中国儿童基本药品可及性多中心研究

目的调查我国儿童基本药品的可及性现状,为提高我国儿童基本药品可及性,促进儿童合理用药提供依据。方法采用现况调查方法,于2017年5月26日至6月2日选取我国东部、中南部、西部和北部地区17个省或直辖市的55家公立医院,以调查表的形式对42种儿童基本药品进行可及性调查。每个药品调查原研药和仿制药两个品种。研究内容包括可获得性、价格、可承受性。42种儿童基本药品在所有调查机构中可以得到的百分比,即为该药品的可获得性。价格研究采用中位价格比值(MPR),即某一种药品单位价格的中位数与国际参考价格的比值,并针对所有药物得出中位MPR。药品费用的可承受性研究,是将治疗某一标准疗程疾病所需的费用,折算成赚取全国日最低工资所花费的天数,计算治疗该常见疾病的可承受性。对可获得性、价格、可承受性指标进行描述性分析。结果在42种调查药品中,原研药和仿制药的平均可获得性分别为33%和32%。原研药和仿制药的中位MPR分别为5.43和1.55;既有原研药又有仿制药的19种药品价格比较,原研药和仿制药的中位MPR分别为7.73和2.04。针对4种常见儿童疾病(肺炎、消化性溃疡、先天性甲状腺功能减低症、难治性肾病)的5种基本药品进行可承受性研究,使用仿制药需要花费0.63(0.16~6.17)d全国日最低工资,使用原研药需要花费1.03(0.16~11.53)d全国日最低工资。结论在42种儿童基本药品中,原研药和仿制药的可获得性均较低。仿制药价格基本合理,可承受性较好;原研药价格明显高于国际参考价,可承受性较差。需进一步提高我国儿童基本药品可及性。     

Evaluation of the World Health Organization criteria for chest radiographs for pneumonia diagnosis in children

Our objective was to compare the inter-observer level of agreement in diagnosing pneumonia using the World Health Organization (WHO) guidelines for the interpretation of radiographs. We conducted a prospective study in a pediatric emergency room. Fifteen observers (13 pediatricians, 2 radiologists) interpreted 200 pediatric (<5 years old) chest radiographs using the WHO guidelines. Observers were blinded to the clinical presentation. Results were analyzed for kappa values. Individual readings were compared to two “gold standard” teams: (1) radiologist and pediatrician and (2) two radiologists. Results: Alveolar pneumonia, non-alveolar pneumonia, and no pneumonia were found (by radiologists) in 12.8%, 2.7%, and 78.6% of readings, respectively. The mean kappa values for alveolar pneumonia, non-alveolar pneumonia, and no pneumonia of observers versus the team consisting of a radiologist and a pediatrician were 0.73, 0.23, and 0.61, respectively. For non-alveolar pneumonia, the mean kappa value was higher for the gold standard consisting of a radiologist and a pediatrician when compared to the two-radiologist team. Pediatricians overdiagnosed “non-alveolar pneumonia” compared with radiologists. In contrast, for the alveolar pneumonia and no-pneumonia diagnoses, no significant differences were found. Conclusions: The WHO guidelines for interpretation of chest radiographs result in high level of agreement between readers for the definition of “alveolar pneumonia” and “no pneumonia” but poor agreement for non-alveolar pneumonia. The disagreement with regard to the latter was associated with overdiagnosis by pediatricians, which may lead to overtreatment. We believe that radiographic non-alveolar pneumonia should not be an endpoint for clinical trials and research, nor should it be implemented in clinical setting.     

Evaluation of children with recurrent pneumonia diagnosed by World Health Organization criteria

BACKGROUND: A World Health Organization (WHO) case management approach has been used to identify and treat children with pneumonia worldwide since 1987. Many children are treated repeatedly: 23% of children with pneumonia in our rural Haitian district had met the WHO criteria on two or more occasions; but underlying disease in such children has not been systematically studied. METHODS: We enrolled 103 children who had been diagnosed with pneumonia on 3 or more occasions by community health workers using WHO criteria. We compared them with 138 children similarly evaluated but never diagnosed with pneumonia, matching by health worker and age. We administered questionnaires to parents and performed complete physical examinations, tuberculin skin tests and serologic testing for HIV on all subjects and chest radiographs on case children. RESULTS: Two percent of case children and 1.5% of controls had positive tuberculin skin test reactions. None of the children tested was HIV-seropositive. Ninety-four case children had normal baseline chest radiographs and three had focal infiltrates. A history of wheezing was reported for 79% of case children and 61% of controls (P = 0.002), and wheezing with exercise was reported for 36% and 22%, respectively (P = 0.02). DISCUSSION: Most children in Haiti with recurrent pneumonia diagnosed by WHO criteria do not have evidence of tuberculosis, HIV infection or pulmonary anomalies, but they may be more likely to have asthma, and this should be considered as an alternative diagnosis. This information should help direct evaluation of such children in other settings and prompt further study of asthma in developing countries.     

