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Gwent Shared Care Protocol
APOMORPHINE (APO-go Pen)
for the treatment of disabling motor fluctuations in Parkinson’s disease
Protocol No. 20
General guidance
PLEASE CHECK http://www.gpmtc.wales.nhs.uk
FOR THE LATEST VERSION OF THIS PROTOCOL
The Gwent Partnership Medicines and Therapeutics Committee has agreed this protocol. It
outlines shared care arrangements for apomorphine (given as intermittent subcutaneous
injections via the APO-go Pen) for the treatment of disabling motor fluctuations in patients
with Parkinson's disease (PD). It does not form a basis for the shared care prescribing of
continuous subcutaneous infusions of apomorphine using an ambulatory pump.
This document should be read in conjunction with:
1. The Shared Care Agreement Form (see below)
2. The Summary of Product Characteristics (Data Sheet) for APO-go Pen:
http://www.medicines.org.uk/EMC/medicine/12941/SPC/APOgo+Pen+10mg+ml+Solution+for+Injection/
1. Licensed
indication
The treatment of disabling motor fluctuations ('on-off' phenomena) in patients with PD
which persist despite individually titrated treatment with levodopa (with a peripheral
decarboxylase inhibitor) and/or other dopamine agonists.
2. Therapeutic use
& Background
information
Apomorphine has been licensed since 1993 for use in patients with disabling motor
fluctuations who are inadequately controlled with levodopa or dopamine agonists. The
licence covers both subcutaneous intermittent injections and continuous subcutaneous
infusions.
Apomorphine is a dopamine agonist, which acts directly on D1 and D2 receptors, stimulating
areas of the brain where dopamine works. It produces a similar effect to levodopa, that is,
the ability to prevent and reverse disabling “off” periods.
Despite its name it has no opiate or addictive properties. Apomorphine cannot be used
orally because it undergoes extensive first pass metabolism (in the liver) to an inactive
metabolite; for this reason it is administered subcutaneously.
1. 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.
2. For those patients who experience more complex motor fluctuations, including
dyskinesias, a continuous subcutaneous infusion using an ambulatory APO-go pump
may be used with the APO-go PFS.
In carefully selected patients who respond to the drug, apomorphine can provide a means of
rescue within 5 to10 minutes of administration, thereby regaining mobility and
independence. The effect usually lasts for about an hour. Apomorphine can improve quality
of life and may keep patients out of costly institutional care for many years.
Apomorphine should be initiated in the controlled environment of a specialist clinic. The
treatment should be supervised by a Specialist team in Parkinson’s disease or Debbie Davies
(Parkinson's Disease Nurse Specialist for ABHB). The patient's treatment with levodopa, with
or without dopamine agonists, should be optimised before starting aporphine treatment.
Patients selected for treatment with the APO-go Pen should be able to recognise the onset
of their 'off' symptoms and be capable of injecting themselves or else have a responsible
carer able to inject for them when required.
3. Contraindications
Apomorphine is contraindicated in patients:
1. with respiratory depression
2. with dementia
This Shared Care Protocol should be read in conjunction with the Summary of Product Characteristics
Status: APPROVED
Issue Date: September 2010
Approved by: GPMTC
Page 1 of 5
Review Date: September 2012
3.
4.
5.
6.
with psychotic diseases
with hepatic insufficiency
under 18 years of age
with a known hypersensitivity to apomorphine or any excipients of the medicinal
product
Intermittent apomorphine treatment is not suitable for patients who have an 'on' response
to levodopa, which is marred by severe dyskinesia or dystonia.
4. Typical dosage
regimen (adults)
By subcutaneous injection (using the APO-go pen), usual range (after initiation as below) 3
to 30mg daily in divided doses; subcutaneous infusion may be preferable in those requiring
division of injections into more than 10 doses daily; max. single dose 10mg
By continuous subcutaneous infusion (those requiring division into more than 10 injections
daily) initially 1mg/hour daily increased according to response (not more often than every 4
hours) in max. steps of 500micrograms/hour, to usual rate of 1 to 4mg/hour (14 to
60micrograms/kg/hour); change infusion site every 12 hours and give during waking hours
only (24-hour infusions not advised unless severe night-time symptoms) – intermittent bolus
boosts also usually needed.
Note Total daily dose by either route (or combined routes) max. 100mg
In rare cases it may be necessary to give higher doses.
