ObjectiveTo build the list of appropriate dosage forms and specifications of essential medicines for children which is subsistent abroad and absent in China. MethodsBased on the authoritative data and expert consultation, we established the selection methodology which included the standard of essential medicine for children, the standard of appropriate dosage for children, the standard of appropriate specifications for children, the standard of urgent classification, the standard of urgent level. ResultsThe list of appropriate dosage forms and specifications included 61 medicines which included 20 dosage forms and 112 specifications. 112 specifications included 27 specifications which belong to level Ⅱ, and 85 specifications which belong to level Ⅲ. ConclusionThe established list can be included by the green channel.
ObjectiveTo investigate the type, development time, regional distribution, development methods, structure and contents of therapeutic drug monitoring (TDM) guidelines, so as to provide references for the development of TDM guidelines in China. MethodsGuidelines concerning TDM were electronically retrieved in PubMed, Ovid-EMbase, CNKI, VIP, CBM, WanFang Data, NGC (National Guideline Clearinghouse ), GIN (Guidelines International Network), World Health Organization (WHO) guideline database, official websites of governments and societies associated with TDM from inception to October 2015. Two reviewers independently screened literature, extracted data including basic characteristics, formulation methods and text structure, etc.. Then a descriptive analysis was conducted. ResultsA total of 37 guidelines concerning TDM were included, which involved 4 guidelines for management of TDM, 32 for technical practice and 1 for both of them. The results of analysis showed that: for the integrity of reporting items of guidelines, three (75%) management guidelines ranked grade A, but only 1 (3.13%) technical guidelines ranked grade A. The management specifications of TDM included four aspects as follows: standard terminology, the process specification, quality control and personnel qualification. The recommendations to TDM technology of specific drugs included evidence of TDM, standards and procedures, and personnel qualification. ConclusionThere is a rapid but unbalanced development for abroad TDM guidelines. Most of them are TDM technical guidelines. Evidence-based methods are suggested to be used to develop local TDM guidelines, especially for commonly used medicines and technologies without supporting of existed guidelines.
ObjectiveTo systematically review the quality of evidence-based guidelines (EBGs) on medication therapy for neonatal bacterial meningitis, and compare differences and similarities of the drugs recommended, in order to provide references for clinical application. MethodsDatabases such as the TRIP, PubMed, CNKI, VIP, WanFang, CBM, National Guideline Clearinghouse and Guidelines International Network were searched to collect evidence-based guidelines on medication therapy for neonatal bacterial meningitis. Methodological quality of included studies was assessed according to the AGREE Ⅱ instrument, and the differences and similarities among recommendations were compared. ResultsA total of 4 EBGs were included. Among them, one guideline was developed by the America and three guidelines were by the UK. Only one guideline was developed specially for neonates, while the rest were for neonates and children of different ages. According to the AGREE Ⅱ instrument, "scope and purpose", "stakeholder involvement", "rigor of development", "clarity and presentation", "applicability" and "editorial independence" were scored more than 60%. The recommendations of different guidelines were basically the same, only with conflicts in some areas. ConclusionAlthough most guidelines concerning neonatal bacterial meningitis are of high quality, grading levels of evidence and strength of recommendation should be unified.
After 38 years of development, the procedure of selection and evaluation of the World Health Organization Essential Medicine List (WHO EML) is increasingly scientific and formal. However, peer review for the applications of WHO EML is always required in a short period. It is necessary to build up a set of methods and processes for rapid review. The most important items for the rapid review of WHO EML peer reviewers are: 1) to confirm the requirements and identify the purposes; 2) to establish the research questions and translate the questions into the ‘Participants, Interventions, Comparators, Outcomes, Study design' (PICOS) format; 3) to search and screen available evidence, for which high-level evidence is preferred, such as systematic reviews or meta-analyses, health technology assessment (HTA), clinical guidelines; 4) to extract data, where we extract primary information based on the purposes; 5) to synthesize data by qualitative methods, assess the quality of evidence, and compare the results; 6) to provide the answers to the applications, quality of evidences and strength of recommendations. Our study established a set of methods and processes for the rapid review of WHO EML peer review, and our findings were used to guide the reviewers to fulfill the 19th WHO EML peer review. The methods and processes were feasible and met the necessary requirements in terms of time and quality. Continuous improvement and evaluation in practice are warranted.
Objective To investigate and compare the demands of dosage forms and specifications of essential medicine for children in different levels of medical institutions, so as to provide references for selection of essential medicines for children by levels of medical institutions. Methods In 13 provinces or municipalities, 104 medical institutions, including tertiary, secondary and primacy medical institutions, were investigated by questionnaires. Kinds of drugs, dosage forms, requirement types and requirement levels of drugs were analyzed and compared in different levels of medical institutions. Results Tertiary medical institutions had higher demands than other levels of medical institutions for the number of drugs types, dosage forms and level of demand on each drug (P < 0.05), secondary medical institutions were higher than primacy medical institutions (P < 0.05), but community health service centers were the same as township health centers. Conclusion The demands of dosage forms and specifications of essential medicine for children in different levels of medical institutions are different. So future studies should develop the essential medicines list for children depend on different levels of care.