Download Apomorphine use in Parkinson`s Disease

GMMMG Interface Prescribing
Subgroup
Shared Care Protocol
Shared Care Guideline for
Reference Number
Apomorphine use in Parkinson’s Disease
Version: 3
Replaces: Version 2 from SRFT
Author(s)/Originator(s): (please state author name and
department)
Carol Miller, Emma Wilson and Chris Kobylecki
Salford Royal Hospital
Neurology Department
Date approved by Interface Prescribing Group:
12/05/2016
Date approved by Commissioners:
dd/mm/yyyy
Issue date:
To be read in conjunction
with the following
documents:
Current Summary of Product
characteristics
(http://www.medicines.org.uk)
BNF
Date approved by Greater Manchester
Medicines Management Group:
16/06/2016
Review Date:
01/01/2018
Please complete all sections
1. Name of Drug, Brand
Name, Form and
Strength
2. Licensed Indications
3. Therapeutic use &
background
Apomorphine (APO-go®) 10mg/ml Solution for Injection in 3ml PEN or 5mg/ml Solution
for Infusion in Pre-Filled Syringe in 10ml syringe (PFS)
The treatment of disabling motor fluctuations (“on-off” phenomena) in patients with
Parkinson's disease which persist despite individually titrated treatment with levodopa
(with a peripheral decarboxylase inhibitor) and/or other dopamine agonists
Parkinson’s disease is a progressive degenerative neurological condition that affects
nerve cells in the substantia nigra and basal ganglia (the parts of the brain controlling
movement). Parkinson’s disease is caused by idiopathic degeneration of dopamine
producing cells in this area. Three ‘cardinal signs’ of Parkinson’s disease are resting
tremor, cogwheel rigidity and bradykinesia. Postural instability, typically a late finding in
Parkinson’s disease is the fourth main symptom. Parkinson’s disease is characterised by
a good symptomatic response to levodopa.
Parkinson’s disease is one of the commonest neurological conditions to affect older
people. It is estimated to affect 160 per 100,000 of the general population.
Apomorphine treatment is to be initiated, and doses optimised by the hospital specialist
team. Continuation of the therapy requires co-operation between the hospital and Primary
Care teams with their roles defined by the shared care protocol.
Apomorphine is a directly acting dopaminergic agonist, licensed for use in patients with
Version: 3
Date: 16/06/2016
Review: 1st Jan 2018
Shared Care Guideline for Apomorphine
use in Parkinson’s Disease
Current version is held on GMMMG Website
Check with internet that this printed copy of the latest issue
Page 1 of 15
Parkinson’s disease who have frequent and/or severe akinesia (“off periods”) not
controlled by levodopa or other dopamine agonists
Apomorphine is a dopamine agonist, which acts directly on D 1 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.
 Apomorphine may be administered as a “rescue therapy” with intermittent
subcutaneous bolus injections given via a prefilled Apomorphine Pen: 10mg/ml
Solution for Injection in a 3ml Pen (Apomorphine Pen)
Patients selected for treatment with Apomorphine 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
 For those patients who experience more complex motor fluctuations, including
dyskinesias, a continuous subcutaneous infusion using an ambulatory Apomorphine
pump may be used with the Apomorphine PFS: 5mg/ml Solution for Infusion in PreFilled Syringe in a 10ml syringe (Apomorphine PFS)
 Apomorphine Ampoules 10mg/ml is also available in 5ml ampoules for continuous
infusion
4. Contraindications
(please note this does
not replace the SPC or
BNF and should be
read in conjunction
with it).
Apomorphine is occasionally used for patients with swallowing difficulties and at the
palliative stage.
 Children and adolescents (up to 18 years of age)
 Known sensitivity to Apomorphine or any other ingredients of the product.
 Respiratory depression
 Dementia
 Psychotic disease
 Hepatic insufficiency
 Intermittent Apomorphine HCl treatment is not suitable for patients who have an 'on'
response to levodopa which is marred by severe dyskinesia or dystonia
With Caution:
 Pulmonary, renal or cardiovascular disease
 Persons prone to nausea and vomiting
 Elderly and/ or debilitated patients
 Pre-existing cardiac disease or in patients taking vasoactive medicinal products such
as antihypertensives, and especially in patients with pre-existing postural hypotension
 Ondansetron should be used with caution due to the risk of hypotension
5. Prescribing in
pregnancy and
lactation
6. Dosage regimen for
continuing care
This shared care protocol does not cover pregnant or breastfeeding women. Under these
circumstances prescribing will remain the responsibility of Specialist.
