Download [acute trust logo] - Coastal West Sussex Formulary

WORKING IN
PARTNERSHIP
WITH
EFFECTIVE SHARED CARE AGREEMENT (ESCA)
DRUG NAME: Somatropin (Growth Hormone)
INDICATION/S COVERED: Growth failure in children
Coastal West Sussex Traffic Light system classification: Amber
N.B. The eligibility criteria included here apply to new patients commencing treatment under this agreement &
not to existing patients whose treatment was initiated under the previous version. However, monitoring and
discontinuation criteria apply to all patients.
NOTES to the GP
Amber drugs: Prescribing to be initiated by a consultant / specialist but with the potential to transfer to primary
care. The expectation is that this agreement should provide sufficient information to enable GPs to be
confident to take clinical and legal responsibility for prescribing these drugs .
The questions below will help you confirm this:
 Is the patient’s condition predictable?
 Do you have the relevant knowledge, skills and access to equipment to allow you to monitor treatment as
indicated in this effective shared care agreement?
 Have you been provided with relevant clinical details including monitoring data?
If you can answer YES to all these questions (after reading this ESCA), then it is appropriate for you to accept
prescribing responsibility. Sign and return a copy of the final page to the requesting consultant / specialist.
Until the requesting consultant / specialist has received a signed copy of the final page indicating that shared
care has been agreed all care (including prescribing) remains with the consultant / specialist.
If the answer is NO to any of these questions, you should not accept prescribing responsibility. You should
write to the consultant / specialist within 14 days, outlining your reasons for NOT prescribing. If you do not
have the confidence to prescribe, we suggest you discuss this with your local Trust/specialist service, which
will be willing to provide training and support. If you still lack the confidence to accept clinical responsibility,
you still have the right to decline. Your Medicines Management pharmacist will assist you in making decisions
about shared care.
Prescribing unlicensed medicines or medicines outside the recommendations of their marketing authorisation
alters (and probably increases) the prescriber’s professional responsibility and potential liability. The
prescriber should be able to justify and feel competent in using such medicines.
The patient’s best interests are always paramount
The GP has the right to refuse to agree to shared care, in such an event the total clinical responsibility will remain with the consultant
Effective from: March 2015
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Review date: March 2016
Somatropin (Growth Hormone) ESCA version
Information
This information sheet does not replace the Summary of Product Characteristics (SPC), which should
be read in conjunction with this guidance. Prescribers should also refer to the appropriate paragraph in
the current edition of the BNF for Children.
There are several brands of somatropin (Growth Hormone) currently available, some of which are
available in more than one presentation; not all of these brands and / or presentations are licenced for
every indication therefore individual SPCs should be consulted.
1. Link to the SPC website:
http://www.medicines.org.uk/emc/
Products available:
Product
Genotropin®
Humatrope®
Norditropin®
NutropinAq®
Omnitrope®
Saizen®
Zomacton®
Manufacturer
Pharmacia
Lilly
Novo Nordisk
Ipsen
Sandoz
Merck Serono
Ferring
2. Background to use for the indication/s, including licence status
Indications for somatropin, as approved by NICE:
(not all brands and / or presentations are licenced for every indication therefore individual SPCs should be
consulted)
 Growth failure in children with growth hormone insufficiency/deficiency (GHD) causing short stature:
- Idiopathic isolated GHD
- Congenital hypopituitarism e.g. anomalies of the pituitary gland such as septo-optic dysplasia
- Acquired hypopituitarism e.g. craniopharyngioma, post cranial irradiation, neuro-surgery or traumatic
brain injury
 Growth failure in girls with Turner Syndrome (confirmed by chromosome analysis)
 Growth failure in children with chronic renal insufficiency
 Improvement in growth and body composition in children with Prader-Willi Syndrome (confirmed by
chromosome analysis)
 Growth failure in children born Small for Gestational Age (SGA):
- Growth failure (current height SDS <-2.5 and parental adjusted height SDS <-1) in short children
born SGA who fail to show catch up growth by 4 years or older.
 Growth failure associated with short stature homeobox gene (SHOX) deficiency (confirmed by DNA
analysis).
Somatropin has a role in protein, lipid and carbohydrate metabolism in addition to increasing linear growth in
children.
3. Dose & administration
Somatropin dosage (calculated in micrograms/kg/day or milligrams/m 2 body surface area/day)
Indication
Dose – micrograms/kg/day
Dose – milligrams/m2/day
GHD
23-39
0.7-1.0
Turner Syndrome
45-50
1.4
Chronic Renal Failure
45-50
1.4
Prader-Willi Syndrome
35 (max 2.7mg/day)
1.0 (max 2.7mg/day)
Small for Gestational Age
35
1.0
SHOX deficiency
45-50
1.4
Duration of somatropin therapy is determined by:

