Policy & Guidelines for the Safe Prescribing, Dispensing & Administration of Systemic Anti-Cancer Therapy (SACT) for Children, Teenagers and Young Adults under the Care of the Haematology/Oncology Team RHC, Glasgow (Ward 6A and Ward 4B at QEUH – Adult Hospital)
The overall responsibility for the safe delivery of systemic anti-cancer therapy (SACT) rests with the Chief Executive of Greater Glasgow and Clyde. This responsibility is delegated to the SACT Lead for GG&C (Sophie Barrett) who then further delegates this to Professor Brenda Gibson (Haematology Consultant & Link Clinician for Haematology/Oncology) as Lead Clinician for SACT for paediatric services – see Appendix 1 - Reporting Structure
Systemic anti-cancer therapy (SACT) encompasses both cytotoxic chemotherapy and biological therapies. Cytotoxic chemotherapies are potentially carcinogenic, mutagenic and hazardous (as defined by the Control of Substances Hazardous to Health Regulations 2002- COSHH). The risks to patients receiving cytotoxic chemotherapy are well documented and must be balanced against clinical benefit. The risk to staff through occupational exposure is less clear. However, there is sufficient evidence to support the implementation of all necessary measures to limit exposure.
SACT must be prescribed, dispensed, administered and disposed of in accordance with the Medicines Act 1968. CEL 30 (2012), Guidance on the safe use of SACT, describes both best practice and the clinical governance framework for all services delivering SACT in NHS Scotland.
This Standard Operating Procedure (SOP) should be read alongside other relevant and related policies.
These guidelines refer to practice in relation to SACT administration (by all routes), when used for the treatment of cancer.
The term Chemotherapy Handling is used to refer to all elements/pathways of chemotherapy delivery from prescription, dispensing, administration and disposal of (Appendix 2).
The term Practitioner refers to the healthcare professional undertaking prescribing, dispensing and/or administration of chemotherapy. A practitioner is a qualified and appropriately trained nurse, doctor, pharmacist or pharmacy technician. These practitioners must work within their professional competencies.
The term carer refers to the parent /carer who administers oral SACT and to the health care professional or parent/carer who may be dealing with patient waste. This will include any person who may be in contact/handling urine, faeces or vomit from a patient who is receiving SACT.
These guidelines assume that local practices and policies for education and training are in place, that adherence is regularly monitored and audited, and that practices and policies are updated.
2.2 Administration of Intrathecal Chemotherapy (RHC-HAEM-ONC-013)
2.3 Intrathecal SACT Assessment Questions (RHC-HAEM-ONC-015)
2.4 Spillage Procedures for Chemotherapy (RHC-HAEM-ONC-005)
2.5 Prevention, Treatment & Follow-up in the Event of Suspected Cytotoxic Extravasation (RHC-HAEM-ONC-009)
2.6 NHSGGC Vascular Access Procedure and Practice Guideline - hospital policy via Staffnet
2.7 Infection Control policy – hospital policy via NHSGGC website
2.8 Needlestick & Exposure to Bodily Fluids policy – hospital policy via Staffnet
2.9 Safe & Secure Handling of Medicines policy – hospital policy via Staffnet
2.10 Control of Substances Hazardous to Health (COSHH) regulations – hospital policy via Staffnet
2.11 Resuscitation guidelines –Resuscitation page on Staffnet
2.12 GG&C Policy for the Out of Hours Supply of SACT – hospital policy via Staffnet
Departmental SOPs can be accessed in the white lever arch files in the Drs Office in Ward 6A or the paediatric hub in Ward 4B at QEUH – Adult Hospital.
The following staff must be aware of this policy and understand its impact on delivery of SACT:
All staff are responsible for documenting clinical incidents relating to SACT on Datix as soon as possible after the incident has occurred or been discovered.
