Objective To determine the extent of off-label drug use in Pediatric Wards of West China Second University Hospital in 2010 and analyze its risk factors, so as to provide baseline data for getting acquainted with the extent of off-label drug use in pediatrics in China, and for making policies of off-label drug use. Methods The proportionate stratified random sampling was conducted to select medical advice and discharge medication for hospitalized children in Pediatric Wards in 2010. According to drug instructions, the off-label drug use of prescriptions of all selected children was analyzed in the following aspects, the category of off-label drug use, age, category of drugs and wards. In addition, a logistic regression was done that modeled the odds of receiving an off-label prescription as a function of the following possible risk factors: age, sex and the rank of doctors. Results The total 749 children were selected, and 14 374 prescriptions involving 385 drugs were analyzed. The rate of off-label drug use was 98.00%, 78.96% and 88.05% in children, prescriptions and drug categories, respectively. The main categories of off-label drug use were no pediatric information (29.41%), indication (18.35%), dosage (17.61%) and dosage range (±20%) (13.52%). The top 2 age groups of off-label drug use were adolescents (83.56%) and children (80.58%). The top 4 drugs of off-label use were those for alimentary tract and metabolism (82.28%), anti-infectives for systemic use (75.06%), blood and blood forming organs (79.27%) and respiratory (58.27%). The top 2 wards of off-label drug use were Pediatric Hematology (88.27%) and Neonates (79.12%). In hospital, children, adolescents and male patients had higher risk factors of off-label drug use, and doctors with senior rank prescribed more off-label prescriptions than those with intermediate rank. Conclusion The off-label drug use in Pediatric Wards is common in West China Second University Hospital. On the one hand, drug instructions lack the pediatric information, and, on the other hand, it’s badly in need of developing relevant legislations, regulations or guidelines to regulate off-label drug use, in order to avoid doctor’s professional risks and ensure the safety of pediatric drug use.
Objective To determine the extent of off-label drug use in pediatric outpatients of West China Second University Hospital in 2010, and to analyze its possible risk factors, so as to provide baseline data for getting acquainted with the extent of off-label drug use in pediatrics in China and developing policy of off-label drug use. Methods The stratified random sampling was conducted to select prescriptions of children aged 0 to 18 years in pediatric outpatients of the West China Second University Hospital in 2010. According to drug instructions, off-label drug use of prescriptions of all selected children was analyzed in the following aspects, the category of off-label drug use, age, category of drugs. In addition, an analysis was conducted to check the relationship between off-label use and following possible risk factors: age, sex, essential medicines and over-the-counter drugs. Results A total of 2 640 prescriptions with 8 588 medical advices involving 329 drugs were extracted and analyzed, with incidence rates of off-label drug use accounting for 76.59%, 40.88% and 83.89%, respectively. The main categories of off-label drug use were no pediatric information (35.57%), indication (25.44%), and dosage (25.31%). The top 2 age groups with highest incidence rate of off-label drug were neonates (54.35%) and adolescents (49.64%). The top 4 drugs with highest incidence rate of off-label drug were respiratory system medicines (48.12%), Chinese patent medicines (48.12%), digestive and metabolic system medicines (33.36%), and systemic anti-infectives (16.27%). The off-label use risks in all age groups in the hospital were indifferent, and the essential medicines and prescription medicines were likely to present higher risks of drug off-label. Conclusion Off-label drug use in pediatric outpatients is common with growth trend in pediatric outpatients of the West China Second University Hospital. On the one hand, drug instructions lack pediatric information, and on the other hand, it’s badly in need of developing relevant legislation, regulations or guidelines to regulate off-label drug use, providing more evidence by conducting clinical trials on pediatric drugs, encouraging the development and production of the applicable drugs and dosage forms for children, and establishing the children essential medicine list, so as to avoid doctor’s professional risk and ensure the safety of pediatric drug use.
