Cytotoxic drugs are used widely in healthcare settings as well as in the community in the treatment of cancers as well as other diseases.
This page provides information to employers and employees on the occupational hazards associated with cytotoxic drugs and the precautions to take when handling them. It is not aimed at manufacturers.
Cytotoxic drugs (sometimes known as antineoplastics) describe a group of medicines that contain chemicals which are toxic to cells, preventing their replication or growth, so are used to treat cancer. They can also be used to treat a number of other disorders such as rheumatoid arthritis and multiple sclerosis. Once inside the body, their action is not generally tightly targeted, and they can produce side effects both to the patients and others who become exposed.
They are used in range of settings including hospitals, specialist oncology units, hospices, care homes, charitable organisations, and domestic homes. They may also be used in veterinary clinics.
What is the risk?
The toxicity of cytotoxic drugs means that they can present significant risks to those who handle them. Occupational exposure can occur when control measures are inadequate. Exposure may be through skin contact, skin absorption, inhalation of aerosols and drug particles, ingestion and needlestick injuries resulting from the following activities:
- drug preparation
- drug administration
- handling patient waste
- transport and waste disposal
- cleaning spills
Inadequate control measures could lead to:
- abdominal pain, hair loss, nasal sores, vomiting, and liver damage
- contact dermatitis and local allergic reactions
- foetal loss or malformations in the children of pregnant women
- alterations to normal blood cell count
- abnormal formation of cells and mutagenic activity or mutations forming
Who is at risk?
Anyone working with patients (or animals) receiving cytotoxic drugs is at risk of exposure. This includes pharmacists, pharmacy technicians, medical and nursing staff, and laboratory staff. Veterinary practitioners are equally at risk when using cytotoxics in animals. Appropriate control measures must be in place to protect them all.
What you need to do
Cytotoxic drugs are hazardous substances, as defined by the Control of Substances Hazardous to Health Regulations (COSHH).
Under COSHH, employers must assess the risks from handling cytotoxic drugs for employees and anyone else affected by this type of work, and take suitable precautions to protect them.
You can find more specific information in the COSHH Approved Code of Practice (ACOP). You should:
- identify the hazards - which cytotoxic drugs are handled and what are their potential adverse effects on health?
- decide who might be harmed and how - which employees and others might be exposed to cytotoxic drugs and how might this happen? For example, this could happen through surface contamination of drug vials, or leakage of drugs during preparation and administration. Pay attention to groups of workers who may be at particular risk, such as young workers, trainees and new and expectant mothers. Pregnant workers are especially at risk, as some drugs may be harmful to the unborn child. Consider others who could be indirectly exposed, such as cleaners, contractors and maintenance workers
- evaluate the risk - assess how likely it is that cytotoxic drugs could cause ill health and decide if existing precautions are adequate or whether more should be done. Exposure from all routes should be prevented or adequately controlled. Factors to consider include:
- the frequency and scale of contact with cytotoxic drugs;
- information from incident records (including near-misses)
- the effectiveness of control measures
- record your findings - record the significant findings of the risk assessment and keep a written record for future reference. If you have fewer than 5 employees you do not have to write anything down
- review your risk assessment - to establish if there are any significant changes and revise it if necessary. It is good practice to review the assessment periodically, to ensure that precautions are still suitable
Employees have a legal duty to take care of their own health and safety and that of others affected by their actions. They must make full and proper use of control measures put in place by the employer. In addition, they should cooperate with their employer, so they can comply with any legal duties placed on them.
Control of exposure
Measures to control exposure should be applied in the following order:
- use totally enclosed systems where reasonably practicable
- control exposure at source, for example, by using adequate extraction systems and appropriate organisational measures
- issue personal protective equipment where adequate control cannot be achieved by other measures alone
The broad measures described above will include more specific controls, such as:
- reducing the quantities of drugs used; the number of employees potentially exposed; and their duration of exposure, to the minimum
- ensuring safe handling, storage and transport of cytotoxic drugs and waste material containing or contaminated by them
- using good hygiene practices and providing suitable welfare facilities, for example prohibiting eating, drinking and smoking in areas where drugs are handled and providing washing facilities
- training staff who handle cytotoxic drugs or deal with contaminated waste, on the risks and the precautions to take
Personal protective equipment
Personal protective equipment (PPE) should be provided and used wherever risks cannot be adequately controlled in other ways. PPE should be selected based on your risk assessment. It is important that the PPE offers adequate protection for its intended use. Employees must be trained in the use of PPE and it must be adequately maintained and stored.
You can find more information on personal protective equipment (PPE).
Monitoring exposure in the workplace
Monitoring includes any periodic test or measurement which helps confirm the effectiveness of controls. Under COSHH, monitoring is necessary when:
- deterioration of control measures could result in a serious health effect
- measurement is required to ensure an occupational exposure limit or in-house working standard is not exceeded
- any change occurs in the conditions affecting employees' exposure which could mean that adequate control is no longer being maintained
In accordance with the COSHH ACOP, monitoring is normally necessary where there is potential for exposure to carcinogenic compounds. The HSE publication, Biological monitoring in the workplace, provides further information.
Occupational health services
Where appropriate, using an occupational health service can help you identify risks, get advice on suitable precautions and control measures, and provide services such as:
- health surveillance programmes
- feedback and advice to employers following employee health assessments, for example pre-employment, following sickness absence, or rehabilitation and return to work
- employee information and training in the health aspects of their work
Dealing with spillages and contamination
Clear procedures, which staff who handle cytotoxics or contaminated waste should be familiar with, must be in place for dealing with spillages or contamination of people or work surfaces. Measures to prevent or contain spillages should be used at all times. Any spillages that do occur should be dealt with promptly.
Waste disposal
Procedures must be in place for the safe disposal of waste. All relevant staff should be familiar with these procedures. Excreta from treated patients may contain unchanged cytotoxic drugs or active metabolites.
Information, instruction and training
Employees handling cytotoxic drugs must be given suitable and sufficient information, instruction and training, relevant to their work. Employees must be made aware of the risks of working with cytotoxics and the necessary precautions.
Reporting incidents
Under the Reporting of Injuries, Diseases and Dangerous Occurrences Regulations (RIDDOR) the accidental release of any substance which may cause a major injury or damage to health is classed as a dangerous occurrence and should be reported. However, a small spillage of a cytotoxic drug which is well contained and easily dealt with is not reportable. Spillage of a large amount, to which people could have been exposed, is reportable.
Further information
- COSHH Approved Code of Practice and guidance
- Safe Handling of Oral Chemotherapeutic Agents in Clinical Practice: Recommendations: From an International Pharmacy Panel. Journal of Oncology Practice January 2011
- Structures and processes of care in ambulatory oncology settings and nurse-reported exposure to chemotherapy BMJ Quality and Safety August 2011