Download ROTIGOTINE patches (Neupro®) for Parkinson`s

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