Safe handling of cytotoxic medicines and cytotoxic waste including spillage management

Publication: 02/01/2020  --
Last review: 01/01/1900  
Next review: 02/01/2023  
Standard Operating Procedure
CURRENT 
ID: 6727 
Approved By: SACT steering group 
Copyright© Leeds Teaching Hospitals NHS Trust 2020  

 

This Standard Operating Procedure is intended for use by healthcare professionals within Leeds unless otherwise stated.
For healthcare professionals in other trusts, please ensure that you consult relevant local and national guidance.

Good practice guidance for the safe handling of cytotoxic medicines and cytotoxic waste including spillage management

  1. Introduction
    1.1 Training Programmes
    1.2 Exemptions from these guidelines
    1.3 Information for individual staff groups
  2. Section A: General Information for all staff
    2.1 Personal Protective Equipment (PPE)
    2.2 Transport
    2.3 Storage
    2.4 Disposal of cytotoxic medicines and contaminated equipment
    2.5 Spillage
    2.6 Accidental exposure
    2.7 Documentation and reporting of Spillages

Appendix 1 - Patient leaflet How to deal with a spill of chemotherapy at home

Appendix 2 - Guidance for management of telephone call reporting a spillage at home/out of hospital

1. Introduction

Cytotoxics (also called anticancer chemotherapy, chemo, anti-neoplastics) are medicines that interfere with cell division because of their ability to kill tumour cells. They are used extensively to treat cancer. However, they also have other medical applications in the treatment of non malignant conditions. Their actions are not specific to tumour cells and normal cells may also be damaged. As a result, they can produce significant side-effects in patients or others exposed.

Cytostatics are medicines that stop cells from multiplying but do not kill cells. They are also used in the treatment of cancer, but are used to treat a range of other medical conditions. A widely used class of medicines in this category would be hormone therapies.

Both cytotoxics and cytostatics are designated as hazardous medicines by virtue of the fact that they possess all or some of the following characteristics i.e. toxic, carcinogenic, toxic for reproduction or mutagenic.

The main focus of this document is the safe handling of cytotoxics. However the principles laid down will be applicable to cytostatic medicines in relation to waste disposal of these medicines on LTH premises. The disposal of non-hazardous pharmaceutical waste is beyond the scope of this guidance. Please refer to the LTHT Waste disposal policy.

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 needle stick injuries resulting from the following activities:

  • drug preparation
  • drug administration
  • handling patient waste
  • transport and waste disposal, or
  • cleaning spills.

Information on the chronic health effects of cytotoxic medicines mainly comes from data in animals and from patients given therapeutic doses. It is not certain how relevant this is to healthcare workers involved in handling these medicines. Any occupational exposures are likely to be at much lower levels, although there is potential for them to be repeated over a prolonged period. Little is known about the consequences of repeated exposure to small quantities of cytotoxic medicines.

Under the Health and Safety at Work Act 1974, the Management of Health and Safety at Work Regulations 1999 and COSHH Regulations 2002, LTHT has a legal duty to protect the health of its employees and others, e.g. the public, who may be affected by its work.

As an employee of LTHT, staff have a legal duty to take care of their own health and safety and that of others affected by their actions. Employees must make full and proper use of control measures put in place by LTHT. All staff handling cytotoxics/cytostatics are accountable and responsible for their own practice and must be aware of their limitations in relation to preparation, handling, administration and disposal.

Healthcare personnel who prepare, transport, administer or who work in areas where these medicines are used, may be exposed to these agents in the air, on work surfaces, contaminated clothing, medical equipment, patient excreta or via other sources. Patients and carers are also at risk in hospital settings and where cytotoxic medicine is given in the home environment.

The risk of exposure can be minimised through the implementation of sound procedures in the safe handling of cytotoxic medicines and related waste. It is good practice to ensure that all personnel who may come into contact with cytotoxic medicines receive education and training as laid down within this guidance document..

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1.1 Training Programmes

The contents of this good practice guidance should be read and understood by all staff involved in handling these medicines as part of a standard induction package. Each head of department where cytotoxic medicines are prescribed, dispensed or administered is responsible for ensuring appropriate training is provided for their staff and that records of that training are maintained.

Managers of individual groups of staff should ascertain which sections are relevant to their workforce and ensure these are used in their induction package. For example; porters should be aware how to handle spillages if they transport patients with infusion devices attached, but do not need to be familiar with sections on spillages in patients’ homes.

Registered nurses new to chemotherapy within LTHT must complete a chemotherapy education programme and competencies before administering cytotoxic chemotherapy, appropriate to their area of practice e.g. nurses employed by the Oncology CSU should complete the UKONS Systemic Anti-Cancer Therapy (SACT) Passport competency package. This framework incorporates training and assessment of competence in the handling of chemotherapy and the management of storage, transportation, waste disposal and spillage.

It is recommended that areas delivering cytotoxic medicines outside the Oncology CSU consider adopting relevant parts of the chemotherapy/SACT education programme for the education and assessment of competence in these issues for their registered nursing staff.

