WORKING IN PARTNERSHIP WITH EFFECTIVE SHARED CARE AGREEMENT (ESCA) DRUG NAME: ACETYLCHOLINESTERASE-INHIBITORS AND MEMANTINE INDICATION/S COVERED: Dementia in Alzheimers Disease Coastal West Sussex Traffic Light system classification: Amber N.B. The eligibility criteria included here apply to new patients commencing treatment under this agreement & not to existing patients whose treatment was initiated under the previous version. However, monitoring and discontinuation criteria apply to all patients. NOTES to the primary care prescriber Amber drugs: Prescribing to be initiated by a consultant / specialist but with the potential to transfer to primary care. The expectation is that this agreement should provide sufficient information to enable primary care prescribers to be confident to take clinical and legal responsibility for prescribing these drugs. The questions below will help you confirm this: Is the patient s condition predictable? Do you have the relevant knowledge, skills and access to equipment to allow you to monitor treatment as indicated in this effective shared care agreement? Have you been provided with relevant clinical details including monitoring data? If you can answer YES to all these questions (after reading this ESCA), then it is appropriate for you to accept prescribing responsibility. Sign and return a copy of the final page to the requesting consultant / specialist. Until the requesting consultant / specialist has received a signed copy of the final page indicating that shared care has been agreed all care (including prescribing) remains with the consultant / specialist. If the answer is NO to any of these questions, you should not accept prescribing responsibility. You should write to the consultant / specialist within 14 days, outlining your reasons for NOT prescribing. If you do not have the confidence to prescribe, we suggest you discuss this with your local Trust/specialist service, which will be willing to provide training and support. If you still lack the confidence to accept clinical responsibility, you still have the right to decline. Your Medicines Management pharmacist will assist you in making decisions about shared care. Prescribing unlicensed medicines or medicines outside the recommendations of their marketing authorisation alters (and probably increases) the prescriber s professional responsibility and potential liability. The prescriber should be able to justify and feel competent in using such medicines. The patient s best interests are always paramount The primary care prescriber has the right to refuse to agree to shared care, in such an event the total clinical responsibility will remain with the consultant Effective from: 8/11/12 Review date: 8/11/14 Page 1 of 7
Information This page should include general information relevant to the specific drug and indication/s. It should include information on the dose of the drug for the indication, cautions, contraindications, common side effects and interactions to look out for. This section should have input from a specialist consultant in the field. This information sheet does not replace the Summary of Product Characteristics (SPC), which should be read in conjunction with this guidance. Prescribers should also refer to the appropriate paragraph in the current edition of the BNF. 1. Link to the relevant SPC website: http://www.medicines.org.uk/emc Summary of Product Characteristics: donepezil tablets, orodispersible tablets Summary of Product Characteristics: galantamine m/r capsules Summary of Product Characteristics: galantamine tablets Summary of Product Characteristics: rivastigmine hard capsules, patches & oral solution Summary of Product Characteristics: memantine tablets, oral solution 2. Background to use for the indication/s, including licence status Donepezil, galantamine and rivastigmine inhibit acetylcholinesterase. This raises the concentration of acetylcholine at sites of neurotransmission. Galantamine also enhances the action of acetylcholine on nicotinic receptors. The acetylcholinesterase inhibitors are licensed and indicated for the symptomatic treatment of mild to moderate dementia in AD commonly defined by a mini mental-state examination (MMSE) score of between 10 and 20 points (moderate) and 20 and 26 points (mild), however there are a number of exceptions to this as laid out in the related NICE guidelines 1,2. Rivastigmine is also licensed and indicated for symptomatic treatment of mild to moderate dementia in patients with idiopathic Parkinson's disease. Memantine belongs to a group of medicines called NMDA-receptor antagonists. Memantine acts on these NMDA-receptors improving the transmission of nerve signals and the memory. Memantine does not cure the condition but in some people it may improve the underlying decline. Memantine is licensed and indicated for the symptomatic treatment of people with moderate AD who are intolerant of or have