Prevalence of Off-Label Use of Oral Oncolytics at a Community Cancer Center

Kalis, Joseph; Pence, Simon J.; Mancini, Robert; Zuckerman, Dan Sayam; Ineck, Joseph R.

doi:10.1200/jop.2014.001354

Cited by 19 publications

(24 citation statements)

References 7 publications

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“…The general characteristics of various studies, such as the extent and outcomes of off‐label chemotherapies, are described in Table . There were 23 studies reporting prevalence of off‐label use . Off‐label drug use was classified as category 1 ( n = 16), category 2 ( n = 10), category 3 ( n = 12) and category 4 ( n = 11) …”

Section: Resultsmentioning

confidence: 99%

“…There was no use of formulary, guidelines, package inserts or books for defining off‐label use. Five studies gave limited or no information on baseline patient characteristics . No study provide a rationale for sample size.…”

Section: Resultsmentioning

confidence: 99%

“…For ambulatory care patients, 7%–50% of prescriptions were for off‐label use . Off‐label drug use unsupported by standard treatment guidelines, or drug compendia was in the range of 7%–31% …”

Section: Resultsmentioning

confidence: 99%

“…The most commonly administered off‐label medicines were carboplatin, doxorubicin, fluorouracil, paclitaxel, docetaxel, vinorelbine, gemcitabine and oxaliplatin . The most commonly used off‐label targeted therapies include bevacizumab, trastuzumab, cetuximab, rituximab, gefitinib and erlotinib . Bevacizumab was prescribed in an off‐label manner for the treatment of metastatic colorectal cancer in a range of 10%–62% patients .…”

Section: Resultsmentioning

confidence: 99%

“…Bevacizumab was prescribed in an off‐label manner for the treatment of metastatic colorectal cancer in a range of 10%–62% patients . Off‐label use of oral and intravenous anticancer drugs was reported to be 29% and 30%, respectively . Off‐label use of patented drugs was reported to be 23% and 30% in two studies …”

Section: Resultsmentioning

confidence: 99%

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Off-label drug use in oncology: a systematic review of literature

2017

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SUMMARYWhat is known and objective: The off-label use of medicines is widespread in several diseases. This type of prescribing practice is particularly more acute in oncology. However, the suitability of anticancer medications for off-label use remains an issue of controversy, due to uncertainty around the clinical benefits and potential toxicities, limited evidence to support clinical decisionmaking, increased out-of-pocket costs for patients and ethical concerns around the lack of informed consent. Currently, data pertaining to the global prevalence of off-label use in cancer therapy are lacking. The aim of this review was to provide an overview of off-label drug use prevalence in oncology. Methods: A systematic literature search was performed in PubMed as per the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines from 1975 to 2016. Studies assessing the prevalence of off-label use of anticancer drugs were included. Data synthesis: Of the 199 eligible papers retrieved, 23 studies were included in this systematic literature review. Off-label drug use in inpatients ranged from 18% to 41%. Among adult patients with cancer, 13%-71% received a minimum of one offlabel chemotherapy. The main reasons for off-label drug use were 'drug unapproved for specific tumour' and 'modified drug applications'. Among adults, metastatic cancers and palliative care patients received the most off-label drugs. The off-label drug use unsupported by standard treatment guidelines or drug compendia was in the range of 7%-31%. Conclusion: Off-label drug use in cancer therapy is commonly practised but outcomes could vary significantly. Hence, greater scrutiny and robust clinical guidance is needed to establish the favourable benefit-risk ratio for patients at the time of prescribing at each level of oncology care to facilitate rational off-label prescribing. WHAT IS KNOWN AND OBJECTIVEOff-label drug use refers to prescribing medicines in a manner that is inconsistent with prescribing information published by regulatory authorities. Off-label drug use can be classified into different categories, such as unapproved indication, use in a special population, through an unapproved route of administration or with a dose not specified in the FDA-approved label.1 Off-label drug use based on little or no scientific evidence is termed as off- 3 Off-label drug use is further differentiated from unlicensed drug use, which refers to the use of a therapeutic entity which has never received any regulatory approval for clinical use in either paediatrics or adult population (Table 1).1 Off-label prescribing is prevalent across different diseases and healthcare settings; however, it is more frequently reported in paediatrics, psychiatry and oncology. [4][5][6] Physicians are generally allowed to prescribe the drug in an offlabel manner in most regions in the world except in countries such as India where it is illegal. 7 The off-label status of a drug could also vary among different countries due to different marketing authorization ...

