Survey
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
Shared Care Agreement Form CONSULTANT REQUEST To: Dr. Your patient: NHS No. (10digit): was seen on: with a diagnosis of: I recommend that the following drug is continued: Rotigotine has been accepted as suitable for shared care by ABUHB’s MTC. I agree to the responsibilities set out in the protocol SCP No. 18 (copy attached). This should be read in conjunction with the definition of shared care at: http://www.wales.nhs.uk/sites3/Documents/371/Doc%202%20Defining%20shared%20care.pdf I am requesting your agreement to sharing the care of this patient. The preliminary tests set out in the protocol have been carried out. I am currently prescribing the stabilising treatment. I would like you to undertake treatment from: The initial treatment will be: The baseline tests are: If you undertake treatment I will reassess the patient in ____ weeks. You will be sent a written summary within 14 days. I will accept referral for reassessment at your request. The medical staff of the department are available at all times to give you advice. Consultant Name: Signature: Department: Hospital: Date: Contact Telephone Nos: GP RESPONSE (Please circle the appropriate number below detailing your response) 1. I am willing to undertake shared care as set out in SCP No.18 for this patient. 2. I would like further information. Please contact me on: _______________________ 3. I am unable to undertake shared care for this patient. G.P. Signature _________________________________________ Date _________ Practice Address/Stamp ________________________________________________ PLEASE RETURN WHOLE COMPLETED FORM OR A COPY TO THE REQUESTING CONSULTANT WITHIN ONE WEEK This Shared Care Protocol should be read in conjunction with the Summary of Product Characteristics Status: APPROVED Issue Date: March 2010 (Revised Sept.2016) Approved by: GPMTC Page 1 of 4 Review Date: Sept. 2018 Gwent Shared Care Protocol ROTIGOTINE patches (Neupro) for the treatment of idiopathic Parkinson’s disease Protocol No. 18 PLEASE CHECK http://www.gpmtc.wales.nhs.uk FOR THE LATEST VERSION OF THIS PROTOCOL General guidance The Gwent Partnership Medicines and Therapeutics Committee has agreed this protocol. It outlines shared care arrangements for rotigotine (Neupro) for the treatment of idiopathic Parkinson’s disease (PD). This document should be read in conjunction with: 1. The Shared Care Agreement Form (see Page 1) 2. The Summary of Product Characteristics (SmPC) for Neupro: https://www.medicines.org.uk/emc/medicine/27412 1. Licensed indication The treatment of the signs and symptoms of early-stage idiopathic PD as monotherapy (i.e. without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or 'on-off' fluctuations). 2. Therapeutic use & background information Rotigotine is a new non-ergot derived dopamine agonist with a very low oral bioavailability (<1%) due to an extensive first-pass effect. Rotigotine is an agonist at all dopamine receptors, showing highest affinity and highest activity via the D3 receptor. 3. Contraindications 1. Hypersensitivity to the active substance or to any of the excipients. 2. Magnetic resonance imaging or cardioversion Special Warnings/Precautions Avoid in pregnancy or breast feeding Avoid in psychotic disorders and severe cardiovascular disease. Avoid abrupt withdrawal (risk of neuroleptic malignant syndrome). OPHTHALMIC COMPLICATIONS: there is a theoretical risk of degeneration of outer retina (seen in albino rats given high doses, but not reported in humans). If patients have visual problems or history of retinal disease baseline testing is recommended by an ophthalmologist. At review by consultant patients will be asked about any night vision problems and checked for visual field loss. DRIVING: Drowsiness (including sudden onset of sleep) may affect performance of skilled tasks; patients should not drive or undertake potentially dangerous activities until stabilised on treatment & not experiencing problems. Patients should be warned about the possible additive effects of other sedating drugs and/or alcohol. 4. Typical dosage regimen Monotherapy, apply ‘2mg/24 hours’ patch to clean dry, non-irritated skin on torso, thigh, or upper arm, removing after 24 hours and siting replacement patch on a different area (avoid using the same area for 14 days); increased in steps of 2mg/24 hours at weekly intervals if required; max. 8mg/24 hours Adjunctive therapy with levodopa, apply ‘4mg/24 hours’ patch to clean dry, non-irritated skin on torso, thigh, or upper arm, removing after 24 hours and siting replacement patch on a different area (avoid using the same site for 14 days); increased in steps of 2mg/24 hours at weekly intervals if required; max. 16mg/24 hours Discontinuation: The daily dose should be reduced in steps of 2 mg/24 h with a dose reduction preferably every other day. 5. Drug interactions Check BNF Appendix Co-administration of dopamine antagonists, such as neuroleptics (e.g. phenothiazines, butyrophenones, thioxanthenes) or metoclopramide, with rotigotine should be avoided. This Shared Care Protocol should be read in conjunction with the Summary of Product Characteristics Status: APPROVED Issue Date: March 2010 (Revised Sept.2016) Approved by: GPMTC Page 2 of 4 Review Date: Sept. 2018 1 before coprescribing any other drug 6. Adverse drug reactions Use of sedating drugs or other CNS depressants (e.g. benzodiazepines, antipsychotics, antidepressants) or alcohol in combination with rotigotine