Which action is recommended to reduce the risk of exposure when administering hazardous medications?

Safe handling of monoclonal antibodies in the cancer care setting

The following recommendations have been adapted from the Clinical Oncology Society of Australia (COSA) and Cancer Pharmacists Group (CPG) position statement 2013r and the Australian Consensus Guidelines 2014.r They apply to currently marketed monoclonal antibodies (MABs) except MABs conjugated to a cytotoxic agent, fusion protein or a radioisotope. These conjugated MABs are considered hazardous and should be prepared and administered following accepted cytotoxic safe handling precautions and regulations related to the handling of cytotoxics and radiopharmaceuticals. 

• Dermal absorption of MABs across intact skin during dose preparation or administration is unlikely due to their high molecular weight; however, the use of gloves and effective hand hygiene are recommended to minimise risks of contamination and infection.
• A respirator mask (P2/N95) and protective eyewear should be worn during dose preparation but are not mandated during the administration of MABs. However, they may be considered during the administration of intravenous formulations where dis/connecting administration lines may present a risk of aerosolisation.
• The use of gowns and/or coveralls are not warranted for either dose preparation or administration of MABs.
• Disposal of waste products, including waste and/or bodily fluids of patients, should be in accordance with the disposal of clinical biohazardous waste, i.e. not as cytotoxic waste, unless conjugated with a cytotoxic agent.

Safe handling of reproductive hazardous drugs

Healthcare workers (both male and female) who are actively trying to conceive and females who are pregnant, breastfeeding or may become pregnant should use full PPE when handling these drugs. Due to their dosage formulation, intact drugs (such as coated tablets or capsules) may not pose the same degree of occupational exposure risk as compounded injectable drugs. The National Institute for Occupational Safety and Health (NIOSH) recommends single gloving for handling and administration for these intact formulations. However, if these formulations are manipulated (crushed, dissolved etc.), they may pose a higher risk, and full PPE is recommended.r All other healthcare workers handling these medications should use precautions as set out by their organisations' policies and procedures.

Safe handling of drugs with unknown hazardous classification

For the handling of drugs that have been classified as unknown risk and have not been categorised by NIOSH,r eviQ recommends at minimum universal precautions be used. eviQ will not include the ongoing safe handling information in protocols containing these drugs; individual institution policies or guidelines should always be followed.   

Definition

Drugs are considered hazardous if they exhibit one or more of the following six characteristics in humans or animals:r

1. carcinogenicity, or the ability to cause cancer; a carcinogen
2. genotoxicity, or the ability to cause a change or mutation in genetic material; a mutagen
3. teratogenicity or other developmental toxicity, or the ability to cause foetal malformation or defects in foetal development; a teratogen
4. reproductive toxicity or fertility impairment
5. serious organ toxicity or adverse health effects at low doses
6. the structure and toxicity profiles of new drugs that mimic existing drugs determined hazardous by the five previous criteria.

Hazardous drugs may include cytotoxic, antiviral, antibiotics, immunomodifiers, biological and molecular targeted drugs.

The adverse effects of exposure to hazardous drugs can be categorised as biologic or health effects, acute or chronic. The most frequently reported biologic effects of occupational exposure to hazardous drugs include genetic damage, chromosomal aberrations, DNA damage and urinary mutagenicity. Health-related effects of hazardous drug exposure include reproductive effects and an increase in cancer occurrence.r

Identification of hazardous drugs

All cytotoxic materials are universally identified by a purple symbol representing a cell in the late phase of division known as telophase.

Hazardous drugs that have the potential to transmit infection should be suitably labelled as per institutional policy and state or territory legislation.

Refer to the eviQ Hazardous drugs table for more information regarding hazardous drugs.

Exposure to hazardous drugs

Exposure to hazardous drugs can occur through:r

• skin absorption
• mucosal absorption
• inhalation of drug aerosols, dust, powder or droplets
• ingestion of contaminated food or drink or other hand-to-mouth contact
• needle stick or sharps injuries.

