CLINICAL GUIDELINE FOR ANTIEMETIC USE IN PAEDIATRIC ONCOLOGY 1. Aim/Purpose of this Guideline

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1 CLINICAL GUIDELINE FOR ANTIEMETIC USE IN PAEDIATRIC ONCOLOGY 1. Aim/Purpose of this Guideline 1.1. This guideline applies to medical and nursing staff working with paediatric oncology patients. 2. The Guidance 2.1. General Guidance: Administer first dose intravenously at least 15 minutes before commencing chemotherapy IV preparations to be used ONLY during chemotherapy or where there is a high emetogenic risk, and then switch to oral unless unable to tolerate When using combined chemotherapy use antiemetics appropriate for the most emetogenic drug Consider treating as second line if recent anti-emetic failure Anti-emetic failure 4 hours of nausea or two vomits in 24 hours 2.2. Anticipatory nausea and vomiting: Consider giving a dose of lorazepam the night before chemotherapy especially in teenagers and young adults where this element can sometimes predominate 2.3. Refractory emesis Hyoscine patches are a useful adjunct. Levomepromazine may be added as third line for refractory emesis. Aprepitant may be considered for children > 12 years suffering severe n&v post-cisplatin or other highly emetogenic chemotherapy 2.4. TTO s and oral anti-emetics Ensure TTOs supplied are in-line with child s anti-emetic requirements considering chemotherapy received and previous experience TTOs should be limited to a maximum of 5 days. In patients undergoing intensive chemotherapy blocks it may be appropriate to provide sufficient medication to cover the whole block of treatment. Patients/parents should be advised when to stop antiemetic treatment to ensure treatment is not overused, and use should be reviewed regularly 2.5. Duration Regular antiemetics should be reviewed 1-2 days after completion of chemotherapy. Those drugs marked with a black triangle may cause delayed emesis, which may require longer treatment with antiemetics Page 1 of 11

2 2.6. Choice of Antiemetic According to Chemotherapy Regime: Chemotherapy Regimen Carmustine > 250 mg/m 2 Cisplatin Clofarabine Cyclophosphamide >1000mg/m 2 Cytarabine > 1000mg/m 2 Dacarbazine Ifosfamide Melphalan Thiotepa > 300mg/m 2 Actinomycin D Busulfan Carboplatin Carmustine < 250 mg/m 2 Cyclophosphamide 750mg- 1000mg/m 2 Cytarabine mg/m 2 Daunorubicin/Doxorubicin / Epirubicin / Idarubicin Irinotecan Etoposide (oral) Imatinib Lomustine Methotrexate > 250 mg/m 2 Mitoxantrone Procarbazine Temozolomide Radiotherapy, lower chest and abdomen Cyclophosphamide < 750mg/m 2 Cytarabine 100mg/m 2 Etoposide Methotrexate mg/m 2 Thiotepa < 300mg/m 2 Topotecan Triple IT Asparaginase Bleomycin Cladribine Fludarabine Hydroxycarbamide Mercaptopurine Methotrexate IT Methotrexate < 50mg/m 2 Rituximab Thiotepa Tioguanine Vinca alkaloids Emetogenic Risk High 60-90% Moderate 30-60% Low 10-30% Minimal <10% Anti-Emetics First Line Second Line Ondansetron IV pre-chemotherapy As for first line and consider adding: then PO BD for up to 48 hours (see notes) Regular Metoclopramide PO/IV PLUS OR Dexamethasone IV/PO BD for Change to Cyclizine PO/IV each day of chemotherapy Hyoscine patch Metoclopramide TDS PRN Ondansetron IV pre-chemotherapy then PO BD for up to 48 hours (see notes) Metoclopramide TDS PRN Ondansetron IV pre-chemotherapy then PO BD No medication Antiemetic failure: Consider levomepromazine or Aprepitant with next cycle As for first line and consider adding: Regular Metoclopramide PO/IV OR Change to Cyclizine PO/IV Hyoscine patch Dexamethasone IV/PO Antiemetic failure: Consider Levomepromazine or Aprepitant with next cycle As for first line and consider adding one of the following: Domperidone po/pr OR Metoclopramide po/iv Hyoscine top Cyclizine po Consider Ondansetron when required. Additional antiemetics such as metoclopramide and hyoscine can be considered as necessary NOTE: Aprepitant can be used with highly emetogenic chemotherapy where there is anti-emetic failure. This is unlicensed in children and use should be discussed with the PTC. Aprepitant increases dexamethasone levels and may increase the risk of encephalopathy when used with ifosfamide, and this should be considered before use. Page 2 of 11

