Effective Shared Care Agreement (ESCA) Ropinirole Immediate Release (IR) and Modified Release (MR) ESCA: For the treatment of parkinson’s disease AREAS OF RESPONSIBILITY FOR THE SHARING OF CARE This shared care agreement outlines suggested ways in which the responsibilities for managing the prescribing of ropinirole IR/MR for parkinson’s disease can be shared between the specialist and general practitioner (GP). You are invited to participate however, if you do not feel confident to undertake this role, then you are 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. Sharing of care assumes communication between the specialist, GP and patient. The intention to share care will be explained to the patient by the specialist initiating treatment. It is important that patients are consulted about treatment and are in agreement with it. Patients with parkinson’s disease are usually under regular specialist follow-up, which provides an opportunity to discuss drug therapy. 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. Confirm the diagnosis of parkinson’s disease can 2. Discuss the potential benefits, treatment side effects, and possible drug interactions with the patient 3. Ask the GP whether he or she is willing to participate in shared care before initiating therapy so that appropriate follow on prescribing arrangements can be made 4. Do baseline monitoring prior to initiation of ropinirole IR/MR 5. Initiate treatment and stabilise dose of ropinirole IR/MR 6. Review the patient's condition and monitor response to treatment regularly 7. A written summary to be sent promptly to the GP i.e. within 10 working days of a hospital outpatient review or inpatient stay 8. Report serious adverse events to the MHRA 9. Ensure clear backup arrangements exist for GPs, for advice and support (Please complete details below) General Practitioner responsibilities 1. Reply to the request for shared care as soon as practicable i.e. within 10 working days 2. Prescribe ropinirole IR/MR at the dose recommended 3. In the patient's notes, using the appropriate Read Code listed below, denote that the patient is receiving treatment under a shared care agreement GP Prescribing System Read Code Description GP Prescribing System Read Code Description EMIS and Vision 8BM5.00 Shared care prescribing SystmOne XaB58 Shared care 4. Monitor patient’s response to treatment; make dosage adjustments if agreed with specialist 5. Report to and seek advice from the specialist or clinical nurse specialist on any aspect of patient care that is of concern to the GP, patient or carer and may affect treatment 6. Refer back to specialist if condition deteriorates 7. Report serious adverse events to specialist and MHRA 8. Stop treatment on advice of specialist Patient's role 1. Report to the specialist, clinical nurse 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 ropinirole IR/MR with the specialist, clinical nurse specialist or GP 3. Report any adverse effects to the specialist or GP whilst taking ropinirole IR/MR 4. Attend regular outpatient appointments with the specialist BACK-UP ADVICE AND SUPPORT Trust Contact details Telephone No. Email address: Consultant:- Specialist Nurse Birmingham, Sandwell, Solihull and environs Area Prescribing Committee (BSSE APC) Based on MTRAC template Prepared by Satnaam Singh Nandra 1 Ropinirole Immediate Release (IR) and Modified Release (MR) ESCA Interface Lead Pharmacist Birmingham CrossCity CCG Date: July 2015 Review date: July 2018 SUPPORTING INFORMATION Indication Treatment of Parkinson's Disease under the following conditions: Initial treatment as monotherapy, in order to delay the introduction of levodopa In combination with levodopa, over the course of the disease, when the effect of levodopa wears off or becomes inconsistent and fluctuations in the therapeutic effect occur (“end of dose” or “on-off” type fluctuations) Dosage and Immediate release tablets Modified release tablets Administration Individual dose titration against efficacy and tolerability is recommended. Individual dose titration against efficacy and tolerability is recommended. Ropinirole should be taken three times a day, preferably with meals to improve Ropinirole prolonged-release tablets should be taken once a day and at a similar gastrointestinal tolerance. time each day. The tablets must be swallowed whole and must not be chewed, crushed or divided. The tablets may be taken with or without food. Treatment initiation: The initial dose should be 0.25 mg three times daily for 1 week. Thereafter, the dose of ropinirole can be increased in 0.25 mg three times Initial titration daily increments, according to the following regimen: The starting dose of ropinirole prolonged-release tablets is 2 mg once daily for the first week; this should be increased to 4 mg once daily from the second week of Week treatment. A therapeutic response may be seen at a dose of 4 mg once daily of ropinirole prolonged-release tablets. 