Download Effective Shared Care Agreement (ESCA) for

Effective Shared Care Agreement (ESCA) for
Apomorphine used in the treatment of
Parkinson’s disease.
AREAS OF RESPONSIBILITY FOR THE SHARING OF CARE
This shared care guideline outlines the ways in which the responsibilities for
managing the prescribing of Apomorphine will be shared between the specialist and
general practitioner (GP). If the GP is not confident to undertake these roles, then
he/she is under no obligation to do so. In such an event, the total clinical
responsibility for the patient for the diagnosed condition will remain with the
specialist. If the specialist asks the GP to prescribe this drug, the GP should
reply to this request as soon as practical.
Sharing of care assumes communication between the specialist, GP, specialist
nurse and patient. The intention to share care should be explained to the patient by
the doctor initiating treatment. It is important that patients are consulted about
treatment and are in agreement with it.
The doctor who prescribes the medication legally assumes clinical
responsibility for the drug and the consequences of its use.
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 latestage 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 over 12 hours. Following a single dose,
Apomorphine has an onset of action of 5 – 15 minutes and lasts for 45 – 90 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.
SHARED CARE (MTRAC Statement)
In its guidelines on responsibility for prescribing between hospitals and general
practitioners (circular EL(91)127), the department of Health has advised that the
legal responsibility for prescribing lies with the doctor who signs the prescription.
This ESCA should be read in conjunction with the Summary of Product Characteristics SPC
Approved by Dudley ACE on May 2016
ROLES AND RESPONSIBILITIES
Patient’s/Carer’s Roll
 Report any adverse effects
 Ensure they have a clear understanding of their treatment
 Ensure they attend for monitoring requirements
 Take prescriptions to the pharmacy/dispensing surgery as soon as possible,
so that they have adequate time to obtain supplies of the medicine
General Practitioner Responsibilities
 Reply to the request for shared care
 GP to prescribe Apomorphine dose and relevant equipment as stated in letter
from specialist team following response test
 Prescribe ongoing Apomorphine therapy, equipment and consumables and
Domperidone if required, as recommended by the specialist team
 To inform the specialist team of any significant developments or deterioration
– such as the occurrence of side effects or an inability to administer
Apomorphine
 Arrange ECG prior to challenge if requested by specialist team
 Arrange and monitor blood test results. 4-6 month intervals FBC, LFT’s,
U&E’s. Coomb’s.
 Blood pressure monitoring at 3-6 monthly intervals.
 Facilitate the co-ordination of on-going patient care within the community and
home environment, liaising with the specialist team when necessary.
 Be aware of the MHRA advice regarding the use of domperidone in patients
over 60 years or with underlying cardiac disease. See below.
Specialist Team Responsibilities
 Patient selection and arranging assessment time and location for
Apomorphine challenge
 Conduct any necessary baseline assessments to determine suitability.
 Initiation of either intermittent Apomorphine injection or continuous infusion
driver and optimisation of antiparkinsonian medication.
 Ensure arrangements for continued prescribing are in place and that the GP is
willing to continue treatment.
 Ensure that the patient/carer understand the treatment (Including provision of
information) and plan for follow-up care.
 Advise the GP in a letter of the dose preparation (e.g. pen, pre-filled syringe
or ampoules), and any equipment/consumables that need to be prescribed
post challenge.
 Patient regular monitored by specialist nurse (telephone or home visits as
necessary) and any dose changes over time clearly communicated to GP
 Monitoring and evaluation of adverse drug reactions, disease and drug
response.
 Provision of telephone contact for patients, carers and health professionals.
With clear arrangements for back-up advice and support should further
assistance be required.
This ESCA should be read in conjunction with the Summary of Product Characteristics SPC
Approved by Dudley ACE on May 2016
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Discontinuation of treatment when considered to be no longer efficacious or if
side-effects outweigh benefits, and advice to GP’s on when to stop treatment
or alter dose.
Arrangement of review dates at clinically relevant time intervals.
Perform a full blood count at 3-6 monthly intervals (If not done by GP).
Blood pressure monitoring at 3-6 monthly intervals (If not done by GP).
Prompt communication with GP of any changes in treatment or dose
requirements, results of monitoring undertaken and assessment of adverse
events.
Confirmation of Apomorphine and equipment supply arrangements with
relevant community pharmacy/dispensing surgery.
To facilitate the co-ordination of on-going patient care within the community
and home environment
BACK UP ADVICE AND SUPPORT
CONTACT DETAILS
Dr Shams Duja
Dr Alistair Lewthwaite
Dr Janine Barnes
Trudy Gaskin
Alison Waldron
SPECIALIST
Consultant in Elderly Care
Consultant in Neurology
Specialist Neurology
Pharmacist (CCG)
Community Parkinson’s
Disease Specialist Nurse
Acute Parkinson’s Disease
Specialist Nurse
APO-go Helpline
TELEPHONE NUMBER
0844 880 1327 (24 hours)
PRESCRIBING INFORMATION
This information should be read in conjunction with the current BNF and SPC.