should be avoided. Co-administration of enzyme inducing active substances (e.g. rifampicin, phenobarbital, carbamazepine, phenytoin, St John's wort/Hypericum perforatum) has not been investigated. Co-administration of L-dopa and carbidopa with rotigotine had no effect on the pharmacokinetics of rotigotine, and rotigotine had no effect on the pharmacokinetics of Ldopa and carbidopa. Rotigotine may potentiate the dopaminergic adverse reaction of L-dopa and may cause and/or exacerbate pre-existing dyskinesia. Clinical condition (frequency) Management Dizziness, somnolence, nausea (>1/10) If severe or persistent stop drug and discuss Administration site reactions (>1/10) Normal management – advise patient to avoid direct sunlight on the area. postural/orthostatic hypotension and syncope visual disturbance, photopsia, blurred vision Discuss with specialist 7. Baseline investigations Undertaken by specialist centre BP and baseline ophthalmic examination is recommended by an ophthalmologist for patients with visual problems or history of retinal disease 8. Monitoring Undertaken by specialist centre Blood pressure Ophthalmologic monitoring is recommended at regular intervals or if vision abnormalities occur. 9. Pharmaceutical aspects Patients should store their patches in the refrigerator; patches must not be stored in the freezer; there is no need to bring the patch to room temperature before application. After use the patch still contains active substance. After removal, the used patch should be folded in half, adhesive side inwards so that the matrix layer is not exposed, placed in the original sachet and then discarded out of the reach of children. 10. Specialist centre contact information If stopping the medication or needing advice – please contact: Dr. Huw Morris 01633 234829 Dr. Gareth Llewelyn Neurology, RGH 01633 234453 Dr. Fady Joseph 01633 238057 Debbie Davies 01633 234151 Dr. Murali Hegde Medicine, RGH 01633 238322 Dr. Ken Dawson Neurology, NHH 01873 732739 Dr. Charles D’Souza Medicine, NHH 01873 732517 Dr. Mukund Joglekar Medicine, CDMH 02920 807351 or 807183 11. Criteria for shared care All Wales criteria for Shared Care can be found at: http://www.awmsg.org/docs/awmsg/medman/Criteria%20for%20Shared%20Care.pdf GMC guidance on Shared Care (2013) states: Decisions about who should take responsibility for continuing care or treatment after initial diagnosis or assessment should be based on the patient’s best interests, rather than on convenience or the cost of the medicine and associated monitoring or follow-up. Shared care requires the agreement of all parties, including the patient. Effective communication and continuing liaison between all parties to a shared care agreement are essential. 12. Responsibilities of Specialist Centre I. To confirm patient’s understanding and consent to treatment. II. To advise the patient on potential side effects (particularly somnolence, visual problems and pathologic gambling/increased libido) and the action to be taken should they occur. III. To initiate treatment with rotigotine and provide a minimum of one month’s supply (and This Shared Care Protocol should be read in conjunction with the Summary of Product Characteristics Status: APPROVED Issue Date: March 2010 (Revised Sept.2016) Approved by: GPMTC Page 3 of 4 Review Date: Sept. 2018 to advise patients on the requirements to store their rotigotine patches in a refrigerator). IV. To assess and monitor patient’s response to treatment, to adjust rotigotine dose and to ensure patient tolerates the treatment. V. To perform the on-going monitoring (as above in box 8.). VI. To send the GP a Shared Care Agreement Form and invite them to participate in the shared care management of the patient. VII. To inform the GP of dosage schedule, monitoring measurements and progress of treatment after each appointment. VIII. To inform the GP if the patient fails to attend an appointment and clearly indicate that the patient is receiving rotigotine. IX. Stop the treatment when considered to be no longer appropriate. 13. Responsibilities of patients To attend hospital and GP clinic appointments. Failure to attend will result in the medication being stopped. To report any adverse events to their specialist or GP. (particularly somnolence, and visual problems) To store their rotigotine patches in the refrigerator. 14. Responsibilities of Primary Care To issue ongoing prescriptions for rotigotine as per dosage schedule recommended by the specialist. GPs can consider altering the default on their computer to endorse the prescription ‘to keep refrigerated’ To check for drug interactions in BNF Appendix 1 before co-prescribing any other drug To inform the specialist services if the patient shows significant worsening of control of symptoms or deterioration of PD. To inform the specialist services of severe untoward events or side effects as appropriate and to report all suspected reactions to the MHRA (using the Yellow Card scheme) 15. Additional responsibilities Any suspected serious adverse reactions should be reported to MHRA via the “yellow card scheme.” http://yellowcard.mhra.gov.uk/ 16. Supporting documentation Patient information leaflet: https://www.medicines.org.uk/emc/PIL.20562.latest.pdf 17. GP request letter Shared Care Agreement Form – Page 1 This Shared Care Protocol should be read in conjunction with the Summary of Product Characteristics Status: APPROVED Issue Date: March 2010 (Revised Sept.2016) Approved by: GPMTC Page 4 of 4 Review Date: Sept. 2018