소아청소년정신과에서의 허가 초과 및 비승인 약물 처방Off-label or Unlicensed Drug Prescriptions in Child and Adolescent Psychiatry
- Other Titles
- Off-label or Unlicensed Drug Prescriptions in Child and Adolescent Psychiatry
- Authors
- 이소영
- Issue Date
- 2011
- Publisher
- 대한소아청소년 정신의학회
- Keywords
- Pediatrics; Psychotropic Drugs; Drug labeling; Off-label Use; Unlicensed.; 소아 ·정신과 약물 ·약품관련정보 ·허가 초가 사용 ·비승인 .
- Citation
- 소아 청소년 정신의학, v.22, no.2, pp.67 - 73
- Journal Title
- 소아 청소년 정신의학
- Volume
- 22
- Number
- 2
- Start Page
- 67
- End Page
- 73
- URI
- https://scholarworks.bwise.kr/sch/handle/2021.sw.sch/16857
- ISSN
- 1225-729X
- 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.
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Collections - College of Medicine > Department of Psychiatry > 1. Journal Articles
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