Journal of Pain and Symptom Management
Volume 38, Issue 3 , Pages 365-371, September 2009

Off-Label Prescriptions in Italian Hospices: A National Survey

  • Franco Toscani, MD

      Affiliations

    • Lino Maestroni Foundation Palliative Medicine Research Institute, Cremona, Italy
    • Corresponding Author InformationAddress correspondence to: Franco Toscani, MD, Lino Maestroni Foundation Palliative Medicine Research Institute, via Palestro 1, 26100 Cremona, Italy.
    • ,
  • Paola Di Giulio, RN, MSC

      Affiliations

    • Department of Public Health and Microbiology, University of Torino, Torino, Italy
    • ,
  • Rita Campi, ScD

      Affiliations

    • Laboratory of Mother and Child Health, Mario Negri Institute, Milan, Italy
    • ,
  • Ivanoe Pellerin, MD

      Affiliations

    • Palliative Care Unit, Hospital of Legnano, Legnano, Italy
    • ,
  • Anna De Luca, MD

      Affiliations

    • Palliative Care Unit, Ospedale San Giovanni Battista, Torino, Italy
    • ,
  • Giuseppe Casale, MD

      Affiliations

    • Antea Foundation, Rome, Italy
    • ,
  • End of Life Observatory Research Group

Accepted 10 December 2008. published online 29 June 2009.

Abstract 

Off-label prescription is part of routine care in palliative medicine, but no information is available about the situation in Italy. A cross-sectional observational survey was undertaken on all 66 Italian palliative care freestanding inpatient units to describe off-label prescriptions. Data were collected on 507 patients. Each prescribed drug was matched with Italian Marketing Authorization indications: 159 drugs off-label (4.5% of all prescribed drugs) for the stated indication were given to 128 patients (25.2%), and drugs unlicensed for subcutaneous injection were given to 147 patients (85.4% of all subcutaneous prescriptions, excluding insulin and heparin). The off-label prescriptions were subsequently evaluated by referring to the Italian National Pharmaceutical Formulary (INPF) and the British Palliative Care Formulary (PCF2). Although drugs are frequently prescribed off-label in inpatient palliative care units in Italy, this strategy was not always backed by clinical evidence, and in some cases, official/authoritative sources, such as INPF and PCF2 did not support it. Clinical trials and/or agreed international guidelines are needed to support the off-label use of the most widely prescribed drugs in palliation.

Key Words: Off-label, hospice, palliative medicine, SC drugs, prescriptions in hospices, symptomatic prescriptions

 

 This study was supported by a grant from the Luogo di Vitae e di Incontro Foundation of Milan.

 A complete list of investigators is reported in the Appendix.

PII: S0885-3924(09)00532-6

doi:10.1016/j.jpainsymman.2008.11.014

Journal of Pain and Symptom Management
Volume 38, Issue 3 , Pages 365-371, September 2009

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