Route of administration
Subcutaneously
Preparations available:
 5mg/ml Solution for Infusion in Pre-Filled Syringe 10ml syringe (Apomorphine PFS)
 10mg/ml Solution for Injection in a 3ml Pen (Apomorphine Pen)
 Apomorphine Ampoules 10mg/ml is also available in 5ml ampoules for continuous
infusion
Version: 3
Date: 16/06/2016
Review: 1st Jan 2018
Shared Care Guideline for Apomorphine
use in Parkinson’s Disease
Current version is held on GMMMG Website
Check with internet that this printed copy of the latest issue
Page 2 of 15
Please Prescribe:
 GP to continue dose as specified by specialist team.
 The daily dose of Apomorphine varies widely between patients and the optimal
dosage of Apomorphine is determined on an individual patient basis and the threshold
dose is determined by the specialist using incremental dosing schedules. Once the
optimal dose for an individual patient has been determined and the patient is stable,
the dose is likely to remain relatively constant
 Intermittent injection – typically 1-10 injections per day, each dose no more than 10mg
 Continuous infusion - typically 1–6 mg per hour (but may be higher, dependent upon
individual response), mostly during waking hours but may be necessary for overnight
infusion according to patient’s needs. Considered if the patient experiences so many
‘off’ periods that repeated bolus injections are inappropriate.
 Unless the patient is experiencing severe night-time problems, 24 hour infusions are
not advised. Tolerance to the therapy does not seem to occur as long as there is an
overnight period without treatment of at least 4 hours. In any event, the infusion site
should be changed every 12 hours.
 Maximum licensed daily dose by either route is 100 mg.
Yes – specialist to titrate and
Is titration required
transfer to GP only once
stable
Adjunctive treatment regime:
As per the Association of British Neurologists (ABN) guidance it is essential that the
patient is established on Domperidone 10mg – 20mg oral TDS daily, 48 hours prior to
initiation of Apomorphine.
Once treatment has been established, domperidone therapy may be gradually reduced in
some patients but successfully eliminated only in a few, without any vomiting or
hypotension.
Please see the MHRA drug safety alert for domperidone with apomorphine:
https://www.gov.uk/drug-safety-update/apomorphine-with-domperidone-minimising-risk-ofcardiac-side-effects
Advice for healthcare professionals:
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Before starting treatment, carefully consider whether the benefits of concomitant
apomorphine and domperidone treatment outweigh the small increased risk of
cardiac side effects
Discuss the benefits and risks of apomorphine with patients and carers and
advise them to contact their doctor immediately if they develop palpitations or
syncopal symptoms during treatment
Check the QT-interval before starting domperidone, during the apomorphine
initiation phase and if clinically indicated thereafter (eg if a QT-prolonging or
interacting drug is started or if symptoms of cardiac side effects are reported)
Regularly review domperidone treatment to ensure patients take the lowest
effective dose for the shortest duration
Advise patients to inform their doctor of any changes that could increase their risk
of arrhythmia,
Please see the MHRA drug safety alert for domperidone:
https://www.gov.uk/drug-safety-update/domperidone-risks-of-cardiac-side-effects
There is a low risk of prolonged QT interval which could lead to ventricular arrhythmia.
Patients should not be given domperidone whilst on medications known to prolong the QT
interval or strongly inhibit CYP3A4 eg, ketoconazole or erythromycin.
Version: 3
Date: 16/06/2016
Review: 1st Jan 2018
Shared Care Guideline for Apomorphine
use in Parkinson’s Disease
Current version is held on GMMMG Website
Check with internet that this printed copy of the latest issue
Page 3 of 15
Please see the Association of British neurologists (ABN) guidance for domperidone
https://gallery.mailchimp.com/7f92fc52090d776e2c33ff870/files/domperidone.pdf
Conditions requiring dose reduction (to be determined by treating specialist team):
e.g. impaired renal/ liver function
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Hypotension which is symptomatic to patient.
