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Wednesday, 25 April 2018

Circular details

Title: Safe handling of cytotoxic drugs
Document ID: Operational Circular OP 1961/05
Date of issue: Thursday, 16 June 2005
Status: NO LONGER APPLICABLE
File number(s): 92-08854; 94-06061
Description: Guide to hospitals on the appropriate and safe handling of drugs used in cancer treatment.
Applicable to: Clinical and administrative staff of the Department of Health.
Category: Clinical
Period of effect: from 10 June 2005
Authorised by: Dr Andrew Robertson, Acting Group Director, Statewide Policy Division, 09-Jun-2005
Acrobat version:
Download this circular in Adobe Acrobat format.   Operational Circular - OP 1961/05  [495KB]
Print version: View print version View print version

Attachments:

this attachment in Image - PNG format   Label: CYTOTOXIC WASTE - INCINERATE  [13KB]
Related documents:
  OD 0651/16  (21-Jan-2016) :: Clinical and Related Waste Management Policy
Supersedes:
  OP 0532/95  (10-Jan-1995) :: Safe Handling of Cytotoxic Drugs
Related websites:
Internet Link   National Health and Medical Research Council (NHMRC)  ::  National Guidelines for Waste Management in the Health Industry (1999)
Internet Link   Queensland Workplace Health and Safety  ::  Guide for Handling Cytotoxic (Anti neoplastic) Drugs and Related Waste (1997)

Safe handling of cytotoxic drugs

Introduction:

Cytotoxic drugs are used primarily in the treatment of cancer. Risks of occupational exposure include topical irritation and necrosis, liver damage, mutagenesis, carcinogenesis, teratogenesis and risk of miscarriage.

Managers and employees must be aware of safe working practices that prevent uncontrolled exposure to cytotoxic drugs. This document provides an overview of occupational health and safety aspects of the handling and use of cytotoxic drugs and includes guidelines for inclusion in workplace-specific policies and procedures.

Hospitals and Health Services should ensure that local policies and procedures promote the safe handling of cytotoxic drugs and that employees involved in the handling and use of such drugs receive appropriate training and supervision. Policies and procedures should be reviewed and updated regularly.

Strategies to Minimise the Risk:

Administrative controls

  • Policies, and written safe work procedures need to be established for all work involving cytotoxic drugs.
  • Only personnel who have successfully completed a course of instruction and training should be permitted to handle cytotoxic drugs, waste contaminated with cytotoxics, or spills. Maintenance workers, contractors and cleaning staff who may come into contact with equipment contaminated with cytotoxic agents should also be trained in order to avoid unprotected exposure.
  • The number of staff involved with cytotoxic agents should be kept to a minimum.

Safety cabinet and equipment

It is strongly recommended that cytotoxic drugs are prepared in cytotoxic drug safety cabinets meeting the requirements of Australia Standard (AS) 2567:2002 'Laminar flow cytotoxic drug safety cabinets' and AS 2639:1994 'Laminar flow cytotoxic drug safety cabinets - Installation and use'. Laminar flow cabinets provide protection from exposure to cytotoxic drugs, whilst ensuring that drugs are protected from contamination during their preparation. Cabinets should be located in a room designated for the preparation of cytotoxic drugs. Adequate equipment (syringes, intravenous sets and vials) and resources (designated, appropriately-designed work areas and fixtures) are required. These should be inspected regularly to ensure their continued appropriateness and effectiveness.

Access to areas where cytotoxic drugs are prepared or administered should be restricted to authorised personnel.

If a cytotoxic drug safety cabinet is unavailable, only pre-prepared, ready-to-administer cytotoxic drugs should be used by health services.

Personal protective equipment (PPE)

Appropriate protective clothing and equipment should be provided by the employer for use by staff involved in preparing, administering and handling cytotoxic waste, including spillage clean-up and cleaning or maintenance work in cytotoxic drug facilities. The following clothing and equipment is recommended:

  • A long sleeved gown made from impervious material (possibly disposable overalls) with knit or elastic cuffs.
  • Two pairs of mid arm length, latex gloves to prevent hand contamination on removal, and to increase protection during handling.
  • Where cytotoxic drugs are prepared outside a safety cabinet, additional personal protective equipment is likely to be required, including disposable head covering and overshoes, safety goggles and a Class P2 respirator.

