scholarly journals EFORT recommendations for off-label use, mix & match and mismatch in hip and knee arthroplasty

2021 ◽  
Vol 6 (11) ◽  
pp. 982-1005
Author(s):  
Keith Tucker ◽  
Klaus-Peter Günther ◽  
Per Kjaersgaard-Andersen ◽  
Jörg Lützner ◽  
Jan Philippe Kretzer ◽  
...  
Keyword(s):  
Knee Arthroplasty ◽  
Revision Arthroplasty ◽  
Off Label Use ◽  
Off Label ◽  
Risks And Benefits ◽  
Hip And Knee Arthroplasty ◽  
Primary Hip Arthroplasty ◽  
The One ◽  
Safety Initiative ◽  
Label Use

Off-label use is frequently practiced in primary and revision arthroplasty, as there may be indications for the application of implants for purposes outside the one the manufacturers intended. Under certain circumstances, patients may benefit from selective application of mix & match. This can refer to primary hip arthroplasty (if evidence suggests that the combination of devices from different manufacturers has superior results) and revision hip or knee arthroplasty (when the exchange of one component only is necessary and the invasiveness of surgery can be reduced). Within the EFORT ‘Implant and Patient Safety Initiative’, evidence- and consensus-based recommendations have been developed for the safe application of off-label use and mix & match in primary as well as revision hip and knee arthroplasty. Prior to the application of a medical device for hip or knee arthroplasty off-label and within a mix & match situation, surgeons should balance the risks and benefits to the patient, obtain informed consent, and document the decision process appropriately. Nevertheless, it is crucial for surgeons to only combine implants that are compatible. Mismatch of components, where their sizes or connections do not fit, may have catastrophic effects and is a surgical mistake. Surgeons must be fully aware of the features of the components that they use in off-label indications or during mix & match applications, must be appropriately trained and must audit their results. Considering the frequent practice of off-label and mix & match as well as the potential medico-legal issues, further research is necessary to obtain more data about the appropriate indications and outcomes for those procedures. Cite this article: EFORT Open Rev 2021;6:982-1005. DOI: 10.1302/2058-5241.6.210080

scholarly journals P100 A practical framework for the assessment of risks and benefits of off-label prescribing in paediatrics (ARBOP-P)

2019 ◽  
Vol 104 (6) ◽  
pp. e59.1-e59
Author(s):  
TM Van der Zanden ◽  
NJ Vet ◽  
SN de WIldt
Keyword(s):  
Healthcare Professionals ◽  
Off Label Use ◽  
Dose Selection ◽  
High Quality ◽  
Off Label ◽  
Risks And Benefits ◽  
High Quality Evidence ◽  
Practical Guidance ◽  
Quality Evidence ◽  
Label Use

BackgroundGuidelines for off-label prescribing are emerging.1–6 However, these guidelines do not provide practical guidance to assess the risk benefit balance and select the right paediatric dose We, therefore, aimed to develop a practical framework to guide paediatric healthcare professionals to assess the risks and benefits of off-label use.MethodsWe have reviewed available literature on the suggested criteria for appropriate off-label use and evaluated these criteria for relevance in paediatrics. For guidance on dose-selection we searched for regulatory guidance on paediatric drug development. Next, the literature was searched for strategies that can be applied to assess the risks and benefits of off-label use. Based on literature findings a framework was proposed to provide practical guidance to physicians for off-label prescribing. Finally, the framework was applied to a case.ResultsThe following conditions for appropriate off-label use were identified based on available literature: 1. Medical need for off-label use. 2. Off-label use is based on ‘high quality evidence’. As ‘high quality evidence’ in paediatrics is often lacking-, we propose to replace the need for high quality evidence by a positive risk-benefit assessment based on available evidence. 3. Parents and patients are informed. This is not feasible for every single drug prescribed off-label, we propose a graded approach 4. The outcomes of off-label use are followed up.The PROACT-URL framework7 for decision-making as well as the FDA paediatric decision tree8 seem helpful tools to guide decisions in real-life practice.ConclusionWe identified important aspects and tools to develop a framework (ARBOP-P) to guide healthcare professionals on how to systematically assess and balance the benefits and risks for off-label use, including dose selection, to ultimately optimize efficacy and safety of paediatric off-label prescribing.ReferencesFrattarelli DA, Galinkin JL, Green TP, et al. Off-label use of drugs in children. Pediatrics 2014;133:563–7Online.Dooms M, Killick J. Off-label use of medicines: The need for good practice guidelines. Int J Risk Saf Med. 2017;29:17–23Online.Gazarian M, Kelly M, McPhee JR, Graudins LV, Ward RL, Campbell TJ. Off-label use of medicines: consensus recommendations for evaluating appropriateness. Med J Aust 2006;185:544–8Online.Largent EA, Miller FG, Pearson SD. Going off-label without venturing off-course: evidence and ethical off-label prescribing. Arch Intern Med 2009;169:1745–7Online.Ansani N, Sirio C, Smitherman T, et al. Designing a strategy to promote safe, innovative off-label use of medications. Am J Med Qual 2006;21:255–61Online.Weda M, Hoebert J, Vervloet M, et al. Study on the off-label use of medicinal products in the European Union.: www.ec.europa.com 2017.Hammond J, Keeney R, Raiffa H. Smart Choices:A practical guide to making better decisions. Boston, MA.: Harvard Business School Press.; 2002.Dunne J, Rodriguez WJ, Murphy MD, et al. Extrapolation of adult data and other data in pediatric drug-development programs. Pediatrics. 2011;128:e1242–9 Online.Disclosure(s)Nothing to disclose

