Cytotoxic medicines: Managing the risks from handling cytotoxic medicines

The risk management process

A hazard is something that can cause harm. A risk is the chance of a hazard causing harm. Harm includes injury, illness and death. Like other industries, handling cytotoxic medicines has a wide range of hazards and risks. The risks must be controlled by duty holders, so far as is reasonably practicable.

A safe and healthy workplace requires an organised approach to finding and controlling hazards and risks. This approach is known as the risk management process.

The risk management process follows a series of steps:

Identify hazards.
Assess the risks those hazards create.
Control risks. Do this by eliminating the risk. If it's not reasonably practicable to eliminate risks, reduce them as far as is reasonably practicable.
Review and revise risk control methods.

The importance of consultation

A successful risk management process involves consultation between employers and employees, as well as any Health and Safety Representatives (HSRs). Consultation is a requirement under Part 4 of the Occupational Health and Safety Act 2004 (OHS Act).

Consultation draws on the experience and knowledge of employees and HSRs. It must, so far as is reasonably practicable, happen at each stage of the risk management process. For example:

When identifying hazards and risks arising from cytotoxic medicines. This includes:
- before changing systems of work that are likely to change the risk of managing cytotoxic medicines
- when a registered medical practitioner has identified adverse health effects through health monitoring
- when following up any adverse incident involving managing cytotoxic medicines
- where risk control measures do not adequately control risks
- on request from an HSR.
When determining which control strategies to apply to eliminate or reduce risks from the handling of cytotoxic medicines.
When reviewing the effectiveness of control measures.
After an incident occurs that is notifiable under Part 5 of the OHS Act (notifiable incident) and involves cytotoxic medicines

Consultation should take place as early as possible:

when planning to introduce new cytotoxic medicines into the workplace
if a Safety Data Sheet (SDS) is updated.

Consulting employees and HSRs at each step of the risk management process encourages everyone to:

identify hazards and risks associated with the storage and handling of cytotoxic medicines
put in place effective control measures.

Ways to consult with employees include:

direct discussion
staff meetings
health and safety committee meetings
health and safety inspections
special working parties
any combination of the above.

You must make relevant and accurate safety information available to employees and their HSRs. This may include:

the SDS
any other information relevant to the storage and handling of cytotoxic medicines and their waste.

HSRs need to be given time to:

meet with employees
meaningfully consider options
propose ideas to employers.

It is important to consider the needs of employees and HSRs from non-English-speaking backgrounds. As an employer, you have a duty to provide information, instruction and training to employees in a language they can understand. This is so they can do their work safely and without risks to their health.

The steps of the risk management process

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1

Identify hazards

The following example shows how to identify cytotoxic medicines in the workplace.

Identify which cytotoxic medicines are used and stored in the workplace

Action	Method
Ways to identify a cytotoxic medicine: Obtain a copy of the manufacturer's or importing supplier's SDS. See the manufacturer's label. Contact the manufacturer or importing supplier.	Review the SDS or product information, looking for key information linking it to a cytotoxic medicine. Look for terms including mutagenic, teratogenic, genotoxic and carcinogenic. Check the labelling on the container, looking for the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) health hazard pictogram or purple cytotoxic symbol. Contact the manufacturer or importing supplier to check if the substance is cytotoxic.
Ensure all containers of cytotoxic medicines are labelled with the manufacturer or importing supplier label. Labelling of cytotoxic medicines	Check all containers for labels. If it is necessary to decant the cytotoxic medicine into another container(s), clearly label these containers with the name of the product and state that the contents are cytotoxic. Decanted containers should be labelled with the symbol in Figure 1 or Figure 2. Labelling of cytotoxic medicines
Set up or have access to a hazardous substances register. This must list all the hazardous substances supplied to the workplace, so it should include all cytotoxic medicines in the workplace. Maintain the register so it is up to date.	List the product names of all cytotoxic medicines used at the workplace in the hazardous substances register. Make sure there is information from the manufacturer on safe handling such as an SDS for each cytotoxic medicine used at the workplace. If information for safe handling such as an SDS is not available, contact the manufacturer or importing supplier for the most recent version.

Action

Method

Ways to identify a cytotoxic medicine:

Obtain a copy of the manufacturer's or importing supplier's SDS.
See the manufacturer's label.
Contact the manufacturer or importing supplier.