3 Antiemetic Drug Information: Anti-emetic Dose Comments Preparation Cyclizine (Antihistamine) Dexamethasone (Steroid) Hyoscine Hydrobromide (Anti-muscarinic) IV /PO < 6 years 0.5-1mg/kg TDS (max. 25mg) (unlicensed) 6-11 years 25mg TDS years 50mg TDS Not to be used with metoclopramide IV to be given over 3-5 minutes. If given IV it may cause disorientation and dizziness. If this occurs give injection more slowly. NB IV unlicensed in children IV/PO 2mg/m 2 BD DO NOT USE if: - Chemotherapy includes steroids - Patient is on a brain tumour protocol Topically: 1month-3 years ¼ patch 3-9 years ½ patch > 9 years 1 patch Give 1 st dose with ondansetron 15 minutes before chemotherapy. Give injection slowly Do not give doses too close to bedtime (causes insomnia) Wash hands after applying and wash skin area after removal Apply patch every 72 hours to a clean, dry, hairless area of skin behind the ear, avoiding any cuts or irritation Ideally occlude unrequired portion of patch E.g. If half a patch prescribed occlude the other half with Sleek (waterproof plastic tape). However, patches can be cut with scissors along full thickness of the patch ensuring that the membrane is not peeled away. Do not use with cyclizine due to increased anti-muscarinic side effects Tablets: 50mg scored Injection 50mg/mL Injection 8mg/2ml Oral solution 2mg/5ml Tablets 500mcg (scored), 2mg Transdermal patch 1mg/72 hours Page 3 of 11

4 Anti-emetic Dose Comments Preparation Levomepromazine (Nozinan) (Phenothiazine) Lorazepam (Benzodiazepine) Metoclopramide (Dopamine antagonist) Ondansetron (5-HT3 antagonist) Procyclidine IV/PO micrograms/kg BD Max initial dose 3.125mg (max 25mg/day) IV/PO/SL 1 month 12 years 50 micrograms/kg (max. 1 mg) up to BD > 12 years 1mg IV/PO up to BD IV/PO mcg/kg TDS (max 10mg TDS) IV infusion over 15 minutes 0.15mg/kg BD (max 8mg) PO (based on Body Surface Area) <0.6m 2 2mg BD m 2 4mg BD > 1.2m 2 8mg BD IV Under 2 years: 500mcg-2mg 2-10 years: 2-5mg years: 5-10mg Need to balance sedative and antiemetic effects. Start at lower doses and titrate. Do not give with metoclopramide increased risk of EPS For anticipatory nausea and vomiting start 24 hours before chemotherapy Not recommended < 5 years Maximum 48 hour supply as TTO There are on-going supply issues with the injection. Use oral wherever possible Monitor closely for neurological side effects. MHRA recommends maximum five days continuous treatment. Do not give with cyclizine (reduced effect). Do not give with levomepromazine increased risk of EPS Reduce dose in renal and hepatic failure Treat dystonic reactions with IV bolus of Procyclidine. For dosing see procyclidine entry below. NB Reduced doses required in renal and hepatic failure. Use tablets where possible. For patients unable to swallow tablets use the melt tablets where possible due to cost implications May increase QTc. Ensure K + and Mg 2+ are normal prior to administration. Monitor ECG if administered with other agents that prolong QTc if combination is unavoidable. Should not be used first line non-chemo related nausea and vomiting For dystonic reactions associated with metoclopramide Injection 25mg/ml Tablets 25mg (may be cut into eighths to give dose increments of 3.125mg) Injection 4mg/ml Tablets 1mg (may be give S/L) Tablets 10mg Oral solution 5mg/5ml Injection 5mg/ml Injection 4mg/2ml, 8mg/4ml Tablets 4mg, 8mg Melt tablets 4mg, 8mg Syrup 4mg/5ml Page 4 of 11

