Standard Operating Procedure 18 (SOP 18) Administering Cytarabine to Children in the Community Setting Why we have a procedure? Cytarabine is a chemotherapy drug which is prescribed for some children as a treatment for certain malignancies. Cytarabine has the potential to be carcinogenic, mutagenic and/or teratogenic and can pose a potential risk to any person coming into contact with the medication. This procedure shows clear guidance that should be used to protect patients, staff and families by supporting safe working practices. Appropriately trained staff form the children s nursing team will be able to administer the medication and will support the concept of providing care closer to home. A central venous access device may be used if a child has poor venous access, if the drugs being used are extremely irritant or if the child s treatment will span several weeks or months. Administration of specified and agreed intravenous drugs by bolus can be safely carried out in the child s home via a central venous line. The West Midlands Children s Cancer network Coordinating Group (WMCCNCG) reviews and approves which chemotherapy agents can safely be administered in the home in this region. Standard dose bolus Cytarabine is the only chemotherapy agent which is approved by the WMCCNCG as safe to administer to children in the home Sub Cutaneous Administration Cytarabine by subcutaneous injection is not given as frequently as intravenous but is a route of administration of Cytarabine in the home environment. It is noted in Birmingham Children s Hospital Training package (2008) that it is worth remembering some children prefer to have local anaesthetic cream applied prior to their injection in which case you need to let parents/carers know the timing of your visit. The purpose of this SOP is for staff to follow clear guidelines for administration of Cytarabine to children and young people via a central line in the community with evidence based practice and best practice. Comply with the referring specialist hospital and oncology guidelines. The indication for administration must be within the WMCCNCG CCN List of Low Risk Regimes. This states Cytarabine can be delivered by the Community Nursing teams within the West Midlands. This is routinely administered intravenously but, if needed, can be administered by the subcutaneous route. A community prescription will be completed by the referring hospital clinician Administering Cytarabine to Children in the Community Setting Page 1 of 10 Version 1.0 September 2017
What overarching policy the procedure links to? Children s Community Nursing Team Operational Policy Which services of the trust does this apply to? Where is it in operation? Division Inpatients Community Locations Mental Health Services Learning Disabilities Services Children and Young People Services Who does the procedure apply to? This procedure applies to Trust nurses who are routinely involved with children and young people in administration of intravenous medication via central venous access device or administering cytarabine sub cutaneouly and have completed the training package DVD compiled by Birmingham Children s Hospital (BCH) and Birmingham City University, for administration of cytarabine and assessed by competent practitioner. The clinical staff are responsible for maintaining their own competencies and working within their scope of professional practice. When should the procedure be applied? Cytarabine administration in the community should only be undertaken if: The staff member is assessed as competent to administer this specific medication and feels competent to administer the medication The staff member has undertaken the DVD training provided by the specialist hospital (BCH) The staff member is aware of the following polices- drug administration, central line, sharps, spillage, PPE, adrenaline This SOP has been approved by the relevant Governance Assurance Unit The staff member has the relevant competencies to support this particular SOP (i.e accessing a central line) The relevant, equipment, medication, PPE, prescription charts, patient assessments are available (see below) How to carry out this procedure It is the responsible of the specialist hospital to prescribe the Cytarabine and ensure that the parents/carers receive the correct advice on storage and transportation of the medication. All medication will be stored in the child s home and it is BCH responsibility to ensure the medication is delivered on time BCH should also provide the necessary sharps bins and arrange a system for collecting these. Administering Cytarabine to Children in the Community Setting Page 2 of 10 Version 1.0 September 2017
Prior to Administration 1. Patient is referred to the CCN team for administering Cytarabine in the community 2. Usual referral criteria should be applied (i.e. patient has a Dudley G.P. and is under 18yrs old) 3. A referral form is completed by BCH 4. A prescription sheet is completed by BCH. Two registered nurses should check the prescription sheet for the drug doses, date, time and route of administration and that it is signed, to ensure it is completed correctly. 5. The prescription sheet should be faxed to the community children s nurses and the original should be given to the parents/carers for use in the home setting. 6. Once the course of treatment is completed, both the fax copy and the original copy of the prescription sheet should be filed in the Trust notes. 7. The spillage kit and relevant sharps boxes should be dispensed by BCH 8. The named nurse should ensure that all the relevant PPE, charts/ information has been received. 