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1.2 Exemptions from these guidelines

Biological Agents
Certain medicines used within LTHT are classified as biological agents. Biological agents (as opposed to chemical or physical agents) are defined as any micro-organism, cell culture, or human endoparasite which may cause any infection, allergy, toxicity or otherwise create a hazard to human health including any that have been genetically modified. These include genetically modified organisms, virus and viral vectors, naked DNA, cell and tumour lysates. As such they have specific handling requirements as specified by the LTHT Biological Safety Committee. Each agent has its own individual SOP covering all aspects from medicine receipt to patient wastes. Only specially trained staff are permitted to have any involvement with such agents and have appropriate spillage kits and guidance.
The procedure to deal with spillage of these agents during manipulation is held in the relevant pharmacy department. When these medicines are transported to wards and departments, they are accompanied by a spillage instruction sheet which should be followed in the event of spillage.

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1.3 Information for individual staff groups

The LTHT guidance for the safe handling of cytotoxic medicines have been separated into the following sections for ease of use

  1. General information for all staff
  2. Information for pharmacy staff
  3. Information for nursing and medical staff who administer cytotoxic drugs
  4. Information for portering staff
  5. Information for handling in patient’s homes

For staff working in pharmacy aseptics this guidance should be read in conjunction with local standard operating procedures located in section 17 of the procedure manual.

SECTION A

2. GENERAL INFORMATION FOR ALL STAFF

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2.1 PERSONAL PROTECTIVE EQUIPMENT (PPE)

Under the Personal Protective Equipment at Work Regulations (1992 & 2002) personal protective equipment should be provided and used wherever there are risks to health and safety that cannot be controlled in other ways. It is important that PPE offers adequate protection for its intended use. The selection of PPE should be based on the COSHH. risk assessment
It is imperative that staff are aware of the location and proper usage of PPE, eyewash and spillage kits.

Gloves
There is evidence that nitrile gloves offer good protection to the operator from cytotoxic medicine contamination and therefore the glove of choice should be made of nitrile material except where practitioners have an allergy to nitrile material. Latex gloves should not be used. Please refer to the LTHT Latex Policy

Gloves should be;

  • Worn at all times when contact with cytotoxic medicine is possible.
  • Changed regularly (at least every 2 hours) and always changed between patients.
  • Changed immediately when damaged.
  • Powder free to reduce the risk of contamination.

Hands must be washed thoroughly before and after the use of gloves.

Gowns and Aprons.
Disposable plastic aprons are suitable for use during administration of cytotoxic medicines and should be;

  • Plastic and disposable
  • Worn for a single procedure
  • Immediately discarded after use and disposed of as cytotoxic medicine contaminated waste

The garments used within the aseptic pharmacy departments are beyond the scope of this guidance and local procedures should be followed.

Eye and Face Protection
Eye and face protection should be used where there is an increased risk of spillage or aerosol formation or when managing a situation where this has arisen and poses a risk to health.

  • Eye protection should be disposable.

Overshoes
These are required during the containment of spillages, but are not required during routine administration.

  • Overshoes should be constructed from an impermeable material and should completely enclose the sole and uppers.

Respirator
The Health and Safety Executive require the use of a respirator when managing a spillage of arsenic trioxide. A respirator is located in Pharmacy Aseptics in Bexley Wing, Level -1. (Instructions for use are available in the Pharmacy Aseptics Procedure Manual PPS 17.405 Use of the 3M Jupiter respirator). Pharmacy aspectics can be accessed 24/7 by the oncall Pharmacist.

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2.2 TRANSPORT

This section relates to advice on transporting individual patient treatments and their associated wastes. It does not take into account bulk transportation of cytotoxic medicines or waste. These are subject to different regulations and further advice should be sought in these circumstances from LTHT Medicines Management Pharmacy Services (MMPS)

Transport within LTHT premises
All staff involved in the transportation and handling of cytotoxic medicines should be aware of the hazardous nature of these products and have received appropriate training in what to do in the event of a spillage.

Parenteral cytotoxic medicines and oral medicines in a liquid presentation will be packaged in specially designed transport pouches and will be clearly labelled as to alert the staff of the cytotoxic nature of the package. Solid dose oral formulations are not subject to this practice.

Cytotoxic drugs should never be transported via the POD air tube system.

Transport outside LTHT Premises
Where carriers transport cytotoxic medicines, either between LTHT premises or to patient’s homes, it is imperative they are given the contact names and numbers of the department from where transport was initiated and be made aware of the cytotoxic nature of the medicine and informed to contact the department in the event of a spillage.

Whenever cytotoxic medicines are transported by car they should be secured in the boot, in an appropriately labelled container - see section B

The department that initiates delivery should ensure recipients are made aware of the storage requirements. A signature should be obtained to record safe receipt of the cytotoxic medicines at the correct destination where transport carriers are used.
N.B. This does not apply to patients transporting their own cytotoxic medicines home, or nurses delivering and administering medicines in patients’ homes.

Cytotoxic medicines requiring refrigeration should be packaged, under the direction and supervision of the Pharmacy Department (MMPS). It may not be necessary to undertake ice packing when journey time home is short or for less temperature dependent medicines. Advice should be obtained from the Pharmacy Department. Patients/parents/carers should be made aware of the need for refrigeration as soon as they reach home.

Cytotoxic medicines MUST NOT be sent by routine post. The Royal Mail classifies it as restricted material. Use of the postal service could expose members of the general public to unnecessary risk (e.g. delivery of cytotoxic medicines to an incorrect address). Safe transport arrangements must be organised..

Cytotoxic medicines in liquid form need particular care and should be packaged in rigid containers that allow protection to members of the public and all those who may come into contact with them.

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2.3 STORAGE

The temporary storage of cytotoxic medicines on wards and in departments should be separate and identified with designated storage for Fridge and room temperature storage. This is mandated in the Manual for Cancer Services and LTHT Medicines Code.

