Italy. Annex 4-1.10 [Recent legislation developments]

Currently, there are over 250 nuclear medicine departments in Italy, for a population of 60 million, where around 65% of them are in public hospitals, while the others are in private institutions. Approximately 50% of NM departments include PET/CT scanners. Classic nuclear medicine examinations are 650 000 a year, while ~200 000 PET a year are performed. Over 50% of the nuclear medicine departments are engaged in the therapy with radiopharmaceuticals, although most of them make use of commercially available, 'ready-to-use' radiopharmaceuticals, and only a few centres are involved in their preparation 'on site'. About 35% of SPECT procedures are bone scintigraphy, followed by a 25% of myocardial perfusion imaging. ^99mTc labelled radiopharmaceuticals are prepared within nuclear medicine departments by specifically trained technicians, under the responsibility of the nuclear medicine doctor. PET scans are most often (>95%) performed in the field of oncology with most of these utilising [¹⁸F] FDG; remaining PET examinations are represented by myocardial perfusion studies with [¹³N] NH₃, and PET brain scans again with [¹⁸F] FDG and, more recently with the 'new wave' of radiopharmaceuticals for β-amyloid plaque imaging. An increasing number of Institutes (about 20, to date) are currently equipped for the preparation of ⁶⁸Ga labelled peptides, in particular [⁶⁸Ga] DOTATOC. PET radiopharmaceuticals, including those prepared using generator produced radionuclides, may be prepared, for internal use, by nuclear medicine radiopharmacies. However, due to their enhanced complexity, preparations are performed under the responsibility of highly trained personnel. There are 38 cyclotrons in Italy, 26 are included in public or private hospitals, while 12 are owned and operated by commercial manufacturers. Due to specific national legislation, it is currently allowed in Italy for hospital radiopharmacies to prepare and distribute [¹⁸F]FDG [IV-26]. Although, a significant proportion of the overall [¹⁸F] FDG doses (ca 70%) are distributed by commercial manufacturers, which are based in 12 production sites located throughout the country, with the capability to cover most of the Italian regions.