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.

Off-Label Therapeutic Potential of Crisaborole

2020 ◽  
Vol 24 (3) ◽  
pp. 292-296 ◽  
Author(s):  
Caitlyn Makins ◽  
Ravina Sanghera ◽  
Parbeer S. Grewal
Keyword(s):  
Therapeutic Potential ◽  
Case Reports ◽  
Controlled Trial ◽  
Seborrheic Dermatitis ◽  
Off Label Use ◽  
Off Label ◽  
Therapeutic Uses ◽  
Adults And Children ◽  
Dermatologic Disease ◽  
Label Use

Crisaborole, a topical phosphodiesterase-4 inhibitor, was recently approved in 2016 for the treatment of mild to moderate atopic dermatitis in adults and children greater than 2 years of age. Since that time, several case reports and a small randomized controlled trial have been published regarding the off-label use of crisaborole for the treatment of other inflammatory dermatologic disorders. This paper reviews the current, albeit limited, evidence for off-label use of crisaborole for psoriasis, seborrheic dermatitis, vitiligo, and inflammatory linear verrucous epidermal nevus. Additional potential therapeutic uses for crisaborole are also postulated, based on its mechanism of action. Future studies are required to elucidate the full therapeutic potential of crisaborole; however, it is a welcome addition to the current nonsteroid topical treatments for inflammatory dermatologic disease.

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 Off-label prescription of medicines: what do we know about the legislation in EU member states?

2021 ◽  
Author(s):  
Renske Caminada ◽  
Max Polano ◽  
Anna M. G. Pasmooij ◽  
Violeta Stoyanova-Beninska
Keyword(s):  
Treatment Guidelines ◽  
European Medicines Agency ◽  
The European Union ◽  
Off Label Use ◽  
Drug Label ◽  
Member States ◽  
National Legislation ◽  
Off Label ◽  
Eu Member States ◽  
Label Use

Aim: Off-label prescription is not regulated on the European Union (EU) level and therefore not harmonised in the EU Member States (MS). Despite this, the use of medicines outside of the drug label occurs in clinical practice, and it can be included in treatment guidelines and/or reimbursed in some cases. It is, however, currently not clear to what extent off-label use can be included in regulatory discussions at a European level at the different committees at the European Medicines Agency. In this article, we provide an overview of the current legislation on MS level regarding off-label prescription in order to support EU regulatory discussions. Methods: Relevant national legislation regarding off-label prescription from MS was identified by distributing a questionnaire to EMACOLEX. Case law was excluded. The identified categorical elements and prerequisites in the national legislation were then categorised. Subsequently, a comparison was made to the five Good Off-Label Use Practice (GOLUP) principles. Results: Based on the obtained responses from 10 MS, we observed a large heterogeneity in the legislation of MS regarding off-label prescription. Five (out of 10) MS regulate off-label prescription explicitly and seven (out of 10) MS have prerequisites. One or more prerequisites per MS were reflected in the GOLUP principles as formulated in 2017. Conclusion: The main contribution of this work is to flag that off-label prescription actually needs to be well defined and understood before it can be appropriately taken into consideration in regulatory discussions. There is a heterogeneity in legislation regarding off-label prescription in the investigated MS, which may lead to different perspectives. A common understanding of the concept and more alignment in off-label prescription practices and their regulation at MS level may contribute to further regulatory discussions.

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

scholarly journals Research on Approaches for Regulation of the “Off-label” use of Medicinal Products in the European Union

2017 ◽  
Vol 44 (1) ◽  
pp. 17-21 ◽  
Author(s):  
M. Drenska ◽  
I. Getov
Keyword(s):  
European Union ◽  
European Countries ◽  
Time Range ◽  
The European Union ◽  
Off Label Use ◽  
Medicinal Products ◽  
Weak Point ◽  
Off Label ◽  
Regulatory Information ◽  
Label Use