Cytotoxic medicines to be administered into the cerebrospinal fluid are stored in designated fridges clearly labelled for that purpose (see Intrathecal chemotherapy policy).

Vinca alkaloids are delivered in designated Vinca Alkaloid transport boxes and the contents should be stored in these containers until administration (See Vinca Alkaloid policy).

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2.4 DISPOSAL OF CYTOTOXIC MEDICINES AND CONTAMINATED EQUIPMENT

Every area within LTHT handling cytotoxic medicines should comply with the following basic statements.

  • Suitable containers clearly labelled and reserved solely for cytotoxic waste should be available in all areas where these medicines are handled.
  • Cytotoxic waste containers must conform to BS 7230. For disposal of sharps e.g. syringe with needles, a yellow with tightly fitting purple lid bin is required. Non sharps contaminated with cytotoxic medicine waste containers are blue with a tightly fitting purple lid and these should be used for disposal of IV bags, giving sets and other medicinal packaging. Containers must be puncture resistant. Cytotoxic waste bags are coloured yellow with a purple stripe and these are used for non-medicinal, non-sharp cytotoxic waste.
  • Cytotoxic waste containers must be sealed when the container is 2/3 full.
  • Containers must be labelled with the corresponding lid colour i.e. purple label for purple lid

PPE should be worn at all times when handling cytotoxic medicines, including dismantling and disposing of equipment used during administration and cleaning spillages.

All waste generated during the preparation and use of cytotoxic medicines and the cleaning of spillages must be segregated, packaged and disposed of in accordance with the LTHT Waste policy.

Contaminated products must be disposed using the cytotoxic waste stream. These include materials used in the preparation and administration of cytotoxic medicines, such as needles, syringes, infusion bags and IV tubing. Needles should not be disconnected from syringes nor re-sheathed nor should bags be disconnected from IV tubing before disposal.

Non Sharps
Sharps

Any remaining non sharp waste that has or may have been contaminated with cytotoxics including wipes, wound dressings, aprons and gloves are disposed of in the yellow with purple stripe clinical waste bags. Specific cytotoxic waste stream storage carts and collection should be used.

Spillages of vomit, urine or faeces on the floor within the drug specific timeframe from administration for having active metabolites present (up to 7 days) should be treated as a cytotoxic spill and cleaned accordingly.

For non-cytotoxic contaminated waste, please refer to the LTHT Waste management policy.

Contaminated products must not be transported long distances before being disposed of into a cytotoxic waste bin. The cytotoxic waste bin should be taken to the area of clinical activity.

All waste generated within LTHT must be double bagged and tied using the swan neck method with the appropriate coded tie securely fastened before placing for collection. Ties are provided by Facilities staff. These ties enable the producer of the waste to be traced should the need arise, and help to prevent the waste leaking from the bag. Facilities staff will not remove waste that has not been appropriately and securely fastened.

Cytotoxic waste within LTHT should be stored at the designated collection points ready for incineration. All cytotoxic waste (both colours of disposal bins and yellow with purple stripe bags) must be placed into large wheelie bins that have had a purple tag attached. These are also identified by posters above the bins. All cytotoxic waste is incinerated at 11000C. Staff should make themselves aware of these places. Cytotoxic waste should not be allowed to accumulate.

Areas that have access to cytotoxic bins should dispose of unused cytotoxic medicines in the clinical area.

Non-disposable equipment may become contaminated. Therefore clinical areas should have ensured that items such as trolleys and trays are cleaned in between each patient as per LTHT infection control policy.

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2.5 SPILLAGE

Management of Cytotoxic Spillage
All staff involved in the preparation, handling, storage, transportation and administration of cytotoxic medicines should be familiar with the procedures to be followed in the event of spillage, including the requirement to wear appropriate PPE. Only staff that have undergone training in these areas are to be involved in the management of a cytotoxic spill. Domestic/Housekeeping staff should not be involved in the management of a cytotoxic spillage.

All staff who are pregnant or breast feeding should NOT be involved in managing spillages of cytotoxics

Wherever cytotoxic medicines are prepared or administered, the following must be readily available;

  • A suitable LTHT cytotoxic spillage kit
  • Adequate supplies of absorbent and cleansing material
  • An eye irrigation kit and access to a mains water supply

Groups of staff that may have intermittent contact with cytotoxic medicines e.g. porters, should be aware that LTH has a cytotoxic spillage procedure and be able to take appropriate action should the need arise.

The initial stages of managing a cytotoxic spillage are the same in all areas:

  • Assess the spillage for size, type and danger to others
  • Call for assistance and do not leave the spillage site unattended
  • Protect yourself with suitable personal protective equipment

In the event of a spill or suspected contamination staff must act immediately
The area must be isolated to prevent further spread
All spillages and contaminations must be reported through Datix

A cytotoxic spillage kit for use in LTHT premises should include:
Disposable apron
Plastic forceps
Gloves
Over sleeves
Absorbent wipes
Cytotoxic Waste Bag

A cytotoxic spillage kit for use in patients’ homes should include:
2 pairs of Nitrile gloves
2 Aprons
2 Yellow with purple stripe contaminated waste bag
Information leaflet on how to deal with a spillage
Rigid cytotoxic waste bin (Yellow or blue with Purple top)
Advice to have a supply of absorbent paper towel (kitchen roll) available

Spillages onto Hard Surfaces within LTHT
The contents of a LTHT Cytotoxic spillage kit should be used to manage the spillage as detailed below;

