Dataset Information

Current practice and awareness of pediatric off-label drug use in Shanghai, China -a questionnaire-based study.

ABSTRACT:

Background

Off-label drug use is widespread in pediatric drug treatment, and the implementation of guidelines on this topic remains challenging. The objective of this study was to evaluate current practice and awareness of healthcare professionals towards pediatric off-label drug use, as well as the barriers to guideline implementation among pediatric healthcare professionals in Shanghai, China.

Methods

A validated questionnaire was issued to representatives of pediatricians, pharmacists, nurses and administrators from hospitals with pediatric qualification in Shanghai.

Results

A total of 679 completed questionnaires from 69 hospitals were included in the analysis. Nearly half (47.9%) of the pediatricians acknowledged that they had prescribed off-label drugs. Most (88.4%) of the pharmacists acknowledged that they had dispensed off-label medicines. The main reason for off-label prescribing was the lack of pediatric dosage information. The most common category of off-label prescribing in children was dosage. Nearly half (42.0%) of the participating hospitals had developed internal protocols for off-label drug use. However, approximately half of the respondents reported that they did not adhere to the guidance and that it had barriers to implementation. Most respondents (84.5%) declared that they were familiar with the term "off-label drug use". However, the awareness rate of the Chinese Expert Consensus of Pediatric Off-Label Drug Use was low (45.7%). More than half (55.4%) of the respondents declared that they did not adhere to the process proposed in the consensus and that barriers existed for its utilization.

Conclusions

Pediatric off-label drug use is widespread in Shanghai, China, and barriers exist to the implementation of the guideline. A legally recognized national guideline with a broad scope of application for off-label drug use is urgently needed; at the same time, more education and training on off-label drug use should be provided to targeted healthcare professionals.

SUBMITTER: Mei M

PROVIDER: S-EPMC6691537 | biostudies-literature | 2019 Aug

REPOSITORIES: biostudies-literature

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Publications

Current practice and awareness of pediatric off-label drug use in Shanghai, China -a questionnaire-based study.

Mei Mei M Xu Hong H Wang Libo L Huang Guoying G Gui Yonghao Y Zhang Xiaobo X

BMC pediatrics 20190813 1

<h4>Background</h4>Off-label drug use is widespread in pediatric drug treatment, and the implementation of guidelines on this topic remains challenging. The objective of this study was to evaluate current practice and awareness of healthcare professionals towards pediatric off-label drug use, as well as the barriers to guideline implementation among pediatric healthcare professionals in Shanghai, China.<h4>Methods</h4>A validated questionnaire was issued to representatives of pediatricians, phar ...[more]

PMID: 31409339

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Project description:IntroductionThe use of electronic cigarettes (e-cigarettes) in adults is increasing globally, and similar trends may be observed in the young population. Our objective was to estimate the awareness and use of e-cigarettes among the students from two comprehensive universities in Shanghai, China, and to identify the factors that may influence their decision to use e-cigarettes and their possible adverse effects.MethodsAn online cross-sectional survey was conducted among the students of Shanghai Jiao Tong University and Fudan University. A total of 869 students (412 males and 457 females), mean age 21.09 years (SD=2.44), were recruited in 2018. Multivariate binary logistic regression analyses were performed to explore the associations between ever e-cigarette use and influencing factors.ResultsOf the responding students, 88.4% were aware of e-cigarettes, 4.6% had used e-cigarettes at least once in their lifetime, and 1.7% were current e-cigarettes users. Males and smokers were more likely to use e-cigarettes (ever used e-cigarettes even once) than females (OR=3.51; 95% CI: 1.69-7.27; p=0.001) and non-smokers (OR=28.58; 95% CI: 14.03-58.20; p<0.001). University students were easily motivated to use e-cigarettes when their peers also used them, and the risk ratio was 4.15 (95% CI: 2.11-8.19) compared with if their peers never used e-cigarettes. The major factors found to motivate university students to use e-cigarettes were the belief that e-cigarettes were less harmful or not harmful (55.0%) and the perception that e-cigarettes were helpful to quit smoking (37.5%). The survey also indicated that 72.4% of the respondents heard about e-cigarettes from television advertisements, 42.7% from websites online, and 41.2% from their parents and friends.ConclusionsUniversity students who were males, cigarette smokers and whose peers used e-cigarettes were more likely to use e-cigarettes. The use of traditional cigarettes should be controlled strictly in order to reduce the likelihood of e-cigarette use among university students.

Project description:BackgroundThe "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.MethodsWe 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).ResultsWe developed the first guideline for the management of pediatric off-label use of drugs in China.ConclusionsThe 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.

Dataset Information

Current practice and awareness of pediatric off-label drug use in Shanghai, China -a questionnaire-based study.

Background

Methods

Results

Conclusions

Publications

Current practice and awareness of pediatric off-label drug use in Shanghai, China -a questionnaire-based study.

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