Gluten-Free Food (GFF) Service Implementation and Support Pack

Gluten-Free Food (GFF) Service Implementation and Support Pack

Acknowledgements NHS Education for Scotland gratefully acknowledges the assistance of all those involved with the Tayside Gluten-Free Food Service. Writer: Paul Gunnion Project Manager: Ailsa Power Specialist reviewers: Alpana Mair, Jacqueline Walker, Andrew Radley, Una Martin, Fiona Headridge, Derek McAllister and Peter Gillett Disclaimer While every precaution has been taken in the preparation of these materials, neither NHS Education for Scotland nor external contributors shall have any liability to any person or entity with respect to liability, loss or damage caused or alleged to be caused directly or indirectly by the information. NHS Education for Scotland 2013 ISBN 978-0-85791-035-6

Contents Aim and learning outcomes 4 Introduction to National Gluten-Free Food Service 5 What is Coeliac Disease (CD)? 5 What is Dermatitis Herpetiformis (DH)? 8 How many gluten-free units should be prescribed for a patient? 9 Examples of Common Foods That are Gluten-Free, Not Gluten-Free and Products You May Need To Check For Gluten 10 How the Gluten-Free Food Service will work 12 National Gluten-Free Food Service Flow Chart 15 Pharmacy Annual Health Check (on PCR) 17 Frequently Asked Questions 18 Details of Coeliac UK 21 References 22 Gluten-Free Exercise 23 Gluten-Free Exercise Answers 24 Appendix 1 Gluten-Free Food Service Patient Registration Form 25 Appendix 2 Gluten-Free Food Requirement Order Form 26 Appendix 3 Annual Health Check Form in PCR 27 Patient Profile 27 Support Tool Assessment 28 Concordance 29 Interactions and precautions 30 Adverse effects 31 Monitoring 32 Review 33 Appendix 4 Example referral letters 34 Appendix 5 How to Calculate Body Mass Index (BMI) 36 Appendix 6 PCA (P) (2013) 29 NHS Circular Annex B 37 3

Aim and learning outcomes Aim To provide community pharmacists with the necessary information and understanding to enable them to implement the National Gluten-Free Food (GFF) Service and provide support to patients with Coeliac Disease (CD) and Dermatitis Herpetiformis (DH). Learning Outcomes After completing this support pack you will: Have an understanding of the conditions which require a gluten-free diet and what the complications are when a gluten-free diet is not strictly adhered to. Know what the role of the community pharmacist is within the Service. Understand the actions needed by community pharmacy to ensure the delivery of the service. Understand what is required of the community pharmacy in the Adult Coeliac Disease Pharmacy Annual Health Check on PCR. 4 Gluten-Free Food (GFF) Service Implementation and Support Pack

Introduction to National Gluten-Free Food Service This implementation and support pack has been designed to assist community pharmacists gain a general understanding of conditions requiring a gluten-free diet and provide them with the necessary information they need to deliver the service. Pharmacists are also encouraged to undertake other national training on this topic available from NES. This pack will complement the information you receive at any NES training event. What Is Coeliac Disease (CD)? Coeliac Disease is an autoimmune disorder that involves a heightened immunological response to ingested gluten in genetically susceptible people. Gluten is a protein found in wheat, barley and rye and therefore treatment is the avoidance of foods containing gluten (1). It was believed that Coeliac Disease was uncommon but population based studies show that it is more prevalent than previously thought with a likely prevalence of 1 in 100 of the population (1). Coeliac Disease is often unrecognised and is consequently under-diagnosed. Only about 10-15% of people with the condition are clinically diagnosed, and diagnosis can take many years (1). A significant number of people with undiagnosed Coeliac Disease undergo extensive medical investigation without a definite diagnosis, and the symptoms of Coeliac Disease will remain untreated. A delayed diagnosis or undiagnosed Coeliac Disease or failure to adhere to treatment, can result in growth failure, delayed puberty, nutritional deficiencies (iron, folate, vitamin B12 and vitamin D) and dental problems in children. It can also lead to long-term complications such as osteoporosis, unfavourable pregnancy outcomes and a small increased risk of intestinal cancer (1,2,3). Coeliac Disease can be treated by following a gluten-free diet and it is important to identify people with the condition so that they can obtain individual treatment. To improve the recognition and increase the number of people diagnosed with Coeliac Disease the National Institute for Health and Clinical Excellence (NICE) have developed a clinical guideline on Coeliac Disease (1). The guideline provides evidence-based recommendations to support health professionals in recognising and assessing Coeliac Disease in children and adults. Conditions and issues associated with Coeliac Disease are: First-degree relatives (parents, siblings or children) with Coeliac Disease Autoimmune thyroid disease Dermatitis herpetiformis Irritable bowel syndrome Type 1 diabetes Down s syndrome 5

The most common signs and symptoms of Coeliac Disease include: chronic or intermittent diarrhoea, sudden or unexpected weight loss, unexplained iron-deficiency anaemia, prolonged fatigue (`tired all the time`), recurrent abdominal pain, cramping or distention, constipation, bloating, failure to thrive or faltering growth in children and persistent or unexplained gastrointestinal symptoms including nausea and vomiting. A community pharmacist may wish to refer patients presenting with these symptoms to an appropriate healthcare professional for investigative tests for Coeliac Disease. Some people with this condition however have no clear symptoms. The diagnosis of Coeliac Disease will include serological tests. Dietary considerations are required before serological testing and clinicians require to inform people (and their parents or carers as appropriate) that testing is accurate only if they follow a gluten-containing diet. A gluten-containing diet requires them to eat gluten in more than one meal every day for at least 6 weeks prior to testing. It is important that they do not start a gluten-free diet until diagnosis is confirmed by intestinal biopsy (even if the serological test is positive). NICE recommends using the immunoglobulin A (IgA) anti- tissue transglutaminase antibody (ttga) and IgA anti-endomysial antibody (EMA) serological tests because of their high sensitivity and specificity. People with positive results (or negative results but with ongoing clinical suspicion) require referral to a gastrointestinal specialist for intestinal biopsy to confirm or exclude Coeliac Disease. New guidance for diagnosis and management of Coeliac Disease in children has been recently published by the British Society of Paediatric Gastroenterology Hepatology and Nutrition (BSPGHAN) (http://bspghan.org.uk/documents/static/coeliac%20guidelines%202013.pdf). This guidance aims to simplify and shorten the diagnostic process for many children. The main difference from the NICE guideline is that some children may not undergo an intestinal biopsy and may have genetic testing for Coeliac Disease undertaken. If this new strategy is to be considered, it must be under the guidance of the local paediatric gastroenterologist and dietitian. Treatment The Coeliac Disease guidelines of the BSPGHAN (2013) and the British Society of Gastroenterology (BSG) (http://www.bsg.org.uk/images/stories/clinical/bsg_coeliac_10. pdf) both state that patients require to start a gluten-free diet AFTER confirmed diagnosis and that the diet is lifelong and will require dietetic support. BSPGHAN guidelines indicate that children will require paediatric dietetic support within 1-2 weeks of diagnosis and then regular follow up at 3-6 month intervals in the first year and annually thereafter (2). 6 Gluten-Free Food (GFF) Service Implementation and Support Pack

