Guideline for the management of pediatric off-label use of drugs in China (2021).

Adult Child China Drug Labeling Evidence-Based Medicine Humans Off-Label Use Pediatricians Physicians
Children Guideline Management Off-label use of drugs

Journal

BMC pediatrics
ISSN: 1471-2431
Titre abrégé: BMC Pediatr
Pays: England
ID NLM: 100967804

Informations de publication

Date de publication:
23 07 2022
Historique:
received: 06 03 2022
accepted: 27 06 2022
entrez: 22 7 2022
pubmed: 23 7 2022
medline: 27 7 2022
Statut: epublish

Résumé

The "Law on Doctors of the People's Republic of China," which was officially implemented on March 1, 2022, emphasizes the requirements for rational drug use and the necessity for appropriate management of off-label drug use. The safety and ethical considerations related to off-label drug use are different in children than in adults. There is so far no management guideline for pediatric off-label use of drugs in China, and the applicability of foreign guidelines is limited. Establishing a localized evidence-based management guideline for pediatric off-label use of drugs to support the national legislation and clinical practice is of critical importance. We established a guideline working group, including experts from a broad range of disciplines and developed recommendations following the guidance of the World Health Organization Handbook and the Chinese Medical Association. The following themes were identified by questionnaires and expert interviews to be of great concern in the management of off-label drug use in children: general principles and characteristics of management of pediatric off-label drug use; establishment of expert committees; evidence evaluation; risk-benefit assessment; informed consent; monitoring and assessment of the risk; and monitoring and patient education. Two rounds of Delphi surveys were organized to determine the final recommendations of this guideline. We graded the recommendations based on the body of evidence, referring to the evaluation tool of the Evidence-based management (EBMgt) and the Oxford Center for Evidence-Based Medicine: Level of Evidence (March 2009). We developed the first guideline for the management of pediatric off-label use of drugs in China. The guideline is to offer guidance for pediatricians, pharmacists, medical managers, policymakers, and primary care physicians on how to manage off-label drug use in pediatrics and to provide recommendations for Chinese healthcare policy in the future.

Sections du résumé

BACKGROUND
The "Law on Doctors of the People's Republic of China," which was officially implemented on March 1, 2022, emphasizes the requirements for rational drug use and the necessity for appropriate management of off-label drug use. The safety and ethical considerations related to off-label drug use are different in children than in adults. There is so far no management guideline for pediatric off-label use of drugs in China, and the applicability of foreign guidelines is limited. Establishing a localized evidence-based management guideline for pediatric off-label use of drugs to support the national legislation and clinical practice is of critical importance.
METHODS
We established a guideline working group, including experts from a broad range of disciplines and developed recommendations following the guidance of the World Health Organization Handbook and the Chinese Medical Association. The following themes were identified by questionnaires and expert interviews to be of great concern in the management of off-label drug use in children: general principles and characteristics of management of pediatric off-label drug use; establishment of expert committees; evidence evaluation; risk-benefit assessment; informed consent; monitoring and assessment of the risk; and monitoring and patient education. Two rounds of Delphi surveys were organized to determine the final recommendations of this guideline. We graded the recommendations based on the body of evidence, referring to the evaluation tool of the Evidence-based management (EBMgt) and the Oxford Center for Evidence-Based Medicine: Level of Evidence (March 2009).
RESULTS
We developed the first guideline for the management of pediatric off-label use of drugs in China.
CONCLUSIONS
The guideline is to offer guidance for pediatricians, pharmacists, medical managers, policymakers, and primary care physicians on how to manage off-label drug use in pediatrics and to provide recommendations for Chinese healthcare policy in the future.

Identifiants

DOI: 10.1186/s12887-022-03457-1 PMID: 35869466 PMC: PMC9307429
pubmed: 35869466
doi: 10.1186/s12887-022-03457-1
pii: 10.1186/s12887-022-03457-1
pmc: PMC9307429
doi:

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

442

Informations de copyright

© 2022. The Author(s).

