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Effective Shared Care Agreement (ESCA) Pramipexole 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 pramipexole 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 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 pramipexole 5. Initiate treatment and stabilise dose of pramipexole 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 pramipexole 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 pramipexole with the specialist, clinical nurse specialist or GP 3. Report any adverse effects to the specialist or GP whilst taking pramipexole 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 Pramipexole ESCA Date: July 2015 Review date: July 2015 Interface Lead Pharmacist Birmingham CrossCity CCG

SUPPORTING INFORMATION Indication For treatment of the signs and symptoms of idiopathic Parkinson’s disease, alone (without levodopa) or in combination with levodopa. Dosage and The daily dose is administered in equally divided doses 3 times a day Administration Doses should be increased gradually from a starting dose of 0.264 mg of base (0.375 mg of salt) per day and then increased every 5-7 days. Providing patients do not experience intolerable undesirable effects, the dose should be titrated to achieve a maximal therapeutic effect. Ascending dose schedule of pramipexole Week Dose Total Daily Dose Dose Total Daily Dose (mg of base) (mg of base) (mg of salt) (mg of salt) 1 3 x 0.088 0.264 3 x 0.125 0.375 2 3 x 0.18 0.54 3 x 0.25 0.75 3 3 x 0.35 1.1 3 x 0.5 1.50 If a further dose increase is necessary the daily dose should be increased by 0.54 mg of base (0.75 mg of salt) at weekly intervals up to a maximum dose of 3.3 mg of base (4.5 mg of salt) per day. However, it should be noted that the incidence of is increased at doses higher than 1.5 mg (of salt) per day.

Maintenance treatment The individual dose of pramipexole should be in the range of 0.264 mg of base (0.375 mg of salt) to a maximum of 3.3 mg of base (4.5 mg of salt) per day. Further dose adjustments should be done based on the clinical response and the occurrence of adverse reactions. In advanced Parkinson's disease, pramipexole doses higher than 1.1 mg of base (1.5 mg of salt) per day can be useful in patients where a reduction of the levodopa therapy is intended. It is recommended that the dose of levodopa is reduced during both the dose escalation and the maintenance treatment with pramipexole, depending on reactions in individual patients.

Treatment discontinuation Abrupt discontinuation of therapy can lead to the development of a neuroleptic malignant syndrome. Pramipexole should be tapered off at a rate of 0.54 mg of base (0.75 mg of salt) per day until the daily dose has been reduced to 0.54 mg of base (0.75 mg of salt). Thereafter the dose should be reduced by 0.264 mg of base (0.375 mg of salt) per day.

Renal Impairment Creatinine No dose adjusted required clearance above 50 ml/min Creatinine The initial daily dose of pramipexole should be administered in two divided doses, clearance starting at 0.088 mg of base (0.125 mg of salt) twice a day (0.176 mg of base/0.25 between 20 mg of salt daily). A maximum daily dose of 1.57 mg pramipexole base (2.25 mg of and 50 ml/min salt) should not be exceeded Creatinine The daily dose of pramipexole should be administered in a single dose, starting at clearance less 0.088 mg of base (0.125 mg of salt) daily. A maximum daily dose of 1.1 mg than 20 pramipexole base (1.5 mg of salt) should not be exceeded ml/min If renal function declines during maintenance therapy the pramipexole daily dose should be reduced by the same percentage as the decline in creatinine clearance, i.e. if creatinine clearance declines by 30%, then the pramipexole daily dose should be reduced by 30%. The daily dose can be administered in two divided doses if creatinine clearance is between 20 and 50 ml/min and as a single daily dose if creatinine clearance is less than 20 ml/min. Hepatic Dose adjustment in patients with hepatic failure is probably not necessary, as approx. 90% of impairment absorbed active substance is excreted through the kidneys. However, the potential influence of hepatic insufficiency on pramipexole has not been investigated. Contra-indications Contraindication:- / Special Hypersensitivity to pramipexole or excipients precautions Use in , lactation and in women of childbearing potential unless adequate contraception is used. Patients with psychotic disorders should only be treated with agonists if the potential Birmingham, Sandwell, Solihull and environs Area Prescribing Committee (BSSE APC) Based on MTRAC template Prepared by Satnaam Singh Nandra 2 Pramipexole ESCA Date: July 2015 Review date: July 2015 Interface Lead Pharmacist Birmingham CrossCity CCG

