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

• Authors: Janusz Jaroszyński , Aneta Mela , Marzena Furtak-Niczyporuk , Anna Staniszewska , Łukasz A. Poniatowski , Jan Dąbrowski , Anna Czajka-Bełz , Agnieszka Zimmermann , Piotr Dreher , Bartłomiej Drop
• Languages of publication: EN

Abstracts

EN

The off-label use of medicinal products raises many interpretation-related issues, not only among physicians, but also pharmacists and lawyers. The use of drugs in a manner other than that specified in the Summary of Product Characteristics is not regulated by Polish law. The authors’ goal is to discuss the topic mainly from the practical perspective, while also considering its theoretical aspects, and to identify systemic solutions to several problems, that are extremely important for the proper functioning of the entire healthcare system. The paper highlights that there is a fine line between experimental medicinal practices and those that are in keeping with current medical knowledge.

Keywords

EN

health policy; pharmaceuticals; medicinal products; off-label drug use; prescribing

• Journal: Acta Poloniae Pharmaceutica - Drug Research
• Year: 2019
• Volume: 76
• Issue: 4
• Pages: 621-628

Dates

published

2019-08-30

Contributors

author

Janusz Jaroszyński

author

Aneta Mela

author

Marzena Furtak-Niczyporuk

author

Anna Staniszewska

author

Łukasz A. Poniatowski

author

Jan Dąbrowski

author

Anna Czajka-Bełz

author

Agnieszka Zimmermann

author

Piotr Dreher

author

Bartłomiej Drop

Identifiers

DOI

10.32383/appdr/105795