Cognitive impairment
Hallucinations
Obsessive compulsive disorder
Impulse control disorder
Somnolence and episodes of sudden sleep onset
Usual response time:
Following a single dose, Apomorphine has an onset of action of 4-12 minutes and lasts for
about one hour with the Apomorphine Pen or is continuous with the infusion with the
Apomorphine PFS.
Duration of treatment:
Apomorphine therapy is a treatment for a chronic disease and therefore course length can
be many years. It is used in complex Parkinson’s disease and when the disease is
beginning to fluctuate, but is not controlled with oral medication.
Treatment to be terminated by:
Specialist Consultant or Parkinsons Disease Nurse Specialist
N.B. All dose adjustments will be the responsibility of the initiating
specialist.
7.Drug Interactions
The following drugs must not be prescribed without consultation with the specialist:
For a comprehensive
list consult the BNF or
Summary of Product
Characteristics
It is recommended to avoid the administration of Apomorphine with other drugs known to
prolong the QT interval. Examples being: Amiodarone, Chlorpromazine, Cisapride,
Citalopram, Clarithromycin, Clomipramine, Disopyramide, Erythromycin, Flecainide,
Haloperidol, Mesoridazine, Moxifloxacin, Pentamidine, Procainamide, Sotalol, Vandetanib
See BNF for full details
8. Adverse drug
reactions
For a comprehensive list
(including rare and very
rare adverse effects), or if
significance of possible
adverse event uncertain,
consult Summary of
Version: 3
Date: 16/06/2016
Review: 1st Jan 2018
Specialist to detail below the action to be taken upon occurrence of a particular
adverse event as appropriate. Most serious toxicity is seen with long-term use
and may therefore present first to GPs.
Adverse event
System – symptom/sign
Localised discomfort at
needle site
Action to be taken Include
whether drug should be stopped prior to
contacting secondary care specialist
Assessment
Shared Care Guideline for Apomorphine
use in Parkinson’s Disease
Current version is held on GMMMG Website
Check with internet that this printed copy of the latest issue
By whom
Nurse
Page 4 of 15
Product Characteristics
or BNF
Version: 3
Date: 16/06/2016
Review: 1st Jan 2018
Nodule formation at
needle or infusion site.
Usually asymptomatic but
may persist in patients on
high doses. Severe nodule
formation may lead to
worsening of symptoms
due to erratic absorption
of Apomorphine
Rotate injection site.
Massage to injection sites is
recognised to reduce nodule
formation. Ultrasound therapy
has been anecdotally said to
alleviate severe nodule
formation.
Anecdotally Hirudoid cream
can be used on nodules
Nausea & vomiting.
Usually transient and
resolved within 6-8 weeks
Treatment with Domperidone
10-20mg oral TDS daily, 48
hours before and during
Apomorphine therapy is
essential . Once treatment
has been established
Domperidone* therapy may
be gradually reduced and can
be successfully discontinued
in most patients within 6-8
weeks
* please refer to latest
recommendations for
Domperidone
Where Domperidone is
contraindicated, consider
requesting secondary care to
prescribe alternative (e.g.
Ondansetron)
Allergic reactions including
bronchospasm and
anaphylaxis (due to
sodium bisulphate)
Light-headedness
Withhold and discuss with
Consultant/PDNS
GP
Discuss with Consultant
/PDNS
GP
Postural hypotension is
seen infrequently and is
usually transient
Care should be exercised in
patients with pre-existing
cardiac disease or in patients
taking vasoactive medicinal
products such as
antihypertensives, and in
patients with pre-existing
postural hypotension.
