Objective To compare the 2009 edition national essential medicine list (part of basic medicine and heath institution ) in China and WHO model list of essential medicines for children update in 2010, so as to provide the evidence for model list of essential medicines for children of China. Methods We compared the diference in composition of content, the categories, speciic drugs, formulation, and introduction and sign of list by descriptive analysis. Results (1) WHO model list of essential medicines for children were comprised with core and complimentary lists, which were not in the 2009 edition national essential medicine list of China; (2) The 2009 edition essential medicine lists of China included 20 categories in WHO model list of essential medicines for children ,while lacked of antineoplastic agents, blood products, disinfectants, peritoneal dialysis luid and speciic medicines for neonatal care; (3) he average conincidence rate with WHO model list of essential medicines for children of the same drugs was 52.61%. here were 15 categories in the interval of 20%-80%, which accounted for 75%. he average conincidence rate with 2009 edition national essential medicine list of China was 44.19%. here were 11 categories in the interval of 20%-50%,which accounted for 55%. the same drugs of regulate water, electrolyte and acid-base balance in the two list accounted for more than 80% of WHO model list of essential medicines for children. Drugs of ear, nose and throat were totally diferent. (4) he 2009 edition essential medicine list of China didn’t have speciication and sign of drug for children, age limitation, instruction of list, suitable drug formulations for children such as suspension, syrup, drops, granules, scored tablets, etc. Conclusion 2009 edition national essential medicine list of China can’t meet the demand of children. WHO model list of essential medicines for children which bases on global burden of disease, can not be copied into China. We suggest to reference fromWHO model list of essential medicines for children to carry out selecting essential medicines for children in China, formulating essential medicine list for children in China which bases on burden of children disease and clinical demand in China to improve rationality of drugs in children.
ObjectiveTo learn the development and implementation of orphan drug policies, in order to provide decision-making references for the establishment of orphan drug policy according with China's national conditions. MethodsWe electronically searched databases including CBM, CNKI, VIP, EMbase, PubMed, Web of Knowledge, National Library of Medicine, CRD database, The Campbell Library, The Cochrane Library and the drug administration websites of USA, Canada, UK, Ireland, the Netherlands, Germany, Spain, France, Australia, New Zealand, China, India, South Korea, Japan, and South Africa to collect studies about orphan drug policy. The search date was up to February 2014. Two reviewers independently screened literature, and extracted data. Then, all included orphan drug policies were summarized and a comparative analysis was performed. ResultsA total of 110 studies were included. USA, Singapore, Japan, Australia, European Union, Chinese Taiwan and South Korea had introduced orphan drugs incentive policies. South Africa, India, Canada, New Zealand and Chinese Hongkong were producing orphan drugs policy frameworks. The main items of orphan drug policy included marketing exclusivity, tax incentives, technical assistance, grant funding, expedite approval process and prolong re-evaluated time. ConclusionIn mainland China, there is no orphan disease management policy. China should establish specific organization and working procedures, promote orphan drug policy related legislative work, clarify the definition and prevalence of orphan diseases, provide incentive mechanism to promote the research and development of orphan drugs, provide enterprises to develop compensation mechanism to safeguard the rights and interests of patients, as well as establish patients register network platform to track the processes of the diseases.
ObjectiveTo systematically review the medication adherence in children with tic disorder to assist in the selection of clinical treatment options and enhance the efficacy of medications for tic disorder.MethodsDatabases including Medline (Ovid), EMbase (Ovid), The Cochrane Library, PsycINFO (EBSCOhost), CINAHL Plus (EBSCOhost), CNKI, WanFang Data and VIP were searched from inception to August 2020, and original studies on medication adherence in children with tic disorder were included. Two researchers independently screened literature, extracted data on the definition of compliance, compliance rate, and factors affecting compliance, and evaluated risk bias of included studies. Systematic review was performed to analyze the status of medication adherence in children with tic disorder.ResultsA total of 12 studies were included, involving seven randomized controlled trials, two case series studies, and three cross-sectional studies. Most studies failed to specify the definition of compliance. The results of cross-sectional studies showed that the proportion of children with good medication compliance was 29.3% to 47.1%. The first-line treatment drugs, tiapride, risperidone, aripiprazole, and clonidine, had relatively good adherence. Medication adherence was affected by drug factors, patient and family factors, and environmental factors.ConclusionsThe adherence rate of medications for tic disorder varies between studies. Few studies have analyzed the factors that affect medication adherence for tic disorder, and some influencing factors are controversial. The first-line treatment drugs, tiapride, risperidone, aripiprazole, and clonidine, have high medication adherence and are recommended for clinical use.
