be deemed fit for treatment.

Pre-treatment assessment, at baseline and prior to each cycle, should include:

> full blood count, renal and liver function tests prior to each treatment cycle (as per individual treatment protocols), and between cycles or recovery phases as recommended. If blood parameters are abnormal notify a medical officer

> symptom/side effect toxicity review

> allergy and drug reaction history

> performance status

> weight, height, body surface area (BSA). Any changes in weight of more than 10% should be referred to a medical officer

> psychosocial screening.

Equipment To minimise risks, 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, 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, rigid walled, wide-necked, cytotoxics sharps disposal containers that are readily accessible

> personal protective equipment as outlined in Section 13

> a spill kit as outlined in Section 15.

Particular care should be taken when using complex administration lines to ensure that all necessary connections are made and the system remains closed.

9 Administration


Parenteral administration

Prior to administration, calculate the body surface area (or other parameters), then calculate the required dose and check against the medication order.

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, 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.g. after intrapleural, 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.e. unopened/unspiked bags) to the pharmacy, 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.

During drug administration, 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).

Applying the decision making process (see page 34) including the hierarchy of control measures to the administration of

cytotoxic drugs is essential.

9 Administration


Intravesical administrationDue to the nature of this route of administration, 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, if the patient feels discomfort or a bladder spasm occurs, 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 13.5 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, designating a toilet for these patients and double flushing the toilet, 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.

Topical administration Topical agents may be in the form of creams, ointments, lotions or eye drops.

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.

Oral administration Oral agents are generally given as tablets and capsules.

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, to avoid direct handling

> not crushing or breaking tablets or capsules – e.g. oral, 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, 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.


> Model Procedure 6 – Administration of Oral Cytotoxic Drugs in the Health Service.


9 Administration


10 Caring for Patients in the Community

This section provides a risk management framework to assist in the development of local policies and procedures, 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. It also provides guidance to health services, who supervise treatment in the community, on community specific considerations.




> Section 9 – Administration







While most patients undergoing cytotoxic drug therapy are treated in health care facilities such as hospitals, day hospitals and clinics, the number of patients being treated in community or in residential facilities is increasing. The risk from handling cytotoxic drugs and related waste in community settings is somewhat different to those faced by health care facilities. 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.

Nursing and medical staff in community and aged care facilities may be involved in administering cytotoxic drugs. Nursing, medical staff and other carers might care for patients after cytotoxic drugs have been administered. Ambulance officers might also be involved in caring for and transferring patients who have received cytotoxic drug treatments. Others who may be at risk of exposure include waste collection workers and trades people working around the facility.

10.1 Community dispensingOral cytotoxic drugs may be dispensed in the community. Most cytotoxic tablets and capsules are provided in blister packs so the pharmacist will not usually need to take extra precautions when dispensing, 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, disposable counting spatulas

> clean equipment immediately after use with an appropriate cleaning agent (see Section 12 – Cleaning) and rinse thoroughly with water


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).



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.

Parenteral cytotoxic drugs should not be prepared in the community setting. Health care workers preparing parenteral cytotoxic drugs without adequate precautions have been shown to contaminate themselves and their work environment. 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, such as a cytotoxic drug safety cabinet or a pharmaceutical isolator (Section 6 – Preparation and Dispensing).

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, equipment and trained personnel to provide prepared cytotoxic drug doses.

See Section 6 – Preparation and Dispensing for further information.

10.2 Role of the treating facility The treating facility is the hospital, pharmacy or treating doctor supervising the patient receiving the cytotoxic therapy. Written information must be provided to residential care facility staff, community health care workers, general practitioners and, where applicable, ambulance officers. 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.

10.3 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).



10.4 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.

10.5 Administration of cytotoxic drugs Nursing and medical personnel may be involved in administering cytotoxic drugs in community settings. When setting up a drug administration in a community setting, care should be taken to comply with the instructions outlined in Section 9 – Administration as closely as possible.

10.6 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.

Cytotoxic waste generated must be disposed of safely to reduce the risk of exposure to waste management workers. This waste may include dressings, nappies, incontinence aids, ostomy bags, catheters, catheter bags and the like. The waste should be disposed in a cytotoxic waste bin and taken back to the health care facility, in the boot of a vehicle, for disposal in a cytotoxic waste bin.

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.e. urine, faeces, vomitus, 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.e. clean up contaminated waste, then wash affected area with water and detergent. With gloves still on, discard soiled cloths into a plastic bag, discard gloves into the bag, seal the bag (preferably with a cable tie or a knot in the top of the bag) and discard it into the household waste.

For additional information see Section 16 – Contaminated Body Waste and Section 17 – Waste Management.



10.7 Safe work procedures With the assistance of the treating facility, safe work procedures should be developed. 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, such as urine, faeces, vomitus, the contents of colostomy and urostomy bags, 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.

10.8 Emergency proceduresPlanning for emergencies is an essential part of risk management. Systems should be in place to manage sharps injuries, spills and personal contamination. Any incident should be reported so that the cause can be investigated and determined and follow-up action taken if required.


Written information must be provided by the treating facility to residential care facility staff, community health care workers, general

practitioners and, where applicable, ambulance officers.


11 Caring for Patients at Home

This section provides a risk management framework to assist in the development of local policies and procedures, 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.











Regardless of where cytotoxic drug therapies are administered, cytotoxic safety precautions, especially those related to handling contaminated body waste, are an ongoing concern in a patient’s home.

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. If children are present in the setting or will be undertaking administration activities, it is strongly recommended that the treating facility undertake a robust risk assessment of the patient’s home and ensure appropriate storage, disposal, etc controls are in place and that the child, if undertaking administration activities, is able to understand and comply with safe handling procedures.

11.1 Home care by nursing staffAll nurses administering chemotherapy in the patient’s home must be adequately trained and competency assessed for the administration of cytotoxic agents.

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, and that the facilities and equipment meet recommended standards. All cytotoxic drug therapy used in the home care situation must be prepared under the same conditions as all other cytotoxic drug therapies; specifically in the hospital pharmacy department or in a production facility complying with the same requirements.

Nursing staff should not reconstitute parenteral cytotoxic drugs in the patient’s home.




Setting up a patient care area Before proceeding with chemotherapy in the home, the nurse must verify that the following facilities are available:

> hand-washing facilities

> laundry facilities

> access to a flushable toilet

> appropriate waste disposal – e.g. cytotoxic waste bins

> a patient care area set up in a non-carpeted area of the home.

EquipmentThe 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.

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. Nursing staff should have a spill kit available and details of whom to contact in case of emergency.


11.2 Home care by relatives and/or patientIf the home care is to be provided by either relatives or by the patient, it is very important that this care is organised and coordinated in advance. In this way, with close cooperation between hospital staff, all aspects of the treatment may be explained and full education and training provided. 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. Carers should be advised about special requirements of the particular drug used.

Patients, family and carers must be provided with education, including:

> what constitutes cytotoxic waste

> detailed information about the drugs which will be administered. 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, contained transfer devices, 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, training on the care of infusion lines, catheter care, 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, instructions on how to clean up a spill and treating team’s contact details, with a spill kit provided

> instructions on how to proceed in the event of an emergency or other incident. For example, extravasation of any vesicant, 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. 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.



12 Cleaning

This section provides a risk management framework to assist in the development of local policies and procedures, and aims to provide practical advice on considerations for the development of cleaning procedures, choice and assessment of cleaning agents, work place monitoring and training of cleaners.



Preventing contamination of surfaces and equipment with cytotoxic drugs/drug residues is the best strategy to minimise staff and patient exposure. However, it is recognised that, despite the most robust systems that are put in place, there is inevitably some risk of environmental contamination.

The implementation of effective cleaning practices to decontaminate the work area is recommended.

Effective cleaning practices include:

> choice of cleaning materials, such as use of:

– disposable cleaning materials were possible

– low lint materials in the CDSC

> use of decontaminating and deactivating agents, such as sodium hypochlorite solution

> hygiene, 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, including the frequency of cleaning

> cleaning technique.

12.1 Cleaning agentsThe numbers and classes of cytotoxic drugs in use in health services, 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, multiple sclerosis and auto-immune diseases.

The prevalence and often presence of many cytotoxic drugs in a single physical location, such as a pharmacy preparation area or ward, means that cleaning to remove contaminating cytotoxic drug residues is a complex process.

A number of studies over the past 20 years have evaluated various deactivating and decontaminating agents for use on surfaces contaminated with cytotoxic drugs.

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. Sodium hypochlorite solutions are therefore often recommended for decontamination purposes, however sodium hypochlorite solutions are not effective with all cytotoxic drugs (including dicarbozide and carmustine (under some conditions)). 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.

A number of other agents and combination of agents appear in the literature, such as:

> alkaline cleaning agents

> 70% sterile alcohol

> sterile water.

12 Cleaning


In addition, there is also a number of propriety cleaning products which have been developed to decontaminate/deactivate surfaces contaminated with cytotoxic drugs.

Whichever cleaning agent or combination of agents is used, 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.

One approach, as recommended in international standards, is to investigate the most commonly used cytotoxic drugs – for example 5-fluorouracil, methotrexate, ifosfamide, cyclophosphamide – by wipe sampling of the surfaces before and after cleaning. If an analytical procedure is available, investigation of lipophilic drugs (e.g. carmustine and paclitaxel) would also be done to ensure that the cleaning procedure is efficient for both for lipophilic and hydrophilic drugs.

Unless otherwise indicated by the manufacturer or in the literature, consideration should be given to piloting validation studies with sodium hypochlorite solution at a 0.5% concentration.

Whichever cleaning reagent(s) is used, note that they may themselves be considered to be hazardous substance depending on the concentration at which they are prepared at (i.e. sodium hypochlorite solution is classed as a hazardous substance in concentrations of 5% and above).

More information on cut-off concentration levels for hazardous substance classification can be located on the Hazardous Substance Information Service web site: http://hsis.ascc.gov.au/SearchHS.aspx.

Particular attention should be given to ensuring that the cleaning agent that is used does not degrade the cytotoxic drug into more toxic components.

12.2 Work place monitoringThe regular and random monitoring of surfaces in areas where there is a risk of contamination with cytotoxic drugs surfaces, such as the pharmacy preparation and storage areas and patient administrations areas, is key to provide an assurance of the effectiveness of the cleaning practices.

12.3 Cleaning staffGeneral cleaning staff, who may be involved in cleaning areas where cytotoxic drugs are stored, prepared or administered, must be informed of the potential hazards associated with cytotoxic drugs and be trained in safe cleaning procedures. They should also be educated on the importance of their role in the removal of this contamination or in the decontamination.

12 Cleaning


13 Personal Protective Equipment (PPE)

This section provides a risk management framework to assist in the development of local policies and procedures, and aims to provide practical advice on the selection of PPE.





The correct selection and use of personal protective equipment (PPE) is required to both protect those who handle cytotoxic drugs and related waste, and ensure the sterility of the end product. Listed in the table below are general recommendations. Before selecting PPE, a risk assessment should be performed for each activity within the particular setting and an appropriate PPE selected.

Co

vera

lls a

nd

go

wn

s

Glo

ves

Pro

tect

ive

eyew

ear

Sho

e co

vers

or

ove

rsh

oes

Res

pir

ato

ry P

rote

ctiv

e Eq

uip

men

t (R

PE)

Hea

d c

ove

rin

g

Preparation of cytotoxic drugs – inside an isolated cytotoxic drug safety cabinet (CDSC) l l l l l l

Cleaning of cytotoxic drug preparation areas and equipment l l l l l l

Drug administration and patient care l l l l

Cleaning spills l l l l l

Laundry – handling cytotoxic contaminated linen bags l l l

Handling cytotoxic drug contaminated waste l l

Handling contaminated body waste l l l l l

Receiving and storing cytotoxic drugs l

13.1 Coveralls and gownsSelection considerations for coveralls or gowns include:

> should be made of impermeable material, e.g. 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.

Gowns should not be shared and care should be taken in removal of gowns to minimise the risk of personal contamination.

Gowns should be used for a maximum of one shift and contaminated garments should be removed immediately and disposed of or laundered as appropriate.



13.2 GlovesGlove use is essential and gloves must be chosen to maximise protection by minimising permeability. 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.

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.

