Shared Care Protocol for the Prescribing and Monitoring of Donepezil, Rivastigmine, Galantamine and Memantine in Accordance with NICE TA217
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Shared Care Protocol – Donepezil, Rivastigmine, Galantamine and Memantine Shared care protocol for the prescribing and monitoring of Donepezil, Rivastigmine, Galantamine and Memantine in accordance with NICE TA217 PATIENT’S NAME: PATIENT’S ADDRESS: HOSPITAL NAME AND NHS NUMBER / PATIENT IDENTIFIER: CONSULTANT’S NAME AND CONTACT DETAILS: GP’s NAME: Click here for SEPT prescribing guidelines on management of Alzheimer’s disease What are key elements of the process to ensure good shared care arrangements are in place? It is imperative that the GP is contacted to discuss shared care arrangements before treatment is commenced to ensure that they are willing to jointly manage the patient’s therapy. It is reasonable to expect the hospital clinician to prescribe if the patient will have to regularly attend hospital for specialist monitoring. PCT policies on clinical effectiveness should be adhered to. The GP should have sufficient information on the drug to either allow them to monitor the patient’s response to therapy and adjust dosages as required or know in what circumstances they should refer the patient back to the hospital clinician. Where the hospital clinician retains responsibility for monitoring drug therapy or making dosage adjustments, the general practitioner must be informed of any dose changes as soon as possible to avoid an incorrect dose being prescribed/administered. Similarly if the GP changes the patient’s medication then the hospital clinician involved in the shared care agreement should be informed of any changes that the GP undertakes. If a GP is unhappy to participate in a shared care agreement, the PCT should be asked for assistance in facilitating suitable prescribing arrangements for the patient. Informing the patient’s usual community pharmacist of the medication will help ensure that supplies are available. 1 Approved by Medicines Management Committee November 2011/Beds & Luton Joint Prescribing Committee December 2011 Shared Care Protocol – Donepezil, Rivastigmine, Galantamine and Memantine SUMMARY OF SPECIALIST / MEMORY ASSESSMENT SERVICE RESPONSIBILITIES. 1. Confirm the diagnosis of Alzheimer’s disease, including type. 2. Assess the likelihood of patient/carer compliance. Counsel carers as to the likely benefits and risks of treatment, including the consequence of poor compliance. 3. Offer advice as to the limited effectiveness of treatment over time as the illness progresses. 4. Clear documentation of mental capacity assessments/power of attorney in patient notes 5. Provide the GP, in the form of a detailed report, information relating to the initial memory clinic assessment. The Prescription Clinic will inform the GP of progress with dose titration at weeks 4, 8, 12 and 16 (depending on the cognitive enhancing drug prescribed) during the medication titration phase. 6. On initiation provide the GP and patient with information about treatment, particularly with regard to stopping treatment in due course, and the conditions/circumstances when treatment may be stopped, and the benefits that might be expected from a successful trial period for that patient in accordance with NICE TA217 7. Offer an initial trial period of treatment for approximately 3 months, and assess response during, and at the end of the trial period. The dose should be titrated according to response and tolerance. When the requisite response has been elicited at a dose commensurate with patient tolerability (usually 3 months), consideration can be given to transferring to the GP for shared care. 8. Prescriptions should be always be generated in the generic form. 9. Liaise with the GP to agree to share the patient’s care after the maintenance dose has been achieved. 10. Assessing the patient’s continuing response to treatment every 6 months or sooner if deemed necessary by the GP. 11. The prescription clinic will inform the GP of the patient’s tolerance to the medication and initial qualitative carer reports of its efficacy at the time that the maintenance dose is achieved. The Prescription Clinic will review the patient if further mental health input is warranted, e.g. behavioural disturbances. Information on re- assessments will be communicated to the GP after each clinic visit. 12. Deal with any behavioural difficulties experienced by the patient, including those arising from the use of an acetylcholinesterase inhibitor and any other adverse events reported by the GP relating to the treatment of this condition. 13. Evaluate adverse events noted by the GP or the patient. 14. Overall monitoring of disease status and drug therapy. 15. Dosage adjustment. 16. On discontinuing treatment, consider restarting/switching treatment if the patient experiences a dramatic deterioration of cognitive function or unacceptable side effects. Inform GP and patient/carer of rationale. 2 Approved by Medicines Management Committee November 2011/Beds & Luton Joint Prescribing Committee December 2011 Shared Care Protocol – Donepezil, Rivastigmine, Galantamine and Memantine SUMMARY OF GP RESPONSIBILITIES 1. Provide a full drug/medical history (preferably as recorded on the GP computerised records) to the Memory Assessment Service. 