Shared Care Agreement Apomorphine For use in Parkinson s Disease

Transcription

1 Shared Care Agreement Apomorphine For use in Parkinson s Disease This shared care agreement outlines suggested ways in which the prescribing responsibilities can be shared between the specialist and GP. GPs are invited to participate. If the GP feels that undertaking the roles outlined in the shared care agreement is outside their area of expertise or have clinical concerns about the safe management of the drug in primary care, then he or she is under no obligation to do so. In such an event, clinical responsibility for the patient s health remains with the specialist. If a specialist asks the GP to prescribe, the GP should reply to this request as soon as practicable. Sharing of care assumes communication between specialist, GP and patient. If a specialist asks a GP to prescribe, the GP should respond to this request within 2 weeks. The prescriber of the medication legally assumes clinical responsibility for the drug and the consequences of its use. Specialist s name: Specialist s Trust: address: Specialist s information Specialist s signature: GP name: GP Surgery: address: General Practitioner s information General Practitioner s signature: Patient s name: NHS Number: Date of Birth: Patient s information Patient s signature: Signing indicates agreement with the responsibilities suggested in this document, and that the patient has been informed of the need to report any issues with their treatment to their doctor. TW CCG Medicines Management v2 Page 1 of 5

2 Section 1: Responsibilities for prescribing Section 1.1: Specialist responsibilities Patient selection and assessment of suitability of patient for apomorphine hydrochloride treatment Provide patient/carer with relevant (preferably written) information on use of apomorphine, side-effects and need for monitoring of medication. Perform baseline assessments for use of apomorphine o Apomorphine Challenge (see description below) o Monitoring therapy and evaluation of adverse drug reactions o BP monitoring (e.g. standing and sitting) during initiation (first month) and any dose titration phase o Inform patient to report nodule formation and or ulceration to PDNS or GP If apomorphine use is suitable, initiate treatment and adjust dose Perform ongoing monitoring, full blood count, U+E and LFTs at 4-6 monthly interval. Specialist will need to inform GP of results in a timely manner to enable the GP to safely continue prescribing. Invite the GP to participate in shared care, await response Prescribe apomorphine until patient and/or carer is thoroughly conversant with the use of apomorphine and patient considered suitable for prescribing to be continued in primary care If necessary, organise for the district nursing team to be initially involved to support the patient and family in the use of the pump (training for district nursing team to be provided by PDNS as required). Ensure prompt communication with GP of any changes in treatment or dose requirements, results of monitoring undertaken and assessment of adverse events. Ensure the patient undergoes review of apomorphine for adequate control of Parkinson Disease symptoms (every 6-12 months) Test the patient for toxicity every 6-12 months using Coombs Positive test (by specialist unless otherwise stated) Advise GP when treatment is considered to be no longer efficacious or if side-effects outweigh benefit and treatment is to be discontinued. Provide any other advice or information for the GP including dose adjustments as necessary Apomorphine Challenge Before therapy initiation an Apomorphine Challenge is necessary in order to: Determine whether a patient has a positive response to the medication Establish the optimum dose for the individual patient Observe the patient for side effects such as nausea, vomiting, postural hypotension, hallucinations Three days prior to the challenge, Domperidone 20mg/30mg orally three times a day (TDS) is commenced (usually at home) to avert the significant emetic effects of Apomorphine. The patient can have the challenge either as an inpatient or as a day case depending on the local service provision and support of a Parkinson s Disease Nurse Specialist. It is important that the challenge is performed in a safe clinical environment with medical support. Section 1.2: Primary Care responsibilities Respond to the specialist s request to shared care as soon as is practicable If in agreement with shared care, to continue prescribing of apomorphine at the recommended dose after agreed date Inform the specialist team of any significant development or deterioration in the following areas: skin problems at injection site, motor performance, hallucinations, confusional states, psychosis, depression or an inability to administer apomorphine. The GP should not adjust the dose of apomorphine without discussion with specialist services at SATH. Report any adverse drug reactions to specialist and usual bodies (e.g. MHRA). Ensure no drug interactions with other medicines. Symptoms or results are appropriately actioned, recorded and communicate to secondary care when necessary. Section 1.3: Patient responsibilities To take the prescribed medication regularly unless advised by GP or specialist To attend scheduled reviews with specialist team and for monitoring as detailed in this document. Prescribing by GP will be stopped if patient does not attend regular review by the specialist team. Report any adverse effects to the consultant or GP Share any concerns in relation to treatment TW CCG Medicines Management v2 Page 2 of 5

