NORTH WALES CANCER SERVICES



NORTH WALES CANCER NETWORK

DRAFT

GUIDANCE ON THE MANAGEMENT OF CYTOTOXIC CHEMOTHERAPY

December 2008

CONTENT

PAGE

1. Policy Statement 3

2. Purpose 3

3. Scope of Policy 3

4. Organisation and Responsibilities 3

5. Definitions 3

6. Facilities, Storage and Transportation 4

7. Personnel and Training 5

8. Safety 7

9.0 Prescribing 7

9.1 Electronic prescribing 8

10. Timing 8

11. Preparation and Labelling 9

12. Cytotoxic Waste 10

13. Cytotoxic Spillage 11

14. Administration of chemotherapy 11

14.1 Administration procedure 11 14.2 Record keeping 11

14.3 Verification Procedure 11

14.4 Consent 11 14.5 Pre-treatment assessment 12

14.6 Chemotherapy referral 12

15. Extravasation 12

16. Audit and External Assessment 12

17.0 Exceptional Circumstances 13

17.0 Administration of chemotherapy in non-essential areas 13

18. Policy Development 13

19. References 14

1. Policy statement

This policy is based upon the recommendations of a report by the Joint Council for Clinical Oncology (1994) and is compliant with the following;

• Department of Health Standards for Cancer Services (2001)

• Manual of Cancer Services (2004) NHS Executive

• National Cancer Standards (2005)

• National Guidance on the Safe Administration of Intrathecal Chemotherapy (2008)

• The Health and Safety at Work Act (1974)

• The Health and Safety Executive Guidance on the Safe Handling of Cytotoxic Drugs (2003)

• Hazardous Waste Regulations (England and Wales), (2005)

• Carriage of Dangerous Goods (Classification, Packaging and labelling) Regulations (1996)

2. Purpose

This guidance is intended to safeguard patients and staff, by defining best practice for all disciplines involved in cytotoxic chemotherapy. The guidance is not intended to be prescriptive but to provide a framework of principles upon which local policies can be based. However, any deviations from this guidance must be specified and justified in any local policy.

3. Scope of policy

This document is primarily aimed at staff delivering chemotherapy for patients with malignant disease, at in-patient, out-patient and community settings.

The guidance applies to;

• oral, intravenous, intra-arterial, intramuscular, subcutaneous, intravesical, intravitreal, intrapleural and subconjunctival cytotoxic drugs.

• all staff involved in any aspect of cytotoxic chemotherapy within the organisation, for example urology, dermatology, ophthalmic, haematology and oncology.

• the administration of other anticancer therapies for example Monoclonal Antibodies.

Intrathecal chemotherapy is within the scope of this policy but is controlled by a separate policy in the organisation adhering to; A Guide to the Safe Handling and Administration of Intrathecal Chemotherapy (WAG, 2008).

4. Organisational responsibilities

Responsibility for compliance with this policy lies with the appropriate Lead Clinician, Lead Nurse and Manager identified and designated as such by the organisation.

5. Definitions

Cytotoxic chemotherapy throughout this policy refers to all drugs with direct anti-tumour activity including conventional anticancer drugs, monoclonal antibodies, partially targeted treatments and drugs such as thalidomide. It excludes hormonal treatment.

Management of cytotoxic chemotherapy includes prescribing, preparation, storage, administration, transportation, safe handling and disposal.

Approved clinical areas are equipped for the administration of cytotoxic chemotherapy. They may be either specialist wards or those on which cytotoxic drugs are an essential part of the treatment of patients, but used less frequently.

In approved areas where the drugs are not used frequently, it may not be possible to ensure that appropriately trained staff are available to administer cytotoxic drugs, in such circumstances patients or staff should be moved as appropriate to ensure safe administration.

Specialist wards or departments are those designated areas within the organisation where cytotoxic chemotherapy is administered as part of everyday practice. These units are equipped for the purpose and have staff trained to administer the drugs and to care for patients who have received cytotoxic chemotherapy.

