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GMMMG Interface Prescribing Subgroup Shared Care Protocol Shared Care Guideline for Reference Number Riluzole for Amyotrophic Lateral Sclerosis (a form of Motor Neurone Disease) Version: 1 Replaces: n/a Author(s)/Originator(s): (please state author name and department) MND Team, Salford Royal Foundation Trust Date approved by Interface Prescribing Group: 08/10/2015 Date approved by Commissioners: dd/mm/yyyy Issue date: 19/11/2015 To be read in conjunction with the following documents: Current Summary of Product characteristics (http://www.medicines.org.uk) BNF Date approved by Greater Manchester Medicines Management Group: 19/11/2015 Review Date: 19/11/2017 Please complete all sections 1. Name of Drug, Brand Name, Form and Strength 2. Licensed Indications Riluzole 50mg tablets Riluzole is indicated to extend life or the time to mechanical ventilation for patients with amyotrophic lateral sclerosis (ALS). Clinical trials have demonstrated that riluzole extends survival for patients with ALS. Survival was defined as patients who were alive, not intubated for mechanical ventilation and tracheotomy-free. There is no evidence that riluzole exerts a therapeutic effect on motor function, lung function, fasciculations, muscle strength and motor symptoms. Riluzole has not been shown to be effective in the late stages of ALS. Safety and efficacy of riluzole has only been studied in ALS. Therefore, should not be used in patients with any other form of motor neurone disease. 3. Criteria for shared Prescribing responsibility will only be transferred when care Version: 1 Date: 19/11/2015 Review: 19/11/2017 Treatment is for a specified indication and duration. Treatment has been initiated and established by the secondary care specialist. The patient’s initial reaction to and progress on the drug is satisfactory. The GP has agreed in writing in each individual case that shared care is appropriate. Shared Care Guideline for Riluzole for ALS Current version is held on GMMMG Website Check with internet that this printed copy of the latest issue Page 1 of 12 The patient’s general physical, mental and social circumstances are such that he/she would benefit from shared care arrangements background Unstable disease state Patient does not consent to shared care Patient does not meet criteria for shared care Amyotrophic lateral sclerosis (ALS) is a form of Motor Neurone Disease (MND). It is a progressive and fatal neurodegenerative disorder with a poor prognosis. Patients experience a gradual loss of muscle function involved in swallowing and breathing. From onset of symptoms 5 year survival is 5 - 15% and median survival time is about 3 years. Riluzole is indicated to extend life or the time to mechanical ventilation in patients with ALS. 6. Contraindications Riluzole is currently the only drug licensed for treating ALS in the UK. The National Institute for Health and Care Excellence (NICE) has approved its use for ALS, so it is available to people who have been diagnosed. In the trials in which Riluzole has shown some benefit, eligible patients were up to 75 years of age, were in a reasonable state of general health, had suffered from the disease for no greater than 5 years and had a forced vital lung capacity of not less than 60% predicted. Hypersensitivity to the active substance or to any of the excipients. Hepatic disease or baseline transaminases greater than 3 times the upper limit of normal. Patients who are pregnant or breast-feeding. Children Riluzole is not recommended for use in patients with impaired renal function, as studies at repeated doses have not been conducted in this population. 4. Patients excluded from shared care 5. Therapeutic use & (please note this does not replace the SPC or BNF and should be read in conjunction with it). Caution: Liver impairment Riluzole should be prescribed with care in patients with a history of abnormal liver function, or in patients with slightly elevated serum transaminases (ALT/SGPT; AST/SGOT up to 3 times the upper limit of the normal range (ULN)), bilirubin and/or gamma-glutamyl transferase (GGT) levels. Baseline elevations of several liver function tests (especially elevated bilirubin) should preclude the use of riluzole (see section 4.8). Because of the risk of hepatitis, serum transaminases, including ALT, should be measured before and during therapy with riluzole. ALT should be measured every month during the first 3 months of treatment, every 3 months during the remainder of the first