3 Report to the consultant or GP if they do not have a clear understanding of the treatment Section 2: Drug information Introduction Apomorphine is a directly acting dopaminergic agonist, licensed for use in patients with Parkinson s disease who have frequent and/or severe akinesia ( off periods ) not controlled by levodopa or other dopamine agonists. Research has shown that Apomorphine reduces the daily off period time by up to 80% in patients with late-stage Parkinson s disease associated with refractory on-off oscillations. Treatment is by intermittent sub-cutaneous injection at the onset of an off period or by continuous sub-cutaneous infusion usually over 12 hours. Following a single dose, apomorphine has an onset of action of 5-15 minutes and lasts for minutes. Candidates for apomorphine therapy are those capable of recognising and anticipating off episodes. They must also be capable and motivated in order to use the treatment safely. Apomorphine is occasionally used for patients with swallowing difficulties at the palliative stage a bolus injection before mealtimes can help reduce the need for a PEG etc. Licensed indications: Refractory motor fluctuations in Parkinson's disease ( off episodes) inadequately controlled by co-beneldopa or cocareldopa or other dopaminergics (for capable and motivated patients under specialist supervision) Adult dosage and administration The dose of Apomorphine is carefully titrated on an individual basis, and can range from a few milligrams daily by intermittent subcutaneous injections, up to 100 mg daily by continuous infusion. The total daily dose should not exceed 100mg. In rare cases it may be necessary to give higher doses Apomorphine may be administered as a rescue therapy with intermittent subcutaneous bolus injections given via a prefilled APO-go Pen or a standard 1ml syringe. For those patients who experience more complex motor fluctuations, including dyskinesia s, a continuous subcutaneous infusion using an ambulatory APO-go pump may be used with the APO-go PFS. Use by sub-cutaneous infusion An APO-go (continuous infusion) ambulatory pump is used for patients that have shown a good on response to the drug but whose overall control remains unsatisfactory using intermittent injections. Alternatively patients who require frequent injections (6-8 per day) may be transferred to a continuous infusion administered via an APO-go pump to reduce potential problems with injection sites. Some patients are initiated on a pump without first trying intermittent injections. Patients experiencing disabling and exhausting dyskinesia s may also benefit from a continuous infusion, as it may allow their oral levodopa medication to be reduced. Experience at other hospitals has found that managing this group of patients on a combination of Apomorphine and oral dopamine agonists and subsequently reducing or even stopping levodopa can dramatically reduce dyskinesia s. It is thought a 30% reduction in levodopa can be made almost immediately once an infusion is commenced. Genus Pharmaceuticals/Evolution supplies both the APO-go pump which is loaned to the patient and specific syringes, which fit the pump. A FP10 will need to be written for drugs and also for the Neria infusion sets. The APO-go pump has been specifically designed for use with APO-go, with many benefits: 1. Easy adjustment of the dose rate in small increments 2. Flow rate accuracy 3. The pump is used with a specially developed 20ml syringe, which means, for most patients, treatment can be given without the need to change syringes during the waking day. Despite being a 20ml syringe pump, it can be programmed to deliver either 10 or 20ml quantities of Apomorphine (diluted) 4. The pump is neat, compact and lightweight. 5. The size of the bolus dose can be set for occasional use. 6. Time display, so the user knows exactly how long the infusion will run. 7. If a bolus dose is used it is automatically subtracted from the total time left to run on the pump TW CCG Medicines Management v2 Page 3 of 5