Objective To assess the global situation of off-label drug use in outpatient children.Methods A search was conducted in PubMed, EMbase, CBM, CNKI and VIP for collecting studies on off-label drug use in outpatient children aged 0 to 18 years, and the publication language was limited to English and Chinese. The quality assessment was based on Crombie Criteria for cross-sectional studies, and the descriptive analysis was performed to analyze the incidence of off-label drug use at all levels of medical institutes and different age groups, the common types of off-label used drugs, and the constitution ratio of off-label use drugs. Results A total of 20 cross-sectional studies were included, involving 1 933 760 children and 5 262 573 prescriptions. The results of descriptive analysis showed: a) The incidence of off-label drug use in outpatient children in primary care and tertiary care institutes were 19.5% (IQR 13.5%, 24.5%) and 26.0% (IQR 24.0%, 35.0%), respectively; b) The primary studies reported that neonate, infant and adolescent had the highest incidence of off-label drug use, while the other children had the lowest incidence; c) Drugs for respiratory system, anti-infection, sensory organs, and dermatosis were listed as the top 5 frequently used off-label drugs by more than half of the studies; d) The studies with issue of “lack of instruction for children” showed it was exactly the type with highest incidence of off-label use, while other studies without that issue showed the highest incidence was over aged off-label use. Conclusion a) Off-label drug use is common in outpatient children. The incidence of off-label drug use may be higher in tertiary care institutes than primary care institutes, and it is higher in neonate, infant and adolescent rather than other age groups of children; b) Incidence of off-label use may be higher in inpatient children than outpatient ones; c) Drugs for respiratory system, anti-infection, sensory organs, and dermatosis were most common types of off-label use; and d) Off-label use due to both “lack of instruction for children” and “over aged use” is more common. So it suggests that further studies trials should focus on fields in which clinical trials of drugs are totally absent.
ObjectiveTo investigate the knowledge of drug safety among parents of some children with epilepsy in Henan Province, and to provide a basic advice for drug safety and health education for children with epilepsy.sMethodUsing a questionnaire to parents of epilepsy children from the Children's Hospital in Henan Province and the First Affiliated Hospital of Zhengzhou University in July 2019, a total of 336 questionnaire were conducted by the professionals responsible for after the training, including parents and children basic situation, drug habits and attitudes, medication safety consciousness and antibiotic drug use knowledge.Results320 questionnaire were collected, 314 of which were valid questionnaires, with an effective rate of 98.1%. 66 (21%) of parents chose juice or milk for oral administration, and 87 (27.7%) of parents chose sugar water. 104 (33.1%) of the parents chose to stop the medication immediately after the child's condition improved. 126 (40.1%) of parents believe that combination of two or more antibiotics is more effective, 178 (56.7%) of parents will give their children antibiotics when they have a cold or fever, and more than 254 (80%) of parents are not aware of adverse reactions to antibiotics.ConclusionIn the investigation, the parents of children with epilepsy in Henan Province still have insufficient knowledge of safe drug use, and there are many non-standard drug use behaviors. Local medical professionals for epilepsy should be strengthened to guide and monitor the children and their parents.
Objective To explore the application effect of a nursing management mode based on Swiss cheese model in safe medication for chemotherapy patients in daytime wards. Methods The study included chemotherapy patients in the Department of Day Care Ward of Tianjin Medical University Cancer Institute & Hospital between February and March 2023 (before improvement) and between June and July 2023 (after improvement). Before the improvement, a conventional nursing management mode was adopted, and after the improvement, a nursing management mode based on the Swiss cheese model was adopted. The medication safety ability of nurses, adverse drug events, and patients’ satisfaction of nursing before and after improvement were compared. Results Finally 150 patients were included before and after improvement, respectively. There was no statistically significant difference in age, gender, educational level, per capita monthly household income, tumor staging, and disease diagnosis between the two groups of patients (P>0.05). The total score of patients’ satisfaction of nursing after improvement was higher than before improvement (22.99±1.52 vs. 20.45±2.14, P<0.05), but there was no statistically significant difference in the dimensions of treatment environment and service attitude (P>0.05). There was no change in the nursing staff before and after the improvement, and a total of 34 nurses were included in the Department of Day Care Ward. The total score of the nurses’ medication safety ability was higher than before improvement [162.00 (160.75, 166.25) vs. 136.00 (135.00, 138.00), P<0.05], but there was no statistically significant difference in the dimensions of improving medication safety issues, multidisciplinary collaboration ability, and nursing professional responsibility (P>0.05). The incidences of adverse events during daytime chemotherapy after improvement were lower than before improvement (P<0.05). Conclusion The nursing management mode based on Swiss cheese model can improve the safety medication ability of nurses, reduce adverse events of chemotherapy medication in daytime wards, and improve patient satisfaction, which can be promoted in clinical practice.