Objective We aimed to develop a self-management assessment scale for children with epilepsy and test its reliability and validity. Methods A research group was established, and the items were revised through literature review, group discussion and pre-investigation, and 280 patients with epilepsy in children were included, and the reliability and validity of the scale were tested. Results 28 items in 4 dimensions were developed to form the scale, namely, knowledge and belief of diseases and medication, compliance of medication and treatment, self-efficacy of medication and obstacles of medication. Confirmatory factor analysis extracted four common factors with characteristic roots greater than 1, and the cumulative variance explanation rate was 65.639%. The factor load of all items is > 0.5. The overall Cronbach’s alpha is 0.880, and the coefficients in seven measurement dimensions are all greater than 0.8. Conclusion The self-management assessment scale for children’s epilepsy drugs has good reliability and validity, and can provide a measuring tool for the drug management of children’s epilepsy diseases.
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.
Objective To compare the newest essential medicine lists (EMLs) of China and the World Health Organization (WHO) in 2009, so as to provide the evidence for the selection, adjustment and implementation of the newest national EML of China. Methods Differences in the procedures of selection, implementation and the categories as well as the number of medicines in 2009 EMLs of the WHO and China were compared by descriptive analysis. Result Principles and procedures of selecting and updating EML of China were based on those of the WHO EML. However, the transparency of procedures, methods of selection, and evidence of efficacy, safety, cost-effectiveness and suitability were not enough. Essential medicines of the WHO were categorized by the Anatomical-Therapeutic-Chemical (ATC) classification system, while those of China were classified by clinical pharmacology. Twenty-one identical categories of the first class were found in the two lists. There were 8 and 3 unique categories in the WHO EML and China EML, respectively. A total of 358 and 255 medicines (including medicines in its explanation) were included in the EMLs of the WHO and China, respectively, with 133 identical medicines as well as 206 and 108 unique medicines. There were 51 antiinfective medicines in China EML, accounting for half of the WHO EML. Forty medicines were the same in both lists, and 11 and 60 anti-infective medicines were unique in EMLs of China and the WHO, except for 40 identical medicines. Among them, 22 and 31 antibacterials were included in the lists of the WHO and China with 17 identical medicines. Antifungal, antituberculosis and antiviral medicines in China EML were fewer than those in the WHO EML. The numbers of the identical medicines acting on the respiratory, digestive, and nervous systems and hormones in the both lists were 1, 7, 9, and 17, respectively, while the unique ones in China EML were 6, 12, 7, and 14, respectively. However, most of them were selected without adequate evidence in efficacy and safety. The medicines acting on cardiovascular system were 19 and 29 in both lists with 14 identical medicines. Some antihypertensive and antiarrhythmic medicines were included in China EML with similar mechanism, whereas some of them were excluded by the EML. Conclusion The total numbers of both EMLs are close to each other with half of the identical medicines. The selection of China EML mostly meets the needs of disease burden in China. However, the transparency of selection and evidence are not enough. We suggest that health authorities should cooperate with other stakeholders to promote the transparency of selection, to enhance the capacity of producing high-quality evidence, to develop related technical documents and guidelines, and to disseminate and monitor the implementation of EML.
Objective To study the medication usage in children with crush syndrome in Wenchuan Earthquake. Methods The information of the medications of 7 children with crush syndrome in West China Second University Hospital, Sichuan University was collected by medical history. The cases and times of medication, the total number of drugs, the drug cost per capita and the drug cost per day were calculated by Excel. Results A total of 113 drugs in 19 categories were appl ied to 7 children with crush syndrome. Most children used Vitamins and antibacterial agents. The cost of gamma globul in injection was the highest. Conclusions The rational ity valuation for children medication lacks international vulgate index and needs more basic research.