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Anti-Emetics Use in the Prevention and Treatment of Chemotherapy Induced
Nausea and Vomiting Clinical Guideline
V4.0
June 2019
Anti-Emetics Use in the Prevention and Treatment of Chemotherapy Induced Nausea and Vomiting Clinical Guideline V4.0
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1. Aim/Purpose of this Guideline
1.1. This Guideline aims to provide the best anti-emetic prophylaxis to all patients receiving chemotherapy / SACT. 1.2. To reduce inappropriate prescribing of anti-emetics. 1.3. To improve patients understanding and compliance with prophylactic treatment, therefore improving its effectiveness. 1.4. To provide guidance on the prescribing of anti-emetics to all individuals who prescribe chemotherapy / SACT. 1.5. To provide all nursing staff working with chemotherapy / SACT with the evidence and guidance in the management of Chemotherapy Induced Nausea and Vomiting (CINV). 1.6. This version supersedes any previous versions of this document. 1.7. Data Protection Act 2018 (General Data Protection Regulation – GDPR) Legislation The Trust has a duty under the DPA18 to ensure that there is a valid legal basis to process personal and sensitive data. The legal basis for processing must be identified and documented before the processing begins. In many cases we may need consent; this must be explicit, informed and documented. We can’t rely on Opt out, it must be Opt in. DPA18 is applicable to all staff; this includes those working as contractors and providers of services. For more information about your obligations under the DPA18 please see the ‘information use framework policy’, or contact the Information Governance Team [email protected]
2. The Guidance
2.1. Introduction
2.1.1. CINV is a common adverse event associated with cancer treatment especially when administering chemotherapy / SACT. 2.1.2. Up to 80%of patients will experience some form of CINV (cancer.gov 2018). 2.1.3. It can negatively impact on a patient’s quality of life. 2.1.4. Uncontrolled CINV can lead to or prolong hospital admission.
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2.1.5. Apart from the administration of chemotherapy / SACT, there are other factors that can impact on the grade of nausea and/or vomiting experienced by the patient such as:
CINV is more common in people who are anxious / high levels of anxiety relate to a greater risk (NICE 2016).
Previous history of motion sickness leads to a greater risk of CINV (Navari 2015).
Previous history of pregnancy related nausea
Gender – greater risk of CINV in females
Alcohol intake – a lower incidence of CINV is reported by those patients with a long history of alcohol consumption.
Age – a lower incidence of CINV is reported in those below 6 years of age and a higher incidence in those 50 years or above
Previous cycles of chemotherapy / SACT administration where nausea and vomiting were poorly controlled increases the risk of CINV and anticipatory nausea and vomiting (Riola et al 2016). 2.1.6. There are 5 recognised different types of CINV:
2.1.6.1. Acute - occurs within the first 24hrs immediately after chemotherapy /SACT administration. Acute CINV is also related to the emetogenicity of the drug being administered and the dose of that drug. 2.1.6.2. Delayed – Delayed CINV occurs more than 24 hours after the administration of chemotherapy / SACT and symptoms may persist for up to 7 days. 2.1.6.3. Anticipatory – Anticipatory nausea and vomiting (ANV) occurs prior to attending for a new cycle of chemotherapy / SACT. Repeated treatments of chemotherapy / SACT can increase the risk of ANV developing (Kamen et al 2014). It can be attributed to the adverse memory of CINV from previous cycles of SACT and in response to conditioned stimuli (eg. Smell, taste, odour, sights, sounds) or linked to an anxiety response.
2.1.6.4. Breakthrough - CINV is when symptoms of nausea or vomiting are poorly controlled despite the use of standard anti-emetic medications or when anti-emetics are not given for the entire expected period of CINV. It requires the use of additional ‘rescue’ anti-emetics.
2.1.6.5. Refractory – This occurs in subsequent cycles of chemotherapy / SACT, despite the use of anti-emetic agents. Refractory CINV typically occurs when patients fail on both standard and rescue medications.
2.1.7. Other causes of nausea and vomiting should also be considered in the assessment of a patient experiencing CINV and treated accordingly. Examples of these include: medication interactions (eg. opioids, anti-depressants), constipation, bowel obstruction, anxiety, uremia, metabolic abnormalities, radiotherapy and vestibular disease (cancer.gov 2018).
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2.1.8. The SACT prescriber should determine the emetic potential of each drug to be administered and prescribe the appropriate anti-emetic according to the recommended guidelines.
