Legal requirements for managing cytotoxic medicines

Occupational health and safety laws

Under the Occupational Health and Safety Act 2004 (OHS Act), employers have a duty to provide and maintain a working environment that is safe and without risks to health. This includes protecting the health and safety of people who manage cytotoxic medicines, such as:

• employees
• independent contractors
• employees of independent contractors. This may include manufacturers and suppliers who have agreements to provide services related to cytotoxic medicines

Employers must do this so far as is reasonably practicable.

Employer obligations under the OHS Act extend to protecting the health and safety of people affected by the administration of cytotoxic medicines. This applies so far as is reasonably practicable and may include:

• patients
• family members or other care-givers
• animal owners

Under the OHS Act, manufacturers must provide information on the safe handling of all substances that are supplied to a workplace. This includes cytotoxic medicines. All employees who work with cytotoxic medicines have a right to receive information on safe handling of specific medicines on request.

The Occupational Health and Safety Regulations 2017 are another set of laws. Known as the OHS Regulations, they build on the OHS Act. They set out how to fulfil duties and obligations and processes that support the OHS Act.

Cytotoxic medicines as hazardous substances

Most cytotoxic medicines:

• are classified as hazardous by Part 3 (Health Hazards) of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS)
• fall under the definition of 'hazardous substances' in the OHS Regulations

The medicines are regulated by Part 4.1 (Hazardous Substances) of the OHS Regulations where:

• this definition of 'hazardous substances' applies
• their use is related to a work activity and does not otherwise fall within an exception to Part 4.1

This is distinct from the personal use of a cytotoxic medicine by a patient at home without the aid of a carer or nurse.

The aim of Part 4.1 is to create safe working environments for employees who handle hazardous substances that can harm their health.

All manufacturers and importing suppliers who supply hazardous substances to workplaces must:

• Determine if a substance meets the definition of a hazardous substance before it is first supplied to a workplace.
• Prepare and provide a Safety Data Sheet (SDS) for hazardous substances.
• Update the SDS:
  • at least every five years
  • when there is any new information for the product
  • when the product changes
• Correctly label any container containing a hazardous substance before it is supplied to the workplace.

Employers must:

• Obtain an SDS for each hazardous substance supplied for use in the workplace.
• Prepare a register of hazardous substances.
• Be able to identify hazards associated with the hazardous substances. For example, by looking at the SDS.
• Ensure hazardous substances are appropriately labelled.

WorkSafe's Compliance code: Hazardous substances gives practical guidance for duty holders on how to comply with the OHS Regulations.

Cytotoxic medicines as dangerous goods

Some cytotoxic medicines are classified as dangerous goods. For example, cyclophosphamide monohydrate. Where these medicines are managed, the following legislation applies:

• Dangerous Goods Act 1985
• Dangerous Goods (Storage and Handling) Regulations 2022

Other relevant sources

See Information sources for references to other information on managing cytotoxic medicines and related waste. This includes a comprehensive list of:

• relevant standards
• codes
• guidance notes
• websites

Find more information about employer and employee duties on the WorkSafe website. You can also call the WorkSafe Advisory Service on 1800 136 089.

Health monitoring

Health monitoring checks for changes in the health of an employee who has been exposed to hazardous substances in the workplace. It can let the employer know if:

• control measures are not effective
• someone's health is being affected by exposure to hazardous substances

Health monitoring is not a substitute for effective control measures.

When health monitoring is required

Under section 22(1)(a) of the OHS Act, employers must monitor the health of employees so far as is reasonably practicable. It is the employer's obligation to determine if health monitoring is required. The OHS Regulations require an employer to provide health monitoring for employees when:

• they are exposed to any hazardous substance listed in Schedule 9 of the OHS Regulations
• it is reasonably likely that an employee's health will be adversely affected by the exposure under the conditions of work at the workplace

For cytotoxic medicines, this means that health monitoring may need to be provided where:

• an employee is exposed to cytotoxic medicines
• this exposure is reasonably likely to have an adverse effect on their health

Situations where the employer may be required to provide health monitoring include:

• Symptoms have been reported that are likely to be related to exposure to cytotoxic medicines.
• Incidents (such as spillages) have occurred, and employees have not been protected from exposure to cytotoxic medicines by adequate control measures.

• Where an employee is preparing cytotoxic medicines and the risk to health is primarily controlled by lower level control measures. For example, the use of PPE or administrative controls.

  See 'Hierarchy of control for cytotoxic medicines' in Managing the risks from handling cytotoxic medicines for more information.

Employers should consult with a medical practitioner to see if a health monitoring program is needed in their workplace. The practitioner should be qualified and experienced in occupational medicine. This should consider:

• the cytotoxic medicines being used
• the method of use
• the routes of exposure
• current controls
• any employee health and safety concerns
• the scope of any health monitoring program

A risk assessment will help to identify employees who may require a health monitoring program. This should consider:

• if they routinely manage cytotoxic medicines as part of their job
• the conditions in which they manage the cytotoxic medicines

Considerations of a health monitoring program

To develop a health monitoring program, employers need to consult with:

• the medical practitioner
• employees
• any HSRs

Where health monitoring is required, employers need to ensure that:

• It is carried out under the supervision of a registered medical practitioner who is appropriately trained in occupational medicine.
• Acceptable arrangements are made for employees to participate. For example, employees should not have to travel long distances.
• The registered medical practitioner prepares a report. Copies are given to the employer and relevant employee.
• Employees are aware that monitoring reports are kept confidential.

Employers may also consider:

• giving prospective employees information about the risks of working with cytotoxic medicines and the process of health monitoring
• doing pre-employment or baseline health monitoring, where applicable
• establishing appropriate governance and file storage systems
• developing internal procedures

The medical practitioner should inform any employer review of risk controls to ensure they remain effective. Recommendations from the medical practitioner should be applied. Employers must consult any HSRs in this process.

Biological monitoring

Biological monitoring is a way to identify a person’s exposure to a chemical:

• The exposed person produces a biological sample. For example, urine, blood or breath.
• The sample is measured for the chemical or its breakdown products.

There is currently no internationally recognised form of biological monitoring or health assessment technique to predict the effect of exposure to cytotoxic medicines. Research is continuing in this area.

Employers should be aware of and apply developments for monitoring the health of employees who manage cytotoxic medicines. Safe Work Australia's guidance may help when considering the benefits and inclusions of a health monitoring program:

• Health monitoring for registered medical practitioners guide
• Health monitoring when you work with hazardous chemicals
• Health monitoring: Guide for cyclophosphamide.