5. Drug interactions
Check BNF Appendix
1 before coprescribing any other
drug.
Effects of apomorphine antagonised by antipsychotics (clozapine may be used to reduce the
symptoms of neuropsychiatric complications).
Effects of apomorphine possibly enhanced by entacapone
Effects of dopaminergics possibly enhanced by memantine
Antiparkinsonian effect of dopaminergics antagonised by methyldopa
As the effects of apomorphine on the plasma concentrations of other drugs have not been
studied caution is advised when combining apomorphine with drugs that have a narrow
therapeutic range.
6. Adverse drug
reactions
All healthcare
professionals have a
responsibility to
patients in
advising/acting on
suspected adverse
drug reactions.
Clinical condition (frequency)
Management
Sedation, dizziness and somnolence including sudden onset of
sleep
(≥1/100 to <1/10)
If severe discuss
Injection-site reactions including nodule formation, ulceration,
erythema and tenderness. Most patients experience injection
site reactions, particularly with continuous use. Other local
reactions (such as irritation, itching, bruising and pain) may
also occur
(>1/10)
Change injection sites in rotation
Neuropsychiatric disturbances including confusion and visual
hallucinations
(≥1/100 to <1/10)
Discuss with specialist
Nausea and vomiting, particularly when apomorphine is first
initiated
(≥1/100 to <1/10)
If severe or persistent discuss
with specialist
less common: postural hypotension, breathing difficulties, dyskinesias during ‘on’ periods
(may require discontinuation), haemolytic anaemia and thrombocytopenia with levodopa,
and rash;
rare: eosinophilia; peripheral oedema, pathological gambling, dizziness, increased libido,
and hypersexuality also reported
7. Baseline
investigations
Undertaken by specialist centre
Coombs test (for autoimmune hemolytic anemia) FBC, LFTs, U&Es, ESR, BP and ECG
This Shared Care Protocol should be read in conjunction with the Summary of Product Characteristics
Status: APPROVED
Issue Date: September 2010
Approved by: GPMTC
Page 2 of 5
Review Date: September 2012
8. Monitoring
undertaken by
specialist centre
Apomorphine treatment requires the involvement of a multidisciplinary team, including a
Parkinson's Disease Nurse Specialist (PDNS) who regularly visits the patient at their home.
Coombs test and FBC, LFTs, U&Es and BP at 6 monthly intervals.
9. Pharmaceutical
aspects
APO-go Pen 10mg/ml is a disposable multiple dose pen injector system incorporating a clear
glass cartridge containing a clear solution for injection. Do not use if the solution in the Pen
is green.
Discard each APO-go Pen no later than 48 hours after first use.
Patients, carers and community nurses should be made aware that apomorphine when spilt
on cloths and most surfaces will leave a permanent olive green stain which is almost
impossible to remove (lemon juice is reported to help).
10. Specialist centre
contact
information
If stopping the medication or needing advice please contact
Debbie Davies (Parkinson’s Disease Nurse Specialist Aneurin Bevan Health Board)
01633 234151 or 07944467611
11. Criteria for
shared care
Prescribing responsibility will only be transferred when:
 Treatment is for a specified indication and duration.
 Treatment has been initiated and established by the Specialist Centre and Debbie Davies
(PDNS).
 The patient’s initial reaction to and progress on the drug is satisfactory.
 The patient’s general physical, mental and social circumstances are such that he/she
would benefit from shared care arrangements.
12. Responsibilities
of initiating
specialist
 To provide a patient information leaflet indicating the risks and benefits associated with
apomorphine therapy and to outline the shared care arrangements.
 To confirm patient’s understanding (and spouse/carer’s understanding as appropriate)
and consent to treatment and to advise on the action to be taken in relation to potential
side effects should they occur.
 To undertake baseline monitoring (including a Coombs test and a full blood count),
initiate apomoprhine, and make any dosage adjustments.
 Following the apomorphine challenge, to initiate apomorphine in combination with
domperidone (20mg three times daily) and optimise other antiparkinsonian drug
therapy.
 To provide the patient with an initial supply of APO-go Pens, needles and a sharps bin
sufficient for the first 4 weeks of treatment.
 To train the patient and /or carer in the use of the APO-go Pen device (this should include
the safe storage and disposal of the Pens and sharps).
