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Suffolk Health Suffolk Drug & Therapeutics Committee Shared Care Guidelines for Growth Hormone Replacement in Adult Growth Hormone Deficiency What is a shared care document? Suffolk D&T operates a traffic light system in an attempt to clarify prescribing responsibility and improve consistency across Suffolk: Double Red – Prescribing within hospital or general practice would not be supported. Red – Hospital only Amber – Hospital initiated but suitable for GP prescribing if a suitable shared care document is in place. Green – Hospital initiated; GP prescribing Double Green – GP prescribing The basic principles of a shared care arrangement are: 1) The shared care document will include a clear statement of the hospital specialist/GPs responsibilities 2) Shared care documents must provide sufficient information such that after patient stabilisation under hospital supervision, prescribing responsibility could safely be transferred to primary care 3) Both hospital specialist and general practitioner have a duty of care for the overall management of the patient 4) Patient convenience may be a major factor for GPs taking on prescribing responsibility and not the cost of the therapy 5) The onus is on the hospital specialist to liase with the GP, and if the GP does not wish to undertake the clinical and legal responsibility for the drug he does not have to do so. Responsibility to prescribe will therefore remain with the hospital 6) Agreement to accept prescribing responsibility should be obtained from the GP before the patient is informed For more details please refer to the traffic light document on the Suffolk Public Health website www.sphn.nhs.uk Document prepared on behalf of the Departments of Diabetes and Endocrinology at The Ipswich Hospital, West Suffolk Hospital. Contact details as follows: Drs C Parkinson, G Rayman and PD Fowler Department of Diabetes and Endocrinology The Ipswich Hospital NHS Trust Heath Road Ipswich IP5 5PD Tel 01473 704181 (Sec to Dr C Parkinson) Drs Clark, Majeed and Wijenaike West Suffolk Hospitals NHS Trust Hardwick Lane, Bury St Edmunds Suffolk, IP33 1QZ Tel 01284 713000 This is an NHS Suffolk document that has been adopted by the WSCCG. Please note that Dr Huston at James Paget Hospital was consulted regarding his involvement in the development of this shared care protocol. However, the majority of patients he considers for this treatment reside in catchment areas served by the Norfolk and Norwich Hospital. The small number of patients residing within East Suffolk will therefore be referred to The Ipswich Hospital Trust for investigation and consideration of treatment. Date received by Suffolk D&T and approved by the Local Medical Committee March 2005 Review Date March 2006 Persons consulted in the development of this document: Dr PD Fowler, Dr C Parkinson, Dr G Rayman, Dr J Clark, Dr J Majeed, Dr N Wijenaike and Dr N Huston. Background to shared care document: Growth Hormone Deficiency (GHD) has long been recognised as a condition in children. It is only since the late 1980s that it has been realised that adults are also physically and psychologically disadvantaged as a result of GHD and can benefit from replacement therapy1. Over the last decade adult patients with GHD have been treated in clinical trials with replacement biosynthetic growth hormone (GH). GH treatment has shown positive benefits for both short-term and long-term health. Replacement therapy has also improved quality of life (QOL) in selected patients, bringing energy and vigour back to these patients, and enabling them to lead a more normal life2. In the future an increased awareness of this endocrine deficiency and consequent increase in diagnosis will lead to a growth in this treatment area. With an estimated incidence of 1:10,000, GHD in adults is a condition which general practitioners will now occasionally come into contact with in the course of their work. The Suffolk D&T Committee has not previously reviewed GH therapy in adults. NICE technology appraisal guidance number 64 (www.nice.org.uk/Docref.asp?d=83429) discusses GH therapy in patients with GHD. Section 1.1 of this guidance states “Recombinant human growth hormone (somatropin) treatment is recommended for the treatment of adults with GH deficiency only if they fulfil 3 selection criteria (see later)”. It is suggested in this appraisal that prescribing maintenance therapy may take place in primary care under an approved shared care guideline. The role of growth hormone replacement in the treatment of adult growth hormone deficiency Growth hormone is released from the pituitary gland with secretion rates peaking during the night. Although production declines after the growth spurt of adolescence, GH continues to be produced and to play an important metabolic role