Section A: To be completed by the hospital consultant initiating the treatment GP Practice Details: Patient Details: Address:...

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1 Epsom and St. Helier University Hospitals NHS Trust Kingston Hospital NHS Trust Croydon University Hospital NHS Trust Royal Marsden Hospital NHS Foundation Trust St George s Hospital NHS Trust Somatropin Shared Care Guideline: Prescribing Agreement Section A: To be completed by the hospital consultant initiating the treatment GP Practice Details: Name: Address: Tel no: Fax no: NHS.net Consultant name: Clinic name:. Contact details: Patient Details: Name: Address: DOB: / / Hospital number: NHS number (10 digits): Address:... Tel no: Fax no: NHS.net Diagnosis: Drug name (include brand where appropriate) & dose to be prescribed by GP:. Next hospital appointment: / /.. Dear Dr..., Your patient was seen on../.. / and I have started.(insert drug name and dose) for the above diagnosis. I am requesting your agreement to sharing the care of this patient from../../.. in accordance with the (attached) Shared Care Prescribing Guideline (approval date:././..). Please take particular note of Section 2 where the areas of responsibilities for the consultant, GP and patient for this shared care arrangement are detailed. Patient information has been given outlining potential aims and side effects of this treatment and * supplied (* insert any support materials issued such as patient held monitoring book etc where applicable). The patient has given me consent to treatment possibly under a shared care prescribing agreement (with your agreement) and has agreed to comply with instructions and follow up requirements.. The following investigations have been performed on / / and are acceptable for shared care. Please monitor...every.. Test Result Test Result Tick box form showing patient fits NICE guidance (attached by consultant) Other relevant information:.... Section B: To be completed by the GP and returned to the hospital consultant as detailed in Section A above Please sign and return your agreement to shared care within 14 days of receiving this request Tick which applies: I accept sharing care as per shared care prescribing guideline and above instructions I would like further information. Please contact me on:. I am not willing to undertake shared care for this patient for the following reason:. GP name:.. GP signature: Date: / /.. Date prepared: July

2 Epsom and St. Helier University Hospitals NHS Trust Kingston Hospital NHS Trust Croydon University Hospital NHS Trust Royal Marsden Hospital NHS Foundation Trust St George s Hospital NHS Trust working in partnership SHARED CARE PRESCRIBING GUIDELINE SOMATROPIN in children with growth failure [According to NICE Technology Appraisal No. 188] NOTES to the GP The expectation is that these guidelines should provide sufficient information to enable GPs to be confident to take clinical and legal responsibility for prescribing this drug. The questions below will help you confirm this: Is the patient s condition predictable or stable? Do you have the relevant knowledge, skills and access to equipment to allow you to monitor treatment as indicated in this shared care prescribing guideline? Have you been provided with relevant clinical details including monitoring data? If you can answer YES to all these questions (after reading this shared care guideline), then it is appropriate for you to accept prescribing responsibility. If the answer is NO to any of these questions, you should not accept prescribing responsibility. You should write to the consultant 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, who 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 PCT pharmacist will assist you in making decisions about shared care. It would not normally be expected that a GP would decline to share prescribing on the basis of cost. The patient s best interests are always paramount Date prepared: 07/10/2010 (update from original version dated July 2005) Review date: 07/10/2012 Re-approved on behalf of SWL PCTs by: NHS Kingston Medicines Management Committee Date Approved: 14/10/2010 Originally prepared