Whilst undertaking:r

• drug preparation
• drug administration
• handling of patient waste
• handling of drug waste products
• drug and patient transport
• cleaning up spills
• contact with equipment/surfaces in areas where hazardous drugs may be used or administered
• contact with contaminated linen from patients who have received hazardous drugs. 

Personnel likely to be involved in these activities include:r

• pharmacists
• nurses
• cleaning, maintenance and waste disposal staff
• medical officers
• paramedics
• laboratory staff
• hospital assistants and wardspersons
• carers. 

Minimising exposure to hazardous drugs

Storage

The Society of Hospital Pharmacists of Australia (SHPA) recommends that cytotoxic drugs should be stored in separate, clearly marked storage areas, including refrigerated areas.r NIOSH recommend that hazardous drugs are stored separately from other drugs in closed containers that minimise the risk of breakage.r

Packaging

Prepared hazardous drugs should be packaged:

• in a sealed leak-proof container with the outer bag heat sealed where possible
• in a container offering protection from light if required
• in a manner that will protect the drug container from breakage and contain any leakage if breakage occurs in transit
• and labelled 'do not cut or crush' in the case of oral drugsr
• and labelled with an appropriate label or sticker identifying the hazard, i.e. cytotoxic or biohazard.rr

© Cancer Institute NSW 2019

Personal protective equipment (PPE)

When used appropriately, personal protective equipment (PPE) is an effective way to prevent exposure to hazardous drugs. The Oncology Nursing Society (ONS) defines PPE as chemotherapy tested gloves, gowns made of materials tested for use with chemotherapy, respirators (respiratory protective equipment) and face shields or goggles.r

© Cancer Institute NSW 2021

PPE should be worn during any activity which has the potential to cause exposure to hazardous drugs and related waste products. These activities include the reconstitution, administration and disposal of hazardous drugs and handling waste contaminated or potentially contaminated with hazardous drugs, including body waste products. A detailed discussion of PPE can be found in the personal protective equipment section below.

Transportation

Containers used to transport hazardous drugs should be robust, hard-walled, securely closed and labelled with appropriate warnings. A spill kit should always accompany hazardous drugs during transportation, and personnel required to transport hazardous drugs should be aware of the risks involved and be able to contain a spill if it occurs.rr

© Cancer Institute NSW 2019

Waste management

Hazardous drug waste, including contaminated waste and related equipment, should be sealed in appropriate secondary packaging to contain any leaks and disposed of into the appropriate hazardous waste bin. Cytotoxic waste should be segregated and double bagged (the first bag being sealable) and discarded into specifically labelled cytotoxic waste containers with a sealable lid as per relevant legislation. Other hazardous waste should be discarded as per relevant legislation.r Patients having treatment at home or receiving anti-cancer therapy may require approved containers for disposal of cytotoxic drugs and related waste.rrr These measures ensure that hazardous drug waste is handled separately from other waste and the individuals (environmental services) handling the waste are protected from exposure.r

© Cancer Institute NSW 2021

Eating and drinking

Avoid eating and drinking in areas where hazardous drugs are prepared and administered as there is a risk that food and drink can be contaminated and then ingested.rrr

Cleaning

It is important to establish regular cleaning routines for all surfaces which have the potential to become contaminated with hazardous drugs and related waste. These include any surface in the administration area or any area likely to be contaminated with hazardous waste, including body waste.r Thorough cleaning with water and a detergent solution is recommended in areas where hazardous drugs are handled.r Use detergent and water or water-based detergent wipes to clean surfaces that come into contact with hazardous drugs.r

Personal protective equipment (PPE)

Gloves

Glove use is essential and should be chosen to maximise protection by minimising permeability. Standard surgical gloves may not provide the required level of protection due to drug and/or carrier permeability.r Information regarding the permeability and testing of gloves can be found on their box. 