Individuals handling cytotoxic drugs and related wastes should be double gloved if they are not wearing purpose manufactured gloves. This can be done with two pairs of powder-free latex gloves. Note: With double gloving, both gloves must be changed.

Gloves should be changed at:

> intervals recommended by the manufacturer, or

> intervals of 30 minutes, or

> when punctured, torn or contaminated.

13.3 Protective eyewearProtective eyewear should be provided to prevent exposure to the mucous membranes of the eye from liquid splashes.

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).

A risk assessment should be used to determine whether a worker wearing prescription glasses should use additional protection. 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.

Disposable eyewear should be disposed of as cytotoxic waste.

13.4 Shoe covers and overshoesSelection considerations for shoe covers and overshoes include:

> shoe covers must be made of impervious material, e.g. bonded polyethylene fibre. Paper, disposable shoe covers, such as used in operating rooms, 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.

Contaminated, non-disposable footwear should be cleaned with a detergent solution and rinsed thoroughly after each use, and reusable overshoes should be stored for laundering

Disposable shoe covers should be disposed of as cytotoxic waste.



13.5 Respiratory protective equipment (RPE)Suitable RPE should be selected, used, stored and maintained as recommended in AS/NZS1715: 1994 – Selection, use and maintenance of respiratory protective devices or comparable internationally accepted standard.

Selection considerations for RPE include:

> a particulate filter P2 (N95) mask is recommended when dealing with situations in which aerosols may be generated.

> a requirement for a worker to wear prescription glasses should be taken into account in selection and fitting of RPE.

Staff required to wear RPE must be fit tested.

When using reusable RPE, an effective storage and regular maintenance program should be implemented with procedures covering:

> cleaning and disinfection, 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.

Replaceable filters are to be disposed of as cytotoxic waste at the end of service life.

Disposable RPE are to be disposed of as cytotoxic waste after each use or following any contamination incident.

It should be noted that surgical respirators do not offer sufficient respiratory protection against exposure to powders, liquids or aerosols (particulates).

13.6 Head coveringHead coverings should be worn to contain hair and minimise contamination. They should cover exposed hair, including beards and moustaches. 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, caps and facial enclosures should not interfere with respiratory protection.



14 Laundry

This section provides a risk management framework to assist in the development of local policies and procedures, and aims to provide practical advice on dealing with contaminated laundry in the health service, the community and home environments.




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.

Systems should be established to:

> protect laundry personnel from cytotoxic residues

> prevent contamination of other materials being laundered

> ensure personal protective equipment, linen and clothing is decontaminated prior to sterilisation or reuse.

14.1 Key risk control measures The following key risk controls should be considered a priority:

> if possible, disposable personal protective equipment and linen should be used

> in order to reduce or contain contamination of linen, patients who need to be washed in bed should be washed with disposable moist tissues. When using this technique, no water will be spilled.

14.2 General recommendationsWhen handling contaminated laundry, wear two pairs of disposable gloves.

> Contaminated laundry should be labelled as ‘Hazardous’ if transporting the laundry to a laundering facility.

> Store the contaminated laundry separate from other laundry prior to washing.

> Wash the contaminated laundry separately from other laundry.

> Domestic washing powder is suitable.

> To avoid the generation of dust; do not stir up the linen.

> The washing process should be at a maximum cycle and in either hot or cold water.

> The laundry can be dried on a line or in a dryer.

In the case of linen and patient clothing, these procedures should continue for several days after a patient has completed treatment with the cytotoxic agent. In the absence of any specific detailed information, general recommendations should be followed for up to 7 days (see Cancer Institute of NSW: eviQ Cancer Treatments On-line).

Once laundered, previously contaminated personal protective equipment, linen and clothing can be reused.

14.3 Other contaminated beddingBed mattresses should be cleaned with decontaminating solution (see Section 12 – Cleaning).

14 Laundry


15 Spills

This section provides a risk management framework to assist in the development of local policies and procedures, and aims to provide practical advice on setting up a spill management strategy. 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.






Spills of cytotoxic drugs and waste must be contained immediately as they may present a high risk of exposure.

Employers should develop a spill management strategy which includes a cytotoxic spills register.

Spills may occur wherever cytotoxic drugs and waste are handled, stored, transported or disposed.

People in the immediate vicinity of a spill should be alerted of the incident immediately and told to stay clear, with the area being isolated.

Ancillary workers should assist only in the containment of a spill while alerting trained personnel.

15.1 Sources of spillsA risk assessment should identify all likely areas where there is a risk of a cytotoxic spill.

Spills may involve:

> cytotoxic drugs in all forms – liquid, powder, broken tablets, tablets or creams

> cytotoxic drugs spilt (or leaking) during preparation, 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.

Spills may result in the contamination of floors, work surfaces, equipment, bedding and clothing as well as the patient and carer/staff member.

15 Spills


15.2 Spill kits A risk assessment should be completed for each area to determine the contents of the cytotoxic drug spill kit, with the minimum content requirements listed in the table below.

Locations for storing a cytotoxic drug spill kit should be selected and clearly sign-posted.

A cytotoxic drug spill kits contents must be reviewed regularly to ensure its contents have not deteriorated, have been restocked upon use and that it remains appropriate to the designated area.

It is not recommended that P2 masks be included in the cytotoxic drug spill kits.

P2 masks must be fit tested to each individual. 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.

Spill kits should be co-located with a selection of P2 masks, or a ‘P2 mask station’.

The minimum contents of cytotoxic drug spill kit should include:

Item Quantity

1 Documented and laminated instructions/procedure – e.g. safe work procedures for the management of a cytotoxic spill.

1

2 Signs to identify and isolate the spill (caution tape can be used to quarantine an area). 2

3 Personal protective equipment:

> latex and/or nitrile gloves

> head cover

> gown or coveralls

> overshoes*

> safety glasses

> full-face chemical splash shield.

2

1

1

1

1

1

4 Adequate quantities of absorbent materials – e.g. swabs, absorbent towels, spill pillow, chemical absorbent pads, protective mats (bluey or ‘chemomat’).

As required

5 A small scoop to collect any glass fragments e.g. dedicated dustpan or disposable scoop. 1

6 Plastic waste bags, clearly identified as cytotoxic. 2

7 Bag ties. 2

8 Strong alkaline cleaning agent. As required

9 150 mL water in bottle. 1

* Shoe covers must be made of impervious material, e.g. bonded polyethylene fibre. Paper, disposable shoe covers, such as used in operating rooms, do not provide sufficient protection from cytotoxic spills.

Note that there are commercially available cytotoxic spill kits. Prior to purchase, these kits should be assessed for applicability to your particular environment and validated before use.

15 Spills


15.3 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.

If personnel exposure has occurred, seek medical ATTENTION AS DEEMED NECESSARY. Refer to Section 4 – Staff Health (Emergency Procedures).

Responsibility for managing the cytotoxic drug spill clean up MUST be allocated to a person that has NOT been exposed.

Location of spill How to manage

Health care facilities See Model Procedure 8 – Spill Management of Cytotoxic Drugs

In the community Home and community care patients must be provided with a cytotoxic spill kit with contents appropriate to community care and easy-to-understand instructions.

Instructions should be based on the Model Protocol – Spills.

Cytotoxic Drug Safety Cabinets or cleanrooms

> See Model Procedure 8 – Spill Management of Cytotoxic Drugs.

> Appendix C of AS 2639-1994 Laminar flow cytotoxic drug safety cabinets – installation and use.

15 Spills


15.4 Reporting proceduresEmployers should have a system in place for employees to report spills or personnel contamination to management as soon as possible. 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.

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, including cytotoxic drugs (OHSW Regs, Part 6, Division 6.6).


> Model Procedure 1 – Health Surveillance of Staff Handling Cytotoxic Drugs and Related Wastes.


> Model Procedure 8 – Spill Management of Cytotoxic Drugs.

15 Spills

Employers must notify SafeWork SA of any work related incident involving cytotoxic drugs.


16 Contaminated Body Wastes

This section provides a risk management framework to assist in the development of local policies and procedures, and aims to provide practical advice on dealing with contaminated body wastes in the health service, community and home environment.










After cytotoxic drugs have been administered, nursing, medical and pathology staff and others may care for patients. Ambulance officers, too, may be involved in caring for and transporting patients after they have received cytotoxic drug treatment.

Cytotoxic drugs are primarily eliminated from the patient by renal and hepatic excretion. All body substances may be contaminated with the unchanged drug or with active drug metabolites.

Exposure to cytotoxic waste may occur through:

> removing or inserting catheters

> handling vomitus, blood, excreta or fluid drained from body cavities

> handling bedpans, urinals, emptying urinary catheter bags, colostomy or urostomy bags, or vomitus bowls, wet nappies and incontinence pads, and wet dressing materials

> handling bed linen or clothing soiled with a patient’s waste, 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.

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).

Workplace design and set-up, use of appropriate equipment and resources, safe work practices and personal protective equipment are required to ensure that the risks associated with handling patients are adequately controlled. To ensure that safe work practices are developed, understood, implemented and maintained, education, training and supervision are crucial.




16.1 Assessment of contaminated body waste To assist in determining whether body wastes are potentially contaminated, 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.

16.2 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, use equipment to prevent generating aerosols when handling a patient’s vomitus, blood, 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, such as urine, faeces, vomitus and the contents of colostomy and urostomy bags and incontinence aids into a hot pan flusher or a toilet with a lid. Disposable nappies, empty but used colostomy and urostomy bags, 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.


17 Waste Management

17 Waste Management

This section identifies the key elements for setting up a waste management strategy, taking into consideration the requirements of the environmental protection legislation and the industry standards from the Waste Management Association of Australia and Standards Australia.







17.1 What is cytotoxic waste? Cytotoxic waste includes any residual cytotoxic drug following a patient’s treatment, and the materials or equipment associated with the preparation, transport or administration of the drug therapy. It includes:

> unused cytotoxic pharmaceuticals

> contaminated waste from preparation processes

> sharps and syringes, 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, Webster packs, etc

> contaminated personal protective equipment – e.g. gloves, disposable gowns, shoe covers, respirators

> materials used to clean cytotoxic contaminated equipment or spills

> contaminated body substance receptacles – e.g. disposable vomit bags

> dressings and bandages

> linen

> contaminated specimens from the laboratory.

As cytotoxic waste is hazardous to human health and the environment, 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). These requirements cover the generation, storage and transportation of waste that is pre-classified as a listed waste.

In the situation where cytotoxic waste may be transported between South Australia and another state or territory, the requirements of The National Environment Protection (Movement of Controlled Waste between States and Territories) Measures (2010) apply.

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.


17.2 Establishing a waste management strategy Employers should develop and periodically review a comprehensive strategy to safely manage and dispose of cytotoxic waste. The strategy should be developed after a comprehensive audit of all sections of the organisation that generate or handle cytotoxic waste. Other waste-handling requirements for individual premises may be included in a comprehensive waste management strategy.

To streamline work activities and provide consistent safe practices for all those involved in waste management, procedures should be uniform from one organisation to the next.

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. In dealing with cytotoxic waste, other related waste derived from clinical settings, such as clinical waste and pharmaceutical waste, should also be considered, as cytotoxic waste is often associated with such wastes.

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, 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, including those generating the waste, 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; EPA Guidelines on Medical Waste – Storage, 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, Management of clinical and related wastes.

17.3 Key risk control measuresTo minimise the risk of exposure to cytotoxic waste, control measures may include:

> elimination, 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, packaging, storage, transport, administration and disposal

> identification of cytotoxic waste through designated labelling, 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, 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.

17 Waste Management


17.4 Identification, containment and segregation

Identification To minimise the risk of exposure to cytotoxic materials and to ensure the safe and correct disposal of cytotoxic waste, the identification of contaminated waste is essential.

All cytotoxic waste should be placed into compliant bags or containers that are appropriately labelled. 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.

Storage areas should be appropriately sign-posted to distinguish cytotoxic waste from general or infectious waste, particularly if different waste management contractors are used.

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.

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, 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, such as a wheelie bin (of the appropriate colour and labelling), for transport to a collection area

> containers and bins secured with mobile or fixed stands.

17 Waste Management


17 Waste Management

17.5 Requirements and licensing for handling or storage of cytotoxic wasteMedical waste is a listed waste under the EP Act.

Under the EP Act any person who carries on an activity in which medical waste is produced must be licensed.