year, and periodically thereafter. ALT levels should be measured more frequently in patients who develop elevated ALT levels. Riluzole should be discontinued if the ALT levels increase to 5 times the ULN. There is no experience with dose reduction or rechallenge in patients who have developed an increase of ALT to 5 times ULN. Readministration of riluzole to patients in this situation cannot be recommended. Neutropenia: Patients should be warned to report any febrile illness to their physicians. The report of a febrile illness should prompt physicians to check white blood cell counts and to discontinue riluzole in case of neutropenia. Interstitial lung disease Cases of interstitial lung disease have been reported in patients treated with riluzole, some of them were severe. If respiratory symptoms develop such as dry cough and/or dyspnea, chest radiography should be performed, and in case of findings suggestive of interstitial lung disease (e.g. bilateral diffuse lung opacities), riluzole should be discontinued immediately. In the majority of the reported cases, symptoms resolved after Version: 1 Date: 19/11/2015 Review: 19/11/2017 Shared Care Guideline for Riluzole for ALS Current version is held on GMMMG Website Check with internet that this printed copy of the latest issue Page 2 of 12 drug discontinuation and symptomatic treatment. 7. Prescribing in pregnancy and lactation 8. Dosage regimen for continuing care Use in pregnancy and breastfeeding is contraindicated. Clinical experience in pregnancy is lacking and it is not known whether riluzole is excreted in breast milk. Route of administration Preparations available: Riluzole 50mg tablets Oral Although not strictly necessary, side effects such as nausea are less likely if riluzole is taken on an empty stomach (if possible, one hour before or two hours after a meal). It comes in tablet form and should be swallowed whole, but if there are problems swallowing, the tablets may be crushed and mixed with foods to aid swallowing. Riluzole should not be dissolved in water as it does not dissolve well. When crushed, the drug can produce a temporary numbing effect in the mouth. It may be easier to swallow if crushed and mixed with a soft food product such as a puree, yoghurt, ice cream or a thick beverage and eaten in the usual way. Once it is crushed riluzole should be taken immediately due to limited stability problems Please note: tablets should not be crushed in order to feed through a PEG tube as this may block the tubing. If swallowing riluzole becomes particularly problematic, please consult your health care team for advice. Please prescribe: Riluzole 50mg twice a day Is titration required No Adjunctive treatment regime: Not applicable Conditions requiring dose reduction: e.g. impaired renal/ liver function No dose reduction is required Usual response time : Riluzole is not a cure, and will not reverse any damage to the motor neurones already present. After 18 months of treatment, it may increase survival by two to four months on average. Those taking riluzole will not be aware of any difference in the symptoms of their ALS, but taking this drug may marginally slow down the progression of the disease. Duration of treatment: Treatment will initially be for 12 months, with annual review. Treatment should cease when patients enter the terminal phase of the disease. Treatment to be terminated by: Specialist Consultant or MND specialist nurse NB. All dose adjustments will be the responsibility of the initiating specialist care unless directions have been specified in the medical letter to the GP. Version: 1 Date: 19/11/2015 Review: 19/11/2017 Shared Care Guideline for Riluzole for ALS Current version is held on GMMMG Website Check with internet that this printed copy of the latest issue Page 3 of 12 9.Drug Interactions For a comprehensive list consult the BNF or Summary of Product Characteristics The following drugs must not be prescribed without consultation with the specialist: Not applicable The following drugs may be prescribed with caution: No drug interactions are listed for riluzole in the BNF. 10. Adverse drug reactions For a comprehensive list (including rare and very rare adverse effects), or if significance of possible adverse event uncertain, consult Summary of Product Characteristics or BNF Specialist to detail below the action to be taken upon occurrence of a particular adverse event as appropriate. Most serious toxicity is seen with long-term use and may therefore present first to GPs. Adverse event System – symptom/sign