Guidance on Prescribing Gluten Free Products in Newcastle Gateshead, North Tyneside and Northumberland CCGs
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1 North of Tyne, Gateshead and North Cumbria APC 1 Guidance on Prescribing Gluten Free Products in Newcastle Gateshead, North Tyneside and Northumberland CCGs Some gluten free products have ACBS (Advisory Committee on Borderline Substances) approval (bread and bread mixes only) on the basis that they may be regarded as drugs for the management of specified conditions and allowing them to be prescribed on the NHS for patients with: Coeliac disease Gluten sensitivity Dermatitis herpetiformis FP10 prescriptions must be annotated ACBS. Gluten free products MUST NOT be supplied at NHS expense for other conditions such as irritable bowel syndrome, wheat intolerance or Asperger s Syndrome that do not have ACBS approval. Any such prescribing/supply should be stopped. Disease A person with coeliac disease who does not adhere to a strict gluten free diet is prone to develop complications, such as osteoporosis (due to chronic malabsorption of calcium), anaemia due to malabsorption, lymphoma and fertility problems. NICE CG86 covers the Recognition and Diagnosis of Coeliac Disease General Advice Patients should be encouraged to eat natural gluten free foods as part of their balanced diet Stop smoking Reduce alcohol Increase physical activity Dietary advice is available from Coeliac UK, and patients should be referred to a dietitian for a full dietary assessment, including calcium, and for support in maintaining their gluten free diet and to discuss in detail choice of gluten free products available. Additional information for patients under the care of Newcastle upon Tyne FT can be found in Appendix 1. Requirements for NHS supply Gluten-free staple items such as flour and bread were first made available on FP10 prescription in the late 1960s. Previously there was limited access to these special foods other than via the NHS. Only gluten-free staple foods that are approved by the ACBS can be prescribed for people with a medical diagnosis of coeliac disease. More recently there has been greater access to gluten-free products available in supermarkets and prices that were previously high are more comparable to standard equivalent gluten containing branded products. Many patients continue to receive supplies at substantial greater expense to the NHS than equivalent supermarket products. From 4 th December 2018 the NHS has restricted the availability of gluten-free products available for supply at NHS expense, with many products now black listed. Products which remain available to supply include gluten-free bread and gluten-free mixes (see Table 1). This guidance is designed to ensure patients receive a supply of staple foods on the NHS and to acknowledge that there is still a level of price differential between standard and gluten-free products. The revised level of supply is intended to compensate for any residual price differential rather than provide the full quantities at NHS expense that are outlined in Coeliac 1
2 UK s National Prescribing Guidelines for GF food on NHS prescription. Supply should only be given for non-black listed products bread and flour mixes (see Table 1). - Only obtain fresh bread from suppliers that do not have surcharges - Ensure prescribed quantities do not exceed a total of 6-8 units/ month of bread or flour (depending on the age of the patient) Table 2 gives guidance on monthly quantities that a patient may require. Not all of this will be prescribed at NHS expense. Table 1. Products available at NHS expense It is important to ensure that all products supplied at NHS expense are readily available from local wholesalers or by ordering direct from the manufacturer as ordering lines that are not normally stocked at wholesalers may incur handling or carriage charges (which are charged to NHS budgets). GP practices and community pharmacies should work closely together so that extra charges are kept to a minimum. Barkat gluten-free all purpose flour mix Barkat gluten-free brown rice bread Barkat gluten-free hi-fibre bread mix Barkat gluten-free par-baked baguettes Barkat gluten-free par-baked rolls Barkat gluten-free par-baked white bread sliced Barkat gluten-free wheat free multigrain rice bread Barkat gluten-free white rice bread Barkat gluten-free wholemeal sliced bread Ener-G gluten-free brown rice bread Ener-G gluten-free dinner rolls Ener-G gluten-free rice loaf Ener-G gluten-free Seattle brown loaf Ener-G gluten-free tapioca bread Ener-G gluten-free white rice bread Finax gluten-free coarse flour mix Finax gluten-free fibre bread mix Finax gluten-free flour mix Genius gluten-free brown sandwich bread sliced Genius gluten-free seeded brown farmhouse loaf sliced Genius gluten-free white sandwich bread sliced Glutafin gluten-free 4 white rolls Glutafin gluten-free baguettes Glutafin gluten-free bread mix 32 Glutafin gluten-free fibre bread mix Glutafin gluten-free fibre loaf sliced Glutafin gluten-free high fibre loaf sliced Glutafin gluten-free multipurpose white mix Glutafin gluten-free part-baked 2 long white rolls Glutafin gluten-free part-baked 4 fibre rolls Glutafin gluten-free part-baked 4 white rolls Glutafin gluten-free Select bread mix Glutafin gluten-free Select fibre bread mix Glutafin gluten-free Select fibre loaf sliced Glutafin gluten-free Select fresh brown loaf sliced Glutafin gluten-free Select fresh seeded loaf sliced Glutafin