GP
Dyskinesias during ‘On’
periods
Discuss with Consultant
/PDNS
GP
Shared Care Guideline for Apomorphine
use in Parkinson’s Disease
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Patient / carer
GP as advised by
Consultant / PDNS
Page 5 of 15
Coombs positive
Haemolytic anaemia
Coombs’ test is carried out at
baseline (if deemed
appropriate). If positive, the
patient should have a further
blood screen of the same
parameters after one month’s
treatment and then have FBC
and reticulocyte count at 6
monthly hospital visits from
then on but no requirement to
keep doing Coombs’ tests
provided FBC remains
normal
Consultant/PDNS as
required
Eosinophilia in up to 10%
of patients
Discuss with Consultant
/PDNS
GP
Dopamine dysregulation,
neuropsychiatric
complications –
hallucinations, euphoria,
increased libido,
confusion, personality
changes, agitation,
restlessness, psychosis,
sleep disturbances,
pathological gambling and
over eating
Discuss with Consultant
/PDNS
GP
Sedation. Usually
transient
Advise patients not to drive /
operate machinery if affected.
If persists discuss with
Consultant / PDNS
GP
The patient should be advised to report any of the following signs or symptoms to
their GP without delay:
Patients and carers should be made aware that behavioural symptoms of impulse control
disorders including pathological gambling, increased libido, hypersexuality, compulsive
spending or buying, binge eating and compulsive eating can occur in patients treated with
dopamine agonists including apomorphineN/A
Apomorphine has been associated with somnolence and episodes of sudden sleep onset
Patients must be informed of this and advised to exercise caution whilst driving or
operating machines during treatment with apomorphine. Patients who have experienced
somnolence and/or an episode of sudden sleep onset must refrain from driving or
operating machines.
Other important co morbidities:
N/A
Any adverse reaction to a black triangle drug or serious reaction to an established
drug should be reported to the MHRA via the “Yellow Card” scheme.
Version: 3
Date: 16/06/2016
Review: 1st Jan 2018
Shared Care Guideline for Apomorphine
use in Parkinson’s Disease
Current version is held on GMMMG Website
Check with internet that this printed copy of the latest issue
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9.Baseline
investigations
List of investigations / monitoring undertaken by secondary care
Baseline assessment should include lying and standing blood pressure, FBC, reticulocyte
count and a Coombs’ test (if appropriate), which will be carried out by secondary care.
As per the MHRA drug safety alert for domperidone with apomorphine:
https://www.gov.uk/drug-safety-update/apomorphine-with-domperidone-minimising-risk-ofcardiac-side-effects
Advice for healthcare professionals:

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Before starting treatment, carefully consider whether the benefits of concomitant
apomorphine and domperidone treatment outweigh the small increased risk of
cardiac side effects
Discuss the benefits and risks of apomorphine with patients and carers and
advise them to contact their doctor immediately if they develop palpitations or
syncopal symptoms during treatment
Check the QT-interval before starting domperidone, during the apomorphine
initiation phase and if clinically indicated thereafter (eg if a QT-prolonging or
interacting drug is started or if symptoms of cardiac side effects are reported)
Regularly review domperidone treatment to ensure patients take the lowest
effective dose for the shortest duration
Advise patients to inform their doctor of any changes that could increase their risk
of arrhythmia,
During hospital visits the patient should have a further blood screen of the same
parameters after one month’s treatment and then have FBC and reticulocyte count at 6
months and 12 months. If the results are within normal parameters at this stage then they
should be repeated annually but no requirement to keep doing Coombs tests.
10. Ongoing
monitoring
requirements to be
undertaken by GP
11. Pharmaceutical
Is monitoring required?
Yes
Monitoring
Frequency
Results
Action
By whom
FBC
6 monthly
Communicated to
Consultant/PDNS
Communicated to
Consultant/PDNS
GP
aspects
Do not store above 25°C. Store in the original package. Do not use if the solution has
turned green. The solution should be inspected visually prior to use. Only clear, colourless
solutions should be used.
12. Criteria for shared
Prescribing responsibility will only be transferred when
care
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13. Patients excluded
 Unstable disease state
 Patient does not consent to shared care
 Patient does not meet criteria for shared care
from shared care
Version: 3
Date: 16/06/2016
Review: 1st Jan 2018
Treatment is for a specified indication.
Treatment has been initiated and established by the secondary care specialist.
The patient’s initial reaction to and progress on the drug is satisfactory.
The GP has agreed in each individual case that shared care is appropriate.