Action to be taken Include whether drug should be stopped prior to contacting secondary care specialist By whom Interstitial lung disease If respiratory symptoms develop such as dry cough and/or dyspnoea, the patient should be referred to the consultant neurologist and chest radiography should be performed. In findings suggestive of interstitial lung disease (e.g. bilateral diffuse lung opacities), riluzole should be discontinued immediately. In the majority of the reported cases, symptoms resolved after drug discontinuation and symptomatic treatment. GP Elevations in liver function tests As per monitoring GP Neutropenia Abdominal symptomsnausea, diarrhoea, abdominal pain, vomiting As per monitoring Symptomatic treatment GP Patient/GP Headache, dizziness, oral paraesthesia and somnolence Symptomatic treatment Patient/GP The patient should be advised to report any of the following signs or symptoms to their GP without delay: Patients should be made aware that they need to report any febrile illness, fever, sore throat, bruising or unexpected bleeding, and respiratory symptoms (such as dry cough and/or dyspnoea. Other important co morbidities: Non-applicable Version: 1 Date: 19/11/2015 Review: 19/11/2017 Shared Care Guideline for Riluzole for ALS Current version is held on GMMMG Website Check with internet that this printed copy of the latest issue Page 4 of 12 Any adverse reaction to a black triangle drug or serious reaction to an established drug should be reported to the MHRA via the “Yellow Card” scheme. 11.Baseline investigations 12. Ongoing monitoring requirements to be undertaken by GP List of investigations / monitoring undertaken by secondary care The Consultant will arrange for LFTs and FBC to be done at baseline. The Neurologist will review the patient every 3 months, advise the patient, carers and GP, enquire as to whether FBC and LFT testing are due and supervise other treatments that may be needed (physiotherapy, occupational therapy, speech therapy, dietary advice, gastrostomy, respiratory support). Yes Is monitoring required? Monitoring Frequency Results Action By whom Serum transaminases including ALT Monthly for 3 months, 3monthly for 12 months then annually thereafter. Discuss with Consultant Treatment should be stopped if the ALT rises to five times the upper limit of normal. Discontinue riluzole in case of neutropenia. GP Full Blood Counts 13. Pharmaceutical Monthly during Discuss with the first 3 Consultant months in view of the rare reported cases of neutro-penia This medicinal product does not require any special storage conditions. GP aspects 14. Responsibilities of initiating specialist Version: 1 Date: 19/11/2015 Review: 19/11/2017 Confirm the diagnosis, if necessary by repeating the examination and tests such as neurophysiology. Check LFTs and FBCs before commencement of treatment Give the MND Association Riluzole information sheet to the patient and/or their carers stressing the importance of regular blood test monitoring, the need to report symptoms suggesting neutropenia e.g. fever, sore throat etc, bruising or unexpected bleeding Arrange follow up in the MND clinic at SRFT (typically three monthly) Initiate treatment and prescribe until the patient is stable (usually 3 months supply) Monitor patient’s initial reaction to and progress on the drug. During the first three months of therapy the patient is seen twice by MND clinic, once by the specialist nurse 2 weeks after starting riluzole and then by the neurologist after 3 months. Ensure that the patient has an adequate supply of medication until GP supply can be arranged. Patients will be considered suitable for transfer to GP prescribing ONLY when they meet the criteria listed in section 3 above. The consultant team will write formally to the GP to request shared care using the Shared Care Agreement Form (Appendix 2) which must be fully completed. Failure to supply all the required information will result in the refusal of the request until all information has been supplied. Patients will only be transferred to the GP once the GP has agreed via signing copies of the Shared Care Agreement Form (Appendix 2). Continue to monitor and supervise the patient according to this protocol, while the patient remains on this drug, and agree to review the patient promptly if contacted Shared Care Guideline for Riluzole for ALS Current version is held on GMMMG Website Check with internet that this printed copy of the latest issue Page 5 of 12 15. Responsibilities of the GP Version: 1 Date: 19/11/2015 