J Korean Acad Child Adolesc Psychiatry.  2011 Jun;22(2):67-73.

Off-label or Unlicensed Drug Prescriptions in Child and Adolescent Psychiatry

• Lee SI

Abstract

The purpose of licensing system is to ensure that the medicines are examined for safety, efficacy and quality. Nevertheless, off-label or unlicensed drug usages in pediatric practice is widespread in Korea and worldwide. Psychotropics are one of the most commonly used off-label or unlicensed drugs. The most valid approach to face this dilemma will be to have more evidences from pediatric pharmacological studies. Clinicians, in addition, need to monitor closely their off-label or unlicensed drug prescriptions to minimize the trial and error in practice. Researchers should publish their experiences and provide guidelines. Pharmaceutical companies, regulatory authorities, and consumer organizations should endeavor altogether for the children's right to get safe and efficacious drugs as adults do. Here, the definition as well as the current status of off-label and unlicensed drug prescriptions will be introduced. Critical issues regarding the off label drugs are discussed. In addition, I will describe the present condition as to the off-label and unlicensed drugs in child and adolescent psychiatry and the authorization process of off-label drug prescription in Korea. Lastly, direction we should like to take in this field will be mentioned.

Keyword

Pediatrics; Psychotropic Drugs; Drug labeling; Off-label Use; Unlicensed

MeSH Terms

Adolescent
Adolescent Psychiatry
Adult
Child
Consumer Organizations
Dietary Sucrose
Drug Labeling
Drug Prescriptions
Humans
Korea
Licensure
Off-Label Use
Organothiophosphorus Compounds
Pediatrics
Psychotropic Drugs
Dietary Sucrose
Organothiophosphorus Compounds
Psychotropic Drugs