Review of the Gluten-free Food Additional Pharmaceutical Service

1 Chapter 1: Introduction

A review of the trial Gluten-free Food Service (GFFS) being provided as an Additional Pharmaceutical Service was conducted on behalf of the Scottish Government by Margaret Ryan within NHS Scotland. This report sets out the findings and provides recommendations.

The review focussed on the service delivery model i.e. providing the service through NHS community pharmacies rather than the traditional model through general practice, and was undertaken to assess if the new model should continue after the trial period concludes at end September 2015.

1.1 Context

1.1.1 Coeliac disease is a lifelong autoimmune disease caused by intolerance to gluten, a protein found in wheat, barley and rye. Prevalence of coeliac disease is up to 1 in 100 of the population although only about 10-15% with the condition are clinically diagnosed. Many of the remainder may be well, but a significant minority will have chronic problems which result in chronic ill health1. Individuals may go undetected for many years despite multiple presentations to both primary and secondary care. This may reflect the fact that affected individuals have subtle or no gastrointestinal symptoms^[6].

1.1.2 Dermatitis herpetiformis (DH) is the skin manifestation of coeliac disease and it affects around 1 in 3300 people^[7]. In 2014, research from the University of Nottingham revealed a fourfold increase in the rate of diagnosed cases of coeliac disease in the UK over the past two decades^[8]. In the UK, however, there is an estimated three-quarters of people with the disease who remain undiagnosed.

1.1.3 Once diagnosed with coeliac disease, or DH, the treatment is a lifelong gluten-free diet. 'Gluten' is used here as a generic term to encompass all the proteins derived from wheat, rye and barley. Following a gluten-free diet requires specific education, which should be provided by a dietitian with experience in coeliac disease1. It is important that coeliac patients are advised on alternative foods to include in their diet to maintain a healthy and varied intake and to increase the likelihood of adherence. Many ingredients are naturally gluten-free such as rice, potatoes, corn, fruits, eggs, cheese, vegetables, meat and fish. The modern Western diet, however, commonly includes bread, breakfast cereals and pasta made from wheat, barley and rye as staple ingredients and is therefore high in gluten. In order to replace these foods and to maintain variety and palatability, manufacturers produce a range of gluten-free substitute products such as bread, pasta, pizza and breakfast cereals6.

1.1.4 Patients can help to minimise the potential for negative clinical outcomes by maintaining a gluten-free diet for life. Potential long-term complications of coeliac disease include osteoporosis, malnutrition, ulcerative jejunitis and vitamin D and iron deficiency. Some research has suggested that having undiagnosed or untreated coeliac disease may increase the risk of developing certain types of cancer including lymphoma ^[6].

1.1.5 Gluten-free products are generally more expensive than conventional ingredients and this potentially may adversely affect adherence to a gluten-free diet. Gluten-free staple foods are a category of product identified by the UK Advisory Committee of Borderline Substances (ACBS) as falling within the definition of Borderline Substances3. As such, they can be prescribed on the NHS for example by General Practitioners (GPs), using a standard GP10 prescription form. Guidance recommends the minimum monthly prescription of gluten-free foods, on the basis that approximately 15% of energy intake is derived from these products4.

1.1.6 The traditional model has been that gluten-free items are prescribed for patients in primary care by their GP then dispensed by community pharmacies. Few GPs would have been able to fully implement the gluten-free food prescribing guide recommendations as in-depth knowledge around the products available on prescription would have been required. This results in some instances in patients being provided with either not enough^[9] or too many gluten-free products.

1.1.7 During 2010, the NHS Tayside Nutrition Managed Clinical Network (TN MCN) tested a new local model of gluten-free food prescribing as part of coeliac disease service improvement programme which re-aligned the patient pathway with clinical guidelines^[10]. The prescribing model developed was based on gluten-free food schemes in England. In the re-design, patients were involved alongside other stakeholders including general practice, dietetics, gastroenterology and community pharmacy. Patients ordered their gluten-free prescribable products direct with community pharmacy rather than going via the GP for a GP10 prescription. Annual coeliac disease health checks for adults in community pharmacy were developed in the Tayside model as many coeliac patients were identified as not being offered reviews as indicated by coeliac disease clinical guidelines4. The Tayside model was found to be cost effective, efficient and liked by patients, GPs and community pharmacy.

1.2 Background

1.2.1 On 28 November 2013, the Scottish Government published Circular PCA(P)(2013)295, announcing the introduction of the new Gluten-free Food Additional Pharmaceutical Service (GFFS) to the Community Pharmacy Contract on a trial basis for a period of 12 months from April 2014.

1.2.2 The trial GFFS introduced a new model replacing the need for eligible and qualifying patients to request individual prescriptions for gluten-free items from their GP. Instead the model enables them to register their condition with a community pharmacy of their choice, provided that the contractor concerned had opted into providing the GFFS. The service aimed to build on the scheme already successfully initiated by NHS Tayside in 2010.

1.2.3 The objectives for GFFS were to:

• Support the provision of direct NHS pharmaceutical care to patients with coeliac disease or DH 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.

1.2.4 To be eligible to use the new Scottish Gluten-free Food Service, patients must:

• have a clinically confirmed diagnosis of coeliac disease or DH;
• live in Scotland and whose main or usual residence is not a care home; and
• be registered as an NHS patient with a GP practice.