4 The dose and duration of the pump is individualised to patient need. Daily doses will not normally exceed 100mg; though in rare cases higher daily doses have been used. The duration of the infusion is usually throughout the waking day (for example 14 hours) but on rare occasions the infusion may run over 24 hours. Apomorphine must not be administered by the intravenous route Do not use if the solution has turned green. The solution should be inspected visually prior to use. Only clear, colourless and particle free solution should be used. Available as: APO-go Pen 10 mg/ml Solution for Injection APO-go PFS 5 mg/ml Solution for Infusion in Pre-filled Syringe Adverse effects, Precautions and Contra-indications Adverse effects Nausea and vomiting Postural hypotension usually only transient on initiation of treatment Neuro-psychiatric disturbances, e.g. abnormal involuntary movements, hallucinations, delusions and confusional states. Less common than oral dopamine agonists. Inflammation and formation of nodules at injection sites. Dyskinesia s less common when administered continuously via a pump. Eosinophilia in up to 10% of patients May rarely cause haemolytic anaemia Precautions Apomorphine HCl should be given with caution: to patients with renal, pulmonary or cardiovascular disease, prone to nausea and vomiting, or with pre-existing postural hypotension; in pregnant women and women of childbearing age. Female patients should not breast feed. Neuropsychiatric problems may be exacerbated by apomorphine. Avoid abrupt withdrawal. Severe allergic reactions / bronchospasm due to sodium bisulphite in APO-go preparations. Patients must be advised to exercise caution while driving or operating machines during treatment with apomorphine. Patients who have experienced somnolence must refrain from driving or operating machines. Contra-indications In patients with respiratory depression, dementia, psychotic diseases or hepatic insufficiency. Apomorphine HCl treatment must not be administered to patients who have an 'on' response to levodopa which is marred by severe dyskinesia or dystonia. Apomorphine should not be administered to patients who have a hypersensitivity to apomorphine or any excipients of the medicinal product. Apomorphine is contra-indicated for children and adolescents under 18 years of age. Common Drug Interactions Patients should be monitored for potential interactions during initial stages of apomorphine therapy. Particular caution should be given in patients with pre-existing cardiac disease or in patients taking vasoactive medicinal products such as antihypertensives, and especially in patients with pre-existing postural hypotension. Effects of apomorphine antagonized by antipsychotics Effects of apomorphine possibly enhanced by entacapone Effects of dopaminergics possibly enhanced by memantine Antiparkinsonian effect of dopaminergics antagonized by methyldopa TW CCG Medicines Management v2 Page 4 of 5

5 Communication Ancillary products/apparatus which may need to be prescribed by GP on FP10 (a) APO-go Pens are prescribable on FP 10. The patient will usually have been given one by the hospital. Please prescribe in multiples of 5. This is a disposable multiple dose pen injector system incorporating a clear glass cartridge and supplies of Novofine Needles for use with the Pen will be made free of charge with the Pens. (b) APO-go Pre-Filled Syringe for use with an Apo-Go syringe driver for continuous sub-cutaneous infusion. It is a prediluted syringe that will need to be prescribed on the FP10 along with Neria infusion sets. Service supply infusion sets (line plus needle plus dressing) via FP10 which don t need dressings so district nursing team should no longer need to supply anything. Genus/Evolution Home delivery service supplies the Apo-Go syringe drivers. Availability/obtaining Supplies APO-go Pump and Apo-Go Pen Ambulatory Infusion Pump, dedicated 20ml syringes and connectors are supplied free of charge for use with APO-go PFS by: Genus Pharmaceuticals Park View House 65 London Road Newbury RG14 1JN Tel: Head Office Tel: APO-go 24 hour Helpline For any queries relating to this patient s treatment with this drug, please contact the consultant named on the first page of this document. Contact Telephone No. Bleep Fax No. address Specialist: Hospital Pharmacy: Other: This information is not inclusive of all prescribing information, potential adverse effects and drug interactions. Please refer to full prescribing data in the Summary of Product Characteristics ( or the British National Formulary ( TW CCG Medicines Management v2 Page 5 of 5