Anti-Emetic Guidelines for Adults Receiving Chemotherapy

Transcription

1 Anti-Emetic Guidelines for Adults Receiving Chemotherapy Version 2 Date of Publication: February 2007 Updated February Original Author(s): Sue Robinson Lead Pharmacist Arden Cancer Network Edited & adapted by: N/A Name of responsible committee/individual: Target audience: Date of Ratification: April Arden Cancer Network Chemotherapy Group All staff involved in the management of chemotherapy induced nausea and vomiting Ratified by: Arden Cancer Network Executive Group Date for review: April 2015 Page 1 of 19

2 Version History Version Date Brief Summary of Changes 1 February February Updated following updated international Guidance. Main changes: increased doses of ondansetron and dexamethasone prior to very high risk chemotherapy. MOSAIC anti-emetic definitions added Fosaprepitant included in same indications for Aprepitant CONTENTS Section Description Page 1 Background Types of Nausea and Vomiting associated with Chemotherapy Risk factors for Nausea and Vomiting associated with Chemotherapy 4 Other possible causes 6 5 General Principles of Antiemetic Therapy 6 6 Anti-emetic failure (refractory) 7 7 Anticipatory Nausea: 7 8 On completion of chemotherapy: 7 9 Funding 7 10 Routine Anti-Emetics 8 11 MOSAIC Anti-emetic TTO s 9 12 Emetogenic Potential of Individual Chemotherapy 13 Emetic Potential of Chemotherapy Regimens Principle Side Effects of Anti-emetics Consultation and Communication Process Equality Impact Assessment Review and Revision Arrangements including Version Control 18 Dissemination and Implementation References Document Circulation Page 2 of 19

3 1.0 Background Nausea and vomiting (CINV) are amongst the most distressing side effects of cancer treatment and despite the introduction of newer anti-emetic strategies, they remain two of the five toxicities patient most dread. Table 1: Ranking studies carried out over several years 1 = worst Rank Vomiting Nausea Nausea Death 2 Nausea Loss of hair Loss of hair Vomiting 3 Loss of Hair Vomiting Constantly tired Nausea 4 5 Thought of coming for treatment Time taken by treatment Constantly tired Vomiting Injections Taste Disturbance Fatigue Other Side effects of treatment Table 2: Incidence of CINV Study Date Chemotherapy Acute Nausea/Vomiting Delayed Nausea/Vomiting HEC/MEC* 45% 78% Anthracycline NR/23% NR/21% HEC/MEC* 36.2%/13.2% 54.3%/32.5% HEC = Highly Emetogenic Chemotherapy MEC = Moderately Emetogenic Chemotherapy Uncontrolled CINV has many consequences both on quality of life for the patient and clinically on treatment outcomes Table 3: Possible consequences of uncontrolled CINV 8 Patient s Quality of Life unable to work reduced function at home reduced food intake increased anxiety and depression increased financial burden embarrassment reduced social interaction Treatment Outcomes unable to take prescribed medication delayed therapy reduced or omitted doses dehydration physical damage electrolyte disturbances increased hospitalisation Page 3 of 19

4 2.0 Types of Nausea and Vomiting associated with Chemotherapy Acute nausea and or vomiting Occurs within the first 24 hours following chemotherapy administration Delayed nausea and or vomiting Can occur any time after the first 24 hours following chemotherapy, usually up to 5 days following chemotherapy Breakthrough nausea and or vomiting Nausea and or vomiting that occurs as a single incidence despite normally good control, reason for break in normally good control is often identifiable eg car journey, particular smell Refractory vomiting Vomiting, often repeatedly, despite standard anti-emetic therapy Anticipatory nausea and or vomiting Nausea and or vomiting that occurs in advance of chemotherapy treatment. May be learned from previous experience. All these areas of nausea and vomiting can be inter related. If an acute phase is poorly controlled the patient is much more susceptible to symptoms in the delayed phase or to experience anticipatory symptoms prior to the next cycle of chemotherapy. 3.0 Risk factors for Nausea and Vomiting associated with Chemotherapy The risk of a patient experiencing nausea and vomiting can be predicted from two groups factors: treatment factors and patient factors 3.1 Treatment Factors The chemotherapy regimen is the most important risk factor for determining if patients are likely to experience nausea and vomiting. See Appendix I for emetic potential of individual cytotoxic drugs and Appendix II for emetic potential of combination chemotherapy regimens 3.2 Patient Factors High Risk younger patients Female Pre-treatment expectation of vomiting History of anxiety Previous experience of vomiting after chemotherapy History of motion sickness Vomiting during pregnancy (morning sickness) Other medication the patient is taking may affect risk Co-morbidities If the patient has a history of anxiety add: LORAZEPAM 1mg on starting 1-2 days prior to chemotherapy for 3-5 days If a patient scores 2 or more of the above risk factors consider adding aprepitant or fosaprepitant from cycle 1. Page 4 of 19