The BSG guideline states that following a gluten-free diet requires specific education, which should be provided by a dietitian with experience in Coeliac Disease (3). This should involve a simple explanation of the principles of a gluten-free diet and provision of written information on which foods contain gluten, how to obtain gluten-free products (prescribable and nonprescribable products) and how to access and use relevant sources of information. Mostly there are at least two separate appointments with a dietitian as it is likely that questions will arise in the first few months of a gluten-free diet. Emphasis should be given to encouraging adherence with a gluten-free diet and the use of alternative products. Following this, patients should ideally have access to a dietitian, independently where possible or via their primary or secondary care physician. Within the National Gluten-Free Food Service, the community pharmacist in some areas may also be able to provide access to a dietitian when necessary. Adherence to a gluten-free diet requires a proactive approach by all professionals involved and both patients and pharmacists are strongly recommended to join Coeliac UK (membership is free for all healthcare professionals). This is a charity which provides invaluable support to people with Coeliac Disease and Dermatitis Herpetiformis. Coeliac UK also have a helpline which is an invaluable aid for health professionals and publish a book (The Food and Drink Directory) of gluten-free products and manufacturers. This directory is published annually and updates provided regularly. A wide range of information leaflets for professionals and patients, as well as a very useful sheet detailing gluten-free foods is available from https://www.coeliac.org.uk/home/ The sensitivity to ingested gluten varies greatly between patients. For some, small amounts of gluten ingestion on a regular basis can cause mucosal changes even when the patient feels asymptomatic. From 2012, only foods that contain 20 parts per million (ppm) or less can be labelled as gluten-free. This applies to both substitute gluten-free products and naturally gluten-free food items. The gluten-free label may also be used for uncontaminated oat products. Specialist substitute foods (e.g, breads and pasta containing Codex wheat starch) containing between 21 and 100 ppm gluten may be labelled as very low gluten (The Codex Alimentarius Commission develops harmonised international food standards to protect the health of consumers). These guidelines are more stringent than previous UK definitions of gluten-free as <200 ppm and are covered by law. A small proportion of coeliac patients will be sensitive to oats. Due to the milling process oats can be contaminated by gluten from other milled products such as wheat and rye. Therefore it is essential that patients use only uncontaminated oats and these are labelled as gluten-free. Patients newly diagnosed will be asked to avoid oats usually for the first year or until they are symptom free. Only once they have established a strict gluten-free diet should they have oats re-introduced and should be monitored carefully for any changes in symptoms. 7

Monitoring The BSPGHAN (2013) guideline states that the majority of paediatric patients/parents are well motivated and access good levels of support from Coeliac UK but ongoing monitoring by an experienced paediatric dietitian and paediatric gastroenterologist or paediatrician with a special interest is still necessary to ensure long-term adherence (3). The BSG (2010) guidance indicates that gastroenterology or general practice reviews for asymptomatic patients may include blood monitoring for full blood count, ferritin, folate, vitamin B12 and bone profile (3). Coeliac serology may be required to assess adherence. New or changed symptoms should be investigated accordingly and treated. If symptoms remain unexplained by conventional investigation, then specialist investigations should be undertaken. These gastroenterology or general practice reviews are in addition to the Pharmacy Annual Health Check for ADULT coeliac patients carried out by the community pharmacist as part of the Gluten-Free Food (GFF) Service. What is Dermatitis Herpetiformis (DH)? The BSG (2010) guidance describes dermatitis herpetiformis as a cutaneous manifestation of Coeliac Disease. It manifests as an intensely itchy, blistering rash on the trunk and extensor surfaces of the limbs. The rash can precede any evidence of enteropathy and only 20% have gastrointestinal symptoms. Diagnosis is confirmed by skin biopsy of an adjacent non-blistered area. Nearly 100% of patients have an abnormal duodenal biopsy. A gluten-free diet is advised but improvement will often take 6-12 months to be seen. Some patients with this condition may also require additional medication to control their symptoms. 8 Gluten-Free Food (GFF) Service Implementation and Support Pack

How many gluten-free units should be prescribed for a patient? National recommendations exist for the number of gluten-free units a patient should receive. These recommendations vary by age and gender. The amount of gluten-free units patients are given should meet their individual dietary needs. (www.coeliac.org.uk) Below are the national recommendations of gluten-free units per month based on age and sex: Age and Sex 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 years 18 Male 60-74 years 16 Male 75+ years 14 Female 19-74 years 14 Female 75+ years 12 Breastfeeding +4 3 rd trimester of pregnancy +1 If a patient feels they need more than these recommendations, the pharmacist should initially issue as per the above and then refer the patient to their GP or dietitian as per local Health Board policy. How much is a gluten-free unit worth? Each prescribable gluten-free food item has been valued on the following basis: Food Item Units 400g bread/rolls/baguette 1 500g flour/bread mix 2 200g biscuits/crackers/crispbreads 1 250g pasta 1 2 pizza bases 1 300g breakfast cereal/500g oats 1½ However, some prescribable products do not fit the above standard sizes. Therefore a team of dietitians and pharmacists have worked together and agreed the unit sizes of all prescribable products for the National Gluten-Free Food Service and Health Boards are advised to use this as a basis for their local formularies. Is there an electronic web application? There is a possibility of a national Gluten-Free Food (GFF) Service App being developed. It may not be available to all Health Boards initially but may be rolled out in 2014. It has been developed to make ordering easier for patients www.scotlandglutenfree.org.uk It will assist patients with identifying the foods they want to order and calculate the units for them and works from the local Health Board formulary. It can be used on a PC, smart phone or tablet. 9

