Off-label prescribing in oncology

Poole, Susan; Dooley, Michael

doi:10.1007/s00520-004-0593-6

Cited by 58 publications

(49 citation statements)

References 19 publications

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“…OLDU is a common practice throughout the world with rates reported to be between 18% and 36% in adults (3)(4)(5)(6) and 3%-87% in pediatric patients (7)(8)(9)(10)(11)(12)(13)(14)(15). Moreover, the incidence of OLDU may vary depending on several factors such as the healthcare facility and the disease profile (11).…”

Section: Introductionmentioning

confidence: 99%

A nationwide evaluation of off-label drug utilization in Turkey

Özdamar¹,

Akıcı²,

Alkan³

et al. 2017

Turk J Med Sci

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Background/aim: Off-label drug use (OLDU) is under the control of the Turkish Medicines and Medical Devices Agency (TMMDA) in Turkey. It was aimed to investigate demographic and medical features of patients with OLDU applications in Turkey. Materials and methods:A total of 4426 electronic OLDU application records of the TMMDA were evaluated retrospectively. Information regarding patients' demographic characteristics, diagnoses, requested drugs, institutions, and specialties of the physicians were evaluated.Results: OLDU applications were mostly made by rheumatologists (21.5%) and 95.2% of them were approved by the TMMDA. The mean age of the patients was 35 years and 54.4% of them were female. Off-label drugs were mostly prescribed for patients aged 18-64 years (62.1%) and were most frequently prescribed by physicians from university medical centers (81.0%). Systemic lupus erythematosus (10.1%) was the most common diagnosis. Mycophenolate (16.1%) and rituximab (10.1%) were the most frequently prescribed off-label drugs. There were differences regarding some characteristics of patients and their physicians among most frequently prescribed off-label drugs (P < 0.05). Conclusion:It is noteworthy that OLDU applications showed demographical and institutional differences. It is expected that this study will provide important contributions to physicians working in the relevant area with respect to treatment alternatives of diseases with treatment challenges.

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Section: Introductionmentioning

confidence: 99%

A nationwide evaluation of off-label drug utilization in Turkey

Özdamar¹,

Akıcı²,

Alkan³

et al. 2017

Turk J Med Sci

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“…The off-label use of drugs in oncology has been estimated to reach 50%, or even more [2][3][4]. In pediatrics, the off-label issue is particularly widespread, all the more in pediatric oncology [5].…”

Section: Editorialmentioning

confidence: 99%

The off-label use of drugs in oncology: a position paper by the European Society for Medical Oncology (ESMO)

Casali

2007

Annals of Oncology

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“…As mentioned in the introduction medication used in children is in many instances off-label or unlicensed [17,18]. This is due to the free choice of pharmaceutical companies to apply for a specific indication.…”

Section: Discussionmentioning

confidence: 99%

Licensing and labelling of drugs in a paediatric oncology ward

Berg

Tak

2011

Brit J Clinical Pharma

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WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT• High percentages of off-label and unlicensed drug use are common in paediatrics.• Data in paediatric oncology patients hardly exist.• Extemporaneously prepared formulations are common. WHAT THIS STUDY ADDS• Off-label and unlicensed use is substantially higher for cytostatic drugs in paediatric as compared with adult oncology.• Comparison with other paediatric reports on drug use cannot be made due to different percentages of diseases in the reports and other rules to dispense medication in the out-patient setting.• There is an urgent need for suitable formulations, licensing of dosages and provision of data on safety and efficacy in children with malignancies. AIMPaediatric drug prescriptions are known for their high percentages of off-label and unlicensed use. In paediatric oncology data available are scarce. The aim of this paper is an analysis of the licensing and labelling status of all prescribed medication over a 2 week period in a Dutch paediatric oncology centre. METHODSAn analysis of the delivery of medication by the hospital pharmacy to patients admitted to the paediatric oncology centre was carried out. RESULTSIn total 268 precriptions were filed for 39 patients. In 87% of children unlicensed medication was used. Fifty-nine per cent of the children received at least two unlicensed drugs. In total 72% of the drugs were used licensed and on-label was found in 57% of the prescriptions. There was a trend that in younger children percentages were lower. International and local guidelines necessitated in many cases unlicensed use, e.g. intrathecal prednisolone, low dose medication such as heparin, ethanol and vancomycin for locking intravenous devices and higher intravenous vancomycin dosages. There were no major differences with respect to type of malignancy. CONCLUSIONOur figures are substantially higher than the figures reported from adult oncology. Comparison with other paediatric reports are cumbersome, due to different percentages of diseases in the reports and other rules to dispense medication in the outpatient setting. Our data are in line with reports mentioning the higher percentages of unlicensed and off-label use. Our data further underpin the need for more research on suitable formulations, dosages, safety and efficacy in these children.

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Off-label prescribing in oncology

Cited by 58 publications

References 19 publications

A nationwide evaluation of off-label drug utilization in Turkey

A nationwide evaluation of off-label drug utilization in Turkey

The off-label use of drugs in oncology: a position paper by the European Society for Medical Oncology (ESMO)

Licensing and labelling of drugs in a paediatric oncology ward

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