The patient’s general physical, mental and social circumstances are such that he/she
would benefit from shared care arrangements
Shared Care Guideline for Apomorphine
use in Parkinson’s Disease
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Check with internet that this printed copy of the latest issue
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14. Responsibilities
of initiating specialist
/ Parkinson’s disease
nurse specialist
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Version: 3
Date: 16/06/2016
Review: 1st Jan 2018
Patient suitability/selection
Provision of information to patient & primary care team regarding Apomorphine
therapy.
Baseline tests as described above
Provision of information to patient, carer ( DVD and written material)
Before starting treatment, carefully consider whether the benefits of concomitant
apomorphine and domperidone treatment outweigh the small increased risk of cardiac
side effects as per MHRA Drug Safety Update.
To arrange prescription for /prescribe Domperidone 10-20mg oral TDS daily, 48 hours
prior to initiation/response test of Apomorphine.
Arrange Apomorphine challenge/initiation within outpatient clinic, community setting or
hospital inpatient clinic
Arrange provision of patient/carer education and training
Provision of information to primary care team
Notify community pharmacy of ordering information via Genus Pharmaceuticals: Tel
0844 8801326.
Liaise with community pharmacy to ensure no delay and break in continuity of supply.
Arrange infusion pump training for District Nurses
Advise District Nurse as required on dose and titration
Agree with GP responsibility for 6 monthly FBC if required
Optimisation and evaluation of medication
Monitor and evaluate potential adverse drug reactions
Provision of information and support to patient, carers and primary care team as
appropriate
Provide point of contact for community team and patients
Monitor blood results
Provide clear, documented advice about changes if necessary.
Initiate treatment and prescribe until dose is stable
Dose adjustments.
Monitor patient’s initial reaction to and progress on the drug.
Ensure that the patient has an adequate supply of medication until GP supply can be
arranged.
Patients will be considered suitable for transfer to GP prescribing ONLY when they
meet the criteria listed in section 3 above.
The consultant team will write formally to the GP to request shared care using the
Shared Care Agreement Form (Appendix 2) which must be fully completed. Failure to
supply all the required information will result in the refusal of the request until all
information has been supplied.
Patients will only be transferred to the GP once the GP has agreed via signing copies
of the Shared Care Agreement Form (Appendix 2).
Continue to monitor and supervise the patient according to this protocol, while the
patient remains on this drug, and agree to review the patient promptly if contacted by
the GP
Provide GP with diagnosis, relevant clinical information and baseline results,
treatment to date and treatment plan, duration of treatment before consultant review.
Provide GP with details of outpatient consultations, ideally within 14 days of seeing
the patient or inform GP if the patient does not attend appointment.
Provide GP with advice on when to stop this drug.
Provision of GP/District Nurses/Community Pharmacy with information on
ordering/prescription on FP10 script of any required needles, dressings, lines and
sharps bins (if homecare not applicable).
Act upon communication from the GP in a timely manner.
Shared Care Guideline for Apomorphine
use in Parkinson’s Disease
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Check with internet that this printed copy of the latest issue
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15. Responsibilities
of the GP & District
Nurses
Version: 3
Date: 16/06/2016
Review: 1st Jan 2018
Provide patient with relevant drug information to enable Informed consent to therapy.
Provide patient with relevant drug information to enable understanding of potential
side effects and appropriate action.
Provide patient with relevant drug information to enable understanding of the role of
monitoring.
Be available to provide patient specific advice and support to GPs as necessary.
GPs:
 Prescribe ongoing Apomorphine and any domperidone as directed by the specialist
 Report side effects or issues relating to Apomorphine treatment to PDNS/treating
Consultant
 6 monthly FBCs as advised specialist team with results communicated to secondary
care.
 Symptoms or results are appropriately actioned, recorded and communicated to
secondary care when necessary
 To monitor and prescribe in collaboration with the specialist according to this protocol
 Provision of dressings, lines and sharps bins via FP10 script following advice from
specialist/PD nurse specialist. (if homecare not applicable)
 Ensure no drug interactions with concomitant medicines.
 Act upon communication from the specialist in a timely manner.