by: Krystyna Olejnik, Paediatric Pharmacist E&StH Hospital Dr. Chris Arulrajah, GP, NHS Sutton and Merton Brigitte van der Zanden, Chief Pharmacist, NHS Sutton and Merton Reviewed by: Catherine Ho, Principal Pharmacist, Kingston Hospital Dr A Alston, Consultant Paediatrician, Paediatric Endocrinologist & Diabetologist, E&StH Hospital Dr J Edwards, GP, NHS Kingston Seema Buckley, Chief Pharmacist, NHS Kingston Dr Andrew Winrow, Consultant Paediatrician, Kingston Hospital Professor Peter Hindmarsh, Developmental Endocrinology Research Unit, Institute of Child Health, UCL. Dr Albanese, Consultant Paediatrician, St George s Hospital This shared care prescribing guideline has been signed off by the following individuals on behalf of their respective organisations: Participating Primary Care Trusts: Participating Hospital Trusts: NHS Kingston Croydon University Hospital NHS Trust Dr Jonathan Edwards, GP Medicines Management Dr S Hart, Consultant Paediatrician Committee Obafemi Shokoya, Chief Pharmacist Seema Buckley, Chief pharmacist Date prepared: July

3 Epsom and St. Helier University Hospitals NHS Trust Kingston Hospital NHS Trust Croydon University Hospital NHS Trust Royal Marsden Hospital NHS Foundation Trust St George s Hospital NHS Trust NHS Croydon GP name (of host PCT) and designation Eileen Callaghan, Chief pharmacist NHS Richmond GP name (of host PCT) and designation Emma Richmond, Interim Chief pharmacist NHS Sutton and Merton Dr Chris Arulrajah, GP Brigitte van der Zanden, Chief Pharmacist NHS Wandsworth GP name (of host PCT) and designation Nick Beavon, Chief Pharmacist Epsom and St Helier University Hospitals NHS Trust Dr Aileen Alston, Consultant Paediatrician Anne Davies, Chief Pharmacist Kingston Hospital NHS Trust Dr Andrew Phillip Winrow, Consultant Paediatrician Derek Cock, Chief Pharmacist Royal Marsden Hospital Dr A Albanese, Paediatric Endocrinologist Ian Costello, Chief Pharmacist St George s Hospital Dr A Albanese, Paediatric Endocrinologist Chris Evans, Chief Pharmacist Date prepared: July

4 SOMATROPIN SHARED CARE PRESCRIBING GUIDELINE SOMATROPIN IN CHILDREN WITH GROWTH FAILURE 1. CIRCUMSTANCES WHEN SHARED CARE IS APPROPRIATE Prescribing responsibility will only be transferred when the consultant and the GP are in agreement that the patient s condition is stable or predictable. Patients will only be referred to the GP once the GP has agreed in each individual case and the hospital will continue to provide prescriptions until successful transfer of responsibilities as outlined below. The hospital will provide the patient with a minimum initial supply of THREE months therapy. Please note - GPs will be asked to prescribe before the patients have their follow up hospital appointment in out-patients at 6 months. 2. AREAS OF RESPONSIBILITY Consultant Confirm diagnosis for one of the following: - GH deficiency, - Small for Gestational Age (SGA) with subsequent growth failure at 4 years of age or later, - Short Stature Homeobox (SHOX) Deficiency, - Turner Syndrome (TS), - Chronic Renal Insufficiency (CRI): Patient s renal function should be below 50% of normal before institution of therapy. To verify growth disturbance, growth should be followed for a year preceding institution of therapy. 1 - Prader-Willi Syndrome (PWS): signs for upper airway obstruction, sleep apnoea, or respiratory infections should be assessed before treatment. 1 Ensure that corticosteroid replacement therapy has been adjusted before initiation of therapy as it may inhibit growth. 1 Initiate treatment and provide prescriptions (minimum of 3 months) Monitor in outpatients: 6-monthly. See section 4, page 5 for Monitoring requirements. Check for concordance with treatment. Discontinue treatment when indicated: See section 4, page 5 for Duration of treatment. Communicate with GP including: - Clinic letters to GP advising of dose changes and results of assessments/ tests. - Liaison with local children s community nursing team on issues around injection technique and problems with injection sites.provide annual letter summarising response to therapy and justification for continuation of therapy GP Prescribe somatropin once the