Review of the Gluten-free Food Additional Pharmaceutical Service

Executive Summary

Background

Coeliac disease is a lifelong autoimmune disease caused by intolerance to gluten, a protein in wheat, barley and rye. Prevalence of coeliac disease is up to 1 in 100 of the population^[1] although only about 10-15% with the condition is clinically diagnosed^[2]. Dermatitis herpetiformis (DH) is the skin manifestation of coeliac disease. Once diagnosed with coeliac disease, or DH, the treatment is adherence to a lifelong gluten-free diet. Potential long-term complications of coeliac disease include osteoporosis, ulcerative jejunitis, reproductive issues, vitamin D deficiency and iron deficiency.

Many food ingredients are naturally free from gluten such as rice, corn, potatoes, fruits, eggs, cheese, vegetables, meat and fish. The Western diet, however, usually has bread, pasta and wheat flour products as staple ingredients which contain gluten.

A range of gluten-free substitute products such as bread, flour and pasta are available which if Advisory Committee of Borderline Substances^[3] (ACBS) approved can be prescribed on the NHS. Guidance recommends the minimum monthly prescription of gluten-free foods (GFF) on the basis, that approximately 15% of energy intake, is derived from these products^[4]. The traditional model has been that gluten-free items are prescribed for patients in primary care by their GP then dispensed by community pharmacies.

Situation

On 28 November 2013, the Scottish Government published Circular PCA(P)(2013)29^[5], announcing the introduction of the new Gluten-free Food Service (GFFS) to the Community Pharmacy Contract as an Additional Pharmaceutical Service on a trial basis for a period of 12 months from April 2014 which has subsequently been extended to 30th September 2015 to allow evaluation of the service.

The trial GFFS introduced a new model replacing the need for eligible and qualifying patients to request individual prescriptions for gluten-free food items from their GP. Instead, the model enabled patients 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 a scheme already successfully initiated by NHS Tayside since 2010.

Patients to be eligible for the new service must:

• have a clinically confirmed diagnosis of coeliac disease or dermatitis herpetiformis;
• 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

The objectives for the trial GFFS were set out 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.

Service Outcomes

The trial service was reviewed in 2015 using a range of methods to collect stakeholder views (surveys, letters to stakeholders and meetings with stakeholders) and prescribing information. The main observed outcomes from the review were:

• There was strong support from all stakeholders for the GFFS, with all supporting its continuation and integration into NHS services.
• Stakeholders universally indicated that the provision of direct NHS pharmaceutical care to patients with coeliac disease or DH had been improved
• There was universal agreement that the patient experience of obtaining GFFs on prescription was improved with reduced number of visits needed to GP surgeries and that GP time was released.
• The majority opinion across the stakeholders was that the service allowed clinicians from different professions to utilise their skills better. Community pharmacists found that the service allowed improved interaction with patients and occasions to provide opportunistic healthcare advice.
• The general impression from respondents across the three surveyed populations was the impact, effect and value of the annual health check by community pharmacy for adult coeliac disease patients was as yet not evidenced. Further assessment of the health check to assess its value would be beneficial if GFFS continues.
• There was strong agreement from all stakeholders that the service empowered patients to actively manage their own condition. One example of this was the association found between the ease that patients can change their order and how often they do so. Both patients and community pharmacists noted that GFF orders had altered more frequently since the introduction of the GFFS.
• The service was considered to improve national consistency in the management of patient needs but that further improvements could be delivered. At present there is a Scotland wide national GFF list which contains all ACBS approved GFF. This list is used to develop local Health Board formularies which account for local population needs. There is however, nearly a tenfold variation in the number of formulary choices across Health Boards available for patients, the necessity of which requires review. The current situation has raised equity issues for patients and community pharmacies especially if they border the boundaries of two Health Boards affecting engagement with the service.
• There was a general agreement across all stakeholders that GFFS allowed eligible patients who could access a community pharmacy to access a convenient service customised to their needs. Concerns were raised why care home patients were excluded from the service and rural areas highlighted that some of their population were unable to access the service.
• The prescribing information indicates that although there has been a 31.6% increase in prescribing volume the cost increase has only been 4.6%. This reflects patients increasing the variation of their food order within their GFF unit allocation. The majority of prescribing is for bread then secondly pasta. Since the GFFS introduction, all GFF main categories had seen increased prescribing. The highest increase was in the GFF cereals and secondly crackers/crispbreads.
• There was agreement that the service supported better demand management on members of the healthcare team. There was recognition that work had shifted from GPs to community pharmacists. The main issue highlighted was the administration time required to complete the handwriting of the Community Pharmacy Urgent Supply (CPUS) forms. It was universally stated that electronic prescribing was required. The Pharmacy Care Record (PCR) was also highlighted as difficult to use and needed review plus presently not linked with the pharmacy Patient Medication Record (PMR).
• There was a unanimous response that this service had freed up GP time as they no longer were required to prescribe GFF. One proposal from GPs and dietitian stakeholders was for dietitians and not GPs to decide on unit allocation and commence patients on the GFFS with referral straight to the community pharmacist. This move to remove GPs from the GFF process has already been undertaken in collaboration with GPs in NHS Tayside.
• The incidence of out of pocket expenses (OOPE) incurred as a consequence of community pharmacy dispensing individual prescriptions for gluten-free foods reduced significantly when the four main manufacturers stopped charging in the year before the GFFS trial started. During the trial there has been little change in OOPE with one suggestion is that this was the result of local GFFS formularies in general excluding items with OOPE. This would be a general ongoing matter to ensure Health Board formularies obtain best value for the taxpayer balanced along with maximum choice for patients.