5 4.0 Other possible causes It is important to consider other possible causes for any nausea or vomiting. These may include: Radiotherapy Infections Brain metastases, especially posterior fossa Migraines UTI s Bowel obstruction Peritoneal carcinomatosis without bowel obstruction Steroid-related severe dyspepsia Electrolyte imbalances inc hypercalcaemia, hyperglycaemia, hyponatremia Other medications for example opioids, antibiotics, antifungals Other possible causes should be particularly considered if: nausea and vomiting occurs mid-cycle or in the absence of acute post chemotherapy symptoms or if the nausea and vomiting coincides with other symptoms such as abdominal pain, bloating, headache or atxia. 5.0 General Principles of Antiemetic Therapy Optimal emetic control in the acute phase is essential to prevent nausea and vomiting in the delayed phase Prophylaxis is better than treatment. The risk of emesis and the severity of symptoms depend on the dose and combination of Cytotoxic drugs (Appendix 3+ 4). Always commence anti-emetics before chemotherapy. Give oral doses at least 30 minutes before chemotherapy Anti-emetic therapy should be administered regularly and reviewed with each cycle of chemotherapy Patients should be advised to start their oral anti-emetics as they leave the department or in the evening of treatment and continue them regularly at appropriate intervals for the required duration. See Appendix 1 for approved anti-emetic regimens Initiate anti-emetics at Lowest level appropriate for chemotherapy prescribed Generally the appropriate anti-emetics for a particular chemotherapy regimen are detailed on the prescription. There is no significant benefit of intravenous anti-emetics over oral if a patient is not vomiting, provided sufficient time is allowed for the drug to take effect. For combination chemotherapy choose the appropriate regimen for the most emetogenic drug included For multi-day regimens choose appropriate pre-chemotherapy regimen for each day and on discharge give the antiemetics suggested for the day with the highest emetogenic potential For older and younger patients, and patients naïve to it, use metoclopramide with caution and restrict individual doses to 10mg; see note in appendix about pycho-motor and extrapyramidal problems. In haematology, dexamethasone TTO s should only be used for very highly emetogenic haematology regimens, and should only be added to subsequent courses if there has been a previous anti-emetic failure. Dexamethasone should be given prophylactically where indicated, and not used as a treatment for emesis. Co-administration of ranitidine or omeprazole, for a minimum of 5-7 days or continuously. Dexamethasone should be given no later than 6pm (and ideally prior to 2pm) to minimise wakefulness in the evening and may require a 3 day reducing dose for patients who experience a post dexamethasone low. Page 5 of 19

