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Clinical and economic benefits of expanded access programs: should we strengthen these pharmacist-led initiatives?
  1. Marcella Mezza1,
  2. Roberto Brunoro2,
  3. Girolama Iadicicco2,
  4. Mariassunta Miscio2,
  5. Daniele Mengato2,
  6. Dario Gregori1,
  7. Francesca Venturini2
    1. 1UBEP - Unità di Biostatistca, Epidemiologia e Sanità pubblica, Universita degli Studi di Padova, Padova, Veneto, Italy
    2. 2Department of Hospital Pharmacy, Azienda Ospedale Universita Padova, Padova, Veneto, Italy
    1. Correspondence to Dr Roberto Brunoro, Department of Hospital Pharmacy, Azienda Ospedale Universita Padova, Padova, Veneto, Italy; roberto.brunoro{at}

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    In Italy the therapeutic use of a drug undergoing clinical trials, also known as expanded access (EA) or compassionate use (CU), is legislated by the ministerial decree of 7 September 2017 which established that patients facing serious illnesses with limited treatment options can access this pathway on positive evaluation by the local Ethics Committee and the willingness of the manufacturer to provide the drug at no cost.

    Healthcare providers should be aware of this possibility and collaborate in order to grant its application. In this regard, hospital pharmacists, as part of healthcare’s multidisciplinary teams, actively contribute to improve patient care at every step of expanded access by offering services and expertise to ensure the implementation …

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    • Contributors Planning, conception and reporting: DM. Conducting, data acquisition and analysis: MM and RB. Interpretation and review: FV and DM. Paper review: DG, GI and MAM. Guarantor: DM.

    • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

    • Competing interests None declared.

    • Provenance and peer review Not commissioned; internally peer reviewed.