Examples of Common Foods that are Gluten-Free, Not Gluten-Free and Products You May Need To Check For Gluten Gluten-free foods Agar from algae, can be used as an alternative to gelatine Almond often ground and used as an alternative to flour in baking Amaranth traditional plant used in Africa Buckwheat used to make flour and noodles Carageenan from red seaweed, used as a food additive Cassava (manioc) the white or yellow flesh can be boiled and used as an accompaniment for meat dishes. Tapioca starch is produced from dried cassava root. Chestnut ground and used for flour Corn also called maize, used for flour Flax/linseed seeds can be added to muesli Gram flour (besan) from ground chickpeas Hemp flour and seeds used in bakery and cereal products Hops used in the brewing of beer Maize also called corn, used for flour Millet/bajra cereal used in porridge Mustard plant used for flour and powder Polenta boiled cornmeal Potato used to thicken sauces and soups, flour/starch used in baking Pulses (peas, beans, lentils) can be ground into flour and used in a variety of dishes Quinoa closely related to beets and spinach, used in muesli, salads and baking Rice e.g. wild, arborio, basmati Sago starch extracted from sago palms, used as a thickener Sesame seeds used in baking Sorghum sorghum malt used in gluten-free brewing Soyabean ground to make soya flour Tapioca starch from the root of the cassava, commonly used to make tapioca pudding Teff a grass with small seeds, used to make flour Urd/urid/urad flour ground lentils. 10 Gluten-Free Food (GFF) Service Implementation and Support Pack

Not gluten-free foods Barley including products that contain malted barley such as malted drinks, beers, ales, lagers and stouts Bulgar wheat part-cooked wheat Couscous granules made from semolina Durum wheat wheat used in making pasta and bread Einkorn ancient form of wheat Emmer wheat, also known as faro Kamut ancient wheat grain Pearl barley barley which has the hull and bran removed Rye closely related to barley and wheat Semolina coarse particles of wheat, used to make pasta and puddings Spelt ancient form of wheat Triticale a cross between wheat and rye Wheat used to make bread, pasta, biscuits and cakes. Foods you may need to check for gluten Barley malt extract Used for flavouring. Some breakfast cereals containing barley malt extract are suitable Oats often contaminated with gluten, but most people can eat uncontaminated oats. Check with your dietitian before introducing oats into your gluten-free diet as your condition may need to be monitored Some flours made from naturally gluten-free grains may be milled with wheat, barley or rye so can be contaminated. Flours labelled gluten-free will guaranteed to be free from contamination. Information taken from the Coeliac Disease Website www.coeliac.org.uk 11

How the Gluten-Free Food Service will work Patient Identification Patients are currently eligible to register for the service if they are registered with a Scottish GP practice, apart from a patient who is a care home resident. Patients will be identified and informed of the new National Gluten-Free Food (GFF) Service by their General Practitioner (GP). They will inform the patient how many units they can order using the nationally agreed allocation or information from a dietitian. They will also provide the patient with the Patient Registration Form. Registration The patient will bring their partially completed Patient Registration Form (see opposite and also Appendix 1) from the GP to the pharmacy of their choice. At this point they will need further explanation of the Service, which the pharmacist will be required to give. A Pharmacy Care Record (PCR) should be initiated at this point. A patient does not need to be registered for the Chronic Medication Service (CMS) to receive the Gluten-Free Food Service but must have a confirmed diagnosis of either Coeliac Disease or Dermatitis Herpetiformis. Qualifying patients who do NOT wish to opt into the service and ineligible patients will continue to access prescriptions from their GP as at present. Pharmacists should always check with any newly registered patient that they are not already registered with another community pharmacy for the GFF Service. Ordering Products will be chosen from the local Health Board Formulary of Prescribable Gluten-Free Foods. This is available from their community pharmacist or on the Gluten-Free App (if available in your local Health Board). The patient can write down their choices up to their maximum allocated units on a Gluten-Free Food Requirement Order Form (Appendix 2). They may need some assistance from the pharmacist with their first order. Alternatively they could choose to use the Scottish Gluten-Free Food (GFF) Service App (if available in your local Health Board) which will assist them to create their order electronically. Emailed orders should only be accepted if this has been agreed between patient and pharmacy. If the patient wishes to get a copy of their order form, pharmacy staff can photocopy it for them or the patient can be encouraged to keep a duplicate copy on a spare form. The prescription should then be processed and the patient informed when their order is ready for collection. When patients have ordered fresh products it is essential that they are contacted by telephone as soon as possible and advised their order is ready. When the patient s order is complete, the Gluten-Free Food Requirement Order Form should be retained in the pharmacy for 12 months. Please ensure that the patient has spare order forms for future ordering. These forms can be sourced from your local Health Board or the patient can download themselves from the NHS Inform Website www.nhsinform.co.uk/coeliacdisease (available from 21.01.14). 12 Gluten-Free Food (GFF) Service Implementation and Support Pack

Gluten-Free Food Service Patient Registration Form GPs please complete and sign this part of the form and allow patients to take it to the pharmacy of their choice. Patient s full name Patient s CHI number Date of birth Male Female Address Postcode Patient s GP/ Surgery Patient s contact telephone no. and /or e-mail address Condition Coeliac Disease Dermatitis Herpetiformis Carer Details (if appropriate) The above patient should receive the following GFFS units per month (in figures) (in words). Please see Coeliac UK recommended allocated units (www.coeliac.org.uk). I have / have not (please delete) given prescriptions for one months supply of products. I will no longer supply GFF for this patient from / / (date). GP s Signature Date GP s Name GMC No Pharmacists please complete and sign this part of the form. Registration date Patient Care Record (PCR) completed Yes No Pharmacy Coeliac Annual Assessment required Yes No Name and address of Phamacy Pharmacist s declaration I declare that the information I have given on this form is correct and complete. Pharmacist s signature Date Contractor s Code Pharmacy Stamp Patients please complete and sign this part of the form. I agree to obtain my gluten-free foods from the above pharmacy as detailed. Patient s signature Date 13