3.1 LEAD CLINICIAN – PROFESSOR BRENDA GIBSON
The following staff support the Lead Clinician in the safe delivery of SACT in their specific areas:
3.2 PHARMACY SUPPORT
3.3 NURSING SUPPORT
3.4 MEDICAL SUPPORT
3.5 ADMINISTRATIVE SUPPORT
4.1 INFORMATION AND SUPPORT GIVEN TO PARENTS/PATIENTS BY PHARMACY
Both verbal and written information must be available for parents/patients. Clear explanation and instruction must be given throughout the administration of anti-cancer agents. This should include the specific side-effects of the drug(s) being given.
4.2 AREAS SUITABLE FOR INTRATHECAL CHEMOTHERAPY DRUG ADMINISTRATION (SEE INDIVIDUAL DOOR SIGNAGE - IF UNSURE PLEASE CHECK WITH WARD MANAGER)
NB: UNDER NO CIRCUMSTANCES SHOULD INTRAVENOUS AND INTRATHECAL DRUGS BE ADMINISTERED AT THE SAME TIME OR IN THE SAME ROOM/AREA
PATIENTS WHO ATTEND DAY SURGERY FOR ADMINISTRATION OF INTRATHECAL THERAPY AND/OR BONE MARROW ASPIRATE, BUT THE PROCEDURE IS CANCELLED, MUST STILL NEVER RECEIVE INTRAVENOUS VINCA ALKALOIDS ON THAT DAY.
4.3 AREAS DESIGNATED AS SUITABLE FOR INTRAVENOUS CHEMOTHERAPY ADMINISTRATION (SEE INDIVIDUAL DOOR SIGNAGE - IF UNSURE CHECK WITH WARD MANAGER)
NB: ADMINISTRATION OF INTRAVENOUS OR INTRATHECAL CHEMOTHERAPY MUST ONLY BE CARRIED OUT IN DESIGNATED AREAS
All nurses who are new to the Schiehallion Inpatient Ward and Daycare Unit receive induction training which will include an overview of SACT. This will be the responsibility of the Clinical Nurse Educator.
Nursing staff who are involved in the administration of chemotherapy must undergo an accredited Systemic Anti Cancer Therapy course prior to any independent involvement in any aspect of SACT administration.
Nursing staff new to oncology may be involved in the delivery of intramuscular and oral chemotherapy but only under the direct supervision of a chemotherapy trained nurse. All doses of SACT must be checked and signed for by two chemotherapy certified nurses who will check that the name on the patient’s wrist band matches the name on the printed prescription and on the drug product.
SACT must be prescribed on specific chemotherapy prescriptions. A SACT trained nurse is a nurse who has been passed as competent to deliver infusional chemotherapy. Nurses are only deemed competent to administer intravenous bolus chemotherapy when additional training has been completed.
All nursing staff must be aware of and understand the following:
5.1.1 Annual Updates:
Nurses involved in the delivery of SACT must complete the E-learning (Learn-Pro) module on chemotherapy / SACT delivery annually.
5.1.2 Biannual Updates:
Nurses involved in any aspect of the administration of intrathecal chemotherapy must complete the chemo competency IT assessment – RHC-HAEM-ONC-015 every 2 years.
Intrathecal cytotoxic drugs can only be checked by a registered nurse who is listed on the directorate intrathecal register for this role.
5.2 PRE-ADMINISTRATION VERIFICATION CHECKS – PRIOR TO FIRST AND SUBSEQUENT CYCLES OF SACT:
5.3 VENOUS ACCESS
5.4 SELECTION OF CANNULATION SITE
Joint flexions should be avoided and in particular the antecubital fossa, especially for vesicants.
If a vein in the antecubital fossa has to be used this should be flushed with 20mls 0.9% saline prior to bolus administration or infusion. The cannula should be flushed with 30mls of 0.9% saline post administration (weight appropriate volume in infants). The site must be observed throughout the infusion.