  1. Areas affected by a spillage should be cordoned off to minimise spread.
  2. All non-essential staff, patients, carers, relatives and visitors must be asked to leave the affected area whilst the spillage is dealt with.
  3. Minimise air flow to the area by shutting doors and windows and switching fans and air conditioning off if possible
  4. Do not leave the spillage unattended.
  5. Put on PPE as supplied in the spillage kit.
  6. Work from the edge of the spillage towards its centre
  7. If the area is hazardous due to for example, the presence of broken glass, carefully pick up any sharp or broken material using the scoop or forceps provided in the Cytotoxic Spillage kit and place into a cytotoxic yellow with purple lid bin.
  8. For a liquid spillage, gently lay the absorbent pad from the spillage kit onto the spill. The pad will absorb and contain the spillage. A number of pads may be required for larger volume spillages.
  9. For a non-liquid spillage, gently cover the area with a wipe (or wipes) ensuring minimal agitation of the substance. If the substance is powdery, first carefully moisten the wipe so that any substance is contained and can be easily gathered onto the wipe.
  10. Carefully place contaminated pads or towels and any contaminated package material into a yellow with purple stripe clinical waste bag
  11. Once the spillage has been removed, clean the area at least three times using a mild detergent and clean water.
  12. Dry the area thoroughly using absorbent towels.
  13. Discard all cleaning materials into a yellow with purple stripe clinical waste bag (including gloves, aprons and overshoes). Bags must be immediately secured.
  14. Wash hands thoroughly after cleaning the spillage.

Complete a Datix.
A copy of this report must be sent to the secretary of the Service manager of LTHT Aseptics and COSHH Steering Group within LTHT pharmacy. (This should be addressed to the QA/QC Department, Moor House on 3927043 or 3927030).

Inform the Occupational Health department, if there has been exposure to staff.

Replace used cytotoxic spillage kit.

Spillages onto Soft Furnishings and Furniture within Ward and Departments.
If a spillage occurs onto soft furnishings, as much spillage as possible should be absorbed using the procedure detailed above.
The soft furnishings should be quarantined away from patient areas until a risk assessment has been performed. The size and nature of the spillage must be ascertained. This information must be relayed to QA/QC Department, Moor House on 3927043 or 3927030 who will advise on individual circumstances. It may be necessary in some circumstances to destroy the item/s or to employ specialist cleaning.
Where spillage occurs onto bed mattresses and pillows, these should be cleaned with detergent and hot water but should be discarded as cytotoxic waste if:

  • Heavily soiled or contaminated
  • The mattress/pillow casing covering is split, or
  • The surface cannot be cleaned.

The Environmental Manager (on extension 64006) should be contacted for large items that cannot be disposed of using existing means

Spillages onto Linen/Clothing in LTHT
Contaminated linen and clothing should be removed immediately and laundered as soon as possible and handled separately from other items. However, if the spillage is large, then consideration should be given to disposal of the item into a yellow with purple stripe bag.

If the spillage is small, once it has been contained, follow the procedure set out in the LTHT Bagging Policy for ‘Infected Linen’ as follows;

  1. Place the contaminated article in red alginate bag and seal at the point of contamination. This alginate bag is water soluble.
  2. The alginate bag should be placed in a yellow with purple stripe bag to contain any leakage. This outer bag is then also sealed and prepared for laundry following LTHT procedures
  3. This bag is then placed in the usual designated place for collection of linen.

Where the spillage has occurred onto a patient’s own property, a risk assessment should be undertaken which considers the extent of the spill. Where it is felt this is easily contained, the items should be securely double bagged and appropriate advice given to the patient/parent/ carer -see section E.

Spillage onto equipment

  1. Remove any visible surface spill following the instructions for the management of surface spills.
  2. Quarantine any equipment onto which cytotoxic chemotherapy has been spilt.
    If possible, place this equipment inside two yellow cytotoxic chemotherapy bags. Please ensure that the outer bag is a yellow with purple stripe cytotoxic bag. Clearly mark the equipment as contaminated with cytotoxic chemotherapy.
  3. Seek specialist advice from Medical Equipment or Pharmacy about the possible decontamination of the contaminated equipment or need for disposal of the item

Spillage during Transport within LTHT
If a cytotoxic medicine is damaged and leaks during transportation, it should be disposed of immediately into a blue with purple lid bin. The bin should be packed with absorbent cloths before it is sealed, to ensure that the chance of spillage is minimised. If it is thought likely that leakage could occur then place the bin in a yellow with purple stripe waste bag and secure.

Any spillage that has resulted in a leak to the surrounding environment should be handled as described previously.

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2.6 ACCIDENTAL EXPOSURE

Contamination of a person must be dealt with promptly as a priority over any other
All contamination of staff must be reported immediately to the senior nurse on duty.

Accidental Contact of Cytotoxic with Eyes
An eye irrigation kit and access to a mains water supply must be available where cytotoxic medicines are administered to be used in the event of eye contamination.
It is the responsibility of the individual practitioner to ensure that this facility is available at all times in community settings.

Eye wash kits should contain sodium chloride 0.9% and this should be used for all cytotoxic medicines except oxaliplatin. If eyes come into contact with oxaliplatin, sterile water should be used and areas should make sure bottles of this are available to use for this purpose.