treatment has been established and the patient is stabilised on a dose advised by the Consultant (not sooner than 3 months after initiation of therapy). Monitor for any adverse effects (see section 4, page 5 Summary of adverse effects and page 6 Monitoring requirements for further advice). Check for interactions with other drugs and report to the Consultant significant changes or additions to patient s medication. Re-refer or seek specialist advice if concerned about the patient s condition in-between regular reviews. Patient Attend follow up appointments with the GP/consultant including any scheduled blood tests. Use the treatment provided as intended, following any instructions either written or verbal and seeking help and advice from health care professionals, where necessary. Ensure medicines are stored correctly and out of reach of children. Ensure a sufficient quantity of medicine is available for use at all times during therapy without storing excess amounts. Inform GP/consultant of any changes in relation to their therapy eg. Side effects and introduction of new medicines or difficulties actually undertaking the injections. 4

5 SOMATROPIN SHARED CARE PRESCRIBING GUIDELINE 3. COMMUNICATION AND SUPPORT Hospital contacts: (the referral letter will indicate named consultant) Epsom and St. Helier University Hospitals NHS Kingston Hospital NHS Trust Trust St. Helier Hospital, Wrythe Lane, London SM5 1AA Kingston Hospital, Galsworthy Road, Kingston upon Epsom Hospital, Dorking Road, Epsom KT18 7EG Thames, KT2 7QB Consultant Paediatrician, Endocrinology (St Helier): Dr A Alston Tel: ; Fax: ; aileen.alston@esth.nhs.uk Specialist Paediatric Nurse Endocrine (St Helier): Sue Basford (Weds & Thurs only), Tel: Paediatric Pharmacist (St Helier): Krystyna Olejnik, Tel: ; krystyna.olejnik@esth.nhs.uk On call general paediatric specialist registrar or on call pharmacist via Epsom and St. Helier switchboard (tel: ) Consultant Paediatrician: Dr Andrew Phillip Winrow Tel: Ext 2410 Senior Pharmacist Paediatrics and Women s Health: Haroon Hafeez Tel: ext 2091 bleep 293 The on call registrar is contactable on bleep 732 Specialist support/resources available to GP including patient information: Medicines Information, Pharmacy Department Tel: Medicines Information, Pharmacy Department, Kingston Hospital, Tel Croydon University Hospital (CUH), 530 London Road, Croydon, CR7 7YE. Dr S Hart, Paediatric Consultant, Visiting Clinician: Dr P C Hindmarsh, Professor in Endocrinology, GOSH Specialist Clinic: Endcrine and Growth In Willows on a three monthly basis Dr S Hart via CUH Switchboard Tel: Royal Marsden Hospital, Downs Road, Sutton, Surrey, SM2 5PT. Consultant Paediatrician, Endocrinology Dr Assunta Albanese Tel: ; Fax: ; a.albanese@nhs.net Specialist Paediatric Nurse Endocrine Amanda Allen Tel: ; Fax: ; amanda.allen@rstgeorges.nhs.uk Patients seen in either: (1) RMH long term follow-up clinic (Tuesday) (2) RMH Brain tumour long term follow up clinic (Wednesday). Dr A Albanese, Paediatric Endocrinologist, pager number SG597, via St George s switchboard Specialist support/resources available to GP including patient information: Pharmacy Department Office: Medicines Information, Pharmacy Department, Royal Patient Medicines Information Helpline (9:15 17:00) Marsden Hospital St George s Hospital, Blackshaw Road, Tooting, London SW17 0QT Consultant Paediatrician, Endocrinology (St Specialist Paediatric Nurse Endocrine ( St George s Hospital): George's Hospital): Dr Assunta Albanese Amanda Allen Tel: ; Fax: ; Tel: ; Fax: ; a.albanese@nhs.net amanda.allen@stgeorges.nhs.uk Dr A Albanese, Paediatric Endocrinologist, pager number SG597, via St George s switchboard Specialist support/resources available to GP including patient information: Efe Bolton, Principal Pharmacist Women and Children, Tel: bleep