5 3. Monitoring compliance and effectiveness Element to be monitored Lead Tool Frequency Reporting arrangements Acting on recommendations and Lead(s) Correct drug use and prescription. Pharmacy ward rounds. S.Tierney Observation and review of drug charts, EPMA system At point of patient contact and 3 yearly review of guideline. Paediatric oncology team S.Tierney- pharmacist Child health audit and guidelines meeting Paediatric oncology team S.Tierney- pharmacist Required actions will be identified and completed in 3-6 months Change in practice and lessons to be shared Required changes to practice will be identified and actioned within 3-6 months. A lead member of the team will be identified to take each change forward where appropriate. Lessons will be shared with all the relevant stakeholders 4. Equality and Diversity 4.1. This document complies with the Royal Cornwall Hospitals NHS Trust service Equality and Diversity statement which can be found in the 'Equality, Diversity & Human Rights Policy' or the Equality and Diversity website Equality Impact Assessment The Initial Equality Impact Assessment Screening Form is at Appendix 2. Page 5 of 11

6 Appendix 1. Governance Information Document Title Date Issued/Approved: June 2017 Clinical guideline for antiemetic use in paediatric oncology Date Valid From: June 2017 Date Valid To: June 2020 Directorate / Department responsible (author/owner): S.Tierney. paediatric pharmacist Dr.K.MacDonald associate specialist Contact details: Brief summary of contents Clinical guideline for antiemetic use in paediatric oncology Suggested Keywords: Target Audience Executive Director responsible for Policy: Oncology Paediatric antiemetic RCHT PCH CFT KCCG Executive director Date revised: June 2017 This document replaces (exact title of previous version): Approval route (names of committees)/consultation: Clinical guideline for antiemetic use in paediatric oncology Paediatric oncology team Child health audit and guidelines Divisional Manager confirming approval processes Name and Post Title of additional signatories Signature of Executive Director giving approval Publication Location (refer to Policy on Policies Approvals and Ratification): Document Library Folder/Sub Folder Links to key external standards Related Documents: Sheena Wallace Not Required {Original Copy Signed} Internet & Intranet paediatrics none Intranet Only 1. Anon HT 3 -receptor antagonists as antiemetics in cancer. Drug and Therapeutics Bulletin 43; 8; Page 6 of 11

7 2. Gralla R.J., Osoba D, Kris M.G. et al (from the American Society of Clinical Oncology) Recommendations for the use of antiemetics: Evidence-based, clinical practice guidelines. Journal of Clinical Oncology 17; 9; Kris M.G., Hesketh P.J., Somerfield P.F., Clark- Snow R. et al American Society of Clinical Oncology guideline for anti-emetics in oncology: Update Journal of Clinical Oncology 24; 18; Antiemetic subcommittee of the multinational association of supportive care in cancer (MASCC) Prevention of chemotherapyand radiotherapy-induced emesis: results of the 2004 Perugia International Antiemetic Consensus Conference. Annals of Oncology 17; Antonarakis E.S., Evans J.L., Heard G.F. et al Prophylaxis of acute chemotherapyinduced nausea and vomiting in children with cancer: what is the evidence? Pediatric Blood Cancer 43; Roila F., Aapro M., Stewart A Optimal selection of antiemetics in children receiving cancer chemotherapy. Support Care Cancer 6; Medicines for Children 2003 RCPCH Publications Limited London 8. BNF-C,. Accessed June Palmer R.. Clinical Guideline: BMT and Paediatric Haematology/Oncolgy anti-emetic guideline. University Hospitals Bristol. Version 2, Feb Correspondence from Merck Sharp and Dohme Ltd Medical Information to Vanessa McLelland 12 Dec Management of Chemotherapy induced nausea and vomiting. Alder Hey Children s NHS Foundation Trust. Accessed on line 5 th Jan Ondansetron (Zofran): risk of QTc prolongation important new intravenous dose restriction. July Drug Safety Update 6(12) afetyupdate/con Domperidone: small risk of serious ventricular arrhythmia and sudden cardiac death. May Drug Safety Update 5(10) afetyupdate/con Training Need Identified? No Page 7 of 11

