Managing the risks from handling cytotoxic medicines
Guidance on how to find and control hazards and risks when handling cytotoxic medicines in the workplace.
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 a health and safety representative.
- 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
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. See: 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. See: 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.
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.
- 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.
- 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.
- 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.
- 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 are 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.
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
- needleless 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.
Employers must review risk controls to make sure they are working as planned:
- Before changing any system of work in a way that could alter the risk associated with the handling of cytotoxic medicine. This could be, for example, when introducing a new cytotoxic medicine.
- If a registered medical practitioner advises that health monitoring has identified adverse health effects.
- If the risk control measures do not adequately control the risks. For example, employees are unable to identify patients who require cytotoxic precautions.
- After a notifiable incident involving cytotoxic medicines at the workplace.
- After receiving a request for review from an HSR. An HSR can make a request if they believe, on reasonable grounds, that:
- any of the circumstances listed above exist
- the employer has failed to properly review the risk controls
- in conducting a review of, or revising, the risk controls, the employer has failed to consider any of the circumstances listed above. For example, the employer has failed to consider a change to a work system that may lead to an increase in risks.
It is also good practice to review risk controls periodically.
Employers can review the effectiveness of risk controls by, for example:
- conducting regular safety inspections
- asking for feedback from employees who use the risk controls.
Review control measures
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.
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:
|
Level 2: Reduce the risk | |
Control | Examples |
Substitution Substitution involves using a less hazardous substance or a substance in a less hazardous form. |
|
Isolation Isolation involves separating people from the substance by distance or barriers to prevent or reduce exposure. | Using the following control measures together:
|
Engineering controls Engineering controls are physical controls or processes that:
| Prepare cytotoxic medicines in a purpose-designed clean room that comprises:
Use:
Incorporate secure storage facilities. |
Level 3: Use administrative controls | |
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. |
|
Level 4: Use PPE | |
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:
Make sure PPE is:
See: Personal protective equipment for handling cytotoxic medicines for more information. | 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:
|
Step 4: Review and revise risk controls
Employers must review risk controls to make sure they are working as planned:
- Before changing any system of work in a way that could alter the risk associated with the handling of cytotoxic medicine. This could be, for example, when introducing a new cytotoxic medicine.
- If a registered medical practitioner advises that health monitoring has identified adverse health effects.
- If the risk control measures do not adequately control the risks. For example, employees are unable to identify patients who require cytotoxic precautions.
- After a notifiable incident involving cytotoxic medicines at the workplace.
- After receiving a request for review from an HSR. An HSR can make a request if they believe, on reasonable grounds, that:
- any of the circumstances listed above exist
- the employer has failed to properly review the risk controls
- in conducting a review of, or revising, the risk controls, the employer has failed to consider any of the circumstances listed above. For example, the employer has failed to consider a change to a work system that may lead to an increase in risks.
It is also good practice to review risk controls periodically.
Employers can review the effectiveness of risk controls by, for example:
- conducting regular safety inspections
- asking for feedback from employees who use the risk controls.
Review control measures | |
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:
|
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.
Describe the process: |
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Cytotoxic medicine(s) used: | Person performing assessment:
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Date: | |||||
Possible health effects | Routes of exposure | Current control measures | Are extra control measures needed? If yes, state what and the reason | Actions, including consultation | |
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Related pages
This information is from WorkSafe's Handling cytotoxic medicines in the workplace guidance. The complete guide is available in two formats.