2.2. Pathophysiology of CINV
2.2.1. This process involves a complex network of transmitters and receptors within the body. The emetic response is triggered by the stimulation of receptors in the central nervous system (CNS) and the gastrointestinal (GI) tract, which in turn deliver information to the vomiting centre found within the medulla region of the brain. The chemoreceptor trigger zone is also located in this region and contains many neurotransmitter receptors. 2.2.2. The 3 main neurotransmitters present in the emetic response include serotonin, dopamine and Substance P (Janelsins et al 2013). 2.2.3. Serotonin (5HT) and Substance P are transmitters intrinsically linked to the receptors 5-Hydroxytryptamine (5-HT3) and neurokinin-1 (NK-1). 2.2.4. Medicines that block the neurotransmitter receptors involved in nausea and vomiting are used to control CINV (see 2.6 in this policy for advice).
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2.3. Emetogenic Risk of Chemotherapy / SACT
Each agent has a different emetogenic risk potential. The emetogenic potential of minimal or low risk drugs can be increased when given in combination and consideration of this should be taken when prescribing for combination regimens. (Refer to MASCC/ESMO 2015 guidance for additional drugs)
HIGH EMESIS RISK
IV CHEMOTHERAPY SACT
IV CHEMOTHERAPY SACT
ORAL CHEMOTHERAPY SACT
ORAL CHEMOTHERAPY SACT
Anthracycline/cyclophosphamide combination (AC regime) Cyclophosphamide>1500mg/m2 Carmustine
Cisplatin Dacarbazine Mechlorethamine Streptozocin
Procarbazine Hexamethylmelamine
MODERATE EMESIS RISK
Alemtuzumab Azacitidine Bendamustine Carboplatin
Epirubicin Idarubicin Ifosfamide Irinotecan
Bosutinib Ceritinib Crizotinib Cyclophosphamide
Clofarabine Cyclophosphamide<1500mg/m2
Oxaliplatin Romidepsin
Imatinib Temozolomide
Cytarabine >1000mg/m2 Daunorubicin
Temozolomide Thiotepa
Vinorelbine
Doxorubicin Trabectedin
LOW EMESIS RISK
Aflibercept Belinostat Blinatumomab Bortezomib
Ixabepilone Methotrexate Mitomycin Vinflunine
Olaparib Nilotinib Pazopanib Ponatinib
Afatinib Axatinib Capecitabine Dabrafenib
Brentuximab Cabazitaxel
Mitoxantrone Nab-paclitaxel
Regorafenib Sunitinib
Dasatinib Everolimus
Carfilzomib Catumaxumab
Paclitaxel Panitumumab
Tegafur uracil Thalidomide
Etoposide Fludarabine
Cetuximab Cytarabine <1000mg/m2 Docetaxel
Pemetrexed Pegylated liposomal doxorubicin
Vandetanib Vorinostat
Ibrutinib Idelalisib Lapatinib
Eribulin Etoposide
Pertuzumab Temsirolimus
Lenalidomide
5-Fluorouracil Gemcitiabine Ipilimumab
Topotecan Trastuzumab-emtansine
MINIMAL EMESIS RISK
Bevacizumab Bleomycin Busulfan 2-Chlorodeoxyadenosine
Pembrolizumab Pixantrone Pralatrexate Rituximab
Pomalidomide Ruxolitinib Sorafenib 6-Thioguanine
Chlorambucil Erlotinib Gefitinib Hydroxyurea
Cladribine Fludarabine
Trastuzumab Vinblastine
Vemurafenib Vismodegib
Melphalan Methotrexate
Nivolumab Ofatumumab
Vincristine Vinorelbine
L-phenylalanine mustard
Referenced from: MASCC/ESMO guidelines (2016) MASCC and ESMO Consensus Guidelines for the Prevention of Chemotherapy and Radiotherapy-Induced Nausea and Vomiting: ESMO Clinical Practice Guidelines. F. Roila, A. Molassiotis, J. Herrstedt, M. Aapro, R. J. Gralla, E. Bruera, et al. On behalf of the participants of the MASCC/ESMO Consensus Conference Copenhagen 2015. Ann Oncol. 2016; 27(suppl 5):v119-v133, 2016.