9. The named nurse should ensure that the correct equipment is available. This will include Gloves, Apron, Armlets, Safety Spectacles, Adrenaline Spillage procedure (recommended by BCH 2010 when handling cytotoxic drugs) Disposal All cytotoxic waste from materials used for the administration in the community should be disposed in sharp containers (purple top bins). Healthcare at Home (BCH) will provide appropriate waste containers. It will be the responsibility of the parents/carers to ensure that the waste is collected/ delivered by Healthcare at home. The relevant contact details will be provided to parents by the oncology team. Excretion Cytotoxic drugs are excreted by different routes such as urine, faeces and vomit and the excretion times vary depending on drug given. Precautions are taken with all patients for 7 days as the chemotherapy may be excreted at various times. It is essential that staff administering chemotherapy are aware of this and can educate patients and families on the precautions to take. Patients/ families and staff should be aware of the following Aprons and gloves need to be worn when handling excretion from patients receiving chemotherapy and these can be purchased cheaply from supermarkets. For dealing with excretions non sterile gloves can be used. In the community nappies should be double bagged to protect refuse collectors regardless of the chemotherapy given. Contaminated clothes and bedding should be washed on a full wash as soon as possible in the home washing machine. This should be washed separately from other clothing and on a cycle appropriate to material being washed. Spillage Please refer to spillage policy. The patient should be discharged from BCH with a spillage kit. Dosage The nurse administering the Cytarabine must be familiar with the prescription and understand that the dose is calculated by the child s surface area A chart of Body Surface Area in Children charts can be found in the BNF for children (latest version). Administering Cytarabine to Children in the Community Setting Page 3 of 10 Version 1.0 September 2017
The administering nurse and the second checker are then able to confirm the dose prescribed with the protocol and check any anomalies with the prescriber prior to commencing administration as per the NMC Standards for the Administration of medication. Drug doses are not included in this SOP in the interests of safety over the progression of time. All dose queries should be checked with the prescribing paediatrician. The Child's parents may also have been issued with a treatment plan which will provide the treatment protocol name, the sequence of drugs used and the dose calculation. Assessment of the Patient Prior to Administering Chemotherapy Regardless of any instruction from another professional to administer Cytarabine via the prescription sheet, the administering nurse must ensure that the patient is fit for treatment. Good basic nursing assessment should confirm this. Are their vital signs within normal parameters? Pulse rate & rhythm, Temperature, Respiratory rate and rhythm (consider nasal flaring, accessory muscle use, mottling, tracheal tug), skin colour. (BP monitoring and pulse oximetry is not necessary for community observations - the vital signs above will be sufficient indication of problems) Is their behaviour and level of play / activity normal for them - include carers views? Is the child drinking well & passing urine normally? Are there signs of dehydration? Is the child vomiting? Is there any diarrhoea? Are there any other signs of infection - e.g. inflamed skin, pain? N.B. A small number of children get a mild fever and mild skin rash when on Cytarabine therapy - but you may wish to discuss such symptoms with the local Oncology Team, until you are familiar with the individual child's pattern on treatment Any concerns with the patient s condition or the methodology of administering the medication should be discussed with family and the oncology team at BCH prior to the administration. If medication is omitted due to the assessment of the child, this should be documented in the child s health records and the referring oncology team/paediatrician should be made aware of the omitted dose. Cytarabine Side-Effects Symptoms that require discussion and / or referral to the referring paediatrician/oncology team Early Effects Mild nausea and vomiting - a few children may require oral Ondansetron which is an anti-emetic drug. This side effect is dose related and therefore not common with out-patient / community bolus therapy. diarrhoea Temporary decrease in blood cell count after 7-14 days, with recovery in 2-3 weeks. The team would have to discuss blood results with Birmingham Children s Hospital. Administering Cytarabine to Children in the Community Setting Page 4 of 10 Version 1.0 September 2017