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

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Off-label drug use in oncology: a systematic review of literature

2017

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State insurance mandates and off-label use of chemotherapy

Smieliauskas

Sharma

Hurley³

et al. 2017

Health Economics

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Access to cancer drugs used off-label is important to cancer patients but may drive up healthcare costs with little evidence of clinical benefit. We hypothesized that state health insurance mandates for private insurers to provide coverage for off-label use of cancer drugs cause higher rates of off-label use. We used Truven MarketScan data from 1999 to 2007 on utilization of 35 infused chemotherapy drugs in private health plans in the United States, covering the period when eight states implemented off-label coverage laws. We studied trends in off-label use of drugs, distinguishing between appropriate and inappropriate off-label use according to drug compendia, and estimated difference-in-difference regressions of the effect of state laws on off-label use. We estimate 41% of utilization was off-label, including 17% of use conservatively defined as inappropriate. Trends show gradual declines in off-label use over time. We also find no discernable effect of state laws mandating coverage of off-label use of cancer drugs on utilization patterns under multiple empirical specifications. Our conclusion is that policymakers should consider shifting away from mandating coverage as a way to ensure access to drugs off-label and towards incentivizing adherence to clinical practice guidelines to improve the quality and value of off-label use.

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Childhood cancer drugs in China: An overview and comparison of regulatory approvals in China and the United States

Zhang

Wagner

Han

et al. 2021

Intl Journal of Cancer

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Different from less developed countries, 80% of children with cancers in the United States are cured. Traditional chemotherapy drugs are the mainstay of therapies; new targeted medications have become available recently. Using publicly available data, we created a database of cancer drugs with paediatric malignancy indications approved by 31 October 2020 in China and the United States. We compared numbers, type, indications and listing on the World Health Organization Model List of Essential Medicines for Children (WHO EMLc) between the two countries, assessed the correlation between paediatric indications and cancer incidences, and described evidence supporting approvals of targeted medications in the two settings. Our study showed that by 31 October 2020, 31 and 39 cancer drugs available in China and the United States were approved for use in children, corresponding to 137 and 102 paediatric cancer indications, respectively. About half of these drugs (17 in China and 18 in the United States) were listed on the WHO EMLc. The correlation between indications and burden of disease was higher in the United States (r = 0.68) than China (r = 0.59). More traditional chemotherapy drugs were approved in China (n = 27) than the United States (n = 19). Of 20 targeted childhood anticancer medicines approved in the United States, mainly on the basis of single arm trials (27/32 indications, 84.4%), only four were approved for paediatric indications in China, at a median of 2.8 years after US Food and Drug Administration approval.A harmonised, evidence-based regulatory framework is needed to ensure approvals of needed, safe and efficacious childhood cancer drugs across the world.

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Prevalence of Off-Label Use of Oral Oncolytics at a Community Cancer Center

Abstract: Oral chemotherapies are more often used on label than off label in current practice at our community cancer center. The majority of off-label use of oral oncolytics in this study was supported by NCCN guideline recommendations.

Cited by 19 publications

References 7 publications

Off-label drug use in oncology: a systematic review of literature

Off-label drug use in oncology: a systematic review of literature

State insurance mandates and off-label use of chemotherapy

Childhood cancer drugs in China: An overview and comparison of regulatory approvals in China and the United States

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