Prescribing Guidelines on Gluten-Free products Information for GPs This guideline should be used in conjunction with NICE clinical guideline 86 Coeliac disease: recognition and assessment of coeliac disease. May 2009. Acknowledgment: NHS Sutton & Merton for sharing the guideline. Contributors: Shaneez Dhanji, GP Prescribing Support Pharmacist. NHS Wandsworth Auline Cudjoe, Primary Care Prescribing Lead Dietitian, Community Services Wandsworth Date Prepared: February 2011 Approved by: NHS Wandsworth Clinical Effectiveness and Medicines Management Group Date Approved: March 2011 Date for review: March 2013 1
Clinical Presentation Signs, symptoms and conditions associated with coeliac disease a) Box A. Offer serological testing to children and adults with any of the following signs, symptoms and conditions b) Signs and symptoms c) Conditions Chronic or intermittent diarrhoea Failure to thrive or faltering growth (in children) Persistent or unexplained gastrointestinal symptoms including nausea and vomiting Prolonged fatigue ( tired all the time ) Recurrent abdominal pain, cramping or distension Autoimmune thyroid disease Dermatitis herpetiformis Irritable bowel syndrome Type 1 diabetes First-degree relatives (parents, siblings or children) with coeliac disease Sudden or unexpected weight loss Unexplained iron-deficiency anaemia, or other unspecified anaemia d) Box B. Consider offering serological testing to children and adults with any of the following Addison's disease amenorrhoea aphthous stomatitis (mouth ulcers) autoimmune liver conditions autoimmune myocarditis chronic thrombocytopenia purpura dental enamel defects depression or bipolar disorder Down s syndrome epilepsy low-trauma fracture lymphoma metabolic bone disease (such as rickets or osteomalacia) microscopic colitis persistent or unexplained constipation persistently raised liver enzymes with unknown cause polyneuropathy recurrent miscarriage reduced bone mineral density sarcoidosis Sjögren's syndrome Turner syndrome unexplained alopecia unexplained subfertility. 2
Recognition and assessment Investigation And Diagnosis Does the person have any of the signs, symptoms or conditions listed in box A or box B? No Person is unlikely to need testing for coeliac disease at this point, unless there is a continuing medical problem or clinical suspicion Yes Is the person on a glutencontaining diet? No Is the person willing/able to reintroduce gluten to their diet? No Refer to a gastrointestinal specialist Yes Offer serological testing if the person has any of the signs, symptoms or conditions in box A Consider offering serological testing if the person has any of the conditions in box B Important: Do not use serological testing for coeliac disease in infants before gluten has been introduced to the diet 3
Information needs Dietary considerations before serological testing Inform people (and their parents or carers as appropriate) that: testing (serology and biopsy if required) is accurate only if they follow a gluten-containing diet when following a gluten-containing diet they should eat some gluten in more than one meal every day for at least 6 weeks before testing they should not start a gluten-free diet until diagnosis is confirmed by intestinal biopsy (even if a self-test or other serological test is positive) Other information before serological testing Inform people who are considering, or who have undertaken, self-testing for coeliac disease that any result from self-testing needs to be discussed with a healthcare professional and confirmed by laboratory-based tests. Before seeking consent to take blood for serological tests, explain: what coeliac disease is that serological tests do not diagnose coeliac disease, but indicate whether further testing is needed the implications of a positive test (including referral for intestinal biopsy and implications for other family members) the implications of a negative test (that coeliac disease is unlikely but it could be present or arise in the future). Inform people (and their parents or carers as appropriate) that a delayed diagnosis of coeliac disease, or undiagnosed coeliac disease, can result in: continuing ill health long-term complications, including osteoporosis and increased fracture risk, unfavourable pregnancy outcomes and a modest increased risk of intestinal malignancy growth failure, delayed puberty and dental problems (in children). 4
