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Coeliac disease: opportunities and challenges for pharmacists

Tony Cartwright, a pharmaceutical regulatory consultant who was diagnosed with coeliac disease at the age of 62, and Bob Allison, secretary of Northamptonshire Local Pharmaceutical Committee, describe schemes to improve the availability of gluten-free foods. They also look at new guidance and explain why pharmacists should raise awareness of coeliac disease in those with gastrointestinal symptoms

by Tony Cartwright and Bob Allison

Coeliac
 

This month (August 2009) sees the start of a pilot in Allerdale, Cumbria, which will use pharmacies to increase the availability and choice of gluten-free (GF) foods to patients with coeliac disease.

This disease affects one in 100 of the UK population.

Rather than having to see their GP and obtain an FP10, through the scheme, patients will be able to order their foods from the pharmacy.

Pharmacists will receive £5 for each patient registering for the service, a dispensing fee (£2, including excess charges for delivery of fresh bread) for each item and reimbursement for the products supplied.

The scheme follows a similar service in Northamptonshire, which has been running since December 2007 (see below ). If it is successful, Cumbria Primary Care Trust will extend the scheme across the PCT.

Although a number of treatments for coeliac disease are in early clinical trials, currently the only treatment for patients is life-time avoidance of all gluten (the major protein component in wheat, rye and barley) in the diet. Once patients start on a GF diet their symptoms improve — usually within days — and their intestinal villi usually partly recover in two to three months.

However, a survey of 750 Coeliac UK members in Leeds, Cardiff, Birmingham and Reading found that only eight out of 10 receive prescriptions. Of those who did not get foods prescribed 43 per cent said it “wasn’t worth the hassle” and 7 per cent reported that their GPs would not prescribe the foods. A simpler and easier system for obtaining GF foods would help improve patient compliance.

GF foods have been available on prescription since the 1960s. Eligible items are listed in the Drug Tariff by the Advisory Committee on Borderline Substances. Prescribable items include bread, flour mixes and pasta.

In 2001, the Cabinet Office Regulatory Impact Unit published a report on reducing GP paperwork, and recommended that GPs should no longer need to issue prescriptions for GF foods. Instead, patients with coeliac disease should be able to obtain GF foods from a pharmacist.

As a result of concerns regarding cost, the Department of Health reviewed this recommendation and issued a further report entitled “Gluten free foods — local options” to PCTs considering alternatives to GP prescribing.

Northamptonshire service

The Northamptonshire Teaching PCT (now NHS Northamptonshire) initiative was set up by two PCT pharmacists. It is based on a local enhanced service contract that funds pharmacies and GP dispensing practices to supply GF foods to patients with coeliac disease. Once diagnosed, patients are given a referral letter by their GP or dietitian, which is handed to their local pharmacy on registering for the service.

Registered patients receive their GF products according to a local guideline drawn up in consultation with Coeliac UK. This describes different categories of patient (eg, male aged 19–59 years, pregnant women) and allocates units to each product (eg, 400g of bread equals one unit and 500g of flour mix equals two units).

Each category of patient has a monthly unit allowance. For example, men aged 60–74 require 16 units worth of GF foods each month to maintain nutrition and can be supplied with this by the service provider. Patients who are highly active (eg, manual labourers) are allowed an extra four units.

Patients complete a standard monthly order form and can request a change in products supplied or quantities, so the system gives them more choice over what they eat. A single A4 form is used for the patient supply. There is no longer a need to wait for an FP10 from the surgery.

A large range of products is available and these are obtained from main full line wholesalers or direct from the manufacturer in singles or sensible minimum quantities.

About one and a half hour’s training (one evening) was needed for those wanting to provide the service. Staff from the participating pharmacies and dispensing GP practices were trained on the management of coeliac disease and the organisation of the scheme.

Funding is from the PCT prescribing budget. Pharmacies are paid an annual fee per patient (£70) and reimbursed monthly for the GF products supplied and excess delivery charges. Records of supplies to each patient are retained by the pharmacy for audit purposes.

Completion of the claim form is quick, using the invoice received, and these can be sent at any time to the PCT, but an online claim system is being introduced which will speed up payments and reduce the paper work. After 18 months the PCT reports that the scheme runs well and the cost per patient is comparable to that for GP prescribing.