Requirements for a licensed facility under the EP Policy include:

> storing the medical waste in containers that:

– are weatherproof, shatterproof, insect and verminproof and leakproof (if only storing medical sharps, container does not have to be leakproof, 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, transport and disposal.

Note: A licence is not required if the medical waste is produced in the course of any of the following activities:

> medical practice, 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.

17.6 Waste disposal and treatmentWaste treatment of the cytotoxic waste must render it inactive or no longer hazardous and must meet standards to protect the environment. At the time of writing this guide, incineration (at 1100°C) is the only approved technology for treating cytotoxic waste. All incinerators used for the treatment of cytotoxic waste must be licensed with the EPA and meet the prescribed standards. Patient waste such as urine, faeces, vomitus and the contents of colostomy and urostomy bags may be disposed of in the normal sewage system. The following limitations should be noted:

> sewerage authorities do not allow disposal of incontinence aids to sewer. Further information can be obtained from the relevant sewerage authority

> where materials such as incontinence aids are contaminated with expressible blood, or originate from patients with communicable diseases, 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. Further information should be obtained from the manufacturer or supplier of the system.

Note: If using a contractor to dispose of cytotoxic waste, the contractor must be a licensed waste transporter authorised to collect and transport medical waste by the EPA or a council.

17.7 Model proceduresThe following model procedure is associated with this section:

> Model Procedure 9 – Managing Cytotoxic Waste.


18 Animal Research Facilities


Research staff, veterinarians, veterinary nurses, 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.










In animal research, exposure to cytotoxic drugs can occur when cytotoxic drugs and related waste are handled, stored, administered, transported or disposed.

In addition, exposure can also occur through contact with animal waste during treatment or cleaning procedures.

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. Refer to other sections and appendices for related information.

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.

18.1 Establishing an animal care area > Ensure a secure area accessible by authorised personnel only.

> Provide a cytotoxic waste disposal bin.

> Provide a cytotoxic spill clean up kit.

> Provide safety data sheets (or MSDS) for personnel to access.



18.2 Equipment requiredSuitable 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.

The contents of the cytotoxic spill kit are outlined in Section 15 – Spills.

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.

Animal cages and cleaning > Animal cages must be signed with “receiving cytotoxic drug therapy“.

> Use purpose-designated or disposable equipment.

> If equipment is non disposable, it MUST be cleaned. For guidance on cleaning agents refer to Section 12 – Cleaning.

> Ensure animals are washed down immediately with water if they become contaminated.

> Dispose of cytotoxic waste as per Section 17 – Waste Management.

18.3 Safe work proceduresStandard 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, animals receiving treatment or related waste products

> dispose of contaminated items (such as gloves) as cytotoxic waste.


Appendix 1 – Glossary

Appendices


Appendix 1

Glossary

A

administrative control a type of control measure which involves minimising the risk through the use of procedures or instruction e.g. SOPs, labelling, training

ADG Code Australian code for the transportation of dangerous goods by road and rail, as published by the Commonwealth of Australia and amended from time to time

ALARA ‘as low as reasonably achievable’

alginate bag bag made of artificial fibres spun from a constituent of kelp – the fibres become gelatinous when moist and so are biodegradable

ASCC Australian Safety and Compensation Council – national body that leads and coordinates national efforts to prevent workplace death, injury and disease in Australia, formerly known as National Occupational Health and Safety Commission (NOHSC)

aseptic manipulation activity performed so as to exclude micro-organisms

aseptic suite work space free from micro-organisms in the working area

B

BCG an attenuated, live culture preparation of the Bacillus of Calmette and Guerinstrain of Mycobacterium bovis

biological monitoring measurement and evaluation of hazardous substances or their metabolites in the body tissue, fluids or exhaled air of a person

C

carcinogen substance or physical agent with the potential to cause cancer in certain circumstances or to make cancer more likely to occur

cleanroom a room with environmental control of particulate contamination, temperature and humidity, constructed and used in such a way as to minimise the introduction, generation and retention of particles inside the room

code of practice an approved industry code of practice is a practical guide to employers and others who have obligations under the Occupational Health, Safety and Welfare Act 1986 (OHSW Act) and the Occupational Health, Safety and Welfare Regulations 2010 (OHSW Regs) with respect to 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. An approved industry code of practice is advisory rather than mandatory. However, in legal proceedings under the OHSW Act or OHSW Regs, failure to observe a relevant approved industry code of practice is admissible as evidence concerning an offence under the OHSW Act or OHSW Regs

cytogenic to do with the formation of cells

cytotoxic harmful to cells of the body, particularly those that reproduce rapidly

cytotoxic contaminated body waste

body fluid/substance that is contaminated with cytotoxic drugs following drug administration

cytotoxic drug drugs that cause the death of certain cells and that are used to treat conditions such as cancer, rheumatoid arthritis, multiple sclerosis and some ophthalmic conditions

cytotoxic spill a spill of cytotoxic drugs or related wastes



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 a type of control measure in which the hazard is eliminated

employer a person who employs persons under contracts of employment or apprenticeship

employee an individual who works under a contract of employment or apprenticeship

engineering control a type of control measure which uses technological means to isolate or remove hazards

exposure standards exposure standards are the calculated airborne concentrations of individual chemical substances which, according to current knowledge, should neither impair the health of, nor cause undue discomfort to, nearly all workers. The exposure standards serve as guides only and the control measures selected must ensure that the applicable exposure standard is not exceeded

extravasation unplanned escape of a liquid from a vessel or tube into surrounding body tissues

H

hazard a hazard is the potential for a substance to adversely affect the health and safety of people in the workplace

hazardous substance substance listed in the List of designated hazardous substances produced by the Australian Safety and Compensation Council (ASCC), 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. Note: The list and the criteria are now part of the electronic database called the Hazardous substances information system (HSIS) administered by the ASCC

hazardous substances register

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

health monitoring monitoring of individuals for the purpose of identifying changes to health status due to occupational exposure to a substance

health surveillance the monitoring of persons to identify changes (if any) in their health due to exposure to a hazardous substance. includes biological monitoring, but does not include the monitoring of atmospheric contaminants

HEPA (high efficiency particulate air) filter

filter that is made to be at least 99.97 per cent efficient in removing an aerosol of particles with a diameter of 0.3 micrometres when tested with a standardised procedure

I

intravesical infusion introduction of liquid through a urinary catheter into the bladder

isolation a type of control measure that uses barriers to prevent exposure

L

lyophilised cytotoxic drugs cytotoxic drugs preserved during manufacture by being rapidly frozen and dehydrated in a vacuum – they do not require refrigeration, although sterile distilled water needs to be added before use

M

MABs see Monoclonal antibodies

manufacturer an obligation holder under the OHSW Act




material safety data sheet (MSDS)

see safety data sheet

Monoclonal antibodies laboratory produced, humanised proteins with very specific cell binding properties. They are produced by cloning numerous identical cells from a single parent cell. A monoclonal antibody therefore consists of a single type of protein (antibody). Monoclonal antibodies have been developed for targeting specific tissues and are use in treating certain cancers and other conditions

MSDS see material safety data sheet

mutagen substance with the potential to change DNA, the part of a body cell that controls its growth and multiplication – being a mutagen also gives a substance the potential to cause cancer

N

NOHSC National Occupational Health and Safety Commission – see ASCC (Australian Safety and Compensation Council)

O

obligation a legal requirement to take specified action under the OHSW Act or OHSW Regs

occupational exposure exposure to cytotoxic drugs during a work activity

OHS committee an occupational health and safety committee or committees established by the employer and employees for the place of work or the employer’s undertaking

OHS representative an occupational health and safety representative/s elected by the employees

ostomy a surgically created artificial opening, usually created through the abdominal wall, to allow the discharge of bodily wastes

P

parenteral administration of cytotoxic drug by methods other than through alimentary canal, such as intravenous, subcutaneous, intramuscular, intrapleural, intraperitoneal, intravesical

PEG percutaneous endoscopic gastostromy

percutaneous injury a route of exposure – taking in cytotoxic drug or waste through a puncture of the skin

personal protective equipment

clothing, equipment and substances designed to be worn by a worker to protect them from the risk of injury or illness

pH measure of how strongly acidic or basic a substance is when dissolved in water – acids have a pH less than 7; bases have a pH greater than 7

place of work premises where persons work (under the OHSW Act )

plant includes machinery, equipment, appliances, pressure vessels, implement and tools, personal protective equipment, and any components, fittings, connections and accessories to plant

PPE personal protective equipment

premises under the OHSW Act, includes any place and, in particular, includes:

> any land, building or part of any building

> any vehicles, vessel or aircraft

> any installation on land, on the bed of any waters or floating on any waters

> any tent or movable structure



preparation (of drugs) handling of cytotoxic drugs up to the stage of administration to a patient – includes manufacture, forming tablets and capsules, preparing a pre-measured single dose unit (e.g. drawing liquid cytotoxic drug into a syringe from a vial), and crushing or dissolving tablets or emptying capsules to prepare part doses

R

respirator see respiratory protective equipment

respiratory protective equipment

equipment designed to prevent inhalation of contaminated air

risk 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, the amount of hazardous substance used and the duration and frequency of exposure

risk assessment 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, the frequency and duration of exposure, control measures in use (engineering, administrative or personal protective equipment) and their effectiveness, and conditions of use

risk control 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, ranked from most desirable form of control to least desirable – elimination, substitution, isolation, engineering controls (e.g. local exhaust ventilation), administrative controls, personal protective equipment

risk management analysis and judgment that uses the results of risk assessments to produce decisions about environmental actions to be initiated – i.e. the giving of priorities to various risks, the delivery of risk-averting outcomes and the continuing audit of outcomes and trends

RPE see respiratory protective equipment

S

safety data sheet a document that describes the properties and uses of a substance – identity, chemical and physical properties, health hazard information, precautions for use and safe handling information

SHPA Society of Hospital Pharmacists of Australia

specific test diagnostic or screening test that correctly indicates disease is absent in a high proportion of persons tested that do not have the disease

safe work procedure(s) a set of instructions or steps to be followed to complete a job safely and in accordance with legal, operational and company or institutional requirements – SOPs should be written for any processes an individual or group performs

SDS See safety data sheet

sterile free from living organisms

substitution a type of control measure that substitutes a hazardous substance or process with a less hazardous one

supplier an obligation holder under the OHSW Act


T

telophase the last of four stages in the division of a single body cell into two identical cells

teratogen agent capable of causing harm to an embryo or foetus to produce birth defects

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, column 1 of the ADG code (6th edition, 1998) – e.g. cytotoxic drugs that meet the classification criteria of Class 6.1 are listed in the ADG code as UN 2810 or UN 2811

urostomy diversion of urine away from a diseased or defective bladder through a surgically created opening in the skin of the abdominal wall

use (of cytotoxic drugs) includes administration, preparation, handling, storage, movement and disposal of cytotoxic drugs and related waste

V

vesicants cytotoxic drugs that induce tissue damage and necrosis

W

work work as an employee or as a self-employed person under the OHSW Act

workplace see place of work

work injury an injury to a person that requires first aid or medical treatment if the injury was caused by work, a workplace, a work activity or specified high risk plant

the recurrence, aggravation, acceleration, exacerbation or deterioration of an existing injury in a person if first aid or medical treatment is required for the injury; and it was caused by work, a workplace, a work activity or specified high risk plant

any serious bodily injury, if the injury was caused by work, a workplace, 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



Appendix 2

Information Sources The following acts, regulations, standards, codes of practice and guidance notes apply to work involving handling of cytotoxic drugs and cytotoxic waste.

South Australian Acts and Regulations > Occupational Health, Safety and Welfare Act 1986.

> Occupational Health, Safety and Welfare Regulations 2010.

> Dangerous Substances Act 1979.

> Dangerous Substances Regulations 2002.

> Dangerous Substances (Dangerous Goods Transport) Regulations 2008.

> Controlled Substances Act 1984.

> Controlled Substances (Poisons) Regulations 1996.

> Environment Protection Act 1993.

> Environment Protection Regulations 2009.

> Environmental Protection (Waste to Resources) Policy 2010.

Codes and Standards > Code of practice for the control of workplace hazardous substances 2006.

> Code of practice for the labelling of workplace substances 2006.

> The National Environment Protection (Movement of Controlled Waste between States and Territories) Measures 2010.

