• YAKHAK HOEJI
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• v.58 no.2
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• pp.112-124
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• 2014

This study aimed to develop a regulation system for off-label drug use to secure the safe use of marketed drugs. We searched governmental documents for national and global regulating systems of off-label drug uses and a body of academic literature to explore current regulating trends. We included European Union, United Kingdom, United States of America, Australia and Japan, and critically reviewed the regulation of off-label drug use in four issues, which were a regulatory structure, safety control before and after off-label use, and information management. The findings of the present investigation called for several measures in off-label drug uses: enhancing prescribers' self-regulation, providing up-to-date information to prescribers for evidence-based practice and to patients for their informed consent, making evidence with scientific rigor, building an official registering process for off-label use in good quality and extending the role of pharmaceutical industry in pharmacovigilance. At last, we proposed a new system so as to regulate and evaluate off-label drug uses both at national and institutional level. In the new system, we suggested a clear-cut definition for clinical evidence that applicants would submit. We newly introduced an official 'Off-Label Drug Use Report' to evaluate the safety and clinical efficacy of a given off-label drug use. In addition, we developed an algorism of the regulation of off-label drug use within an institution to help set up the culture of evidence-based practices in off-label drug uses.

• Korean Journal of Clinical Pharmacy
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• v.24 no.4
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• pp.265-271
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• 2014

Objective: This study aims to explore the perception of off-label use of medications and the provision of informed consents from the general public's perspective. Methods: The study subjects (n=291) were recruited from 7 cities in Korea through a convenience sampling method. The self-administered questionnaire with 13 items was issued and collected. The study subjects who have had a pharmaceutical job were excluded. Results: The total of 231 respondents was included. Only 23% of respondents were familiar with the concept of off-label use of medications. Eighty five percent of respondents (n=196) stated that the prescribers should explain the off-label use of a medication to their patients. The preferred method for delivering the message was the oral explanation (n=122, 53%), followed by oral explanation plus a pamphlet (n=94, 41%). The safety issue is the most concerned aspect regarding the off-label drug use, also effectiveness and insurance coverage. The majority of respondents (n=217, 94%) agreed that the prescriber should get a consent from patients before prescribing medications for off-label use. They preferred written consent to oral consent (140 vs. 77). Conclusion: This study demonstrated general publics are infrequently aware of off-label use of medications. It is important to raise public awareness of the off-label use of medications and to openly discuss its pros and cons for safe and effective drug therapy.

• Journal of the Korean Academy of Child and Adolescent Psychiatry
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• v.22 no.2
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• pp.67-73
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• 2011

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.

• Journal of the Korean Academy of Child and Adolescent Psychiatry
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• v.22 no.2
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• pp.74-80
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• 2011

Attention-deficit hyperactivity disorder (ADHD) is a neurobehavioral disorder with an onset of symptoms before 7 years of age, often starting as early as the preschool years. The off-label use of methylphenidate (MPH) for 3- to 6-year-old preschool children with ADHD is being more common, although MPH is not licensed for use in children younger than age 6 years, in most countries. Despite the limited data, the review of the literature suggests that MPH meets evidence based criteria as beneficial and safe for carefully diagnosed ADHD preschool children. Carefully monitored administration of evidence-based psychotropic medication in preschool children with ADHD may be indicated if psychosocial treatments are ineffective.

• Archives of Obesity and Metabolism
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• v.1 no.1
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• pp.43-45
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• 2022

Intensive lifestyle modifications and anti-obesity medications are essential for obesity treatment. Antiobesity medications should be selected according to the patient's comorbidities, symptoms, and preferences. This case report describes the treatment of a morbidly obese patient with a history of depression, who complained of tingling and numbness after total thyroidectomy for papillary thyroid cancer. Very low-dose controlled-release phentermine/topiramate was prescribed and intensive lifestyle modifications were encouraged. As a result, the patient effectively lost weight and reached a near-normal weight without adverse drug effects. This implies that even an off-label anti-obesity medication low dose may be better for some patients, and the most important factor in obesity treatment is patient-tailored treatment.

• Journal of Korean Neurosurgical Society
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• v.66 no.3
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• pp.308-315
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• 2023

Recent updates in genomic-integrated glioma classification have caused confusion in current clinical practice, as management protocols and health insurance systems are based on evidence from previous diagnostic classifications. The Korean Brain Tumor Society conducted an electronic questionnaire for society members, asking for their ideas on risk group categorization and preferred treatment for each individual diagnosis listed in the new World Health Organization (WHO) classification of gliomas. Additionally, the current off-label drug use (OLDU) protocols for glioma management approved by the Health Insurance Review and Assessment Service (HIRA) in Korea were investigated. A total of 24 responses were collected from 20 major institutes in Korea. A consensus was reached on the dichotomic definition of risk groups for glioma prognosis, using age, performance status, and extent of resection. In selecting management protocols, there was general consistency in decisions according to the WHO grade and the risk group, regardless of the individual diagnosis. As of December 2022, there were 22 OLDU protocols available for the management of gliomas in Korea. The consensus and available options described in this report will be temporarily helpful until there is an accumulation of evidence for effective management under the new classification system for gliomas.