1 2 3 4 Unit dose (mg) of ropinirole 0.25 0.5 0.75 1.0 Patients who initiate treatment with a dose of 2 mg/day of ropinirole prolonged- Total daily dose (mg) of ropinirole 0.75 1.5 2.25 3.0 release tablets and who experience side effects that they cannot tolerate, may benefit from switching to treatment with ropinirole film-coated (immediate Therapeutic regimen: After the initial titration, weekly increments of 0.5 to 1 mg release) tablets at a lower daily dose, divided into three equal doses. three times daily (1.5 to 3 mg/day) of ropinirole may be given. Therapeutic regimen A therapeutic response may be seen between 3 and 9 mg/day of ropinirole. If Patients should be maintained on the lowest dose of ropinirole prolonged-release sufficient symptomatic control is not achieved, or maintained after the initial tablets that achieves symptomatic control. titration as described above, the dose of ropinirole may be increased up to 24 mg/day. If sufficient symptomatic control is not achieved or maintained at a dose of 4 mg once daily of ropinirole prolonged-release tablets, the daily dose may be increased Doses of ropinirole above 24 mg/day have not been studied. by 2 mg at weekly or longer intervals up to a dose of 8 mg once daily of prolonged- release tablets. If treatment is interrupted for one day or more re-initiation by dose titration should be considered (see above). If sufficient symptomatic control is still not achieved or maintained at a dose of 8 mg once daily of ropinirole prolonged-release tablets, the daily dose may be When ropinirole is administered as adjunct therapy to L-dopa, the concurrent increased by 2 mg to 4 mg at two weekly or longer intervals. The maximum daily dose of L-dopa may be reduced gradually according to the symptomatic response. dose of ropinirole prolonged-release tablets is 24 mg. In clinical trials, the levodopa dose was reduced gradually by around 20% in patients treated with ropinirole as adjunct therapy.. In patients with advanced It is recommended that patients are prescribed the minimum number of ropinirole Birmingham, Sandwell, Solihull and environs Area Prescribing Committee (BSSE APC) Based on MTRAC template Prepared by Satnaam Singh Nandra 2 Ropinirole Immediate Release (IR) and Modified Release (MR) ESCA Interface Lead Pharmacist Birmingham CrossCity CCG Date: July 2015 Review date: July 2018 Parkinson's disease receiving ropinirole in combination with L-dopa, dyskinesias prolonged-release tablets that are necessary to achieve the required dose by can occur during the initial titration of ropinirole. In clinical trials it was shown that utilising the highest available strengths of ropinirole prolonged-release tablets. a reduction of the L-dopa dose may ameliorate dyskinesia When ropinirole prolonged-release tablets are administered as adjunct therapy to When switching treatment from another dopamine agonist to ropinirole, the levodopa, it may be possible to gradually reduce the levodopa dose, depending on manufacturer's guidance on discontinuation should be followed before initiating the clinical response. In clinical trials, the levodopa dose was reduced gradually by ropinirole. approximately 30% in patients receiving ropinirole prolonged-release tablets concurrently. In patients with advanced Parkinson's disease receiving ropinirole As with other dopamine agonists, it is necessary to discontinue ropinirole prolonged-release tablets in combination with L-dopa, dyskinesias can occur treatment gradually by reducing the number of daily doses over the period of one during the initial titration of ropinirole prolonged-release tablets. In clinical trials it week. was shown that a reduction of the L-dopa dose may ameliorate dyskinesia When switching treatment from another dopamine agonist to ropinirole, the marketing authorisation holder's guidance on discontinuation should be followed before initiating ropinirole. As with other dopamine agonists, it is necessary to discontinue ropinirole treatment gradually by reducing the daily dose over the period of one week. Switching from ropinirole immediate release tablets to ropinirole prolonged- release tablets Patients may be switched overnight from ropinirole immediate release tablets to ropinirole prolonged-release tablets. The dose of ropinirole prolonged-release