If there is any suspicion that there has been exposure of the eye to cytotoxic medicines, then the individual concerned must:

  1. Immediately flood the eye with eyewash solution for at least 10 minutes. This is done by holding apart the upper and lower lids of the eye and exposing the eyeball to the eye wash fluid
  2. Rotate the eyeball to ensure the whole surface has been exposed to eyewash fluid
  3. Remove and discard contact lenses. Do not attempt to clean and re-use
  4. Ensure that the face area is washed with copious amounts of water, as skin contamination may also be likely

Once this has been performed, the individual concerned must attend the accident and emergency department to obtain medical attention. It is important that the individual can communicate the name of medicine to which the eye has been exposed to the medical staff performing the examination.

An incident form should be completed and a copy of the form must be sent to the secretary of the COSHH Steering Group within LTHT pharmacy. (This should be addressed to the QA/QC Department, Moor House on 3927043 or 3927030).

Ensure used eyewash solution is replaced.

Accidental Contact of Cytotoxic with Skin
Any areas of skin that come into contact with cytotoxic medicines must be rinsed immediately with copious quantities of cold water. This is to minimise absorption through the skin.

Contaminated clothing should be removed and handled as described in the section above.

An incident form should be completed and a copy of the form must be sent to the secretary of the COSHH Steering Group within LTHT pharmacy. (This should be addressed to the QA/QC Department, Moor House on 3927043 or 3927030)

Accidental Inoculation of Cytotoxic Medicines
The following immediate first aid measures should be taken following accidental percutaneous inoculation of a cytotoxic medicine:

  1. DO NOT suck the wound.
  2. Needle stick injuries should be gently encouraged to bleed. This can be achieved by squeezing the affected part into disposable material e.g. tissues, or by squeezing into a sink under running warm water. If disposable material is used, it should be discarded of in an appropriate cytotoxic waste container
  3. The wound should be washed with soap and water, dried and covered with a waterproof plaster

An incident form should be completed and a copy of the form must be sent to the secretary of the COSHH Steering Group within LTHT pharmacy. (This should be addressed to the QA/QC Department, Moor House on 3927043 or 3927030)

The Occupational Health Department should be informed.

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2.7 DOCUMENTATION AND REPORTING OF SPILLAGES

Under the requirements of the Reporting of Injuries, Diseases and Dangerous Occurrences Regulations 2013 (RIDDOR), spillages of large amounts of cytotoxic medicines to which people have been exposed is reportable. Small spillages which are easily contained and dealt with are not reportable under RIDDOR. However, all small spillages must be reported on the documentation associated with local reporting procedures (Datix). This will enable any trends/ training needs to be identified and appropriate corrective action taken. A copy of all incident reports must be sent to the secretary of the COSHH Steering Group within LTHT pharmacy. (This should be addressed to the QA/QC Department, Moor House on 3927043 or 3927030

COSHH ASSESSMENTS
All areas in LTHT handling ANY medicines, including cytotoxics must complete annual COSHH assessments. Please refer to the LTHT COSHH policy.
Eating and drinking are prohibited in areas where cytotoxics are prepared or administered

RISK ASSESSMENTS FOR INDIVIDUALS STAFF MEMBERS
Individual person-specific risk assessments should be carried by line managers where there is the potential for harm from exposure to cytotoxic medicines. This is of particular relevance to staff who are trying to conceive, pregnant or are breastfeeding.

HEALTH SURVEILLANCE
There are several methods which have been suggested to monitor the health of staff handling cytotoxic medicines. However, none of the methods have been shown to produce clear evidence of benefit and produce results that are difficult to interpret. For these reasons, the routine monitoring of staff is not undertaken at LTHT.

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SECTION B

3. INFORMATION FOR PHARMACY STAFF

Cytotoxic medicines for parenteral use or oral liquid presentations transported to a clinical area must be packaged to ensure that there is no leak or spillage during transportation.

Packaging must be suitable for the product and sufficiently robust to withstand normal conditions of transport and handling.

Individual patient’s parenteral or liquid cytotoxic medicines are contained in plastic packaging, purpose designed for the transportation of cytotoxic medicines. The plastic packaging is clearly labelled to show the nature of the contents, with an appropriate warning symbol. When batches of individual treatments are delivered to the area of use, they must be transported in a rigid container, able to withstand puncture. Such containers should be;

  • Robust and tamper-evident
  • Able to provide protection for the handler
  • Able to contain any leakage
  • Clearly labelled to state the nature of the contents (for example, cytotoxic or biohazard) with the appropriate warning symbol
  • Labelled with the phrase “It is important that protective equipment is used when cleaning spillage of the contents of this container”
  • Clearly labelled with a contact name and telephone extension number in the case of an emergency

Dedicated and distinct chemotherapy transport boxes are used exclusively for the transport of chemotherapy administered into the cerebrospinal fluid within LTHT. Chemotherapy designated for other routes of administration MUST NOT be transported in these containers.

Vinca alkaloids are only transported in a designated Vinca alkaloid transport box. This is clear box with an orange front.

Medicines which are not cytotoxic should be transported in a separate container from cytotoxic medicines.

Cytotoxic medicines must not be transported using the pneumatic air-tube system. They must be received at their destination by a member of staff who will be responsible for opening the container and ensuring that its contents are appropriately stored before use.

Bulk Unpacking of Cytotoxic Medicines
All staff involved in bulk unpacking of cytotoxic medicines must undertake formal training prior to taking part in this process. The medicine must be received at its destination by a competent trained member of pharmacy staff who will be responsible for opening the package and ensuring that its contents are appropriately stored. The member of pharmacy staff unpacking the cytotoxic medicines must make use of appropriate PPE.

