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.

Off-Label Use of Medicines: A Comparative Study on the Regulation of Medicinal Products in Selected European Union Member States

2020 ◽  
pp. 1-22
Author(s):  
Wolney da Cunha SOARES JÚNIOR
Keyword(s):  
European Union ◽  
Off Label Use ◽  
Off Label ◽  
Pharmaceutical Firms ◽  
Regulatory Systems ◽  
Trade Offs ◽  
Long Run ◽  
Drug Regulations ◽  
European Union Member States ◽  
Label Use

Many governments have implemented a controlled off-label use of medicines as a tool combined with reimbursement decisions, among other policies, to avoid pharmaceutical firms gaming regulatory systems based on the requirement for marketing authorisation. This article aims to compare the drug regulations in selected European Union countries (France, Italy and Germany) in order to identify specific provisions and concrete solutions implemented by them regarding that matter. The employment of an economic analysis of the law as a theoretical framework allows for the identification of the incentives created in the long run by the referred regulations. The scholarly literature identifies a myriad of drawbacks and advantages associated with off-label practices, and a welfare analysis is ambiguous. Off-label practices are a reality; thus, it is advisable to elaborate policy measures in order to address these practices and condition them on some requirements, taking into account that off-label practices imply trade-offs among access to healthcare, protection of public health, competitiveness and innovation in the industry.

scholarly journals Off-label use of bevacizumab for wet age-related macular degeneration in Europe

2019 ◽  
Vol 258 (3) ◽  
pp. 503-511
Author(s):  
Tomas Bro ◽  
Magdalena Derebecka ◽  
Øystein Kalsnes Jørstad ◽  
Andrzej Grzybowski
Keyword(s):  
Macular Degeneration ◽  
European Countries ◽  
Age Related Macular Degeneration ◽  
Off Label Use ◽  
Off Label ◽  
Age Related ◽  
Governmental Institutions ◽  
Very High ◽  
Wet Amd ◽  
Label Use

Abstract Purpose To analyse current off-label use of bevacizumab for wet age-related macular degeneration (AMD) in Europe. Methods The study was conducted as a combined survey and literature review. It included the 22 most populous countries in Europe. In each country, ophthalmologists with particular knowledge about off-label treatment responded to a questionnaire. Results Answers were obtained from twenty European countries. The off-label use of bevacizumab for wet AMD greatly differed between nations; the bevacizumab proportion varied from non-existent (0%) to very high (97%). There were also large disparities within single countries (e.g. 0–80%), which were attributable to differences in regional decision-making. Both governmental institutions and national ophthalmological societies expressed highly diverging opinions on the use of off-label treatment. Intravitreal administration of bevacizumab had been a matter of legal dispute in several countries. The question about responsibility for off-label therapy mainly remained unanswered. Conclusions There was a highly varying utilization of bevacizumab between European countries. Despite an intention of a consistent approach to medical regulations, Europe has not yet reached a professional or political consensus on the ophthalmic off-label use of bevacizumab.

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.

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.

scholarly journals OFF-LABEL USE OF MEDICINAL PRODUCTS - LEGAL RULES AND PRACTICES

2019 ◽  
Vol 76 (4) ◽  
pp. 621-628
Author(s):  
Janusz Jaroszyński ◽  
Aneta Mela ◽  
Marzena Furtak-Niczyporuk ◽  
Anna Staniszewska ◽  
Łukasz A. Poniatowski ◽  
...  
Keyword(s):  
Off Label Use ◽  
Medicinal Products ◽  
Legal Rules ◽  
Off Label ◽  
Label Use
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