sore eyes/ skin rashes with high doses (not expected with low doses administered in community) pyrexia - mild low grade fever, alopecia chest pain - rare bone pain & muscle pain - rare urine retention - rare nephrotoxicity is not expected with doses seen in the community, but review drug interactions and bear in mind that children with cancer & leukaemia may have had other nephrotoxic drugs. Cytarabine syndrome - bone & muscle pain, chest pain, fever, general weakness, reddened eyes, and skin rash. Not expected with dose administered in the community. Late Effects liver toxicity kidney toxicity Central Nervous System toxicity (not expected with dose administered in community) Equipment Required Prescribed Cytarabine in a prefilled luer lock intravenous syringe that is labelled with the dose and the child s name. The syringe must be in date Saline injection 10mls and in date Heparin 100 units/ml (2ml ampoule) per lumen and in date Prescription chart that is fully and correctly completed Drug information chart Filter needles Intravenous 10 ml syringes Sharps bin for Cytotoxic use (purple lid) Single use disposable Apron Single use disposable armlets Goggles Single use disposable gloves as required Closed system bung Sterile dressings Tray Cleaning wipes 70% alcohol & 2% chlorhexidine Swabs 2% chlorhexidine in 70% IPA Anaphylaxis pack to be used in an emergency Spillage Kit Administering Cytarabine to Children in the Community Setting Page 5 of 10 Version 1.0 September 2017
Using a Central Venous Line to Administer Cyterabine ACTION 1. Before any treatment, an age appropriate explanation should be given to child and family of the steps to be taken. Ensure verbal consent is taken and documented in the child s notes. 2. Check heparin prescription and appropriate medication prescription is present in the child s home notes. Check child s name, address and date of birth with the parent/carer who is present. Check expiry date of the drug and the dose. 3. Wash hands as per Trust policy, dry thoroughly. Collect all equipment. Apply protective clothing including armlets/ eye protection, dressing pack. 4. Collect all equipment and calculate the correct dosage of medication of Cytarabine. The child s weight is required and the dose is calculated at per square meter using the calculator in the BNF for children (latest edition). The mg per square meter should be prescribed on the sheet. 5. Disinfect a tray with 70% Isopropyl alcohol and allow to dry. Empty a dressing pack onto this surface ensuring a non-touch technique. 6. Open sterile equipment onto dressing pack. If using 2% Chlorhexidine gluconate in 70% Isopropyl alcohol solution pour into gallipot or open 70% Isopropyl alcohol wipes. 7. The Cytarabine syringe will come prelabelled. With scissors cut open the packet and carefully place syringe ensuring key parts are uppermost and not in contact with tray. 8. Check and open saline vial and heparin vial and place next to sterile field. 9. Open sterile gloves onto dressing pack. Alcogel hands, allow to dry and then apply sterile gloves. 10. Draw up saline and heparin in separate intravenous syringes. Label all syringes appropriately. Use filter needles for glass vials. RATIONALE To reduce distress and ensure that the child and family are aware of the procedure and can actively cooperate. Ensure safe drug administration. To ensure the correct dose of medication is to be given for the child. To reduce risk of infection Ensure correct drug and dose are given. To prevent glass particles being drawn into injectable solutions. Administering Cytarabine to Children in the Community Setting Page 6 of 10 Version 1.0 September 2017
ACTION 11. Discard needles directly into sharps bin. Expel air from intravenous syringes. 12 Encourage parent/carer to prepare their child as required. Help the child get into a comfortable position. Ask child or parent/carer to expose line. 13. Check the catheter, clamp and bung for damage or displacement. Check the catheter exit site for pain, redness or swelling. 14. Place dressing towel under the line. Use 2% Chlorhexidine gluconate in 70% Isopropyl alcohol solution or 70% Isopropyl alcohol wipe to clean bung and end of central line then discard bung. Allow to dry for at least 30 seconds. 15. Attach a 10mls syringe and slowly withdraw 3-5 mls blood and discard. Clamp on positive pressure. 16. Attach the pre-filled syringe with the Cytarabine drug. Slowly administer the medication, according to recommendations. Clamp on positive pressure 17. Use saline-labelled 10ml IV syringe to flush the line with at 10mls of saline. Close clamp on positive pressure, remove syringe and replace on the edge of the sterile field. If there is any resistance or pain close clamp and seek advice. 18. Slowly inject the heparin, do not empty the IV syringe completely. When there is 1ml left in the IV syringe continue to inject, but at the same time, close the clamp i.e. still exerting positive pressure. Repeat for each lumen if required. 19. Secure the central line ensuring the end is covered for protection when appropriate. Make sure the child is comfortable and replace clothing. 20. Ensure needle and syringes have been disposed of in a cytotoxic sharps bin (purple lid). Remove gloves and PPE and dispose as of Trust policy. RATIONALE To prevent needle stick injury prevent air embolus To encourage child and family participation. To enable the detection of a displaced damaged catheter. To ensure it is safe to proceed. To ensure bung is changed regularly. To check the line patency and to expel previous hepsal To ensure the correct administration of prescribed drugs. To prevent the mixing of incompatible drugs To heplok the central venous line. To prevent occlusive clot formation. To minimize the risk of line displacement. To maintain a safe environment. To minimize the risks of cross Administering Cytarabine to Children in the Community Setting Page 7 of 10 Version 1.0 September 2017