Storage in Pharmacy
Prior to manipulation, cytotoxic medicine that requires refrigeration must be stored either in a cold store on shelving reserved solely for that purpose and clearly labelled as such or in a refrigerator reserved solely for that purpose, and clearly labelled as such.

Prior to manipulation, cytotoxic medicine that requires storage at room temperature must be stored in a store on shelving reserved solely for that purpose and clearly labelled as such or in a cupboard reserved solely for that purpose and clearly labelled as such.

All products must be stored in alphanumeric order. In some circumstances where packaging is similar to other products, risk management may have deemed storage out of alphanumeric order. Local guidance should be followed.

Prior to release of parenteral medicines to clinical areas, cytotoxic medicines must be stored in the designated areas for refrigerated and non-refrigerated items.

Spillages within Isolator Cabinets
The spillage should be managed as follows

  1. Carefully pick up any remaining sharp or broken material with forceps or a wipe and place into a yellow with purple lid sharps bin
  2. For a liquid spill, gently cover and absorb the liquid using available absorbent material.
  3. For a powder spill, switch off isolator immediately and then gently cover the powder with a pre-moistened wipe ensuring minimal agitation of the powder. If necessary further dampen the pre-moistened wipe so that any powder dissolves and the resulting solution is absorbed into the wipe
  4. Place contaminated wipes into a yellow with purple bin sharps bin if spill contained sharp material or into a yellow with purple strip bag if waste doesn’t contain sharp material.
  5. Spray and wipe the affected area as per aseptic cleaning SOP’s.
  6. Repeat the previous step three times and place all contaminated wipes into appropriate waste receptacle as number 4)
  7. Ensure that all waste from the spillage is labelled and treated as cytotoxic waste.
  8. Change isolator gloves (and test glove/sleeve integrity) in accordance with LTH pharmacy procedures.

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SECTION C

INFORMATION FOR NURSING STAFF AND MEDICAL STAFF WHO ADMINISTER CYTOTOXIC DRUGS

Management of Contaminated Patient Waste Products within LTHT
There is evidence to suggest that contamination from the urine, faeces, sweat, saliva, semen or vomit of a patient receiving cytotoxic medicines places handlers at risk of exposure to cytotoxic medicines. Potentially hazardous amounts of these medicines or their active metabolites have been identified in excreta.

Staff handling this waste should wear appropriate PPE gloves and gown. If there is a risk of splashing a mask should also be worn. Pregnant and breastfeeding women should not participate in the management of waste from patient receiving cytotoxic medicine.

The risk period following cytotoxic medicine administration depends on the following:

  • The particular medicine involved
  • Pharmacodynamic factors (dose, route of administration, duration of therapy, renal/and or hepatic function)
  • Concomitant medicine therapy which may influence elimination rates.

As a general rule, the excreta from patients who are receiving these medicines should be assumed to be hazardous for up to 7 days after the completion of treatment.
Waste such as urine, faeces and vomit may be disposed of safely in the normal sewage system. Disposable bedpans and vomit bowls should be used for these patients and should be disposed in the ward macerator. Where children’s nappies may contain contaminated bodily waste matter, these should be disposed of into a yellow with purple stripe clinical waste bag. Particular care should be taken with the urine of patients who have received intravesicular treatment.

Male patients should be encouraged to urinate whilst sitting on the toilet, to minimise splashing. The toilet lid should be put down before flushing to minimise aerosols and patients should be encouraged to double flush the toilet.

Patients using toilet facilities to manage stoma or incontinence care should be asked to dispose of potentially contaminated products into yellow with purple stripe waste bags.

Patients should be advised to wash their hands well after using toilet facilities.

Toilet facilities should be arranged so that patients use separate toilets from carers/visitors and staff.

Spillages of vomit or urine on the floor within the drug specific timeframe must be treated as a cytotoxic spill and cleaned accordingly.

Administration of oral chemotherapy

Patients can be supported to self-administer oral cytotoxic medications using a non-touch technique and advised to wash their hands following taking the tables. If nursing staff are assisting oral cytotoxic administration PPE should be worn. Empty bottles and blister packs should be disposed on in a rigid purple top/blue bottom container for disposal in the cytotoxic waste stream.

Administration of oral chemotherapy to patients unable to swallow tablets or capsules

When patients are unable to swallow oral medications, they may need to be given an oral liquid or capsules may need to be opened or tablets dispersed. The latter two methods should only be used if a liquid preparation is not available. Always refer to the information on the chemotherapy patient information leaflet on how to safely give the medicine to a patient. This leaflet also contains information on the safe disposal of the associated waste.

Near Patient preparation of subcutaneous trastuzumab

Preparation of this treatment should not be undertaken by pregnant or breast feeding nurses

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SECTION D

INFORMATION FOR PORTERING STAFF/ PHARMACY PORTERS AND MESSENGERS

Portering staff are often required to transport patients around LTHT and some of these patients may have cytotoxic medicine infusions attached to them. In the event that the infusions become detached from the patient and leaks on the surrounding area, the porter should;

  1. Obtain help by calling the ward from which the patient was collected
  2. Keep other members of staff or the general public away from the contaminated area
  3. Re-assure the patient

Pharmacy porters and messengers may carry cytotoxic medicines from department to department without a patient.
Should a spillage occur during transportation, the member of staff should

  1. Obtain help by calling the ward or pharmacy
  2. Keep other members of staff or the general public away from the contaminated area
  3. follow advice regarding management of contaminated clothing and/or skin

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SECTION E

6. INFORMATION FOR HANDLING IN PATIENTS HOMES

Storage in Patients Home
Prior to a cytotoxic medicine being supplied for a patient to store at home, the appropriate discharging clinical area should be satisfied that the patient/parent/carer has a good understanding of the hazardous nature of the medicines and the need to minimise risks to other household members and has access to suitable storage facilities.