8 Version Control Table Date Versio n No V1.0 Initial Issue Summary of Changes Changes Made by (Name and Job Title) Dr.K.MacDonaldassociate specialist S.Tierney- Pharmacist Feb 2014 V2.0 Review and re format Dr.K.MacDonald-associate specialist S.Tierney- Pharmacist Tabitha Fergus- deputy ward manager- re format only June 2017 V3.0 Review and re format Dr.K.MacDonald-associate specialist S.Tierney- Pharmacist All or part of this document can be released under the Freedom of Information Act 2000 This document is to be retained for 10 years from the date of expiry. This document is only valid on the day of printing Controlled Document This document has been created following the Royal Cornwall Hospitals NHS Trust Policy on Document Production. It should not be altered in any way without the express permission of the author or their Line Manager. Page 8 of 11

9 Appendix 2. Initial Equality Impact Assessment Form Name of Name of the strategy / policy /proposal / service function to be assessed Clinical Guideline for Antiemetic use in paediatric oncology Directorate and service area: Child Health Name of individual completing assessment: S Tierney 1. Policy Aim* Is this a new or existing Policy? Existing Telephone: Clear guidance on prescribing and recommended medication choice for antiemetic use in paediatric oncology Who is the strategy / policy / proposal / service function aimed at? 2. Policy Objectives* Clear guidance on prescribing and recommended medication choice for antiemetic use in paediatric oncology 3. Policy intended Outcomes* Evidence based standardised practice 4. *How will you measure the outcome? Patient charts and epma review 5. Who is intended to benefit from the policy? 6a Who did you consult with Children and families Workforce Patients Local groups External organisations Other b). Please identify the groups who have been consulted about this procedure. This is not a person-related document What was the outcome of the consultation? This is not a person-related document 7. The Impact Please complete the following table. Page 9 of 11

10 Are there concerns that the policy could have differential impact on: Equality Strands: Yes No Rationale for Assessment / Existing Evidence Age Sex (male, female, transgender / gender reassignment) Race / Ethnic communities /groups Disability - learning disability, physical disability, sensory impairment and mental health problems Religion / other beliefs Marriage and civil partnership Pregnancy and maternity Sexual Orientation, Bisexual, Gay, heterosexual, Lesbian You will need to continue to a full Equality Impact Assessment if the following have been highlighted: You have ticked Yes in any column above and No consultation or evidence of there being consultation- this excludes any policies which have been identified as not requiring consultation. or Major service redesign or development 8. Please indicate if a full equality analysis is recommended. Yes No x 9. If you are not recommending a Full Impact assessment please explain why. No areas indicated Signature of policy developer / lead manager / director T.Fergus Date of completion and submission Feb 2014 Names and signatures of members carrying out the Screening Assessment Keep one copy and send a copy to the Human Rights, Equality and Inclusion Lead, c/o Royal Cornwall Hospitals NHS Trust, Human Resources Department, Knowledge Spa, Truro, Cornwall, TR1 3HD A summary of the results will be published on the Trust s web site. Signed _S.Teirney and K.MacDonald Page 10 of 11

11 Date June 2017 Page 11 of 11