Age at start of somatropin treatment

Age at which epiphyseal fusion and final adult height are achieved

Response to somatropin treatment. Height improvement in severe GH deficiency is impressive and
helps confirm the diagnosis. In less severe GH deficiency, which overlaps with normal variant short
Effective from: March 2016
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Somatropin (Growth Hormone) ESCA version
stature, the response may be equivocal and the cost benefit of continued therapy has to be examined
at regular intervals
Discontinuation of treatment
Treatment with somatropin should be discontinued if any of the following apply:

Growth velocity increases less than 50% from baseline in the first year of treatment

Final height is approached and growth velocity is less than 2 cm total growth in 1 year

There are insurmountable problems with adherence

Final height is attained.
In Prader–Willi syndrome evaluation of response to therapy should also consider body composition.
Treatment should not be discontinued by default. The decision to stop treatment should be made in
consultation with the patient and/or carers either by:

a paediatrician with specialist expertise in managing growth hormone disorders in children, or

an adult endocrinologist, if care of the patient has been transferred from paediatric to adult services,
where by the patient has been transferred in advance adulthood.
Administration
Somatropin is administered by subcutaneous injection or needle free transjection once daily. Depending on
brand, injections may be prepared from multi-dose ampoules or by using cartridges in a multi-dose pen
injection device or other disposable devices.
The subcutaneous injection sites should be rotated to prevent lipoatrophy
The current arrangement is that manufacturers of somatropin provide suitable disposable syringes, needles
and a range of injection devices. These are usually distributed through specialist hospital clinics, but
alternative local supplies can be organised in liaison with clinic and/or supplier. Storage containers and safety
bins are also provided,
4. Contraindications
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Hypersensitivity to the active ingredients or excipients
Patients with acute critical illness suffering complications following open heart surgery, abdominal
surgery, multiple accidental trauma, acute respiratory failure or similar conditions
Evidence of tumour (complete antitumour therapy and ensure intra-cranial lesions are inactive before
starting)
Post renal transplant
Children with closed epiphyses (or near closure in Prader-Willi syndrome)
Severe obesity in Prader-Willi syndrome
Severe respiratory syndrome in Prader-Willi syndrome
5. Cautions
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Major surgery – somatropin should be stopped as a precaution
Diabetes mellitus – adjustment of antidiabetic therapy may be required
Papilloedema
Relative deficiencies of other pituitary hormones (notably hypothyroidism)
History of malignant disease
Disorders of the epiphysis of the hip (monitor for limping)
Resolved intra-cranial hypertension (monitor closely)
Initiation of treatment close to puberty not recommended in children born small for corrected gestational
age
Silver-Russell syndrome
In the post-marketing experience rare cases of sudden death have been reported in patients affected by
Prader-Willi syndrome treated with somatropin, (although no causal relationship has been
demonstrated)
Pregnancy
Interrupt treatment if pregnancy occurs
Breast feeding
Absorption from milk unlikely
Effective from: March 2016
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Review date: March 2018
Somatropin (Growth Hormone) ESCA version
6. Side effects
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Antibody formation to somatropin can be detected but is rarely of physiological relevance.
Fluid retention and peripheral oedema can occur in adults, but is less common in children
Fluid retention may play a role in the generation of raised intra-cranial pressure (benign intra-cranial
hypertension). This may occur at the onset of somatropin therapy and is associated with severe
headache and papilloedema. In such cases the somatropin therapy is discontinued for 2-3 weeks and
then re-commenced at a lower dose and gradually increased to the full dose.
Local injection site reactions are unusual and are more likely to be due to unnecessary use of spirit
based cleanser.
Repeated injection at the same site may lead to local fat atrophy, hence the need for rotation of injection
site.
Somatropin therapy is associated with insulin insensitivity; there is a rise in serum insulin concentrations
but blood glucose and glycated haemoglobin concentrations usually remain within normal limits.
Slipped femoral epiphysis is anecdotally recognised and patients on somatropin therapy should be
clinically monitored for limping and other hip problems
Leukaemia and other tumours: Some children receiving somatropin are at risk of primary tumour
recurrence or secondary tumour e.g. those who have become GH deficient secondary to a tumour or
attendant radio-therapy. Extensive surveys have not suggested increased risk of tumour recurrence or
progression with somatropin therapy.
Myositis is a very rare adverse event that may be related to the preservative metacresol. In the case of
myalgia or disproportionate pain at injection site, myositis should be considered and if confirmed, a
presentation without metacresol should be used
In children with Turner syndrome increased growth of hands and feet has been reported during
somatropin therapy
Somatropin may cause worsening of scoliosis due to increasing spinal growth, if scoliosis is already
present
7. Interactions