Dosage and administration
Treatment is by intermittent sub-cutaneous injection at the onset of an “off” period or
by continuous subcutaneous infusion usually over 12 hours. Usual range 3 – 30mg
daily in divided doses. Following a single dose, apomorphine has an onset of action
of 5-15 minutes and lasts for 45-90 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 properly. 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.
1. Apomorphine may be administered as a “rescue therapy” with intermittent
subcutaneous bolus injections given via a prefilled 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
pump may be used with the pre-filled syringe (PFS).
This ESCA should be read in conjunction with the Summary of Product Characteristics SPC
Approved by Dudley ACE on May 2016
A 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 a 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
dyskinesias may also benefit from a continuous infusion, as it may allow their oral
levodopa medication to be reduced. Experience 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
dyskinesias. It is thought a 30% reduction in levodopa can be made almost
immediately once an infusion is commenced.
The Ambulatory Infusion Pump, dedicated 20ml syringes and connectors are
supplied free of charge by Britannia Pharmaceuticals.
Note: The total daily dose by either route (or combined routes), max. 100mg, in rare
cases it may be necessary to give higher doses.
Link to the relevant SPC website
APO-go®: http://www.medicines.org.uk/emc/medicine/12941
APO-go® Pre-Filled Syringe: http://www.medicines.org.uk/emc/medicine/15992
Contra-indications
Apomorphine is contraindicated in patients:
1. With respiratory depression
2. With dementia
3. With psychoses
4. With hepatic insufficiency
5. Under the age of 18
6. With a known hypersensitivity to apomorphine
Intermittent apomorphine treatment is not suitable for patients who have an ‘on’
response to levodopa, which is marred by severe dyskinesia or dystonia.
Adverse drug reactions
All health care professionals have a responsibility to patients in advising/acting on
suspected adverse drug reactions. Please refer to Figure 1.
Figure 1:
Very
Common
(>1/10)
Injection site
Common
(>1/100 to
<1/10)
Uncommon
(>1/1000 to
<1/100)
Rare
(>1/10,000 to
<1/1,000)
Special caution
Haemolytic
Eosinophilia
Not Known
(cannot be
estimated
from the
available
data)
Class effect:
This ESCA should be read in conjunction with the Summary of Product Characteristics SPC
Approved by Dudley ACE on May 2016
reactions
–
anaemia and
neuropsychiatric thrombocytopenia
disturbances
Dyskinesias
Transient
sedation,
Postural
somnolence,
hypotension
dizziness and
lightheadedness
Breathing
Difficulties
Nausea &
vomiting
Local and
(usually with
generalised
domperidone
rashes
omission
Injection site
Yawning
necrosis and
ulceration
Allergic
reactions
Dopamine
agonists,
pathological
gambling,
increased
libido and
hypersexuality
Peripheral
oedema
Positive Coomb’s
tests
Ref: ApoGo website
NB: Domperidone
This is started 3 days prior to the ‘Response Test’ at a dose of 20mg tds. The MHRA
issued a safety
warning in 2012 highlighting that it may be associated with a small increased risk of
serious ventricular
arrhythmia or sudden cardiac death. These risks may be higher in patients older than
60 years and in
patients who receive daily oral doses of more than 30mg.It should be used at the
lowest effective dose.
Cost
Product
APO-go® PFS 5mg/ml
APO-go® Pen 10mg/ml
APO-go® Ampoules
10mg/ml solution for
injection or infusion
Pack Size
10ml prefilled syringe
3ml pen injector
2ml ampoule
5ml ampoule
Cost
£14.62
£24.78
£7.59
£14.62
Ref: BNF online
REFERENCES
Summary of Product Characteristics for APO-go® –
www.medicines.org.uk/emc/medicine/12941
This ESCA should be read in conjunction with the Summary of Product Characteristics SPC
Approved by Dudley ACE on May 2016
Summary of Product Characteristics for APO-go® Pre-filled Syringe –
www.medicines.org.uk/emc/medicine/15992
British National Formulary Online accessed 30/06/2015
APO-go® website accessed 30/06/2015
MTRAC website accessed 30/06/2015
Effective sared care agreement for the treatment of severe motor complications in
people with Parkinson’s disease with apomorphine (APO-go®) – North Staffordshire
and Stoke on Trent area prescribing committee 01/10/2013
Shared care guidelines for Shrewsbury and Telford Hospital Trust/Shropshire and
Telford and Wrekin for apomorphine treatment in patients with Parkinson’s disease
May 2012
Shared care prescribing guideline for Surrey and Sussex Healthcare NHS Trust.
Apomorphine hydrochloride for the treatment of motor fluctuations (‘on-off’
phenomena) in patients with Parkinson’s disease which are not sufficiently controlled
by oral anti-Parkinson medication.
Guidelines for the use of Apomorphine in Patients with Parkinson’s disease.
University Hospitals Birmingham NHS Foundation Trust. October 2014
Updated: April 2016
Approved: May 2016
Review date: May 2018
This ESCA should be read in conjunction with the Summary of Product Characteristics SPC
Approved by Dudley ACE on May 2016