Effective Shared Care Agreement (ESCA) Rasagiline 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 rasagiline 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 rasagiline 5. Initiate treatment and stabilise dose of rasagiline 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 rasagiline 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 rasagiline with the specialist, clinical nurse specialist or GP 3. Report any adverse effects to the specialist or GP whilst taking rasagiline 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 Rasagiline ESCA Date: July 2015 Review date: July 2018 Interface Lead Pharmacist Birmingham CrossCity CCG
SUPPORTING INFORMATION Indication For the treatment of idiopathic Parkinson's disease (PD) as monotherapy (without levodopa) or as adjunct therapy (with levodopa) in patients with end of dose fluctuations. Dosage and Rasagiline is administered orally, at a dose of 1 mg once daily with or without levodopa. Administration Renal Impairment No change in dose is required Hepatic Mild Use with caution impairment Moderate Not recommended Severe Contra-indications Contraindication:- / Special Hypersensitivity to the active substance or to any of the excipients precautions Concomitant treatment with other monoamine oxidase (MAO) inhibitors (including medicinal and natural products without prescription e.g. St. John's Wort) or pethidine. At least 14 days must elapse between discontinuation of rasagiline and initiation of treatment with MAO inhibitors or pethidine. Rasagiline is contraindicated in patients with severe hepatic impairment.
Cautions:- The concomitant use of rasagiline and fluoxetine or fluvoxamine should be avoided. At least five weeks should elapse between discontinuation of fluoxetine and initiation of treatment with rasagiline. At least 14 days should elapse between discontinuation of rasagiline and initiation of treatment with fluoxetine or fluvoxamine. Impulse control disorders (ICDs) can occur in patients treated with dopamine agonists and/or dopaminergic treatments. Similar reports of ICDs have also been received post-marketing with rasagiline. Patients should be regularly monitored for the development of impulse control disorders. Patients and carers should be made aware of the behavioural symptoms of impulse control disorders that were observed in patients treated with rasagiline, including cases of compulsions, obsessive thoughts, pathological gambling, increased libido, hypersexuality, impulsive behaviour and compulsive spending or buying. Since rasagiline potentiates the effects of levodopa, the adverse effects of levodopa may be increased and pre-existing dyskinesia exacerbated. Decreasing the dose of levodopa may ameliorate this side effect. There have been reports of hypotensive effects when rasagiline is taken concomitantly with levodopa. Patients with Parkinson's disease are particularly vulnerable to the adverse effects of hypotension due to existing gait issues. The concomitant use of rasagiline and dextromethorphan or sympathomimetics such as those present in nasal and oral decongestants or cold medicinal product containing ephedrine or pseudoephedrine is not recommended. During the clinical development program, the occurrence of cases of melanoma prompted the consideration of a possible association with rasagiline. The data collected suggests that Parkinson's disease, and not any medicinal products in particular, is associated with a higher risk of skin cancer (not exclusively melanoma). Any suspicious skin lesion should be evaluated by a specialist. Caution should be used when initiating treatment with rasagiline in patients with mild hepatic impairment. Rasagiline use in patients with moderate hepatic impairment should be avoided. In case patients progress from mild to moderate hepatic impairment, rasagiline should be stopped.
Side Effects Very common headache Common Influenza, skin carcinoma, leucopenia, allergy, depression, hallucinations, conjunctivitis, vertigo, angina pectoris, rhinitis, flatulence, dermatitis, musculoskeletal pain, neck pain, arthritis, urinary urgency, fever, malaise Monitoring Blood pressure Liver function
Birmingham, Sandwell, Solihull and environs Area Prescribing Committee (BSSE APC) Based on MTRAC template Prepared by Satnaam Singh Nandra 2 Rasagiline ESCA Date: July 2015 Review date: July 2018 Interface Lead Pharmacist Birmingham CrossCity CCG
Rasagiline has the following interaction information: Drug interactions Note: Rasagiline is a MAO-B inhibitor (highlighted interaction are the Antidepressants, SSRI increased risk of CNS toxicity when rasagiline given with SSRIs significant ones) Antidepressants, increased risk of CNS toxicity when rasagiline given with tricyclics
Tricyclic
Ciprofloxacin plasma concentration of rasagiline increased by ciprofloxacin
Dextromethorphan avoid concomitant use of rasagiline with dextromethorphan
Entacapone plasma concentration of rasagiline possibly reduced by entacapone
Fluoxetine after stopping rasagiline do not start fluoxetine for 2 weeks, also rasagiline should not be started until at least 5 weeks after stopping fluoxetine
Fluvoxamine after stopping rasagiline do not start fluvoxamine for 2 weeks
MAOIs risk of hypertensive crisis when rasagiline given with MAOIs , avoid MAOIs for at least 2 weeks after stopping rasagiline
Note: For interactions of reversible MAO-A inhibitors (RIMAs) see Moclobemide, and for interactions of MAO-B inhibitors see Rasagiline and Selegiline; the antibacterial Linezolid is a reversible, non-selective MAO inhibitor
Pethidine risk of CNS toxicity when rasagiline given with pethidine (avoid pethidine for 2 weeks after rasagiline )
Sympathomimetics avoid concomitant use of rasagiline with sympathomimetics
Rasagiline belongs to Dopaminergics and will have the following interactions:
Memantine effects of dopaminergics possibly enhanced by memantine
Methyldopa Anti parkinsonian effect of dopaminergics antagonised by methyldopa
References Rasagiline SmPC Rasagiline BNF NICE CG 35 - Parkinson's disease: Diagnosis and management in primary and secondary care ______
I agree to participate in this shared care agreement for the treatment of the below named patient with rasagiline 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 3 Rasagiline ESCA Date: July 2015 Review date: July 2018 Interface Lead Pharmacist Birmingham CrossCity CCG