CLINICAL GUIDELINE and Subcutaneous Chemotherapy For use in (clinical areas): Macmillan Unit For use by (staff groups): Registered Nurses (see section 5) For use for (patients): All patients requiring cytotoxic drug therapy Document owner: Cytotoxic Users Group Status: Approved Contents Page 1 Purpose 2 2 Introduction 2 3 Personal Protective Equipment 2 4 Staff authorised to cannulate and administer chemotherapy 2 5 Staff authorised to check chemotherapy 2 6 Prescription 2 7 Consent for treatment 2 8 Critical test results 3 9 Drug Checks 4 10 Administration of cytotoxic drugs via a peripheral cannula 5 11 Administration of cytotoxic drugs via a central venous access device (CVAD) 6 12 Administration of Subcutaneous Chemotherapy 8 13 Patient education 8 14 Documentation 8 15 References 8 16 Development of the guideline 9 Source: Cytotoxic Users Group Issue date: February 2011 Page 1 of 10 Status: Approved Valid until: February 2012
1. Purpose This guideline is for use within the Macmillan Unit for all those Registered Nurses involved in the preparative checks and administration of cytotoxic drugs, to ensure safe practice in the checking & administration of cytotoxic drugs. 2. Introduction 2.1. At all times two NMC registered nurses are responsible for the checking procedure prior to the administration of cytotoxic drugs (or one nurse and one doctor/pharmacist, see section 5) 2.2. All areas where chemotherapy is to be administered should have access to an emergency bell, resuscitation equipment, anaphylaxis equipment, extravasation and spillage kits 2.3. Additional checks are required for intrathecal chemotherapy administration. Staff should refer to the policy and procedure for intrathecal chemotherapy prior to undertaking any aspects of checking or administration. 3. Personal Protective Equipment 3.1. At all times when handling cytotoxic drugs staff must wear: Disposable Aprons Latex (PVC if allergic to latex) Gloves 3.2. Staff are advised to wear protective eye goggles when handling cytotoxic drugs 4. Staff authorised to cannulate and administer chemotherapy (excluding intrathecal) 4.1. Only staff who have completed their cannulation training within the Macmillan Unit and/or have been assessed as competent can cannulate patients receiving chemotherapy, with the following exception: HSCW band 3 and below can not cannulate patients who are receiving any drug which may cause an extravasation as either documented in the Cancer Chemotherapy Book or on the labels produced by pharmacy. 4.2. A registered nurse (RN) who has completed and been assessed as competent in: IV drug administration package Cytotoxic drug administration training package Mandatory cardio pulmonary resuscitation (Annual Updates) The use of the individual infusion and volumetric pumps used in the department 5. Staff authorised to check chemotherapy A RN who has completed module 4 of the chemotherapy education package and/or been assessed as competent and medical staff authorised to prescribe chemotherapy. Source: Cytotoxic Users Group Issue Date: February 2011 Page 2 of 10
6. Prescription of Cytotoxic Drugs Refer to West Suffolk Hospitals Prescription, Dispensing and Administration of Cytotoxic Drugs. 7. Consent 7.1. It is the responsibility of the prescribing doctor to ensure written consent is obtained prior to prescribing chemotherapy on a West Suffolk Hospital Macmillan Unit Chemotherapy Consent form, completing an additional Clinical Trial consent form if appropriate. 7.2. It is the responsibility of the consenting doctor to discuss the treatment intent, scheduling, potential side effects and late complications with the patient. 7.3. Consent forms should be completed in full with a patient addressograph, treatment for which the patient is being consented and which information sheets have been given to the patient 7.4. For oncology patients the details should include: For trial treatment, the trial name and arm of the trial. E.g. Tango For non-trial treatment, the name of the treatment protocol, e.g. E-CMF chemotherapy 7.5. For haematology patients the details should include: For trial treatment, the trial name: e.g. AML 15 chemotherapy For non-trial treatment, where a patient is going to be prescribed a specific drug regimen, the name of the treatment protocol should be stated: e.g. CHOP For non-trial treatment, where a patient may receive a different drug regimen each cycle, the name of the diagnosis should be stated: e.g. AML chemotherapy (i.e. where a patient may receive ADE followed by MACE followed by MIDAC etc throughout their treatment regimen). 7.6. The patient should sign and print their name and date the consent from. 7.7. One copy of the consent form is filed in the patient s medical records, a second copy is attached to the chemotherapy prescription chart, and a third copy offered to the patient. 