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 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.
Toscani
Franco
F
Lino Maestroni Foundation Palliative Medicine Research Institute, Cremona, Italy. istitutomaestroni@fastpiu.it
Di Giulio
Paola
P
Campi
Rita
R
Pellerin
Ivanoe
I
De Luca
Anna
A
Casale
Giuseppe
G
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003430:Cross-Sectional Studies; D005260:Female; D019538:Health Care Surveys; D006738:Hospices / Q000706:statistics & numerical data*; D006801:Humans; D007558:Italy; D008297:Male; D008875:Middle Aged; D056687:Off-Label Use / Q000706:statistics & numerical data*; D013727:Terminal Care / Q000706:statistics & numerical data*