Early recognition of coeliac disease through community pharmacies: a proof of concept study
Heidi Urwin, David Wright, Michael Twigg, Norma McGough
Int J Clin Pharm. 2016; 38(5): 1294–1300.
Coeliac disease is an autoimmune response to eating gluten that causes inflammation of the small intestines. Delayed diagnosis and untreated coeliac disease could lead to unexplained fertility, osteoporosis and in rare cases, small bowel lymphoma. It is therefore imperative to improve diagnosis and in turn, improve quality of life.
Int J Clin Pharm. 2016; 38(5): 1294–1300.
Coeliac disease is an autoimmune response to eating gluten that causes inflammation of the small intestines. Delayed diagnosis and untreated coeliac disease could lead to unexplained fertility, osteoporosis and in rare cases, small bowel lymphoma. It is therefore imperative to improve diagnosis and in turn, improve quality of life.
It is believed that coeliac disease effects 1% of the population, with only 24% of those effected diagnosed, resulting in half a million undiagnosed coeliacs within the UK. Reasons for which could include lack of awareness and misdiagnosis.
Traditionally, coeliac screening has been the responsibility of the primary care physician. However, this approach is limited, since patients are required to present themselves for investigation. Symptoms of coeliac disease are similar to those of Irritable Bowel Syndrome (IBS) and can also be a cause for anaemia and vitamin deficiencies, all of which may be treated using over the counter (OTC) products, thus bringing patients in contact with their community pharmacist.
The aim of the paper is to provide a proof of concept study, which determines the service feasibility and acceptability of providing coeliac screening in a number of community pharmacies to help improve diagnosis. The availability of reliable point of care tests (POCTs) enables community pharmacies to offer screening for coeliac disease with a relatively quick turnaround, compared to that of a GP, which would often require patients to wait weeks or months before an appointment.
Fifteen community pharmacies across England were recruited through the National Association of Primary Care’s Primary Innovation Network. Pharmacies were purposely recruited to ensure a wide geological spread and a mix of locations, for example, stand-alone pharmacies, those linked to a GP and independently managed companies.
Senior pharmacists from each pharmacy were involved in the design and trained by Tillotts Pharma Ltd on the use of Simtomax POCT’s. These individuals then trained staff within the recruited pharmacies, including how to identify, approach and recruit patients.
Individuals who met the criteria for screening, such as those who presented with symptoms of diarrhoea, anaemia, constipation or those being treated for Irritable Bowel Syndrome, were offered the POCT test. The test measures both total immunoglobulin A (IgA) and IgA tissue transglutaminase antibodies (IgA tTGA) from a finger prick blood sample. Adults with a positive test were then referred to secondary care to confirm a diagnosis of coeliac disease using endoscopy with biopsy. In a pilot study the specificity and sensitivity of the POCT used was found to be consistent with current NHS laboratory tests.
Each pharmacy was requested to carry out 40 POCT’s during the study period, totalling 600 POCT’s. For which, age, gender, medication which triggered the approach, presenting symptoms and outcome of the test was recorded. In total, 551 participants (>18 years) were recruited for targeting, of which 56.5% (312) were recruited due to purchasing over the counter medicines indicative of coeliac disease. The medicine groups which were the most likely to result in recruitment were either for the treatment of IBS or diarrhoea. Of those who were tested, 9.4% (52) were given a positive result for coeliac disease using the POCT test. Results of later confirmatory biopsies for these subjects were not provided in this paper.. Reasons for declining the test were reported by 15 individuals, 46.7% (7) of which stated lack of time and 20% (2) preferred to speak directly with their GP.