• The Transactions of The Korean Institute of Electrical Engineers
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• v.67 no.9
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• pp.1224-1231
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• 2018

Automatic age estimation has been used in many social network applications, practical commercial applications, and human-computer interaction visual-surveillance biometrics. However, it has rarely been explored. In this paper, we propose an automatic age estimation system, which includes face detection and convolutional deep learning based on an inception module. The latter is a 22-layer-deep network that serves as the particular category of the inception design. To evaluate the proposed approach, we use 4,000 images of eight different age groups from the Adience age dataset. k-fold cross-validation (k = 5) is applied. A comparison of the performance of the proposed work and recent related methods is presented. The results show that the proposed method significantly outperforms existing methods in terms of the exact accuracy and off-by-one accuracy. The off-by-one accuracy is when the result is off by one adjacent age label to the above or below. For the exact accuracy, the age label of "60+" is classified with the highest accuracy of 76%.

• Clinical and Experimental Pediatrics
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• v.59 no.3
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• pp.105-113
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• 2016

Diffuse alveolar hemorrhage (DAH) is a life-threatening pulmonary complication in patients with hematologic malignancies or autoimmune disorders. The current treatment options, which include corticosteroids, transfusions, extracorporeal membrane oxygenation (ECMO), and immunosuppressants, have been limited and largely unsuccessful. Recombinant activated factor VII (rFVIIa) has been successfully administered, either systemically or bronchoscopically, to adults for the treatment of DAH, but there are few data on its use in pediatric patients. The current literature in the PubMed database was reviewed to evaluate the efficacy and risk of rFVIIa treatment for DAH in pediatric patients. This review discusses the diagnosis and treatment of DAH, as well as a new treatment paradigm that includes rFVIIa. Additionally, the risks and benefits of off-label use of rFVIIa in pediatric patients are discussed.

• Korean Journal of Clinical Pharmacy
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• v.30 no.3
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• pp.143-148
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• 2020

Objective: This study aimed to investigate pharmaceutical care for critically ill neonates and suggest targeted strategies compatible with the Korean health-system pharmacy. Methods: Articles that reported pharmacy practices for critically ill neonates were reviewed. Pharmaceutical care practices and roles of neonatal pharmacists were identified, and criteria were developed for neonates in need of specialized care by clinical pharmacists. Results: Neonatal pharmacists play many roles in the overall medication management pathway. For clinical decision support, multidisciplinary ward rounds, clinical pharmacokinetic services, and consultation for pharmacotherapy and nutrition support were conducted. Prevention and resolution of drug-related problems through review of medication charts contributed to medication safety. Pharmaceutical optimization of intravenous medication played an important role in safe and effective therapy. Information on the use of off-label medicine, recommended dosage and dosing schedules, and stability of intravenous medicine was provided to other health professionals. Most clinical practices for neonates in Korea included therapeutic drug monitoring and nutrition support services. Reduction in medication errors and adverse drug reactions, shortening the duration of weaning medicines, decreasing the use and cost of antimicrobials, and improvement in nutrition status were reported as the outcomes of pharmacist-led interventions. The essential criteria of pharmaceutical care, including for patients with potential high-risk factors for drug-related problems, was developed. Conclusion: Pharmaceutical care for critically ill neonates varies widely. Development and provision of standardized pharmaceutical care for Korean neonates and a stepwise strategy for the expansion of clinical pharmacy services are required.

• Journal of Korean Neurosurgical Society
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• v.62 no.3
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• pp.361-365
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• 2019

Epilepsy has been known to humankind since antiquity. The surgical treatment of epilepsy began in the early days of neurosurgery and has developed greatly. Many surgical procedures have stood the test of time. However, clinicians treating epilepsy patients are now witnessing a huge tide of change. In 2017, the classification system for seizure and epilepsy types was revised nearly 36 years after the previous scheme was released. The actual difference between these systems may not be large, but there have been many conceptual changes, and clinicians must bid farewell to old terminology. Paradigms in drug discovery are changing, and novel anti-seizure drugs have been introduced for clinical use. In particular, drugs that target genetic changes harbor greater therapeutic potential than previous screening-based compounds. The concept of focal epilepsy has been challenged, and now epilepsy is regarded as a network disorder. With this novel concept, stereotactic electroencephalography (SEEG) is becoming increasingly popular for the evaluation of dysfunctioning neuronal networks. Minimally invasive ablative therapies using SEEG electrodes and neuromodulatory therapies such as deep brain stimulation and vagus nerve stimulation are widely applied to remedy dysfunctional epilepsy networks. The use of responsive neurostimulation is currently off-label in children with intractable epilepsy.