scholarly journals THE ETHICS OF PRESCRIBING OFF-LABEL DRUGS IN CHILDREN.THE DILEMMA OF SILDENAFIL

2015 ◽  
Vol 64 (2) ◽  
pp. 126-130
Author(s):  
Laszlo-Zoltan Sztankovszky ◽  
◽  
Magdalena Iorga ◽  
Cristian Gheonea ◽  
Georgiana Russu ◽  
...  
Keyword(s):  
Pediatric Cardiology ◽  
The Other ◽  
Off Label Use ◽  
Off Label ◽  
Other Hand ◽  
Widespread Phenomenon ◽  
The One ◽  
Age Range ◽  
Label Use

The off-label prescription means that medicines are administered by an unlicensed route, in an unlicensed formulation or dosage or to a child below the stated age range. The use of drugs in an off-label or unlicensed manner to treat children is widespread. Because many prescribed treatments for children have not been adequately tested in children, this population of patients remains a vulnerable one. On the one hand, prescribing off-label use drugs in children determines a lot of controversies but, one the other hand, without this possibility, could be deprived of a chance to be treated. The paper presents the widespread phenomenon of off-label us drugs in children, reflecting in scientific studies in USA and Europe. An important focus is on Romanian statistic of Sildenafil prescription and on dilemmatic use of it in pediatric cardiology unit.

scholarly journals Analysis of primary outpatient data for off-label use of medicines in neurology

Pharmacia ◽  
2019 ◽  
Vol 66 (4) ◽  
pp. 165-170
Author(s):  
Maria Drenska ◽  
Savina Elitova ◽  
Velina Grigorova ◽  
Emilia Naseva ◽  
Ilko Getov
Keyword(s):  
Product Information ◽  
National Level ◽  
The European Union ◽  
Off Label Use ◽  
Off Label ◽  
Medical Needs ◽  
Wide Range ◽  
Adults And Children ◽  
The One ◽  
Label Use

Introduction: The off-label use of medicines is a common practice that covers a wide range of therapeutic areas in both, adults and children. So far, the extent of off-label use among neurology patients in Bulgaria has not been studied. The aim of this study is to provide data on the off-label use in neurology patients in Bulgaria and to contribute to planning actions by the European Commission and EMA to provide a harmonized guideline and to regulate the off-label use of medicines within the European Union. Materials and methods: The data on prescriptions of 360 neurology outpatients, treated in a 1 – year period, were recorded and provided for analyses. The Summaries of Product Characteristics, were used as reference documents for assessment of prescriptions. Results: The results from this study show that most neurology patients (63%) were exposed to off-label use. Most of the medicines prescribed off-label (90%), were used for a therapeutic indication, other than the one listed in the authorized product information. Meloxicam is found to be the most commonly prescribed off-label medicine. Other medicines, like trasadone, pentoxyfylline and fupentixol / melitracen were prescribed less frequently, but deserve special attention, as they were found to be used off-label to a very large extent, some of them in 100% of prescriptions. Half of the top 10 medications, most commonly used off-label in neurology, were found to be non-steroidal anti-inflammatory drugs. Conclusion: The results reveal a big gap between the authorized medicines and the real medical needs. Further studies based on a larger number of medical centers are needed to establish more accurate data on off-label prescribing in neurology patients on a national level.

