TEMPLATE EFFECTIVE SHARED CARE AGREEMENT (topiramate) Topiramate (Topamax®) ESCA: For the prevention of migraine headache in adults AREAS OF RESPONSIBILITY FOR THE SHARING OF CARE This shared care agreement outlines suggested ways in which the responsibilities for managing the prescribing of topiramate for the prevention of migraine can be shared between the specialist and general practitioner (GP).* GPs are invited to participate. If the GP is not confident to undertake these roles, then he or she is under no obligation to do so. In such an event, the total clinical responsibility for the patient for the diagnosed condition remains with the specialist. If a specialist asks the GP to prescribe this drug, the GP should reply to this request as soon as practicable. Sharing of care assumes communication between the specialist, GP and patient. The intention to share care is usually explained to the patient by the doctor initiating treatment. It is important that patients are consulted about treatment and are in agreement with it. The doctor who prescribes the medication legally assumes clinical responsibility for the drug and the consequences of its use. RESPONSIBILITIES and ROLES Specialist responsibilities 1 Initiate topiramate and titrate dose to achieve optimal clinical outcome. 2 Discuss the benefits and side effects of treatment with the patient. 3 Ask the GP whether he or she is willing to participate in shared care, and agree with the GP as to who will discuss the shared care arrangement with the patient. 4 Regular follow-up of patient. 5 Communicate promptly with the GP when treatment is changed. 6 Have a mechanism in place to receive rapid referral of a patient from the GP in the event of deteriorating clinical condition. 7 Advise GP on dosage adjustment and when and how to stop treatment. 8 Report adverse events to the CSM. 9 Ensure that clear backup arrangements exist for GPs to obtain advice and support. General Practitioner responsibilities 1 Reply to the request for shared care as soon as practicable. 2 Prescribe topiramate at the dose recommended. 3 Adjust the dose as advised by the specialist. 4 Report to and seek advice from the specialist on any aspect of patient care that is of concern and may affect treatment. 5 Refer patient to the specialist if his or her condition deteriorates. 6 Stop treatment on the advice of the specialist or initiate tapered withdrawal if advised to do so. 7 Report adverse events to the specialist and CSM. Patient's role (or that of carer) 1 Report to the specialist or GP if he or she does not have a clear understanding of the treatment. 2 Share any concerns in relation to treatment with topiramate. 3 Report any adverse effects to the specialist or GP whilst taking topiramate. BACK-UP ADVICE AND SUPPORT Contact details Telephone No. Bleep: Fax: Email address: Specialist: Hospital Pharmacy Dept: Other: Or any primary care prescriber This ESCA should be read in conjunction with the Summary of Product Characteristics (SPC) and the Midlands Therapeutics Review and Advisory Committee (MTRAC) verdict and summary sheet (VS09/04) Template updated by MTRAC in February 2009 for local adaptation and adoption. TEMPLATE EFFECTIVE SHARED CARE AGREEMENT (topiramate) SUPPORTING INFORMATION Licensed indication Topamax is indicated in adults (over 16 years) for the prophylaxis of migraine headache. Dosage and Administration Titration of topiramate should begin at 25 mg nightly for one week, increasing by 25 mg per day at one-week intervals (or longer intervals if the dose is not tolerated). The recommended dose of topiramate for prevention of migraine is 100 mg daily given in two divided doses. Some patients experience a benefit at 50 mg daily; no extra benefit has been demonstrated from doses higher than 100 mg daily. If treatment is to be discontinued, the dose should be gradually decreased over at least two weeks to minimise the possibility of rebound migraine headaches. Monitoring Significant weight loss may occur during long-term topiramate treatment for migraine prophylaxis. In clinical trials, a mean weight loss of 5.5 kg was observed over 20 months. Therefore it is recommended that patient’s weight be monitored regularly. Contraindications and precautions for use Hypersensitivity to any component of the product. Therapeutic Use Refer to MTRAC verdict and summary sheet VS09/04. Side Effects Adverse events commonly associated with topiramate include paraesthesia, fatigue, anorexia, nausea, weight loss and difficulties with memory or cognition. The Summary of Product Characteristics (SPC) lists decreased serum bicarbonate concentrations as a potential adverse event. See the SPC for further details. Drug Interactions The SPC lists potential interactions with other antiepileptic drugs, digoxin (reduced AUC reported in a single study), CNS depressant drugs, oral contraceptives (50 microgram oestrogen or an alternative non-hormonal method is recommended), lithium, hydrochlorothiazide, and some antidiabetic agents. In most cases the clinical relevance has not been established. See the SPC for further details. Cost At current prices, the cost of one year’s treatment with topiramate 100 mg daily is £409. References MTRAC verdict and summary sheet for topiramate for prevention of migraine, VS09/04. Topamax. Janssen-Cilag Ltd. Summary of Product Characteristics. 2008. This ESCA should be read in conjunction with the Summary of Product Characteristics (SPC) and the Midlands Therapeutics Review and Advisory Committee (MTRAC) verdict and summary sheet (VS09/04) Template updated by MTRAC in February 2009 for local adaptation and adoption.