Off-Label Medication: From a Simple Concept to Complex Practical Aspects

Carmen-Maria Rusz, Bianca-Eugenia Ősz, George Jîtcă, Amalia Miklos, Mădălina-Georgiana Bătrînu and Silvia Imre
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Carmen-Maria Rusz: Doctoral School of Medicine and Pharmacy, I.O.S.U.D., George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Târgu Mureș (UMPhST), 540142 Târgu Mureș, Romania
Bianca-Eugenia Ősz: Department of Pharmacology and Clinical Pharmacy, Faculty of Pharmacy, George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Târgu Mureș (UMPhST), 540142 Târgu Mureș, Romania
George Jîtcă: Department of Pharmacology and Clinical Pharmacy, Faculty of Pharmacy, George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Târgu Mureș (UMPhST), 540142 Târgu Mureș, Romania
Amalia Miklos: Department of Biochemistry, Faculty of Pharmacy, George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Târgu Mureș (UMPhST), 540142 Târgu Mureș, Romania
Mădălina-Georgiana Bătrînu: Doctoral School of Medicine and Pharmacy, I.O.S.U.D., George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Târgu Mureș (UMPhST), 540142 Târgu Mureș, Romania
Silvia Imre: Department of Analytical Chemistry and Drug Analysis, Faculty of Pharmacy, George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Târgu Mureș (UMPhST), 540142 Târgu Mureș, Romania

IJERPH, 2021, vol. 18, issue 19, 1-15

Abstract: Off-label use of drugs is widely known as unapproved use of approved drugs, and it can be perceived as a relatively simple concept. Even though it has been in existence for many years, prescribing and dispensing of drugs in an off-label regimen is still a current issue, triggered especially by unmet clinical needs. Several therapeutic areas require off-label approaches; therefore, this practice is challenging for prescribing physicians. Meanwhile, the regulatory agencies are making efforts in order to ensure a safe practice. The present paper defines the off-label concept, and it describes its regulation, together with several complex aspects associated with clinical practices regarding rare diseases, oncology, pediatrics, psychiatry therapeutic areas, and the safety issues that arise. A systematic research of the literature was performed, using terms, such as “off-label”, ”prevalence”, ”rare diseases”, ”oncology”, ”psychiatry”, ”pediatrics”, and ”drug repurposing”. There are several reasons for which off-label practice remains indispensable in the present; therefore, efforts are made worldwide, by the regulatory agencies and governmental bodies, to raise awareness and to ensure safe practice, while also encouraging further research.

Keywords: off-label; practice; clinical; safety; regulation (search for similar items in EconPapers)
JEL-codes: I I1 I3 Q Q5 (search for similar items in EconPapers)
Date: 2021
References: View complete reference list from CitEc
Citations: View citations in EconPapers (1)

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