To receive payment, the pharmacist should complete a Community Pharmacy Urgent Supply (CPUS) form detailing the CHI number of the patient concerned and the detail of the items supplied each month. This should be submitted to Practitioner Services at the end of each month. Payments will not be made unless the form contains the patient s CHI number. Pharmacy Annual Health Check on PCR As part of the Gluten-Free Food (GFF) Service, pharmacists are required to undertake and record an annual health check with ADULT Coeliac Disease patients through a discussion with the patient. Monitoring on an annual basis is included as part of the PCR record for patients and this should be completed for adults only. The annual health check may be undertaken at one of the regular visits of the patient to the pharmacy to collect their gluten-free product order. The format of the annual health check is guided by a series of prompt questions in the support tool in the Patient Care Record. More details about the PCR are found in Appendix 3. Activity Point 1 1. Download and make copies of your local Health Board Formulary of Prescribable Gluten-Free Foods for reference purposes for the patient. This activity will need to be repeated on a monthly basis as the list will constantly be updated with new products added or items removed. 2. Go to NHS Inform www.nhsinform.co.uk/coeliacdisease (available from 21.01.14) and download the Gluten-Free Foods Patient Information Sheet for reference purposes 14 Gluten-Free Food (GFF) Service Implementation and Support Pack

Gluten-Free Food Service National Flowchart Registration Patient brings in Patient Registration Form initiated by their GP. (Page 13 or Appendix 1). This service is available to adult and paediatric patients. Service explained to patient. Patient Registration Form completed and signed by pharmacist and patient. Refer patient to local Health Board Formulary of Prescribable Gluten-Free Foods. Create a PCR for this patient. This will capture basic information whether or not a Pharmacy Annual Health Check is suitable for this patient and forms the patient profile of PCR. Ordering Patient brings in Gluten-Free Food Requirement Order Form (Appendix 2). Provide a copy if requested by patient. Check units do not exceed patient s allocation. To receive payment and process order, a CPUS form is completed detailing the CHI number of the patient concerned and the detail of the items supplied each month. This should be submitted to Practitioner Services at the end of each month. Payments will not be made unless the form contains the patient s CHI number. A copy of the Gluten-Free Food Requirement Order Form is retained in the pharmacy for 12 months. Contact patient to collect goods phone patient on the day that the fresh bread is received. Supply patient with new Gluten-Free Food Requirement Order Form if required. Pharmacy Annual CD Health Check Arrange appointment with patient to complete a Pharmacy Annual CD Health Check on PCR (Appendix 3). This will take place sometime after creating patient profile in PCR at registration by completing the support tool. Complete the responses and identify any pharmaceutical care issues that require to be actioned. N.B. To be completed only if patient is an ADULT (16 years and older) and has CD. Paediatric assessments are not carried out by pharmacists. Complete a referral letter if appropriate (Appendix 4). Re-Registration A new Patient Registration Form (Appendix 1) should be completed by the GP if: A patient moves house and requires to change their community pharmacy. A change in the agreed GFF Service units is required (e.g. if the patient moves into a new age bracket). 15

Activity Point 2 Go to the web application site www.scotlandglutenfree.org.uk (if available in your local Health Board) and create an appropriate monthly gluten-free order using these forms as if you were the patient suffering from Coeliac Disease. If your Health Board does not have access to the web application site, create a monthly order for yourself on the paper copy of the Gluten-Free Food Requirement Order Form (Appendix 2) 16 Gluten-Free Food (GFF) Service Implementation and Support Pack

Pharmacy Annual Health Check (on PCR) This is an opportunity for patients to be signposted or referred to relevant health professionals where there is a clinical need. This process also ensures that the evidence-based Coeliac Disease guidelines are being met, which recommend that Coeliac Disease patients have an annual review. The health check is only for adults with Coeliac Disease and should be conducted in private (See Appendix 3). Some patients may not wish to have an annual health check or take part in some parts of the assessment. If this is the case, please record this on the PCR and inform their GP using the standard letter (Appendix 4). The text boxes on the Annual Health Check Form provide prompts for discussion with patients dependent on how they answer the questions. It also provides guidance for the pharmacist conducting the assessment. Some further guidance on the health check can be found in Appendix 3. Given that following a gluten-free diet is complex and difficult, some people may not be following a strict gluten-free diet. This can be for various reasons such as willing to take the risk, not enough information and/or lack of support. The risks associated with non-compliance are osteoporosis, anaemia and gut lymphoma. Some patients are quite happy to take this risk and therefore have no desire to discuss their diet further. Others, however, may not be fully aware of the long-term risks of continuing to include gluten in their diets and have become used to low grade symptoms, for example, lethargy. The role of the community pharmacist is to help these patients to adhere to their gluten-free diet and seek appropriate support. If the pharmacist weighs and checks the height of each patient using calibrated equipment this information can then be used to calculate Body Mass Index (BMI) (Appendix 5). Where this is not possible the patient may be able to provide these details. Body Mass Index (BMI) is measured as patients can be under- or overweight and require appropriate intervention. Unexplained or unintentional weight loss, no matter what their present BMI is (patient could be overweight) should be discussed and the patient referred to their GP using the standard letter (Appendix 4). The pharmacist should ask the patient if they are experiencing a number of symptoms, for example, nausea, blood in stools. If they report that they do not always manage to follow a gluten-free diet this might be the reason for the symptoms. If this is the case, encourage a gluten-free diet and offer dietetic or GP referral as per local Health Board policy. If they claim to be following a strict gluten-free diet then they should be encouraged to see their GP for further investigation and the standard letter should be sent to the GP (Appendix 4). N.B. For newly diagnosed patients, symptoms can take up to two years to fully resolve. Coeliac Disease patients have an increased requirement for calcium due to malabsorption and as a consequence are at greater risk of osteoporosis. This is also the reason for enquiring about a bone density scan. Standard letters are provided for GP referral if patients need to see another healthcare professional (Appendix 4). 17