Gloves:

• are disposable
• should be purpose manufactured or manufacturer-recommended for handling hazardous drugs
• must be long enough to cover wrist cuffs of gown while arm is bent or stretched
• should be changed:
  • at the end of a procedure
  • prior to contact with another patient
  • at intervals of 30 minutes OR as recommended by the manufacturer OR when punctured, torn, or contaminated.rrrr

Note: ONS and NIOSH recommend that 2 pairs of gloves are worn during any activity involving hazardous drugs except during administration of intact oral drugs.rr However, the various state and territory Work Health Safety guidelines of Australia and New Zealand recommend wearing one pair of purpose manufactured gloves as part of standard PPE for hazardous drugs, unless attending to a hazardous spill where two pairs are recommended.rr

Gowns

Gowns designed for use with hazardous drugs should be made of an impermeable material and changed per the manufacturer's instructions. Non-disposable gowns should be put in an alginate bag and processed through an appropriate laundry facility. Care should be taken when removing the gown to minimise the risk of personal contamination.

The gown should:  

• have a closed front and long sleeves with elastic cuffs and secure at the back of the body
• be disposed of immediately (as contaminated waste) if overt contamination occurs
• not be worn in non-clinical areas, e.g. offices, tea rooms
• not be shared
• be used for a maximum of one shift.rrr

Protective eyewear

PProtective eyewear should be worn to protect against liquid splashes to the eye's mucous membranes. A worker wearing prescription glasses must undertake a risk assessment in line with local policies and procedures to determine if additional protection is required.

Eye protection:

• can be provided by:
  • goggles
  • protective eyewear with side shields
  • a transparent full face chemical splash shield
  • full-face respiratory protective equipment
• should be cleaned with neutral detergent solution and allowed to air dry at the end of the shift or when contaminated
• if disposable should be disposed of as cytotoxic waste.rrrr

Respiratory protective equipment

Respiratory protective equipment (RPE) with a P2/N95 particulate filter is recommended to contain aerosols generated by handling hazardous drugs and related waste; surgical masks do not provide sufficient protection.

• Effective storage and maintenance for reusable RPE should be implemented as per the manufacturers' recommendations.
• Workers must be fit tested as per the manufacturers' instructions to ensure the mask is the correct size, especially for those who wear prescription glasses
  • the positive and negative pressure seal of the respirator should be tested to ensure correct fit by gently exhaling and inhaling; if air escapes or the respirator is not drawn into the face during inhalation, the respirator needs to be adjusted.rrrr

Overshoes

• should be made of impervious material with skid-resistant plastic soles 
• should be high enough to cover trouser cuffs and designed not to slip down
• should be worn when cleaning a hazardous drug or related waste spill
• disposable paper shoe covers (those used in operating rooms) do not provide sufficient protection against cytotoxic contamination.rrr

Hair-net or head covering 

• should be worn to contain exposed hair, including beards and moustaches, and minimise contamination when cleaning a hazardous drug or related waste spill.rrr

Removing and discarding PPE

To minimise potential contamination, PPE should be removed in the following order and disposed of in cytotoxic waste. 

Removing PPE if wearing one pair of gloves

1. Remove gloves
2. Perform hand hygiene with soap and water
3. Remove gown
4. Remove protective eyewear or face shield
5. Remove respiratory protective equipment 
6. Perform hand hygiene with soap and water.rr

Removing PPE if wearing two pairs of gloves

1. Remove outer glove
2. Remove gown
3. Remove protective eyewear or face shield
4. Remove respiratory protective equipment
5. Remove inner gloves
6. Perform hand hygiene with soap and water.rr

Note: Perform hand hygiene between steps if hands become contaminated at any point. 