> National Drugs and Poisons Schedule Committee, Department of Health and Ageing, Australian Government; Standard for the uniform scheduling of medicines and poisons.

> Federal Office of Road Safety, Federal Department of Transport and Communications, Australian Government Publishing Service, Canberra; Australian Code for the Transport of Dangerous Goods by Road and Rail (ADG code).

> International Air Transport Association (IATA); Dangerous Goods Regulations 51st Edition.

> Safe Work Australia; National Code of Practice for the Preparation of Material Safety Data Sheets 2nd Edition [NOHSC: 2011 (2003)].

> Safe Work Australia; 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)]).

> Safe Work Australia; List of designated hazardous substances in Hazardous Substances Information System (HSIS) (previously available as List of designated hazardous substances [NOHSC: 10005 (1999)]).

> Safe Work Australia; Adopted national exposure standards for atmospheric contaminants in the occupational environment in Hazardous Substances Information System (HSIS) on http://hsis.ascc.gov.au/Default.aspx (previously available as Adopted national exposure standards for atmospheric contaminants in the occupational environment [NOHSC: 1003 (1995)].

> Australian Commission on Safety and Quality in Health Care; National Recommendations for User-applied Labelling of Injectable Medicines, Fluids and Lines August 2010.

> South Australian Environment Protection Authority; Hazardous Waste Strategy.

> South Australian Environment Protection Authority; EPA Guidelines on Medical Waste – Storage, Transport and Disposal.

Appendix 2 Information Sources


Australian Standards > AS 1386-1989 Cleanrooms and clean workstations.

> AS/NZS 1715-2009 Selection, use and maintenance of respiratory protection equipment.

> AS/NZS 1716-2003/Amdt 1-2005 Respiratory protective devices.

> AS/NZS 2243.1-2005 Safety in laboratories – Planning and operational aspects.

> AS/NZS 2243.2-2006 Safety in laboratories – Chemical aspects.

> AS/NZS 2243.3-2010 Safety in laboratories – Microbiological aspects and containment facilities.

> AS 2243.4-1998 Safety in laboratories – Ionizing radiations.

> AS 2243.5-2004 Safety in laboratories – Non-ionizing radiation – Electromagnetic, sound and ultrasound.

> AS 2243.6-2010 Safety in laboratories – Plant and equipment aspects.

> AS 2243.7-1991 Safety in laboratories – Electrical aspects.

> AS/NZS 2243.8:2006 Safety in laboratories – Fume cupboards.

> AS 2243.9-2009 Safety in laboratories – Recirculating fume cabinets.

> AS 2243.10-2004 Safety in laboratories – Storage of chemicals.

> AS 2567-2002 Laminar flow cytotoxic drug safety cabinets.

> AS 2639-1994 Laminar flow cytotoxic drug safety cabinet – Installation and use.

> AS/NZS 2982.1-2010 Laboratory design and construction – General requirements.

> AS/NZS 3831–1998 Waste management – Glossary of terms.

> AS 4031-1992 Non-reusable containers for the collection of sharp medical items used in health care areas.

> AS 4031-1992/Amdt1-1996 Non-reusable containers for the collection of sharp medical items used in health care areas.

> AS 4273-1999 Guidelines for the design, installation and use of pharmaceutical isolators.

> AS 4273-1999/Amdt1-2000 Guidelines for the design, installation and use of pharmaceutical isolators.

> HB 202-2000 A management system for clinical and related wastes – Guide to application of AS/NZS 3816-1998, Management of clinical and related wastes. Standards Australia.

> HB 436-2005/Amdt 1-2005 Risk management guidelines – Companion to AS/NZS 4360: 2004, Risk Management. Standards Australia.

SA Health Documents > 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.

> SA Health; Risk Management Policy.

> SA Health; Occupational Health, Safety and Welfare and Injury Management Policy.

> SA Health; Performance Review and Development (PR&D) Planning Record http://in.health.sa.gov.au/wc.

> SA Health; Performance Review and Development (PR&D) Guide Information Sheet 7 http://in.health.sa.gov.au/wc.



Additional Reference Materials Australian

> WorkCover NSW; Cytotoxic Drugs and Related Waste – Risk Management Guide 2008.

> 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.

> WorkCover Victoria; Training Competencies: Handling Cytotoxic Drugs in Health Care Establishments 1997.

> Queensland Department of Industrial Relations; Guide for the Handling of Cytotoxic Drugs and Related Waste 2005.

> Society of Hospital Pharmacists of Australia; Standards of practice for the safe handling of cytotoxic drugs in pharmacy departments, J Pharm Pract Res 2005 35(1): 44-52.

> Society of Hospital Pharmacists of Australia; Standards of practice for the transportation of cytotoxic drugs from pharmacy departments. Aust J Hosp Pharm 2000 30(3): 116-17.

> Cancer Institute of NSW: eviQ Cancer Treatments On-Line (accessed Sep – Nov 2010).

> The Australian National Cancer Nursing Education Project; EdCaN On-line.

> Cancer Australia; Cancer Leaning On-line.

> National Occupational Health and Safety Commission; Competencies for Health Surveillance 1998.


> Clinical Oncology Society of Australia; Guidelines for the Safe Prescribing, Dispensing and Administration of Cancer Chemotherapy 2008.

> Waste Management Association of Australia (WMAA); The Industry Code of Practice for the Management of Clinical and Related Wastes 6th Ed 2010.

> Pharmaceutical Society of Australia (PSA); Australian Formulary and Handbook 21st Edition 2010.

> Australian Commission on Safety and Quality in Health Care; Medication Alert No. 2 December 2005.

International > International Society of Oncology Pharmacy Practitioners (ISOPP); Standards of Practice: Safe Handling of

Cytotoxics, J Oncol Pharm Pract 2007, 13 Suppl:1-81.

> PIC/S; Guide for Good Manufacturing Practice of Medicinal Products in Healthcare Establishments (PE010-3) 2008.

> American Society of Health-System Pharmacists (ASHP); Guidelines on Handling Hazardous Drugs Am J Health-Syst Pharm 2006 63.

> US CDC/NIOSH; Guidelines on Occupational Exposure to Antineoplastic Agents www.cdc.gov/niosh/topics/antineoplastic/sampling.html#b accessed 09 Nov 2010.

> World Health Organisation; Safe Management of Wastes from Health Care Activities 1999.



Technical Reports > Vos, MC et al. Nosocomial Mycobacterium bovis-bacille Calmette-Guérin infections due to contamination of

chemotherapeutics: case finding and route of transmission. J Infect Dis 2003 188(9): 1332-1335.

> Tkaczuk M et al. Surface contamination of cytotoxic drug 5-fluorouracil (5-FU) and decontamination. J Health Saf Environ 2010; 26(2):171-181.

> Siderov J et al. Surface contamination of chemotherapy preparation areas with cyclophosphamide in Australian hospital pharmacy departments. J Pharm Pract Res 2009; 39:95-9.

> Touzin K et al. A. Pilot study comparing the efficacy of two cleaning techniques in reducing environmental contamination with cyclophosphamide. Ann Occup Hyg. 2010; 53(3):351-259.

> Touzin K et al. Cyclophosphamide contamination observed on the surface of drug vials and the efficacy of cleaning on vial contamination. Ann Occup Hyg. 2008; 1-7.

> Lee S-G et al. Surface contamination from cytotoxic chemotherapy following preparation and administration. J Pharm Pract Res 2007; 37(4):271-276.

> Roberts S et al. Studies on the decontamination of surfaces exposed to cytotoxic drugs in chemotherapy workstations. J Oncol Pharm Practice. 2006; 12:95-104.

> Barek J et al. Chemical degradation of wastes of antineoplastic agents amsacrine, azathioprine, asparaginase and thiotepa. Ann Occup Hyg. 1998; 42:259-266.

> Castegnaro M et al. Chemical degradation of wastes of antineoplastic agents 2: Six anthracyclines: idarubicin, doxorubicin, epirubicin, pirarubicin, aclarubicin, and daunorubicin. Int Arch Occup Environ Health. 1997; 70:378-384.

> Hansel S et al. Chemical degradation of wastes of antineoplastic agents: cyclophosphamide, ifosfamide and melphalan. Int Arch Occup Environ Health. 1997; 69:109-114.

> Benvenuto JA et al. Degradation and inactivation of antitumor drugs. J Pharm Sci. 1993; 82:988-991.

> Wren AE et al. Decontamination methods for cytotoxic drugs. 1. Use of a bioluminescent technique to monitor the inactivation of methotrexate with chlorine-based agents. J Clin Pharm and Therap. 1993; 18:133-137.

> Lunn G et al. Degradation and disposal of some antineoplastic drugs. J Pharm Sci. 1989; 78:652-659.

> Lunn G and Sansone EB. Reductive destruction of dacarbazine, procarbazine hydrochloride, isoniazid, and iproniazid. Am J Hosp Pharm. 1987; 44:2519-2524.

> Sessink.P et al. Drugs hazardous to health workers: Evaluation of methods for monitoring occupational exposure to cytostatic drugs. Drug safety 1999; 20(4):347-359.

> Venitt.S. et al. Monitoring of exposure of nursing and pharmacy personnel to cytotoxic drugs: Urinary platinum as markers of absorption. the Lancet 2003; 323:74-77.



Appendix 3

Monoclonal Antibodies (MABs)There are currently no available Australian guidelines on the safe handling of monoclonal antibodies (MABs) in the clinical setting. Manufacturers have no formal data on the possible risks to staff of handling monoclonal antibodies, predominantly because they are not required to provide this information for licensing purposes. Safety Data Sheets, which are a legal requirement, are available but tend to be geared towards industrial scale handling of raw material and are not easily translated to the clinical setting. The potential level of occupational exposure is difficult to quantify.1

As these drugs have only been in clinical use for a relatively short period of time, there is no appreciable in-use data on the risks of chronic low level exposure. The extrapolation of toxicity data obtained in therapeutic situations can be misleading.

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, and that they are potentially receiving low level exposure or potentially exposing an unborn foetus to these agents.

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. 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.

Although a risk management/assessment is generally advocated to determine procedures for the safe handling of any drug, it should be noted that there are a number of intrinsic difficulties with performing sound risk assessments on MABs. 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. 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. Exposure during occupational handling is lower but chronic.

Other jurisdictions have published guidance on the handling of MABs.3 Key considerations recommended in the guidance produced by the British National Health Service in 2008 include:

> given the animal origin of MABs, 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.

In 2010, 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, 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, especially when external exposure is probable.

References1. Pan Birmingham Cancer Network Site Specific Groups (UK); Guideline for the preparation or manipulation of Monoclonal Antibodies

(MABs) used in the Treatment of Cancer (November 2008).

2. Halsen, G and Krämer, I; Assessing the risk to health care staff from long-term exposure to anticancer drugs – the case of monoclonal antibodies, J. Oncol Pharm Pract. 2010; 17(1):68-80.

3. NHS Pharmaceutical Quality Assurance Committee (UK); Guidance on the Safe Handling of Monoclonal Antibody (MAB) Products 4th Edition (January 2008).

Appendix 3 – Monoclonal Antibodies (MABs)

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Hazardous Substances (Cytotoxic Drugs) Register

Organisation:

Site/area: Date:

Person compiling register:

Product nameLocation or process

where product is used

Notification to SafeWork SA?

Yes/No/ Not required

Safety Data Sheet* Risk assessmentActions/Comments

Yes/No Date Yes/No Date

Date for review of register:*Safety Data Sheet should be no more than five years old

For information on the Appendix, refer to Section 2.App

endi

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– H

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dous

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stan

ces

(Cyt

otox

ic D

rugs

) Reg

iste

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Appendix 5

Risk Assessment Tool for Cytotoxic Drugs and Related Wastes

Rationale: This risk assessment is required to be completed, in consultation with the work area Health and Safety representative where appropriate, 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).