Review: 19/11/2017 by the GP Provide GP with diagnosis, relevant clinical information and baseline results, treatment to date and treatment plan, duration of treatment before consultant review. Provide GP with details of outpatient consultations, ideally within 14 days of seeing the patient or inform GP if the patient does not attend appointment. Provide GP with advice on when to stop this drug. Act upon communication from the GP in a timely manner. Provide patient with relevant drug information to enable Informed consent to therapy. Provide patient with relevant drug information to enable understanding of potential side effects and appropriate action. Provide patient with relevant drug information to enable understanding of the role of monitoring. Provide patient with monitoring booklet where appropriate. Be available to provide patient specific advice and support to GPs as necessary. Provide ongoing monitoring Monitor the FBC and LFTs in collaboration with the specialist at monthly intervals for the first 3 months, then every 3 months during the remainder of the first year and annually thereafter. Monitor clinically for symptoms of liver dysfunction (jaundice, pain, bruising, bleeding) or bone marrow suppression (fever, sore throat, bruising bleeding) or respiratory symptoms. To formally reply to the request for shared care from the specialist within 14 days. Continue treatment as directed by the specialist and prescribe Riluzole 50mg bd. Act upon communication from the specialist in a timely manner. Ensure no drug interactions with concomitant medicines. To monitor and prescribe in collaboration with the specialist according to this protocol. Symptoms or results are appropriately actioned, recorded and communicated to secondary care when necessary. Formally reply to the consultant’s request to shared care within 14 days of receipt, using the shared care agreement forms (Appendix 2). NB the GP should only agree to the transfer of prescribing if all details of the form have been completed. If the GP does not feel it is appropriate to take on the prescribing then the prescribing responsibilities will remain with the specialist. The GP should indicate the reason for declining. Enter a READ code (e.g. 8BM5.00) on to the patient record to highlight the existence of shared care for the patient. Undertake more frequent tests if there is evidence of clinical deterioration, abnormal results, or other risk factors. Contact consultant team for advice on monitoring in these circumstances if required. Check all monitoring results prior to issuing a repeat prescription to ensure it is safe to do so. Monitor the patient’s general wellbeing. Inform the consultant immediately if a patient has become pregnant or is planning to become pregnant for treatment options to be considered Seek urgent advice from secondary care if: Toxicity is suspected Non-compliance is suspected The GP feels a dose change is required There is marked deterioration in the patient’s condition The GP feels the patient is not benefiting from the treatment Shared Care Guideline for Riluzole for ALS Current version is held on GMMMG Website Check with internet that this printed copy of the latest issue Page 6 of 12 16. Responsibilities of the patient 17.Additional Responsibilities e.g. Failure of patient to attend for monitoring, Intolerance of drugs, Monitoring parameters outside acceptable range, Treatment failure, Communication failure The shared care agreement will cease to exist, and prescribing responsibility will return to secondary care, where: The clinical situation deteriorates such that the shared care criterion of stability is not achieved. The clinical situation requires a major change in therapy. The patient is a risk to self or others GP feels it to be in the best stated clinical interest of the patient for prescribing responsibility to transfer back to the Consultant. The Consultant will accept such a transfer within a timeframe appropriate to the clinical circumstances. There must be discussion between the consultant team and GP on this matter and agreement from the consultant team to take back full prescribing responsibility for the treatment of the patient. The consultant team should be given 14 days’ notice in which to take back prescribing responsibilities from primary care. To take medication as directed by the prescriber, or to contact the GP if not taking medication To attend hospital and GP clinic appointments. Failure to attend will result in medication being stopped (on specialist advice). To report