6 Carefully consider the risks and benefits of the use of steroids in diabetic patients and in patients who are severely immunocompromised. Aprepitant may a suitable alternative. Omit dexamethasone pre-chemotherapy if patient is on a steroid-containing regimen e.g. CHOP, ESHAP, CVAMP 6.0 Anti-emetic failure (refractory) Anti-emetic failure is defined as either prolonged, distressing nausea or 2 or more episodes of vomiting in 24 hours. Consider the current anti-emetic has failed only when you have checked patient compliance, and their understanding of the instructions given. Current anti-emetic regimen has failed Initiate second line treatment by starting anti-emetic regimen for next level of emetogenicity for the next chemotherapy cycle. Eg In the event of a moderate risk regimen failure initiate high risk treatment for further courses of chemotherapy Start at Level 1 and move up the levels as required If all else fails consider the following options: Ensure patient is taking the anti-emetics regularly Ensure maximum anti-emetic cover on each day of treatment, including starting any oral antiemetics in the evening of day 1 Lorazepam orally for any anxiety related nausea or vomiting Fosaprepitant 150mg iv injection before chemotherapy Palonosetron 0.25 iv injection before chemotherapy Cyclizine orally or in a syringe driver Levomepromazine in a syringe driver Domperidone suppositories Proclorperazine tablets or suppositories Olanzepine may be considered as an option if all else fails 7.0 Anticipatory Nausea: Anticipatory nausea and vomiting is believed to be a learned response to chemotherapy and develops in up to 20% of patients by the fourth cycle of treatment If post-chemotherapy nausea and vomiting does not occur, anticipatory nausea and vomiting is very unlikely. Treat with lorazepam 1-2mg orally starting the night before or on the morning of chemotherapy treatment. Lorazepam can also be administered sublingually or IV minutes prior to chemotherapy. Levomepromazine 6.25mg orally TDS or up to 12.5 mg via Subcutaneous syringe driver may also be useful for persistent anticipatory nausea. 8.0 On completion of chemotherapy: Oral dexamethasone is not generally required for TTO s following haematology chemotherapy regimens Always omit oral dexamethasone if the patient is on a steroid-containing chemotherapy regimen e.g. CHOP, PMitCeBo. For patients receiving a taxane steroids are obligatory for prophylaxis of acute and chronic hypersensitivity reactions; separate anti-emetic steroids are not required and should be avoided Consider omitting steroid or reducing length of course if the patient is on a weekly regimen or an oral cytotoxic course longer than 3 days 9.0 Funding Individual Trusts may not have all drugs listed within this policy on their formulary. Please check prior to use and if not please follow internal processes for that Trust prior to prescribing. Page 6 of 19

7 10.0 Routine Anti-Emetics It is important to note that haematology patients may not require dexamethasone either pre chemotherapy or as a TTO if steroids are already part of the chemotherapy regimen. Always check if not sure. Level 1: For use with LOW RISK chemotherapy only Pre - Chemotherapy On Completion of Chemotherapy METOCLOPRAMIDE 10mg PO or IV DOMPERIDONE 10-20mg PO QDS PRN x 3-5/7 Level 2: For use with MODERATE RISK chemotherapy or for patients who have refractory CINV on Level 1 anti-emetics Pre - Chemotherapy On Completion of Chemotherapy ONDANSETRON 8mg PO or IV +/- DEXAMETHASONE 8mg PO or IV DOMPERIDONE 10-20mg PO QDS PRN x 3-5/7 +/- DEXAMETHASONE 2mg PO TDS x 3/7 Level 3: For use with HIGH RISK chemotherapy or for patients who have refractory CINV on Level 2 anti-emetics Pre Chemotherapy ONDANSETRON 8mg PO or IV + DEXAMETHASONE 8mg IV Given on each day of chemotherapy On Completion of Chemotherapy DOMPERIDONE 10-20mg PO QDS PRN x 3-5/7 + DEXAMETHASONE 4mg PO TDS x 3/7 + ONDANSETRON 8mg PO BD x 2/7 starting on evening of day 1 chemotherapy Level 3A: for use with HIGH RISK chemotherapy where steroids administered as part of a premedication or the chemotherapy protocol or where an extended course of antiemetics is required (eg 10 days oral chemotherapy) Pre Chemotherapy ONDANSETRON 8-16mg PO or IV Given on each day of chemotherapy On Completion of Chemotherapy DOMPERIDONE 10-20mg PO QDS PRN x 3-5/7 + ONDANSETRON 8mg PO BD x 2-5/7 starting on evening of day 1 chemotherapy Level 4: For use with VERY HIGH RISK chemotherapy or for patients who have refractory CINV on Level 3 anti-emetics Pre - Chemotherapy ONDANSETRON 16mg IV + DEXAMETHASONE 16mg IV Given on each day of chemotherapy On Completion of Chemotherapy DOMPERIDONE 10-20mg PO QDS PRN x 3-5/7 + DEXAMETHASONE 4mg TDS x 3/7 + ONDANSETRON 8mg PO BD x 2/7 starting on evening of day 1 chemotherapy Level 4A: For use with VERY HIGH RISK chemotherapy MULTIPLE DAY REGIMEN Chemotherapy Days ONDANSETRON 16mg IV pre chemotherapy + DEXAMETHASONE 16mg IV pre chemotherapy +/- ONDANSETRON 8mg IV post chemotherapy Given on each day of chemotherapy On Completion of Chemotherapy DOMPERIDONE 10-20mg PO QDS PRN x 3-5/7 + ONDANSETRON 8mg PO BD x 2/7 starting the day after the last day of chemotherapy Level 5: For patients who have refractory CINV on Level 4 anti-emetics or who are on BEP chemotherapy Pre - Chemotherapy ONDANSETRON 16mg IV on each day or PALONESTRON 0.25mg IV day one only + DEXAMETHASONE 8-16mg IV on each day + APREPITANT 125mg PO or FOSAPREPITANT 150mg IV on each day +/- LORAZEPAM 1mg PO or IV starting day before chemotherapy daily On Completion of Chemotherapy + DOMPERIDONE 10-20mg PO QDS PRN x 3-5/7 + DEXAMETHASONE 4mg BD x 3/7 + APREPITANT 80mg OD x 2-4/7 (only with oral apprepitant not with iv fosaprepitant) Page 7 of 19