ACTION 21. Wash and dry hands, apply Alco gel as per hand washing policy. 22. Ensure prescription is signed and care is recorded in the nursing documentation. RATIONALE To minimize the risks of cross To ensure compliance with medication regime and document any problems that may have arisen. Administering Cyterabine Sub Cutaneouly Equipment 23-25 G needle Single use gloves, eye protection and apron Sharps bin (purple lid) Plaster or small dressing Prescription chart that is fully and correctly completed Drug information chart Prescribed Cytarabine in a prefilled luer lock intravenous syringe that is labelled with the dose and the child s name. The syringe must be in date Tray Anaphylaxis pack to be used in an emergency Spillage Kit ACTION 1. Before any treatment, an age appropriate explanation should be given to child and family of the steps to be taken. Ensure verbal consent is taken and documented in the child s notes. 2. Check appropriate medication prescription is present in the child s home notes. Check child s name, address and date of birth with the parent/carer who is present. Check expiry date of the drug and the dose. 3. Wash hands as per Trust policy, dry thoroughly. Collect all equipment. Apply protective clothing including armlets/ eye protection, non-sterile gloves 4. Collect all equipment and calculate the correct dosage of cytarabine. The child s weight is required and the dose is calculated at per square meter using the calculator in the BNF for children (latest edition) as prescribed. 5. Disinfect a tray with 70% Isopropyl alcohol and allow to dry. Empty a dressing pack onto this surface ensuring a non touch technique. 6. The Cytarabine syringe will come prelabelled. With scissors cut open the packet and carefully place syringe ensuring key parts are uppermost and not in contact with tray 7. Identify the desired site for injection i.e. upper outer arms, the abdomen on either side of umbilicus or upper outer thigh. RATIONALE To reduce distress and ensure that the child and family are aware of the procedure and can actively co-operate. Ensure safe drug administration. To ensure the correct dose of medication is to be given for the child. contamination and infection To ensure the injection is administered safely and appropriately. Administering Cytarabine to Children in the Community Setting Page 8 of 10 Version 1.0 September 2017
ACTION 8. Observe skin to ensure visibly clean. If the skin is visibly soiled, wash it with soap and water and dry. 9. Clean skin using 70% alcohol and chlorhexidine 0.5% swab for 30 seconds and allow to dry. 10. Inject at a 45 degree angle to the skin, while bunching up the skin. 11. Administer the medicine slowly and once complete release the skin. Ideally wait for 10 seconds before withdrawing the needle. 12. Dispose of all equipment. Ensure needle and syringes have been disposed of in a cytotoxic sharps bin (purple lid). 13. If any bleeding is noted, apply gentle pressure and apply a small dressing such as a plaster if necessary. 14. Remove gloves, apron and face protection dispose appropriately. 15. Alcohol hand rub gel may be used on visibly clean hands. 16. Ensure prescription is signed and care is record in the nursing documentation. RATIONALE To reduce risk of infection. To reduce risk of infection. To expose adipose tissue. To allow dissipation of medication. To maintain a safe environment and minimise risk of infection. To prevent haematoma formation To reduce the risk of infection To reduce the risk of infection. To comply with NMC (2008a) Standards for Medicine Management and NMC (2009) Record and Record keeping. Additional Information/ Associated Documents Dimond, B. (1995) Legal Aspects of Nursing. Prentice Hall International: London. Nursing and Midwifery Council (2010) Standards for Medicines Management. NMC: Portland place Infection Prevention and Control Assurance - SOP 1 - Standard Infection Prevention and Control Precautions Waste Management Policy Infection Prevention & Control Assurance Policy Children's Community Nursing Team - SOP 6 - Vascuport Children s Community Nursing Team Operational Policy Where do I go for further advice or information? Team Leader, Physical Health Nurse Training All staff with responsibility for administering the cytarabine will have have the appropriate training and competencies/ training database completed and follow the guidelines & policies provided. Staff must be aware of the local guidance as well as trust wide guidance. Training will be updated every three years and recorded on the training database. Administering Cytarabine to Children in the Community Setting Page 9 of 10 Version 1.0 September 2017
Monitoring / Review of this Procedure In the event of planned change in the process(es) described within this document or an incident involving the described process(es) within the review cycle, this SOP will be reviewed and revised as necessary to maintain its accuracy and effectiveness. Data Protection Act and Freedom of Information Act Please refer to overarching policy Standard Operating Procedure Details Unique Identifier for this SOP is State if SOP is New or Revised BCPFT-CYPF-SOP-OP-18 New Policy Category Executive Director whose portfolio this SOP comes under Policy Lead/Author Job titles only Committee/Group Responsible for Approval of this SOP Month/year consultation process completed Children s Services Month/year SOP was approved June 2017 Next review due June 2020 Disclosure Status Executive Director of Nursing, Quality, AHPs and Psychology Team Leader, Community Paediatric Specialist Team Quality and Risk Safety Group Medicines Management Committee 2017 B can be disclosed to patients and the public Review and Amendment History Version Date Description of Change Sep 1.0 New SOP for BCPFT 2017 Administering Cytarabine to Children in the Community Setting Page 10 of 10 Version 1.0 September 2017