Abstract 2563: Off Label Use Of Sirolimus Eluting Stent Increases The Rate Of Death And Stent Thrombosis Without Jeopardizing The Efficacy: Result Of The Evastent Matched Corhort Registry

Circulation ◽  
2007 ◽  
Vol 116 (suppl_16) ◽  
Author(s):  
Aude Boignard ◽  
Alison Foote ◽  
Jean Louis Quesada ◽  
Mohamed Sahnoun ◽  
Nicolas Danchin ◽  
...  
Keyword(s):  
Stent Thrombosis ◽  
Safety Concern ◽  
Diabetic Patients ◽  
Off Label Use ◽  
Off Label ◽  
Risk Of Death ◽  
Sirolimus Eluting Stent ◽  
One Year ◽  
The One ◽  
Label Use

In everyday practice the off label use of DES is widespread, but are SES as effective in reducing the need for revascularisation when used on-label and do certain types of off-label use raise greater safety concerns? The EVASTENT nationwide matched cohort registry was designed to assess the efficacy and safety of the SES in diabetic patients with single or multiple vessel disease (SVD and MVD) compared to non-diabetic patients. 1731 pts were included (844 diabetic and 730 MVD patients). Although on-label use of SES was required patients presenting with various categories of off-label lesions were included. 428 (24% ) patients included and 514/ 2730 lesions (19%) treated were off-label: bifurcation lesions (n=182), lesions with thrombus (n=139), highly calcified lesions (n=134), ostial lesions (n=102), very long (>30 mm) lesions (n=15), left-main stenosis n=11), EF<0.30 (n=7). In 73 cases the lesion was off-label for more than one reason. Complete interim one year follow-up data are available for 98% of the patients and in October 2007 most patients will have been followed for 3 years. All MACES (cardiac death, non-fatal myocardial infarction and Stent thrombosis ST) have been evaluated by an independent critical events committee and cases of ST have been classified according to the ARC criteria. Results: off-label use was not more frequent in diabetic patients but occurred more often in MVD patients. Table 1 shows the one-year comparison between on and off-label use. Subgroup analysis suggests that highly calcified, bifurcation and ostial lesions are particularly at risk for ST. In multivariate analysis off-label use remained an independent predictor of death and the occurrence of MACEs. Conclusion: Off-label use of SES does not reduce the efficacy of the SES, but increases the risk of death and ST. This safety concern must be taken into consideration when designing studies to evaluate new indications for these DES. On and Off-Label comparison

Indikationsfremde Anwendung von Medikamenten und Medizinprodukten in der Notfallmedizin

2019 ◽  
Vol 14 (04) ◽  
pp. 361-371
Author(s):  
Karl Peter Ittner ◽  
Joachim Koppenberg ◽  
Ute Walter
Keyword(s):  
Off Label Use ◽  
Off Label ◽  
Label Use

ZusammenfassungWenn zugelassene Arzneimittel außerhalb der in der entsprechenden Fachinformation dargelegten Beschreibungen angewendet werden, dann spricht man von einer nicht zulassungskonformen Anwendung oder von einem Off-Label-Use. Wie in fast allen medizinischen Fachgebieten gibt es auch im Rettungsdienst sogenannte Off-Label-Use-Pharmakotherapien. Sofern evidenzbasierte Informationen zu einer nicht zulassungskonformen Anwendung vorliegen, und insbesondere im konkreten Notfall keine zulassungskonforme Möglichkeit besteht, dann ist diese gerechtfertigt. Verwendet ein Notarzt aber ein Medizinprodukt außerhalb der Zulassung, dann stellt er ein neues Produkt her und haftet persönlich bei einem Patientenschaden.

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