Abstract Despite the increasingly strict legislation on medicinal products, the „off-label use“ or „use of medicinal product outside the approved summary of product characteristics (SmPC)“ is a weak point of today’s drug regulation and raises many questions about the risk, ethics, and legality of this type of practice. In recent years, through guidance and legal changes in some countries were defined the conditions and responsibilities, but in the most European countries still lack rules for off-label prescribing. The purpose of this study was to identify and analyse different approaches to regulation, adopted by some member states as well as to summarize the efforts in demand of common harmonized approach to solve this problem within the European Union. In the study, we used the available regulatory information in different electronic resources associated with the off-label drug use in selected European countries without limited time range. The results show that decisions taken to regulate the issue have significant differences and specific approach, while none of them is enough satisfactory and comprehensive. In conclusion, it can be claimed that the existing regulatory rules in various countries require significant improvement and update.

scholarly journals The knowledge and experience with the off-label use – results of a survey

Pharmacia ◽  
2019 ◽  
Vol 66 (4) ◽  
pp. 217-221 ◽  
Author(s):  
Maria Drenska ◽  
Emilia Naseva ◽  
Ilko N. Getov
Keyword(s):  
Current Knowledge ◽  
National Level ◽  
Medical Doctors ◽  
Off Label Use ◽  
Inclusion Criteria ◽  
Off Label ◽  
Eu Member States ◽  
Local Current ◽  
Statistical Program ◽  
Label Use

Introduction: The aim of this survey is to assess the current knowledge and experience of medical doctors in regard to off-label use and to determine whether it is legal, according to them, as the local current legislation on medicinal products does neither prohibit nor explicitly permit such use. Materials and methods: One hundred medical doctors from inpatient and outpatient medical care participated and answered 10 questions. The inclusion criteria were to have a degree in medicine and right to prescribe medications. Statistical analysis was performed using the SPSS v19.0 statistical program. Results: The results show that 8 out of 10 medical doctors have knowledge in regard to the meaning of the term “off-label”. More than half (62%) stated they have prescribed off-label medicine in their medical practice. Half of the respondents (49%) experienced some kind of trouble when prescribing off-label. In regard to whether the law allows this practice, opinions were divided. To a larger extent (88%), medical doctors support the introduction of clearer rules for off-label use in Bulgaria. Conclusion: Edical doctors have significant knowledge about off-label use, but feel uncertainty in their actions when they use medicines off-label. It is necessary to consider regulating this use at a national level, following the good examples of other European Union (EU) member states, until a harmonized solution within EU is found.

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 Fertility Preservation in Female Pediatric Patients With Cancer: A Clinical and Regulatory Issue

2021 ◽  
Vol 11 ◽  
Author(s):  
Serena Brancati ◽  
Lucia Gozzo ◽  
Laura Longo ◽  
Daniela Cristina Vitale ◽  
Giovanna Russo ◽  
...  
Keyword(s):  
Fertility Preservation ◽  
Ovarian Function ◽  
Product Information ◽  
Treatment Options ◽  
Health Care Facilities ◽  
Adult Women ◽  
Off Label Use ◽  
Off Label ◽  
Regulatory Issue ◽  
Label Use

Fertility preservation represents one important goal of cancer patients’ management due to the high impact on health and quality of life of survivors. The available preventive measures cannot be performed in all patients and are not feasible in all health-care facilities. Therefore, the pharmacological treatment with GnRHa has become a valuable non-invasive and well-tolerated alternative, especially in those who cannot access to cryopreservation options due to clinical and/or logistic issues. Supporting data demonstrate a significant advantage for the survivors who received GnRHa in the long-term maintenance of ovarian function and preservation of fertility. The prevention of the risk of ovarian failure with GnRHa is a typical off-label use, defined as the administration of a medicinal product not in accordance with the authorized product information. Italy has officially recognized the off-label use of GnRHa in adult women at risk of premature and permanent menopause following chemotherapy. However, fertility preservation still represents an unmet medical need in adolescents who cannot access to other treatment options.

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