1.2.5 The quantity of GFF items a patient has been recommended is based on a personalised clinical assessment, and the supply of GFF items in accordance with those GFF items that are covered within the formulary published by their local Health Board. The terms and conditions for the GFFS were provided in Circular PCA(P)(2013)295.

1.2.6 In December 2014, Circular PCA(P)(2014)30^[11] advised that the trial service was extended until 30 September 2015. It also stated that a review of the service would be conducted to assess how successful the trial has been in terms of improving clinical benefit for appropriately diagnosed patients, cost effectively by comparison with the previous arrangements plus any other impact on participating parties.

1.3 Implementation

1.3.1 National food list and local GFF formularies

Prior to the introduction of the GFFS in April 2014, prescribing practice for GFF varied across Health Boards. Across Scotland, the existence of individual Health Board formularies for NHS prescribed GFF was not consistent. Where formularies did exist there were inconsistencies in the approach used to develop the formulary including no stated unit allocation and the same product having a different unit allocation. The British National Formulary (BNF) listed GFFs available for NHS prescribing do not necessarily have designated gluten-free units with the potential result of patients are prescribed either above or below the optimum units required for their needs.

In 2011, Coeliac UK produced "Gluten-free Foods: a prescribing guide" which defines a unit of prescribable GFF and the maximum number of units an individual can receive on prescription based on their sex and age per month. This was updated in 2012 after the Advisory Committee on Borderline Substances (ACBS) decision to include breakfast cereals and oats on prescription. The National Prescribing Guidelines^[12] were endorsed by the Primary Care Society for Gastroenterology (PCSG) and the British Dietetic Association (BDA) and British Society of Paediatric Gastroenterology Hepatology and Nutrition (BSPGHAN)

This has been used to support the development of a Scotland wide gluten-free food (GFF) prescribable product list. A small working group of dietitians and a pharmacist collated a list of all ACBS approved gluten-free foods from all manufacturers for prescribing on a NHS prescription to minimise the variation in unit allocation for GFFs across Scotland. Where manufacturers asked to be excluded from the list, this has been done.

The gluten-free food prescribable product list lists practical information on units per item, PIP codes, minimum order numbers, costs, and days of delivery for fresh GFF foods, distributor and manufacturer details. The unit allocation used within this listing is based on the Coeliac UK guidelines. As the current Coeliac UK guidelines do not provide unit allocation for every pack size the unit allocation was expanded to cover all sizes of gluten-free products.

The gluten-free food prescribable product list is the starting point for Health Boards when developing a GFF prescribable product formulary and aids standardised practice across Scotland in unit allocation. The GFFS relies on each Health Board having an up-to-date and accurate GFF NHS prescribable product local formulary list which provides patients, prescribers and community pharmacy with the information they need for delivery of this service.

The final resource which was circulated by Scottish Government contained guidance on:

• the Coeliac UK prescribing guidelines which stipulate how many units of gluten-free foods and individual dependant on sex and age may receive on prescription
• the name and PIP code which is required by community pharmacy to order the product
• the number of units each product contains
• manufacturer information on minimum orders and delivery information for each product
• cost of each item and the range of carriage costs associated with each item between August 2012 - January 2013

This resource was shared with all NHS Scotland Health Boards to allow them to develop local formularies for gluten-free products prior to the commencement of the GFFS trial. The listing was subsequently updated in May 2015 with the addition of new products, new manufacturer information and deletion of discontinued products.

1.3.2 Gluten-free Food Service Implementation and Support Pack

The GFFS implementation and support pack was developed by National Education for Scotland (NES) with input from Scottish Government, ATOS, pharmacists, consultant paediatric gastroenterologist and dietitians. The training pack was developed to assist community pharmacists gain a general understanding of coeliac disease and DH and provide them with the necessary information to deliver the GFFS.

In addition to education material on coeliac disease and DH, the pack explained in detail the process for patients accessing prescribable gluten-free foods through community pharmacies. Copies of the nationally agreed GFFS patient registration form, gluten-free food requirement form and sample letters for community pharmacy communication with the GP after a patient's annual review were included in the pack.

1.3.3 Training of Community Pharmacists on the Gluten-free Food Service

To support the implementation of the GFFS, NES developed a webinar for community pharmacists. This training provided by dietitians and pharmacists delivered education on coeliac disease and DH, their treatment and how the new GFFS would be implemented as part of the management of these conditions. The webinar training has remained available for pharmacists on the NES website to refresh their knowledge and for new pharmacists preparing to provide the service.

NES organised other training events across the country where community pharmacists could attend in the evening which provided similar training and allowed attendees the opportunity to ask questions on the service provision.

1.3.4 Communication prior to commencement of the Gluten-free Food Service

In addition to the activities above, NES, using the same contributors as the community pharmacy pack, also developed an information pack for GPs on the new GFFS with the materials they required to implement the transfer of patients to the community pharmacy service.

A section on the GFFS was developed for the NHS Inform website http://www.nhsinform.co.uk and included all the necessary patient information needed for patients to transfer to the new service, seamlessly. NHS Inform also updated the coeliac disease and DH information on the patient information website. The development was undertaken with contributions from a group of dietitians, pharmacists and gastroenterologists.

The Scottish Government provided master copies of the patient registration form and gluten-free food order form to aid uniform implementation of the GFFS. Information was also provided by Scottish Government to Health Boards to aid development of local gluten-free food formularies to support the trial GFFS.