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2.4. Anti-emetics for CINV
2.4.1. Dopamine Antagonists
2.4.1.1. Metoclopramide – The UK MHRA (August 2013) has given new guidance for the administration of oral metoclopramide. A review confirmed the well-known risks of neurological effects such as short term extra-pyramidal symptoms / disorders and tardive dyskinesia. The conclusion was that the risks outweigh the benefits in long term and high dose treatment. If the patient is over 60kg, the dose should be 10mg three times daily (TDS) and if the patient is under 60kg, the dose should be 500mcg per kg of body weight in three divided doses. 2.4.1.2. Domperidone – The UK MHRA (May 2014) gave guidance for domeridone to only be given for symptom relief of nausea and vomiting at the lowest effective dose. Patients being prescribed this should also be considered for any contraindications (eg. cardiac impairment). The recommended dose in adults over 35 kg is 10 mg up to 3 times daily (TDS)
2.4.2. 5-HT3 Receptor Antagonists –
2.4.2.1. A common side effect of 5-HT3 Receptor Antagonists can be constipation and headaches. Patients will need education and advice in the best management of these potential side effects. 2.4.2.2. Granisetron – IV/PO routine. A patch is available for patients for highly emotogenic chemotherapy regimens and would be considered on an individual patient need for patients that would otherwise require IM antiemetic’s in the community setting. Discussion is required with the Specialist Cancer Pharmacist before prescribing. 2.4.2.3. Ondansetron -The UK MHRA has given guidance for the administration of IV ondansetron based on further information on the risk of dose-dependent QT interval prolongation, (first reported in August 2012). 2.4.2.4. The updated guidance is the following: for patients aged 65 years or older, all IV doses should be diluted in 50–100mL saline or other compatible fluid and infused over at least 15 minutes. The maximum single IV dose of ondansetron may be up to 16mg (maximum 8mg in patients aged 75 years or older.
2.4.3. Corticosteroids Dexamethasone
2.4.4. Benzodiazepines Lorazepam
2.4.5. Neurokinin NK1 receptor antagonist Aprepitant
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2.5. Additional points
2.5.1. The suitability of the anti-emetics outlined in section 2.6 below should be assessed on an individual patient basis.
2.5.2. Patients must be educated regarding the risk of uncontrolled CINV (acute renal failure due to dehydration) and be given full and clear instructions on how and when to contact the appropriate departments within RCHT. If further advice is needed contact relevant specialist medic, cancer specialist nurse or contact the 24 hour SACT/chemotherapy advice line (mobile telephone: 07833 057 447). 2.5.3. The effectiveness of anti-emetic cover for previous cycles of chemotherapy/SACT should be reviewed and subsequent cover modified accordingly. 2.5.4. For patients who are unable to tolerate oral anti-emetics, other routes of administration can be considered, including suppositories, sub- cutaneous injections and transdermal patches. Advice regarding these can be sought from the Specialist Cancer Pharmacist or from the Palliative Care Team. 2.5.5. Local Joint Formulary can be consulted for advice regarding the management of CINV and for the management of the side effects of the anti-emetics used. 2.5.6. Advice regarding refractory CINV not resolved by standard anti-emetics can be sought from the Palliative Care Team.
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2.6. Recommended Aniti-Emetic Regimens for Chemotherapy/SACT:
Acute Delayed Second line
Highly
5-HT3 Antagonist - Orally/IV prior to each injection And/ or Dexamethasone – 20mg orally/IV starting on the day of chemotherapy, continuing for each day of chemotherapy. Note - Reduce dose to 8mg if using with Aprepitant. And/ or Aprepitant- Orally 125mg on day one, followed by 80mg for two days.
Dopamine Antagonists- normally either: Metoclopramide – dosed as above Domperidone – 10mg orally three times a day (TDS) for 5 days immediately after chemotherapy. And/or Dexamethasone – 4mg orally twice a day usually for 2-5 days. And/or 5-HT3 Antagonist -
Orally/IV continuing twice a day for three days post and then as required by patient.
Aprepitant- Orally 125mg on day one, followed by 80mg for two days.
Lorazepam – 1mg orally, sublingual or IV up to 8hrly. or Cyclizine – 50mg three times a day or 150mg daily by S/C infusion. or Dexamethasone- 4mg
twice a day for up to one week Haloperidol - 1.5-3mg bd or Levomepromazine 6.25mg nocte/bd (or by syringe driver 6.25-25mg over 24 hours) Granisetron Patch – see
notes above
Moderate 5-HT3 Antagonist - Orally/IV prior to each injection of chemotherapy And/or Dexamethasone – 8mg orally/IV starting on the day of chemotherapy.