Handling body waste

© Cancer Institute NSW 2019

Hazardous drugs are primarily eliminated from the patient by renal and hepatic excretion. All body substances may be contaminated with either the unchanged drug or active drug metabolites. Exposure to hazardous substances may occur through:

• handling vomit, saliva, blood, excreta and fluid drained from body cavities
• handling bedpans, urinals, soiled incontinence aids, emptying urinary catheter bags, colostomy/urostomy bags and vomit bowls
• handling bed linen or clothing soiled with patient waste, or potentially contaminated with the hazardous drug
• touching or handling contaminated surfaces or equipment
• cleaning body fluids from the floor; this should be considered a hazardous drug spill.r

After treatment, the period during which body substances may be contaminated with drug metabolites will differ for individual drugs and patients. Due to the varying time frames for different drugs, some areas adopt a standard time frame for all drugs, although care should be taken to identify drugs with extended excretion. eviQ has used a standard timeframe of up to seven days for supporting documents.

It is recommended that:

• full PPE is worn for the period of time that elimination is indicated from the completion of treatment when handling patient bodily fluids
• the date of drug administration and length of time for PPE should be documented in the patients' medical record
• staff are careful to avoid splashes and spills
• an indwelling catheter or appropriate incontinence aids is recommended for incontinent patients
• urine is not decanted into a jug for measurement due to the risk of aerosol contamination; when urine is required to be measured, it should be:
  • weighed
  • measured using a graduated urine measurement collector (disposable toilet and pan liners); the type used must be leak-proof and show volume measurement
• appliances such as colostomy, ileostomy or urostomy bags, urinary catheters or incontinence aids, and heavily exuding dressing materials are double bagged prior to weighingr and placed into the appropriate cytotoxic/hazardous waste bin.r

Toilets

Patients should be instructed to be seated when urinating to reduce the risk of splashes and aerosol contamination. Patients should be instructed to close the toilet lid and use a full flush. When a lid is not present, consider covering the open toilet with a plastic-backed liner prior to flushing to prevent splashing.r This covering should be disposed of as hazardous drug waste.

Note: Patients treated with intravesicular Mycobacterium bovis (Bacillus Calmette and Guerin (BCG) strain) should be instructed to sit while voiding to minimise splashes and add two cups of undiluted household bleach or one sachet of sodium hypochlorite to the toilet containing the urine.r This should then be left to stand for 15 minutes prior to flushing. The patient must repeat this procedure for every void for the first six hours after instillation.r

Septic tanks, composting and eco-friendly toilet systems

The operation of onsite sewerage treatment systems may be affected by cytotoxic body waste. Therefore it is important to contact the manufacturer or supplier of the system.rr

Contaminated linen

Safe work procedures for handling contaminated laundry should be established in consultation with the local laundry service provider or contractor. Health care facilities should have documented procedures for the collection, transportation and storage of linen.r 

The ONS recommend the following ways to reduce contamination of linen with hazardous drugs:

• using incontinence aids or catheterisation for incontinent patients
• using plastic- or vinyl-covered mattresses, pillows and chairs for ease of cleaning
• encourage ambulatory patients to use the toilet rather than bedpans/urinals as they are prone to spilling.r

When contamination does occur:

• contaminated linen should be double-bagged at the location of use. First in a specially marked alginate/dissolvable bag and then in a labelled impermeable bag identified as hazardous. This ensures that the contents are laundered separately. 
• if the linen is deemed 'grossly contaminated' it should be double-bagged and discarded into an appropriate cytotoxic/hazardous waste bin.rr

Contaminated bed mattresses and pillows should be cleaned with detergent and water in a way that will not generate aerosols.r

For patients at home, see Chemotherapy safety at home. 

Spill and accidental exposure management

© Cancer Institute NSW 2010

Spill management

Spills of hazardous drugs and related waste must be dealt with immediately as they present a health risk to those exposed. Spills may occur in all areas where hazardous drugs and related waste are handled, stored, transported and disposed of. All spills should be managed and reported per the local legislation and WHS guidelines. Training in spill containment and decontamination procedures and spill reporting must be provided to all workers who are likely to be involved in spill management.rrrr

Read more about Hazardous drug spill management.

