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					                            TEMPLATE EFFECTIVE SHARED CARE AGREEMENT (topiramate)

                                          Topiramate (Topamax®)
    ESCA: For the prevention of migraine headache in adults
    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.

                                                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
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.

Contact details                                     Telephone No.              Bleep:        Fax:                   Email address:
Hospital Pharmacy Dept:
    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)

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.

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.

At current prices, the cost of one year’s treatment with topiramate 100 mg daily is £409.

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.