Introduction to cytotoxic medicines

Managing cytotoxic medicines

In this guidance, 'managing' cytotoxic medicines includes:

• handling
• preparing
• transporting
• administering
• storing
• disposing of related waste
• managing spills

WorkSafe recommends that cytotoxic medicines are managed as hazardous substances. To determine any exceptions to this, employers must always refer to the:

• product information including the relevant Safety Data Sheet (SDS)
• Globally Harmonized System of Classification and Labelling of Chemicals (GHS)

What are cytotoxic medicines?

Cytotoxic medicines contain chemicals that can damage or kill cells, mainly through how they affect cell reproduction.

Once inside the body, they are known to be highly toxic to non-target cells. Their effect is:

• greatest on cells that reproduce/divide most rapidly
• dose-specific.

This is why cytotoxic medicines are commonly used to treat cancer.

Many cytotoxic medicines are:

• carcinogenic, which means they can cause cancer
• mutagenic, which means they can cause mutations to DNA that may be transmitted to future generations
• teratogenic, which means they can cause birth defects and fetal malformation, or halt a pregnancy
• genotoxic, which means they can damage the genetic material of a cell.

In lower doses, cytotoxic medicines are also used to treat other medical conditions such as:

• rheumatoid arthritis
• ectopic pregnancies
• multiple sclerosis
• auto-immune disorders.

This guidance does not cover all types of cancer treatments as not all are cytotoxic. For example, the Bacillus of Calmette and Guerin Strain of Mycobacterium bovis (BCG). To ensure safe handling, it is best practice to:

• check the SDS
• do a risk assessment.

The toxicity of cytotoxic medicines means they can present significant risk to those who manage them. This includes from:

• handling any waste, such as the bodily substances of a patient who has received cytotoxic medicine
• touching equipment used to prepare or administer the cytotoxic medicine.

Exposure to cytotoxic medicines

Exposure to cytotoxic medicines may occur in the following settings:

• hospitals
• pharmacies – hospital and community
• analytical or research laboratories
• doctors' surgeries and medical practice rooms
• domiciliary ambulatory clinics
• patient homes
• nursing homes and hostels
• veterinary clinics
• ambulance vehicles and other transport services
• pharmacy and pathology courier services
• waste collection and disposal facilities
• warehousing and distribution
• mortuaries.

After cytotoxic medicine is administered, all the patient's bodily fluids can be contaminated with either:

• the unchanged drug
• active drug metabolites.

The period during which bodily fluids and waste may be contaminated with cytotoxic medicines will differ for individual drugs and patients.

The Cancer Institute NSW (eviQ) recommends cytotoxic precautions are taken with all patients for a standard period of seven days from administration, although care should be taken to identify drugs with extended excretion. The medicine's SDS or product information will confirm if there is an excretion time beyond seven days. If so, there will need to be cytotoxic precautions in place for this extended period.

Workplace exposure to cytotoxic medicines can occur if:

• there are no control measures for preparing, administering, storing and handling the medicines and related waste
• control measures are inadequate
• control measures are not properly followed
• control measures fail
• accidents occur, such as spills or breakages.

Cytotoxic medicines can create a risk to the health of employees through:

• Inhalation: breathing in the substance as aerosols, powder or droplets.
• Ingestion: swallowing contaminated food/drinks or other hand-to-mouth contact.
• Absorption through the skin or eyes from:
  • direct contact, including a cytotoxic spill
  • contaminated surfaces, clothing or handling bodily waste products.
• Injection into the body by contaminated sharp objects or needlestick injury.

Activities that might expose people to cytotoxic medicines can include:

• preparing, administering, transporting or storing medication
• managing spills or contaminated body fluids
• contact with equipment or surfaces where cytotoxic medicines are prepared or administered
• handling biological waste from people treated with cytotoxic medicines – this can include soiled dressings and used continence aids
• contact with contaminated linen
• handling, transporting and disposing of cytotoxic waste.

It is important to consider all people at the workplace who may perform these activities, such as:

• pharmacists and pharmacy technicians
• nurses and medical officers
• laboratory employees
• cleaning, maintenance and waste disposal employees
• laundry employees
• patient care assistants
• carers
• veterinary employees
• ambulance officers and drivers
• allied health employees
• manufacturers of cytotoxic medicines and employees in the drug supply chain
• researchers
• couriers and delivery drivers.

Potential health effects

Exposure to cytotoxic medicines, such as preparing medicines without proper risk controls or managing a spill without appropriate personal protective equipment (PPE), may have serious health effects. These can include:

• abnormal formation of cells and genetic mutation
• changes to normal blood cell count
• abdominal pain, hair loss, nasal sores and vomiting
• liver damage
• contact dermatitis, or local toxic or allergic reaction
• foetal loss or malformations
• fertility changes in males and females.

Refer to the relevant SDS for further information. If exposure does occur, seek medical advice.

Employers must take all reasonably practicable steps to eliminate the risks of exposure to cytotoxic medicines. Where appropriate risk control measures are followed, the risks to health are greatly reduced.

Employees may elect not to manage cytotoxic medicines when they are:

• planning parenthood
• pregnant
• breastfeeding.

Employers should support requests from these employees that will further reduce their exposure.