Objective To make an individualized administration scheme via evidence-based medicine methods, namely adding heparin into the total nutrient admixture (TNA) solution, so as to help a neonate to prevent the occlusion of peripherally inserted central catheter (PICC). Methods After carefully assessing the condition of neonate, this clinical issue was put forward in accordance with the PICO principles. Randomized controlled trials (RCTs) and systematic reviews on neonates’ PICC occlusion were collected from The Cochrane Library, CCTR, DARE, NGC, MEDLINE (Ovid) and CBM from inception to 2011. The clinical intervention scheme was finally made after the assessment of the retrieved evidence and neonate’s physiological condition. Results A total of 4 RCTs and 1 systematic review related to the issues were identified. The following scheme was finally made for the neonate through the assessment of the retrieved evidence and combination of intentions of the patient’s family members: heparin (0.5 U/mL) was added into TNA to prevent PICC occlusion. During the application, blood routine test and blood coagulation were monitored, and the catheter opening time and extubation reason were recorded. Through the above treatment, the neonate successfully completed the treatment before extubation. The time of both PICC detaining and opening was 20 days in total, and there were no PICC occlusion, no catheter thrombosis, and no catheter related bloodstream infection. Moreover, no observation showed thrombopenia and aggravated coagulation disorders resulted from heparin. Conclusion The evidence-based medicine method is an effective way to make reasonable heparin scheme for neonate, so as to prevent PICC occlusion, reduce catheter thrombosis, decrease risks of catheter related blood circulation infection, assure successful completion of treatment, and guarantee the safety of patients.
Objective Inappropriate drug dosage is a serious problem in pediatrics, mainly due to the lack of clinical evidence in children, suitable preparation formulation, and standardized methods for dose adjustment. A method for evaluating and monitoring appropriate dosage in pediatrics is urgently needed. The drug utilization index (DUI) based on the Anatomical Therapeutic Chemical/Defined Daily Dose (ATC/DDD) has been widely used in the assessment of appropriate dosage in adults. We explored possible methods for assessing appropriate dosage in children. Methods Based on our previous studies, we discuss cDUI in the assessment of appropriate dosage in children as follows: the meaning of cDDD, the establishment of a standardized system, and the classified evaluation of dosage in pediatrics. Results Although the definition of cDDD draws on the concept of defined daily dose (DDD), the meaning of cDDD is different from that of the latter. Specifically, the purpose of cDDD is to evaluate appropriate pediatric dose, while DDD is a unit of measurement. cDDD could be used to assess dose rationality for common and serious pediatric diseases, and would be refined over time. A single cDDD should be assigned per drug and indication and given per drug and route of administration. The influence of age, weight, diagnosis, and administration route on the dosage should be considered. Classified evaluation should be used and weight should be given to the above mentioned factors in order to evaluate the appropriate dose objectively and comprehensively. Conclusion Dosage regulation in pediatrics has an important role in improving medical quality and protecting the safety, effectiveness, and economy of medical therapy in children. The establishment of a cDUI system is a good try in pediatric dosage evaluation. Although there are still defects within this proposed system and methodology, the principle seems feasible.
Objective To provide evidence for the definition, current development and prospect of Evidence-based pharmacy through systematically assessing the extant literatures. Methods We searched CBM, VIP, CNKI, PubMed, EMbase, and Google for supplement. We extracted definitions of evidence-based pharmacy, types of studies, published year, topics of studies, and the author information from the included studies. We compared the definitions on different domains, and assessed the current development of evidence-based pharmacy literature. Results a) The definition of evidence-based pharmacy: We found 4 definitions, and there were great differences among them on the people who practiced evidence-based pharmacy as well as the methods and areas of the practice. b) The evidence-based pharmacy literature: 12 English and 202 Chinese articles were included in the review. The number of Chinese evidence-based pharmacy articles was increasing annually, especially in recent 3 years; Most of their authors were from hospitals, especially from pharmacy department; Their study orientations mostly involved clinical pharmacy and hospital pharmacy; The topics mainly refered to the practice and development of clinical pharmacy, rational drug use, and development of hospital pharmacy. Conclusion a) There is yet no consensus on the definition of evidence-based pharmacy. b) Few researchers worldwide know or show interest in evidence-based pharmacy, while, so far, more and more researchers are getting to know evidence-based pharmacy in China. c) Further efforts should be made to develop the theoretical system of evidence-based pharmacy and the pattern of its practice.
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.
ObjectivesTo systematically evaluate the structure, publication type and contents of current guidelines for guideline development, so as to provide methodology references for guideline development in China. MethodsSix biomedical research literature databases, six guideline databases and 18 websites of academic institutions and health administrative departments were searched to locate guidelines for guideline development. We included the latest versions of guidelines from guideline development departments or academic institutions. We extracted information consisting of general guideline information, structure, principles, methods and procedure of guideline development. A descriptive analysis was conducted to analyze the general information, structure, principles, methods and procedure of guidelines among different guidelines for guideline development. ResultsAmong all the included 25 guidelines for guideline development published from 1998 to 2014, 50% of them were from North America. Structure of these guidelines were similar while detail levels of recommended guideline development methods and procedures were slightly different. The guideline development groups, systematic literature search, evidence assessment and recommendation formulation were vital part of guideline development. The ineffective promotion and implementation of guidelines for guideline development were common problems of current guidelines. ConclusionsProcedures recommended by current guidelines for guideline development are almost the same, but the methods and statements are different. We could develop our own guideline for guideline development based on the current relative high-quality guideline in order to provide guidance to the clinical guideline development in China.