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Auteurs

Min Meng (M)

Department of Pediatric Research Institute, Children's Hospital of Chongqing Medical University, Chongqing, 400014, China.
National Clinical Research Center for Child Health and Disorders, Ministry of Education Key Laboratory of Child Development and Disorders, China International Science and Technology Cooperation Base of Child Development and Critical Disorders, Children's Hospital of Chongqing Medical University, Chongqing, 400014, China.
Chongqing Key Laboratory of Pediatrics, Chongqing, 400014, China.
Gansu Provincial Hospital, Lanzhou, 730000, China.

Enmei Liu (E)

Department of Pediatric Research Institute, Children's Hospital of Chongqing Medical University, Chongqing, 400014, China.
National Clinical Research Center for Child Health and Disorders, Ministry of Education Key Laboratory of Child Development and Disorders, China International Science and Technology Cooperation Base of Child Development and Critical Disorders, Children's Hospital of Chongqing Medical University, Chongqing, 400014, China.
Chongqing Key Laboratory of Pediatrics, Chongqing, 400014, China.

Bo Zhang (B)

Department of Pharmacy, Peking Union Medical College Hospital, Beijing, 100730, China.

Quan Lu (Q)

Department of Pulmonology, Shanghai Children's Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, 200040, China.

Xiaobo Zhang (X)

Children's Hospital of Fudan University, Shanghai, 201102, China.

Bin Ge (B)

Gansu Provincial Hospital, Lanzhou, 730000, China.

Ye Wu (Y)

Peking University First Hospital, Beijing, 100034, China.

Li Wang (L)

Peking University, Beijing, 100871, China.

Mo Wang (M)

Department of Pediatric Research Institute, Children's Hospital of Chongqing Medical University, Chongqing, 400014, China.
National Clinical Research Center for Child Health and Disorders, Ministry of Education Key Laboratory of Child Development and Disorders, China International Science and Technology Cooperation Base of Child Development and Critical Disorders, Children's Hospital of Chongqing Medical University, Chongqing, 400014, China.
Chongqing Key Laboratory of Pediatrics, Chongqing, 400014, China.

Zhengxiu Luo (Z)

Department of Pediatric Research Institute, Children's Hospital of Chongqing Medical University, Chongqing, 400014, China.
National Clinical Research Center for Child Health and Disorders, Ministry of Education Key Laboratory of Child Development and Disorders, China International Science and Technology Cooperation Base of Child Development and Critical Disorders, Children's Hospital of Chongqing Medical University, Chongqing, 400014, China.
Chongqing Key Laboratory of Pediatrics, Chongqing, 400014, China.

Ziyu Hua (Z)

Department of Pediatric Research Institute, Children's Hospital of Chongqing Medical University, Chongqing, 400014, China.
National Clinical Research Center for Child Health and Disorders, Ministry of Education Key Laboratory of Child Development and Disorders, China International Science and Technology Cooperation Base of Child Development and Critical Disorders, Children's Hospital of Chongqing Medical University, Chongqing, 400014, China.
Chongqing Key Laboratory of Pediatrics, Chongqing, 400014, China.

Xiaoling Wang (X)

Beijing Children's Hospital, Capital Medical University, Beijing, 100045, China.

Wei Zhao (W)

Shandong University, Jinan, 250100, China.

Yi Zheng (Y)

Shandong University, Jinan, 250100, China.

Xinan Wu (X)

The First Hospital of Lanzhou University, Lanzhou, 730000, China.

Ruiling Zhao (R)

Children's Hospital of Shanxi, Taiyuan, 030012, China.

Wenbo Meng (W)

The First Hospital of Lanzhou University, Lanzhou, 730000, China.

Li Xiang (L)

Beijing Children's Hospital, Capital Medical University, Beijing, 100045, China.

