Impact of Italian Medicines Agency Note 96 on the use of vitamin D in Italy

Luca Degli Esposti 1, Margherita Andretta 2

1 CliCon S.r.l. Benefit Corporation, Bologna; 2 UOC Assistenza Farmaceutica Territoriale, Azienda ULSS 8 Berica (Berica Local Health Service 8 Territorial Pharmaceutical Assistance Unit), Vicenza

DOI 10.30455/2611-2876-2022-2e

Vitamin D plays a key role in maintaining serum calcium levels required for musculoskeletal health and bone metabolism within their natural physiological range.

Vitamin D ensures proper bone mineralisation. Vitamin D deficiency is a risk factor for skeletal fragility in the elderly and osteoporotic fractures. Moreover, scientific studies have shown that Vitamin D supplementation prevents systemic bone loss following a fracture and reduces the risk of multiple fractures.

National and international guidelines on the management of osteoporosis recommend adequate calcium and vitamin D supplementation in addition to anti-osteoporotic therapies.

AIFA Note 79, in defining which drugs for primary and secondary prevention of the risk of osteoporotic fractures are reimbursable, states that, before starting therapy with these drugs, an adequate intake of calcium and vitamin D is recommended, resorting, where diet and sun exposure are inadequate, to supplements with calcium salts and vitamin D3 (and not its hydroxylated metabolites).

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