Dataset Information

Off-label use of drugs and devices in the neuroendovascular suite.

ABSTRACT:

Summary

The off-label use of drugs and devices in neuroendovascular procedures is common. Neurointerventionalists should be well aware of the level of evidence available in support of the off-label use of drugs and devices in their practice and some of the potential adverse events associated with them. These uses are categorized as I or II if they have been evaluated as primary or ancillary interventions in prospective trials/registries of neuroendovascular procedures and III if they were evaluated in case series. Category IV use is based on evaluation as primary or ancillary interventions in prospective trials/registries of non-neuroendovascular procedures. Physicians are allowed to use off-label drugs and procedures if there is strong evidence that they are beneficial for the patient. The neurointerventional professional societies agree that off-label use of drugs and devices is an important part of the specialty, but practicing providers should base their decisions on sound evidence when using such drugs and devices.

SUBMITTER: Abdihalim MM

PROVIDER: S-EPMC7964838 | biostudies-literature | 2013 Nov-Dec

REPOSITORIES: biostudies-literature

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Publications

Off-label use of drugs and devices in the neuroendovascular suite.

Abdihalim M M MM Hassan A E AE Qureshi A I AI

AJNR. American journal of neuroradiology 20130321 11

<h4>Summary</h4>The off-label use of drugs and devices in neuroendovascular procedures is common. Neurointerventionalists should be well aware of the level of evidence available in support of the off-label use of drugs and devices in their practice and some of the potential adverse events associated with them. These uses are categorized as I or II if they have been evaluated as primary or ancillary interventions in prospective trials/registries of neuroendovascular procedures and III if they wer ...[more]

PMID: 23518356

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Project description:ImportanceIn many health systems, access to off-label drug use is controlled through reimbursement restrictions by health insurers, especially for expensive cancer drugs.ObjectiveTo determine whether evidence from randomized clinical trials is associated with reimbursement decisions for requested off-label use of anticancer drugs in the Swiss health system.Design, setting, and participantsThis cross-sectional study used reimbursement requests from routinely collected health records of 5809 patients with drug treatment for cancer between January 2015 and July 2018 in 3 major cancer centers, covering cancer care of approximately 5% of the Swiss population, to identify off-label drug use. For each off-label use indication with 3 or more requests, randomized clinical trial evidence on treatment benefits was systematically identified for overall survival (OS) or progression-free survival (PFS). Data were analyzed from August 2018 to December 2020.ExposuresAvailable randomized clinical trial evidence on benefits for OS or PFS for requested off-label use indications.Main outcomes and measuresThe main outcome was the association between evidence for treatment benefit (expressed as improved OS or PFS) and reimbursement in multivariable regression models.ResultsAmong 3046 patients with cancer, 695 off-label use reimbursement requests in 303 different indications were made for 598 patients (median [interquartile range] age, 64 [53-73] years; 420 [60%] men). Off-label use was intended as first-line treatment in 311 requests (45%). Reimbursement was accepted in 446 requests (64%). For 71 indications, including 431 requests for 376 patients, there were 3 or more requests. Of these, 246 requests (57%) had no supporting evidence for OS or PFS benefit. Reimbursement was granted in 162 of 246 requests without supporting evidence (66%). Of 117 requests supported by OS benefit, 79 (67%) were reimbursed, and of 68 requests supported by PFS benefit alone, 54 (79%) were reimbursed. Evidence of OS benefit from randomized clinical trials was not associated with a higher chance of reimbursement (odds ratio, 0.76, 95% CI, 0.45-1.27).Conclusions and relevanceThese findings suggest that in a health care system enabling access to off-label use, it was frequently intended as a first-line treatment in cancer care. Availability of randomized clinical trial evidence showing survival benefit was not associated with reimbursement decisions for off-label anticancer drug treatment in Switzerland. A transparent process with criteria considering clinical evidence is needed for evidence-based reimbursement decisions to ensure fair access to cancer treatments.

Project description:BackgroundThe "Law on Doctors of the People's Republic of China," which was officially implemented on March 1, 2022, emphasizes the requirements for rational drug use and the necessity for appropriate management of off-label drug use. The safety and ethical considerations related to off-label drug use are different in children than in adults. There is so far no management guideline for pediatric off-label use of drugs in China, and the applicability of foreign guidelines is limited. Establishing a localized evidence-based management guideline for pediatric off-label use of drugs to support the national legislation and clinical practice is of critical importance.MethodsWe established a guideline working group, including experts from a broad range of disciplines and developed recommendations following the guidance of the World Health Organization Handbook and the Chinese Medical Association. The following themes were identified by questionnaires and expert interviews to be of great concern in the management of off-label drug use in children: general principles and characteristics of management of pediatric off-label drug use; establishment of expert committees; evidence evaluation; risk-benefit assessment; informed consent; monitoring and assessment of the risk; and monitoring and patient education. Two rounds of Delphi surveys were organized to determine the final recommendations of this guideline. We graded the recommendations based on the body of evidence, referring to the evaluation tool of the Evidence-based management (EBMgt) and the Oxford Center for Evidence-Based Medicine: Level of Evidence (March 2009).ResultsWe developed the first guideline for the management of pediatric off-label use of drugs in China.ConclusionsThe guideline is to offer guidance for pediatricians, pharmacists, medical managers, policymakers, and primary care physicians on how to manage off-label drug use in pediatrics and to provide recommendations for Chinese healthcare policy in the future.

Project description:PurposeEffective standardization of medical device labels requires objective study of varied designs. Insufficient empirical evidence exists regarding how practitioners utilize and view labeling.ObjectiveMeasure the effect of graphic elements (boxing information, grouping information, symbol use and color-coding) to optimize a label for comparison with those typical of commercial medical devices.DesignParticipants viewed 54 trials on a computer screen. Trials were comprised of two labels that were identical with regard to graphics, but differed in one aspect of information (e.g., one had latex, the other did not). Participants were instructed to select the label along a given criteria (e.g., latex containing) as quickly as possible. Dependent variables were binary (correct selection) and continuous (time to correct selection).ParticipantsEighty-nine healthcare professionals were recruited at Association of Surgical Technologists (AST) conferences, and using a targeted e-mail of AST members.ResultsSymbol presence, color coding and grouping critical pieces of information all significantly improved selection rates and sped time to correct selection (α = 0.05). Conversely, when critical information was graphically boxed, probability of correct selection and time to selection were impaired (α = 0.05). Subsequently, responses from trials containing optimal treatments (color coded, critical information grouped with symbols) were compared to two labels created based on a review of those commercially available. Optimal labels yielded a significant positive benefit regarding the probability of correct choice ((P<0.0001) LSM; UCL, LCL: 97.3%; 98.4%, 95.5%)), as compared to the two labels we created based on commercial designs (92.0%; 94.7%, 87.9% and 89.8%; 93.0%, 85.3%) and time to selection.ConclusionsOur study provides data regarding design factors, namely: color coding, symbol use and grouping of critical information that can be used to significantly enhance the performance of medical device labels.

Dataset Information

Off-label use of drugs and devices in the neuroendovascular suite.

Summary

Publications

Off-label use of drugs and devices in the neuroendovascular suite.

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