Dataset Information

International Coherence of Pediatric Drug Labeling for Drug Safety: Comparison of Approved Labels in Korea and the United States.

ABSTRACT: The objective of this study was to analyze information on pediatric use in Korean drug product labels and compare it with that in US Food and Drug Administration (FDA) labeling information. Prescription information on pediatric use contained in the commonly used drugs' product labels approved by Korean government was compared with that approved by the FDA. Among the top 50 commonly prescribed drugs, 20 drugs were deemed to have insufficient prescribing information in Korean drug labels. Pediatric prescribing information regarding indication, approved age, formulations, and safety was insufficient in Korean drug labels compared with those in the FDA. Most important, the adverse events frequently reported in Korean children were not sufficiently presented in drug labels. In conclusion, this study highlights the urgent need for the Korean regulatory agency to encourage and accelerate research and development to increase the extent of pediatric prescribing information to be added to drug labels to promote appropriate drug prescribing for children.

SUBMITTER: Song YK

PROVIDER: S-EPMC7028218 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

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International Coherence of Pediatric Drug Labeling for Drug Safety: Comparison of Approved Labels in Korea and the United States.

Song Yun-Kyoung YK Han Nayoung N Burckart Gilbert J GJ Oh Jung Mi JM

Clinical pharmacology and therapeutics 20191110 3

The objective of this study was to analyze information on pediatric use in Korean drug product labels and compare it with that in US Food and Drug Administration (FDA) labeling information. Prescription information on pediatric use contained in the commonly used drugs' product labels approved by Korean government was compared with that approved by the FDA. Among the top 50 commonly prescribed drugs, 20 drugs were deemed to have insufficient prescribing information in Korean drug labels. Pediatri ...[more]

PMID: 31544241

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Project description:BackgroundAdverse Drug Reactions (ADRs) are of great public health concern. FDA-approved drug labeling summarizes ADRs of a drug product mainly in three sections, i.e., Boxed Warning (BW), Warnings and Precautions (WP), and Adverse Reactions (AR), where the severity of ADRs are intended to decrease in the order of BW > WP > AR. Several reported studies have extracted ADRs from labeling documents, but most, if not all, did not discriminate the severity of the ADRs by the different labeling sections. Such a practice could overstate or underestimate the impact of certain ADRs to the public health. In this study, we applied the Medical Dictionary for Regulatory Activities (MedDRA) to drug labeling and systematically analyzed and compared the ADRs from the three labeling sections with a specific emphasis on analyzing serious ADRs presented in BW, which is of most drug safety concern.ResultsThis study investigated New Drug Application (NDA) labeling documents for 1164 single-ingredient drugs using Oracle Text search to extract MedDRA terms. We found that only a small portion of MedDRA Preferred Terms (PTs), 3819 out of 21,920 or 17.42%, were observed in a whole set of documents. In detail, 466/3819 (12.0%) PTs were in BW, 2023/3819 (53.0%) were in WP, and 2961/3819 (77.5%) were in AR sections. We also found a higher overlap of top 20 occurring BW PTs with WP sections compared to AR sections. Within the MedDRA System Organ Class levels, serious ADRs (sADRs) from BW were prevalent in Nervous System disorders and Vascular disorders. A Hierarchical Cluster Analysis (HCA) revealed that drugs within the same therapeutic category shared the same ADR patterns in BW (e.g., nervous system drug class is highly associated with drug abuse terms such as dependence, substance abuse, and respiratory depression).ConclusionsThis study demonstrated that combining MedDRA standard terminologies with data mining techniques facilitated computer-aided ADR analysis of drug labeling. We also highlighted the importance of labeling sections that differ in seriousness and application in drug safety. Using sADRs primarily related to BW sections, we illustrated a prototype approach for computer-aided ADR monitoring and studies which can be applied to other public health documents.

Project description:INTRODUCTION:The receipt of remote clinical care for children via telecommunications (pediatric telemedicine) appears to improve access to and quality of care in U.S. emergency departments (EDs), but the actual prevalence and characteristics of pediatric telemedicine receipt remain unclear. We determined the prevalence and current applications of pediatric telemedicine in U.S. EDs, focusing on EDs that received telemedicine from clinicians at other facilities. METHODS:We surveyed all 5,375 U.S. EDs to characterize emergency care in 2016. We then randomly surveyed 130 (39%) of the 337 EDs who reported receiving pediatric telemedicine. The second survey was administered by phone to ED directors primarily. It confirmed that the ED received pediatric telemedicine services in 2017 and asked about ED staffing and the nature, purpose, and concerns with pediatric telemedicine implementation. RESULTS:The first survey (4,507/5,375, 84% response) showed that 337 (8%) EDs reported receiving pediatric telemedicine. Among the randomly sampled EDs completing the second survey (107/130, 82% response), 96 (90%) confirmed 2016 use and 89 (83%) confirmed 2017 use. Reasons for discontinuation included technical and scheduling concerns. Almost all who confirmed their pediatric telemedicine use in 2017 also reported 24/7 availability (98%). The most widely reported use was for patient placement and transfer coordination (80%). Many EDs (39%) reported no challenges with implementing pediatric telemedicine and described its utility. However, the most frequently reported challenges were process concerns (30%), such as concerns about slowing or interrupting providers' work flow and technological concerns (14%). CONCLUSION:Few EDs receive telemedicine for the delivery of pediatric emergency care nationally. Among EDs that do use telemedicine for pediatric care, many report process concerns. Addressing these barriers through focused education or interventions may support EDs in further developing and optimizing this technological adjunct to pediatric emergency care.

Dataset Information

International Coherence of Pediatric Drug Labeling for Drug Safety: Comparison of Approved Labels in Korea and the United States.

Publications

International Coherence of Pediatric Drug Labeling for Drug Safety: Comparison of Approved Labels in Korea and the United States.

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