contraindications to acetylcholinesterase inhibitors or those with severe AD. 3. Dose & administration Donepezil: 5mg once daily at bedtime. Increase if necessary after four weeks to 10mg once daily at bedtime. (Note many patients will be adequately maintained on the 5mg dose). Maximum 10mg daily. Galantamine: 8mg daily (with food) for four weeks. (m/r) Increase to 16mg daily for four weeks. Usual maintenance dose 16mg-24mg daily. Maximum 24mg daily. Galantamine: 4mg twice daily (with food) for four weeks. (i/r) Increase to 8mg twice daily for four weeks. Usual maintenance dose 8mg-12mg twice daily. Maximum 12mg twice daily. Rivastigmine: 1.5mg twice daily (with food) for at least two weeks. Increase in steps of 1.5mg twice daily at intervals of at least two weeks. or 4.6mg/24hr by patch increasing if needed after a minimum of 4 weeks to 9.5mg/24hrs. Usual maintenance dose 3-6mg twice daily or 4.6mg to 9.5mg/24 hrs. Maximum 6mg twice daily (orally) or 9.5mg (patch). See BNF if considering switching from oral to patches or a patient on the 9.5mg patch fails to remove it for several days. Memantine: 5mg daily for seven days, then 10mg daily for seven days, then 15mg daily for seven days, then 20mg thereafter. Usual maintenance dose 20mg daily. Maximum dose 20mg daily. Effective from: 8/11/12 Review date: 8/11/14 Page 2 of 7
4. Cautions Acetylcholinesterase inhibitor should be used with caution in patients with sick sinus syndrome or other cardiac conduction abnormalities as they may have vagotonic affects on heart rate e.g. bradycardia. Their use is also cautioned in patients with susceptibility to peptic ulcers, asthma, chronic obstructive pulmonary disease and renal and hepatic impairment. Memantine should be used with caution in patients with a history of convulsions and renal and hepatic impairment. 5. Contraindications Acetylcholinesterase inhibitor and memantine Contraindicated in severe hepatic impairment. Also contraindicated in patients with known hypersensitivity to the active substance, its derivatives and any excipients listed in the product formulation. 6. Side effects Very common (frequency estimate > 10%) side effects include: Acetylcholinesterase inhibitors Diarrhoea, nausea and vomiting Common (frequency estimate 1% to 10%) side effects include: Acetylcholinesterase inhibitors Dyspepsia, anorexia, dizziness, fatigue, insomnia, headache, agitation, anxiety, and tremor. Memantine Drug hypersensitivity, dizziness, somnolence, hypertension, dyspnoea, constipation and headache. Suspected adverse drug reactions If an adverse reaction to the drug is suspected, a Yellow Card should be completed. For black triangle ( ) drugs all adverse reactions should be reported For established drugs only serious adverse reactions should be reported 7. Interactions Plasma concentrations of galantamine increased by erythromycin, ketoconazole and paroxetine. Ketoconazole and quinidine, inhibitors of CYP3A4 and 2D6 respectively, inhibit donepezil metabolism. Therefore these and other CYP3A4 inhibitors, such as itraconazole and erythromycin, and CYP2D6 inhibitors, such as fluoxetine could inhibit the metabolism of donepezil. Galantamine, rivastigmine and possibly donepezil enhance the effect of suxamethonium but antagonise the effect of non-depolarising muscle relaxants. Concomitant administration of acetylcholinesterase inhibitors with other inhibitors of acetylcholinesterase, agonists or antagonists of the cholinergic system should be avoided. Concomitant use of memantine and amantadine should be avoided, owing to the risk of pharmacotoxic psychosis. The same may be true for ketamine and dextromethorphan. The mode of action of memantine suggests that the effects of L-dopa, dopaminergic agonists, and anticholinergics may be enhanced by concomitant treatment with NMDA-antagonists such as memantine. The effects of barbiturates and neuroleptics may be reduced. Concomitant administration of memantine with the antispasmodic agents, dantrolene or baclofen, can modify their effects and a dosage adjustment may be necessary. 8. Criteria for use As given under licensed indications and NICE TA217. 9. Any further information (e.g. supporting therapies) AD must be diagnosed in a specialist clinic that should also assess cognitive, global and behavioural functioning, activities of daily living and the likelihood of compliance with treatment. The carer s views of the condition should be sought before and during drug treatment. The patient should be reassessed 2-4 months after maintenance dose is established. Following any assessment, drug treatment should continue only if it is considered to be having a worthwhile effect on cognitive, global, functional and behavioural symptoms. These guidelines should be used in conjunction with the donepezil, galantamine, rivastigmine and memantine Summaries of Product Characteristics (SPC) and the recommendations of the consultant responsible for the management of Alzheimer s disease (AD). These guidelines are for use only when a decision has been made Effective from: 8/11/12 Review date: 8/11/14 Page 3 of 7