6 SOMATROPIN SHARED CARE PRESCRIBING GUIDELINE 4. CLINICAL INFORMATION Indication(s): Place in Therapy: Therapeutic summary: Dose & route of administration: (Note. Individual SPCs doses differ slightly) Somatropin is available as seven preparations on the UK market (see below) and is licensed for children with: Growth Hormone Deficiency Turner syndrome (TS) Chronic renal insufficiency (CRI) (all brands except Zomacton ) Prader- Willi syndrome (PWS) (Genotropin and Omnitrope brand only) Small for Gestational Age (SGA) (all brands except Zomacton and NutropinAq ) with subsequent growth failure at 4 years of age or later, as per NICE 2 Short Stature Homeobox (SHOX) Deficiency (Humatrope brand only) Brand name (Manufacturer): Available strengths: Genotropin (Pfizer Ltd) 5.3mg / 12mg cartridges; single dose MiniQuick cartridges 0.2mg, 04mg, 0.6mg, 0.8mg, 1mg, 1.2mg, 1.4mg, 1.6mg, 1.8mg, 2mg Norditropin SimpleXx (Novo Nordisk Ltd) 5mg/1.5mL, 10mg/1.5mL, 15mg/1.5mL injection Saizen (Merck Serono) 1.33mg / 3.33mg / 8mg click easy injection Zomacton (Ferring Pharmaceuticals) 4mg and 10mg vial Humatrope (Eli Lilly & Co Ltd) 6mg / 12mg / 24mg NutropinAq (Ipsen Ltd) 10mg/2mL injection Omnitrope (Sandoz Ltd) 5mg/1.5mL, 10mg/1.5mL injection NICE has published TA 188 (May 2010) which recommends somatropin as a treatment option for children with growth failure associated with the indications listed above. Somatropin is a potent metabolic hormone of importance for the metabolism of lipids, carbohydrates and proteins. Somatropin stimulates linear growth and increases growth rate. It also maintains a normal body composition. The dosage and administration schedule should be individualised to the patient s needs, but generally the recommended doses (as per NICE) are 2 : mg/kg/day ( mg/m 2 /day) for Growth Hormone Deficiency mg/kg/day (1.4mg/m 2 /day) for Turner syndrome and Chronic Renal Insufficiency mg/kg/day (1.0mg/m 2 /day) for Prader-Willi syndrome (Max. 2.7mg daily) mg/kg/day (1.0mg/m 2 /day) for Small Gestational Age (SGA) mg/kg/day for Short Stature Homeobox (SHOX) Duration of treatment: Summary of adverse effects 1 : (See summary of product characteristics (SPC) for full list) See also monitoring requirements for further details. Administer by subcutaneous injection - vary site of injection to prevent lipoatrophy Treatment should normally be stopped if: Poor response increase in growth velocity of < 150% from baseline in first year. 2 Final height is approached - growth velocity is less than 2cm total growth in 1 year. 2 There are insurmountable problems with concordance 2. Final height is attained. 2 Adverse effect Frequency Management Transient local skin reactions at Uncommon Vary site of injection and refer injection site back to consultant if troublesome. Formation of antibodies to growth Very rare Refer to consultant. hormone (lack of response to therapy) Peripheral oedema, arthralgia, myalgia Uncommon Refer to consultant. /Rare Diabetes Mellitus type II Rare HbA1c yearly 4 (see under monitoring requirements). Benign intracranial hypertension Rare Refer to consultant (see under monitoring requirements). Leukaemia Very Rare Immediate hospital attention. 6

7 Monitoring Requirements 1 : SOMATROPIN SHARED CARE PRESCRIBING GUIDELINE Slipped femoral epiphyses Slight increase in frequency Examine the child clinically if limping and refer to consultant. Consultant At least annual review with height velocity data, biochemical analysis: IGF-1, TFT, HbA1c, fasting insulin and glucose. Please note: In children and young people with diabetes, close monitoring and anti-diabetic therapy might require adjustment when somatropin is instituted. There may be a reduction in serum T4 and an increase in serum T3 concentrations particularly advisable to test thyroid function after starting treatment and after dose adjustments. Once patient stabilised thyroid function should be tested on an annual basis. 3 Monitoring of renal function will be jointly coordinated with paediatric nephrologists (usually Guy s or GOSH) (CRI only). Annual calculation of height velocity. GH deficiency secondary to a malignant disease should be examined frequently for progression or recurrence of the underlying disease process. If proliferative retinopathy develops, treatment with somatropin should be discontinued. Anyone failing treatment should be tested for antibodies to somatropin. Organise review of injection technique by specialist Paediatric Endocrine Nurse 3 or Children s community Nurse to ensure accuracy and compliance. For Turner Syndrome (only): Increased risk of developing primary hypothyroidism associated with anti-thyroid antibodies (affecting response to somatropin) - treat with replacement thyroid hormone if indicated. Monitoring of growth of hands and feet and if increased growth observed - a dose reduction to the lower part of the dose range should be considered. These patients have an increased risk of otitis media - periodic otological evaluation is recommended. For CRI (only): Monitor for progression of renal osteodystrophy. 7

