Compassionate drug uses in Italy. Analysis at single-center level.

Aims: Using a database from two pharmaceutical companies that managed several compassionate use programs in the last few years in Italy, we have previously analyzed the data by the number of patients and centers in each region and province, showing that the use of compassionate drugs is largely diffused in the country, in a manner directly related to the size of population of each region. In the present study we used the same database to expand the analysis to single-center level, aiming to test the hypothesis whether, despite a good diffusion of compassionate drug uses in each region, the majority of them concentrates within a relatively low number of centers.

Methods: Data from different programs were grouped per center, and the centers were ordered per the number of compassionate uses dispensed, and per region. Two cutoff levels, at 75% and 90%, were drawn to look at the number of centers accounting for such percentages of compassionate uses in each region.

Results: Out of 343 centers throughout Italy, 93 and 156 centers (i.e., 27.11% and 45.48% of the total) account for about 75% and 90% of all compassionate drugs dispensed in Italy. In 6 regions out of 20 (Valle d'Aosta, Liguria, Umbria, Lazio, Molise and Campania) the centers accounting for 75% of all compassionate drugs dispensed are located in a single town. Forty and 20 out of the 93 centers dispensing 75% of all compassionate drugs are academic hospitals and research hospitals (Istituti di Ricovero e Cura a Carattere Scientifico, IRCCS), respectively.

Conclusions: In this study we have demonstrated that, in spite of widespread diffusion of compassionate drug uses in all Italian regions, their management is restricted to a relatively low number of dispensing centers in each region.