Ruggero Dittadi^1,15,16, Sabrina Corbetta^2,3,15, Giuseppe Banfi^2,4,15, Francesco Bertoldo^5,15, Silvia Migliaccio^6,15, Stefano
Gonnelli^7,15, Maurizio Rossini^5,17, Marco Migliardi^8,16, Antonio Fortunato^9,16, Fabio Vescini^10,18, Andrea Palermo^11,18,
Cristina Vassalle^12,15, Silvia Gelsumini^13,15, Giovanni Lombardi^2,14,15,19
1UOC Medicina di Laboratorio, Ospedale dell’Angelo, ULSS3 Serenissima, Mestre
²IRCCS Istituto Ortopedico Galeazzi, Milano
³Dipartimento di Scienze Biomediche Chirurgiche e Odontoiatriche, Università degli Studi di Milano
⁴Università Vita Salute San Raffaele, Milano
⁵Dipartimento di Medicina, Università di Verona
⁶Dipartimento di Scienze Motorie, Umane e della Salute, Unità di Endocrinologia, Università degli Studi di Roma “Foro Italico”,
Roma
⁷Dipartimento di Medicina, Chirurgia e Neuroscienze, Università di Siena, Policlinico Le Scotte, Siena
⁸UOC Laboratorio Analisi, A.O. Ordine Mauriziano di Torino
⁹UOC Patologia Clinica ASUR Marche – Area Vasta 5 – Ascoli Piceno
¹⁰SOC Endocrinologia e Malattie del Metabolismo, Azienda Sanitaria-Universitaria Integrata, Santa Maria della Misericordia di
Udine
¹¹UO di Endocrinologia e Diabete, Università Campus Bio-Medico, Roma
¹²Fondazione CNR-Regione Toscana G Monasterio, Pisa
¹³UOC SMeL2 Analisi Chimico Cliniche ASST Papa Giovanni XXIII, Bergamo
¹⁴Poznań University of Physical Education, Poznań, Polska
¹⁵Membro del Gruppo di Studio inter-societario SIBioC-SIOMMMS Marcatori biochimici del turnover del tessuto osseo e del
tessuto muscolare
¹⁶Membro del Consiglio Direttivo ELAS
¹⁷Presidente SIOMMMS
¹⁸Membro del Gruppo di lavoro AME Metabolismo minerale e osseo
¹⁹Member of the Working Group IFCC Bone markers

Vitamin D, and its metabolites, have key roles in the functioning of virtually all tissues. Indeed, besides the unquestioned role in bone mineral metabolism, evidences have pointed out roles in inflammation and autoimmunity, skeletal muscle and cardiac function, neuromuscular communication. Therefore, vitamin D deficiency associates with rickets in the child, osteomalacia and increased risk of fracture in the adulthood and possibly with the increased risk of other pathological conditions.
In order to regulate the prescription of vitamin D supplementation (cholecalciferol, cholecalciferol/calcium salts, calcifediol) to the adult population, and consequently to contain the costs sustained by the National Health System, the Italian Medicine Agency (AIFA) has recently drafted the “Nota 96” identifying the categories of patients, based on the laboratory measurement of serum levels of 25(OH)D, that can benefit from the reimbursement of vitamin D therapy. If the “Nota 96”, AIFA has the merit to define rules in a field only sligtly regulated, several considerations emerged from its analysis. From an analytical point of view, the “Nota 96” does not consider the issues of reliability and reproducibility of 25(OH)D measurement and standardization of the units of measurement and reporting. On the clinical side, the “Nota 96” does not consider the epidemic vitamin D insufficiency/deficiency that needs an adequate preventive approach and, furthermore, beyond its roles, the agency indicates the clinical conditions for whom vitamin D prescription is allowed. This document analyses the content of “Nota 96” highlighting the points that need further evaluations and by giving possible different solutions; the document provides also recommendations on laboratory reporting of vitamin D measurements