Review the SDS or product information, looking for key information linking it to a cytotoxic medicine. Look for terms including mutagenic, teratogenic, genotoxic and carcinogenic.
Check the labelling on the container, looking for the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) health hazard pictogram or purple cytotoxic symbol.
Contact the manufacturer or importing supplier to check if the substance is cytotoxic.

Ensure all containers of cytotoxic medicines are labelled with the manufacturer or importing supplier label.
Labelling of cytotoxic medicines

Check all containers for labels.
If it is necessary to decant the cytotoxic medicine into another container(s), clearly label these containers with the name of the product and state that the contents are cytotoxic. Decanted containers should be labelled with the symbol in Figure 1 or Figure 2.
Labelling of cytotoxic medicines

Set up or have access to a hazardous substances register. This must list all the hazardous substances supplied to the workplace, so it should include all cytotoxic medicines in the workplace. Maintain the register so it is up to date.

List the product names of all cytotoxic medicines used at the workplace in the hazardous substances register.
Make sure there is information from the manufacturer on safe handling such as an SDS for each cytotoxic medicine used at the workplace.
If information for safe handling such as an SDS is not available, contact the manufacturer or importing supplier for the most recent version.

2

Assess risks

This stage determines whether there is a risk to employees' health from cytotoxic medicines. The following step-by-step procedure may help employers with the risk assessment process.

1. Decide who will carry out the risk assessment

Action	Method
Select a competent person or team made up of: employees HSRs supervisors and managers. Seek expert external advice if required – for example, from an occupational hygienist or a medical practitioner.	Look for: appropriate skills, knowledge and experience to evaluate the risks a practical understanding of work being undertaken at the workplace an understanding of health and safety legislation the ability to deal with the complexity of the assessment process or the work being assessed.

Action

Method

Select a competent person or team made up of:

employees
HSRs
supervisors and managers.

Seek expert external advice if required – for example, from an occupational hygienist or a medical practitioner.

Look for:

appropriate skills, knowledge and experience to evaluate the risks
a practical understanding of work being undertaken at the workplace
an understanding of health and safety legislation
the ability to deal with the complexity of the assessment process or the work being assessed.

2. Obtain and review information about cytotoxic medicines used at the workplace

Action	Outcome
Identify the routes of exposure (the SDS may help with this).	Depending on the medicine/s in the workplace, routes may include: inhalation of aerosols, particulates and droplets skin or eye contact ingestion after incidental contact – for example, with contaminated body fluids, contaminated surfaces or dressings accidental injection due to injuries from sharps accidents or breakages.
Determine the form of the substance (the SDS may help with this).	This may include: liquid powder solid tablet, including coated tablets creams, ointments and lotions for topical application.
Find out the potential harmful effects (refer to the SDS).	These may include: carcinogenic, mutagenic, genotoxic or teratogenic effects alterations to normal blood cell count foetal loss, congenital malformations abdominal pain, hair loss, nasal sores, vomiting liver damage contact dermatitis, local toxic or allergic reaction, irritation to the skin.
Find out the properties and hazards associated with the substance (refer to the SDS or other available information for each medicine).	This may include: health hazard information first-aid information precautions for use safe handling information.

3. Evaluate the nature of the work involving cytotoxic medicines

Action	Method
Determine where cytotoxic medicines are handled at the workplace.	For example: receiving medicines to the pharmacy store preparing medication in the pharmacy administering medication in the ward, daycare centre or home handling, transporting and disposing of cytotoxic medicines and waste on the premises patient care after administration.
Examine work practices and conditions. Involve employees and HSRs who are working with the cytotoxic medicines.	Look for: how cytotoxic medicines are handled in specific tasks, such as during preparation and administration the quantities used and doses given frequency and duration of exposure who may be exposed level of potential exposure risk control measures already in place and their effectiveness handling and disposal of biological waste.
Review information about near misses, incidents or symptoms of exposure.	Review incident records. Identify any problems associated with storage and transport of cytotoxic medicines. Determine whether employees have suffered any harm. Find out if there have been any spills. Determine whether incidents have been reported and followed up.

Action

Method

Determine where cytotoxic medicines are handled at the workplace.

For example:

receiving medicines to the pharmacy store
preparing medication in the pharmacy
administering medication in the ward, daycare centre or home
handling, transporting and disposing of cytotoxic medicines and waste on the premises
patient care after administration.

Examine work practices and conditions.

Involve employees and HSRs who are working with the cytotoxic medicines.

