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Compassionate drug uses in Italy. Analysis at single-center level
Daniela Pilunni1, Maria Erica Blandino1, Pierluigi Navarra2
1Farmacia Prodotti Sperimentali, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
Compassionate drug use is widespread across Italy but concentrated in a few specialized centers. This study reveals that a small percentage of healthcare facilities manage the majority of these essential treatments.
Area of Science:
- Pharmaceutical Medicine
- Health Services Research
Background:
- Compassionate use programs provide access to investigational drugs for patients with serious conditions.
- Previous analysis showed broad geographical diffusion of compassionate drug use in Italy, linked to regional population size.
Purpose of the Study:
- To investigate the distribution of compassionate drug dispensing at the single-center level.
- To test if compassionate drug use concentrates in a limited number of centers within each region.
Main Methods:
- Data from pharmaceutical company compassionate use programs in Italy were analyzed.
- Centers were ranked by the number of compassionate uses dispensed.
- Cutoff levels (75% and 90%) were used to determine the number of centers responsible for these percentages.
Main Results:
- A small proportion of centers dispense the majority of compassionate drugs: 27.11% and 45.48% of centers account for 75% and 90% of uses, respectively.
- In several regions, centers dispensing 75% of compassionate drugs are concentrated in a single town.
- Academic and research hospitals (IRCCS) are significantly represented among these high-dispensing centers.
Conclusions:
- Despite widespread availability across Italian regions, compassionate drug management is centralized.
- A limited number of dispensing centers handle the bulk of compassionate drug use nationwide.
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