throughout life. Key Effects of GH – Important role in the regulation of metabolism and body composition in adults. Widespread effects include stimulation of cartilage and bone growth, lypolysis resulting in reduced body fat, anti-naturiuretic action leading to increased extra-cellular water, anabolic action leading to increased cell mass and direct / indirect effects on mental function / QOL. Causes of GHD – Adult GHD is a relatively rare condition, affecting approximately 1 in 10,000 of the total population3. The majority of patients have pituitary or peri-pituitary tumours, or have been treated for such tumours in the past. GHD is a side effect of cranial radiotherapy for other cancer and approximately one third of children with idiopathic GHD will remain GH deficient as adults. Signs and symptoms of GHD – The most obvious reduction is in physical well- being and the most prominent of these indicators are low energy levels, social isolation, lack of positive well-being, depressed mood and increased anxiety. While QOL indicators are difficult to quantify, the symptom severity of each patient should be assessed together with the overall degree of dysfunction. Evidence exists for the benefits of GH replacement on QOL over baseline assessments. In addition there is growing evidence to suggest that some of the changes associated with adult GHD may be responsible for increased morbidity and mortality from cardiovascular disease which occurs with a higher frequency in these patients. Physical signs of GHD include increased body fat, reduced muscle mass, reduced bone mineral density, reduced exercise capacity, poor physical performance, raised serum cholesterol, reduced cardiac muscle mass and impaired cardiac function. Benefits of GH replacement – Many of the psychological and physical features of GHD are improved by replacement. Clinical trials have shown improvements as follows4, 6, 7. • Improved lipid profile • Cardiac structure and function improved • Increased exercise capacity • Improved bone mineral density • Normalisation in body cell mass and extra-cellular water • Reduction in body fact (particularly intra-abdominal fat) • Improved renal function • Improved well-being and QOL • Increased vitality While GH replacement improves a range of cardiovascular markers, further studies are required to confirm the effects of therapy on cardiovascular related mortality and morbidity. Patient Selection for GH replacement – To be carried out by a hospital endocrinology specialist. • Patients seen at the James Paget Hospital who reside in East Suffolk may be referred to the Ipswich Hospital for consideration of GH replacement therapy. • The condition is diagnosed at hospital level by initial clinical suspicion in patients likely to have GHD. Patients under clinical suspicion will include: o Patients with known or suspected hypothalamic or pituitary disease o Patients who have received cranial irradiation o Patients with a deficiency of one or more other pituitary hormones o Patients who have undergone pituitary surgery o Adults who have received GH in childhood for GHD • An accepted definition of severe adult GHD is a peak GH response below 3ng/ml or 9mU/L during a provocative test. • The insulin tolerance test is the gold standard provocative test used in the diagnosis of adult GHD. The glucagon stimulation and arginine stimulation tests are alternatives. • Tests should be considered only after stabilisation of treatment for other pituitary deficiencies and at least one month after pituitary surgery. Childhood treatment with GH should be interrupted for an appropriate period (usually 3 months) before retesting GH status. • In accordance with the NICE technology appraisal guidance (number 64) treatment will only be recommended if patients fulfil all three of the following criteria: o They have severe GHD as a peak GH response less than 9mU/L (3ng/ml) during an insulin tolerance test or a cross- validated GH threshold in an equivalent test. o They have a perceived impairment of QOL, as demonstrated by a reported score of at least 11 in the disease-specific ‘Quality of life assessment of GHD in adults’ (QOL-AGHDA) questionnaire (copy included with this document) o They are already receiving treatment for any other pituitary hormone deficiencies as required Hospital Specialist Responsibilities For the purposes of this document a hospital endocrinology specialist may refer to either a consultant physician, GP with a specialist interest in endocrinology and Specialist Registrar or Endocrine Nurse Practitioner working under the supervision of a clinician • Selection of patients for GH therapy, including discussion with the patient of the dosage and method of administration, side effect profile, special precautions. • The hospital specialist
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