Food intolerance testing
Regulatory notice 03/2018 Issued: 29 January 2018
Circulation list: All registered pharmacists and pharmacy owners
Responsibility for action: Superintendent pharmacist and pharmacy owner
The Health Products Regulatory Authority (HPRA) published a Medical Devices Information Notice on Food Intolerance Testing on Monday, 29 January 2018.
The HPRA has undertaken a review of the types of food intolerance tests available on the market and has consulted with clinical experts. Following this review, the HPRA has clarified that, as the cause of food intolerance is unknown, any test which claims to indicate an intolerance to food is of little clinical validity and confirms that there is no single test available to diagnose food intolerance. The HPRA is advising the public and healthcare professionals not to rely on food intolerance tests for the purpose of a diagnosis or as the basis for dietary change.
The HPRA states that products being promoted as food intolerance tests, cannot diagnose food intolerance and the results of such tests should not be acted on without expert advice from a medical doctor or registered dietician.
As regulated healthcare professionals, pharmacists are a trusted source of advice for the public on medicines and health matters in the community. In order to uphold that trust, the PSI expects that all information and services provided by pharmacists is accurate, clinically valid and in line with current evidence and best practice.
Therefore, the PSI wishes to advise superintendent pharmacists and pharmacy owners that offering food intolerance testing in pharmacies, to diagnose food intolerance, is not appropriate.
Background information
The following provides some information for pharmacists on food intolerance from the Health Products Regulatory Authority (HPRA) and the Food Safety Authority of Ireland (FSAI) as well as information for pharmacists on requirements under the Code of Conduct and providing testing services in pharmacies.
Information from the HPRA and FSAI on food intolerance
The Health Products Regulatory Authority (HPRA) published a Medical Devices Information Notice on Food Intolerance Testing on Monday, 29 January 2018, following a notice also in 2015.
The Food Safety Authority (FSAI) has also published an information leaflet on food hypersensitivity.
The HPRA notice and FSAI leaflet clarify some important information on food intolerance testing that is relevant for pharmacists and pharmacies. Both resources highlight the important distinction between a food allergy and a food intolerance. Pharmacists should be familiar with the advice from both agencies in the area of food intolerance.
Diagnosing food intolerance
The FSAI advises that diagnosis of either a food allergy or food intolerance should involve medical consultation and that changes to a person’s diet should only be undertaken in consultation with suitably qualified experts. The HPRA provides a similar statement, and is informing the public that the only clinically valid method for the diagnosis and treatment of food intolerance is an elimination diet. The HPRA states that elimination diets must be undertaken in close consultation with an experienced clinician or registered dietician, who can provide specialist advice on maintaining a balanced diet throughout the elimination test.
The FSAI outlines that an incorrect diagnosis of food intolerance can result in the cause of a health problem being overlooked and in unnecessary dietary restrictions.
Providing Testing Services in Pharmacies
In the provision of a testing services, it is essential that patients’ expectations of the standard of care provided by their pharmacist are met and that they can be assured of the quality, accuracy and reliability of such testing.
Any tests or health checks should only be performed by pharmacists or offered in pharmacies where there is an established clinical and scientific evidence base and for which the validity, accuracy and reliability of the test(s) can be assured. The purpose, health benefit and clinical need for the use of a particular test must be established prior to its introduction and re-evaluated at regular intervals. Where available, relevant national healthcare strategy, health promotion campaigns, clinical guidelines and best practice should be observed in the provision of testing services.
Any testing service in a pharmacy should only be provided in line with PSI guidance on providing testing services in pharmacies.
Code of Conduct for Pharmacists
Under the Code of Conduct pharmacists are expected to:
- provide a proper standard of care to those for whom they provide professional services
- use their professional knowledge, competence and specialised knowledge about medicines, health related products and medicinal and non-medicinal therapies for the benefit of patients
- provide honest, accurate, current and appropriate information to patients regarding the nature, cost, value and benefit of medicines, health-related products and services provided by them.
Conclusion
In accordance with the information provided above and the conclusions of the HPRA review, any test which claims to indicate an intolerance to food is of little clinical validity, and therefore the PSI wishes to advise superintendent pharmacists that offering food intolerance testing services to diagnose food intolerance is not appropriate.
Members of the public that purchase a self-test should be made aware of the limitations of such products and the HPRA advice that they should not rely on food intolerance tests for the purpose of a diagnosis or as the basis for dietary change.
The resources referred to above should be consulted for correct and accurate information on food allergies and food intolerance.
Pharmacists and pharmacies are important sources of information and advice for members of the public, so it is important that all pharmacists and pharmacy staff who may be dealing with queries from the public in relation to food intolerance are familiar with the advice of the HPRA and the FSAI and current best practice. Pharmacists continue to have an important professional role in assisting the public in managing any symptoms they may have, including referral for medical assessment as appropriate.