Gang Wang (G)

Department of Pediatric Research Institute, Children's Hospital of Chongqing Medical University, Chongqing, 400014, China.
National Clinical Research Center for Child Health and Disorders, Ministry of Education Key Laboratory of Child Development and Disorders, China International Science and Technology Cooperation Base of Child Development and Critical Disorders, Children's Hospital of Chongqing Medical University, Chongqing, 400014, China.
Chongqing Key Laboratory of Pediatrics, Chongqing, 400014, China.

Yuntao Jia (Y)

Department of Pediatric Research Institute, Children's Hospital of Chongqing Medical University, Chongqing, 400014, China.
National Clinical Research Center for Child Health and Disorders, Ministry of Education Key Laboratory of Child Development and Disorders, China International Science and Technology Cooperation Base of Child Development and Critical Disorders, Children's Hospital of Chongqing Medical University, Chongqing, 400014, China.
Chongqing Key Laboratory of Pediatrics, Chongqing, 400014, China.

Yongchuan Chen (Y)

The First Affiliated Hospital of Third Military Medical University (Army Medical University), Chongqing, 400038, China.

Xiaoyan Dong (X)

Department of Pulmonology, Shanghai Children's Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, 200040, China.

Lina Hao (L)

Children's Hospital Affiliated to Shandong University, Jinan, 250022, China.

Chengjun Liu (C)

Department of Pediatric Research Institute, Children's Hospital of Chongqing Medical University, Chongqing, 400014, China.
National Clinical Research Center for Child Health and Disorders, Ministry of Education Key Laboratory of Child Development and Disorders, China International Science and Technology Cooperation Base of Child Development and Critical Disorders, Children's Hospital of Chongqing Medical University, Chongqing, 400014, China.
Chongqing Key Laboratory of Pediatrics, Chongqing, 400014, China.

Meng Lv (M)

Department of Pediatric Research Institute, Children's Hospital of Chongqing Medical University, Chongqing, 400014, China.
National Clinical Research Center for Child Health and Disorders, Ministry of Education Key Laboratory of Child Development and Disorders, China International Science and Technology Cooperation Base of Child Development and Critical Disorders, Children's Hospital of Chongqing Medical University, Chongqing, 400014, China.
Chongqing Key Laboratory of Pediatrics, Chongqing, 400014, China.

Xufei Luo (X)

School of Public Health, Lanzhou University, Lanzhou, 730000, China.

Yunlan Liu (Y)

School of Public Health, Lanzhou University, Lanzhou, 730000, China.

Quan Shen (Q)

Department of Pediatric Research Institute, Children's Hospital of Chongqing Medical University, Chongqing, 400014, China.
National Clinical Research Center for Child Health and Disorders, Ministry of Education Key Laboratory of Child Development and Disorders, China International Science and Technology Cooperation Base of Child Development and Critical Disorders, Children's Hospital of Chongqing Medical University, Chongqing, 400014, China.
Chongqing Key Laboratory of Pediatrics, Chongqing, 400014, China.

Wenjuan Lei (W)

Gansu Provincial Hospital, Lanzhou, 730000, China.

Ping Wang (P)

Evidence-Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou, 730000, China.

Yajia Sun (Y)

Evidence-Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou, 730000, China.

Juanjuan Zhang (J)

School of Public Health, Lanzhou University, Lanzhou, 730000, China.

Ling Wang (L)

School of Public Health, Lanzhou University, Lanzhou, 730000, China.

Ruobing Lei (R)

Department of Pediatric Research Institute, Children's Hospital of Chongqing Medical University, Chongqing, 400014, China.
National Clinical Research Center for Child Health and Disorders, Ministry of Education Key Laboratory of Child Development and Disorders, China International Science and Technology Cooperation Base of Child Development and Critical Disorders, Children's Hospital of Chongqing Medical University, Chongqing, 400014, China.
Chongqing Key Laboratory of Pediatrics, Chongqing, 400014, China.