Special laundering facilities are required for reusable protective garments. These garments should be placed in purple, colour-coded, sealed and labelled containers for transport to a laundry which is capable of conforming with the requirements of AS 2013.2:1989 'Cleanroom Garments - Processing and use'.

Non-disposable personal protective equipment should be decontaminated routinely after each use, stored away from sources of contamination and regularly maintained. Respirators should be selected, used and maintained in accordance with AS/NZS 1715:1994 'Selection, use and maintenance of respiratory protective devices'. Staff should be trained in the use of respiratory protection devices.

Transporting and packaging

All cytotoxic preparations must be placed in labelled, sealed, impervious containers capable of protecting from spillage, leakage or breakage during transport.

Emergency spillage procedure

A written procedure must be established for containing and decontaminating cytotoxic drug spillages.

In general the procedures should provide the following:

  • Designated staff
    Only designated staff who have been trained in the handling, use and emergency clean up of cytotoxic material should be involved.
  • Evacuation
    All persons not directly concerned with the emergency should be excluded from the contaminated area.
  • Personal protective clothing and equipment
    Appropriate equipment should be worn to protect against skin contact and inhalation exposure as outlined above.
  • Clean up
    This should generally involve the use of a pre-prepared spillage containment system. Liquids should be absorbed using spill pads or absorbent material. Powder should be removed with damp absorbent material eg. damp pads or towelling.
  • Disposal
    Waste from spills must be placed in labelled, sealed, impervious containers and disposed of correctly as outlined below.
  • Records
    Details of the spillage date, time, type, quantity, causation factors and personnel involved (including clean up personnel) must be documented. All such incidents should be thoroughly investigated with a view to preventing recurrence.

Health surveillance

Health status checks are required for personnel before commencing and during periods of work with cytotoxic drugs (at least annually). Any examinations should take into account the potential adverse health effects of the specific cytotoxic drugs used and their clinical signs and symptoms. Routine screening of blood, urine or cytogenetic screening is not generally warranted as it has little or no predictive value.

The health surveillance program should be conducted by a suitably qualified medical practitioner.

Transport, labelling and disposal of waste

All cytotoxic waste, including contaminated sharps, must be placed in labelled, sealed, impervious containers capable of protecting from spillage, leakage or breakage during transport. Containers for cytotoxic waste can be obtained commercially from medical suppliers and should be clearly labelled with a purple label incorporating the symbol for cytotoxic waste, as attached, and the words: CYTOTOXIC WASTE - INCINERATE

Cytotoxic waste must be incinerated because it is highly toxic. It must be incinerated at 1100°C with a minimum retention time of one second for the flue gases at this temperature. Waste with low concentrations of cytotoxic drugs, such as urine, faeces and vomitus, may be disposed of safely by flushing into the sewage system.

Appropriate precautions must be taken when handling these materials, to ensure against skin and inhalation exposure. This includes the use of personal protective equipment described previously.

Exclusion from handling cytotoxic drugs

Pregnant or breastfeeding women should not handle cytotoxic agents or cytotoxic waste unless adequate exposure protection can be assured at all times. Male and female personnel planning pregnancy should be made aware of the potential risks and offered alternative duties, if necessary.

Documentation

Health Care Units should maintain records of the following:

  • cytotoxic drugs prepared;
  • personnel involved and their training and accreditation;
  • details of equipment used, e.g. safety cabinets, including maintenance records;
  • personal protective equipment issued and worn;
  • monitoring and assessments performed;
  • health surveillance checks implemented;
  • emergency spillage and other incidents.

Further reading

National Guidelines for Waste Management in the Health Industry. National Health and Medical Research Council. 1999
(http://www.nhmrc.gov.au/publications/pdf/eh11.pdf)

Standards of Practice for the Safe Handling of Cytotoxic Drugs in Pharmacy Departments March 1997, Aust J Hosp Pharm 1999; 29 (2): 108-16

Guide for Handling Cytotoxic (Anti neoplastic) Drugs and Related Waste. Queensland Workplace Health and Safety. 1997
(http://www.whs.qld.gov.au/guide/gde17.pdf)


Dr Andrew Robertson
ACTING GROUP DIRECTOR
STATEWIDE POLICY DIVISION

This circular last updated: Thursday, 16 June 2005 at 10:21am

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