Approved chemotherapy protocols and regimens. Detailed written chemotherapy protocols should be used for the management of all cancer sites treated by the organisation. Protocols should include regimen/s and indication, drug doses and scheduling, investigations, and dose modifications. Each protocol should be validated by appropriate personnel and contain a date of validation and review. First and second line treatment should be those approved for use in the Network Formulary.

6. Facilities, storage, packaging and transportation

In-patient cytotoxic chemotherapy is administered only in approved clinical areas where it is an agreed part of, or whole of the activity of that ward or department.

Outpatient cytotoxic chemotherapy is administered in approved clinical areas where it is an agreed part of, or whole of the activity of that ward or department.

The appropriate Lead Clinician, identified and designated as such by the organisation, maintains a list of the approved clinical areas within their division. They will ensure that an up to date list of approved clinical areas is available to the relevant wards and departments including pharmacy.

All approved clinical areas must have a copy of the “Guidance for the Management of Cytotoxic Chemotherapy available”.

All clinical areas must have access to a copy of the treatment protocols for the drug regimens used and copies of procedures and equipment necessary for the management of emergencies, such as cardiac arrest, anaphylaxis, extravasation of cytotoxic drugs and spillage of cytotoxic drugs

All approved clinical areas must have a dedicated area within them for the storage and for the organisation of chemotherapy before administration.

Patients receiving cytotoxic chemotherapy in the community should be given verbal and written information on how to handle cytotoxic drugs appropriately (this may be included in the treatment information provided to the patient). This information must include the safe and appropriate storage of cytotoxic drugs in the home, safe disposal of cytotoxic waste; safe transportation of cytotoxic drugs from hospital to home and administration techniques if self-administering the drugs.

A patient information leaflet (PIL) should be provided with oral chemotherapy drugs. Refer to Network and local guidance on oral anti-cancer medicines for further detail.

It is the responsibility of the prescriber to ensure a patient is capable of self-administering oral chemotherapy in the community. If not capable e.g. due to disability such a blindness or learning disabilities, the prescriber must ensure the patient has a support system in place e.g. a family member who can administer, or a district nurse. If in any doubt, a risk assessment should be carried out to ascertain whether treatment should be given, or not given if appropriate arrangements for safe administration cannot be put into place.

All cytotoxic drugs should be packaged;

• to ensure any spillage is contained

• only use luer lock syringes

• be transparent to allow for identification and awareness of leakage

• identifying the hazardous nature of the contents

• offer UV protection if the contents are light sensitive

• indicate the storage requirements once received

Transportation of cytotoxic drugs should;

• utilise containers which provide adequate protection to both the drugs and the environment

• identifying the hazardous nature of the contents

• indicate the storage requirements once received

• allow segregation of drugs for individual patients

For transportation involving a third party, e.g. porter, there should additionally be;

• tamper evident outer containers

• access to a spillage kit

• information on how to deal with a spillage

Take home oral cytotoxic chemotherapy should;

• be labelled with patients name, hospital number, name of drug, dosage, length of treatment, instructions and date dispensed

• contain patient information leaflet

• identify the hazardous nature of the contents, where appropriate

• indicate the storage requirements once received

• offer UV protection if the contents are light sensitive

7. Personnel and Training

The training of staff in all aspects of cytotoxic chemotherapy must be undertaken by staff trained and accredited to do so.

The Medical Director- or an individual identified by the Medical Director to act on his/her behalf must ensure that arrangements are made for the training and assessment of medical staff, to which the responsibility for prescribing of these drugs is delegated.

The organisation must have a named Lead Nurse for chemotherapy who will oversee the training and assessment of nurses involved in administration and checking of cytotoxic chemotherapy.

The Chief Pharmacist in the organisation will ensure that a process is in place where pharmacy staff who prepare, check or supply cytotoxic chemotherapy are trained and assessed regularly.

The appropriate Clinical Director or Lead Clinicians, Lead Nurses and the Chief Pharmacist will maintain up to date registers of accredited medical, nursing and pharmacy staff respectively. The register will include details of the role the individual is accredited to undertake (the registers are held in each area and do not form part of this policy).

A written record of the assessment must be maintained at both a personal and organisational level.

Administration of cytotoxic chemotherapy by intravitreal, subconjunctival and ocular routes will only be carried out by consultant ophthalmologists or specialist registrars accredited to so. There should be separate local policies for these specialised procedures.