Look for:

how cytotoxic medicines are handled in specific tasks, such as during preparation and administration
the quantities used and doses given
frequency and duration of exposure
who may be exposed
level of potential exposure
risk control measures already in place and their effectiveness
handling and disposal of biological waste.

Review information about near misses, incidents or symptoms of exposure.

Review incident records.
Identify any problems associated with storage and transport of cytotoxic medicines.
Determine whether employees have suffered any harm.
Find out if there have been any spills.
Determine whether incidents have been reported and followed up.

4. Evaluate the risks

Conclusion
Reduced or minimal likelihood of injury or illness This means that employers have a high degree of confidence that existing work practices are sound and employees are protected.	It may be reasonable to reach this conclusion where risks have been eliminated or reduced by using all reasonably practicable controls, such as: medication packaging with in-built breakage prevention systems compounding cytotoxic medicines in an enclosed area, such as an operational cleanroom with a laminar-flow cytotoxic drug safety cabinet (CDSC) needle-less drug administration systems or retractable needles use of a closed system drug transport system for administration evidence-based clinical practice guidelines and procedures employee training and competency Closed System Transfer Devices (CSTDs) for preparation and administration.
Likelihood of injury or illness This means work practices need improvement.	It may be reasonable to reach this conclusion where, for example: medication is not prepared in an operational cleanroom with a laminar-flow CDSC where appropriate medication is not administered using needle-less systems where appropriate housekeeping is poor there is no spill management system personal protective equipment (PPE) such as gloves and skin covering is not worn during activities that could involve skin contact the workforce has not received appropriate training control measures are not maintained or serviced.
Likelihood of injury or illness is uncertain This means employers are not sure if: the substances are cytotoxic work practices are adequate to protect employees.	It may be reasonable to reach this conclusion where employers are not sure if there is a risk to health from cytotoxic medicines in the workplace. Employers may need to do more work, for example: Engaging a suitably competent person such as an occupational hygienist to do a workplace assessment. This may include atmospheric monitoring or wipe testing. Reviewing and revising when they receive new information on hazards, risks and controls.

Conclusion

Reduced or minimal likelihood of injury or illness

This means that employers have a high degree of confidence that existing work practices are sound and employees are protected.

It may be reasonable to reach this conclusion where risks have been eliminated or reduced by using all reasonably practicable controls, such as:

medication packaging with in-built breakage prevention systems
compounding cytotoxic medicines in an enclosed area, such as an operational cleanroom with a laminar-flow cytotoxic drug safety cabinet (CDSC)
needle-less drug administration systems or retractable needles
use of a closed system drug transport system for administration
evidence-based clinical practice guidelines and procedures
employee training and competency
Closed System Transfer Devices (CSTDs) for preparation and administration.

Likelihood of injury or illness

This means work practices need improvement.

It may be reasonable to reach this conclusion where, for example:

medication is not prepared in an operational cleanroom with a laminar-flow CDSC where appropriate
medication is not administered using needle-less systems where appropriate
housekeeping is poor
there is no spill management system
personal protective equipment (PPE) such as gloves and skin covering is not worn during activities that could involve skin contact
the workforce has not received appropriate training
control measures are not maintained or serviced.

Likelihood of injury or illness is uncertain

This means employers are not sure if:

the substances are cytotoxic
work practices are adequate to protect employees.

It may be reasonable to reach this conclusion where employers are not sure if there is a risk to health from cytotoxic medicines in the workplace. Employers may need to do more work, for example:

Engaging a suitably competent person such as an occupational hygienist to do a workplace assessment. This may include atmospheric monitoring or wipe testing.
Reviewing and revising when they receive new information on hazards, risks and controls.

3

Control risks

Risks must be eliminated, so far as is reasonably practicable. If risks cannot be eliminated, they must be reduced so far as is reasonably practicable.

Controlling risks requires the use of risk control measures. Risk control measures are also known as risk controls or controls. Deciding on appropriate risk controls involves the following:

Identifying the options for risk controls. A risk control option may be a single control or it may be made up of multiple controls. Together, the controls provide protection against a risk.
Considering risk control options and selecting suitable options. A suitable option is one that most effectively eliminates or reduces risk in the circumstances. Reducing the risk might require multiple risk controls, not just one.
Implementing all controls that are reasonably practicable. For example, using both:
- a CDSC where drugs are prepared
- needle-less drug administration.
The ways of controlling risks can be ranked from the highest level of protection and reliability to the lowest. This ranking is known as the hierarchy of risk control. The following guidance explains the hierarchy of risk control. Always start at the most effective control – Level 1, eliminate the hazard – and work down the hierarchy.