Sources of spills

A risk assessment should identify all areas where there is a hazardous drug or related waste spill risk. This includes all areas where hazardous drugs and related waste are stored, transported, handled and disposed of. Spills may result in the contamination of floors, work surfaces, equipment, bedding and clothing. A spill may involve: 

• hazardous drugs in all forms (liquid, powder, broken tablets or creams)
• drugs spilt or leaking during preparation, storage or transport
• drugs spilt or leaking during administration
• transport of patients with hazardous drug therapy in situ
• body substances contaminated with hazardous drugs
• hazardous drug contaminated laundry
• hazardous drug waste in all forms.rrr

 

© Enware Australia PTY Limited

Home and community care settings

A patient treated at home or in a community care setting should be provided with a spill kit to enable them to deal with a hazardous drug spill safely. Education should be provided to the patient by a health professional. In addition to the spill equipment, the kit should contain:

• easy-to-read instructions
• a list of contents
• information on the replacement and disposal of used items.rrr

Accidental contamination

Accidental contamination may include contamination of clothing and PPE, penetrating injuries, skin, eye, mucous membranes and other body contact. 

Clothing and PPE

1. Immediately remove PPE and any contaminated clothing
2. Place disposable PPE in hazardous waste bin
3. Contaminated clothing should be bagged, machine washed separately, and line dried
4. Wash any affected skin with soap and clean thoroughly with copious amounts of waterrr

Penetrating injuries, skin and other body contact

Skin exposure

1. Remove contaminated clothing as above
2. Wash the affected skin with soap and clean thoroughly with copious amounts of water
3. Report to supervisor immediately
4. Seek immediate medical advice and further medical attention as necessaryrr

Needle-stick injuries

1. Wash thoroughly as per skin exposure
2. If the needle-stick injury results in the injection of a hazardous drug, refer to the local extravasation procedure
3. Report to supervisor immediately
4. Seek medical advice and further medical attention as necessaryr

Mucosal exposure, e.g. eyes

1. Immediately flood the affected eye with an isotonic saline solution for at least 15 minutes – continuous irrigation may be facilitated with an intravenous infusion set connected to a bag of normal saline 0.9%
2. Report to supervisor immediately
3. Seek immediate medical advice and further medical attention as necessaryrrr

Documentation 

Document occurrence of the incidence as per institutional incident management and reporting guidelines.​rrr

Health surveillance and monitoring

Health surveillance refers to the monitoring of persons to identify changes (if any) in their health status due to possible occupational exposure to hazardous substances. This includes health and biological monitoring but does not include atmospheric or environmental monitoring. It is important to follow the local legislation and comply with WHS recommendations when developing local policies regarding health surveillance.

Health surveillance may include:

• health monitoring: the monitoring and counselling of individuals, including pre-employment and on an ongoing basis
• biological monitoring: the measurement and evaluation of a substance or its metabolites in body tissue, fluids or exhaled air of an exposed person.rrr

Planning parenthood, pregnancy and lactation

Staff who are pregnant, breastfeeding or planning parenthood and are involved in handling hazardous drugs and related waste should be informed of the reproductive risks and potential effects on foetal development. 

Workers required to perform these duties may elect not to do so. In such cases, appropriate and suitable alternative duties must be provided.r 

Patient education

Patient and carer education should be provided both verbally and in writing and should cover:

• the safe handling and waste management of hazardous drugs
• containing waste that is generated from drug administration in the home, i.e.:
  • keeping waste containers secure and appropriately labelled
  • to sit when going to the toilet and to close the lid and flush using a full flush
• the use and disposal of incontinence aids, colostomy and ileostomy bags
• handling and washing of contaminated linen.

Patients and carers should be supplied with any required information and 24 hour medical and nursing contact details.

Patients receiving home ambulatory chemotherapy should also be provided with:

• appropriate equipment
• a spill kit with instructions on how to clean up a spill.

For more information, see Chemotherapy safety at home. 