adverse effects to their Specialist or GP e.g. febrile illness, respiratory symptoms. List any special Action required By whom Date considerations [insert] 18. Supporting [insert] [insert] [insert] documentation The SCG must be accompanied by a patient information leaflet. (Available from http://www.medicines.org.uk/emc OR http://www.mhra.gov.uk/spc-pil/) 19. Patient monitoring MND Association Riluzole information sheet: http://www.mndassociation.org/wpcontent/uploads/2015/07/5A-Riluzole.pdf Non-applicable booklet (may not be applicable for all drugs) 20. Shared care agreement form Attached below 21. Contact details See Appendix 1 Version: 1 Date: 19/11/2015 Review: 19/11/2017 Shared Care Guideline for Riluzole for ALS Current version is held on GMMMG Website Check with internet that this printed copy of the latest issue Page 7 of 12 Appendix 1 – Local Contact Details Lead author contact information Name: [insert text here] Email: [insert text here] Contact number: [insert text here] Organisation: [insert text here] Commissioner contact information Name: [insert text here] Email: [insert text here] Contact number: [insert text here] Organisation: [insert text here] Secondary care contact information If stopping medication or needing advice please contact: Dr [insert text here] Contact number: [insert text here] Fax:[insert text here] Hospital: [insert text here] Version: 1 Date: 19/11/2015 Review: 19/11/2017 Shared Care Guideline for Riluzole for ALS Current version is held on GMMMG Website Check with internet that this printed copy of the latest issue Page 8 of 12 Shared Care Agreement Form Specialist request *IMPORTANT: ACTION NEEDED Dear Dr [insert Doctors name here] Patient name: [insert Patients name here] Date of birth: [insert date of birth] NHS Number: [insert NHS Number] Diagnosis: [insert diagnosis here] This patient is suitable for treatment with [insert drug name] for the treatment of [insert indication] This drug has been accepted for Shared Care according to the enclosed protocol (as agreed by Trust / CCG / GMMMG). I am therefore requesting your agreement to share the care of this patient. The patient has been fully counselled on the medication. Treatment was started on [insert date started] [insert dose]. If you are in agreement, please undertake monitoring and treatment from [insert date] NB: date must be at least 1 month from initiation of treatment. Baseline tests: [insert information] Next review with this department: [insert date] You will be sent a written summary within 14 days. The medical staff of the department are available at all times to give you advice. The patient will not be discharged from out-patient follow-up while taking [insert text here]. Please use the reply slip overleaf and return it as soon as possible. Thank you. Yours [insert Specialist name] Version: 1 Date: 19/11/2015 Review: 19/11/2017 Shared Care Guideline for Riluzole for ALS Current version is held on GMMMG Website Check with internet that this printed copy of the latest issue Page 9 of 12 Shared Care Agreement Form GP Response Dear Dr [insert Doctors name] Patient [insert Patients name] NHS Number [insert NHS Number] Identifier [insert patient date of birth/address] I have received your request for shared care of this patient who has been advised to start [insert text here] A I am willing to undertake shared care for this patient as set out in the protocol B I wish to discuss this request with you C I am unable to undertake shared care of this patient. My reasons for not accepting are: (Please complete this section) GP signature Date GP address/practice stamp Version: 1 Date: 19/11/2015 Review: 19/11/2017 Shared Care Guideline for Riluzole for ALS Current version is held on GMMMG Website Check with internet that this printed copy of the latest issue Page 10 of 12 Shared Care Guideline Summary: RILUZOLE for the treatment of AMYOTROPHIC LATERAL SCLEROSIS (a form of Motor Neurone Disease) Drug Indication Overview Specialist’s Responsibilities Riluzole 50mg tablets Amyotrophic lateral sclerosis (ALS) - a form of Motor Neurone Disease (MND) Amyotrophic lateral sclerosis (ALS) is a form of Motor Neurone Disease (MND). It is a progressive and fatal neurodegenerative disorder with a poor prognosis. Patients experience a gradual loss of muscle function involved in swallowing and breathing. From onset of symptoms 5 year survival is 5 - 15% and median survival time is about 3 years. Riluzole is indicated to extend life or the time to mechanical ventilation in patients with ALS. Riluzole