gluten-free Select fresh white loaf sliced Glutafin gluten-free Select multipurpose fibre mix Glutafin gluten-free Select multipurpose white mix Glutafin gluten-free Select seeded loaf sliced Glutafin gluten-free Select white loaf sliced Glutafin gluten-free wheat-free fibre mix Glutafin gluten-free white loaf sliced Glutenex gluten-free white bread mix Innovative Solutions gluten-free bakery blend Just: gluten-free good white bread sliced Just: gluten-free good white rolls Just: gluten-free white sandwich bread Juvela gluten-free bread rolls Juvela gluten-free fibre bread rolls Juvela gluten-free fibre loaf sliced Juvela gluten-free fibre loaf unsliced Juvela gluten-free fibre mix Juvela gluten-free fresh fibre loaf sliced Juvela gluten-free fresh fibre rolls Juvela gluten-free fresh white loaf sliced Juvela gluten-free fresh white rolls Juvela gluten-free harvest mix Juvela gluten-free loaf sliced Juvela gluten-free loaf unsliced Juvela gluten-free mix Juvela gluten-free part-baked fibre bread rolls Juvela gluten-free part-baked fibre loaf Juvela gluten-free part-baked loaf Juvela gluten-free part-baked white bread rolls Lifestyle gluten-free brown bread Lifestyle gluten-free brown bread rolls Lifestyle gluten-free high fibre bread rolls Lifestyle gluten-free white bread rolls Mums Mill gluten-free quick bread mix Orgran gluten-free bread mix Proceli basic mix Proceli gluten free part-baked baguettes Tobia Brown Teff Bread Mix Tobia White Teff Bread Mix Tritamyl gluten-free brown bread mix Tritamyl gluten-free flour mix Tritamyl gluten-free white bread mix Warburtons gluten free brown bread sliced Warburtons gluten free brown rolls Warburtons gluten free white bread sliced Warburtons gluten free white rolls 2
3 Table 2. Recommended quantities of gluten free staple products allowed at NHS expense* across North of Tyne and Gateshead The number of units per month given below is a guide only, the patient does not have to have this many units if they do not require them. Age group Recommendation for NHS supply across xxx CCGs Male Female years years 75+ years years 75+ years Breastfeeding 3rd trimester pregnancy 8 x 400g bread (or 4 x 500g mix suitable for making bread) 6 x 400g bread (or 3 x 500g mix suitable for making bread) Add 4 units Add 1 unit High physical activity level 1-3 years 4-6 years No additional units 6 x 400g bread (or 3 x 500g mix suitable for making bread) Child 7-10 years years years 8 x 400g bread (or 4 x 500g mix suitable for making bread) *Gluten-free foods: a revised prescribing guide Coeliac UK, The British Dietetic Association, PCSG, BSPGHAN Where: 1 unit is equivalent to 400g bread/rolls 2 units is equivalent to 500g flour mix 3
4 Putting these Guidelines into practice - a quick guide for practices 1. Confirm all patients that are to be prescribed GF staple products have a diagnosis of gluten sensitivity, Coeliac disease or Dermatitis Herpetiformis. Check this diagnosis of coeliac disease is confirmed by duodenal biopsy and positive coeliac serology or confirmed by a consultant gastroenterologist. (Prescribing for patients with IBS or wheat intolerance is not allowed on the NHS). 2. Prescribe only the products and quantities outlined in tables 1 & 2 3. Consider issuing prescriptions for one-month supply only. The shelf-life of products varies considerably and some products are difficult to store. Practices should consider carefully the quantity of each product that is given on prescription. Some products such as bread can be frozen, however their palatability may be affected depending on the length of time that they are frozen. N.B. Gluten Free loaves are only 400g in weight, whereas ordinary bread (containing gluten) is usually 800g. 4. Patients who pay for prescriptions can apply for a pre-payment certificate. 5. All children should be assessed by a paediatric dietitian on diagnosis and their changing nutritional requirements supported by regular review at paediatric dietetic/coeliac clinics (varies according to Trust). 6. Adult patients are advised to have an annual review with their Consultant, GP or dietitian. Further information and support is available from your Medicines Optimisation support team. 4
5 Contacts Name Title Base Telephone Number Dr N Thompson Consultant Gastroenterologist Freeman Hospital Ext Dr J Mansfield Consultant Gastroenterologist RVI Ext Dr C Mountford Consultant Gastroenterologist Freeman and RVI Dr S Hearnshaw Consultant Gastroenterologist RVI Dr RA Speight Consultant Gastroenterologist Freeman and RVI Dawn Smith Lead Dietitian in Coeliac Disease RVI James Callaghan Paediatric Dietetic Manager RVI Dr Anil Bhagwat Consultant Gastroenterologist HGH Ext 5647 Dr Matthew Warren Consultant Gastroenterologist NTGH Ext 4104 Dr Chris Haigh Consultant Gastroenterologist Berwick Ext 3290 Emma Emmerson Head of Nutrition and Dietetics Service NHCT Dr Emma Johns Gastroenterologist QE Topaz Clarke Specialist Dietitian QE