Agreement between Subjective Global Nutritional Assessment and the nutritional assessment of the World Health Organization

Objective

To assess the agreement between the results of the Subjective Global Nutritional Assessment questionnaire, adapted for children and adolescents of the Brazilian population, and the nutritional status assessment method through growth curves and the classification of the World Health Organization in a pediatric hospital service.

World Health Organization growth charts for monitoring the growth of Australian children: time to begin the debate

The recently released World Health Organization growth charts are methodologically robust, as well as clinically useful tools for monitoring the growth of children. They have been endorsed by premier organisations such as the Royal College of Paediatrics and Child Health (UK), Canadian Pediatric Society, Australian Breastfeeding Association, United Nations Standing Committee on Nutrition, International Union of Nutrition Sciences, International Pediatric Association and the European Childhood Obesity Group. The Centers for Disease Control and Prevention (CDC) as well as the American Academy of Pediatrics have also recently endorsed these charts for the 0- to 24-month age group in USA. These growth charts have been adopted by many countries including Canada, UK and New Zealand. Nearly 140 countries are at various stages of implementing them. They offer significant advantages over the currently used CDC 2000 growth charts. They have the potential to contribute in reducing the worldwide incidence of obesity as well as under nutrition in children. Except Northern Territory, Australia continues to use the CDC 2000 growth charts. Paediatricians need to initiate and lead robust debate involving key stakeholders about the implementation of World Health Organization growth charts for monitoring the growth of Australian infants and children.     

Medicines for cancers in children: The WHO model for selection of essential medicines

Pressures to include more cancer medicines in the WHO Model List of Essential Medicines (EML) pose challenges for the Expert Committee responsible for recommending changes to the list. How do medicines for cancer fit within a definition of essential medicines as those meeting the priority health needs of the population? Will identifying a medicine as “essential” offer some leverage to improve access to effective cancer medicines in low and middle‐income countries (LMICs)? The addition of a number of medicines for the treatment of cancers in children to the Model List of Essential Medicines for Children (EMLc) in 2011 provides important insights into previous Expert Committee decision‐making and offers a platform for future deliberations. As combination chemotherapy is required for effective treatment of many malignancies, a disease‐based approach makes more sense than an agent‐based approach. Inadequate financing to purchase essential medicines is a reality in many LMICs, thus a consideration of health impact is central to decisions on the selection and procurement of medicines. Inclusion in national EMLs should identify medicines that have priority for procurement in the public sector. This article will discuss some of the factors taken into account by the Expert Committee in developing the WHO EMLc. We argue that the disease‐based approach coupled with the assessment of the magnitude of the clinical benefit provides an appropriate approach for considering further additions of medicines for pediatric cancers and for the review of the adult cancer section of the Model List. Pediatr Blood Cancer 2015;62:1689–1693. © 2015 Wiley Periodicals, Inc.

     

Extemporaneous (magistral) preparation of oral medicines for children in European hospitals

Aim: To evaluate methods of preparation of oral medicines in European children's hospitals when drugs prescribed are unlicensed or off-label, and to determine whether such extemporaneously prepared medicines are available as suitable, authorized products in other countries. Methods: A questionnaire was distributed to 41 hospital pharmacists in 18 European countries, requesting information on the most frequent extemporaneously prepared oral liquid, powder and capsule medicines, and on their formulation and stability. Information was gathered on the availability of suitable authorized forms of these medicines in other European countries, the USA and Australia. Results: 21 questionnaires from 16 countries returned showed that the methods of extemporaneous preparation vary in different European countries with, for example, liquid preparations predominating in England and Sweden, capsules in France and Spain, and powders in Finland and Italy. The top 20 preparations are made in many different strengths and formulations. The same drug may be prepared in liquid, capsule or powder form, depending on the country. Many of the extemporaneous preparations were available as suitable authorized paediatric medicines in other countries. The quality of information available on formulation and stability was limited, and there was concern about the availability and quality of chemical ingredients.

Conclusion: Preparation of children's oral medicines is subject to much variation in hospitals throughout Europe and there is little harmonization of formulations or information on stability of products. The European Union could be the focus for improving the availability of appropriate authorized medicines for children and ensuring that when extemporaneous preparation is necessary it is of a common high standard.     

New growth references of the World Health Organization based on breast fed infants

The World Health Organization Multicenter Growth Reference Study is a multinational project to develop new growth references for infants and young children. The design combines a longitudinal study from birth to 24 months with a cross-sectional study of children aged 18 to 71 months. The pooled sample from the six participating countries (Brazil, Ghana, India, Norway, Oman, and the United States) consists of 8440 children. The new WHO Child Growth Standards confirm that all children worldwide, given an optimum start in life, have the same potential for growth and prove that differences in children's growth to the age of 5 years are more influenced by nutrition, feeding practices, environment, and healthcare than by genetics or ethnicity. The new standards are based on the breast fed child as the norm for growth and development. For the first time, this ensures coherence among the tools used to assess growth and national and international infant feeding guidelines, which recommend breast feeding as the optimal source of nutrition during infancy.