Contractors are satisfied with the levels of remuneration and it is believed that the success of this project will lead to more pharmacy enhanced services within NHS Northamptonshire.

This sort of scheme is in line with the recommendations of the pharmacy White Paper. In particular, it :

  • Reduces the time-consuming administration of repeat prescriptions in GP surgeries
  • Contributes to the expansion of the range of clinical services offered by pharmacies, particularly to those with a long-term condition
  • Expands patient’s access to treatment, making better use of pharmacists’ skills and helping to improve patient care

 

Long-term consequences

Coeliac disease is an autoimmune disease in which the body’s immune system reacts to gluten in food by attacking its own tissues. The lining of the small bowel is damaged (villous atrophy) and absorption of food, minerals and vitamins impaired. However, only about one in eight people with the disease is diagnosed so there are approximately 500,000 people with undiagnosed coeliac disease in the UK.

Some of these people appear well, but others suffer from problems, such as lethargy and anaemia, and have gastrointestinal symptoms, resulting in chronic ill health and long-term consequences and significant implications for the health service.

Undiagnosed women can suffer from infertility and spontaneous abortion, and have low birth weight infants. Moreover, all undiagnosed patients are at increased risk of fractures due to osteopenia or osteoporosis and an increased risk of cancers such as small bowel cancer, non-Hodgkin’s lymphoma, oesophageal cancer and melanoma.

Coeliac disease is most frequently diagnosed in 40- to 60-year olds. In May 2009, the National Institute for Health and Clinical Excellence issued a new clinical guideline entitled “Recognition and assessment of coeliac disease”. The guideline

recommends that practitioners offer serological testing to children and adults with any of the factors listed in the Panel (below).

Reasons for diagnostic test

Signs and symptoms

  • Persistent unexplained gastrointestinal symptoms, including chronic or intermittent diarrhoea, abdominal pain, cramping or distension
  • Faltering growth in children
  • Prolonged fatigue
  • Sudden or unexplained weight loss
  • Unexplained anaemia

Conditions

  • Autoimmune thyroid disease
  • Dermatitis herpetiformis
  • Irritable bowel syndrome
  • Type 1 diabetes

History

  • First degree relatives (parents, siblings or children) with coeliac disease

 

Diagnosis involves an IgA tissue trans-glutaminase (tTGA) test, followed by an IgA endomysial antibody (EMA) test if the tTGA result is equivocal. Patients with positive results are usually referred to a gastroenterologist for endoscopic examination and intestinal biopsy.

How else pharmacists can help

Although the guideline is primarily addressed to medical practitioners pharmacists can play a significant role in identifying potential cases of coeliac disease and ensuring that these people are tested.

Pharmacists will know that anti-bacterial drugs are not generally prescribed for gastroenteritis because, according to the British National Formulary, most episodes are self limiting and many cases have a viral cause. As a result, they may be reluctant to refer straightforward cases of diarrhoea to a GP, who is only likely to advise the patient to maintain fluid intake to prevent fluid and electrolyte depletion.

However, patients consulting pharmacists in relation to recurrent bouts of diarrhoea should be referred to their GP for further investigation.

Patients who request advice from the pharmacist in relation to prolonged fatigue (“tired all of the time”) should also be referred to their GP. Many patients with coeliac disease are severely anaemic by the time of diagnosis.

People with coeliac disease are sometimes misdiagnosed as having irritable bowel syndrome. If an IBS patient’s symptoms are not relieved by treatment he or she should be advised to go back to the GP and raise the possibility of coeliac disease.

Many people with undiagnosed coeliac disease are also intolerant to lactose in dairy products as a result of the damage to the intestinal epithelium, and such patients can be advised to ask for further testing to check if they have coeliac disease.

By raising awareness of coeliac disease, helping people to get an early diagnosis and supporting those who have been diagnosed, pharmacists can improve quality of life and play a part in reducing chronic health problems.

 

Resources

Catassi C, Fasano F. Celiac Disease. Current Opinions in Gastroenterology 2008:24;687–91.

Department of Health. Gluten-free foods — local options (accessed on 20 July 2009).

National Institute for Health and Clinical Excellence. Coeliac disease: recognition and assessment of coeliac disease (clinical guideline 86).  (accessed on 20 July 2009).

Citation: The Pharmaceutical Journal URI: 10974195

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