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<p>The diagnosis and treatment of pernicious anaemia, the result of a vitamin B12
(cobalamin) deficiency, is well established and reported in the British Committee
for Standards in Haematology (BCSH) guidance document, <em>Guidelines for the diagnosis
and treatment of Cobalamin and Folate disorders</em>, which was updated in May 2014.
A copy of the BCSH guidance document is attached.</p><p> </p><p>The BCSH operates
independently of the Department and NHS England and produces evidence based guidelines
for both clinical and laboratory haematologists on the diagnosis and treatment of
haematological disease, drawing on the advice of expert consultants and clinical scientists
practicing in the United Kingdom. It would be for the BCSH, not the Department, to
consider whether any adjustments to current best practice, in the diagnosis and treatment
of patients with pernicious anaemia were needed, including whether any new or additional
tests were appropriate.</p><p> </p><p> </p><p> </p><p>The BCSH guidance sets out that
cobalamin status is the recommended first line diagnostic test. The Department has
no data relating to false positive results in relation to the test. The guidance also
states that clinical picture is the most important factor in assessing the significance
of the test results.</p><p> </p><p> </p><p> </p><p>When anaemia is diagnosed, most
patients respond well to treatment through quarterly intramuscular injection of vitamin
B12. Whilst some patients with pernicious anaemia might prefer to have more frequent
injections, or for other forms of vitamin B12 to be self-administered, these are matters
for individual patients to discuss with their general practitioners.</p><p> </p><p>
</p><p> </p><p>Although the Medicines Healthcare products Regulatory Agency is currently
reviewing claims made by some clinics that are administering vitamins and minerals
intravenously for nutritional therapy purposes, the agency has not encountered any
clinics making claims to treat pernicious anaemia. In addition, the Department does
not have any information regarding patients purchasing additional supplies of B12
from unregulated sources.</p><p> </p><p> </p><p> </p><p>Regarding the mandatory fortification
of flour with folic acid, the Scientific Advisory Committee on Nutrition recommended
a number of measures to ensure monitoring and surveillance of the impact of fortification
of flour, should it be implemented. This included appropriate systems to monitor any
potential adverse effects, including cancer and a review of the evidence on benefits
and postulated risks after five years. The National Diet and Nutrition Survey monitors
folate intakes and the most recent data, which was published earlier this year, will
be carefully considered alongside other information sources before any decision is
made on mandatory fortification.</p><p> </p><p> </p><p> </p><p>The Department has
made no assessment of the social and economic costs of misdiagnosis or late diagnosis
of pernicious anaemia and other vitamin B12 deficiencies.</p><p> </p>
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