Dopamine Antagonists- normally either: Metoclopramide – dosed as above Domperidone – 10mg orally three times a day (TDS) for 5days immediately after chemotherapy. And/or Dexamethasone – 4mg
orally twice a day usually for 2-5 days. And/or 5-HT3 Antagonist -
Orally/IV continuing twice a day for three days post and then as required by patient.
Aprepitant- Orally 125mg on day one, followed by 80mg for two days.
Lorazepam – 1mg orally,
sublingual or IV up to 8hrly. or Cyclizine – 50mg three times a day or 150mg daily by S/C infusion. or Dexamethasone- 4mg twice a day for up to one week Haloperidol - 1.5-3mg bd or Levomepromazine 6.25mg nocte/bd (or by syringe driver 6.25-25mg over 24 hours)
Low No routine prohylaxis required Or
Dopamine Antagonists- normally either: Metoclopramide – 10-20mg orally three times a day or Domperidone - 10-20mg orally three times a day (TDS) Both for 4-5days and then as required by patient.
Dopamine Antagonists- normally either: Metoclopramide – dosed as above Domperidone – 10mg orally three times a day (TDS) for 5days immediately after chemotherapy.
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3. Monitoring compliance and effectiveness
Element to be monitored
Effective prescribing of anti-emetic’s for CINV
Lead SACT MDT
Tool ARIA prescribing system / EPMA prescribing system
Frequency As required/ongoing
Reporting arrangements
SACT MDT
Acting on recommendations and Lead(s)
SACT MDT
Change in practice and lessons to be shared
Required changes to practice will be identified and actioned within 3 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, Inclusion & Human Rights Policy' or the Equality and Diversity website.
4.2. Equality Impact Assessment The Initial Equality Impact Assessment Screening Form is at Appendix 2.
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Appendix 1. Governance Information
Document Title Anti-Emetics Use in the Prevention and Treatment of Chemotherapy Induced Nausea and Vomiting Clinical Guideline V4.0
Date Issued/Approved: February 2019
Date Valid From: June 2019
Date Valid To: June 2022
Directorate / Department responsible (author/owner):
Rachel Hopper – Clinical Matron Claire Tapping – Clinical Practice Educator (on behalf of the SACT MDT)
Contact details: 01872 25 3842 01872 25 8095
Brief summary of contents
General overview of CINV including guidance on the prescribing of antiemetic’s for CINV
Suggested Keywords: Emesis, nausea, vomiting, chemotherapy, anti-emetics, SACT
Target Audience RCHT CFT KCCG
Executive Director responsible for Policy:
Chief Nurse
Date revised: February 2019
This document replaces (exact title of previous version):
Clinical Guideline for the use of Anti-emetics for the Prevention and Treatment of Chemotherapy induced Emesis V3.0
Approval route (names of committees)/consultation:
SACT MDT (e-mailed Feb 2018) GSSC Governance DMB (14.04.15)
Care Group General Manager confirming approval processes
Charlotte Timmins
Name and Post Title of additional signatories
Not Required
Name and Signature of Care Group/Directorate Governance Lead confirming approval by specialty and care group management meetings
{Original Copy Signed}
Name: Suzanne Atkinson
Signature of Executive Director giving approval
{Original Copy Signed}
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Publication Location (refer to Policy on Policies – Approvals and Ratification):
Internet & Intranet Intranet Only
Document Library Folder/Sub Folder Clinical / Cancer Services / Cancer Services and General Surgery
Links to key external standards N/A
Related Documents:
2016 MASCC / ESMO guidelines Cancer.Gov (2018) – www.cancer.gov ‘Treatment Related Nausea and Vomiting: Health Professional Version’ (last updated 11/05/2018 – accessed via https://www.cancer.gov/about-cancer/treatment/side-effects/nausea/nausea-hp-pdq/ - accessed online 28/02/2019). Janelsins, M.C, Mohamed, T, Kamen, C, Peoples, A, Mustian, K.M and Morrow, G.R (2013) ‘Current Pharmacotherapy for Chemotherapy-Induced Nausea and Vomiting in Cancer Patients’, Expert Opinion Pharmacotherapy. 2013 Apr; 14(6): 757–766. Kamen C, Tejani M.A, Chandwani K, Janelsins M, Peoples A.R, Roscoe J.A, and Morrow G.R (2014) ‘Anticipatory nausea and vomiting due to chemotherapy’ European Journal of Pharmacology 2014 Jan 5; 0: 10.1016/j.ejphar.2013.09.071. Roila F, Molassiotis A, Herrstedt J, Aapro M, Gralla R.J, Bruera E, et al (2016) MASCC and ESMO Consensus Guidelines for the Prevention of Chemotherapy and Radiotherapy-Induced Nausea and Vomiting: ESMO Clinical Practice Guidelines. On behalf of the participants of the MASCC/ESMO Consensus Conference Copenhagen 2015. Ann Oncol. 2016; 27(suppl 5):v119-v133, 2016. NCCN (2011) National Comprehensive Cancer Network (NCCN). Anti emesis. NCCN Guidelines 2011; Version 3. 2011. http://www.nccn.org/professionals/physician_gls/PDF/antiemesis.pdf (accessed 15/02/19). Navari R M (2015). Management of Nausea and Vomiting. Cancer
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Management. 1st June 2015 (accessed via https://www.cancernetwork.com/cancer-management/management-nausea-and-vomiting - accessed online 27/02/2019). NICE (2016) Prevention of chemotherapy induced nausea and vomiting in adults: netupitant/palonosetron -Published: 01/03/2016 (accessed via https://www.nice.org.uk/advice/esnm69/chapter/key-points-from-the-evidence - accessed online 27/02/2019).