7.8. If a patient is not legally competent to give consent, i.e. he/she is unable to comprehend and retain information to and /or unable to weigh and use the information that has been given to make an informed decision, the doctor proposing the treatment should complete the West Suffolk Hospital Consent Form Number 3. It should also be stated in the medical notes that treatment is being given in the patient s best interest. 7.9. No one can give consent on behalf of an incompetent adult. If the patient lacks capacity to consent all discussion with relatives/carers relating to the proposed treatment should be clearly documented in the patients medical notes. 7.10. When undergoing preparative checks prior to the administration two RN s will ensure that the patient has fully completed a consent form, and that the confirmation of consent is signed 8. Critical Test Results Source: Cytotoxic Users Group Issue Date: February 2011 Page 3 of 10
8.1. All critical test results should be checked in accordance with requirements documented on the prescription sheet, i.e., full blood count, creatinine/creatinine clearance, liver function tests, lung function tests, cardiac function 8.2. Haematology Results 8.2.1. Full blood counts (FBC) must be reviewed prior to the administration of any chemotherapy. 8.2.2. For the first cycle of chemotherapy an FBC taken within 2 weeks prior to the administration of treatment is satisfactory Consultant Patient Group FBC Parameters Haematology Consultants Oncology Consultants All newly diagnosed haematology patients starting chemotherapy. All haematology patients (>1 st cycle) Breast, Upper GI, Lung, Colorectal, Urology, Lymphoma First course of chemotherapy; FBC irrelevant, proceed with treatment. Subsequent cycles Hb irrelevant Neutrophils > 1.0 x 10 9 /l Platelets >100 x 10 9 /l Hb irrelevant WBC irrelevant Neutrophils > 1.0 x 10 9 /l Platelets >100 x 10 9 /l 8.3. Any FBC results outside the stipulated values should be discussed with the prescribing doctor prior to the administration of chemotherapy, unless the doctor has annotated in the patients medical notes or on the chemotherapy chart the reason for proceeding with the treatment protocol. The outcome of any discussion regarding the above should be clearly documented in the nursing documentation. 8.4. If Hb < 10 9 /l discuss with Prescribing doctor / Clinical Nurse Specialist regarding need for blood transfusion. 8.5. For patients in clinical trials, refer to the clinical trials protocol or the clinical research nurses. 8.6. Biochemistry and Liver Function Tests Consultant All consultants Biochemistry Parameters ie U s & E s + LFT s Any new change outside normal limits discuss with Prescribing Consultant / CNS ie if the patient is known to have metastatic liver disease and has always had abnormal liver function tests, unless there is a significant change in the results, there is no need to discuss with the prescribing Consultant. NB Chemotherapy is not to be given is the potassium level is less then 3 Source: Cytotoxic Users Group Issue Date: February 2011 Page 4 of 10
8.7. Organ Function Any organ function results pertinent to the particular chemotherapy regimen i.e. creatinine clearance, lung function, should be reviewed by medical staff and documented on the chemotherapy prescription chart. 8.8. Microbiology Tests All patients in the following groups will need to be MRSA screened prior to commencing their treatment. Patients who are having a CVAD/PICC line inserted New patients who have not been previously screened Patients restarting treatment who have not been screened in the last 12 months 8.9 Timings of Blood Tests for Oncology Patients Diagnosis Oesophageal/Gastric Patients ECF/ECX/E-Carbo-F, Mitomycin 5FU,Carbo/Etop Lung Patients Cisplatin/Vinorelbine Carbo/Vinorelbine Cisplatin/Gemcitabine Carbo/Etoposide Cisplatin/Pemetrexed Docetaxol Colorectal Patients IrMdG/OxMdG OxCap/XELIRI Blood tests FBC within 72 hours of day 1 chemo. FBC within 72 hours of day 1 chemo and FBC within 36 hours of day 8 chemo. FBC within 72 hours of day 1 chemo. CEA every 4 weeks U&E/LFT every 2 weeks FBC within 96 hours of day 1 chemo. Prostate and Bladder Patients Docetaxol Mitoxantrone Carbo/Etoposide Carbo/Gemcitabine FBC within 96 hours of chemo FBC within 72 hours of day 1 chemo. FBC within 72 hours of day 1 chemo and FBC within 36 hours of day 8 chemo. Source: Cytotoxic Users Group Issue Date: February 2011 Page 5 of 10
Breast Patients E-CMF FEC-Docetaxol EC-Docetaxol Docetaxol Tratuzumab FBC within 96 hours of day 1 chemo. Baseline U&E/LFT/FBC & MUGA Then 4 monthly Diagnosis Pancreatic Patients Mayo 5-FU Gemcitabine Clinical Trials Blood Tests FBC within 72 hours of day 1 chemo. FBC within 72 hours of day 1 chemo and FBC within 36 hours of day 8 chemo and day 15 chemo. Consult trial protocols, or as above. 9. Drug Checks 9.1. Following the prescription checks two RN s will check the drugs that have been supplied by the pharmacy department. 9.2. Two RN s will check the patients surface area and calculate the drug doses to be administered. 