scholarly journals Off-label prescriptions in diabetic foot

2014 ◽  
Vol 13 (3) ◽  
pp. 192-197
Author(s):  
Luís Jesuíno de Oliveira Andrade ◽  
Larissa Santos França ◽  
Paulo Roberto Santana de Melo ◽  
Marcelo Araújo
Keyword(s):  
Diabetic Foot ◽  
Scientific Literature ◽  
Off Label Use ◽  
Medical Subject Heading ◽  
International Database ◽  
Off Label ◽  
Search Form ◽  
Potential Benefits ◽  
Targeted Drug ◽  
Methods Of Treatment

Prescription of a drug outside of the indications for which it was originally approved by regulators is internationally known as "off-label" prescription. We describe off-label treatments for the diabetic foot reported in international scientific literature. This is a qualitative and descriptive bibliographical review based on the results of a search of the Medline international database. The criteria for review were publication between January 1985 and November 2013, and the MeSH (Medical Subject Heading) keywords "off-label use" OR "off-label" OR "off-label prescribing" plus "diabetic foot" were input on the search form. Nine studies were selected that contained information about off-label treatments for the diabetic foot. We conclude that the practice of off-label prescribing has potential benefits. In some situations an off-label prescription is the only treatment available for patients, either because a more targeted drug does not exist, or because other methods of treatment are ineffective or unavailable due to patient intolerance.

scholarly journals TYPE 2 DIABETES MELLITUS PREVENTION – PRESCRIPTIONS OFF-LABEL

2014 ◽  
Vol 2 (1) ◽  
Author(s):  
Luis Jesuino De Oliveira Andrade ◽  
Paulo Roberto Santana de Melo ◽  
Mércia Alves Silva Margotto ◽  
Alcina Maria Vinhaes Bittencourt
Keyword(s):  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Inclusion Criteria ◽  
International Database ◽  
Off Label ◽  
Search Form ◽  
Wide Range ◽  
Methods Of Treatment ◽  
Selection Of

The prescribing a drug without the indications for which the drug was originally approved by regulators is internationally known as prescribing “off-label”. Objective: To describe the off-label prescriptions in type 2 diabetes (DM2) prevention, reported international scientific literature, through an integrative bibliographical review. Method: An integrative review was made by searching the Medline international database for review of manuscripts. Selection of these databases was based on the wide range of journals covered by each of them and our goal was to provide an overview of the scientific production devoted to the topic over the timeframe under analysis. The following inclusion criteria were considered during the review: articles published between January 1985 and June 2013; use of the keywords “off-label use” OR “off-label” OR “off-label prescribing” OR “diabetes prevention” OR “prevention” MeSH “diabetes mellitus” entered into the search form, and availability of an abstract in English. Results: A total 852 scientific productions were identified, and 30 studies were selected by contain information about the off-label prescriptions in DM2. Conclusion: The practice of off-label prescribing itself has notable benefits. In some situations, an off-label prescription is the only treatment available to a patient, either because a more targeted drug is does not exist, or because other methods of treatment are ineffective or unavailable due to patient intolerance. In these situations, off-label uses of drugs provide the only chance of restored health.

scholarly journals Communicating Effectively About Emergency Use Authorization and Vaccines in the COVID-19 Pandemic

2020 ◽  
pp. e1-e4
Author(s):  
Sandra Crouse Quinn ◽  
Amelia M. Jamison ◽  
Vicki Freimuth
Keyword(s):  
Diagnostic Procedure ◽  
Approval Process ◽  
Off Label Use ◽  
Off Label ◽  
Risks And Benefits ◽  
The Us ◽  
Life Threatening ◽  
Potential Benefits ◽  
Accelerated Approval ◽  
Potential Risks