Doctors who administer intravenous cytotoxic chemotherapy must;

• Have completed a training programme recognised by the organisation on the administration of cytotoxic chemotherapy. This must include training specific to the route of administration to be used.

• Have had their competence in the administration of cytotoxic chemotherapy, by the route of administration to be used, assessed by the designated assessor.

Registered Nurses who administer intravenous cytotoxic chemotherapy must;

• Have completed a training programme recognised by the organisation in the administration of cytotoxic chemotherapy

• Work in an area where chemotherapy is given regularly, to maintain competency.

• Have had their competency in the administration of cytotoxic chemotherapy assessed annually, by the assigned assessor for the department.

Where administration involves the use of electronic, volumetric, syringe driver or ambulatory infusion pumps, the nurse must be trained and accredited to use the pump in accordance with the organisational requirements.

Nurses caring for patients who have received cytotoxic chemotherapy must be familiar with the appropriate guidelines pertaining to the care of these patients.

Any medical, nursing or pharmacy professional assessed as not competent to practise unsupervised must undergo further training as deemed necessary by their assessor. They must then be re-assessed and deemed competent before being permitted to administer further chemotherapy unsupervised. The Lead Clinician and the Lead Nurse and Chief Pharmacist must be informed if a doctor or nurse is considered to be not competent.

Every professional who administers chemotherapy must keep up to date with current evidence and knowledge regarding chemotherapy administration. Every professional must ensure that they are aware of any new chemotherapy protocol administered for the first time (NMC, 2004).

Having been deemed competent, the onus in then on each individual to only give chemotherapy they feel competent to administer as indicated in the Code of professional conduct, standards for conduct, performance and ethics (NMC, 2004).

8. Safety

The COSHH Regulations (2002) require that monitoring or health surveillance should be implemented if a risk cannot be totally eliminated. Most current methods for staff monitoring are not suitable and produce results that are difficult to interpret, therefore routine health surveillance is not recommended at present.

The adoption of safe handling techniques reduces the potential for exposure to cytotoxic drugs significantly. Records of staff exposure to cytotoxics through spillage, splash or needle-stick injury must be recorded on an Incident Report Form and the individual referred to the Occupational Health Department within the organisation.

All staff handling cytotoxic drugs must be made aware of the risks in relation to pregnancy and conception. This includes male and female staff of reproductive age, including those at risk of occupational exposure through preparation/reconstitution, administration, handling patient excreta/body fluids or cytotoxic waste. All staff must be made aware of the importance of minimising exposure to cytotoxics at all times. Employees should notify their managers as soon as possible if they are pregnant, trying to conceive or are breast feeding. A New and Expectant Mother at Work Risk Assessment Form should be completed in accordance with organisation’s Risk Assessment Policy and appropriate action taken. The Occupational Health Department must be involved. Individuals should be provided with all the information available to enable them to make an informed choice and always be offered alternative duties if they choose not to work with cytotoxics at this time.

All staff involved in the care of patients receiving cytotoxic chemotherapy must challenge colleagues, if, in their judgement, a protocol is either not being adhered to, or the actions of an individual may cause a potential risk to a patient or colleague. Challenging a colleague should not be seen as adversarial, but as an additional check to improve patient safety.

9.0 Prescribing

The decision to treat a patient with cytotoxic chemotherapy should be made by the Consultant and primary chemotherapy discussed at the relevant MDT.

Cytotoxic chemotherapy must be prescribed by a consultant, specialist registrar, staff grade, associate specialist or non-medical prescriber trained to do so. Assurances around the ability of prescribing personnel rest with the Lead Clinician identified by the organisation as responsible for the service.

That Lead Clinician must be satisfied that the Prescriber is trained and competent to prescribe chemotherapy in a manner that meets the requirements of this policy and any local organisational policies relevant to the prescribing of medicines.

Where possible there will be electronic prescribing of all cytotoxic chemotherapy. If this is not feasible a recognised chemotherapy prescription sheet should be used, ideally a pre-printed sheet and the pharmacy department must;

• Hold a register of approved chemotherapy regimens used within the directorate as included in the North Wales Cancer Network Chemotherapy Formulary. The register must indicate a version number for each regimen, the date it was approved and the date superseded or alternative version control method.