8 11.0 MOSAIC Anti-emetic TTO s All chemotherapy regimens added to MOSAIC electronic prescribing system will have an anti-emetic TTO regimen assigned to them. This will be added to the chemotherapy protocol and automatically prescribed with the chemotherapy regimen. The anti-emetic regimen will be chosen following a review of the drug s SPC, published clinical trial data and clinician experience. In order to reduce the requirement for changes the anti-emetic regimens will be added to MOSAIC with the following titles and not individual drugs. Very High Risk anti-emetic regimen High Risk anti-emetic regimen Moderate Risk anti-emetic regimen Low Risk anti-emetic regimen Haematology anti-emetic regimen BEP anti-emetic regimen These consist of the following drugs: Regimen Drugs Supply Label Very High Risk or High Risk Moderate Risk Low Risk Haematology BEP DOMPERIDONE 10mg Tablets DEXAMETHASONE 2mg Tablets ONDANSETRON 8mg tablets DOMPERIDONE 10mg Tablets DEXAMETHASONE 2mg Tablets DOMPERIDONE 10mg Tablets METOCLOPRAMIDE 10mg tablets ONDANSETRON 8mg tablets DOMPERIDONE 10mg Tablets ONDANSETRON 8mg tablets 1 x 30 TTO pack 2 tablets up to 4 times per day as directed for up to 5 days 1 x 18 TTO pack 2 tablets TDS x 3 days 1 x 10 TTO pack 1 x 30 TTO pack 1 tablet BD as directed for 2-3 days 2 tablets up to 4 times per day as directed for up to 5 days 1 x 9 TTO pack 1 tablet TDS x 3 days 1 x 30 TTO pack 1 x 30 TTO pack 1 x 10 TTO pack 1 x 30 TTO pack 1 x 10 TTO pack 2 tablets up to 4 times per day as directed for up to 5 days 1 tablet TDS as directed for up to 5 days 1 tablet BD as directed for 2-3 days 2 tablets up to 4 times per day as directed for up to 5 days 1 tablet BD as directed for 2-3 days Page 8 of 19

9 12.0 Emetogenic Potential of Individual Chemotherapy Low emetogenic potential (Incidence <10-30%) Individual drugs Comments Individual drugs Comments Alemtuzumab Trastuzumab Asparaginase Treosulphan oral Bleomycin Topotecan Weekly 3mg/m 2 Bortezomib Vinblastine Busulfan Doses <10mg Vincristine Capecitabine Vindesine Cetuximab Vinorelbine IV Chlorambucil Cladrabine Etoposide Standard dose (Oral and IV) Erlotinib Estramustine Fludarabine Fluorouracil Gefitnib Moderate emetogenic potential (Incidence<30-60%) Gemtuzumab Individual drugs Comments Hydroxyurea Arsenic Imatinib Carmustine <100mg/m 2 Liposomal Doxorubicin Cyclophosphamide 750mg/m 2 Lomustine oral Cytarabine <900mg/m 2 Melphalan Oral Daunorubicin <50mg/m 2 Mercaptopurine Docetaxel Methotrexate Doses 50mg/m 2 Doxorubicin >20mg or <60mg/m 2 Mitotane Gemcitabine Mitomycin Methotrexate >250mg to 1g/m 2 Mitozantrone Mitomycin C Paclitaxel Weekly 80-90mg/m 2 Mitoxantrone Rituximab Paclitaxel Sunitinib Procarbazine Thioguanine Temozolomide Topotecan Vinorelbine Page 9 of 19