It is of paramount importance that patients/parents/carers are advised to ensure storage is done safely and securely out of the reach of children and animals. The consequences of inadvertent administration particularly by children may be catastrophic. Parents/carers should be advised not to give parenteral chemotherapy and to avoid handling oral chemotherapy it at all possible if they are pregnant or breast feeding.

Patients/parents/carers should be advised that cytotoxic medicines not requiring refrigeration should be stored in cupboards that are of sufficient height to be able to discourage access to young children. These cupboards should not be near any food or in areas where the temperature could rise above 25°C. Conversely, they should not be stored at a height that increases the risk of falling from its storage place resulting in spillage of contents. Ideally, where possible, the cupboard should be locked.

Patients/parents/carers should be advised that cytotoxic medicines requiring refrigeration should be placed in a rigid container on the bottom shelf of the refrigerator to ensure that the cytotoxic medicine does not come into contact with food.

Disposing of Cytotoxic Medicines and Contaminated Equipment in a Patient’s Home
It is recognised that increasing numbers of patients are being treated either as outpatients or at home and this is generating cytotoxic medicine waste that requires disposal in the home setting. Cytotoxic medicine waste must be disposed of in a safe and timely manner.

Materials used in the preparation and administration of cytotoxic medicines, such as needles, syringes, infusion bags and IV tubing, should be disposed of as cytotoxic medicine waste. Gloves and aprons worn during administration should be disposed of in domestic waste unless they are contaminated. In this case they should be disposed along with the other cytotoxic waste. Needles should not be disconnected from syringes or re-sheathed nor should bags be disconnected from IV tubing before disposal.

Empty containers of chemotherapy capsules and tablets should be disposed of at home in the domestic waste, but unwanted part or full containers should be returned at the next hospital visit to either out-patients or Pharmacy for disposal within LTHT waste streams.

All patients/parents/carers should be advised and given written information on storage, segregation and disposal of waste at home.

Disposing of cytotoxic waste for adult patients receiving ambulatory treatment at home

There may be an increased risk of spillage with some types of infusion devices e.g. elastomeric infusors, which can continue to infuse after disconnection from the patient. These patients should be supplied with a cytotoxic spillage kit and cytotoxic bin to place the infusor pump in and should be instructed to use the clamp on the pump tubing if there is one present to prevent further discharge of the drug.. Patients/carers must be instructed to store their cytotoxic waste bin safely at home somewhere cool and out of the way of children and animals. It should have the lid pulled across but not clicked shut to enable multiple pumps to be fitted in..

Patients who are being treated with topical cytotoxic medicines should be instructed to place gloves, applicators etc inside the cytotoxic waste bin and to return this to the hospital when full or treatment has completed.

In exceptional circumstances where patients are unable to swallow oral medications, they may need to dissolve/disperse their cytotoxic tablets and capsules in water. This can create contaminated cytotoxic medicine waste at home. Patients/parents/carers should be provided with an information leaflet detailing how to safely carry out this procedure and dispose of the associated waste.
N.B There are different solutions to managing dysphagia and advice should be sought from pharmacy before advising this procedure to a patient.

Patients/parents/carers should be issued with a Patient Information Leaflet on Dealing with a spill of chemotherapy at home at the time of first administration. See appendix 1 (text only - awaiting leaflet to be formatted by medical illustrations)

Management of Contaminated Patient Waste Products at Home

Male patients should be encouraged to urinate whilst sitting on the toilet, to minimise splashing. The toilet lid should be put down before flushing to minimise aerosols and patients should be encouraged to double flush the toilet. Particular instructions should be provided relating to the urine of patients who have received intravesicular treatment. In addition to the above guidance they should put bleach around the toilet bowl and leave for 15 minutes following the first time they pass urine after treatment having been instilled.

Patients should be advised to wash their hands well after using toilet facilities.

Patients and parents/carers should be encouraged to maintain high levels of cleanliness in their bathrooms to minimise the risks of contamination. Patients/parents/carers should be advised to inform the people in the household who clean the bathroom to ensure disposable gloves are worn throughout this process.

Parents/carers should be advised to wear disposable gloves when changing nappies or wiping patient’s bottoms and to double bag the nappies before putting them in the domestic waste bin.

If there is an accidental spillage of patient waste onto a hard surface, e.g. vomit, faeces or urine, the person cleaning the spillage must wear disposable rubber gloves and mop up the spillage with disposable adsorbent cloths. The area should be thoroughly washed with hot water. All gloves and cloths used in this procedure should be disposed of by placing in two sealed plastic bags prior to placing in household waste.

Where waste has spilled onto soft furnishings/clothing, as much solid waste as possible should be removed using disposable rubber gloves and cloths. Liquid should be mopped up with disposable adsorbent cloths.

The item should be washed /cleaned. All gloves cloths used in this procedure should be disposed of by placing in two sealed plastic bags prior to placing in household waste.