benefits outweigh the risks. Co-administration of medicinal products with pramipexole should be avoided Cautions:-  When prescribing pramipexole in a patient with Parkinson's disease with renal impairment a reduced dose is suggested.  are a known of treatment with dopamine agonists and levodopa. Patients should be informed that (mostly visual) hallucinations can occur.  Sudden onset of sleep and somnolence:- Patients must be informed of this and advised to exercise caution while driving or operating machines during treatment with pramipexole. Patients who have experienced somnolence and/or an episode of sudden sleep onset must refrain from driving or operating machines. Furthermore a reduction of the dose or termination of therapy may be considered.  Dyskinesia - In advanced parkinson's disease, in combination treatment with levodopa, dyskinesia can occur during the initial titration of pramipexole. If they occur, the dose of levodopa should be decreased.  Impulse control disorders:- Patients should be regularly monitored for the development of impulse control disorders. Patients and carers should be made aware that behavioural symptoms of impulse control disorders including pathological gambling, increased libido, , compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists including pramipexole. Dose reduction/tapered discontinuation should be considered if such symptoms develop.  Mania and delirium:- Patients should be regularly monitored for the development of mania and delirium. Patients and carers should be made aware that mania and delirium can occur in patients treated with pramipexole. Dose reduction/tapered discontinuation should be considered if such symptoms develop.  Ophthalmologic monitoring is recommended at regular intervals or if vision abnormalities occur.  In patients with severe cardiovascular disease, blood pressure should be monitored due to the general risk of postural hypotension associated with dopaminergic therapy Side Effects Very common , dyskinesia, somnolence, Common Abnormal dreams, behavioural symptoms of impulse control disorders and compulsions, confusion, hallucinations, , , visual impairment including diplopia, vision blurred and visual acuity reduced, hypotension, constipation, , fatigue, peripheral oedema, weight decrease including decreased Monitoring Renal function Ophthalmologic monitoring Blood pressure Drug Interactions Pramipexole has the following interaction information:

Antipsychotics manufacturer of pramipexole advises avoid concomitant use ofantipsychotics (antagonism of effect) Note: Increased risk of toxicity with myelosuppressive drugs

Cimetidine of pramipexole reduced by cimetidine (increased plasma concentration) Pramipexole belongs to and will have the following interactions:

Memantine effects of dopaminergics possibly enhanced by

Methyldopa antiparkinsonian effect of dopaminergics antagonised by

References Pramipexole SmPC Pramipexole BNF NICE CG 35 - Parkinson's disease: Diagnosis and management in primary and secondary care

Birmingham, Sandwell, Solihull and environs Area Prescribing Committee (BSSE APC) Based on MTRAC template Prepared by Satnaam Singh Nandra 3 Pramipexole ESCA Date: July 2015 Review date: July 2015 Interface Lead Pharmacist Birmingham CrossCity CCG

______

I agree to participate in this shared care agreement for the treatment of the below named patient with pramipexole for parkinson’s disease.

General Practitioner Name (please print)______Signature ______Date______

Hospital Specialist/Consultant Name (please print)______Signature______Date______

Patient’s name Date of birth Sex Home Address Hospital Number

NHS Number

Please keep a copy of this agreement for your own records and forward the original to the above named Consultant at:

Birmingham, Sandwell, Solihull and environs Area Prescribing Committee (BSSE APC) Based on MTRAC template Prepared by Satnaam Singh Nandra 4 Pramipexole ESCA Date: July 2015 Review date: July 2015 Interface Lead Pharmacist Birmingham CrossCity CCG