Serology testing and after Use serological testing for IgA tissue transglutaminase (ttga) as a first-choice test Use IgA endomysial antibodies (EMA) testing if the result of the ttga test is equivocal Negative result Check for IgA deficiency a Negative result but continuing clinical suspicion Positive result Offer IgG ttga tests and/or IgG EMA tests Positive result Negative result, no further reason to suspect coeliac disease Unlikely to have coeliac disease No need to repeat tests Refer to a gastrointestinal specialist for intestinal biopsy to confirm or exclude coeliac disease Positive result Negative result but continuing clinical suspicion a Investigation for IgA deficiency should be done if the laboratory detects a low or very low optical density on IgA ttga test or low background on IgA EMA test. 5
Management Once diagnosis of coeliac disease has been confirmed by a specialist in secondary care, the patient may be referred to primary care for on-going management. Gastroenterologist: Diagnosis: Blood testing & Biopsy Annual Review Dietitian: Dietary Advice & Assessment GP review: Prescription for Gluten Free Foods Blood testing Checklist: Newly diagnosed patient Patient should be diagnosed by a Gastroenterologist (refer to NICE Clinical Guideline 86: Coeliac Disease, Recognition and assessment of coeliac disease May 2009 for full guidance. Ensure a newly-diagnosed patient has been assessed by a Dietitian. The patient could join Coeliac UK for information and support. Included in the membership is a Starter Pack and the Food and the Drink Directory. Emphasise the wide variety of foods now available at local supermarkets. Discuss the risk of osteoporosis in coeliac disease due to calcium malabsorption in the gut and consider increasing calcium intake or recommend a suitable calcium supplement. Checklist: Review patient Refer to the checklist above - Newly diagnosed patient. Check that patient has been reviewed by a dietitian in the past 12 months. The community dietitian can provide valuable information to patients on healthy eating on a gluten-free diet Annually check the patient s calcium status, haemoglobin, ferritin, folate and B12 levels. If low, arrange for a dietetic review. If the patient is of childbearing age, discuss the importance of having a good folate status preconceptually and recommend a folate supplement. To refer to a Community Dietitian, please use the appropriate Referral Form (see Appendix 1 & 2). Contact details can be found in the referral forms, for advice from a dietitian. To obtain a copy of the Coeliac UK Starter Pack, please call 0870 444 8804 or email helpline@coeliac.co.uk 6
Gluten-free Foods General Prescribing Considerations A gluten-free diet may be low in fibre and may cause or worsen constipation. Appropriate dietetic advice should be given. Some people with coeliac disease may also need wheat-free or lactose-free products. Some products may be oat, rye and barley free also. It is important to advise the patient that naturally occurring gluten-free carbohydrates e.g. rice, potatoes are essential. An extensive range of gluten free foods (including those that are not prescribable) are available from supermarkets and retail outlets. Gluten-free foods vary from brand to brand. Foods that may be suitable for one patient will not necessarily suit another. Some foods do not keep for long periods of time, therefore prescribing smaller quantities is advised. ACBS Approved Gluten-free Foods Foods available on prescription Gluten-free foods currently available on prescription are to help replace staple foods in order to achieve a healthy balanced diet. This covers essential basic items that would form part of a staple diet and include: Bread Rolls/baguettes Plain biscuits (savoury) Crackers / crispbreads Flour/flour-type mixes e.g. bread mix, flour mix, pastry mix Pasta Pizza bases Note: Luxury items e.g. double choc-chip cookies should not be available on prescription and can be bought from a supermarket or retail outlet. Cake mix and sweet biscuits: Prescribing of gluten-free cake mix and sweet biscuits should not be available on prescription as these products are not deemed essential to the diet and do not conform to healthy eating. They are widely available in shops to purchase. These should only be considered in exceptional circumstances on clinical advice. 7