The Emergency Use Authorization (EUA) mechanism is central to the US response to coronavirus disease 2019 (COVID-19). It allows the US Food and Drug Administration (FDA) to respond quickly to novel threats by approving a new drug, device, or diagnostic procedure or expanding off-label use of an existing drug through an accelerated approval process.1 To obtain authorization, evidence must support that a drug or product “‘may be effective’ to prevent, diagnose, or treat serious or life-threatening diseases or conditions,” and the known or potential benefits of the product must outweigh known or potential risks.2(p7) The authorization also stipulates that when feasible, a fact sheet is provided to address risks and benefits and make clear that acceptance is voluntary.2 (Am J Public Health. Published online ahead of print November 25, 2020: e1–e4. https://doi.org/10.2105/AJPH.2020.306036 )

scholarly journals Off-label treatment in diabetic retinopathy

2014 ◽  
Vol 13 (1) ◽  
pp. 78
Author(s):  
Luis Jesuino De Oliveira Andrade ◽  
Larissa Santos França ◽  
Luciana Santos França ◽  
Alcina Maria Vinhaes Bittencourt ◽  
Caroline Santos França
Keyword(s):  
Diabetic Retinopathy ◽  
Scientific Literature ◽  
Integrative Review ◽  
Font Size ◽  
International Database ◽  
Off Label

<p class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: justify;"><strong><em><span style="font-size: 8.0pt; font-family: Calibri-BoldItalic; mso-bidi-font-family: Calibri-BoldItalic; mso-ansi-language: EN-US;" lang="EN-US">Introduction: </span></em></strong><em><span style="font-size: 8.0pt; font-family: Calibri-Italic; mso-hansi-font-family: Calibri-BoldItalic; mso-bidi-font-family: Calibri-Italic; mso-ansi-language: EN-US;" lang="EN-US">The prescribing a drug without the indications for which the drug was originally approved by regulators is internationally known as prescribing “off-label”. </span></em><strong><em><span style="font-size: 8.0pt; font-family: Calibri-BoldItalic; mso-bidi-font-family: Calibri-BoldItalic; mso-ansi-language: EN-US;" lang="EN-US">Objective</span></em></strong><em><span style="font-size: 8.0pt; font-family: Calibri-Italic; mso-hansi-font-family: Calibri-BoldItalic; mso-bidi-font-family: Calibri-Italic; mso-ansi-language: EN-US;" lang="EN-US">: To describe the off-label therapy in diabetic retinopathy, reported international scientific literature, through an integrative bibliographical review. </span></em><strong><em><span style="font-size: 8.0pt; font-family: Calibri-BoldItalic; mso-bidi-font-family: Calibri-BoldItalic; mso-ansi-language: EN-US;" lang="EN-US">Method</span></em></strong><em><span style="font-size: 8.0pt; font-family: Calibri-Italic; mso-hansi-font-family: Calibri-BoldItalic; mso-bidi-font-family: Calibri-Italic; mso-ansi-language: EN-US;" lang="EN-US">: Integrative review by searching the Medline international database for review of manuscripts. </span></em><strong><em><span style="font-size: 8.0pt; font-family: Calibri-BoldItalic; mso-bidi-font-family: Calibri-BoldItalic; mso-ansi-language: EN-US;" lang="EN-US">Results</span></em></strong><em><span style="font-size: 8.0pt; font-family: Calibri-Italic; mso-hansi-font-family: Calibri-BoldItalic; mso-bidi-font-family: Calibri-Italic; mso-ansi-language: EN-US;" lang="EN-US">: A total 852 scientific productions were identified, and 37 studies were selected by contain information about the off-label therapy in diabetic retinopathy. </span></em><strong><em><span style="font-size: 8.0pt; font-family: Calibri-BoldItalic; mso-bidi-font-family: Calibri-BoldItalic; mso-ansi-language: EN-US;" lang="EN-US">Conclusion</span></em></strong><em><span style="font-size: 8.0pt; font-family: Calibri-Italic; mso-hansi-font-family: Calibri-BoldItalic; mso-bidi-font-family: Calibri-Italic; mso-ansi-language: EN-US;" lang="EN-US">: The practice of off-label prescribing in diabetic retinopathy has benefits, and in some situations is the only treatment available.</span></em></p>

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.

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