Selegiline Hydrochloride ESCA: for the Treatment of Parkinson's Disease AREAS of RESPONSIBILITY for the SHARING of CARE

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Effective Shared Care Agreement (ESCA) Selegiline hydrochloride 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 selegiline hydrochloride 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 selegiline hydrochloride 5. Initiate treatment and stabilise dose of selegiline hydrochloride 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 selegiline hydrochloride 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 selegiline hydrochloride with the specialist, clinical nurse specialist or GP 3. Report any adverse effects to the specialist or GP whilst taking selegiline hydrochloride 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 Selegiline hydrochloride ESCA Date: July 2015 Review date: July 2018 Interface Lead Pharmacist 1 Birmingham CrossCity CCG

SUPPORTING INFORMATION Indication For the treatment of Parkinson's disease, or symptomatic parkinsonism. It may be used alone in early Parkinson's disease for symptomatic relief to delay the need for levodopa (with or without decarboxylase inhibitor). or as an adjunct to levodopa (with or without decarboxylase inhibitor). Selegiline in combination with maximal levodopa therapy is indicated particularly in patients who experience fluctuations in their condition such as 'end-dose' type fluctuations, 'on-off' symptoms or other dyskinesias. Dosage and 10 mg daily either alone or as an adjunct to levodopa or levodopa/peripheral decarboxylase inhibitor. Administration Selegiline may be administered either as a single dose in the morning or in two divided doses of 5 mg, taken at breakfast and lunch. When selegiline is added to a levodopa regimen it is possible to reduce the levodopa dosage by an average of 10 -30%. Reduction of the levodopa dose should be gradual in steps of 10% every 3 to 4 days. Renal Impairment No dosage adjustment is required Hepatic No dosage adjustment is required impairment Contra-indications Contraindication:- / Special Known hypersensitivity (including severe dizziness or hypotension) to selegiline or any of the precautions excipients In patients receiving treatment with serotonin-agonists (e.g. sumatriptan, naratriptan, zolmitriptan and rizatriptan) Concomitant use with pethidine and other opioids. Selegiline should not be used in patients who are being treated with antidepressant drugs, including MAO inhibitors, tricyclic antidepressants, serotonin noradrenaline reuptake inhibitors (SNRI) (venlafaxine) and selective serotonin reuptake inhibitors (e.g citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine and sertraline Selegiline should also not be used with other drugs which are also monoamine oxidase inhibitors, e.g. linezolid. Selegiline should not be used in combination with sympathomimetics Selegiline should not be used in patients with active duodenal or gastric ulcer. Selegiline should not be used in patients with other extrapyramidal disorders not related to dopamine deficiency. Selegiline in combination with levodopa is contra-indicated in severe cardiovascular disease, arterial hypertension, hyperthyroidism, phaeochromocytoma, narrow-angle glaucoma, prostatic adenoma with appearance of residual urine, tachycardia, arrhythmias, severe angina pectoris, psychoses, advanced dementia and thyrotoxicosis The concomitant intake of alcohol should be avoided Avoid the use of selegiline in pregnancy Selegiline should not be used during breast-feeding. Cautions:- Special care should be taken when administering selegiline to patients who have labile hypertension, cardiac arrhythmias, severe angina pectoris, psychosis or a history of peptic ulceration as aggravation of these conditions may occur during treatment. Selegiline should be used with caution in severe liver or kidney dysfunction Impulse control disorders and compulsions like pathological gambling, increased libido, hypersexuality, binge eating, shopping and different kinds of compulsive/repetitive activities (punding).

Side Effects Very common Stomatitis Common Sleeping disorders, confusion, hallucinations, depression, abnormal movements, vertigo, bradycardia, hypotension, hypertension, nausea, constipation, diarrhoea, mouth ulceration, sweating increased, arthralgia, back pain, muscle cramps, fatigue, fall, mild hepatic enzymes increased Monitoring Blood pressure Renal function Liver function

Drug interactions Selegiline has the following interaction information: (highlighted Note: Selegiline is a MAO-B inhibitor interaction are the 5HT -receptor manufacturer of selegiline advises avoid concomitant use significant ones) 1 Agonists with 5HT1 agonists

Antidepressants, CNS toxicity reported when selegiline given with tricyclics Tricyclic

Citalopram manufacturer of selegiline advises avoid concomitant use with citalopram

Co-beneldopa selegiline enhances effects and increases toxicity of co-beneldopa (reduce dose ofco-beneldopa )

Co-careldopa selegiline enhances effects and increases toxicity of co-careldopa (reduce dose ofco-careldopa )

Dopamine risk of hypertensive crisis when selegiline given with dopamine

Entacapone max. dose of 10 mg selegiline advised by manufacturer of entacapone if used concomitantly

Escitalopram manufacturer of selegiline advises avoid concomitant use with escitalopram

Fluoxetine increased risk of hypertension and CNS excitation when selegiline given with fluoxetine ( selegiline should not be started until 5 weeks after stopping fluoxetine , avoid fluoxetine for 2 weeks after stopping selegiline )

Fluvoxamine increased risk of hypertension and CNS excitation when selegiline given with fluvoxamine ( selegiline should not be started until 1 week after stopping fluvoxamine , avoid fluvoxamine for 2 weeks after stopping selegiline )

Levodopa selegiline enhances effects and increases toxicity of levodopa (reduce dose oflevodopa )

MAOIs enhanced hypotensive effect when selegiline given with MAOIs — manufacturer of selegiline advises avoid concomitant use 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

Memantine effects of selegiline possibly enhanced by memantine

Moclobemide avoid concomitant use of selegiline with moclobemide

Oestrogens plasma concentration of selegiline increased by oestrogens — manufacturer of selegiline advises avoid concomitant use

Opioid Analgesics manufacturer of selegiline advises avoid concomitant use with opioid analgesics

Paroxetine increased risk of hypertension and CNS excitation when selegiline given with paroxetine ( selegiline should not be started until 2 weeks after stopping paroxetine , avoid paroxetine for 2 weeks after stopping selegiline )

Pethidine hyperpyrexia and CNS toxicity reported when selegiline given with pethidine (avoid concomitant use)

Progestogens plasma concentration of selegiline increased by progestogens — manufacturer of selegiline advises avoid concomitant use

Sertraline increased risk of hypertension and CNS excitation when selegiline given with sertraline ( selegiline should not be started until 1 week after stopping sertraline , avoid sertraline for 2 weeks after stopping selegiline )

Sympathomimetics manufacturer of selegiline advises avoid concomitant use with sympathomimetics

Venlafaxine increased risk of hypertension and CNS excitation when selegiline given with venlafaxine ( selegiline should not be started until 1 week after stopping venlafaxine , avoid venlafaxine for 2 weeks after stopping selegiline ) Selegiline belongs to Dopaminergics and will have the following interactions:

Memantine effects of dopaminergics possibly enhanced by memantine

Methyldopa antiparkinsonian effect of dopaminergics antagonised by methyldopa

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

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I agree to participate in this shared care agreement for the treatment of the below named patient with selegiline hydrochloride 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: