Date of Award


Document type


Degree Name

Masters theses/dissertations - taught courses

First Supervisor

Dr. David Smith


Unlicensed drugs, off-label drugs, dermatology, prescriptions, ethics, legal issues and legislation.



Background: It is a common practice for physicians to treat dermatologic conditions with medications that are not indicated for the specific condition being treated. These "off-label" prescriptions are often for drugs that have both well accepted the therapeutic value in the medical community and proven efficacy on the basis of results of clinical trials.

Objective: The aim of this study is 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, patterns, preventive methods, 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 drugs and off-label drugs in dermatology worldwide were identified. The selected studies were between the year 1994 and 2014.

Conclusion: Off-label medications seem to be commonly prescribed in clinical practice in dermatology and differs between countries, inpatient and outpatient settings and age. However, prescribing off-label medications to patients who expect to receive an effective treatment will likely lead to foreseeable ethical and legal difficulties. 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.

Creative Commons License

Creative Commons License
This work is licensed under a Creative Commons Attribution-Noncommercial-Share Alike 4.0 License.

File Size

121 KB


A dissertation submitted in partial fulfilment of the requirement for the Masters in Health Care Ethics and Law