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? Yes No Date of SDS:

Current (Within 5 years of issue): Yes No

Describe how and where this cytotoxic substance will be used:

Please answer the following questions. Refer to the SDS

1. DANGEROUS GOODS CLASSIFICATION Yes No Classification:

2. IS IT A HAzARDOUS SUBSTANCE (according to WorkSafe criteria)? Yes No (*Note: Treat all chemical substances as being hazardous until otherwise defined)

Chemically active ingredient/s:

3. CHEMICAL PROPERTIES

Flammable: Yes No Corrosive: Yes No Carcinogen: Yes No

Toxic: Yes No Oxidising agent: Yes No

Comments:

4. INCOMPATABILITY WITH VARIOUS SUBSTANCES

Comments:

5. FORM OF THE SUBSTANCE

Liquid Solid tablet Powder Creams, ointments and lotions for topical application

6. HEALTH EFFECTS – During the preparation and waste disposal phaseCan the chemical enter the body via:

Ingestion: Yes No Inhalation: Yes No Skin absorption: Yes No

Eyes / Mucus Membrane absorption: Yes No

Comments:

IF THIS PRODUCT IS CURRENTLY USED, OR IS INTENDED TO BE USED, PLEASE CONTINUE WITH ASSESSMENT.

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 AssessmentSTEP 1

> Is the facility required to be licensed under the Environmental Protection Act? Yes No

> If ‘yes’, is the facility currently licensed? Yes No

> Is a cytotoxic drug safety cabinet available, if drug preparation is required? Yes No NA (Refer to Section 6.3 – Engineering controls / ventilation)

> Is a secondary barrier (high efficiency particulate air – HEPA) filter available? Yes No NA (Refer to Section 6.3 – Engineering controls / ventilation)

> Is the use of a closed system drug transfer device, or other similar device available? Yes No NA

> Does the substance require any special storage (bunding/locked cupboard/placarding)? Yes No

Comments:

> What Personal Protective Equipment (PPE) is required as per manufacturer’s Yes No recommendations in SDS?

Comments:

> Is there an effective process for managing spills? Yes No (Refer to Section 15 – Spills)

> Can waste products be disposed of safely in accordance with waste management legisaltion? Yes No (Refer to Section 17.4 – Waste Management)

> Are any special transport requirements required for transporting substance? Yes No

> For new substances, will staff need to be trained in the following?

– Safe and effective use of the product Yes No

– Proper, safe and effective use and maintenance of PPE Yes No

– First aid and emergency procedures Yes No

> Has environmental monitoring, where cytotoxic drugs are prepared, been previously conducted? Yes No

STEP 2Complete 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? Yes No

If determined to be not safe, can an alternative arrangements be organised? Yes No (Refer to Section 6.1 – Alternative Supply Arrangements).

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


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s Attachment A

Job Safety Analysis/Action Plan

Use of Cytotoxic Drugs and Management of Related WastesRefer 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: Department: Date:

SUBSTANCE(S) To be used

DESCRIPTION OF USE(Briefly describe tasks or situations where substance is used and/or exposure may occur)

ROUTES OF EXPOSURE/TYPE OF RISK

EXISTING SAFETY MEASURES IN PLACE(Available/ in place e.g. laminar flow cabinet; SOPs, PPE)

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: HSR’s signature: Date:

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.


Attachment B

Risk MatrixComplete 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) Is expected to occur again either immediately or within a short period of time (daily/weekly)

Likely (Probable) Will probably occur in most circumstances (monthly)

Possible (Occasional) Probably will recur; might occur at some time (yearly)

Unlikely (Uncommon) Possibly will recur; could occur at some time in 2 to 5 years

Rare (Remote) 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 Death or total loss of one or more bodily functions i.e. lose use of arm or over 4 months lost time from work

MajorSevere 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

Moderate Under 2 weeks time lost from work and/or significant property damage

Minor Minor injury (first aid/medical treatment) and/or minor property damage

Insignificant 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 Minor Moderate Major Critical

Like

liho

od

Almost Certain 3 3 2 1 1

Likely 3 3 2 2 1

Possible 4 3 3 2 2

Unlikely 4 4 3 3 2

Rare 4 4 4 3 2

Table 4: Risk Score and Risk Rating Priority. Tick (✔) appropriate score.

1 Extreme risk: take immediate action

2High risk: senior management responsibility required, utilise temporary control, initiate permanent control as soon as possible

3Moderate risk: management responsibility must be specified, utilise temporary control, permanent control 3 – 6 months

4 Low risk: manage by routine procedures, monitor situation and action control within 6 –12 months

Risk ControlThe 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



Attachment C

Hierarchy of Control Process

Safety Control Measures Involving Cytotoxic DrugsELIMINATION is the most effective control: apply the highest category possible.

Safety Measure Explanation and Examples

Elimination, Substitution or Replacement

Eliminate the use of the substance. 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. Examples:Safer substance

> A safer alternative drug is identifiedSafer 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, equipment and

trained personnel to provide prepared cytotoxic drug doses

Isolation Isolate the source of the hazard. 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.

Engineering Physical controls (such as plant/equipment) that eliminate or reduce substances being produced; stop or contain substances; separate people or property from the substance by distance or barriers; or limit the area of contamination in the event of spills and leaks and meet recommended technical and safety standards. Examples:

> Designing buildings that are compatible with the intended substances and designed to reduce contamination

> Handling cytotoxic drugs in an enclosed area, 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. 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

Administrative Work methods employ best practice controls. Examples: > Drugs are stored in dedicated clearly marked storage areas, 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, 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, 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.g. use of duress alarms > Controlled access to preparation areas > Effective management of contaminated laundry

Personal Protective Equipment (PPE)

Protective clothing and equipment for employees, supervisors, volunteers and visitors. Examples: > Coveralls and gowns > Gloves > Protective eyewear > Shoe covers or overshoes > Respiratory protective equipment (RPE) as recommended in AS/NZS 1715:1994 > Head covering


MO

ST E

FFEC

TIV

ELE

AST

EFF

ECTI

VE


Attachment D

Decision Making Process for the Safe Handling of Cytotoxic Drugs

Level 2 ControlIsolation at the Source of the Hazard/Source

Containment

Level 1 ControlElimination,

Substitution or Replacement

Level 5 ControlPersonal Protective

Equipment

Level 4 ControlAdministrative

Controls/ Organisation Measure

Level 5 ControlEngineering

Controls/ Ventilation

Has there

been a risk assessm

ent?

Can this

measure be applied?

Is the risk m


Is the risk m


Is the risk m


Is the risk m


Is the risk m


Is the risk m


Can a closed

system transfer

device be used?

Can another device be

used?

Can this

measure be applied?

Can this

measure be applied?

Can this

measure be applied?

Do not

perform

task

Do not

perform

task

Perform

task

Perform

task

Perform

task

Implem

ent control

Implem

ent control

Implem

ent control

YesYes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

No

No

No

Decisio

n m

aking

pro

cess for th

e safe han

dlin

g o

f cytoto

xic dru

gs

No

No

No

No

No

No

No

No

No

No

Perform

task

Perform

task

Perform

task

Implem

ent control

Implem

ent control

Implem

ent control



Appendix 6

Cytotoxic Drug Precautions Alert Proforma

Cytotoxic Precautions Alert

(Page 1 of 1)

Affix Patient Identification Label Here

Surname UR Number

Given Name DOB

Address 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

MR

____

____

____

____

____

____

_ C

ytot

oxic

Dru

g Pr

ecau

tions

Ale

rt F

ormCease cytotoxic precautions on: Date: / / Time: am / pm

Protective measures

Personal Protective Equipment (PPE)

> 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, 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, i.e. dressings, 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

Appendix 6 – Cytotoxic Drug Precautions Alert Proforma


Appendix 7

Model Procedures

How to use the Model ProceduresThese 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.

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. The model procedures do not represent legal advice, are not comprehensive and do not constitute a complete procedures manual for the safe handling of cytotoxic drugs and related wastes. The model procedures are designed to assist practices in safety and quality improvement.

A Word version of the model procedures is available: www.sahealth.sa.gov.au/HazardousDrugs

Instructions for use:1. Save the model procedure(s) to your computer or network.

2. Review the model procedure(s) to determine changes, additions or deletions that may be needed in your health service document(s). If you have a standard format for procedures, you may wish to reformat the sample language to be consistent with existing health service documents.

Appendix 7 – Model Procedures

page 103


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

The purpose of this document is to ensure that a health surveillance program, which includes health monitoring and biological monitoring, is implemented, monitored and reviewed regularly.

This procedure would apply to approved medical officers undertaking health surveillance of employees handling cytotoxic drugs, employers and OHSW employees.

Abbreviations and definitions

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.

Cytotoxic Harmful to cells of the body, particularly those that reproduce rapidly.

Cytotoxic waste Any residual cytotoxic drug following patient treatment or any material associated with its preparation or administration which may contain traces of drug.

Health surveillance The monitoring of persons to identify changes (if any) in their health status due to the potential for occupational exposure to a hazardous substance.

Health monitoring 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.

General information Prospective employees shall be counselled at interview, induction and as part of an ongoing health surveillance program on the potential risks to health and reproduction, how exposures might occur, and the control measures in place.

Health surveillance should be implemented and provided to all employees involved in the preparation and administration of cytotoxic drugs.

The health surveillance program should be regularly reviewed to include any current developments in health monitoring and/or biological monitoring and changes to legislation.

A health surveillance program may be extended to employees:

> involved in the clean up of spills, if required, based on risk assessment of the spill and control measures in place at the time

> who are not already identified in this procedure.

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.

Model Procedure 1

Health Surveillance for Staff Handling Cytotoxic Drugs and Related Wastes

SAMPLE

page 104



Organisations shall ensure employees are made aware of the health surveillance/health monitoring program and how to access it.

Appointments with an approved medical practitioner are in work time and at the employer’s expense.

Organisations shall ensure that the medical officer complies with the current competencies for health surveillance.

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.

Reports of health and/or biological monitoring are to be provided to the employee after each consultation in an agreed time frame.

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.

Appendices A Questionnaire for Staff Handling Cytotoxic Drugs and Related Wastes.

B Log of Exposure to Cytotoxic Drugs for Pharmacy Staff.

C Log of Exposure to Cytotoxic Drugs for Nursing Staff.

References1. SA Health; Safe Handling of Cytotoxic Drugs and Related Wastes: Guidelines for South Australian Health Services 2012.

2. Occupational Health, Safety and Welfare Act 1986.

3. Occupational Health, Safety and Welfare Regulations 2010.

4. National Occupational Health and Safety Commission; Competencies for Health Surveillance 1998.

5. National Occupational Health and Safety Commission; Guidelines for Health Surveillance 1995.

Model Procedure 1

Health Surveillance for Staff Handling Cytotoxic Drugs and Related Wastes

SAMPLE


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

EmployerPosition

held

Previous work with cytotoxic drugs

Yes/No (Include dates)

Exposure to cytotoxic drugs

(spills/needlestick Injuries)

Current exposure to

cytotoxic drugs


SAMPLE


Section C: Medical history

Question Yes No If yes, please provide details

1 Have you ever smoked cigarettes?

If yes, how many did you smoke per day?

2 Do you have a personal history of cancer?

3 Do you have a family history of cancer in first relatives?

4 Do you have a history of asthma or other systemic allergic reactions?

5 Are you taking immunosuppressive therapy?

6 Are you pregnant or breast feeding?

7 Are you planning parenthood or considering parenthood at sometime in the future?

8 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

Section D: Physical examinationDate of medical assessment / /

Doctor’s comments

Build Height (cm) Weight (kg) BMI

Urinalysis

Blood pressure

Pulse


SAMPLE


Area assessed Normal Abnormal Doctor’s comments

1 Skin

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

2 Other

3

4


SAMPLE



Section F: The following must be reviewed as part of the assessment

Yes Comments

1 Exposure log (includes spills)

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 Normal Abnormal

1 Potential health effects associated with exposure to cytotoxic drugs

2 Optimum standard of control measures to expect in the workplace

3 The potential risks of employees planning parenthood, or those who are pregnant or breast feedingSAM

PLE



Section H: Findings and recommendations

Re-assessment recommended in ________________________ years

Placement recommendations (if required)

Yes No

Report provided to employer advising that the employee has received assessment and health advice/counselling

Report provided to employee advising of any test results, recommendations and health advice received

Other comments

SAMPLE



Appendix B

Log of Exposure to Cytotoxic Drugs for Pharmacy Staff


Surname Page

Given name

Department

Section B: Hours spent handling cytotoxic drugs

Date Hours a.m. Hours p.m. Total hours Cabinet ID Drug name Initials

Section C: Documentation spills or accidents involving cytotoxic drugsNote: Staff member and supervisor to initial and date each entrySAM

PLE



Appendix C

Log of Exposure to Cytotoxic Drugs for Nursing Staff


Surname Page

Given name

Department

Section B: Hours spent handling cytotoxic drugs

Date Hours a.m. Hours p.m. Total hours Cabinet ID Drug name Initials

Section C: Documentation spills or accidents involving cytotoxic drugsNote: Staff member and supervisor to initial and date each entrySAM

PLE

page 112



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. Implementation of this training will minimise risk to the health and safety of staff and patients, and avoid contamination of the environment.