to treat a patient and should not be considered to be a complete referral and management guideline. INFORMATION TO PATIENTS A pharmaceutical company patient information leaflet (PIL) will be provided with each supply. INFORMATION TO BE RECEIVED BY THE GP FROM THE SPECIALIST TEAM The Specialist Team s review letter will be sent after initial assessment and following each further appointment. It is assumed that the GP agrees to the shared care arrangements INFORMATION TO BE RECEIVED BY THE CONSULTANT FROM THE GP The NICE Guidance 1,2 suggests shared care between the specialist clinic and GP. In the rare event that the GP is unwilling to assume prescribing responsibility for the patient the specialist should be informed promptly on receipt of the specialist s letter. In such cases the GP must inform the specialist of all relevant medical information regarding the patient and any changes to the patient s medication regime irrespective of indication. THE GP SHOULD INFORM THE SPECIALIST OF ANY ADVERSE EFFECTS EXPERIENCED BY THE PATIENT. Support groups and information websites Alzheimer s Society: Tel- 0845 300 0336 - www.alzheimers.org.uk Alzheimer s Disease International: www.alz.co.uk Equip Dementia: http://nhslocal.nhs.uk/my-health/equip/view/links?l=dementia Choice and medication website: http://www.choiceandmedication.org/sussex COST OF MONTHLY TREATMENT (Drug Tariff November 2012) Donepezil: 28 x 5mg = 2.19 28 x 10mg = 2.89 Galantamine m/r: 28 x 8mg = 51.88 28 x 16mg = 64.90 28 x 24mg = 79.80 Galantamine i/r: 56 x 8mg = 60.35 56 x 12mg = 74.20 Memantine: 28 x 10mg = 34.50 28 x 20mg = 69.01 Rivastigmine: 56 x 1.5mg = 59.70 56 x 3mg = 59.70 56 x 4.5mg = 59.70 56 x 6mg = 54.26 28 x 4.6mg (patch) = 72.77 28 x 9.5mg (patch) = 72.77 10. References 1. NICE Technology Appraisal Number TA217, Donepezil, galantamine, rivastigmine and memantine for the treatment of Alzheimer s disease (review). (Mar 2011) http://guidance.nice.org.uk/ta217/guidance/pdf/english 2. NICE Clinical Guideline CG42, Dementia (Nov 2006). Amended March 2011. http://guidance.nice.org.uk/cg42/niceguidance/pdf/english Effective from: 8/11/12 Review date: 8/11/14 Page 4 of 7
RESPONSIBILITIES and ROLES Consultant / Specialist responsibilities 1 Confirmation of diagnosis of AD and identification of suitable patients in line with NICE TA 217 following full assessment. 2 Request agreement of shared care with primary care prescriber. 3 Discussion of risks and benefits with patients, outline possible side effects. 4 Initiation of appropriate therapy. 5 Issuing initial prescription(s) until the patient/dosage is stabilised (minimum of one month) and until ESCA is in place. 6 To ensure baseline monitoring of MMSE is performed and psychiatric assessment using appropriate rating scales plus any additional relevant investigations e.g. CT and MRI scan. 7 To monitor the patient s clinical condition, carer s views, drug tolerability, drug compliance and administer the MMSE at every review and act on the results appropriately and communicate these results to the primary care prescriber. 8 To review patient 2-4 months after a maintenance dose is established and every 6 months (or annually if the patient is identified as a slow decliner, until the decline accelerates significantly or the MMSE score gets close to 10 this should be agreed with the primary care prescriber) thereafter or sooner if indicated. 9 To assess on going benefit and consider a trial discontinuation if there has been rapid clinical deterioration or the drug is considered to no longer be having a worthwhile effect on cognitive, global, functional and behavioural symptom. Trial discontinuations/restarting are the responsibility of the specialist team, including written feedback to the primary care prescriber. 10 To consider the use of memantine for the symptomatic treatment of people with moderate AD who are intolerant of or have contraindications to acetylcholinesterase inhibitors or with severe AD. 11 Ensure that all newly treated patients (and/or their carers) receive appropriate education, advice and support regarding their drug therapy and shared care arrangements. This should include written information where appropriate. 12 Providing primary care prescriber with clinic letter stating planned introduction and reviews. 13 Provide outpatient reviews, monitor effectiveness/side effects. 14 Give a copy of the information sheet to the patient / carer and explain their roles. 15 Notify the primary care prescriber of the patient s failure to attend appointments for clinical review or drug monitoring. Primary care prescriber responsibilities 1 Initial referral to secondary care (to include initial MMSE result, medical history, blood screening and physical examination). 