Exposure to cytotoxic medicines and associated contaminated waste

Background

WorkSafe is aware of incidents where employees were required to undertake tasks involving cytotoxic medicines, such as administering chemotherapy medicines, or performing procedures that exposed them to associated cytotoxic contaminated waste 

The tasks required employees to wear sterile gloves as part of personal protective equipment (PPE).

Technical information provided about the gloves did not include information about whether they were manufactured and appropriate for use with tasks involving materials such as: 

• cytotoxic medicines
• body fluids contaminated with cytotoxic medicines, 
• other contaminated waste products, such as intravenous lines used during administration.

For the purposes of this safety alert, these materials are collectively referred to as ‘cytotoxic medicines and associated contaminated waste’.

Employees may have been unknowingly exposed to cytotoxic medicines and associated contaminated waste through skin absorption. 

Cytotoxic medicines and associated contaminated waste are hazardous substances and present a risk to employees who may be exposed during patient care, cleaning, waste handling, transport or other work activities. They are commonly found in hospitals (including where treatments are being administered in a patient’s home), pharmacies, laboratories, aged care facilities, ambulance and pathology.

Cytotoxic medicines and associated contaminated waste are known to have adverse health effects, which can include reproductive abnormalities, genetic changes or cancer.

Safety issues

Key Hazards identified 

Potential exposure to cytotoxic medicines and associated contaminated waste material through skin absorption from inappropriate glove selection and use.

Recommended ways to control risks

• Conduct risk assessments in consultation with employees and health and safety representatives (HSRs) to:
  • identify where cytotoxic medicines and associated contaminated waste products are kept and used; and
  • identify employees that may be exposed. 
• Consider all tasks undertaken by employees that may involve exposure to cytotoxic medicines and associated waste, including dispensing, administration, care provision, environmental services and waste handling. 
• As part of your risk assessment, consider the hierarchy of control and where reasonably practicable, eliminate or reduce exposure through higher order controls (for example: closed system transfer device). PPE is a low-order control and in most circumstances, is not a sufficient risk control when used alone. Often more than one risk control is required to be used in conjunction with other controls. 
• If, after considering the hierarchy of controls it is determined that gloves are necessary for PPE, duty holders should consider whether the selected gloves are fit for purpose and manufactured for use involving cytotoxic substances. To do this, duty holders should consider manufacturer recommendations, and other factors such as relevant standards (example: ATSM D6978-05:2023), glove breakthrough times and the need for double gloving. 
• Use appropriate signage, labelling or product information, including safety data sheets (SDS) to alert employees to the risk of cytotoxic medicines and associated contaminated waste. 
• Provide information, instruction and training to employees on cytotoxic medicines and associated contaminated waste, health impacts and risk controls including PPE and the appropriate type of gloves to be used. This includes safety data sheets being available at point of use.
• Consult with workers and HSRs on where cytotoxic medicines and associated contaminated waste products may be found. This should consider all lifecycle stages including procurement, locations, use and disposal. Consult with manufactures or suppliers of products where appropriate.

Legal Duties 

Under the Occupational Health and Safety Act 2004 (OHS Act), employers have duties to ensure health and safety, which they must fulfil so far as is reasonably practicable. These duties include:

• Providing and maintaining a work environment that is safe and without risks to health

Ensuring persons other than employees are not exposed to risks to their health and safety arising from the conduct of the employer’s undertaking; and

Providing employees and independent contractors with the necessary information, instruction, training, or supervision to enable them to do their work in a way that is safe and without risks to health.

Employers also have a duty to consult with employees and any HSRs when:

• identifying or assessing hazards or risks at the workplace
• asking decisions about risk control measures at the workplace 
• proposing changes to the workplace, plant or work processes that may affect the health and safety of employees.

Most cytotoxic medicines and associated contaminated waste fall under the definition of ‘hazardous substances’ in the Occupational Health and Safety Regulations 2017 (OHS Regulations). This means that they are regulated by Part 4.1 (Hazardous Substances) where their use is related to a work activity and does not fall within an exemption. 

Under the OHS Regulations, employers must: 

• obtain an SDS for each hazardous substance supplied for use in the workplace
• prepare and maintain a register of hazardous substances
• identify hazards and assess and control risks associated with hazardous substances used at the workplace; and
• ensure hazardous substances are appropriately labeled.

Employers may also be required to provide health monitoring for employees where an employee is exposed to cytotoxic medicines and associated contaminated waste and where this exposure is reasonably likely to have an adverse health effect.

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