2018/08/31 by Katlein França, Sergio Litewka · 1 citation
Economics, Econometrics and Finance · Medicine · Pharmacology, Toxicology and Pharmaceutics · #Pharmaceutical Economics and Policy #Pharmaceutical industry and healthcare #Pharmaceutical studies and practices
paper · doi:10.1111/ijd.14222
crossref issued 2018/08/31 · crossref published 2018/08/31 · crossref published-online 2018/08/31 · openalex publication_date 2018/08/31 · crossref created 2018/08/31 · crossref published-print 2019/07/01 · crossref deposited 2023/09/10 · openalex created_date 2025/10/10 · crossref indexed 2026/08/01 · openalex updated_date 2026/08/02
The term "off-label drug use" involves the prescription of medications for unapproved indications or in unapproved dosage, dosage form, or route of administration. Off-label medications are common in the management of dermatologic diseases. In the recent years, new indications for botulinum toxin, biologics, spironolactone, topical calcineurin, and topical vitamin D analogues emerged, and these drugs are being used off-label to treat a variety of conditions. The high cost and long time required for the approval discourage pharmaceutical companies from developing studies and pursuing the approval by regulatory agencies. Patients and physicians may have a different perspective regarding the off-label use of medications. The ethical discussion is based on the different opinions concerning the need for informed consent by the patient and how this could be applicable in the clinical practice.