9.3. The drugs supplied will be checked against the prescription to ensure: Correct patient and hospital number Correct drug(s) and dose, according to the regimen & cycle number prescribed That the drugs are within their expiry date Correct dilution and volume, and any hydration required Correct route of administration Correct rate of administration The batch number(s) on the prescription chart correlate to the cytotoxic drugs supplied That there are no signs of precipitation or discoloration That the drugs have been stored correctly Identify whether any photosensitivity is stated. Identify whether any specific administration sets are required That supportive drugs have been prescribed & administered according to regimen That the correct cycle has been prescribed 9.4. The same two RN s should then identify the patient. 9.5. For in-patients the patients hospital identification band should be checked against the prescription chart and drug. Source: Cytotoxic Users Group Issue Date: February 2011 Page 6 of 10
9.6. For outpatients, the patients should be asked to state his or her name, date of birth and address. This should be checked against those on the prescription chart. 9.7. Both RN s should sign the prescription chart. 10. Administration of IV Cytotoxic Drugs via a Peripheral Cannula 10.1. Peripheral cannulae should be inserted as per the West Suffolk Hospital protocol (Intravenous Cannulation B11). Chemotherapy must not be administered through veins within the anti-cubital fossa. If the patient has a thrombus the contra lateral arm should be used in preference. 10.2. Chemotherapy should be administered via the smallest gauge and shortest length cannula considering the type and duration of treatment. Ideally a 24gauge or 22gauge peripheral cannula should be used. 10.3. If administering chemotherapy via an existing peripheral line extreme care should be taken to ensure that the line is patent and blood can be bled back from the cannula. 10.4. Extreme caution must be taken if multiple cannulation attempts have been made as this carries a high risk of extravasation. 10.5. Always ensure that the cannula is inserted above the site of same day venepuncture or unsuccessful cannulation 10.6. An absorbent pad should be placed underneath the arm/wrist through which the chemotherapy is to be given 10.7. Administer any anti-emetics or appropriate drugs as prescribed 10.8. Administer the chemotherapy drugs in turn giving the vesicant drugs first. The patency of the venous access should be assessed and tested prior to and at regular intervals during the administration of any cytotoxic drugs 10.9. For bolus injections commence a free flowing infusion of compatible fluid using a chemotherapy infusion set to ensure patency, stop the infusion, attach the chemotherapy syringe to the connector port of the infusion set, restart the infusion and then slowly inject the drug into the line ensuring that the infusion runs continuously throughout the period of injection. Ensure that the gauze is placed under the connector port whilst administering the bolus. 10.10. If giving several drugs the cannula should be flushed between drugs to prevent interaction this can be done using the fast running infusion of compatible fluid 10.11. Whilst administering the chemotherapy the site of cannula entry should be visible at all times monitoring for signs of extravasation. 10.12. Should any signs or symptoms of complications such as leakage, venous irritation, allergic reaction, flare reaction, anaphylaxis or extravasation occur, stop infusion or bolus immediately. 10.13. For extravasation please refer to Trust policy for Extravasation CG100058 10.14. Following completion of the bolus injection the syringe is removed from the infusion set with gauze and placed directly into a cytotoxic sharps bin. 10.15. For chemotherapy infusions attach the infusion bag to the infusion set on a horizontal surface, hang the chemotherapy from the drip stand and set the correct rate for the infusion using either the roller clamp or infusion pump Source: Cytotoxic Users Group Issue Date: February 2011 Page 7 of 10
10.16. The nurse should monitor the patient appropriately for any adverse drug reactions and advise the patient to call for assistance of he / she fells unwell 10.17. Following completion of a cytotoxic drug infusion the empty infusion bag should be removed using gauze and placed directly into the cytotoxic sharps bin. The 50ml flush of compatible fluid should be attached to the infusion set and infused at the same rate as the cytotoxic drug. 11. Administration of Cytotoxic Drugs via a Central Venous Access Device (CVAD) 11.1. Place an absorbent sheet beneath the patient line 11.2. Access the CVAD in accordance with WSH guidelines and confirm patency of line 11.3. Connect an appropriate IV chemotherapy administration set primed with compatible fluid to act as a free flowing infusion 11.4. Instruct the patient that they must inform a nurse of any neck or shoulder pain, or any discomfort, pain, burning or stinging at the line site or associated areas at anytime during the administration of cytotoxic drugs 11.5. Administer any anti-emetics or appropriate drugs