Frequently Asked Questions What are the benefits to patients of the Gluten-Free Food Service? Patients can have more variation in their diet as the Service will enable them to make changes to their order, on a monthly basis if they wish. Patients can ensure they are receiving the appropriate number of units. Patients will have regular contact with their community pharmacist who will be a point of contact to other health professionals who they may wish to talk to about aspects of their disease management from time to time. Can a patient go to any community pharmacy for gluten-free foods? Yes. A patient can initially choose which community pharmacy in Scotland they wish to use for their gluten-free foods. Once they register however they must always visit this specific pharmacy. How does a patient register with the Service? Patients take their Patient Registration Form, partially completed by their GP, to the pharmacy from which they wish to receive their gluten-free foods, and the pharmacist will set up the Service for them. What does the patient and pharmacist need to do? The pharmacist will explain to the patient how the Service will work and answer any questions they may have. The pharmacist will also complete their part of the Patient Registration Form and get the patient to sign the form. The pharmacist will provide Gluten-Free Food Requirement Order Forms. The pharmacist will inform them about the Gluten-Free Food (GFF) Service App (if available) and agree or not to accept e-mail orders from the patient. The patient should look through the local Health Board Food List provided by the pharmacist and choose the products they would like to order. These might be the same products they previously had on repeat prescription, or something different. Patients need to ensure they do not go over the total number of units they are allowed for the month. Patients fill in the food order form with their details and the gluten-free product(s) they have chosen and then give the completed food order form to the pharmacist or use the app print off (if available) or e-mail. If they are ordering fresh products, patients need to allow sufficient time for their order to be processed and be prepared to collect on day of delivery. If patients would like a copy of the order for their records, they can either copy it onto a spare form or ask the pharmacist if they will photocopy it. 18 Gluten-Free Food (GFF) Service Implementation and Support Pack

The pharmacist will arrange with patients when their order can be collected. Patients can ask their pharmacist for more order forms, or visit the NHS Inform Website www.nhsinform.co.uk Patients need to complete a new food order form each month they can change the foods they order if they want to. Can patients order whatever they want to each month? No. Prescribable gluten-free foods such as biscuits and cake mixes are luxury items containing little nutritional value and should not be staple foods in their diet. For this reason patients must adhere to the local Health Board Formulary of Prescribable Gluten-Free Foods and Health Board guidance. Can units be carried over to the next month? No. Can more than one order form be submitted in a month? Generally, patients will be encouraged to submit only one form per month. However, some may experience storage problems or may forget to order an essential item. In these circumstances a second order form can be accepted as long as the total number of units does not exceed their monthly allocation. Can patients e-mail their forms? If the pharmacy is able to accommodate this as part of your service, please advise the patient. The Gluten-Free Food (GFF) Service App (if available) does the function of creating the order in pdf format and can be e-mailed but only if this has been agreed by the pharmacy. Where can the patient get additional copies of order forms and more information? The pharmacist should signpost the patient to the NHS Inform website for more patient information www.nhsinform.co.uk/coeliacdisease (available from 21.01.14). Pharmacists will be able to obtain extra copies of the order forms from their local Health Board. Some Health Boards may want to keep all their local Gluten-Free Food Scheme documentation eg patient order forms, on the Community Pharmacy Site. Patients can ask their pharmacist for more order forms, or visit the NHS Inform Website www.nhsinform.co.uk/coeliacdisease (available from 21.01.14). Does the pharmacist need to do anything else with these patients? Yes. Each year the pharmacist must carry out a Pharmacy Annual Health Check on the PCR with each ADULT Coeliac Disease patient using this service. This will help to identify whether or not patients are managing their disease and if they would benefit from being referred to another healthcare professional. Can patients transfer to a different community pharmacy? During the trial, this can only happen if the patient moves house and requires to move to a more convenient pharmacy. The GP would then partially complete a new Patient Registration 19

form for the patient which they would take to their new pharmacy. What if a patient doesn t need any gluten-free foods this month? They do not need to place an order if they do not need anything. Patients simply put in an order form the next time they need gluten-free products. If the patient is moving house what do they need to do? If the patient is moving house but is still able to go to the same pharmacy, they should simply tell the pharmacist of the change of address. If the patient is moving further away (please note that this Service is only available within Scotland), the (new) GP would then partially complete a new Patient Registration Form for the patient which they would take to their new pharmacy. Is it necessary for patients to attend a Pharmacy Annual Health Check? All ADULT patients with Coeliac Disease should have a yearly health check. This brief check will give them the opportunity to discuss any concerns and the pharmacist can signpost them to other health professionals if appropriate. For how long can fresh bread rolls be frozen? The products have all been tested for one month in the freezer. Ensure patients follow the manufacturer s instructions on how to store the product. What should patients do if they have a problem with the quality of any of the products they have ordered? Inform patients to bring the product back to the pharmacy and the staff will arrange for it to be returned. If patients ask, the pharmacist should contact the manufacturer on their behalf. How do patients try different gluten-free products? Inform patients that many manufacturers will send out samples of their products if they contact them. Ensure the patient checks these new products are listed on the local Health Board Formulary for Gluten-Free Prescribable Foods. Crossed Grain the magazine published by Coeliac UK will often have details of new products http://www.coeliac.org.uk. 20 Gluten-Free Food (GFF) Service Implementation and Support Pack

Details of Coeliac UK Coeliac UK is a major source of support and information for people following a gluten-free diet, it is worthwhile encouraging patients to join or rejoin. The address is: Coeliac UK, 1 Saint Colme Street, Edinburgh, EH3 6AA. Telephone: 0131 220 8342 Coeliac UK, 3rd Floor, Apollo Centre, Desborough Road, High Wycombe, Buckinghamshire, HP11 2QW Helpline 0845 305 2060 www.coeliac.org.uk 21

References 1. NICE Guidance on Coeliac Disease (CG86). May 2009. 2. Simon Murch, Huw Jenkins, Marcus Auth, et al. Joint BSPGHAN and Coeliac UK guidelines for the diagnosis and management of coeliac disease in children Arch Dis Child 2013 98: 806-811. 3. British Society of Gastroenterology (2010) The Management of Adults with Coeliac Disease: http://www.bsg.org.uk/images/stories/clinical/bsg_coeliac_10.pdf (accessed 05.11.13). 22 Gluten-Free Food (GFF) Service Implementation and Support Pack