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Corticosteroids – growth promoting effect of somatropin may be inhibited by corticosteroids (but not
when used topically or by inhalation)
Oestrogens – increased doses of somatropin may be needed when given with oestrogens (when used
as oral replacement therapy).
Insulin – somatropin may reduce the efficacy of insulin
Data from an interaction study performed in growth hormone deficient adults, suggest that somatropin
administration may increase the clearance of compounds known to be metabolised by cytochrome P450
isoenzymes. The clearance of compounds metabolised by cytochrome P450 3A4 (e.g. sex steroids,
corticosteroids, anticonvulsants and ciclosporin) may be especially increased resulting in lower plasma
levels of these compounds. The clinical significance of this is unknown.
8. Criteria for use
The early recognition of growth failure is an essential component of a national strategy leading to rational
and effective use of somatropin. Monitoring of growth (height and weight) should be part of all childhood
health surveillance in primary care and in school.
The diagnosis is based on a combination of the following:

Short stature that is inappropriate for the parental height

Subnormal growth rate: i.e. height velocity below 25th centile

Association with other pituitary hormones deficiency, as in multiple pituitary hormone deficiency.

Growth delay confirmed by skeletal maturation (bone age)

Clinical and/or imaging evidence of a structural disorder of the hypothalamo-pituitary axis; this
includes previous cranial irradiation

Exclusion of other genetic, psychosocial and systemic causes of growth failure.