10 Emetogenic Potential of Individual Chemotherapy continued High emetogenic potential (Incidence<60-90%) Very High emetogenic potential (Incidence>90%) Individual drugs Comments Individual drugs Comments Altretamine Treat only using 5-HT 3 antagonist not steroid Busulfan Conditioning doses Amsacrine Carmustine 250mg/m 2 Carboplatin Cisplatin 50mg/m 2 Carmustine >100mg/m 2 Cyclophosphamide >1500mg/m 2 Cisplatin <50mg/m 2 Ifosfamide 3g/m 2 /day Cyclophosphamide Doses >750mg/m 2 to 1500mg/m 2 Cytarabine Doses >900mg/m 2 Dactinomycin Dacarbazine Daunorubicin >50mg/m 2 Doxorubicin 60mg Epirubicin Estramustine Idarubicin Ifosfamide <3g/m 2 Irinotecan Lomustine Melphalan Doses IV >100mg/m 2 Methotrexate Doses > 1000mg/m 2 Oxaliplatin Streptozocin Page 10 of 19

11 13.0 Emetic Potential of Chemotherapy Regimens Low Incidence <30% 5FU/FA Capecitabine + Trastuzumab Capecitabine + XRT VAD Paclitaxel weekly + Trastuzumab Vincristine + Bleomycin Moderate Incidence <30-60% CMF (iv or oral) ChIVPP ChIVPP/PABLOE CVP Cyclo-dex Docetaxel + Prednisolone FAD Flu/Cyclo FMD Mitomycin/FU (low on FU days) MItoxantrone + Prednisolone MMM PABLOE PACEBOM PCV Paclitaxel + Carboplatin weekly Vinorelbine + Trastuzumab AC ADE (High D1-5, otherwise moderate) Carboplatin + etoposide Carboplatin weekly + XRT Cetuximab + FOLFOX Cetuximab + FOLFIRI CHOP CODOX-M (High D1, otherwise moderate) C-VAMP (Moderate D2-4) C-Z-dex DA (High D1,3,5 otherwise moderate) Docetaxel + Epirubicin Docetaxel + Capecitabine Docetaxel + Cyclophosphamide Docetaxel + Gemcitabine EC (75) Epi-CMF ECF/ECX FEC (75) FEC-T (75) 5FU + Mitomycin Gemcitabine + Carboplatin Gemcitabine + Paclitaxel Gemcitabine + Paclitaxel + Trastuzumab ICE Irinotecan + Modified de Gramont IVE MACE MidAC (Moderate D4-5) Mini-BEAM (treat as moderate D2-5) MVP High Incidence <60%-90% Oxaliplatin + Capecitabine Oxaliplatin + Modified de Gramont Paclitaxel + Carboplatin PCV Pemetrexed + Carboplatin PMitCeBo POMB- ACE TC TCH VAC Vinorelbine + Carboplatin Z-DEX Very High Incidence >90% ABVD BEAM (treat as moderate on D2-5) BEP 3/7 BEP 5/7 CAP Carboplatin + Ifosfamide Cisplatin weekly or 3weekly Cisplatin + 5FU Cisplatin + IV Etoposide Cisplatin + oral Etoposide Cisplatin + Topotecan Cisplatin + XRT CX + XRT Doxorubicin + Cisplatin Dox/Ifos EC90 ECX ESHAP (High D2-5) FEC (90/100) FEC-T (100) FLAG-Ida Gemcitabine + Cisplatin High dose MTX Ifosfamide + Doxorubicin IVAC Modified TIP MVP Pemetrexed + Cisplatin VAI VIDE NB. This is not an exclusive list of chemotherapy regimens The incidence relates to the proportion of patients who experience emesis in the absence of effective antiemetic prophylaxis. This does not necessarily relate to the severity of symptoms For Haematology protocols, steroids may sometimes be omitted. Please seek advice from haematology pharmacist if in doubt. Page 11 of 19

