ReviewTherapeutics and clinical risk management2014
Ethical and legal framework and regulation for off-label use: European perspective.
Review in Therapeutics and clinical risk management, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 36 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
36 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- DEGRO practical guideline for central nervous system radiation necrosis part 2: treatment.Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2022Guideline
- A systematic review on the efficacy and safety of chloroquine for the treatment of COVID-19.Journal of critical care · 2020Pooled it
- Off-label and repurposed use of disulfiram beyond alcohol dependence: A systematic review of clinical and preclinical evidence.iScience · 2026Article
- Serious Adverse Drug Reactions Associated with Off-Label and Unlicensed Drug Use in Children: A 14-Year Analysis of VigiBase Reports from Serbia.Children (Basel, Switzerland) · 2026Article
- Off-Label Treatment of Alopecia Areata-Retrospective Study.Biomedicines · 2026Article
- Lidocaine for Depressive Symptoms and Comorbid Pain: A Narrative Review of Mechanisms, Evidence, and Safety.Drug design, development and therapy · 2026Review
- The Expanding Role of Omalizumab: From Food Allergy to Drug Desensitization.International journal of molecular sciences · 2025Review
- Individualized and innovative gender healthcare for transgender and nonbinary youth.Nature reviews. Endocrinology · 2025Review
- Off-Label Treatment in Inflammatory Skin Diseases-European Point of View.Journal of clinical medicine · 2025Review
- Off-label use of medicines in South Africa: a review.Orphanet journal of rare diseases · 2024Review
- The implementation of the guideline for the management of pediatric off-label use of drugs in China: a cross-sectional study.Translational pediatrics · 2024Article
- Stability of Oral Liquid Dosage Forms in Pediatric Cardiology: A Prerequisite for Patient's Safety-A Narrative Review.Pharmaceutics · 2023Review
- Off-label medications in the treatment of hospitalized children with atopic dermatitis.Postepy dermatologii i alergologii · 2023Article
- Recommendations for Off-Label Drug Use in Ophthalmology in China: A Clinical Practice Guideline.Frontiers in pharmacology · 2022Article
- Heterogenous use of misoprostol for induction of labour: results of an online survey among midwives in German-speaking countries.Archives of gynecology and obstetrics · 2021Article
- Off-Label Medication: From a Simple Concept to Complex Practical Aspects.International journal of environmental research and public health · 2021Review
- Measured Glomerular Filtration Rate: The Query for a Workable Golden Standard Technique.Journal of personalized medicine · 2021Review
- Association of Adherence to Surfactant Best Practice Uses With Clinical Outcomes Among Neonates in Sweden.JAMA network open · 2021Observational
- The Challenges of Crizotinib Treatment in a Child With Anaplastic Large Cell Lymphoma.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2021Article
- Understanding the relationship between safety beliefs and knowledge for cognitive enhancers in UK university students.PloS one · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
For more than 20 years the off-label use of drugs has been an essential part of the ethical and legal considerations regarding the international regulation of drug licensing. Despite a number of regulatory initiatives in the European Union, there seems to remain a largely unsatisfactory situation following a number of critical descriptions and statements from actors in the field. The present article gives an overview of the ethical and legal framework and developments in European countries and identifies existing problems and possible pathways for solutions in this important regulatory area. In addition to the presentation of the ethical and legal foundations, some attention is given to criticisms from medical practitioners to the current handling of off-label drug use. The review also focuses on the situation confronted by patients and physicians when off-label prescriptions are necessary. Through legal descriptions from a number of countries, possible solutions for future discussion of European health care policy are selected and explained.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.