Hierarchy of control for cytotoxic medicines

This is an example of a hierarchy of control that may help employers control risks from cytotoxic medicines in the workplace. You may not be able to eliminate the use of cytotoxic medicines, but redesigning processes may eliminate risk for some employees.

Level 1: Eliminate the risk

Control	Examples
Eliminate the risk – most effective	It is rarely possible to eliminate the need for cytotoxic medicines for treatment. A first-level risk control measure may be to identify an alternative supply for cytotoxic drugs, including: Buying cytotoxic medicines in ready-to-administer (RTA) preparations. This eliminates the risk for those who prepare medicines (like pharmacy employees). Establishing supply arrangements with a company or healthcare institution that specialises in preparing cytotoxic medicines.

Control

Examples

Eliminate the risk – most effective

It is rarely possible to eliminate the need for cytotoxic medicines for treatment.

A first-level risk control measure may be to identify an alternative supply for cytotoxic drugs, including:

Buying cytotoxic medicines in ready-to-administer (RTA) preparations. This eliminates the risk for those who prepare medicines (like pharmacy employees).
Establishing supply arrangements with a company or healthcare institution that specialises in preparing cytotoxic medicines.

Level 2: Reduce the risk

Control	Examples
Substitution Substitution involves using a less hazardous substance or a substance in a less hazardous form.	It is rarely possible to provide alternative treatments where cytotoxic drugs are required.
Isolation Isolation involves separating people from the substance by distance or barriers to prevent or reduce exposure.	Using the following control measures together: adopting closed-system transfer devices isolating employees from cytotoxic medicines in a fit-for-purpose secure cleanroom, with a suitable drug preparation cabinet such as a CDSC placing dispensed medication in impermeable packaging for delivery to administration areas using the back-priming technique to administer intravenous preparations.
Engineering controls Engineering controls are physical controls or processes that: reduce the generation of substances suppress or contain substances limit the area of contamination in the event of spills and leaks	Prepare cytotoxic medicines in a purpose-designed clean room that comprises: A primary barrier to provide drug containment and aseptic handling. For example, a CDSC with high efficiency particulate air (HEPA) filters. A secondary barrier to prevent contamination of the outside environment. This should supply HEPA-filtered air to the cleanroom that is at a lower pressure than air outside the cleanroom. Use: wide-bore needles to transfer, reconstitute and draw up cytotoxic medicines CSTDs needle-less injection sets for drug administration Incorporate secure storage facilities.

Control

Examples

Substitution
Substitution involves using a less hazardous substance or a substance in a less hazardous form.

It is rarely possible to provide alternative treatments where cytotoxic drugs are required.

Isolation
Isolation involves separating people from the substance by distance or barriers to prevent or reduce exposure.

Using the following control measures together:

adopting closed-system transfer devices
isolating employees from cytotoxic medicines in a fit-for-purpose secure cleanroom, with a suitable drug preparation cabinet such as a CDSC
placing dispensed medication in impermeable packaging for delivery to administration areas
using the back-priming technique to administer intravenous preparations.

Engineering controls
Engineering controls are physical controls or processes that:

reduce the generation of substances
suppress or contain substances
limit the area of contamination in the event of spills and leaks

Prepare cytotoxic medicines in a purpose-designed clean room that comprises:

A primary barrier to provide drug containment and aseptic handling. For example, a CDSC with high efficiency particulate air (HEPA) filters.
A secondary barrier to prevent contamination of the outside environment. This should supply HEPA-filtered air to the cleanroom that is at a lower pressure than air outside the cleanroom.

Use:

wide-bore needles to transfer, reconstitute and draw up cytotoxic medicines
CSTDs
needle-less injection sets for drug administration

Incorporate secure storage facilities.

Level 3: Use administrative controls

Control	Examples
Administrative controls There may still be a risk even after higher levels of control have been used. Administrative controls such as systems of work and work procedures may further reduce the risk. Administrative controls are ways of working that reduce employee exposure to cytotoxic medicines and related waste. For administrative controls to be effective, employees need to fully cooperate. It is important to consult as controls are developed. Adequate supervision and training are crucial for these new work practices.	Allocate responsibilities for health and safety. This may be an area manager or delegated to an employee. Reallocate jobs for specific risk groups (such as pregnant employees) based on risk assessment. Keep containers of cytotoxic medicines secure when not in use. Use cytotoxic signs and labels to clearly identify all cytotoxic medicines and waste. Store cytotoxic waste in specific, clearly identified areas, separate from other waste. Develop and use standard work procedures for all activities. Set cleaning schedules and clean work areas regularly. Develop emergency procedures to deal with spills. Ban eating and drinking in work areas. Ban wearing of jewelry and cosmetics in preparation areas.