12 14.0 Principle Side Effects of Anti-emetics For the most up to date information always consult the summary of product characteristics available on METOCLOPRAMIDE Can rarely cause agitation, extreme restlessness (akisthisia) or the development of extra-pyramidal symptoms. These can occur up to 24 hours after a dose and may vary from facial grimacing and dystonic movements to odd feelings in the mouth, restlessness, somnolence and irritability. Treat with PROCYCLIDINE 10mg IV stat or DIAZEPAM (Diazemuls) 10mg IV stat, discontinue metoclopramide and do not re-use. Particular caution should be exercised when giving METOCLOPRAMIDE to patients under the age of 20 years. The elderly may also experience Parkinsonian problems. Bowel transit time may be reduced and some patients experience diarrhoea. Substitute with cyclizine. ONDANSETRON Constipation common and often severe. Treat or, better prevent with regular laxatives. As constipation is mediated by reduction of rectal mucus production, and loss of the normal physiological lubricant essential for ease of defecation. The addition of glycerine suppositories may be useful. Unlike opiate induced constipation, the bowel smooth muscle remains active and thus colic is common and may be severe. Ondansetron should therefore only be used with caution in patients with sub acute bowel obstruction. If severe, substitute alternative anti-emetic. Headaches are also common, especially in migrane sufferers. Treat with simple analgesia. DEXAMETHASONE Aside from the more common side effects of fluid retention, dyspepsia and occasionally sleeplessness, hyperactivity and excessive appetite, patients may experience perineal discomfort if the drug is given by iv bolus. This is avoided by intravenous infusion. Caution required if patient is diabetic or in haematology patients. Dose reductions required when used in combination with aprepitant or fosaprepitant. DOMPERIDONE Domperidone is generally well tolerated, but should not be used when stimulation of the gastric motility could be harmful eg gastro-intestinal haemorrhage, mechanical obstruction or perforation. Domperidone can increase in prolactin levels. In rare cases this may lead to neuro-endocrinological side effects such as galactorrhoea, gynaecomastia and amenorrhoea. Some epidemiolical studies have shown that domperidone may be associated with an increased risk of serious ventricular arrhythmias or sudden cardiac death. These risks may be higher in patients older than 60 years and in patients who receive daily oral doses of more than 30mg. Patients should be advised to seek promt medical attention if symptoms such as syncope or tachyarrhythmias appear during treatment. Domperidone should be avoided in patients who are taking concomitant medication known to cause QT prolongation (such as erythromycin and ketokonozole). CYCLIZINE As with other anti-cholinergic agents, cyclizine should be used with caution in patients with glaucoma, obstructive disease of the gastrointestinal tract, hepatic disease, epilepsy and in males with possible prostatic hypertrophy. Cyclizine should also be used with caution in patients with severe heart failure as it may cause a fall in cardiac output associated with increases in heart rate, mean arterial pressure and pulmonary wedge pressure. Page 12 of 19

13 Urticaria, drug rash, drowsiness, headache, dryness of the mouth, nose and throat, blurred vision, tachycardia, urinary retention, constipation, restlessness, nervousness, insomnia and auditory and visual hallucinations have been reported, particularly when dosage recommendations have been exceeded. PROCHLORPERAZINE Prochlorperazine should be avoided in patients with liver or renal dysfunction, Parkinson's disease, hypothyroidism, cardiac failure, phaeochromocytoma, myasthenia gravis, prostate hypertrophy. A mild leukopenia occurs in up to 30% of patients on prolonged high dosage. Other side effects include: Hyperprolactinaemia, Acute dystonia or dyskinesias, ocular changes, Cardiac arrhythmias, Hypotension, dry mouth, transient jaundice. LEVOMEPROMAZINE Avoid in patients with liver dysfunction. Inhibits cytochrome P-450. Common side effects are somnolence, asthenia, dry mouth, hypotension, photosensitivity and skin reactions. HALOPERIDOL Caution in patients with liver disease or renal failure, epilepsy, disturbed thyroid function or patients with risk factors for cardiac arrhythmias. Haloperidol can interact with some anti-epileptics. Side effects include extra pyramidal symptoms, tardive dyskinesia, cardiac effects, dry mouth and constipation. LORAZEPAM Side effects include drowsiness, confusion, muscle weakness, headache. APREPITANT/FOSAPREPITANT Caution in patients with hepatic impairment. Interacts with dexamethasone and irinotecan. Common side effects include hiccups, dyspepsia, diarrhoea, constipation, asthenia, headache, dizziness. Page 13 of 19