 To send the GP a Shared Care Agreement Form (see page 5) and invite them to
participate in the shared care management of the patient – ideally patients should be at
a stage where they no longer require regular domperidone.
 Monitor blood tests including a Coombs test and a full blood count at 6 monthly
intervals.
 To act as a telephone contact for patients, carers and other health professionals.
 To see the patient in the event of any significant deterioration in their condition.
 To inform the GP of dosage schedule, monitoring measurements and progress of
treatment after each appointment.
 To inform the GP if the patient fails to attend an appointment and clearly indicate that
the patient is receiving apomorphine.
 Stop the treatment when considered to be no longer appropriate (i.e. for lack of efficacy
or if adverse effects outweigh benefit).
13. Responsibilities
of Primary Care
 To prescribe and monitor ongoing APO-go Pen therapy in collaboration with the
specialist in accordance with this protocol.
 To inform the specialist services if the patient shows significant worsening of control of
This Shared Care Protocol should be read in conjunction with the Summary of Product Characteristics
Status: APPROVED
Issue Date: September 2010
Approved by: GPMTC
Page 3 of 5
Review Date: September 2012
symptoms or deterioration of PD.
 To inform the specialist services of any significant adverse reactions (and to report
suspected serious adverse reactions to the MHRA using the Yellow Card scheme) or
difficulties with apomorphine administration.
14. Responsibilities
of patients/carer
 Discuss potential benefits and side effects of treatment with the Parkinson Disease Nurse
Specialist (PDNS) and GP, to identify whether they have a clear picture of these from the
PDNS and to raise any outstanding queries
 Check that where possible the specialists have provided a patient-held record or
information sheet for monitoring and/or to alert other clinical staff to the treatment they
are receiving.
 Share any concerns they have in relation to treatment with the medicine.
 Report any adverse effects to their specialist or GP whilst taking the medicine.
 Report to the PDNS or GP if they do not have a clear understanding of their treatment.
 Participate in the monitoring of therapy and the assessment of outcomes, to assist health
professionals to provide safe, appropriate treatment.
 To administer their apomorphine intermittently via the APO-go Pen device and to
ensure that the Pens and sharps are safely stored and disposed of.
 To arrange collection of full sharps bins and the supply of replacement bins (patients
should telephone Gwent NHS Customer Contact Centre 01495 745656)
15. Responsibilities
of all prescribers
Any suspected serious adverse reaction to an established drug should be reported to
MHRA via the “yellow card scheme.” http://yellowcard.mhra.gov.uk/
16. Supporting
documentation /
information
Patient information leaflet:
http://www.medicines.org.uk/EMC/medicine/12414/PIL/APOgo+Pen+10mg+ml+Solution+for+Injection/
Other information:
1. NICE Guidance for Parkinson’s disease http://guidance.nice.org.uk/CG35
2. Treatment of Parkinson’s disease with Apomorphine. UCH Shared Care Guidelines, 5th
edition 2005. http://www.fifeadtc.scot.nhs.uk/interface/fife_scp/apomorphine.pdf
3. Apo-go User Guide – A guide for patients and those who care for them, 2005.
http://www.apo-go.co.uk/administration_p.html
4. Parkinson’s UK (formerly Parkinson’s Disease Society) resources for GPs:
http://www.parkinsons.org.uk/for-professionals/resources/resources-for-gps.aspx
17. GP request letter
Shared Care Agreement Form – Attached below
This Shared Care Protocol should be read in conjunction with the Summary of Product Characteristics
Status: APPROVED
Issue Date: September 2010
Approved by: GPMTC
Page 4 of 5
Review Date: September 2012
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 initiated:
This drug has been accepted as suitable for shared care by the GPMTC. I agree to the responsibilities set out in the
protocol SCP No. 20 (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. _____ for this patient.
2. I would like further information. Please contact me on: _______________________
3. I am unable to undertake shared care for this patient because: (Please state)
_________________________________________________________________________________
G.P. Signature _________________________________________
Date _________
Practice Address/Stamp ________________________________________________
PLEASE RETURN WHOLE COMPLETED FORM OR TO THE REQUESTING CONSULTANT WITHIN 1 WEEK
This Shared Care Protocol should be read in conjunction with the Summary of Product Characteristics
Status: APPROVED
Issue Date: September 2010
Approved by: GPMTC
Page 5 of 5
Review Date: September 2012