Update by the Medicines Agency on the prescribing criteria of Vitamin D following new studies which concluded that supplementation with more than adequate doses of vitamin D (2000 IU per day of cholecalciferol) and for several years (over 5 years in the first study and 3 years in the second) is not able to modify the risk of fracture in the healthy population, without risk factors for osteoporosis. These results were also confirmed among subjects with lower levels of vitamin 25(OH)D. THE NEW NOTE 96
21 FEB –
The Italian Medicines Agency has updated Note 96 (AIFA determination n. 48/2023 published in the Official Gazette n. 43 of 20 February 2023) on the criteria of prescriptive suitability of supplementation with vitamin D and its analogues (cholecalciferol, calcifediol) for prevention and treatment of deficiency states in adults.
The update of the Note, established in 2019, was necessary following the publication of new scientific evidence which further clarified the role of vitamin D in the absence of concomitant risk conditions. The expenditure for Vitamin D paid by the NHS is over 200 million a year. With the first version of Note 96, consumption had decreased but from the last monitoring 31 months after application, Aifa itself signaled that it was losing effectiveness.
In particular, the results of two large randomized clinical trials were taken into consideration, the American VITAL study (LeBoff M et al, NEJM 2022) and the European study DO-HEALTH (Bischoff-Ferrari HA et al, JAMA 2020). Both studies concluded that supplementation with more than adequate doses of vitamin D (2000 IU daily of cholecalciferol) and for several years (over 5 years in the first study and 3 years in the second) is unable to modify the risk of fracture in the healthy population, without risk factors for osteoporosis. These results were also confirmed among subjects with lower levels of vitamin 25(OH)D.
Added to these main studies is the rich literature regarding its use in COVID-19 which has not demonstrated any benefit of vitamin D even in this condition.
On this occasion, some improvements have been included in the text of the Note on the proposal of clinicians or scientific societies.
The changes introduced with the Note 96 update are as follows:
– introduction of the new risk category “persons with serious motor impairments or bedridden who live at home”;
– reduction from 20 to 12 ng/mL (or from 50 to 30 nmol/L) of the maximum level of serum vitamin 25(OH)D, in the presence or absence of specific symptoms and in the absence of other associated risk conditions, necessary for purposes of reimbursement;
– specification of differentiated levels of serum vitamin 25(OH)D in the presence of certain risk conditions (eg malabsorption disease, hyperparathyroidism) already present in the first version of the Note;
– updating of the paragraph relating to the most recent evidence mentioned above and insertion of a short paragraph dedicated to vitamin D and COVID-19;
– introduction of a paragraph on the potential risks associated with the improper use of vitamin D preparations.
February 21, 2023
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