Tianchun Hou (T)

Department of Pediatric Research Institute, Children's Hospital of Chongqing Medical University, Chongqing, 400014, China.
National Clinical Research Center for Child Health and Disorders, Ministry of Education Key Laboratory of Child Development and Disorders, China International Science and Technology Cooperation Base of Child Development and Critical Disorders, Children's Hospital of Chongqing Medical University, Chongqing, 400014, China.
Chongqing Key Laboratory of Pediatrics, Chongqing, 400014, China.

Bo Yang (B)

Department of Pediatric Research Institute, Children's Hospital of Chongqing Medical University, Chongqing, 400014, China.
National Clinical Research Center for Child Health and Disorders, Ministry of Education Key Laboratory of Child Development and Disorders, China International Science and Technology Cooperation Base of Child Development and Critical Disorders, Children's Hospital of Chongqing Medical University, Chongqing, 400014, China.
Chongqing Key Laboratory of Pediatrics, Chongqing, 400014, China.

Qiu Li (Q)

Department of Pediatric Research Institute, Children's Hospital of Chongqing Medical University, Chongqing, 400014, China. liqiu809@hospital.cqmu.edu.cn.
National Clinical Research Center for Child Health and Disorders, Ministry of Education Key Laboratory of Child Development and Disorders, China International Science and Technology Cooperation Base of Child Development and Critical Disorders, Children's Hospital of Chongqing Medical University, Chongqing, 400014, China. liqiu809@hospital.cqmu.edu.cn.
Chongqing Key Laboratory of Pediatrics, Chongqing, 400014, China. liqiu809@hospital.cqmu.edu.cn.

Yaolong Chen (Y)

Department of Pediatric Research Institute, Children's Hospital of Chongqing Medical University, Chongqing, 400014, China. chenyaolong@lzu.edu.cn.
National Clinical Research Center for Child Health and Disorders, Ministry of Education Key Laboratory of Child Development and Disorders, China International Science and Technology Cooperation Base of Child Development and Critical Disorders, Children's Hospital of Chongqing Medical University, Chongqing, 400014, China. chenyaolong@lzu.edu.cn.
Chongqing Key Laboratory of Pediatrics, Chongqing, 400014, China. chenyaolong@lzu.edu.cn.
Evidence-Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou, 730000, China. chenyaolong@lzu.edu.cn.
Research Unit of Evidence-Based Evaluation and Guidelines, Chinese Academy of Medical Sciences (2021RU017), School of Basic Medical Sciences, Lanzhou University, Lanzhou University Institute of Health Data Science, Lanzhou, 730000, China. chenyaolong@lzu.edu.cn.
Lanzhou University Institute of Health Data Science, Lanzhou, 730000, China. chenyaolong@lzu.edu.cn.
WHO Collaborating Centre for Guideline Implementation and Knowledge Translation, Lanzhou, 730000, China. chenyaolong@lzu.edu.cn.
Lanzhou University GRADE Center, Lanzhou, 730000, China. chenyaolong@lzu.edu.cn.

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Classifications MeSH

questionsmedicales.fr › Personnes › Tranches d'âge › Adulte › Guideline for the management of pediatric...
questionsmedicales.fr › Personnes › Tranches d'âge › Enfant › Guideline for the management of pediatric...
questionsmedicales.fr › Régions géographiques › Asie › Extrême-Orient › Chine › Guideline for the management of pediatric...
questionsmedicales.fr › Technologie, industrie et agriculture › Industrie › Emballage de produit › Emballage de médicament › Étiquetage de médicament › Guideline for the management of pediatric...
questionsmedicales.fr › Professions de santé › Médecine › Médecine clinique › Médecine factuelle › Guideline for the management of pediatric...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Guideline for the management of pediatric...
questionsmedicales.fr › Thérapeutique › Traitement médicamenteux › Utilisation hors indication › Guideline for the management of pediatric...
questionsmedicales.fr › Établissements, main d'oeuvre et services de soins de santé › Personnel de santé › Médecins › Pédiatres › Guideline for the management of pediatric...
questionsmedicales.fr › Établissements, main d'oeuvre et services de soins de santé › Personnel de santé › Médecins › Guideline for the management of pediatric...