Gluten-Free Exercise (Answers are available on Page 24) 1. Presence of the tissue transglutaminase (ttg) IgA antibody is associated with gluten-sensitive enteropathies such as Coeliac Disease and Dermatitis Herpetiformis. What is the normal (ttg) IgA antibody level? 2. What are the calcium recommendations for an adult coeliac? 3. How would you check if a drug contained gluten in its formulation? 4. How many units would a GP prescribe on a monthly basis for a male patient aged over 75 years? 5. Name 3 clinical conditions that can result from non-compliance with a gluten-free diet? 6. What would first line advice be about taking oats in a gluten-free diet? 7. Give 3 areas of potential cross contamination of gluten in the home? 8. Maize, polenta, cous-cous or modified starch. Which of these is not gluten-free? 9. For a food product to be gluten-free, the amount of gluten in the product should be less than what value? 10. Name 5 foods where the patient would need to check food labels to identify if they were gluten-free or not? 23

Gluten-Free Exercise Answers 1. This will depend which Scottish laboratory is assessing the sample. Please find out what the laboratory ranges are in your local Health Board area. Please note that this is not a particularly sensitive test for non adherence to a gluten-free diet when small quantities are being ingested. There are thus limitations to antibody testing in long term follow up with these patients. 2. Daily calcium recommendations for an adult coeliac is 1000-1500mg. 3. Need to check unlicensed products, products manufactured outwith Europe and over the counter products. Any medicines that contain wheat starch will have it stated on the label and the patient information leaflet. 4. A male patient 75 years or over can request 14 units on prescription. 5. Clinical conditions that can result from non-compliance with a gluten-free diet are anaemia, osteoporosis, small bowel lymphoma, infertility and faltering growth in children. 6. All oats should be excluded for first 12 months after diagnosis, after which a trial of pure non-contaminated oats could be tried and the response monitored. 7. Areas of potential cross contamination of gluten in the home are the toaster, communal butter or jam, deep frying oil, surfaces, storage tins, bread bins or baking trays. 8. Cous-cous is not gluten-free. 9. The amount of gluten should be less than 20 parts per million. 10. The patient would need to check crisps, chocolate, salad dressing, gravy granules, stock cubes, yogurt, soup and breakfast cereal using packet information and Coeliac UK Food and Drink Directory. 24 Gluten-Free Food (GFF) Service Implementation and Support Pack

Appendix 1 Gluten-Free Food Service Patient Registration Form GPs please complete and sign this part of the form and allow patients to take it to the pharmacy of their choice. Patient s full name Patient s CHI number Date of birth Male Female Address Postcode Patient s GP/ Surgery Patient s contact telephone no. and /or e-mail address Condition Coeliac Disease Dermatitis Herpetiformis Carer Details (if appropriate) The above patient should receive the following GFFS units per month (in figures) (in words). Please see Coeliac UK recommended allocated units (www.coeliac.org.uk). I have / have not (please delete) given prescriptions for one months supply of products. I will no longer supply GFF for this patient from / / (date). GP s Signature Date GP s Name GMC No Pharmacists please complete and sign this part of the form. Registration date Patient Care Record (PCR) completed Yes No Pharmacy Coeliac Annual Assessment required Yes No Name and address of Phamacy Pharmacist s declaration I declare that the information I have given on this form is correct and complete. Pharmacist s signature Date Contractor s Code Pharmacy Stamp Patients please complete and sign this part of the form. I agree to obtain my gluten-free foods from the above pharmacy as detailed. Patient s signature Date 25

Appendix 2 Gluten-Free Food Requirement Order Form Patient Name Address Date of Birth Tel No. Date Units allowed for month Please write below the items you wish to order Manufacturer/Description PIP Code Unit Size Quantity Total Units Glutafin Fibre Loaf Sliced 237 7356 400g 6 6 Total units Hand this form to your community pharmacy to place your order If you wish to keep a copy for your records please use a spare form or ask if your pharmacist can copy it for you. Pharmacy Use: This form should be kept in the pharmacy for 12 months 26 Gluten-Free Food (GFF) Service Implementation and Support Pack

Appendix 3 Patient record in PCR Please Note the pharmacist should consult the PCR user guide for instructions on how to operate the PCR system for the Gluten-Free Food (GFF) Service. Patient Profile Each patient on the GFFS will require a record on the PCR. A new section has been added to the PCR patient profile that records the diagnosis and the number of units to be allocated, as confirmed by the form completed by the patient s GP. Patients should not be commenced on the GFF Service until this form is received. If the patient is pregnant or breastfeeding, the allocated units will be increased by the pharmacist for the duration of the pregnancy or breastfeeding, according to national guidance. The patient will be returned to their normal allocation when this time is completed. As patients become older, their allocated units will also change and these should also be adjusted on the PCR by the pharmacist, as identified. 27

Support Tool Assessment Please note that the Pharmacy Annual Heath Check is only offered to adult patients registered with the GFF Service. The Health Check contained on the PCR tool has a number of sections. These are aimed to be prompts to enable the pharmacist to undertake a conversation with the patient about the management of their condition. 28 Gluten-Free Food (GFF) Service Implementation and Support Pack

Concordance You may find that patients do not adhere strictly to a gluten-free diet. It may be helpful to explore the reasons for this. For example, it may be a lack of knowledge; patients may never have had a gluten-free diet explained to them; patients may not have had the risks of nonadherence explained. 29

Interactions and precautions Patients may have been prescribed vitamin supplements, iron or calcium because of identified issues with malabsorption. Advice for patients to support them in taking their medicines correctly should be offered. 30 Gluten-Free Food (GFF) Service Implementation and Support Pack

Adverse effects Identification of any symptoms experienced by the patient, could prompt you to offer advice, or consider whether further help may be needed, through referral to the patient s GP or to a dietitian (if this is available). 31

Monitoring The pharmacist should confirm that the patient is receiving the appropriate number of units for their profile. The patient s weight and height should be measured and recorded and their Body Mass Index (BMI) calculated. Any unexpected weight loss should be discussed, and this information shared with the patient s GP if indicated. 32 Gluten-Free Food (GFF) Service Implementation and Support Pack