Spillage outside LTH Premises
It is extremely unlikely that a spillage will occur whilst a patient is outside their home environment. In this circumstance, patients/carers should be advised to raise awareness of the risk to people in the vicinity of the spill. The hospital should be contacted immediately for further advice on spillage containment and management.

Spillage in a Patient’s Home
In order to minimise the impact of nocturnal spillages, patients/carers should be advised to purchase mattress protectors prior to their first cytotoxic medicine infusion delivered at home.

As a minimum, the following patients should be given basic spillage equipment and advised to keep at home throughout their cytotoxic medicine treatment together with some absorbent towel/cloths (eg kitchen roll)

  • Those receiving ambulatory intravenous cytotoxic medicine
  • Those receiving oral cytotoxic medicine, where there is need to disperse prior to administration or where liquid oral cytotoxic medicine is provided for use
  • Those receiving subcutaneous cytotoxic medicine at home via a healthcare provider. This should be supplied by the homecare provider

Patients/carers must be provided with verbal and written information on the management of a cytotoxic spillage at home. These patients should be supplied with 2 pairs of nitrile gloves, 2 plastic aprons, 2 yellow with purple stripe waste bags, a patient information leaflet explaining how to manage the spillage and a cytotoxic waste bin.

In the event of a spillage of a cytotoxic medicine, patients/parents/carers should be advised to ensure the spillage is cleaned as soon as possible.

Patients/carers should be advised to click the lid of their cytotoxic waste bin shut after the spillage has been cleaned and contaminated items have been placed inside it.

For spillages onto linen or clothing:

  1. The soiled items should be put twice through a machine wash cycle, without removing the items from the drum after the first wash. This should be done as soon as possible
  2. Contaminated items should be washed separately from any other laundry
  3. The temperature of the wash should be as hot as possible and the economy programme should not be used, as this does not allow maximum water for rinsing.

For spillages onto unprotected soft furnishings:
The patient/parent/carer should be advised to contact their originating ward/department for advice.
The ward/department should seek advice from the pharmacy department. The advice given will be dependent on the type of cytotoxic medicine spilt, the size of the spillage and the type of furnishings involved. It may be necessary for pharmacy to advise specialist cleansing of the item or disposal.

Management of spills and disposal of cytotoxic waste in Nursing/Care homes
Follow the advice given for patient in their own homes for the management of cytotoxic spillage.
For disposal of cytotoxic waste matter ideally the care facility should obtain a cytotoxic waste collection service if a significant amount of cytotoxic contaminated bodily waste is being disposed of such as stoma bags, incontinence products.

Appendix 1

Patient leaflet How to deal with a spill of chemotherapy at home.

Appendix 2

Guidance for management of telephone call reporting a spillage at home/out of hospital

Provenance

Record: 6727
Objective:
Clinical condition:
Target patient group:
Target professional group(s): Secondary Care Nurses
Adapted from:

Evidence base

Allwood, M., Stanley, A., Wright P. The Cytotoxic Handbook 2002. 4th Edition. Radcliffe Publishing.

Brighton, D., Wood, M. (2005). The Royal Marsden Hospital Handbook of Cancer Chemotherapy. Elsevier. Churchill-Livingstone.

Chemotherapy and Biotherapy Guidelines and Recommendations for Practice. 3rd Edition. 2009. Oncology Nursing Society.

Connor, T (2006) Personal Protective Equipment for use in Handling Hazardous Drugs. National Institute for Occupational Health & Safety.

COSHH regulations 2002: Approved Codes of Practice and Guidance Control of Carcinogenic Substances 2013. 6th Edition. HSE Books. http://www.hse.gov.uk/pubns/priced/l5.pdf accessed 23/5/2019

Department of Health, Technical Memorandum 07-01: Safe management of healthcare waste 2013 Online https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/167976/HTM_07-01_Final.pdf

Dougherty, L. & Lam, J. (2008) Intravenous Therapy in Nursing Practice. 2nd Edition. Blackwell Publishing Limited.

European Community Directive 2002/54/EC.

Health Service Executive. COSHH, A Brief Guide to the Regulations. (2012) http://www.hse.gov.uk/pubns/indg136.pdf accessed 23/5/2019

Heatlh and Safety Executive (2017) Safe Handling of cytotoxic drugs in the workplace via web http://www.hse.gov.uk/healthservices/safe-use-cytotoxic-drugs.htm (accessed 4/2/19)

Health and Safety Executive (2015) Handling Cytotoxic Drugs in isolators in NHS pharmacies online Available at http://www.hse.gov.uk/pubns/ms37.pdf

Manual of Cancer Services Standards (2008)

NHS Pharmaceutical Quality Assurance Committee Guidance on the Safe Handling of Monoclonal Antibody Products, 4th edition January 2008

Occupational Safety and Health information Series. Guidelines for the Safe Handling of Cytotoxic Drugs and Related Waste. Department of Labour (1997).

The Personal Protective Equipment Regulations 2002. Consumer Protection – Health & Safety, Statutory Instrument 2002. No.1144. Crown Copyright

Personal Protective Equipment for Health Care Workers Who Work with Hazardous Drugs online at https://www.cdc.gov/niosh/docs/wp-solutions/2009-106/pdfs/2009-106.pdf?id=10.26616/NIOSHPUB2009106

The Reporting of Injuries, Diseases and dangerous Occurences (RIDDOR) 2013 online at http://www.hse.gov.uk/riddor/ accessed 13/3/19

Approved By

SACT steering group

Document history

LHP version 1.0

Related information

Not supplied

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