Controversies in off-label prescriptions in dermatology: the perspective of the patient, the physician, and the pharmaceutical companies

Katlein França, Sergio Litewka

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

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.

Original languageEnglish (US)
JournalInternational Journal of Dermatology
DOIs
StateAccepted/In press - Jan 1 2018
Externally publishedYes

Fingerprint

Occupational Health Physicians
Dermatology
Off-Label Use
Prescriptions
Pharmaceutical Preparations
Spironolactone
Botulinum Toxins
Calcineurin
Dosage Forms
Disease Management
Biological Products
Informed Consent
Vitamin D
Physicians
Costs and Cost Analysis

ASJC Scopus subject areas

  • Dermatology

Cite this

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