14 15.0 Consultation and Communication Process The consultation process involves dissemination of draft documents for comment to: the Arden Cancer Network Chemotherapy Group, consultants haematologists, oncologists, haematology/oncology specialist nurses, ward managers and pharmacists and clinical leads at George Eliot Hospital, Reddich Hospital (part of Worcestershire Acute Hospitals NHS Trust), University Hospitals Coventry and Warwickshire and South Warwickshire NHS Foundation Trust Equality Impact Assessment See Appendix Review and Revision Arrangements including Version Control The Chair of the Arden Cancer Network Chemotherapy Group will nominate an individual to undertake a review of the protocol 3 months prior to the revision date Dissemination and Implementation Once documents are ratified, notification will be sent by to the lead chemotherapy clinician, nurse and pharmacist for each Trust. It will be their responsibility to disseminate and implement the protocol locally. The final version of documents will be placed on the Arden Cancer Network intranet and each individual Trusts intranet via a designated lead for each Trust. Hard copies will not be circulated. It will be the responsibility of departmental managers to include the process to remove outdated copies and to ensure staff are aware of the new version (Appendix D). It is the responsibility of departmental managers to implement any identified training or support References 1. Coates A, Abraham S, Kaye SB, Schwerbutts T, Frewin CH, Fox RH and Tattersall MHN (1983) on the receiving end - patient perception of the side effects of cancer chemotherapy. Eur J Cancer Clin Oncol 19: M de Boer-Dennert, R de Wit, PIM Schmitz, J Djontono, V v Beurden, G Stoterl and J Verweijl. Patient perceptions of the side-effects of chemotherapy: the influence of 5HT3 antagonists. British Journal of Cancer (1997) 76(8), Lindley C, McCune JS, Thomason TE, et al., Perception of chemotherapy side effects cancer versus non cancer patients. Cancer Pract, 1999;7(2): Dubey S, Brown RL, Esmond SL, Bowers BJ, Healy JM, Schiller JH. Patient preferences in choosing chemotherapy regimens for advanced non-small cell lung cancer. J Support Oncol. 2005;3: O'Brien BJ, Rusthoven J, Rocchi A, et al. Impact of chemotherapy-associated nausea and vomiting on Patients' functional status and on costs: survey of five Canadian centres. CMAJ. 1993;149(3): Warr DG et al. Efficacy and tolerability of aprepitant for the prevention of chemotherapyinduced nausea and vomiting in patients with breast cancer after moderately emetogenic chemotherapy. J Clin Oncol 2005 Apr 20;23(12): Page 14 of 19

15 7. Bloechl-Daum, B., Deuson, R.R., Mavros, P., Hansen, M., & Herrstedt, J Delayed nausea and vomiting continue to reduce patients quality of life after highly and moderately emetogenic chemotherapy despite antiemetic treatment. J Clin Oncol, 24, Lindley CM et al. Quality of Life Consequences of chemotherapy-induced emesis. Quality of Life Research , pp, Other References Hesketh PJ, Kris MG, Grunberg SM et al. Proposal for classifying the acute emetogenicity of cancer chemotherapy. Journal of Clinical Oncology 1997:15(1); Basch E, Prestrud A, Hesketh P, Kris M, Feyer F, Somerfield MR, Chesney M, et al. Antiemetics: American Society of Clinical Oncology Clinical Practice Guideline Update. JCO September 26, Affairs/Downloads/Guideline%20Tools%20and%20Resources/Antiemetics/2011/Antiemetics%20F ull%20guideline% pdf Gralla RJ, Osoba D, Kris MG, et al. Recommendations for the Use of Antiemetics: Evidence- Based, Clinical Practice Guidelines. Journal of Clinical Oncology 1999:17; Italian Group for Antiemetic Research. Double-blind, dose-finding study of four intravenous doses of dexamethasone in the prevention of cisplatin-induced acute emesis. Journal of Clinical Oncology 1998:16; Roila F, Basurto C, Bosnjak S et al. Optimal Dose Of Dexamethasone (Dex) In Preventing Acute Emesis Induced By Highly-Moderately Emetogenic Chemotherapy (HMECT): A Randomized, Double-Blind, Dose-Finding Study. ACSO proceeding 2003 abstract 2930 Gralla et al. Supportive Care Cancer. The 2004 Perugia Antiemetic Consensus Guidelines Various Articles 2005, 13: Kris MG, Hesketh PJ, Jorn Herrstedt et al. Consensus proposals for the prevention of acute and delayed vomiting and nausea following high-emetic risk chemotherapy. Support Care Cancer (2005) 13:85-96 Kris MG, Hesketh PJ, Somerfield MR et al. American Society of Clinical Oncology Guideline for Antiemetics in Oncology: Update Journal of Clinical Oncology 2006:24(18) Dominc A. Solimando Drug Information Handbook for Oncology 3 rd Edition Anon. 5HT3 receptor antagonists as anti-emetics in cancer. Drug and Therapeutics Bulletin Aug 2005, 43: European society for Medical Oncology (ESMO). Clinical Guidelines; Recommendations for prophylaxis of Chemotherapy induced nausea. Page 15 of 19

