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.

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.

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.

Botulinumtoxin in der Urologie

2010 ◽  
Vol 29 (09) ◽  
pp. 551-555
Author(s):  
W. N. Vance ◽  
J. Wissel
Keyword(s):  
Off Label Use ◽  
Botulinumtoxin A ◽  
Off Label ◽  
Label Use

ZusammenfassungAlle Indikationen zur Anwendung von Botulinumtoxin A (BoNT A) in der Urologie befinden sich im Status des sogenannten off label use, entsprechend sind Kernfragen wie z. B. die Kostenübernahme nicht geklärt. Erst 20 Jahre nach der ersten Anwendung in der Urologie werden Zulassungsstudien durchgeführt. Andererseits sind insbesondere die Behandlungsmöglichkeiten im Bereich der neurogenen Harnblase so etabliert, dass sie bereits in die urologischen Leitlinien Einzug gefunden haben. Hinsichtlich der Dosierung von BoNT A und der optimalen Anwendungstechnik bestehen weder allgemein anerkannte Handlungsanweisungen noch offizielle Empfehlungen. Dies gilt auch im Bereich der Anästhesie zur Injektion von BoNT A im urologischen Gebiet. Nicht wenige Patienten schrecken davor zurück, sich regelmäßig, zum Teil jährlich, einer Allgemeinanästhesie zu unterziehen. Ein besonderer Hoffnungsschimmer stellt für multimorbide Patienten mit hohem OP-Risiko die sich entwickelnde Behandlung der Prostatahyperplasie mittels BoNT A dar, insbesondere da in allen Studien die Lokalanästhesie angewandt wurde und nur wenige Nebenwirkungen auftraten.

Fallbeispiel eines off-label-use von Bosentan bei sekundärer PAH

Pneumologie ◽  
2008 ◽  
Vol 62 (S 2) ◽  
Author(s):  
W Hohenforst-Schmidt ◽  
K Lorenz ◽  
C Axthelm ◽  
H Altmannsberger
Keyword(s):  
Off Label Use ◽  
Off Label ◽  
Label Use
Sign in / Sign up

Export Citation Format

Share Document