Reimbursement Policies Discourage Off-Label Drug Use

Eastman, Peggy

doi:10.1097/01.cot.0000290944.45158.35

Cited by 5 publications

(4 citation statements)

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“…Our study shows that the OL use of antineoplastic drugs is significantly greater in palliative oncological treatment strategies, in metastatic stages of the disease, and especially as second- and third-line treatments. These findings are consistent with those obtained in the USA by the GAO (Laetz and Silberman, 1991; United States General Accounting Office, 1991; Eastman, 2005) on the OL use of antineoplastic agents and those of other studies with smaller sample sizes (Kocs and Fendrick, 2003; Peppercorn et al, 2008; Roila et al, 2009; Cioffi et al, 2012; Cohen et al, 2013; Joerger et al, 2014).…”

Section: Discussionsupporting

confidence: 89%

The Off-Label Use of Antineoplastics in Oncology Is Limited But Has Notable Scientific Support in a University Hospital Setting

et al. 2019

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Purpose: The off-label (OL) use of antineoplastic drugs for the treatment of various types of tumors in patients of different disease stages is becoming a common occurrence. The objective of this study was to analyze these patterns by quantification and characterization of the OL use of antineoplastic drugs and their level of scientific evidence in a medium/high-complexity Spanish general university hospital.Method: All oncology patients who underwent OL treatment with one or several antineoplastics during the 10 years from 2002 to 2012 were retrospectively selected. The use of these drugs was considered OL if they were used for indications, stages, lines of treatment, or chemotherapy schemes not reflected in the summary of product characteristics published by the European Medicines Agency at the time of prescription. To calculate the prevalence of patients who received one or more OL treatments during the study period, all patients whose primary or secondary diagnosis had been coded with the diagnoses included in the study were selected through the minimum basic data set (MBDS). This database was cross-referenced with that of the Farmatools® program (Dominion®), which collects information on all patients receiving chemotherapy to obtain the total number of patients who received chemotherapy in the hospital during this period.Results: In total, 684 patients and 866 OL treatments were included. The prevalence of patients undergoing OL treatment with antineoplastics was 6%. OL treatments were used mainly for breast, gynecological, lung, and gastric tumors. The most often-used antineoplastic was paclitaxel, followed by gemcitabine, carboplatin, vinorelbine, and capecitabine, which were used mainly in monotherapy and with palliative intent. A total of 56.1% of the OL schemes used had a level of evidence of 2A according to the National Comprehensive Cancer Network, and 55.3% had a level of evidence of 2B according to Micromedex®.Conclusion: The OL use of antineoplastics in oncology patients is limited; their use is mainly focused in a small group of tumors and at advanced stages of disease. OL use of antineoplastics occurs under palliative therapeutic strategies with a limited number of drugs, preferably off-patent drugs. In addition, these OL treatments have high levels of clinical evidence.

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Section: Discussionsupporting

confidence: 89%

The Off-Label Use of Antineoplastics in Oncology Is Limited But Has Notable Scientific Support in a University Hospital Setting

et al. 2019

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“…7–9 The incidence of off-label use for the five most commonly prescribed chemotherapeutic agents has been reported to exceed 50%. 10 Furthermore, off-label prescribing patterns are common in adult critically ill patients. 11 …”

Section: Introductionmentioning

confidence: 99%

A Multicenter Evaluation of Off-Label Medication Use and Associated Adverse Drug Reactions in Adult Medical ICUs

Smithburger

Buckley

Culver

et al. 2015

Critical Care Medicine

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Objective Prior research indicates off-label use is common in the intensive care unit (ICU); however the safety of off-label use has not been assessed. The study objective was to determine the incidence of adverse drug reactions (ADRs) associated with off-label use and evaluate off-label use as a risk factor for the development of ADRs in an adult ICU population. Setting Medical ICUs at three academic medical centers Patients Adult patients (age ≥ 18 years old) receiving medication therapy Interventions All administered medications were evaluated for Food and Drug Administration (FDA) approved or off-label use. Patients were assessed daily for the development of an ADR through active surveillance. Three ADR assessment instruments were used to determine the probability of an ADR resulting from drug therapy. Severity and harm of the ADR were also assessed. Cox proportional hazard regression was used to identify a set of covariates that influenced the rate of ADRs. Measurements and Main Results Overall, 1654 patient days (327 patients) and 16,391 medications were evaluated, with 43% of medications being used off-label. One hundred and sixteen ADRs were categorized dichotomously (FDA or off-label), with 56% and 44% being associated with FDA approved and off-label use, respectively. The number of ADRs for medications administered and number of harmful and severe ADRs did not differ for medications used for FDA approved or off-label use (0.74% vs 0.67%, p = 0.336; 33 vs. 31 events, p=0.567; 24 vs. 24 events, p = 0.276). Age, sex, number of high-risk medications, number of off-label medications, and severity of illness score were included in the Cox proportional hazard regression. It was found that the rate of ADRs increases by 8% for every one additional off-label medication (HR = 1.08; 95 % CI: 1.018–1.154). Conclusion While ADRs do not occur more frequently with off-label use, ADR risk increases with each additional off-label medication used.

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“…The study found that the top five drugs used in oncology practices represent almost 50% of the total number of mentions of physician-administered drugs used off-label. [5] A retrospective survey on the use of rituximab showed that 75% of rituximab prescriptions in a National Cancer Institute (NCI) designated comprehensive cancer center was for off-label indications. [3] A large study conducted in the USA revealed that 33.2% of chemotherapy, including hormonal therapy, administered by oncologists was being used off-label.…”

Section: Introductionmentioning

confidence: 99%