Off-Label Prescriptions in Italian Hospices: A National Survey

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 14 7 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. J Pain Symptom Manage 2009;38:365-371. (C) 2009 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.