The symptoms reported by patients who tested positive using the POCT included regular diarrhoea (26), general gastro-intestinal problems (34), abdominal problems (31), prolonged fatigue (18) and sudden or unexplained weight loss (3). Only 7.9% (43) of patients completed the customer experience questionnaire, of which, 100% would recommend the service and agreed the pharmacy provided a safe, confidential environment and were able to answer all questions. In addition, all 12 community pharmacists who completed the service provider survey believed community pharmacy was a suitable place to carry out POCTs. Pharmacists believed it would help build rapport with patients and also present the opportunity to offer other pharmacy services. Most patients reported they would be willing to pay for the service, however, the actual cost (which was greater than £20) would be too high for most and therefore alternative routes of funding would be required. This raises the question of whether the cost of screening high risk individuals in this manner would be offset by future reductions in health service costs.
Link to original paper
Traditionally, coeliac screening has been the responsibility of the primary care physician. However, this approach is limited, since patients are required to present themselves for investigation. Symptoms of coeliac disease are similar to those of Irritable Bowel Syndrome (IBS) and can also be a cause for anaemia and vitamin deficiencies, all of which may be treated using over the counter (OTC) products, thus bringing patients in contact with their community pharmacist.
The aim of the paper is to provide a proof of concept study, which determines the service feasibility and acceptability of providing coeliac screening in a number of community pharmacies to help improve diagnosis. The availability of reliable point of care tests (POCTs) enables community pharmacies to offer screening for coeliac disease with a relatively quick turnaround, compared to that of a GP, which would often require patients to wait weeks or months before an appointment.
Fifteen community pharmacies across England were recruited through the National Association of Primary Care’s Primary Innovation Network. Pharmacies were purposely recruited to ensure a wide geological spread and a mix of locations, for example, stand-alone pharmacies, those linked to a GP and independently managed companies.
Senior pharmacists from each pharmacy were involved in the design and trained by Tillotts Pharma Ltd on the use of Simtomax POCT’s. These individuals then trained staff within the recruited pharmacies, including how to identify, approach and recruit patients.
Individuals who met the criteria for screening, such as those who presented with symptoms of diarrhoea, anaemia, constipation or those being treated for Irritable Bowel Syndrome, were offered the POCT test. The test measures both total immunoglobulin A (IgA) and IgA tissue transglutaminase antibodies (IgA tTGA) from a finger prick blood sample. Adults with a positive test were then referred to secondary care to confirm a diagnosis of coeliac disease using endoscopy with biopsy. In a pilot study the specificity and sensitivity of the POCT used was found to be consistent with current NHS laboratory tests.
Each pharmacy was requested to carry out 40 POCT’s during the study period, totalling 600 POCT’s. For which, age, gender, medication which triggered the approach, presenting symptoms and outcome of the test was recorded. In total, 551 participants (>18 years) were recruited for targeting, of which 56.5% (312) were recruited due to purchasing over the counter medicines indicative of coeliac disease. The medicine groups which were the most likely to result in recruitment were either for the treatment of IBS or diarrhoea. Of those who were tested, 9.4% (52) were given a positive result for coeliac disease using the POCT test. Results of later confirmatory biopsies for these subjects were not provided in this paper.. Reasons for declining the test were reported by 15 individuals, 46.7% (7) of which stated lack of time and 20% (2) preferred to speak directly with their GP.
The symptoms reported by patients who tested positive using the POCT included regular diarrhoea (26), general gastro-intestinal problems (34), abdominal problems (31), prolonged fatigue (18) and sudden or unexplained weight loss (3). Only 7.9% (43) of patients completed the customer experience questionnaire, of which, 100% would recommend the service and agreed the pharmacy provided a safe, confidential environment and were able to answer all questions. In addition, all 12 community pharmacists who completed the service provider survey believed community pharmacy was a suitable place to carry out POCTs. Pharmacists believed it would help build rapport with patients and also present the opportunity to offer other pharmacy services. Most patients reported they would be willing to pay for the service, however, the actual cost (which was greater than £20) would be too high for most and therefore alternative routes of funding would be required. This raises the question of whether the cost of screening high risk individuals in this manner would be offset by future reductions in health service costs.
Link to original paper
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