• The departmental manager and the haematology/oncology pharmacist must ensure that only the most up to date version of approved treatment regimens are stored in pharmacy.

• Copies of all approved prescribers’ signatures will be held in the pharmacy department.

• Non-formulary regimens and new drugs will only be issued when the Network process of introducing new drugs has been followed.

• Regular use of regimens for first and second line therapy not in the Network Chemotherapy Formulary should be discouraged. The pharmacy department should record instances when the regimens are used and be able to provide this information upon request to the Network.

9.1 Electronic prescribing

The electronic prescribing database is populated with approved protocols, which make up the North Wales Cancer Network Chemotherapy Formulary. It is the responsibility of the systems manager to maintain and update the database.

Each chemotherapy regimen must indicate a version number, the date it was approved and the date it was superseded. Any amendment made to a chemotherapy regimen by the system manager must be validated by another independent pharmacist (QA) and consultant before final approval by the Clinical Director. Copies of all approved prescriber signatures will be held in the pharmacy department.

Authorisation to proceed with the administration of parenteral cytotoxic chemotherapy can be carried out by a validated member of the medical or nursing staff where blood parameters are within acceptable limits and the patient is deemed fit for treatment.

10. Timing

Cytotoxic drug administration is undertaken during normal working hours in order to ensure availability of experienced and senior medical and nursing staff and supporting services, whenever possible.

Some chemotherapy regimens will require administration of drugs to continue overnight or over the weekend. These regimens must be planned and started during working hours unless clinically indicated.

11. Preparation and Labelling

All cytotoxic drug doses must be prepared in the pharmacy department.

Requests for cytotoxic doses should be submitted to the pharmacy at least 48 hours before a dose is required. There will be an agreed cut-off time for each pharmacy cytotoxic department for doses required the same working day, requests after this time will be subject to availability of pharmacy and nursing staff. Requests made on the day of treatment will also be subject to availability of nursing and pharmacy staff.

The organisation should have a system in place to provide urgent out of hours chemotherapy.

The pharmacy will adhere to Medicines and Healthcare Products Regulatory Agency (MHRA) requirements and with NHS standards for aseptic preparation as appropriate.

Preparation and supply are carried out under the supervision of an appropriate pharmacist with relevant experience in aseptic services and oncology/haematology.

The preparation of cytotoxic chemotherapy is undertaken by pharmacy assistants, pharmacy technicians or pharmacists who have received the appropriate training and have been assessed competent.

A written record of the competency assessment is maintained at a personal and organisational level.

The Chief Pharmacist is to be informed when pharmacy staff are accredited or lose accreditation.

Labelling of all cytotoxic chemotherapy should include the following;

• Patient name and hospital number

• Date of preparation

• Name and dose of product

• Route of administration

• Expiry

• Batch number

• Storage conditions

• Wording that identifies the product as a cytotoxic drug

Labelling and dilution of vinca alkalods (vincristine, vinblastine, vindesine and vinorelbine) for intravenous use must be in accordance with CMO (2008), prepared in an infusion bag and administered over 5 minutes monitoring the patient throughout, and must be positively labelled. The pharmacies must ensure labels have in addition to the above details a clear warning of the consequence of administration by other routes- “For Intravenous Use Only - Fatal if given by other routes”

12. Cytotoxic Waste

Any unused chemotherapy should be stored within the clinical area in a designated location where the pharmacy staff can collect or the nursing staff can return to pharmacy at the next available opportunity.

Discontinued infusion bags containing residual fluid should remain connected to the infusion set and clamped. The bag should then be treated as cytotoxic waste and disposed of in an empty sharps bin.

Legislation requires the organisation to segregate hazardous waste from non-hazardous waste. All cytotoxic drugs are classed as Hazardous waste and should be disposed of according to the organisation’s policy on disposal of hazardous waste.

The ward or department manager is responsible for the cytotoxic waste generated during the administration of cytotoxic drugs until the authorised waste collector or porter collects it from the ward or department.