2 To inform the consultant if unwilling to enter into shared-care arrangements. 3 To provide repeat prescriptions once ESCA is agreed and in place and the patient is stabilised (not before initial one months stabilisation period). It is recommended that no more than one month s prescription should be issued at a time. A demonstrable system should be in place to ensure that prescribing is reviewed by the primary care prescriber if there is no record of the fact that monitoring has taken place within the agreed time scales. 4 To record any changes in therapy in the prescribing record on receipt of such communication from secondary care. 5 To monitor patients overall health and well-being and to report any adverse drug reactions or interactions to secondary care. 6 To act upon results communicated by specialist. 7 To review the appropriateness of prescribing for patients who have not been seen by either the Memory Assessment Service or the Living Well with Dementia Team for over 6 months (or 12 months if an annual review has been agreed with the specialist see point 8 above under specialist s responsibilities). 8 Liaise with specialist if any cause for concern or drug discontinued. 9 To provide a copy of this ESCA to the patient to ensure that they are familiar with all roles and responsibilities. 10 To ensure all relevant staff within the practice are aware of the shared care agreement. Effective from: 8/11/12 Review date: 8/11/14 Page 5 of 7
Patient's / Carer s role 1 Ask the consultant / specialist or primary care prescriber for information, if he or she does not have a clear understanding of the treatment. 2 Share any concerns in relation to treatment with antidementia medicine. 3 Tell the consultant / specialist or primary care prescriber of any other medication being taken, including overthe-counter products. 4 Read the patient information leaflet included with the medication and report any side effects or concerns to the consultant / specialist or primary care prescriber. 5 To inform the primary care prescriber if any health problems arise. 6 To attend appointments. 7 Arrange blood tests as per specialist request. 8 To be aware of side effects and report to their primary care prescriber / specialist any such symptoms. BACK-UP ADVICE AND SUPPORT Specialist / Consultant: Alternative specialist (e.g. departmental contact): Name / position Telephone Email Dr Caroline Gorst-Unsworth (Consultant Psychiatrist) West Sussex Memory & Assessment Service South West Sussex Memory & Assessment Service North Hospital Pharmacy: Worthing Hospital St Richards Hospital See below 01903 843 888 01243 791 883 01903 205 111, ext 5698 01243 788 122, ext pharmacy@wsht.nhs.uk Out of hours (e.g. medical team on call): N/A N/A N/A Version History Document Name: Document Type: Relevant to: Acetylcholinesterase-Inhibitor and Memantine Antidementia Drugs Effective Shared Care Agreement All primary care prescribers working within Coastal West Sussex and all relevant clinicians at Western Sussex Hospitals NHS Trust. Version No. Date Author of original development or review Details of document development 1 04 / 09 Ray Lyon, Chief Pharmacist, Sussex Partnership NHS Foundation Trust 2 10 / 12 Nick Rutherford, Medicines Management Technician, Coastal West Sussex CCG Original development Full review and re-draft Approval for organisational use ESCA authorised for use in Coastal West Sussex by Specialist/consultant: Dr Caroline Gorst-Unsworth, Consultant Psychiatrist, (OPMH) Medical Lead, West Sussex - 16 October 2012 Coastal West Sussex Area Prescribing Committee (APC): 25 th July 2012 Effective from: 8/11/12 Review date: 8/11/14 Page 6 of 7
EFFECTIVE SHARED CARE AGREEMENT (ESCA) DRUG NAME: <insert> INDICATION: Dementia in Alzheimers Disease Agreement for transfer of prescribing to PRIMARY CARE PRESCRIBER Patient details: Name: Address: DoB: NHS No: Drug name and dose: <insert> Hospital No: The following tests and investigations have been carried out: <insert details of tests>: Date treatment initiated: At the last patient review the drug appeared to be effectively controlling symptoms / providing benefit: Yes/No The patients has now been stabilised on a dose of: I will arrange to review this patient regularly. Date of next clinic appointment: <Insert title of specialist>: <insert name> Address: <insert relevant department> <insert relevant hospital address> Contact Number: <insert telephone number and extension> Primary care prescriber: Address: Agreement to shared care, to be signed by primary care prescriber and consultant/specialist. Consultant/specialist signature: Date: Primary care prescriber signature: Contact Number: Main Carer: Contact Number: Key worker if appropriate: Contact Number: Date: If shared care is agreed and the primary care prescriber has signed above please return a copy of this page to the requesting consultant or alternatively fax to: <insert> Effective from: 8/11/12 Review date: 8/11/14 Page 7 of 7