is currently the only drug licensed for treating ALS in the UK. The National Institute for Health and Care Excellence (NICE) has approved its use for ALS, so it is available to people who have been diagnosed. In the trials in which Riluzole has shown some benefit, eligible patients were up to 75 years of age, were in a reasonable state of general health, had suffered from the disease for no greater than 5 years and had a forced vital lung capacity of not less than 60% predicted. Initial investigations: Assessment of the patient and diagnosis of ALS. Assess suitability of patient for treatment. Discuss benefits and side-effects of treatment with the patient. The Consultant will arrange for LFTs and FBC to be done at baseline. Initial regimen: Riluzole 50mg twice a day Clinical monitoring: The Neurologist will review the patient every 3 months, advise the patient, carers and GP, enquire as to whether FBC and LFT testing are due and supervise other treatments that may be needed (physiotherapy, occupational therapy, speech therapy, dietary advice, gastrostomy, respiratory support). Safety monitoring: Monitoring for response and adverse drug reactions (ADRs) during initiation period. Evaluating ADRs raised by the GP and evaluating any concerns arising from reviews undertaken by GP Prescribing details: Hospital initiated. Transferred to GP once stabilised after the first 3 months of therapy. To stop the drug or provide GP with advice on when to stop this drug. Documentation: Patients will only be transferred to the GP once the GP has agreed via signing copies of the Shared Care Agreement Form Provide GP with diagnosis, relevant clinical information, treatment plan, duration of treatment within 14 days of seeing the patient or inform GP if the patient does not attend appointment GP’s Responsibilities Maintenance prescription: Prescribe riluzole in accordance with the specialist’s recommendations. Max dose is 50mg twice a day. Clinical monitoring: To report to and seek advice from the specialist on any aspect of patient care which is of concern to the GP and may affect treatment. Safety monitoring: Version: 1 Date: 19/11/2015 Review: 19/11/2017 Shared Care Guideline for Riluzole for ALS Current version is held on GMMMG Website Check with internet that this printed copy of the latest issue Page 11 of 12 As advised by the specialist Serum Monthly for 3 months, 3-monthly transaminases for 12 months then annually thereafter. Full Blood Counts Monthly during the first 3 months in view of the rare reported cases of neutropenia Treatment should be stopped if the ALT rises to five times the upper limit of normal. Discontinue riluzole in case of neutropenia. Duration of treatment: Stop treatment on advice of specialist. Re-referral criteria: Seek urgent advice from secondary care if: Toxicity is suspected e.g. respiratory symptoms The patient becomes pregnant Non-compliance is suspected The GP feels a dose change is required There is marked deterioration in the patient’s condition The GP feels the patient is not benefiting from the treatment Documentation: Formally reply to the consultant’s request to shared care within 14 days of receipt, using the shared care agreement forms Adverse Events Adverse events Interstitial lung disease Elevations in liver function tests Neutropenia Abdominal symptoms- nausea, diarrhoea, abdominal pain, vomiting Headache, dizziness, oral paraesthesia and somnolence Action If respiratory symptoms develop such as dry cough and/or dyspnoea, the patient should be referred to the consultant neurologist and chest radiography should be performed. In findings suggestive of interstitial lung disease (e.g. bilateral diffuse lung opacities), riluzole should be discontinued immediately. In the majority of the reported cases, symptoms resolved after drug discontinuation and symptomatic treatment. As per monitoring As per monitoring Symptomatic treatment Contraindications Cautions Drug Interactions Other Information Please refer to the BNF and/or SPC for information Contact Details Name: [insert text here] Address: [insert text here] Telephone: [insert text here] Symptomatic treatment Patients should be made aware that they need to report any febrile illness, fever, sore throat, bruising or unexpected bleeding, and respiratory symptoms (such as dry cough and/or dyspnoea. Version: 1 Date: 19/11/2015 Review: 19/11/2017 Shared Care Guideline for Riluzole for ALS Current version is held on GMMMG Website Check with internet that this printed copy of the latest issue Page 12 of 12