 Formally reply to the consultant’s request to shared care within 14 days of receipt,
using the shared care agreement forms (Appendix 2). NB the GP should only agree to
the transfer of prescribing if all details of the form have been completed.
 If the GP does not feel it is appropriate to take on the prescribing then the prescribing
responsibilities will remain with the specialist. The GP should indicate the reason for
declining.
 Enter a READ code (8BM5.00) on to the patient record to highlight the existence of
shared care for the patient.
 Undertake more frequent tests if there is evidence of clinical deterioration, abnormal
results, or other risk factors. Contact consultant team for advice on monitoring in these
circumstances if required.
 Check all monitoring results prior to issuing a repeat prescription to ensure it is safe to
do so.
 Monitor the patient’s general wellbeing.
 Notify the consultant of any circumstances that may preclude the use of apomorphine
for example, the use of illicit drugs or contraindications to treatment.
 Seek urgent advice from secondary care if:
 Toxicity is suspected
 Non-compliance is suspected
 The GP feels a dose change is required
 There is marked deterioration in the patient’s condition
 The GP feels the patient is not benefiting from the treatment
 The shared care agreement will cease to exist, and prescribing responsibility will
return to secondary care, where:
 The clinical situation deteriorates such that the shared care criterion of
stability is not achieved.
 The clinical situation requires a major change in therapy.
 GP feels it to be in the best stated clinical interest of the patient for
prescribing responsibility to transfer back to the Consultant.
The Consultant will accept such a transfer within a timeframe appropriate to the
clinical circumstances. There must be discussion between the consultant team and
GP on this matter and agreement from the consultant team to take back full
prescribing responsibility for the treatment of the patient. The consultant team should
Shared Care Guideline for Apomorphine
use in Parkinson’s Disease
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Check with internet that this printed copy of the latest issue
Page 9 of 15
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be given 14 days’ notice in which to take back prescribing responsibilities from
primary care.
Liaise with community pharmacy to ensure no delay and break in continuity of supply.
District Nurses:
 Supervision and support as required
 Inform PDNS/GP/treating Consultant of any problems
 Report side effects or issues relating to Apomorphine treatment to PDNS/treating
Consultant and GP
 Maintain appropriate level of knowledge and skills.
16. Responsibilities
of the patient
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17.Additional
If supplied via Homecare from manufacturer ensure this complies with the requirements of
the Hackett Homecare Report.
Responsibilities
e.g. Failure of patient to
attend for monitoring,
Intolerance of drugs,
Monitoring
parameters
outside
acceptable
range, Treatment failure,
Communication failure
18. Supporting
documentation
To take medication as directed by the prescriber, or to contact the GP if not taking
medication
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Collects prescription as per practices repeat prescription procedure for dispensing at
community pharmacy
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Attend Outpatient and GP appointments
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Attend appointments for tests
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Report concerns and adverse events to GPs / PDNS / Specialist
NB: Ongoing prescribing may depend on attendance at clinics as requested by the
clinicians
The Summary of Product Characteristics (SPC) must be accompanied by a patient
information leaflet.
APO-go® Information is available for both patients and healthcare professionals at
www.apo-go.co.uk
An APO-go Helpline is available for patients and healthcare professionals 24/7, 365 days
a year, tel: 0844 880 1327.
19. Patient monitoring
N/A
booklet
20. Shared care
agreement form
Attached below
21. Contact details
See Appendix 1
Version: 3
Date: 16/06/2016
Review: 1st Jan 2018
Shared Care Guideline for Apomorphine
use in Parkinson’s Disease
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Appendix 1 – Local Contact Details
Lead author contact
information
Name: Carol Miller
Email: [email protected]
Contact number: 0161 206 1887
Organisation: Salford Royal Hospital
Commissioner contact
information
Name: [insert text here]
Email: [insert text here]
Contact number: [insert text here]
Organisation: [insert text here]
Secondary care contact
information
If stopping medication or needing advice please contact:
Dr [insert text here]
Contact number: [insert text here]
Fax Number: [insert text here]
Hospital: [insert text here]
Version: 3
Date: 16/06/2016
Review: 1st Jan 2018
Shared Care Guideline for Apomorphine
use in Parkinson’s Disease
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Check with internet that this printed copy of the latest issue
Page 11 of 15
Shared Care Agreement Form
Specialist request
*IMPORTANT: ACTION NEEDED
Dear Dr
[insert Doctors name here]
Patient name: [insert Patients name here]
Date of birth: [insert date of birth]
Diagnosis:
[insert diagnosis here]
This patient is suitable for treatment with [insert drug name] for the treatment of
[insert indication]
This drug has been accepted for Shared Care according to the enclosed protocol
(as agreed by Trust / CCG / GMMMG). I am therefore requesting your agreement
to share the care of this patient.