2. Prior to referral to the Memory Assessment Service, perform an initial blood screen to rule out possible causes for cognitive impairment (FBC, ESR, U&E, LFT, GGT, calcium profile, blood glucose, TFT, B12 and red cell folate). Also provide a 12-lead ECG if practically possible. 3. Once the patient has been adequately stabilised and benefit from drug therapy has been demonstrated, the GP will accept prescribing responsibility for the relevant drug, usually after 3 months. Generic prescriptions should be generated whenever possible. 4. Monitor the patients overall health and wellbeing during the normal consultation process. 5. Report signs of disease progression to form part of the 6 monthly Specialist/Memory Assessment Clinic assessments. 6. At the time of referral, inform the specialist clinician regarding the availability of a carer or care-worker in order to ensure compliance with treatment. 7. Check for possible drug interactions when newly prescribing or stopping concurrent medication. 8. Report any suspected adverse event to the specialist clinician and, if appropriate, to the MHRA. 9. Deal with any concomitant illness, with specialist clinic support if appropriate. 10. Refer the patient to the specialist clinician upon admission to a nursing home, to evaluate treatment efficacy. 11. Inform the specialist clinic regarding life situation changes. 12. On discontinuation of treatment, refer to the specialist clinician if the patient is observed to experience a dramatic deterioration in cognitive function. COMMUNICATION 1. The GP will be contacted to discuss shared care arrangements to ensure that he/she is willing to jointly manage the patient’s therapy after maintenance dose has been achieved. GPs will be sent a copy of the shared care guidelines. 2. Any changes to a patient’s overall medication that might affect, or be affected by, their treatment with a cognitive enhancing drug should be notified to the Prescription Clinic as soon as possible, ideally prior to the change being made. Drugs that may potentially interact with the cognitive enhancing drugs are detailed in the individual drug fact sheets. It is important that, as far as is possible, a patient’s overall medication remains unchanged during the initial Prescription Clinic phase. 3. The GP and Specialist/Memory Assessment Clinic/Prescribing Clinic should inform each other of any dose changes made as soon as possible to avoid an incorrect dose being administered. 4. The GP should be sent details of full assessments carried out by the Specialist/Memory Assessment Clinic/Prescription Clinic. 3 Approved by Medicines Management Committee November 2011/Beds & Luton Joint Prescribing Committee December 2011 Shared Care Protocol – Donepezil, Rivastigmine, Galantamine and Memantine Where there is a disagreement around prescribing for Dementia/Alzheimer’s Disease for justified reasons, which cannot be resolved satisfactorily, prescribing responsibility will remain with the specialist clinic. PRESCRIBING COSTS Based on Drug Tariff, April 2011 Drug Form Cost of 3 month trial based on Annual Cost at recommended doses indicated below daily doses indicated below Tabs 5 mg, 10 mg £227.63 (5mg od for 1 month, then £718.20(5mg od) Donepezil Orodispersible Tabs 5mg, 10mg 10mg od for 2 months) £982.64 (10mg od) (Aricept Evess®) Caps1.5mg, 3mg, 4.5mg, 6mg £234.75 (cost is same throughout £1017.25 (cost is same throughout dosage range for caps) dosage range for caps) £312.29 (based on titration upto 6mg £1561.45 (based on titration upto Oral solution 2 mg/mL. Rivastigmine bd) 6mg bd) Patches, 4.6 mg/24 hours; 9.5 mg/24 £233.91 (cost is same throughout £935.64 (cost is same throughout hours range) range) (Exelon) Tabs 8mg, 12mg £186.48 (4mg bd for 1 month, then £785.68 (8mg bd) 8mg bd for 1 month & then 12mg bd Oral solution 4mg/mL. £942.48 (12mg bd) for 1 month) £207.00 (8mg od for 1 month, then £765.78 (16mg od) M/R Caps 8mg, 16mg, 24mg (Reminyl 16mg od for a month, then 24mg od Galantamine XL) £925.20(24mg od) for a month) £403.00 (4mg bd for 1 month, then Oral solution 4mg/mL. 8mg bd for 1 month & then 12mg bd £2217.40 (12mgbd) for 1 month) £181.15 (cost based on titration pack Tabs 10mg – 5mg od, increased by 5mg weekly £802.24 (20mg od) to 20mg od Memantine Oral solution 5mg/actuation £123.23 (as above) £765.27 (20mg od) (10mg/ml) Prices are based on current available licensed products and are likely to change with patent expiration and the introduction of generic alternatives. Generic prescribing, where appropriate, is strongly encouraged. Premium formulations, e.g. patches/orodispersible/liquids should only be prescribed when clinically necessary, e.g. swallowing difficulties. Although Aricept tablets and Aricept Evess (Orodispersible tablets) are currently identically priced, it is anticipated that this will change in 2012. The continued use of orodispersible tablets (Evess) should be reviewed in patients receiving this formulation and whenever clinically possible standard generic donepezil should be prescribed to achieve maximum cost savings.