16 20.0 Document Circulation Name Title Trust Dates Circulated Lead Chemotherapy Dec 2011, Feb, April Elaine Watkins* George Eliot Nurse Hospitals NHS Lead Chemotherapy Dec 2011, Feb, April Melanie Taylor Trust Pharmacist Fay Lanham* Lead Chemotherapy Dec 2011, Feb, April Nurse Alexandra Stephanie Cooke Lead Chemotherapy Hospital Dec 2011, Feb, April Pharmacist Carole Connor* Lead Chemotherapy Dec 2011, Feb, April Nurse South Nicola Evans Lead Chemotherapy Warwickshire Dec 2011, Feb, April Pharmacist NHS Foundation Emma Dunne Pharmacist Trust Dec 2011, Feb, April Sam Neale* Lead Chemotherapy Dec 2011, Feb, April Nurse Sue Robinson Lead Chemotherapy Dec 2011, Feb, April Pharmacist University Professor Chris Hospitals Medical Oncologist Poole Coventry and Dec 2011, Feb, Warwickshire Dr Clive Irwin NHS Trust Dr Andrew Stockdale Stephanie Connell Mandy Matthews Suzy Heafield Chair of the Arden Cancer Network Chemotherapy Group Dec 2011, Feb, April Clinical Oncologist Dec 2011, Feb Cancer Service Redesign Manager New Drugs and Technologies Manager Clinical Effectiveness Pharmacist Arden Cancer Network NHS Worcestershire NHS Warwickshire Dec 2011, Feb, April Feb, April Feb, April *Responsible for circulating to relevant staff within their Trust including clinical nurse specialists, lead acute and accident emergency physicians and ward managers. Page 16 of 19

17 Appendix 1 - Equality Impact Assessment Tool Yes/ Comments 1. Does the document/guidance affect one group less or more favourably than another on the basis of: Race Ethnic origins (including gypsies and travellers) Nationality Gender Culture Religion or belief Sexual orientation including lesbian, gay and bisexual people Age Disability - learning disabilities, physical disability, sensory impairment and mental health problems 2. Is there any evidence that some groups are affected differently? 3. If you have identified potential discrimination, are there any exceptions valid, legal and/or justifiable? 4. Is the impact of the document/guidance likely to be negative? 5. If so, can the impact be avoided? N/A 6. What alternative is there to achieving the document/guidance without the impact? 7. Can we reduce the impact by taking different action? ne National requirement Page 17 of 19

18 Appendix 2 Title of document: Date finalised: Previous document already being used? If yes, in what format and where? Plan for Dissemination of Procedural Documents Yes Dissemination lead: Proposed action to retrieve out of date copies of the document: To be disseminated to: Carole Connor Lead Chemotherapy Nurse - South Warwickshire NHS Foundation Trust Dr J Gandla Lead Chemotherapy Clinician George Eliot Hospitals NHS Trust Fay Lanham Lead Chemotherapy Nurse Reddich Hospital Sam Neale Lead Chemotherapy Nurse University Hospitals Coventry and Warwickshire NHS Trust Chemotherapy lead nurse for each Trust to retrieve local neutropenic sepsis documents How will it be disseminated, who will do it and when? To inform all areas that revised network wide electronic version available on Trusts intranet and Arden Cancer network site within 7 days of receipt Format (i.e. paper or electronic) Electronic Comments: Page 18 of 19

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