Treatment was started on [insert date started] [insert dose].
If you are in agreement, please undertake monitoring and treatment from [insert
date]
NB: date must be at least 1 month from initiation of treatment.
Baseline tests:
[insert information]
Next review with this department:
[insert date]
You will be sent a written summary within 14 days. The medical staff of the
department are available at all times to give you advice. The patient will not be
discharged from out-patient follow-up while taking [insert text here].
Please use the reply slip overleaf and return it as soon as possible.
Thank you.
Yours
[insert Specialist name]
Version: 3
Date: 16/06/2016
Review: 1st Jan 2018
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Shared Care Agreement Form
GP Response
Dear Dr [insert Doctors name]
Patient
[insert Patients name]
Identifier
[insert patient date of birth/address]
I have received your request for shared care of this patient who has been
advised to start [insert text here]
A
I am willing to undertake shared care for this patient as set out in the
protocol
B
I wish to discuss this request with you
C
I am unable to undertake shared care of this patient.
My reasons for not accepting are:
(Please complete this section)
GP signature
Date
GP address/practice stamp
Version: 3
Date: 16/06/2016
Review: 1st Jan 2018
Shared Care Guideline for Apomorphine
use in Parkinson’s Disease
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Shared Care Guideline Summary:
APOMORPHINE for the treatment of PARKINSON’S DISEASE
Drug
Apomorphine (APO-go®) 10mg/ml Solution for Injection in 3ml PEN or 5mg/ml Solution for Infusion in
Pre-Filled Syringe in 10ml syringe (PFS)
Indication
The treatment of disabling motor fluctuations (“on-off” phenomena) in patients with Parkinson's disease
which persist despite individually titrated treatment with levodopa (with a peripheral decarboxylase
inhibitor) and/or other dopamine agonists.
Overview
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.
Apomorphine may be administered as a “rescue therapy” with intermittent subcutaneous bolus
injections given via a prefilled Apomorphine Pen: 10mg/ml Solution for Injection in a 3ml Pen
(Apomorphine Pen)
Patients selected for treatment with Apomorphine 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
For those patients who experience more complex motor fluctuations, including dyskinesias, a
continuous subcutaneous infusion using an ambulatory Apomorphine pump may be used with the
Apomorphine PFS.
Specialist’s
Responsibilities
Initial investigations: Assess suitability of patient for treatment. Discuss benefits and side-effects of
treatment with the patient. Undertake baseline investigations (BP, Hb, Reticulocyte count). Carefully
consider whether the benefits of concomitant apomorphine and domperidone treatment outweigh the
small increased risk of cardiac side effects as per MHRA Drug Safety Update.
Initial regimen: The optimal dosage of Apomorphine has to be determined on an individual patient
basis and the threshold dose is determined by the specialist using incremental dosing schedules.
Once the optimal dose for an individual patient has been determined and the patient is stable, the dose
is likely to remain relatively constant. The daily dose of Apomorphine varies widely between patients.
Clinical & Safety monitoring: Monitoring for response and adverse drug reactions (ADRs) during
initiation period. Evaluating ADRs raised by the GP and evaluating any concerns arising from reviews
undertaken by GP.
Prescribing details: Initiate treatment including domperidone. To stop the drug or provide GP with
advice on when to stop this drug.
Documentation: Patients will only be transferred to the GP once the GP has agreed via signing
copies of the Shared Care Agreement Form
Provide GP with diagnosis, relevant clinical information, treatment plan, duration of treatment within 14
days of seeing the patient or inform GP if the patient does not attend appointment.