as prescribed 11.6. Administer the chemotherapy drugs in turn giving the vesicant drugs first 11.7. For bolus injections commence a free flowing infusion of compatible fluid using a chemotherapy infusion set to ensure patency, stop the infusion, attach the chemotherapy syringe to the connector port of the infusion set, restart the infusion and then slowly inject the drug into the line ensuring that the infusion runs continuously throughout the period of injection 11.8. Following completion of the bolus injection the syringe is removed from the infusion set with gauze and placed directly into a cytotoxic sharps bin. 11.9. For chemotherapy infusions attach the infusion bag to the infusion set on a horizontal surface, hang the chemotherapy from the drip stand and set the correct rate for the infusion using either the roller clamp or infusion pump 11.10. The nurse should monitor the patient appropriately for any adverse drug reactions and advise the patient to call for assistance of he / she fells unwell 11.11. Following completion of a cytotoxic drug infusion the empty infusion bag should be removed using gauze and placed directly into the cytotoxic sharps bin. The 50ml flush of compatible fluid should be attached to the infusion set and infused at the same rate as the cytotoxic drug. 11.12. Following completion of the chemotherapy, the CVAD should be accessed according to the WSH guidelines the infusion set should be removed and placed directly into a cytotoxic sharps bin. 12. Administration of Subcutaneous Chemotherapy All chemotherapy for subcutaneous use should be prepared in cytotoxic pharmacy. 12.1. Staff must wear latex (or PVC if allergic to latex) gloves at all times when handling cytotoxic drugs Source: Cytotoxic Users Group Issue Date: February 2011 Page 8 of 10
12.2. Ensure preparative checks have been carried out by 2 RN s prior to administration as per 11.1-11.6 12.3. Carry out the subcutaneous injection as per Trust Guidelines for Intramuscular and Subcutaneous Injections A16 12.4. Ensure gauze available for immediately post injection to absorb any leakage and dispose of all equipment into a cytotoxic sharps bin 13. Patient Education 13.1. Prior to administration the nurse should ensure that the patient is fully informed and has received the up to date written information about their anticancer therapy from CancerBackup. 13.2. Following administration of chemotherapy the nurse should ensure that the patient has A follow up appointment for their consultant and next chemotherapy treatment TTOs with administration instructions Ensure patient aware of appropriate action to be taken should they develop complications Appropriate information sheets see Pre Treatment Checklist in Medical Notes The patient has received the Macmillan Unit Handbook, which continues their treatment plan and any monitoring requirements necessary Relevant contact numbers in the event of problems Spillage kit if being discharged with an ambulatory infusion device 14. Documentation 14.1. Both nurses should sign the prescription chart, clearly indicating who was responsible for checking/administering the chemotherapy. 14.2. Any incident that occurs during the procedure should be reported in accordance with the Trust incident reporting policy. 15. References: 15.1. RCN (1998) Clinical Practice Guidelines. The administration of cytotoxic chemotherapy Technical Report 15.2. RCN (1998) Clinical Practice Guidelines. The administration of cytotoxic chemotherapy. Recommendations 15.3. Trust Policies, Procedures, Protocols & Guidelines: Prescription, Dispensing & Administration of Cytotoxic Drugs, PP(05)116 Nursing & Midwifery Guideline for Intravenous Cannulation, B11 Emergency treatment Guideline for Extravasation, CG100058-6 Nursing & Midwifery Guideline for Intramuscular and Subcutaneous Injections, A16 Incident Reporting & Investigation, PP(05)105 15.4. LILLY (2001) Cytotoxic Chemotherapy 5th Edition Source: Cytotoxic Users Group Issue Date: February 2011 Page 9 of 10
15.5. Cancer Chemotherapy Book (Guidelines for admistration of chemotherapy and nursing care of cancer patients) 2008 Lilley 6 th Edition 15.6. Intrathecal Chemotherapy Policy CG10052-4 Development of the guideline Changes compared to previous document Updated to reflect change in timings for pre chemotherapy FBC results for OXCAP & XELIRI regimes. Statement of clinical evidence Refer to references in section 19. Contributors and peer review The clinical guideline has been reviewed & approved for publication by the Consultant Medical Staff. Distribution list/dissemination method Haematology and Oncology medical and nursing staff will receive an internal memo informing them of the location of the new guideline on the Pink Book. Document configuration information Author(s): Members of the Cytotoxic User Group Other contributors: N/R Approved by: Cytotoxic Users Group, Nursing Directorate Issue no: 8 File name: Supercedes: Issue 7 Additional Information: N/R Source: Cytotoxic Users Group Issue Date: February 2011 Page 10 of 10