Responsibilities of the ward manager include;

• To ensure adequate secure storage is provided for cytotoxic waste

• To ensure cytotoxic waste is appropriately packaged, sealed, identified and labelled as cytotoxic waste

• To ensure cytotoxic waste is segregated from other clinical waste and special waste at the point of production

Responsibilities of waste collectors and porters;

• Internal transport and storage of cytotoxic waste – The authorised waste collector/porter is responsible for the delivery of cytotoxic waste to a secure central storage facility on site.

• Consignment to Third Party for disposal – Where cytotoxic waste is to consigned to a third party for disposal, the collector/porter is responsible for the completion of the appropriate consignment note.

Responsibilities of the organisation’s Waste Manager include;

• Ensuring trust waste collecting staff and external contractors, who collect waste from wards and departments within the trust, are trained in the operation of this policy and in the safe handling of cytotoxic waste.

• To ensure a secure storage area is made available for the on site storage of cytotoxic waste, following collections from wards and departments within the organisation, prior to consignment to external contractors for transport and disposal.

• Completion and archiving of documentation relating to the transport and disposal of cytotoxic waste is maintained in line with current legislation.

• During the selection and monitoring of external contractors for the transport and disposal of cytotoxic waste, ensuring that contractors undertaking this activity are licensed by the Environmental Agency to undertake these activities.

13. Cytotoxic Spillage

All staff involved in chemotherapy, or the collection and transport of cytotoxic waste, should be familiar with the relevant organisational policies. Staff should be trained to deal with cytotoxic spillage in accordance with this policy.

Cytotoxic spillage kits must be available to all staff involved in the preparation/administration of chemotherapy or the collection and transport of cytotoxic waste.

All spillage should be recorded on a Trust Incident Reporting form.

14.0 Administration of chemotherapy

14.1 Administration Procedure

All staff involved in administration of chemotherapy should be familiar with organisational policy for administration of chemotherapy by all routes, for dealing with spillage, human waste and extravasation.

14.2 Record keeping

Adherence with the organisation Policy for Medical Records is essential. Prior to each cycle of chemotherapy, there should be treatment records of each of the following;

• The results of essential serial investigations applicable to that cycle (and prior to an administration within a cycle, if applicable)

• Any dose modifications and whether or not they are intended to be permanent

• Any cycle or administration delays

• Any introduced support drugs

• An appropriate weight should be available

14.3 Verification Procedure

There should be a verification procedure, which is carried out before each physical administration of chemotherapy, in accordance to the organisation Medicines Policy to ensure that the following aspects are correct;

• Patients identification on prescription chart and on all labelled drugs

• Critical test results

• Regimen and individual drug identification

• Diluents and dilution volumes, and any hydration

• Supportive drugs have been given as per prescription

• Administration route and duration

• Cycle number

• The administration as per the schedule within the cycle

14.4 Consent

Written consent must be obtained before a regimen is commenced. If a further or different regimen is used then a new consent form must be processed.

Adequate explanation of what treatment is being prescribed and potential side effects should be given, supported with generic and specific written information.

The practitioner administering the first treatment must ascertain that the patient has given informed consent and understands sufficiently the potential side effects to treatment and completes the consent form accordingly. Adherence to the Trust Consent Policy is essential.

The completed consent form should be evident in the patient’s medical or chemotherapy notes and the patient should be given a copy.

14.5 Pre treatment assessment

Prior to administration of chemotherapy, by any route a pre treatment physical and psychosocial assessment must take place and be documented in the patient’s medical notes. If and when appropriate, the patients’ carer’s needs must be reviewed and support/ referrals made.

14.6 Chemotherapy Referral

There should be treatment record for each patient prior to the start of a course of chemotherapy containing the following;

• Patient identification

• Weight, height, surface area

• Cancer type

• Treatment intention if possible to categorise (palliative, curative, neo-adjuvant, adjuvant)

• Regimen and doses (including all cytotoxic chemotherapy drugs to be used and elective essential support drugs other than antiemetics)

• Route of administration (oral, IV, IM, SC)

• Number of cycles intended

• Frequency of cycles and of administrations within a cycle

• Investigations necessary prior to starting the whole course

• Investigations to be performed serially during the course (to detect/monitor both toxicity and response) and their intended frequency

• For palliative, curative and neo-adjuvant treatments, i.e. any treatment other than adjuvant; the maximum number of cycles after which the response to treatment is to be reviewed prior to continuing the course

• Attendance managed by agreed non-medical staff e.g. nurse led attendances

15. Extravasation

The organisation policy on Extravasation should be followed.