GP’s
Responsibilities
Maintenance prescription: Prescribe apomorphine and domperidone in accordance with
the specialist’s recommendations. Maximum recommended dose as per BNF.
Clinical monitoring: To report to and seek advice from the specialist on any aspect of
patient care which is of concern to the GP and may affect treatment.
Safety monitoring: FBC – 6 monthly
Duration of treatment: Stop treatment on advice of specialist team.
Re-referral criteria: Seek urgent advice from secondary care if:

Version: 3
Date: 16/06/2016
Review: 1st Jan 2018
Toxicity is suspected
Shared Care Guideline for Apomorphine
use in Parkinson’s Disease
Current version is held on GMMMG Website
Check with internet that this printed copy of the latest issue
Page 14 of 15

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The patient becomes pregnant
Non-compliance is suspected
The GP feels a dose change is required
There is marked deterioration in the patient’s condition
The GP feels the patient is not benefiting from the treatment
Documentation: Formally reply to the consultant’s request to shared care within 14 days of
receipt, using the shared care agreement forms.
Adverse Events
Adverse events
Action
Localised discomfort at needle site
Nodule formation at needle or infusion site. Usually
asymptomatic but may persist in patients on high
doses. Severe nodule formation may lead to
worsening of symptoms due to erratic absorption of
Apomorphine
Nausea & vomiting. Usually transient and resolved
within 6-8 weeks
Assessment by nurse.
Rotate injection site.
Massage to injection sites is recognised to reduce
nodule formation. Ultrasound therapy has been
anecdotally said to alleviate severe nodule formation.
Anecdotally Hirudoid cream can be used on nodules
Treatment with Domperidone 10-20mg oral TDS daily,
48 hours before and during Apomorphine therapy is
essential . Once treatment has been established
Domperidone* therapy may be gradually reduced and
can be successfully discontinued in most patients
within 6-8 weeks
* please refer to latest recommendations for
Domperidone
Where Domperidone is contraindicated, consider
requesting secondary care to prescribe Ondansetron
Withhold and discuss with Consultant/PDNS
Allergic reactions including bronchospasm and
anaphylaxis (due to sodium bisulphate)
Light-headedness
Postural hypotension is seen infrequently and is
usually transient
Dyskinesias during ‘On’ periods
Coombs positive Haemolytic anaemia
Eosinophilia in up to 10% of patients
Dopamine dysregulation,
neuropsychiatric complications – hallucinations,
euphoria, increased libido, confusion, personality
changes, agitation, restlessness, psychosis, sleep
disturbances, pathological gambling and over eating
Sedation. Usually transient
Discuss with Consultant /PDNS
Care should be exercised in patients with pre-existing
cardiac disease or in patients taking vasoactive
medicinal products such as
antihypertensives, and in patients with pre-existing
postural hypotension.
Discuss with Consultant /PDNS
Coombs’ test is carried out at baseline (if deemed
appropriate). If positive, the patient should have a
further blood screen of the same parameters after one
month’s treatment and then have FBC and reticulocyte
count at 6 monthly hospital visits from then on but no
requirement to keep doing Coombs’ tests provided
FBC remains normal
Discuss with Consultant /PDNS
Discuss with Consultant /PDNS
Advise patients not to drive / operate machinery if
affected. If persists discuss with Consultant / PDNS
Contraindications
Cautions
Drug Interactions
Please refer to the BNF and/or SPC for information
Please see the MHRA drug safety alert for domperidone with apomorphine:
https://www.gov.uk/drug-safety-update/apomorphine-with-domperidone-minimising-risk-ofcardiac-side-effects
Other
Information
APO-go® Information is available for both patients and healthcare professionals at
www.apo-go.co.uk
An APO-go Helpline is available for patients and healthcare professionals 24/7, 365 days a
year, tel: 0844 880 1327.
Name: [insert text here]
Address: [insert text here]
Telephone: [insert text here]
Contact Details
Version: 3
Date: 16/06/2016
Review: 1st Jan 2018
Shared Care Guideline for Apomorphine
use in Parkinson’s Disease
Current version is held on GMMMG Website
Check with internet that this printed copy of the latest issue
Page 15 of 15