8 Monitoring Requirements 1 (cont d): SOMATROPIN SHARED CARE PRESCRIBING GUIDELINE For PWS (only): Assessment of body composition including initial weight. Before initiation of treatment assess for signs of upper airway obstruction, sleep apnoea or respiratory infection and resolve as necessary (e.g. refer to ENT specialist) Monitor for scoliosis by clinical examination yearly. Scoliosis may progress in any child during rapid growth: monitor signs during treatment 1 Consultant/GP Opportunistic Monitoring and Awareness: Clinical examination if the child is limping for slipped epiphyses of the hip. In case of severe or recurrent headache, visual problems, nausea and/or vomiting, a fundoscopy for papilloedema is recommended. If confirmed, a diagnosis of benign intracranial hypertension should be considered and if appropriate, refer to the consultant for treatment to be discontinued. Monitor patient for any side effects, including those in the Summary of Product Characteristics. Myositis is a very rare adverse event, which may be related to the preservative metacresol. Consider myositis if myalgia/ disproportionate pain at the injection site and, if confirmed, a somatropin presentation without metacresol should be used. Refer to consultant. For PWS (only): Monitor concordance to a calorie-restricted diet. If signs of upper airway obstruction (including onset of or increased snoring), treatment should be interrupted and ENT assessment performed. Monitor if sleep apnoea suspected. Monitor for signs of respiratory infection, which should be diagnosed as early as possible and treated aggressively. Monitor patients weight during growth hormone treatment and control if necessary. Clinically relevant drug interactions 1 : Practical issues 1 : Key references: Compounds metabolised by cytochrome P450 isoenzymes: limited evidence suggesting that somatropin may increase their clearance. Clearance of compounds metabolised by cytochrome P450 3A4 (e.g. sex steroids, corticosteroids, anticonvulsants and ciclosporin) may be especially increased resulting in lower plasma concentrations of these compounds. The clinical significance of this is unknown. Glucocorticoid therapy: may inhibit growth and therefore oppose the growth promoting effects of somatropin. High doses of androgens, estrogens, or anabolic steroids: can accelerate bone maturation and may, therefore, diminish gain in final height. Insulin: Somatropin can induce a state of insulin resistance; insulin doses may have to be adjusted in diabetic patients receiving GH. Product choice: There are no significant therapeutic differences between the preparations but choice may be determined by patient preference, dose requirements, product in-use expiry, product presentation, and licensed indications. 3 Brands should only be changed by the Consultant/Specialist centre since training in a new injection technique may be required. Storage: Refer to the Summary of Product Characteristics for the specified brand. Store in the fridge at 2-8 o C; Protect from light; Do not freeze. Reconstitution: Refer to the Summary of Product Characteristics for the specific brand of product characteristics for all Growth Hormone brands accessed 1 st April Guidance on the use of human growth hormone (somatropin) in children with growth failure. NICE Technology Appraisal Guidance, No. 188, May Treatment of Children with Recombinant Human Growth Hormone. Shared cared guideline by British Society for Paediatric Endocrinology and Diabetes (April 2006) 4. Local consultant opinion (Dr Alston and Prof Hindmarsh annual height velocity, HbA1C, TFT, IGF-1) 8