Quantity Guidance National guidance was produced for healthcare professionals in 2004, in a collaboration between Coeliac UK, the Primary Care Society for Gastroenterology and the British Dietetic Association. The national guidelines set out recommended amounts of gluten-free food per individual per month as units based on nutritional recommendations 3. These guidelines are based on: national nutritional recommendations and make assumptions that in addition to gluten-free food on prescription individuals eat naturally gluten-free carbohydrate food such as rice and potatoes consumption data from the National Diet and Nutrition Surveys (2) and from individual records of NHS patients with coeliac disease the eat well plate where carbohydrates should provide 50% of total energy. The number of gluten-free products people receive on prescription varies from patient to patient. The unit recommendations from 2004 guidance are based on national nutritional recommendations and the amount of products prescribed should follow this guidance. The number of units available should only be exceeded in exceptional circumstances on the advice of the healthcare team. Clinician s discretion should always be applied, especially in cases where nutritional intake is at risk e.g. there may be cases where crackers are recommended instead of bread for older patients with dental problems or biscuits are recommended for individuals who are underweight or additional units are recommended in patients with additional calorie requirements. Dietitians are best placed to assess individual requirements. Tables below provide guidance on the recommended quantities of gluten-free products needed to maintain adequate energy on a monthly basis 2. This should not replace advice given by a Dietitian. Recommended monthly gluten free food prescription requirements: Age and Gender Units per month 1-3 years 10 4-6 years 11 7-10 years 13 11-14 years 15 15-18 years 18 Male 19-59 18 Male 60-74 16 Male 75+ 14 Female 19-74 14 Female 75+ 12 Breastfeeding Add 4 3 rd trimester pregnancy Add 1 High physical activity level Add 4 8
Food Item Units 400 g bread / rolls / baguettes 1 500g bread / flour mix 2 200g plain savoury biscuits / crackers 1 250g pasta 1 2 pizza bases 1 Examples: Buckwheat pasta spiral 250g = 1 unit / 500g = 2 units Pizza bases and mix = 1 unit Pasta shells 250g = 1 unit / 500g = 2 units Harvest mix 500g = 2 units Rice cookies 1 pack = 1 unit Baguette 400g = 1 unit Bread / Dinner rolls 400g = 1 unit Brown rice bread 400g = 1 unit High fibre rolls 400g = 1 unit Mini crackers / Biscuits 100g = ½ unit, 150g = ¾ unit, 200g = 1 unit Crispbread 200g = 1 unit Supermarkets and retail outlets Purchase directly from pharmacy Health Food Shops Mail or telephone order or internet Other sources of Gluten-free Foods Gluten content in oral prescription medicines Wheat products can be used in the manufacturing of prescription medicines in the form of wheat starch, for example, as a tablet binding agent. Any oral prescription medicine must state if it contains wheat starch as an excipient according to European labelling guidelines. Wheat starch used in prescription medicines is of pharmaceutical grade and therefore highly refined and deemed to be gluten-free. The total amount of protein permitted in wheat starch as an excipient is less than 0.3%. As the gluten component will be much less than this it is considered to be below the threshold of clinical relevance for patients with coeliac disease and therefore suitable for these people. References: 1. NICE Clinical guideline 86: Coeliac Disease Recognition and assessment of coeliac disease. May 2009. 2. Gluten-free foods: a prescribing guide. Primary Care Society for Gastroenterology, 2004. 3. Prescribing of gluten-free foods: Coeliac UK s position. <Accessed online January 2011> http://www.coeliac.org.uk/healthcare-professionals/healthcare-professionalnewsletters/january-2011-professionalexg/prescribi?utm_medium=email&utm_campaign=january+2011+professional+exg &utm_content=january+2011+professional+exg+cid_f9f74e58ff947ab3fe5717dc84 a93f7c&utm_source=email+marketing+software&utm_term=prescribing+of+glutenfree+specialist+foods+coeliac+uks+position 4. What is the gluten content of oral prescription medicines? UK Medicines Information (UKMi) Q&A 81.2. Accessed online http://www.nelm.nhs.uk/en/originalsearch/?parent=53949&query=gluten 9