Biochemical evidence of GHD to provocation testing. Consideration should be given to
neurosecretory dysfunction of GH release where provocation may reveal a normal response but
other evidence suggests a diagnosis of GHD
Effective from: March 2016
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Somatropin (Growth Hormone) ESCA version
9. Any further information (e.g. supporting therapies)
NICE have published full guidelines on the use of somatropin in children:
http://www.nice.org.uk/guidance/TA188
10. References
1. Shared Care Guidelines: Paediatric use of Recombinant human Growth Hormone (r-hGH,
Somatropin). British Society for Paediatric Endocrinology and Diabetes; July 2015.
http://www.bsped.org.uk/clinical/docs/SharedcareGH_July2015.pdf (Accessed 21 January 2016)
2. National Institute for Health and Clinical Excellence. TA188. May 2010.
http://www.nice.org.uk/guidance/TA188 (Accessed 21 January 2016)
3. BNF for Children 2015-2016 BMJ Group, Royal Pharmaceutical Society, RCPCH Publications Ltd.
https://www.evidence.nhs.uk/formulary/bnfc/current/6-endocrine-system/65-hypothalamic-andpituitary-hormones/651-hypothalamic-and-anterior-pituitary-hormones-including-growthhormone/anterior-pituitary-hormones/growth-hormone Accessed 21 January 2016
Effective from: March 2016
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Review date: March 2018
Somatropin (Growth Hormone) ESCA version
RESPONSIBILITIES and ROLES
Consultant / Specialist responsibilities
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
To undertake necessary testing to confirm a diagnosis that requires somatropin treatment, as indicated by NICE guidance.
Request agreement of shared care with GP including considering local arrangements necessary for instigation of therapy
and identify any possible barriers to treatment.
Ensure no clinically significant contra indications or interactions with other medication prescribed by the GP or other
specialists.
Discuss risks and benefits with patients / carers, outline possible side effects and ensure a clear understanding of
treatment.
Ensure strict adherence to published NICE and BSPED (British Society for Paediatrics Endocrinology and Diabetes)
guidance for initial prescription of somatropin and monitoring of ongoing somatropin therapy.
Issue initial prescription(s) until the patient is stabilised (minimum of 28 days) and until ESCA is in place.
Ensure that all newly treated patients (and/or their carers) receive appropriate education and advice regarding their drug
therapy including storage, administration of injections and the shared care arrangements. This should include written
information where appropriate.
Provide GP with clinic letter stating planned introduction and reviews.
Monitor patient’s growth, pubertal development, assessment of any other ongoing or evolving endocrinopathy and general
condition at 3-6 monthly intervals following instigation of therapy and to advise about dose and/or preparation changes.
Signs of scoliosis should be monitored during treatment due to progression in any child during rapid growth.
Perform biochemical analysis, monitor hormonal deficiencies and undertake ontological evaluation at a minimum of
annually.
Provide outpatient reviews, monitor effectiveness/side effects.
Provide GP with written information regarding the diagnosis and indication for somatropin therapy along with dose and
preparation to be used.
Give a copy of the information sheet to the patient / carer and explain their roles.
Notify the GP of the patient’s failure to attend for clinical review or drug monitoring.
Supervise the timing for cessation of treatment at final height, reassessment and transition to adult endocrine care where
necessary.
Report any adverse effects to the MHRA via the Yellow Card Reporting Scheme.
GP responsibilities
1
2
3
4
5
6
7
8
9
10
11
12
13
Initial referral to secondary care.
Inform the consultant if willing / unwilling to enter into shared-care arrangements.
Prescribe somatropin as advised by the supervising consultant and, where local practice dictates, discuss with the local
medicines management pharmacist.
Provide repeat prescriptions once ESCA is agreed and in place. A demonstrable system should be in place to ensure that
prescribing is reviewed by the GP if there is no record of the fact that monitoring has taken place in secondary care within
the agreed time scales.
Record any changes in therapy in the prescribing record on receipt of such communication from secondary care.
Monitor and assess adherence to treatment at each review.
Monitor patient’s overall health and well-being and report any adverse drug reactions or interactions to secondary care.
Liaise with supervising consultant or deputy if any cause for concern, adverse effects or drug discontinued.
Provide a copy of this ESCA to the patient / carer to ensure that they are familiar with all roles and responsibilities.
