Off-label prescription of antineoplastic drugs: An Italian prospective, observational, multicenter survey

Tumori

Volumn 95, Issue 6, 2009, Pages 647-651

  Roila, Fausto ^a   Ballatori, Enzo ^b   Labianca, Roberto ^c   De Braud, Filippo ^d   Borgonovo, Karen ^e   Martelli, Olga ^f   Gallo, Ciro ^g   Tinazzi, Angelo ^h   Perrone, Francesco ⁱ  

^a S MARIA HOSPITAL   (Italy)

^b UNIVERSITY OF L'AQUILA   (Italy)

^c Dept of Medical Oncology ^*  (Italy)

^d EUROPEAN INSTITUTE OF ONCOLOGY   (Italy)

^e FATEBENEFRATELLI HOSPITAL   (Italy)

^f MOLINETTE HOSPITAL   (Italy)

^g SECOND UNIVERSITY OF NAPLES   (Italy)

^h Inst of Economics and Statistics   (Italy)

ⁱ NATIONAL CANCER INSTITUTE   (Italy)

Author keywords

Antineoplastic agents; Chemotherapy; Off label

Indexed keywords

ANTINEOPLASTIC AGENT; BEVACIZUMAB; CAPECITABINE; CARBOPLATIN; CETUXIMAB; CISPLATIN; CLADRIBINE; DOCETAXEL; DOXORUBICIN; EPIRUBICIN; ETOPOSIDE; FLUDARABINE; FLUOROURACIL; FOLINIC ACID; GEMCITABINE; IFOSFAMIDE; IRINOTECAN; METHOTREXATE; MITOMYCIN; MITOMYCIN C; NAVELBINE; OXALIPLATIN; PACLITAXEL; RALTITREXED; TOPOTECAN; TRASTUZUMAB; VINBLASTINE;

ADULT; AGED; ANUS CANCER; ARTICLE; BILE DUCT CANCER; BILIARY TRACT CANCER; BLADDER CANCER; BREAST CANCER; CANCER CENTER; CANCER COMBINATION CHEMOTHERAPY; CANCER OF UNKNOWN PRIMARY SITE; CARCINOMATOUS PERITONITIS; COLORECTAL CANCER; CONTROLLED STUDY; ENDOMETRIUM CANCER; ESOPHAGUS CANCER; FEMALE; HEAD AND NECK CANCER; HUMAN; ITALY; KIDNEY CANCER; LUNG NON SMALL CELL CANCER; LUNG SMALL CELL CANCER; MAJOR CLINICAL STUDY; MALE; MELANOMA; MESOTHELIOMA; MONOTHERAPY; NEOPLASM; NONHODGKIN LYMPHOMA; OBSERVATIONAL STUDY; OFF LABEL DRUG USE; OVARY CANCER; PANCREAS CANCER; PLEURA CANCER; PRESCRIPTION; PROSPECTIVE STUDY; SARCOMA; STOMACH CANCER; TESTIS CANCER; THYMUS CANCER; UTERINE CERVIX CANCER;

EID: 76349124677     PISSN: 03008916     EISSN: None     Source Type: Journal    
DOI: 10.1177/030089160909500601     Document Type: Article

References (12)

1. American Society of Clinical Oncology: Reimbursement for cancer treatment: coverage of off-label drug indications. J Clin Oncol, 24: 3206-3208, 2006.
2. Boos J: Off-label use - label off use? Ann Oncol, 14: 1-5, 2003.
3. Giordano SH, Duan Z, Kuo YF, Hortobagyi GN, Freeman J, Goodwin JS: Impact of a scientific presentation on community treatment pattern for primary breast cancer. J Natl Cancer Inst, 98: 382-388, 2006.
4. Redmond K: The US and European regulatory systems: a comparison. J Ambulatory Care Manage, 27: 105-114, 2004.
5. Radley DC, Finkelstein SN, Stafford RS: Off-label prescribing among office-base physicians. Arch Intern Med, 166: 1021-1026, 2006.
6. Rae M: Change at FDA may speed drug approval process and increase off-label use. J Natl Cancer Inst, 90: 805-807, 2003.
7. Hampton T: Experts weigh in on promotion, prescription of off-label drugs. JAMA, 297: 683-684, 2007.
8. O'Reilly J, Dalal A: Off-label or out of bounds? Prescriber and marketer liability for unapproved uses of FDA-approved drugs. Ann Health Law, 12: 295-324, 2003.
9. Benjamin DK Jr, Smith PB, Murphy MD, Roberts R, Mathis L, Avant D, Califf RM, Li JS: Peer-reviewed publication of clinical trials completed for pediatric exclusivity. JAMA, 296: 1266-1273, 2006.
10. Laez T, Silberman G: Reimbursement policies constrain the practice of oncology. JAMA, 266: 2996-2999, 1991.
11. Poole S, Dooley MJ: Off-label prescribing in oncology. Support Care Cancer, 12: 302-305, 2004.
12. Gazzetta Ufficiale no 129 del 6.6.2007, Supplemento Ordinario no 132, Agenzia Italiana del Farmaco, Determinazione 29.5.2007: Aggiornamento dell'elenco dei medicinali, istituito con il provvedimento della Commissione Unica del Farmaco (CUF) datato 20 luglio 2000, pubblicato nella GU no 219 del 19.9.2000 con errata-corrige nella GU no 232 del 4.10.2000, erogabili a totale carico del Servizio Sanitario nazionale, ai sensi dell'articolo 1 comma 4 del decreto legge 21.10.1996 no 536 convertito dalla legge 23.12.1996 no 648.