TNA Training needs assessment.

General informationStaff should not be handling (preparing, administering, transporting and disposing of) cytotoxic agents unless they have been involved in specific skills and work practice training programs. 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, other occupants and the environment from contamination with cytotoxic agents. 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. A competency based training program for nursing and pharmacy staff should be in place in units where cytotoxic drugs are manufactured (pharmacy), handled and administered (nursing staff should not be administering cytotoxic agents unless they have been deemed competent with all elements of this procedure).

Identification of training needs 1. 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.

2. Training needs are identified on ‘Performance Review and Development (PR&D) Planning Record’.1 Recommendations for training topics by profession are provided in Appendix A.

Note: For pharmacists and nurses working in the field of cancer therapy, training competencies are outlined in the following documents:

> 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

3. Training needs can also be identified as and when required to enhance the professional capabilities using ‘PR&D Planning Record’.

Model Procedure 2

Staff Training for the Safe Handling of Cytotoxic Drugs and Related Wastes

SAMPLE

page 113



Training planBased on TNA, an ‘Annual Development Plan’2 should be prepared after consultation with the employee’s line manager. In case of any change, the ‘Annual Development Plan’ is updated. The former ‘Annual Development Plan’ is cancelled by writing ’Cancelled‘, otherwise it will be updated at the end of each year.

In-house and external training1. This development plan covers both in-house and external training of staff , which is based on the training

programs being offered by various providers.

2. Internal trainers are selected, keeping in view their level of competency in the field of training.

3. External trainers can be used, keeping in view their market reputation and cost of training.

Training records1. An attendance record will be completed for all training which includes:

> date of training

> name of training

> summary of training content

> details of the trainer (name, organisation, etc)

> signature of trainee.

2. Training records will be maintained in a separate ‘Training’ folder or in the personnel file of the particular employee.

Validation of training1. Line managers need to confirm that staff have a satisfactory level of knowledge or competency for duties.

2. Guidance on training competencies, which set out the knowledge and skills staff need in order to minimise occupational exposures to cytotoxic drugs and related waste, can be obtained from a number of internal3 and external sources.4

3. The impact of the training should be validated by performing competency checks.

4. Revalidation should occur on a regular basis, although the frequency of revalidation will depend on the training element. For example, staff regularly reconstituting cytotoxics should undergo a validation test annually, at a minimum.

Re-training1. To cover the introduction of new drugs or new technical innovations, it is recommended that training be repeated

every 2-3 years.

2. Training should be repeated whenever any major change in practice occurs.

Model Procedure 2


SAMPLE

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AppendicesA Training Matrix.


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

5. External sources:

> WorkCover Victoria; Training Competencies: Handling Cytotoxic Drugs In Health Care Establishments 1997.

> National Occupational Health and Safety Commission; Competencies for Health Surveillance 1998.


> The Australian National Cancer Nursing Education Project; EdCaN On-line

> Cancer Australia; Cancer Leaning On-line.

Model Procedure 2


SAMPLE


Appendix A

Training MatrixThis 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.

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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 ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔


SAMPLE

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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.


CDSC Cytotoxic drug safety cabinets.



Intrathecal Injection into the fluid-filled space that surrounds the spinal cord.

ISOPP International Society of Oncology Pharmacy Practitioners.

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

PPE Personal Protective Equipment.

SHPA Society of Hospital Pharmacists of Australia.

General informationPersonnel 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

Model Procedure 3

Preparation of Parenteral Cytotoxic Drugs Without a Closed System Transfer Device in the Pharmacy Department

SAMPLE

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Cytotoxic drugs in glass ampoules should be avoided whenever possible. Care must be exercised when using liquid filled ampoules of cytotoxic drugs, as they produce aerosols of drug solution when opened. Ampoules should be opened away from the operator, and to avoid injury or damage to gloves, an ampoule breaker should be used. Filter needles (5 micron) must be used when dispensing from glass ampoules. Any excess solution should be discarded in a sealed syringe for later safe destruction.1

Appropriate steps must be taken to contain excess drug or prevent air contamination when priming syringes and other devices. Excess drug should be returned to the original container or introduced into a closed container to be discarded.1 Opened/used vials should not be left in the cabinet for later use.

Vinca alkaloids must be supplied in a mini-bag (50 mL or 100 mL), not in a syringe.

Procedures

1. 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.

It is important to perform this technique carefully to prevent the formation of aerosols. Also use caution to avoid the needle coming out of the bung which could lead to a needle-stick injury.

Note: If the cytotoxic drug is for intrathecal use it must not be prepared during preparation of any other agents.

Adding diluent solution to the vial > Withdraw required volume of diluent solution into luer-lock syringe and attach 18 G needle.

Note: Refer to institution’s specific drug procedure or manufacturer’s product information leaflet for type of diluent and volume to use.

> Insert needle into bung of cytotoxic drug vial.

> Withdraw a few millilitres of air from vial, creating a negative pressure inside vial and then allow solution to flow from syringe into vial until pressure has equalised. Repeat until all of the solution has been added to vial.

> 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. This may vary from batch to batch (e.g. ifosfamide).

> Swirl vial gently until drug is dissolved. Do not shake vigorously.

Withdrawing solution from vial > Check drug is completely dissolved.

> Draw up air into syringe equivalent to volume of solution to be withdrawn.

> Attach syringe to needle in vial.

> Invert vial and aspirate a few millilitres of solution into syringe, creating a negative pressure in the vial and then allow air in the syringe to flow back into the vial. Repeat until required volume is withdrawn.

> Stand vial on workbench and use forceps to disconnect syringe from needle, leaving needle in vial. Seal syringe with sterile syringe cap.

Note: Syringes must never be sent with a needle attached.

> Discard all cytotoxic waste appropriately.

> Note: If an air-venting device is used instead of a needle then it is not necessary to use negative pressure technique.

Model Procedure 3


SAMPLE

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2. 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.

> Prior to addition to infusion bag, all volumes drawn up by a pharmacy assistant must be checked by a pharmacist. Keep the original ampoules/vials and show to pharmacist at same time.

> Thoroughly clean additive port of infusion bag/bottle with 70% sterile alcohol.

> Using 21 G needle, make the addition. If more than one syringe is to be added to an infusion container, an injection site cap is attached to a 21 G needle and inserted into the additive port of the infusion container. The additions are made into the bung of the injection site cap.

Note: For certain non-PVC bags, an 18 G needle can be used to add to the bag. Refer to manufacturer’s product information.

> Thoroughly agitate to ensure mixing and check for leakage before removing from CDSC.

> Clean additive port with 70% sterile alcohol and remove from CDSC.

> Discard all cytotoxic waste appropriately.

LabellingThe cytotoxic drug must be labelled immediately upon preparation, including:

Primary container/syringe/bagLabelling should include:

> drug name

> dose and volume

> infusion solution, if required/appropriate

> intended route of administration

> expiry date and time, if appropriate

> storage conditions

> other supplementary, cautionary instructions if required, e.g. do not extravasate, fatal if given intrathecally:

Note 1: If the cytotoxic drug is for intrathecal use it must be clearly labelled ’For Intrathecal Use Only‘.

Note 2: Vinca alkaloids must be labelled ‘for intravenous use only – fatal if given by other routes’.

> patient’s full name and a second patient identifier (e.g. medical record number, 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.

Model Procedure 3


SAMPLE

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Packaging > Seal the prepared drug in two layers of plastic (this packaging may also offer protection from light).

> The sealed cytotoxics should then be placed in a dedicated, secure area, ready for transport.

Note: If the cytotoxic drug is for intrathecal use it must be packaged and delivered separately from doses to be administered by other routes.


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

3. PIC/S; Guide for Good Manufacturing Practice of Medicinal Products in Healthcare Establishments (PE010-3) 2008.

4. Australian Standard AS 2639-1994 Laminar flow cytotoxic drug safety cabinet – installation and use.

5. AS/NZS ISO 14644.5-2006 Cleanrooms and associated controlled environments Part 5: Operations.

6. ISOPP; Standards for Practice Safe Handling of Cytotoxics.

7. Australian Council for Safety and Quality in Health Care; Medication Alert No 2, December 2005.

Model Procedure 3


SAMPLE

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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.



General information1. Verify method of transport to be used, such as courier or staff member.

2. If using a courier, identify the telephone number, locations and any special requirement of the courier to be used.

Packaging1. Place sealed luer-lock syringes or infusion containers of prepared cytotoxic solutions into separate plastic bags

(double wrapped).

2. Seal with heat sealer.

3. Room temperature transport: wrap the drugs in the foil bubble wrap and tape closed.

Note: Room temperature is considered to be 25°C. If transporting room temperature drugs during hot summer days or to regional and remote areas (such as Roxby Downs or Ceduna), consideration must be give to ambient temperatures exceeding 40°C.

4. Cold chain transportation:2 at least one ice pack should be included in the packaging. Place the ice brick inside a folded section of the foil bubble wrap, then add the drugs ensuring that the drugs are not in direct contact with the ice brick. Tape the foil bubble wrap closed.

Note: When regularly transporting drugs to regional and remote areas under cold chain conditions, consideration should be given to validating the cold chain measures using a temperature data tracking device wrapped in the foil with the drugs.

5. Attach the ‘CYTOTOXIC – HANDLE WITH CARE’ label (see Appendix A, sample 3) to the bubble wrapped package.

6. Include the administration chart with the drugs if the delivery is for the first date of administration on the order.

7. Include a safety data sheet with the packaging.

8. Use an appropriately sized, hard walled carton (for example a Baxter brown I.V. fluids carton).

9. Seal the carton with packaging tape.

Note: Drugs requiring different storage conditions, i.e. room temperature items and refrigerated items, must be placed into separate cartons. 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).

SAMPLE

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Model Procedure 4


Exceptions: > Calcium folinate injection: Requires cold chain transportation, however if it is sent with other drugs not requiring

refrigeration it may be sent at room temperature.1

Print a bag label. Place the calcium folinate into a brown paper bag with bag label attached. Also attach calcium folinate label (Appendix A, sample 1).

> Carboplatin and gemcitabine: If sending together, send them both in cold chain packaging but attach the label below to the outside of the carton. This instructs staff receiving the carton to store the gemcitabine at room temperature and to store the carboplatin in the refrigerator.2 Attach the carboplatin and gemcitabine label (Appendix A, sample 2).

Labelling > The outer packaging of cytotoxic drugs will display a clear warning label identifying the product clearly as

cytotoxic (Appendix A, sample 3).

> All vinca alkaloids products, including the outer wraps, must have a prominent warning label stating, ‘For intravenous use only – fatal if given by other routes’ (Appendix A, sample 4 for outer wrap label).

> All cytotoxic drugs for intrathecal use must have a prominent warning label on the syringe and outer wrap stating, ‘For Intrathecal Use Only’ label (Appendix A, sample 5 for outer wrap label).

> If the item requires refrigeration, place a large ‘Refrigerate’ label on top of the carton (Appendix A, sample 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, as well as instructions in the event of spillage (Appendix A, sample 7).

> Place the consignment note on top of the box plus a ‘CYTOTOXIC – HANDLE WITH CARE’ label (see Appendix A, sample 3).

> Place ‘This Side Up’ labels on two opposite sides of carton (see Appendix A, sample 8).

> Place the dangerous goods label (diamond with ‘6’), on the top of the carton (see Appendix A, sample 9).

> 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. This is in case the consignment note is accidentally removed from the carton in transit.SAM

PLE

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DocumentationConsignment note Follow the courier’s procedure for the completion of the consignment note, with the following considerations:

> Sender – the name of the cytotoxic preparation pharmacist and their telephone number

> Receiver – the doctor’s name, address and telephone number.

Logs > Complete the ‘Log of Chemotherapy Parcels Sent to External Institutions’ (see Appendix B).

AppendicesA Sample Labels.

B Log of Chemotherapy Parcels Sent to External Institutions.

References 1. Communication with manufacturer.