Review This section summarises the details recorded during the Pharmacy Annual Health Check. Any pharmaceutical care issues identified should be recorded and actioned. Appropriate advice should be offered or referral can be undertaken (according to local health board guidance). The assessment should be set as complete once the pharmacist has captured all the data they require. 33

Appendix 4 Examples of referral letters you may wish to use Example A Your pharmacy details Dear Dr RE: Weight Previous Weight Height BMI Date Date The above named patient recently attended for their annual Coeliac Health Check in the pharmacy. The following issues were identified: unintentional / unexplained weight loss despite following a strict gluten-free diet they are experiencing the following symptoms (please circle symptom(s)): Change in: appetite / nausea / vomiting / abnormally loose bowel movements Blood in stools / abdominal pain / other, please state: The patient is unaware if a DEXA bone scan has been or is due to be carried out. I would appreciate if you could check your records for this information. If a scan has not been offered or if the patient is due for repeat screening I would be obliged if you could initiate this. I have suggested that the patient contacts you for further investigation. Yours sincerely Community Pharmacist 34 Gluten-Free Food (GFF) Service Implementation and Support Pack

Examples of referral letters you may wish to use Example B Your pharmacy details Dear Dr RE: The above named patient: Attended for their annual Coeliac Health Check on: and no issues were identified from the assessment. *declined to attend for their annual Coeliac Health Check Yours sincerely Community Pharmacist 35

Appendix 5: How to Calculate Body Mass Index (BMI) The BMI will calculate automatically in the PCR support tool assessment by clicking the within the monitoring section. BMI (kg/m 2 ) = weight in kg Height in metres x Height in metres Example Height = 1.58 m Weight = 60 kg BMI (kg/m 2 ) = 60 kg 60 = (1.58 x 1.58) 2.50 = 24 kg/m 2 Healthy Range 18.5 25 kg/m 2 < 18.5 kg/m 2 is underweight 25 30 kg/m 2 is overweight < 30 kg/m 2 is obese BMI Healthy Weight On-line Calculator http://www.nhs.uk/tools/pages/healthyweightcalculator.aspx Height/Weight Conversion Chart http://www.nhs.uk/livewell/healthy-living/pages/height-weight-chart.aspx Useful websites to assist with understanding BMI http://www.nhs.uk/livewell/loseweight/pages/bodymassindex.aspx#people http://www.bhf.org.uk/bmi/bmi_calc.html 36 Gluten-Free Food (GFF) Service Implementation and Support Pack

Appendix 6: PCA (P) (2013) 29 NHS Circular Annex B GLUTEN FREE FOOD (GFF) ADDITIONAL PHARMACEUTICAL SERVICE TRIAL SERVICE SPECIFICATION 1. Service Aim and Objectives 1.1 The objectives for GFF APS are to: Support the provision of direct NHS pharmaceutical care to patients with coeliac disease or dermatitis herpetiformis by providing a pharmacy led nationally consistent service; Make optimum use of clinicians skills and empower the patients to actively manage their own condition; Improve the patient experience of obtaining GFFs on prescription by reducing the number of visits needed to GP surgeries; Provide appropriate clinical monitoring for patients directly affected including dietetic intervention and annual pharmacy health check; Provide more systematic nationally consistent management of patient needs; Allow eligible and qualifying patients access to staple Gluten Free Food to access a convenient service customised to their needs which is also cost effective for NHS Scotland Assist through collaborative working the better management of the demand on the time of all members of the primary care team involved in providing this service to patients Remove the need for a GP to be involved in issuing multiple gluten free prescriptions once he/she has determined the unit allocation and the patient has registered with a pharmacy Reduce the incidence of out of pocket expenses incurred as a consequence of community pharmacy dispensing of individual prescriptions for gluten free foods written by GPs. 2. Service Description 2.1 GFF Service allows eligible and qualifying individuals, who are deemed by their GP as likely to benefit from the service, to register with and use their community pharmacy as the first port of call for the consultation about and dispensing of GFF items, instead of having to request a prescription from their GP for each dispensing. The pharmacist advises, dispenses or refers the patient according to their needs. 2.2 The service is available to any eligible and qualifying person (see section 3.1.2 below). 2.3 The initial consultation and all subsequent health checks must be provided by the pharmacist in person. 2.4 Patients should be directed to support groups or health professionals and should be able to obtain appropriate information about coeliac disease or dermatitis herpetiformis and its management from the pharmacy. 37

3. Service Outline 3.1 GFF Service Registration and Withdrawal 3.1.1 Qualifying individuals who are eligible for GFF Service can register with an opting-in community pharmacy of their choice to receive GFF items. 3.1.2 The following persons qualify to register for the service: Patients diagnosed by their GP as having coeliac disease [or dermatitis herpetiformis] and who would benefit clinically from having access to the GFF service and otherwise would be eligible for a prescription for GFF items written directly by their GP; 3.1.3 Qualifying persons are currently eligible to register for the service if they are: registered with a Scottish GP practice, other than a person normally resident in a care home, 3.1.4 It should be noted that some patients instead of registering for the service may wish to continue to receive prescriptions from their GP. Non eligible persons by virtue of being normally resident in a care home will continue to receive prescriptions from their GP as at present. 3.1.5 The following persons are not eligible to register for the service: persons who are not included in the list of eligible persons above; persons not registered with a Scottish GP practice; those living in a care home; and temporary residents; 3.1.6 Individuals can only register with one pharmacy. 3.1.7 During the initial trial period to facilitate the review of the trial an individual registering with a pharmacy for the service should not normally transfer their registration between pharmacies. 3.1.8 The pharmacist registers a person after they present their referral from GP or dietician acting on the GPs behalf. This form must be signed by the GP or dietician (authorised by GP). The patient should sign this together with the pharmacist to say that the patient is registering in that pharmacy for the service. The pharmacist should then create a PCR record for the patient. 3.1.9 Registration is either done in advance of requiring to use the service or at the time when the service is first required. Pharmacists must confirm a person is eligible for GFF Service by 38 Gluten-Free Food (GFF) Service Implementation and Support Pack