5.5 GENERAL GUIDELINES FOR HANDLING AND ADMINISTRATION OF CHEMOTHERAPY BY NURSING STAFF
5.6 GENERAL COMMENTS ON INTRAVENOUS ADMINISTRATION
5.7 STORAGE AND COLLECTION OF CHEMOTHERAPY AGENTS
Children with cancer or associated disorders may be referred by primary, secondary or tertiary care. Appropriate investigations to establish the correct diagnosis and stage of disease is the responsibility of the consultant. Similarly it is the responsibility of the child’s consultant to arrange any necessary investigations to monitor response to treatment, including any toxicities and to investigate suspected or confirmed relapse. Each new patient will be discussed at the disease specific MDT where the diagnosis will be confirmed and treatment agreed. These decisions are recorded on a proforma which is signed off and filed in the patient’s case record. A copy is sent to the patient’s GP. Patients are re-discussed at the MDT at the time of relapse or following any event which might require a change of treatment. They are also discussed at disease specific weekly on-treatment meetings with particular emphasis on toxicities and chemotherapy planning/ordering.
It is the responsibility of each consultant to obtain informed consent for treatment irrespective of whether the patient is on or off trial.
It is also a consultant responsibility to allocate treatment and to ensure that the relevant up to date treatment protocol is available. Copies of all protocols and guidelines are maintained by data management.
All children are treated on NCRI trials if these are open for their particular disease. In the absence of a clinical trial they will be treated on a national guideline. The exceptional child with an extremely rare disorder may be treated according to best practice. The diagnosis and treatment with expected benefits, outcomes and risks are explained to the parents/child.
Written trial specific and age-appropriate information is given to the parents/patient and following an appropriate period of time to allow parental/patient understanding, written consent is obtained. Consent will be documented on a generic consent form for all patients and in addition on a trial specific consent form if recruited to a clinical trial. The site file for each trial will list the medical practitioners who can take consent. Patients/parents/carers for whom English is not their first language will be offered the services of an interpreter at the time of diagnosis, when consent is taken, and later as required.
All patients will be assessed by a doctor or ANP immediately prior to receiving chemotherapy. This assessment will include general fitness for chemotherapy, performance status (PS), necessary critical tests and the presence of associated toxicities.
The results of any clinical test required prior to chemotherapy commencing, PS and grading of any toxicity / co-morbidity MUST be completed and signed off by the doctor/ANP prior to authorising any new course of chemotherapy. Haematological toxicity does not have to be completed for patients with acute lymphoblastic leukaemia/lymphoma, during maintenance treatment when blood counts are reviewed regularly and doses of chemotherapy titrated accordingly
In the very rare circumstance where a chemotherapy trained doctor or ANP is not available to authorise a patient’s treatment a member of the Schiehallion medical team can sign the authorisation, but only after discussion with a Consultant. This must be clearly documented on the prescription and the entry must be countersigned by the Consultant at the earliest opportunity.
The medical practitioner will have received structured education on the principles of chemotherapy. They will have completed induction training within the unit and been deemed competent prior to prescribing cytotoxic drugs. Only consultants, staff grades and trainees of ST4 level and above can prescribe chemotherapy and only after appropriate training.
This SOP assumes that local practices and policies for education are implemented and carried out within the haematology/oncology unit and that adherence to these will be regularly monitored, audited and updated.
The individual practitioner must be familiar with, and adhere to, related policies and protocols noted in section 8 – Related Documentation.
Intrathecal cytotoxic drugs will only be administered by doctors of ST4 level and above, staff in non-Consultant Career Grades and Consultants who have Division certification and are listed on the intrathecal register.
NB: DOCTORS IN TRAINING WILL NOT ADMINISTER BOLUS VINCA ALKALOIDS BY PERIPHERAL VENOUS ACCESS. THIS WILL ONLY BE DONE BY SACT INTRAVENOUS BOLUS TRAINED NURSING STAFF.
Written informed consent for treatment must be taken at an appropriate period of time after the patient/parent has been provided with verbal and written information. This information should be provided by the medical practitioner responsible for starting or initiating the next course of SACT.