2. Trissel, LA; Handbook on Injectable Drugs, 15th Ed (2009).

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

4. ASHP; Guidelines on Handling Hazardous Drugs Am J Health-Syst Pharm 2006 63.

5. SHPA; Standards of Practice for the Transportation of Cytotoxic Drugs from Pharmacy Departments 2007.

6. Australian Council for Safety and Quality in Health Care; Medication Alert No. 2, December 2005.

7. The Australian Code for the Transport of Dangerous Goods by Road and Rail.

8. The International Air Transport Association’s (IATA) Dangerous Goods Regulations.

Model Procedure 4


SAMPLE



Appendix A

Sample no. Example

1PLEASE REFRIGERATE

CALCIUM FOLINATE INJECTION ON ARRIVAL

2

PLEASE NOTE:This package contaiins Gemcitabine which can be stored at room temperature.

On arrival: > Remove the Gemcitabine and store at room te mperature> Store Cartoplatin in the refrigerator

3

4 For Intravenous Use OnlyFatal if given by Other Routes

5 For Intrathecal Use Only

6 REFRIGERATE Do not freeze

7

CYTOTOXIC DRUGHANDLE WITH CARE

Avoid contact with skin

This item has been packaged in accordance with approved guidelines and is safe for transport.

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, immediatelywash the area with large amounts of water

> remove any contaminated clothing

> contact Jane Smith on (08) 8XXX XXXX during business hours or on 04XX XXX XXX after hours.

Name of InstitutionAddress of Institution

8

This Side Up

9

SAMPLE

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12Appendix B – Log of Cytotoxic Drug Parcels Sent to External Institutions

Month: Year:

Date sent Patient name and U.R. no. Destination Name and batch number of drug(s) sent Con. note #

App

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The purpose of this document is to ensure appropriate procedures for the transport of cytotoxic drugs within the health service.



LabellingPrimary packaging

Cytotoxic drug Label requirement Sample

All Primary label has:

> name of the drug

> the dose

> expiry date

> batch number

> patient name and URN

> ‘protect from light’ if drug is light sensitive

> ‘keep out of reach of children’ warning in red text

> name, address and phone number of health service

> date of supply.

KEEP OUT OF REACH OF CHILDREN

CYTOTOXIC INJECTION SOLUTION

DOXORUBICIN100 mg in 50 mL

OWEN, DOUGAL UR: 12345 Ward: DC

ROUTE OF ADMINISTRATION: Intravenous

Rate: over 5 minutes Supplied on: 10/11/10

B: 11100001 Exp: 11/11/10

PROTECT FROM LIGHT

Name of InstitutionAddress & Phone No of Institution

All

Cytotoxic drugs in solution

Name of fluid in which it is diluted 0.9% SODIUM CHLORIDE INTRAVENOUS SOLUTION BP

IntrathecalsFor Intrathecal Use Only

Vinca alkaloids For Intravenous Use Only

Fatal if given by Other Routes

Oral medications Do Not Cut or Crush

Model Procedure 5

Transport of Cytotoxic Drugs Within the Health Service

SAMPLE

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Cytotoxic drug Label requirement Sample

Topical cytotoxic medications e.g. fluorouracil cream

Wear Disposable Gloves Use Spatula to Apply

Vesicants Warning

Do not extravate

Requiring refrigerationRefrigerate Do not freeze

ContainersCytotoxic 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).

Packaging1. Place sealed luer-lock syringes or infusion containers of prepared cytotoxic solutions into separate plastic bags

(double wrapped) and seal with heat sealer.

2. If drug requires protection from light, 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.

First delivery each day 1. The pharmacist/assistant will check the distribution book for patient’s name, ward and drug(s) ordered.

2. Take appropriate drugs for that date from storage location (refrigerator/room temperature).

3. Cross-check patient’s name and drug with distribution list as:

a. there may be more than one patient with the same name

b. a patient may need different drugs delivered on different days.

4. Check the number of containers required (sometimes two or more infusion containers may be required).

5. The pharmacy assistant will assemble the delivery.

6. The pharmacy assistant will initial the distribution book next to each patient entry whose items are included in the delivery.

7. The pharmacist will then check all items are correct and initial the distribution book for each patient. This check may be waived at the discretion of the pharmacist.

8. Place drugs into cytotoxic transport plastic esky or onto cytotoxic transport trolley. These containers are designed to protect the cytotoxic drugs during delivery and also to contain a spill if it occurs. All personnel involved in the delivery of cytotoxic drugs must be aware of the potential hazards and the care required in handling, as well the procedure to follow in the event of a spill.

Model Procedure 5

Transport of Cytotoxic Drugs Within the Health Service

SAMPLE



9. On arrival in the ward, the pharmacy assistant shall:

a. ask the registered nurse-in-charge (or delegate) to check the chemotherapy being delivered. The nurse shall check that all drugs for each patient are correct and still required. The pharmacy assistant shall return those not required to the pharmacy

b. if drugs are not to be given, return them to the Cytotoxic Production Office and notify the pharmacist

c. check whether there are any ‘Cancelled/Delayed‘ forms to be returned to the pharmacy

d. ensure that the form is attached to drug packaging for return to pharmacy.

Subsequent deliveries The pharmacist/assistant is to complete the documentation and the pharmacy assistant is to proceed as steps 8 and 9 above.

Deliveries on weekends and public holidaysDrugs for administration during the weekend/public holidays are delivered on Friday afternoon. If a new order is written on the weekend, it is prepared and delivered on the appropriate day(s).

DocumentationLogsComplete the Distribution Book.

AppendicesA Cancelled Therapy form.

B Sample – Distribution Book of Cytotoxic Drug Sent to Wards.

References1. SA Health; Guidelines for the Safe Handling of Cytotoxic Drugs and Related Wastes in South Australian Health Services 2012.

2. Pharmaceutical Society of Australia; Australian Formulary and Handbook 21st Edition 2010.

3. ASHP; Guidelines on Handling Hazardous Drugs Am J Health-Syst Pharm 2006, 63.

4. SHPA; Standards of Practice for the Transportation of Cytotoxic Drugs from Pharmacy Departments 2007.

5. Controlled Substances Act 1984.

6. Controlled Substances (Poisons) Regulations 1996.

7. National Drugs and Poisons Schedule Committee, Department of Health and Aging, Australian Government; Standard for the uniform scheduling of medicines and poisons (SUSMP).

8. Australian Council for Safety and Quality in Health Care; Medication Alert No. 2, December 2005.

SAMPLE


Appendix A

Cancelled/Delayed Therapy

Form(Page 1 of 1)


Surname UR Number

Given Name DOB

Address Sex


Attach completed form to cytotoxic drug for return to pharmacy.

Dispose of all partially used or opened cytotoxic drugs or ‘spiked’ bags in cytotoxic waste bins in the ward.

DO NOT RETURN THESE TO PHARMACY

Date: / / Time: am / pm

Name of treatment

The treatment has been: Delayed Cancelled

Reason for delay/cancellation:

The treatment has been rescheduled: Yes No

If yes, date: / / Time: am / pm

Details of the nurse completing the alert



SAMPLE

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Appendix B

Sample – Distribution Book of Cytotoxic Drug Sent to Wards

Month: Year:

Date sent Patient name and U.R. no. Delivered to ward

Drug details Storage location O = office F = fridge

Issued/delivered by (initials)Name Dose

Batch number

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SAMPLE

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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, patients, visitors and the environment.

This procedure applies to staff administering oral cytotoxic drugs for patients in in-patient and out-patient settings.


BSA Body surface area.

ECOG European Cooperative Oncology Group.

PPE Personal Protective Equipment.

General informationAll cytotoxic drugs presented for administration should be marked with a prominent label warning the cytotoxic nature of the drug.

No further manipulation of the oral cytotoxic tablet/capsule will occur in the ward area.

Prior to any cytotoxic drug being administered to the patient, carer/family education should be attended, including prescribed therapy, administration, pre-medications, side effects and management of side effects, contact details for the treating institution, and any other information relevant to patient safety.

Current written information should be provided to the patient/carer. There should also be opportunities made for patients/carers to ask questions.

Emergency equipmentPrior to administration of therapy with cytotoxic drugs, ensure emergency equipment is available, which includes:

> general emergency equipment, including oxygen and suction

> emergency equipment, including medications to manage anaphylaxis

> access to eye wash facility (eye station).

Staff trainingCytotoxic 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.

Contaminated wasteContaminated waste such as PPE, disposable medicine cups, etc, must be place into an approved container for cytotoxic waste.

Model Procedure 6

Administration of Oral Cytotoxic Drugs in the Health Service

SAMPLE

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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.

Pre-treatment assessmentPre-treatment assessment at baseline and prior to each treatment should be done by the registered nursing staff and should include:

> full blood count, renal and liver function tests prior to each treatment cycle (as per approved site treatment protocols), between cycles or recovery phases as recommended. If blood parameters are abnormal, notify medical officer or nurse practitioner

> symptom and side effect review – toxicity grading scale utilised

> allergy and drug reaction history

> performance status – for example, ECOG1 scale when undertaking cancer therapy

> weight, height, body surface area (BSA). Any changes in weight of more than 10% should be referred to a medical officer.

Following education about treatment and procedure, consent to commence treatment must be obtained.

Oral administrationMost oral cytotoxic drugs are available as capsules or enteric coated tablets which present minimal hazard, providing breakage has not occurred. The standard ‘no touch technique’ must be used by personnel administering oral cytotoxic drugs to the patient.

> Patient should be deemed fit for treatment by their medical officer.

> Put on nitrile gloves or double gloves.

> Ensure that the patient can swallow the medication(s) and that there are no risk factors for aspiration.

> Medication should not be broken or crushed. If necessary, this procedure should only be performed in pharmacy using a cytotoxic safety cabinet.

> If tablets/capsules are to be counted using a device (e.g. forceps, triangle), the device should be clearly marked and dedicated for cytotoxic agents only. The device should be thoroughly washed after each use.

> Medication should be stored as directed by pharmacy.

> Anti-emetic drugs, if indicated, 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.

> Staff should wear nitrile gloves or double gloves and use the ‘no touch technique’ when placing cytotoxic medication in a disposable pill container.

> Perform the Time Out Procedure (Appendix A) immediately prior to administration of the drug.

> Ensure that medications are given in accordance with food precautions and interactions refer to treatment protocols.

> Patients should be observed to ensure that they have taken the oral medication. Medication should not be left at the bedside. Assist administration if necessary.

> If the patient experiences emesis immediately after ingestion a further dose must not be administered. Inform the treating physician of the episode for further guidance.

> Written information, including a medication profile, should be provided to the patient and their carer if they are returning home with oral cytotoxics.

> Return unused cytotoxic tablets/capsules to the pharmacy, in an appropriately labeled, sealed container.

Model Procedure 6


SAMPLE

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AppendicesA Time Out Procedure.

B Time Out Checklist.

References1. Oken, MM et al; Toxicity and Response Criteria of the Eastern Cooperative Oncology Group, Am J Clin Oncol 1982, 5:649-655.

2. eviQ (www.eviq.org.au) accessed 12 Nov 2010.


4. Cancer Nurses Society of Australia; 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.

Model Procedure 6


SAMPLE


Appendix A

Time Out ProcedureImmediately before any medication is administered, 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, including BSA check

> volume

> route.

This is to be checked against the medication order, the label on chemotherapy syringe and the patient’s armband.

The Time Out Checklist is located in Appendix B.


SAMPLE


Appendix B

Time Out Procedure Checklist(Page 1 of 1)


Surname UR Number

Given Name DOB

Address Sex


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. This procedure should be undertaken immediately prior to cytotoxic drug administration.

Date: / / Time: am / pm

Tick (✔) the boxes and initial any changes or information not appropriate.

Parameter Yes No Actions

Patient and family education

Consent signed

Doctor’s prescription legible and signed If no, do not proceed.

FBC / EUC / LFTs checked If not within normal limits, refer to medical officer.

Toxicities or changes to patient’s ECOG If yes, refer to medical officer.

Allergies / previous drug interactions If previous reactions noted to these drugs, do not proceed until medical officer has reviewed and given authority to proceed.

Medical authority has been given to proceed If no, do not proceed. M

R __

____

____

____

____

____

____

_ Ti

me

Out

Pro

cedu

re C

heck

list

Pre-medication given if indicated

Cannual / CVC patient with brisk blood return If no, seek advice.