checking the person s referral letter from the GP/dietician. A person may not be registered or receive any dispensed GFF items until the appropriate GP referral letter is received, and signed by all relevant parties. 3.1.10 A new registration form signed by the GP will be required if there is a change in units required. (For example change with age, pregnancy.) 3.1.11 Individuals can choose to withdraw from GFF Service at any point. In addition, pharmacists can withdraw an individual; this might be due to, for example, a change in their eligibility or other exceptional circumstances such as suspected misuse of the service. Pharmacists should always check with any newly registering patient that they are not already registered with another pharmacy contractor for GFF Service and if they find that to be the case to advise the patient that they may only access the service during the trial period from the originally chosen pharmacy contractor. The exception to this would be if the patient had moved house during the trial period and could no longer readily visit the originally chosen pharmacy. 3.1.12 National and local publicity initiatives and information leaflets prepared by the Scottish Government are used to raise public awareness of the service. 3.2 GFF Consultation 3.2.1 At the initial consultation all qualifying patients eligible for the service must have appropriate referral from the GP or dietician specifying the number of units that they are entitled to per month. The GP must sign the referral form. The pharmacist should then: ask the patient to sign the relevant section on the referral form together with the pharmacist to indicate that they have been registered for the service. The referral forms should be kept for payment verification purposes fill in the appropriate PCR record for the patient and consider the most appropriate course/s of action, the counselling and advice needs and any requirements for follow up or referral. The pharmacy annual health check should be completed at registration then annually help the patient select the most appropriate products. Pharmacy will make agreements with the individual patients as to the best way for their orders to be presented. Orders will then be checked by the community pharmacy to ensure that patients have not exceeded their monthly unit entitlement before processing the orders. Initially this will be via handwritten CPUS forms. Agreements will be made with patients regarding how best to contact them in a timely manner following the delivery to pharmacy of their products. This is especially important with fresh products to prevent waste. Details of patients contacts will be 39

kept on the PCR. Patients should be told that products cannot be reordered if they fail to collect their orders. A record of all supplies of gluten-free foods made using CPUS forms is required for the duration of the trial period. A summary of the type and quantity of gluten-free food is required for each patient to demonstrate that fulfilment of the maximum monthly unit allocation has not been exceeded. Pharmacists are required to document the care provided to patients using the PCR. Direct access service will be available to patients during all contracted hours. 4. Prescribable Items 4.1 NHS Scotland has adapted the Gluten Free Prescribed Products List produced by Coeliac UK, in so far as this is consistent with ACBS advice, to enable management of the resources assigned to this service. NHS Scotland will attribute a dietary score as a unit to each product. NHS Boards may choose to select a range of products from the Formulary to meet the local needs of patients and enable local arrangements to be made. The patient s dietary assessment will enable an entitlement score (units) to be assigned to each patient based on their clinical and nutritional need. Patients may order any product from the Formulary in line with the local formulary and directions, up to the number of allocated monthly units assigned to them. Patients requiring additional products or products not contained within the local formulary should be advised that it is possible to purchase these products from the pharmacy or local supermarket. 4.2 The Gluten Free Prescribed Products List may be transposed into a local Board level formulary at individual product level to optimise product suitability for patients and cost effectiveness for the Board concerned. 4.3 Pharmacists should prescribe in line with both national and local NHS prescribing policy and guidance. 4.4 GFF service is subject to the same prescribing support as other clinical services. 5. Administration, record keeping and audit 5.1 The patient referral form indicating eligibility for the GFF APS and the number of units they are entitled to per month should be retained by the pharmacist and be used to record the patient s registration on the GFF Service as evidenced by: the signature of the patient; and the signature of the pharmacist. 40 Gluten-Free Food (GFF) Service Implementation and Support Pack

5.2 A PCR record should be used for each person. A person may already be registered for the Chronic Medication Service (CMS) and thus have a PCR record whereas others may not and a new PCR may therefore be required. This should be used to record the patient assessment questions on an annual basis after the initial registration date. 5.3 Where appropriate, this information is also annotated into the patient s medication record on the pharmacy patient medication record system. 5.4 The pharmacist must submit the patient s CHI number and GF products supplied on the CPUS form so that the service can be evaluated. Forms without CHI will NOT be reimbursed. 6. Remuneration and reimbursement 6.1 The pharmacy contractor is remunerated during the trial period to 31 March 2015 for providing the GFF Service on availability for service basis as determined by the Drug Tariff. 6.2 If a pharmacy contractor decides that after initially contracting to provide the service they no longer wish to participate in the GFF Service they must notify the Health Board and remuneration funding will be withdrawn for this service from that contractor from the date of their withdrawal. 6.2 The pharmacy contractor is reimbursed for any product from the local formulary supplied at the reimbursement price set in the Drug Tariff by the Health Board concerned. 7. Training and preparing staff 7.1 The pharmacist providing the service must practise within their own competency. 7.2 The pharmacist providing the service must be aware of and operate within the national service specifications and local formulary guidelines. 7.3 Prepare staff 7.3.1 The scope of the direct access service will be set out in a NHS Scotland Service Implementation Pack called - Gluten-Free Food Service Implementation and Support Pack and this will be available through NHS Education for Scotland (NES). A copy will be posted to each community pharmacy and will be available on the NES website from December 2013. Pharmacy contractors taking part in the GFF service should refer to this Implementation and Support Pack when training staff, but are free to develop their own standard operating procedures to deliver the service in their own pharmacy. It is a requirement that locum staff used by the opting-in contractor are also competent to provide the service so that a seamless approach to care is experienced by the patient. 41

7.3.2 Agreement forms are required to be completed and returned to NHS Boards to ensure that staff are able and willing to participate in the GFF service. By returning the completed agreement forms contractors will have acknowledged that their staff have completed the Implementation and Support Pack and are competent to operate the service. Each pharmacy contractor will designate a named pharmacist(s) to be responsible for the on-going management and delivery of the service. 7.3.3 A training webcast (recording) of the Implementation and Support Pack will be available in December 2013 and NES regional training events will be run in January 2014. 8. Useful references Link to NES website to access Implementation and Support Pack www.nes.scot.nhs.uk Link to webcast (recording) http://www.neswebinars.co.uk/login.aspx To access this webcast you will need to request a password if you have not previously taken part in any webinar training. 42 Gluten-Free Food (GFF) Service Implementation and Support Pack