ObjectiveThis study aims to compare different references for the fetal risk of drugs used in pregnancy to provide evidence for the safety of drug use in pregnancy.MethodsFour drug databases, including Lexicomp, Micromedex, TERIS, and Reprotox, as well as two books of drugs in pregnancy edited by Briggs and Schaefer, were searched. Descriptive analysis was performed regarding the definition of pregnancy recommendations and the specific content of medication.ResultsThe six references employed slightly different approaches to drugs in pregnancy, however, all of them included summaries of the risk in pregnancy, data of crossing the placenta, and human and animal data. The databases of Micromedex, TERIS, and a book edited by Briggs had their risk classification systems for drug use during pregnancy. For specific drugs, the summary of different information in pregnancy was different, the amount and content of listed evidence varied, and there was no evaluation of the quality and relevance of evidence among the references.ConclusionsThere is no consensus on the risk assessment of drugs in pregnancy. Risk classification systems for drugs in pregnancy are still an important method for determining the fetal risk of drugs. The existing references merely list studies of drugs in pregnancy, without comprehensive quality assessment. A methodological study of assessment of the risk of drugs in pregnancy is required.
Objective To analyze drug use for 23 sick and wounded hospitalized in the departments of gynaecology, obstetrics and paediatrics in the West China Second University Hospital, during one month after Lushan earthquake, so as to provide references for the drug use for the sick and wounded women and children. Methods Medication information was retrospectively investigated in the departments of gynaecology, obstetrics and paediatrics in the West China Second University Hospital during one month after Lushan earthquake. We extracted data including hospitalization duration, medication prescriptions, types and costs of essential medicines, types and costs of antibiotic medicines using the HIS system. Discharge diagnosis was standardized and classified according to ICD-10. Indicators of rational drug use included defined daily dose (DDD), defined daily dose statistic (DDDs), drug utilization index (DUI), children defined daily dose (cDDD), children drug utilization index (cDUI), proportion of essential medicines, proportion of antibiotic medicines, mismatch of medicine and diagnosis, repeated drug use, improper combination of drug, incorrect usage and dosage, and frequently drug change. Medication information was evaluated and discussed by the prescription working group. Discrepency was resolved by consulting with the panel. Results A total of 23 sick and wounded women and children were assessed during one month after Lushan Earthquake. There were 13 sick and wounded children in the department of pediatrics (mainly manifested as bronchial pneumonia) and 10 sick and wounded women in the department of gynaecology and obstetrics (mainly involved in cesarean delivery). Proportions of essential medicines were 13/13 in the department of pediatrics and 9/10 in the department of gynaecology and obstetrics. Proportions of antibiotic medicines were 10/13 in the department of pediatrics and 8/10 in the department of gynaecology and obstetrics. Irrational drug use was mainly caused by improper use of antibiotics. Conclusion The drug use for 23 hospitalized sick and wounded is rational in the departments of gynaecology, obstetrics and paediatrics in the West China Second University Hospital during one month after Lushan earthquake. Evaluation methods of rational drug use in high-risk population are urgently needed. Using cDDD and cDUI is an active exploration for the evaluation of pediatric drug use, which needs more practice to test and improve.
Objective To assess the global situation of off-label drug use in hospitalized children. Methods The databases such as PubMed, EMbase, CBM, CNKI and VIP were searched to collect studies on off-label drug use in hospitalized children at age of 0 to 18 years old. The publication language was limited to English and Chinese. The quality assessment was based on Crombie Criteria for cross-sectional studies. The incidence of off-label drug use was described in different wards and age groups, and the proportion of different off-label used drugs was analyzed. Results The total 29 cross-sectional studies were included, involving 8 560 children and 41 655 prescriptions. a) Median (IQR) of off-label use incidence: Neonatal ICU 52.5% (23.0% to 44.8%), Pediatric ICU 43.5% (34.5% to 60%), General pediatric ward 35.5% (23.8% to 43.3%), Pediatric surgical ward 27.5% (23.0% to 44.8%); b) The results of off-label incidence in different age groups were inconsistent among different studies; and c) The off-label drug use for “no pediatric information” had the largest proportion, followed by dose and age. Conclusion a) Off-label drug use exists widely around the world, but the incidence varies a lot in different countries and different types of wards; b) The incidence of off-label drug use may be higher in ICU than in non-ICU, and higher in the neonatal ward than the pediatric ward; c) The off-label drug use for no pediatric information is the commonest type, and further clinical studies should focus on areas in which high quality evidence is totally absent; and d) The multi-center studies with unified design on off-label drug use in hospitalized children in China are urgently needed to provide evidence for policy-making.
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.