6 Appendix 1. Newcastle upon Tyne Hospitals (NuTH) Guidance Monitoring patients with stable Coeliac disease These NuTH guidelines are suggested for adult patients who have been diagnosed with coeliac disease (CD) and comply with guidelines from the Primary Care Society for Gastroenterology (2006), CD will normally have been diagnosed on the basis of positive serology (anti- endomysial or anti-tissue transglutaminase antibodies) and an abnormal small bowel biopsy. Following their diagnosis patients will have been reviewed in hospital out-patients, seeing both a clinician and dietitian, and their response to a gluten-free diet (GFD) assessed, normally in a specialist CD or Nutrition clinic. In these clinics patients may have access to representatives from the gluten free food manufacturers. At around one year following diagnosis a decision can be made as to whether the patient requires continued hospital follow-up or can be discharged back to primary care. The majority of patients will respond to a GFD and once established on a GFD should be reviewed annually in primary care if they do not require regular hospital review. If the patient or GP feel they require continuing hospital review then the patient should be referred back to the gastroenterological service. Regular follow-up by a health professional has a positive impact and helps patients maintain a GFD. All patients should be encouraged to join Coeliac UK (formerly the Coeliac Society), The Coeliac UK Food and Drink Directory is essential to successful compliance with a strict GFD, a gluten free food checker app is also available. The regular annual review of any coeliac patient should assess on-going compliance with a strict GFD and monitor for the complications associated with CD. An experienced dietitian should be available for review of the GFD. Changes in the dietary recommendations occur occasionally, such as consumption of oats being acceptable. These changes should be discussed with the patient at the time of their annual review, by the doctor or dietitian. A falling tissue transglutaminase antibody level, from elevated at diagnosis to normal within 1 year on a sufficiently strict GFD, is likely to indicate compliance with a GFD and may be used serially. ttg > 15 is abnormal, ttg >150 indicates untreated CD, levels of around 50 may be seen in treated CD. Stable patients with ttg<15 and symptom improvement can still be offered an annual dietitian review. Patients should be screened for osteoporosis following diagnosis, using a DEXA scan or plans made for that screening (see below). Deficiency of folate and iron are common and should be screened for regularly (see below). Patients who remain symptomatic, or with evidence of continuing small bowel disease, should remain under the active care of the hospital. Patients who become symptomatic or who develop blood test abnormalities should be referred back to secondary care; these symptoms may include weight loss or unexplained abdominal pain on a GFD. The importance of remaining on a GFD should be emphasised. Not remaining on a GFD may cause: GI symptoms and non-specific symptoms such as lethargy. Anaemia due to iron and folate deficiency. Increased risk of osteoporosis. 6
7 Reduced fertility in women. Increased risk of small bowel lymphoma (risk increased by about 40 fold) this risk returns to that of the normal population with adherence to a GFD. Regular assessment in Primary care: 1. All patients should have an annual check to ensure continuing compliance with their GFD. If they are uncertain about their diet or have additional questions referral to a dietitian is appropriate. Patients should have their weight and BMI recorded. 2. Patients should have a full blood count, red cell folate, ferritin, calcium and liver blood tests checked to look for occult evidence of micro-nutrient deficiency. Quantitative tissue transglutaminase antibody levels may be checked to assess compliance with a GFD (blood sample to immunology labs). 3. Those who have osteopenia or osteoporosis (a T score <-1) should have calcium and vitamin D replacement and check DEXA scan after 2 years. Patients with severe osteoporosis (T score <-3.0) should be considered for referral to the bone clinic. Those who do not have reduced bone density do not require a repeat DEXA scan until aged 55 year for men and the menopause for women or after a fragility fracture at any age. If calcium intake is thought to be inadequate then a calcium supplement should be provided and a vitamin D supplement provided if the patients is housebound. 4. Patients with haematological evidence of hyposplenism on a blood count (present in up to 25% patients) should be considered for vaccination against Pneumococcus, Haemophilus influenza type B, Meningococcus type C and influenza. Life-long prophylactic antibiotics are not necessary. 5. Ensure that GFD prescription is in line with the approved guidance. 6. Family members are at increased risk and should be screened if symptomatic or if they specifically request, using serological tests (as above). Coeliac Annual Review in Primary Care 1. Weight, BMI and symptoms. 2. Member of Coeliac UK? The handbook is essential for adherence to GFD 3. On GFD? Any queries? If yes: refer dietitian. The GFD advice changes and the content of manufactured foods change, so patients are advised to obtain a dietitian update every 2 years. 4. Bloods for FBC, ferritin and ttg antibody measurement. Anaemia, low ferritin or elevated (>50) or rising ttg indicates need for comprehensive dietitian review. 5. Check adequate Calcium and Vit D intake. If BMD is known to be low prescribe supplement and arrange for repeat BMD scan after 2 to 4 years. 6. If hypo splenic on FBC give flu vaccination. 7. Review appropriate use of gluten free prescriptions. 8. Review in 12 months. 7
8 Hospital contact details (could be to any of the luminal gastroenterologists at the RVI or Freeman): Dr John Mansfield Dr Nick Thompson Ward 48 Office, RVI Dept Medicine Tel Tel Fax: Fax
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