Control

Examples

Administrative controls
There may still be a risk even after higher levels of control have been used. Administrative controls such as systems of work and work procedures may further reduce the risk.

Administrative controls are ways of working that reduce employee exposure to cytotoxic medicines and related waste.

For administrative controls to be effective, employees need to fully cooperate. It is important to consult as controls are developed. Adequate supervision and training are crucial for these new work practices.

Allocate responsibilities for health and safety. This may be an area manager or delegated to an employee.
Reallocate jobs for specific risk groups (such as pregnant employees) based on risk assessment.
Keep containers of cytotoxic medicines secure when not in use.
Use cytotoxic signs and labels to clearly identify all cytotoxic medicines and waste.
Store cytotoxic waste in specific, clearly identified areas, separate from other waste.
Develop and use standard work procedures for all activities.
Set cleaning schedules and clean work areas regularly.
Develop emergency procedures to deal with spills.
Ban eating and drinking in work areas.
Ban wearing of jewelry and cosmetics in preparation areas.

Level 4: Use PPE

Control	Examples
Personal Protective Equipment PPE is something worn that provides a barrier between the person and the hazard. It is one of the controls required for employees who handle cytotoxic medicines or waste. Employers must ensure that all employees know how to fit and use PPE. Look for guidance from: suppliers of cytotoxic medicines suppliers of PPE published technical standards Make sure PPE is: properly selected for the individual and task readily available clean and functional correctly used when needed maintained by appropriately trained employees, in keeping with relevant standards Personal protective equipment for handling cytotoxic medicines	PPE needs to meet approved standards for use with cytotoxic medicines. For example, American Society for Testing and Materials International (ASTM) standards. PPE can include: coveralls gowns head coverings closed footwear overshoes nitrile gloves safety glasses respiratory protective equipment (for example, P2/N95)

Control

Examples

Personal Protective Equipment
PPE is something worn that provides a barrier between the person and the hazard. It is one of the controls required for employees who handle cytotoxic medicines or waste.

Employers must ensure that all employees know how to fit and use PPE. Look for guidance from:

suppliers of cytotoxic medicines
suppliers of PPE
published technical standards

Make sure PPE is:

properly selected for the individual and task
readily available
clean and functional
correctly used when needed
maintained by appropriately trained employees, in keeping with relevant standards

Personal protective equipment for handling cytotoxic medicines

PPE needs to meet approved standards for use with cytotoxic medicines. For example, American Society for Testing and Materials International (ASTM) standards.

PPE can include:

coveralls
gowns
head coverings
closed footwear
overshoes
nitrile gloves
safety glasses
respiratory protective equipment (for example, P2/N95)

4

Review and revise risk controls

Action	Example
Look at how control measures are working in practice, to ensure they perform as intended and continue to provide adequate control.	Reviewing control measures may include: frequent inspections visual checks to ensure controls are being properly applied in the workplace testing equipment preventative maintenance remedial work consulting with employees and HSRs monitoring where relevant standards exist; for example, using commercially available wipe-testing kits to check surfaces for cytotoxic medicines.

Risk assessment template for cytotoxic medicines

This risk assessment template will help employers to document the process and any outcomes. You should consider processes or cytotoxic medicines that may need individual assessments.

Managing the risks from handling cytotoxic medicines

The risk management process

The importance of consultation

Communicating across languages

Consultation

The steps of the risk management process

Identify hazards

Identify which cytotoxic medicines are used and stored in the workplace

Assess risks

1. Decide who will carry out the risk assessment

2. Obtain and review information about cytotoxic medicines used at the workplace

3. Evaluate the nature of the work involving cytotoxic medicines

4. Evaluate the risks

Control risks

Hierarchy of control for cytotoxic medicines

Level 1: Eliminate the risk

Level 2: Reduce the risk

Level 3: Use administrative controls

Level 4: Use PPE

Review and revise risk controls

Review control measures

Risk assessment template for cytotoxic medicines

Risk assessment template for cytotoxic medicines (PDF)

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