6.1 INITIAL TREATMENT DECISION
6.2 SACT PROTOCOL
Only a doctor of ST4 and above who has completed the appropriate medical training on chemotherapy can prescribe SACT, with the exception of Hydroxycarbamide which can be prescribed by named nurse prescribers:
All unexpected adverse drug reactions should be reported to www.mhra.gov.uk/yellowcard . In addition , all adverse events occurring in patients not treated on trial will be discussed at the daily handover and the event and management of the SAE will be recorded in the patient’s casenotes. Those requiring treatment modification will be recorded on the treatment plan within the shadow notes .
The performance status must be assessed and recorded prior to each course of chemotherapy
NB: THE INITIAL DECISION TO ADMINISTER CYTOTOXIC CHEMOTHERAPY IS MADE BY AN ACCREDITED HAEMATOLOGY/ONCOLOGY CONSULTANT OR AN APPROPRIATELY TRAINED AND COMPETENT NOMINATED DEPUTY AND THE DECISION MUST BE CLEARLY RECORDED IN THE PATIENT’S CLINICAL NOTES
NB: A VALIDATED ELECTRONIC CHEMOTHERAPY PRESCRIBING SYSTEM IS OPERATING AND UNDER ONGOING DEVELOPMENT WITHIN THE SCHIEHALLION UNIT. ALL PROTOCOLS WILL IN TIME BE AVAILABLE ELECTRONICALLY. IN THE EVENT OF A SYSTEM FAILURE, STAFF WILL REVERT TO PAPER TEMPLATE PRESCRIBING
6.4 OUT OF HOURS
In the absence of medical staff of appropriate grade on site, minor changes to prescribed/scheduled intravenous chemotherapy (such as date/time or pharmacy instituted rounding up or down of doses) can be made by ST3 medical staff after authorisation from the consultant on call and in consultation with the nurse in charge of the unit. Treatment must be countersigned on the ward chart the next day by the consultant.
In the exceptional circumstances that chemotherapy is required out of hours, the requesting consultant will contact the on-call pharmacist who will liaise with a Cancer Care Pharmacist and the out of hours Pharmacy Aseptic Team as per the GG&C Out of Hours Supply of SACT policy.
6.5 DEFERRING OF CHEMOTHERAPY
It is very important to record the reason for any deferral of chemotherapy courses. This should be documented in the appropriate section at the front of the chemotherapy template prescription or electronically on ChemoCare. The reason for the deferral and the next intended treatment date must be recorded.
If any chemotherapy course is delayed for more than 7 days the patient’s consultant must be informed. If a deferral results in a modification to the intended course of treatment the prescription must be amended appropriately or rewritten. Any change to a prescription must be clearly annotated and signed by an appropriate chemotherapy prescriber and the reason documented on the prescription. Any major change must also be documented on the patient treatment plan. Any modified/rewritten prescriptions must be given to the appropriate clinical pharmacy team for rescreening.
Any deferral of chemotherapy must be completed on the appropriate prescription (template or Chemocare) by a member of the clinical team who has reviewed the patient and made the decision to defer. Within the Schiehallion Ward this must be a chemotherapy trained member of medical staff or ANP. Within DCU this can be a chemotherapy trained member of medical staff, ANP, senior nurse in charge or paediatric oncology outreach nurse specialist.
PHARMACEUTICAL VERIFICATION, PREPARATION AND DISPENSING OF SACT
NB: If Chemocare fails the contingency plan is that standard prescription templates on Q pulse will be used. If the internet access fails electronic back-up templates on the pharmacy server will be used. If all IT fails a paper-based generic prescription sheet will be used.
Appendix 1: reporting structure
For the duration of the decant from RHC to QEUH any documentation reflecting Ward 2A (ie record of chemotherapy issued to Sch Ward) will remain the same.
Last reviewed: 01 April 2020
Next review: 30 April 2022
Author(s): Prof Brenda Gibson
Approved By: Sch Clin Gov Group
Document Id: RHC-HAEM-ONC-014