Patient identity confirmed

If no, do not proceed.

Correct treatment

Correct dose including BSA

Correct route

Correct time

The patient has been identified correctly and the treatment is safe to proceed.

Details of the registered nurses undertaking procedure.




SAMPLE

page 135



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.

This procedure would apply to all personnel, but is not limited to, people who are handling, preparing, administering, transporting and managing cytotoxic drugs.




Extravasation Unplanned escape of a liquid from a vessel or tube into surrounding body tissues.

Clothing and personal protective equipment (PPE)1. Immediately remove outer gloves, gown and any contaminated clothing.

2. Place disposable personal protective equipment in the cytotoxic waste container.

3. Contaminated clothing should be bagged separately, machine washed separately and line dried.

4. Remove and dispose of inner gloves into the cytotoxic waste disposal container.

Penetrating injuries, skin and other body contactSkin exposure1. Remove contaminated clothing as above.

2. Wash the affected skin with soap and clean thoroughly with copious amounts of water.

3. Report to supervisor immediately.

4. Seek immediate medical advice and further medical attention as necessary.

Needlestick injuries1. Wash thoroughly as per skin exposure.

2. If the needle stick injury results in the injection of cytotoxic drug, refer to the health service’s extravasation procedure.

3. Do not administer anaesthetic drops or ointments.

4. Refer to the health service’s extravasation procedure where appropriate.



Model Procedure 7

Accidental Exposure to Cytotoxic Drugs and Related Wastes

SAMPLE

page 136



Mucosal exposure, e.g. eyes1. 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.



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.

References1 SHPA; Standards of Practice for the Safe Handling of Cytotoxic Drugs.


Model Procedure 7

Accidental Exposure to Cytotoxic Drugs and Related Wastes

SAMPLE

page 137



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.




PPE 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

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 cabinetAll 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.

Model Procedure 8

Spill Management of Cytotoxic Drugs

SAMPLE

page 138



Small drug spills1. 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:

> Cytotoxic 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.

> Cytotoxic 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.

> Cytotoxic 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

b. enter details into the cytotoxic spills register (Appendix B)

c. ensure that the spill kit is replenished and maintained.

Large drug spills1. 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.

Model Procedure 8


SAMPLE

page 139



Model Procedure 8


Drug spills in a cleanroom but outside a cytotoxic drug safety cabinetTreat as already described with the following additional step:

1. If in a cytotoxic suite – reverse airflow.

2. Alert others in the immediate vicinity that a cytotoxic spill has occurred, isolating the area and informing people to stay clear.

3. Put on personal protective clothing (respirator mask, safety glasses, hairnet, double gloves (second pair over the cuff of the chemo gown), chemo gown and overshoes).

4. Prominently display the “Caution Hazardous Drugs Spill” signs.

5. Contain the spill by placing towelettes around the spill and gently place a chemosorb pad over the spill.

6. Open white and purple waste bags and roll down the tops so items can be placed inside without contaminating their exteriors.

7. Clean the spill – if a powder spill, gently pour water onto chemosorb pad so that it saturates (without flooding) the area. Wait for the water to soak through to the powder.

8. Scoop up broken glass and/or powder slurry using the plastic scoop and scraper and dispose of in a plastic bag.

9. Using towelettes moistened with water, start from the spill’s outside edge to carefully wipe towards the spill’s centre and dispose of in the plastic bag. Use a fresh wipe each time.

10. Dry the area with the remaining towelettes and dispose of in the white bag.

11. Cover the area with strong alkaline cleaning agent and leave for 10 minutes, absorb the solution with fresh towelettes and dispose of in the plastic bag.

12. Rinse the area thoroughly with water, disposing of clean up absorbent towels into the white bag. Dry the area with absorbent towels or other suitable material.

13. If in cytotoxic suite – return air flow to normal.

14. Remove PPE in the following sequence and dispose of in the white bag:

> overshoes

> outer gloves

> chemogown

> safety glasses.

15. Carefully tie the top of the white bag with a cable tie. Do not press down on the bag as broken glass may puncture the bag.

16. Place the plastic bag inside the purple waste bag without touching its exterior then remove the second pair of gloves, mask and hair net, and place them in the purple waste bag.

17. Use the second cable tie to close the purple bag and dispose of the bag in the cytotoxic bin.

18. Wash your hands thoroughly with soap and water.


> complete an incident report

> enter details into the cytotoxic spills register (Appendix B)

> ensure that the spill kit is replenished and maintained.

SAMPLE

page 140



Spills during drug transport, administration and patient care 1. Isolate and secure the area, placing signs around the area where the spill has occurred.

2. The person carrying out the spill clean up MUST be trained in this cytotoxic spill procedure.

3. Access to the cytotoxic spill kit (Appendix A), equipment and PPE should be readily available.

4. The person MUST don the PPE provided for the cytotoxic drug spill clean up.

5. Carefully collect any broken glass, then cover the spill with absorbent. If powder is spilt, carefully place the mat or absorbent pad over the spill and wet the pad or absorbent with water.

6. Carefully collect the absorbent or mat and place in the labelled plastic waste cytotoxic bag.

7. Place the collected waste in the cytotoxic waste bin.

8. Wash/cover the area with a strong alkaline cleaning agent and leave for 10 minutes.

9. Rinse area thoroughly with water, disposing of clean up absorbent towels into the cytotoxic waste bin.

10. Dry the area with absorbent towels or other suitable material.

11. Discard outer gloves into cytotoxic waste bag, discard contaminated PPE and gloves into the cytotoxic waste bag.

12. Don new gloves and seal cytotoxic waste bag.

13. Wash hands thoroughly with soap and water.

14. Remove signs.





Model Procedure 8


SAMPLE

page 141



Spills on carpet1. Access the nearest spill kit (Appendix A).

2. The person MUST don the PPE provided for the cytotoxic drug spill clean up.

3. Absorb as much fluid as possible using absorbent pads.

4. Discard the waste into the cytotoxic waste container.

5. Clean the carpet with a strong alkaline cleaning agent, minimising the seepage into unaffected areas of the carpet. (Note that the carpet may be bleached if sodium hypochlorite solution is used.)

6. If carpet squares are not removable, have the carpet professionally cleaned with a commercial carpet cleaner. Decontamination of the carpet cleaning machines is not considered necessary due to the dilution effect.

7. If carpet squares are removable:

> remove and dispose in the cytotoxic waste container

> replace the carpet squares with new ones.

8. Discard personal protective equipment (gloves, etc) it into a cytotoxic waste container.






2. International Society of Oncology Pharmacy Practitioners (ISOPP); Standards of Practice: Safe Handling of Cytotoxics. J Oncol Pharm Pract 2007, 13 Suppl:1-81.

Model Procedure 8


SAMPLE



Appendix A

Cytotoxic Drug Spill Kits

Item Quantity

1 Safe work procedures for the management of a cytotoxic spill (laminated) 1

2 Cytotoxic spill signs and caution tape 2

3 Personal protective equipment:

> nitrile gloves

> head cover

> gown or coveralls

> bonded polyethylene fibre overshoes

> safety glasses

> full-face chemical splash shield

2

1

1

1

1

1

4 Swabs, absorbent towels, spill pillow, chemical absorbent pads, ‘chemomat’ assorted

5 Disposable scoop 1

6 Plastic waste bags with ‘CYTOTOXIC – HANDLE WITH CARE’ labels affixed 2

7 Bag ties 2

8 Strong alkaline cleaning agent 1 bottle

9 1 L water in bottle 1

SAMPLE

page

143

Safe

Han

dlin

g | C

ytot

oxic

Dru

gs a

nd R

elat

ed W

aste

s G

uide

lines

for

Sou

th A

ustr

alia

n H

ealth

Ser

vice

s 20

12

App

endi

x 7

– M

odel

Pro

cedu

res Appendix B

Cytotoxic Drug Spill Register

Organisation:

Site/area:

Date:

Person compiling register:

Drug nameLocation or process where drug product

was spilt

Notification to SafeWork SA?

Personnel involved

Were any personnel contaminated?

CommentsYes/No/

Not requiredYes/No Action taken

Date for review of register: / /

SAMPLE

page 144



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.

This procedure would apply to all personnel, but is not limited to, people who are handling, preparing, administering, transporting and managing cytotoxic drugs



Cytotoxic waste 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, 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, expired or contaminated stock

> HEPA filters

> contaminated PPE – gloves, disposable gowns and shoe covers, etc

> swabs and materials used to clean and contain spills

> dressings and bandages

> contaminated cleaning equipment (mops, cloths).

Bins and receptacles1. All cytotoxic wastes must be placed in sharps containers and/or and waste bins readily identifiable* with the

telophase cytotoxic symbol.

2. The bins should be identified as ‘Cytotoxic waste – incinerate at 1100ºC’.

3. Purple bin liners should be used

* Either purple bins/containers or yellow medical waste bins with appropriate purple stickers.

Model Procedure 9

Managing Cytotoxic Waste

SAMPLE

page 145



Waste at source (i.e. wards, pharmacy)1. The bags/bins containing the cytotoxic waste shall be removed from the initial collection containers and sealed

before transferring to the contractor supplied, identifiable (see Bins and Receptacles) wheelie bins for collection from a dedicated storage area.

2. Consideration should be given to wrapping glass bottles with liquid waste in bubble wrap and/or absorbent material to avoid breakages.

3. Sharps containers can be placed inside the bins for disposal.

4. 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.

5. 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, whichever is the lesser, and kept in a secured area.

Collection for disposal1. Cytotoxic waste must be collected in purple liners and transferred to readily identifiable bins (see Bins and

Receptacles).

2. Waste should be put out for collection within 7 days of being generated. Cytotoxic wastes shall be held for as long as possible (without exceeding the 7 day limit) to fill the bin.

3. A bin need not be full if the contents of the bin require immediate disposal and the volume cannot be made up. For perishable waste, try to prolong the disposal time (e.g. refrigeration) then transfer to fill a bin for disposal.

4. When bins are placed in public areas they must be locked at all times.

Storage1. All bins used to store cytotoxic waste must be placed in such a manner as to reduce the risk of spill and/or

contamination. Health services should ensure that a cytotoxic waste collection area is:

> a dedicated storage area with adequate lighting and ventilation. This may be situated within the main waste storage area, 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.

2. Cytotoxic waste should be stored in containers, identified as being used for cytotoxic waste, that are capable of being secured. These containers are not to be re-opened on site once they have been secured.

SpillsRefer to Model Procedure – Spill Management.

Model Procedure 9


SAMPLE

page 146



Transporters of cytotoxic waste1. Cytotoxic waste shall be collected and transported only by a person or company with a licence for handling

regulated wastes (cytotoxics). A copy of the licence cover sheet must be supplied by the contractor to the health service before any waste is removed from site.

2. No government or private vehicle is to be used to transport cytotoxic waste generated by the health service.

3. 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, Safety and Welfare Act 1986 and Occupational Health, Safety and Welfare Regulations 2010 (Section 22) specifies that records must be kept for a period of 5 years.


2. Waste Management Associate of Australia (WMAA); Industry Code of Practice for the Management of Clinical and Related Wastes 6th Ed 2010.

3. AS/NZ 3816-1998 Management of clinical and related wastes.

4. HB 202 A management system for clinical and related wastes – guide to application of AS/NZ 3816-1998.

5. The South Australian Environment Protection Act 1970.

6. The South Australian Environment Protection Regulations 2009.

7. The South Australian Environmental Protection (Waste to Resources) Policy 2010.

8. The South Australian Dangerous Substances Act 1979.

9. The South Australian Dangerous Substances (Dangerous Goods) Transport Regulations 2008.

10. Occupational Health, Safety and Welfare Act 1986.

11. Occupational Health, Safety and Welfare Regulations 2010.

12. Australian Code for the Transport of Dangerous Goods by Road and Rail.

Model Procedure 9


SAMPLE

Notes

Notes

For more information

Pharmaceutical Services and Strategy Branch SA Health 11 Hindmarsh Square Adelaide SA 5000

Telephone: 08 8204 1944 www.sahealth.sa.gov.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.gov.au/creative-commons

© Department for Health and Ageing, Government of South Australia. All rights reserved.ISBN: 978-1-74243-233-5 FIS: 10119. March 2012.

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