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Published on 1 January 2004

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New guidance on the safe handling of cytotoxic drugs

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Mark Woods
PhD
Senior Scientific Officer
Medical Sciences Unit
Health and Safety Executive
Bootle
Merseyside
UK

The UK Health and Safety Executive (HSE), which is responsible for regulating almost all the risks to health and safety arising from work activity in Britain, has recently published guidance on Safe handling of cytotoxic drugs. It previously published guidance entitled Precautions for the safe handling of cytotoxic drugs in 1983. The document eventually became outdated and was subsequently withdrawn. However, HSE has continued to receive regular enquiries on the subject. This provided the stimulus for publication of new guidance, which was developed in consultation with other organisations and individuals representing pharmacy, medical, nursing and veterinary interests.

What does the guidance include?
The guidance contains notes on good practice and is aimed at anyone involved in handling cytotoxic drugs. It will be of particular interest to pharmacists, pharmacy technicians, medical and nursing staff and veterinary practitioners. The information and advice it contains can be used as the basis for preparing more detailed local guidance. The topics covered are listed in the textbox below.

Specific technical procedures detailing how to prepare and administer drugs are not included, but a list of further reading where this information can be found if required is provided at the end of the document .

Some key issues
The guidance indicates that, in general, cytotoxic drugs are hazardous substances as defined by the Control of Substances Hazardous to Health Regulations 2002 (COSHH). Under COSHH, employers have a legal duty to assess the risks from handling cytotoxic drugs for employees and anyone else affected by this type of work, and to take suitable precautions to protect their health.

Preparation of cytotoxic drugs in hospitals should be centralised in a pharmacy under the direction of a suitably trained and experienced pharmacist.  Alternatively, if there is a major point of use such as an oncology clinic, it may be more appropriate to operate the centralised service from an outstationed pharmacy unit within the clinic. The work area should be designated for drug preparation and access restricted to authorised staff. Aseptic preparation can be carried out using a suitable safety cabinet or a pharmaceutical isolator. Further guidance on the points to consider when choosing a negative- or positive-pressure isolator has been produced by HSE in conjunction with the Medicines Control Agency (now the Medicines and Healthcare products Regulatory Agency). Totally enclosed systems should be the first choice for controlling exposure to drugs that are carcinogenic. Manipulation of oral or topical medicines containing cytotoxic drugs should be avoided if possible. If unavoidable, tasks such as dividing tablets should be restricted to a controlled environment, ideally within a pharmacy department.

For administration, drugs should be available in a form that does not require additional manipulation.  It should be carried out in quiet, designated areas away from welfare areas where food and drink may be consumed. Clear procedures need to be in place for dealing with any spillages and for safely disposing of waste.

Monitoring exposure to cytotoxic drugs in the workplace may be necessary, depending on the findings of the risk assessment. For certain drugs it is possible to measure their concentration on work surfaces, in the air or in body fluids. There is no recognised standard against which test data can be compared for any of these methods.  However, serial measurements can help to demonstrate whether precautions are still adequate or need to be reviewed. The adequacy of precautions may be demonstrated through good supervision, examining and testing equipment and keeping suitable records. This can be supplemented by other tests if appropriate.

Once again, the results of the employer’s risk assessment will be used to decide whether health surveillance of staff potentially exposed to cytotoxic drugs is required. The guidance recommends that employers keep a health record on all staff potentially exposed. This will contain personal details of each individual together with a record of all jobs involving exposure to cytotoxic drugs in their current employment. HSE is aware that measurements of cytotoxic drugs in body fluids or other biological indicators of exposure have been used to draw inferences about the health of exposed workers. However, the resulting data are difficult to interpret in the context of the health of an individual worker, and the guidance does not recommend their routine use in health surveillance.

Further information
Information sheets containing the guidance on Safe handling of cytotoxic drugs and Handling cytotoxic drugs in isolators in NHS pharmacies can be downloaded free of charge from HSE’s website at www.hse.gov.uk. In addition, the Health and Safety Laboratory, an agency of HSE, has produced the following relevant research reports:

  • Occupational exposure of health workers to cytotoxic drugs: a ward-based study. HEF00/05 2000.
  • Cytotoxic drug exposure in two pharmacies using positive and negative pressure enclosures for the formulation of cytotoxic drugs. HEF01/01 2001.

Copies of these reports can be obtained via HSE’s Infoline (see below for contact details).

More recently, the Health and Safety Laboratory has been examining cytotoxic drug contamination on the outside of vials delivered to hospital pharmacies. A report on this work is currently being prepared, and HSE is continuing to investigate the issue.

General information on worker health and safety in healthcare and other industries can be obtained from HSE’s Infoline by ringing 08701 545500 or by emailing: hseinformationservices@natbrit.com. There is also a section on HSE’s website dedicated to healthcare matters at: www.hse.gov.uk/healthservices.

Resources
UK Health and Safety Executive guidance
Safe handling of cytotoxic drugs
W:http://www.hse.gov.uk/pubns/misc615.pdf
Handling cytotoxic drugs in isolators in NHS pharmacies
W:http://www.hse.gov.uk/pubns/cytotoxic.pdf
European Agency for Safety and Health at Work
W:http://europe.osha.eu.int/good_practice/sector/healthcare
Occupational health and safety advice for the healthcare sector includes links to practical information, examples of good practice and guidelines from Member States, European and international organisations



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