Jordan K, Sippel C, Schmoll H, ( 2007) Guidelines for Antiemetic Treatment of Chemotherapy- induced Nausea and vomiting: past, Present and Future recommendations. The Oncologist 12; 1143-1150 Joint Formulary Committee (2010) British National Formulary 60 September. BMJ publishing group Ltd and RPS Publishing London. Joint Formulary for Royal Cornwall Hospitals Trust (2010) Cornwall Partnership & IoS Community Health Services and GP’s, Nurses and other non- medical prescrbers within Cornwall and Isle of Silly
MHRA
Training Need Identified? No
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Version Control Table
Date Version
No Summary of Changes
Changes Made by (Name and Job Title)
2006 V1.0 New policy
Not known
2011 V2.0 Revised, new trust format
Lisa Nicholls Chemotherapy CNS
2015
V3.0
MRHA alerts, new template,
Lisa Nicholls and Caroline Tonkin Chemotherapy CNS
February 2019
V4.0
MHRA updates (section 2.6), new trust template, revised content, title change.
Rachel Hopper - SACT Lead /Clinical Matron
Claire Tapping - Clinical Practice Educator
(on behalf of the SACT MDT)
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 for the Development and Management of Knowledge, Procedural and Web
Documents (The Policy on Policies). It should not be altered in any way without the express permission of the author or their Line Manager.
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Appendix 2. Initial Equality Impact Assessment Form
Name of the strategy / policy /proposal / service function to be assessed Anti-Emetics Use in the Prevention and Treatment of Chemotherapy Induced Nausea
and Vomiting Clinical Guideline V4.0
Directorate and service area: Cancer Services
New or existing document: Existing
Name of individual completing assessment: Claire Tapping / Rachel Hopper on behalf of the SACT MDT)
Telephone: 01872 258095
1. Policy Aim* Who is the strategy / policy / proposal / service function aimed at?
To provide guidance in the prescribing of CINV
2. Policy Objectives*
To provide good antiemetic cover for chemotherapy / SACT patients
3. Policy – intended Outcomes*
To provide good antiemetic cover for chemotherapy / SACT patients
4. *How will you measure the outcome?
Good control of CINV in patients receiving chemotherapy / SACT
5. Who is intended to benefit from the policy?
Patients receiving chemotherapy / SACT
6a Who did you consult with b). Please identify the groups who have been consulted about this procedure.
Workforce Patients Local groups
External organisations
Other
X
Please record specific names of groups SACT MDT
What was the outcome of the consultation?
Agreed.
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Are there concerns that the policy could have differential impact on:
Equality Strands: Yes No Unsure Rationale for Assessment / Existing Evidence
Age
Sex (male,
female, trans-gender / gender reassignment)
Race / Ethnic communities /groups
Disability - Learning disability, physical impairment, sensory impairment, mental health conditions and some long term health conditions.
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 this relates to 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.
Not indicated
7. The Impact Please complete the following table. If you are unsure/don’t know if there is a negative impact you need to repeat the consultation step.
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Date of completion and submission
February 2019
Members approving screening assessment
Policy Review Group (PRG) APPROVED
This EIA will not be uploaded to the Trust website without the approval of the Policy Review Group. A summary of the results will be published on the Trust’s web site.
