Unlicensed and Off-label Medication Uses in Dermatology

It is a common practice for physicians to treat dermatologic conditions with medications that are not indicated for the specific condition being treated. Objective:To determine the main risk factors of most unlicensed and off-label medications used in treatment of dermatological diseases worldwide and to make a detailed examination of ethical and legal trends, possible solutions and recommendations associated with using unlicensed and off-label drugs in dermatology. Methods:A systemic review of the relevant available studies on unlicensed and off-label medication uses in dermatology worldwide was performed. Results:Ten epidemiological studies regarding the use of unlicensed and off-label drugs in dermatology worldwide were identified.The selected studies were between the year 1994-2014 Conclusion:Some of the key ethical issues include the impact on the patient autonomous decision, informed consent and nature of the relationship between dermatologists and drugs companies.Legally,concerns surrounding the clinical implications, litigation for professional misconduct and FDA policies on off-label uses.A management guideline for off-label drug use is urgently needed.