Patients with Prader-Willi syndrome suffering from respiratory infections should be treated promptly and aggressively.
Patients with Prader-Willi syndrome should be referred if showing sign of upper airway obstruction (onset, increased snoring
and or suspected sleep apnoea).
Refer patients presenting with a limp to the consultant or deputy.
Consider pancreatitis as a diagnosis in patient with acute abdominal pain.
Patient / Carer role
1
2
3
4
5
Ask the consultant, deputy or GP for information, if there is not a clear understanding of the treatment.
Agree with the consultant the most appropriate device for administration.
Share any concerns in relation to treatment with somatropin.
Tell the consultant, deputy or GP of any other medication being taken, including over-the-counter products.
Read the patient information leaflet included with the medication and report any side effects or concerns
to the
consultant, deputy or GP.
6 Store the medication according to the manufacturer’s recommendation.
7 To attend clinic reviews as requested.
8 Request repeat prescriptions at least a week in advance to avoid problems within the supply chain.
9 Administer the somatropin as directed by the supervising consultant, varying the injection site to avoid local adverse
reactions.
10 Arrange blood tests as per consultant or deputy’s request.
11 Report any symptoms / adverse effects to the supervising consultant and/or GP whilst taking somatropin.
Effective from: March 2016
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Review date: March 2018
Somatropin (Growth Hormone) ESCA version
BACK-UP ADVICE AND SUPPORT
Name / position
Telephone
Email
Specialist /
Consultant:
Dr Charles Buchanan
Secretary: 0203 299
3431
[email protected]
Alternative
specialist (e.g.
departmental
contact):
Dr Ekaterini Vamvakiti
Sectretary: 01903
205 111 extension
84690
[email protected]
Worthing Hospital
01903 205 111, ext
85751
01243 788 122, ext
3347 or 5169
01903 205 111
[email protected]
Hospital Pharmacy:
St Richards Hospital
Out of hours (e.g.
medical team on
call):
On call Medical team
N/A
Version History
Somatropin (somatropin) ESCA
Document Name:
Document Type:
Effective Shared Care Agreement
Relevant to:
All GPs working within Coastal West Sussex and all relevant clinicians at Western
Sussex Hospitals NHS Trust.
Version No.
Date
Author of original development or
review
Details of document development
1
9/2014
Christian Chadwick, Clinical
Pharmacist for Women and Children
Original development
2
01/2015
Lucy Simkins, Associate Head of
Pharmacy – Clinical Services, WSHfT
Reviewed and incorporating first 28 days
supply from WSHfT. Rejected as newer version
with comments not acknowledged.
3
03/2015
Lucy Simkins, Associate Head of
Pharmacy – Clinical Services, WSHfT
Reviewed to incorporate first 28 days supply
from WSHfT and comments on version 1 from
J. Robinson RegPharmTech and Dr S Pike.
4
03/2015
Jemma Robinson
Minor amendment following APC approval
5
01/2016
Jane Moffatt, Medicines Optimisation
Reviewed to ensure compliance with current
clinical advice, and to standardise terminology
and syntax
Approval for organisational use
ESCA
authorised for
use in Coastal
West Sussex by
Specialist/consultant:
Dr Vamvakiti - Paediatric Consultant (Western Sussex Hospitals Trust)
Dr Buchanan - Paediatric Endocrinologist (King’s College Hospital)
Coastal West Sussex Area Prescribing Committee (APC):
March 2015
Minor alteration approved January 2016
Effective from: March 2016
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Review date: March 2018
Somatropin (Growth Hormone) ESCA version
EFFECTIVE SHARED CARE AGREEMENT (ESCA)
DRUG NAME: <insert>
INDICATION: <insert>
Agreement for transfer of prescribing to GP
Patient details:
Name:
Address:
DoB:
NHS No:
Hospital No:
Drug name and dose: <insert, specifying brand used>
The following tests and investigations have been carried out:
<insert details of tests>:
Date treatment initiated:
At the last patient review the drug appeared to be effectively controlling symptoms / providing benefit:
Yes/No
The patients has now been stabilised on a dose of:
I will arrange to review this patient regularly. Date of next clinic appointment:
<Insert title of specialist>: <insert name>
Agreement to shared care, to be
signed by primary care prescriber and
consultant/specialist.
Address: <insert relevant department>
<insert relevant hospital address>
Consultant/specialist signature:
Contact Number: <insert telephone number and extension>
Date:
GP:
GP signature:
Address:
Contact Number:
Date:
Main Carer:
If shared care is agreed and the GP
has signed above please return a
copy of this page to the requesting
consultant or alternatively fax to:
<insert>
Contact Number:
Key worker if appropriate:
Contact Number:
Effective from: March 2016
Page 8 of 8
Review date: March 2018