16. Audit and external assessment

All the above measures should be audited.

The Trusts’ waste disposal contractor is audited on a monthly basis by members of the All Wales Clinical Waste Consortium (representatives from each of the Trusts in Wales), to ensure that they are compliant with their PPC licence and that the Trusts’ duty of care is not compromised. All incidents involving the cytotoxic waste consigned for transfer to a third part will be reported via the Trusts’ Adverse Incident Reporting System.

17.0 Exceptional circumstances

Occasionally, in emergencies, it is necessary to start cytotoxic chemotherapy outside normal hours. The decision to do so must be made by the patient’s consultant. A risk assessment must be undertaken and documented by the patient’s consultant.

The patient’s consultant must complete a Clinical Incident Report Form (IR1) so that the frequency of these events can be monitored. The incident should be categorised as “Other: chemotherapy outside normal hours”

17.1 Administration of chemotherapy in non-essential areas.

Occasionally it may be necessary to administer cytotoxic drugs to patients on approved, but non-specialist wards, where there are insufficient suitably trained nursing staff.

It is the patient’s consultant’s responsibility to manage clinical risk and a risk assessment must be undertaken and documented by the consultant.

This may include negotiating for the transfer of the patient to an area in which the drugs can be administered by suitably trained staff or for suitably trained staff to come to the approved area to administer drugs.

If the transfer of patients or staff is necessary, the patient’s consultant must complete a Clinical Incident Report Form, so that the frequency of these events can be monitored. The incident should be categorised as “Other: chemotherapy administration on non-specialist area” or “Other: patient transferred for chemotherapy”, as appropriate.

Some departments use cytotoxic chemotherapy on an occasional basis. In this circumstance, it may not be possible to maintain a sufficient number of nurses who are trained, assessed and accredited to administer cytotoxic chemotherapy as described above. An alternative is for the department to identify key nurse who can administer the chemotherapy. The following conditions should apply:

• The designated nurse/(s) should be the sole person performing this procedure.

• Have completed an appropriate training programme recognised by the organisation in the administration of named chemotherapy

• Have had their competency in the administration of cytotoxic chemotherapy assessed annually, by the assigned assessor for the organisation.

18. Policy development

Key personnel and departments have been consulted and have contributed to the development of this Policy.

References

Administration of cytotoxic therapies by registered nurses: a guide to the issues involved. (1999) Welsh Association of Chemotherapy Specialist Nurse Group.

Administering subcutaneous methotrexate for inflammatory arthritis. RCN Guidance for Nurses (2004)

A Guide to the Safe Handling and Administration of Vince Alkaloids. CMO (WAG 2005, 2008)

A Guide to the Safe Handling and Administration of Intrathecal Chemotherapy CMO (WAG 2005, 2008).

Cancer Services in Wales – Publication of National Cancer Standards and the implication for Commissioners and Providers, through the Cancer Networks. WHC (2005) 051

Environmental protection Act (1990)

Health and Safety at Work Act (1974)

Lisa Dougherty, Sara Lister, eds. The Royal Marsden Hospital Manual of Clinical Nursing Procedures, 2004: Blackwell, London.

Nursing and Midwifery Council (2004) The NMC Code of professional conduct, standards for conduct, performance and ethics. London; NMC.

National Guidance on the Safe Administration of Intrathecal Chemotherapy. (2001) Department of Health. London

Royal College of Radiologists, London

Standard for Cancer Services (2001), DoH, London

Hazardous Waste Regulations (2005)

Safe Handling of Cytotoxic Drugs (2003) HSE Information Sheet MISC615, Health and Safety Executive.

Quality Control in Cancer Chemotherapy: Managerial and Procedural Aspects (1994). The Joint Council for Clinical Oncology, Royal College of Physicians and Royal College of Radiologists, London.

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