Literature search

Flinders Filters has partnered with eviQ to build reliable, robust search filters to retrieve core high level evidence on topics of significance to eviQ. The project goal is the provision of a sustainable model for evidence retrieval to ensure ongoing currency of content.

These search filters have been developed to retrieve the most up to date evidence from PubMed, in real time, using specifically designed search filters built to meet our needs.   

Guidelines and reviews is a search filter used when there is a low volume of high level evidence available. Please click on this link  to access the Pubmed searches.

Access Flinders Filters, a division of the Flinders Digital Health Research Centre at Flinders University to read more about research solutions to searching problems.

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History

Version 8

DateSummary of changes

14/01/2022	Clinical resource reviewed electronically by eviQ Nursing Reference Committee and ADAC Clinical Advisory Committee. Changes made to the wording throughout the document. Reviewed and aligned with current guidelines, new references added throughout. Images of PPE and waste management updated. Version changed to V.8. Review in 2 years.

Version 7

DateSummary of changes08/02/2021

The following sections added: safe handling of reproductive hazardous drugs safe handling of drugs with unknown hazardous classification version change to V.7.

Version 6

DateSummary of changes04/12/2019

Reviewed electronically with the following changes:  images updated references updated version change to V.6.  for review in 2 years

Version 5

DateSummary of changes20/09/200924/01/201108/07/201102/10/201220/02/201401/03/201307/07/201401/08/201405/02/201510/02/201513/04/201630/11/201631/05/201707/02/201816/07/2019

Information migrated from CI-SCaT 20 September 2009. Ci-ScaT UIDs on request. New sections developed in compliance with NSW Workcover guidelines & ISOPP Standards of Practice Safe handling of cytotoxics. PPE Containment devices Health surveillance Monoclonal antibodies Waste management Spill procedure updated 2008  Patient education Excretion table updated

Version 2 published developed to incorporate the safe handling and waste management of all drugs classified as hazardous to bring in line with International standards. PPE rewritten to incorporate fit testing and fit checking procedures for RPE and procedure for removal of gloves. Spill Management made into a new clinical procedure on request. Literature review made as new item due to requests to make it searchable. Excretion table made as a separate item to make it searchable.

Version 3 Information reviewed. New information on hazardous drugs and safe handling of monoclonal antibodies incorporated.  New tables on the order of putting on PPE and new images uploaded.

Remove link to patient information as superseded.

Waste management wording updated.

Version 4 update information and add links to all sections for eviQEd safe handling module.

Added section on MABs to reflect WCMICS consensus guidelines and COSA CPG position statement.

Removed link to 'Drug Excretion Table'.

Updated the link to Queensland Workplace Health and Safety Strategy. 2014. Guide for Handling Cytotoxic Drugs and Related Waste.

Links to CDC and NHMRC guidelines (infection control) for putting on and removing PPE removed.

Added 'OR' between at 30 minute interval and as recommended by the manufacturer.

Document reviewed, no changes required. Review in 2 years.

Transferred to new eviQ website. Version number change to v.5.

NSW WorkCover link and reference changed to new Safework NSW guidelines throughout document.

Bacillus Calmette-Guerin (BCG) drug name updated to Mycobacterium bovis (Bacillus Calmette and Guerin (BCG) strain) to align with product information.

This document reflects what is currently regarded as safe practice. While every effort has been made to ensure the accuracy of the content at the time of publication, the Cancer Institute NSW does not accept any liability, with respect to loss, damage, injury or expense arising from any such errors or omission in the contents of this work. Any reference throughout the document to specific pharmaceuticals and/or medical products as examples does not imply endorsement of any of these products. While eviQ endeavours to link to reliable sources that provide accurate information, eviQ and the Cancer Institute NSW do not endorse or accept responsibility for the accuracy, currency, reliability or correctness of the content of linked external information source. Use is subject to eviQ’s disclaimer available at www.eviQ.org.au

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First approved: 30 September 2009 Last reviewed: 14 January 2022 Review due: 30 June 2024

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11 Dec 2022

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