Verbal Abuse, Physical Assault, and Harassment in Pediatric Medical Settings: A Nationwide Survey in Japan

Background: Verbal abuse, physical assault, and harassment of pediatric healthcare workers by patients and their families have become increasingly serious. These incidents lead to various problems, including the deterioration of staff members’ mental health and employee turnover. Methods: This study was conducted as the first Japanese nationwide survey to assess the abuse perpetrated by patients and families and experienced by medical staff in pediatric medical settings in 2018, countermeasures employed, and staff member evaluations of the countermeasures. Results: Responses from 526 facilities were received, clinics accounted for 79.8% of these facilities;88.1% of the respondents were females. Further, 10.5% of the facility staff reported having experienced verbal abuse, violence, or harassment from patients or family members. Of 1103 cases of victimizations, there were 719, 136, and 248 cases of verbal abuse, violence, and harassment, respectively. Manuals and guidelines had been created and training and drill performances were conducted as countermeasures in 10.7% and 9.0% of facilities, respectively;7.3% of staff members felt that the countermeasures were effective, corresponding to 45.6% of the affected staff. Conclusion: The findings suggest the necessity of thoroughly familiarizing staff with existing facility countermeasures as well as introducing new countermeasures such as victimization simulations.

Recent landscape and trends for industry-sponsored pediatric clinical trials in China from 2013 to 2022

Importance:Pediatric medication is a challenging issue globally.Promoting trials of medications for children and implementing measures to encourage innovation for addressing unmet medical and health needs are important.Objective:To explore the recent landscape of pediatric clinical trials of new investigational drugs conducted by pharmaceutical enterprises in China from 2013 to 2022 to provide insight into pediatric drug development in the pharmaceutical industry and regulatory policy formulation.Methods:We performed a cross-sectional observational investigation of pediatric clinical trials registered from January 1,2013,to December 31,2022,on the Registration and Information Disclosure Platform for Drug Clinical Trials,the official registration platform established in 2013 for trials of new investigational drugs initiated by biopharmaceutical enterprises.Trials that included pediatric participants(under 18 years old)were retrieved,and their relevant characteristics were extracted and analyzed.Results:In total,895 pediatric clinical trials were collected,accounting for 5.1%of the total registered clinical trials initiated prior to January 1,2023.The overall average annual growth rate for the number of pediatric clinical trials was 12%(P<0.001).Phase III trials accounted for the highest proportion(49.1%,439).Of the 895 trials included,736(82.2%)were domestic trials,and 159(17.8%)were international multicenter trials.In terms of tested drugs,investigations of biological products accounted for the largest proportion of trials(67.4%,603).Among pediatric clinical trials,studies of vaccines accounted for the largest proportion of trials(41.0%,367),followed by trials for rare diseases(17.2%,154).Furthermore,geographical distribution analysis revealed that the largest and smallest numbers of trials were conducted in North China(35.7%,320)and Northeast China(0.8%,7),respectively.Interpretation:The growth trends for industry-sponsored clinical trials involving children illustrate the progress and increasing capability of pediatric drug development achieved in China since 2013.Current challenges and potential areas of focus for policymakers and stakeholders include investigating orphan drugs for rare diseases according to the unique epidemiological characteristics of Chinese children,expanding the scope of pediatric clinical trials,and improving the uneven geographical distribution of leading research centers.

New technologies as a strategy to decrease medication errors: how do they affect adults and children differently?

Background:Medication error can occur throughout the drug treatment process,with special relevance in children given the risk of adverse effects resulting from a medication error is more prevalent than in adults.The significance of medication error in children is also greater because small error that would be tolerated in adults can cause significant damage in children.Moreover,the likelihood of injury is higher than in adults.Data sources:Based on the data published,most medication errors take place in prescribing and administration stages in both populations.Taking in account that child's risk factors are different from those of adults,with some specific causes to pediatrics,we have reviewed available data about new technologies as a strategy to reduce pediatric medication errors.Results:Even though there is a lack of standardized definitions and terminology that makes studies difficult to compare,we checked that new technologies have proven to be effectives in reducing medication errors,mainly computerized physician order entry(CPOE)and platforms to aid decision-making.However,we also observed that the use of these informatic tools can also generate new errors.Conclusions:Implementation of CPOE programs for pediatrics,communication improvement between healthcare professionals taking care of admitted children and the knowledge of these programs should be the mayor priorities for the safety of hospitalized children.