Public health relevance of medicines developed under paediatric legislation in Europe and the USA: a systematic mapping study.

BACKGROUND: Legislation in the European Union (EU) and the USA promoting the development of paediatric medicines has contributed to new treatments for children. This study explores how such legislation responds to paediatric health needs in different country settings and globally, and whether it should be considered for wider implementation. METHODS: We searched EU and US regulatory databases for medicines with approved indications resulting from completed paediatric development between 2007 and 2018. Of 195 medicines identified, 187 could be systematically mapped to the burden of the target disease for six study countries (Australia, Brazil, Canada, Kenya, Russia, South Africa) and globally, using disability-adjusted life years (DALYs). All medicines were also screened for inclusion on the WHO Model List of Essential Medicines (EML) and the EML for children under 13 years (EMLc). RESULTS: The studied medicines were disproportionately focused on non-communicable diseases, which represented 68% of medicines and 21% of global paediatric DALYs. On the other hand, we found 28% of medicines for communicable, maternal, neonatal and nutritional disorders, representing 73% of global paediatric DALYs. Neonatal disorders and malaria were mapped with two medicines, tuberculosis and neglected tropical diseases with none. The gap between medicines and paediatric DALYs was greater in countries with lower income. Still, 34% of medicines are included in the EMLc and 48% in the EML. CONCLUSIONS: Paediatric policies in the EU and the USA are only partially responsive to paediatric health needs. To be considered for wider implementation, paediatric incentives and obligations should be more targeted towards paediatric health needs. International harmonisation of legislation and alignment with global research priorities could further strengthen its impact on child health and support ongoing efforts to improve access to medicines. Furthermore, efforts should be made to ensure global access to authorised paediatric medicines.

Relations between early majority language and socioemotional development in children with different language backgrounds.

This study explored whether the directionality of the relation between majority language and various facets of socioemotional development (three to 5 years old) differs between children with different language backgrounds. 12,951 children (49% girls; 85% White, 6% Pakistani and Bangladeshi, 3% Black, 3% Mix, 2% Indian) from the British Millennium Cohort Study (2001-2006) were included in two-time-point cross-lagged analyses. Models controlling for important covariates found a bidirectional association for monolinguals (ßs = .05, -.07, -.04), a unidirectional effect of majority language on socioemotional difficulties for dual language learners (DLLs) speaking English and minority language(s) at home (ß = .14), and a unidirectional effect of socioemotional strength on majority language for DLLs speaking only minority language(s) at home (ß = -.17).

Inequalities in Resources for Preschool-Age Children by Parental Education: Evidence from Six Advanced Industrialized Countries.

This paper provides new evidence on inequalities in resources for children age 3-4 by parental education using harmonized data from six advanced industrialized countries-United States, United Kingdom, France, Germany, Netherlands, and Japan-that represent different social welfare regime types. We analyze inequalities in two types of resources for young children-family income, and center-based child care-applying two alternative measures of parental education-highest parental education, and maternal education. We hypothesize that inequalities in resources by parental education will be less pronounced in countries where social policies are designed to be more equalizing. The results provide partial support for this hypothesis: the influence of parental education on resources for children does vary by the social policy context, although not in all cases. We also find that the measurement of parental education matters: income disparities are smaller under a maternal-only definition whereas child care disparities are larger. Moreover, the degree of divergence between the two sets of estimates differs across countries. We provide some of the first systematic evidence about how resources for young children vary depending on parents' education and the extent to which such inequalities are buffered by social policies. We find that while early inequalities are a fact of life in all six countries, the extent of those inequalities varies considerably. Moreover, the results suggest that social policy plays a role in moderating the influence of parental education on resources for children.

Teacher judgements and gender achievement gaps in primary education in England, Germany, and the US.

We examined whether inaccurate teacher judgements of primary school student achievement correlate with students' gender and whether such bias contributes to gender achievement gaps in language and mathematics. Our study used ex-post harmonised longitudinal data from England, Germany, and the US. We observed domain-specific teacher judgement bias with a positive bias for girls in the language domain and for boys in mathematics. Furthermore, biased teacher judgements partly mediated the effect of gender on later achievement. Despite these common findings, cross-country differences emerged in the extent of teacher judgement bias as well as its mediation of gender achievement gaps. We conclude that this is a topic of relevance across national contexts and where the institutional and societal setting needs more attention in future research.

International differences in gradients in early childhood overweight and obesity: the role of maternal employment and formal childcare attendance.

BACKGROUND: There are significant cross-country differences in socio-economic gradients in later childhood and adulthood overweight/obesity; few studies assess whether this cross-national variation is evident from early childhood. Furthermore, the role of childcare in explaining overweight/obesity gradients might vary across countries, given differences in access, quality and heterogeneity within. Additionally, childcare is linked to parental characteristics such as maternal employment. The interplay between childcare and employment in producing early overweight/obesity gradients has received little attention, and might vary cross-nationally. METHODS: Using harmonized data from six high-quality, large datasets, we explore the variation in gradients in early overweight/obesity (at age 3-4 years old) by parental education across several high-income countries (USA, UK, France, the Netherlands, Germany and Japan). We then assess whether differential formal group care use attenuates some of these gradients, and whether this varies across maternal employment. RESULTS: Gradients in early childhood overweight/obesity by parental education are evident across several developed countries. Countries with higher overall prevalence of early overweight/obesity did not have the largest inequalities across education groups. The contribution of formal group care to producing these gradients varied across countries and across maternal employment status. CONCLUSION: Early childhood inequalities in overweight/obesity are pervasive across developed countries, as noted for older children and adults. However, mechanisms producing these gradients vary across national contexts. Our study shows that, given the right context, quality childcare and maternal employment can successfully support healthy weight trajectories and not contribute (or even reduce) social inequalities in early overweight/obesity.

Does EU and US paediatric legislation improve the authorization availability of medicines for children in other countries?

AIM: For over 15 years, the pharmaceutical industry has been engaged in developing medicines for children to comply with the European Union (EU) and the United States (US) regulatory requirements. We assessed the authorization availability of these medicines in countries without paediatric regulatory obligations. Special attention was given to the authorization availability of paediatric formulations. METHODS: Medicines for children were sampled from the US Food and Drug Administration and European Medicines Agency websites. We carried out systematic content analysis of product information and compared paediatric labelling in Australia, Brazil, Canada, Russia and South Africa with the EU or the US. The authorization availability of paediatric formulations in originator and generic medicines was reviewed. In Kenya, the authorization availability of sampled medicines and paediatric formulations was investigated. RESULTS: A total of 161 medicines authorized in the EU or the US were sampled. Whilst at least one paediatric indication was found in 70% of the medicines, the EU and US level of authorization was on average 38% in Australia, Brazil, Canada, Russia and South Africa. Paediatric formulations were authorized on average for 40% of originator and 36% of generic medicines. Kenya had the lowest authorization availability of medicines (40%) and formulations (26%). CONCLUSIONS: The authorization availability of novel medicines for children is lower in countries without paediatric regulatory obligations. Paediatric formulations often do not reach other countries if left unregulated, and their generic uptake is low. To increase authorization availability, submission of paediatric development results should become obligatory in each jurisdiction. Policy initiatives to stimulate the introduction of developed formulations should be encouraged.

Protocol for a web survey experiment studying the feasibility of asking respondents to capture and submit photos of the books they have at home and the resulting data quality.

This document presents the protocol of a study conducted as a part of the WEB DATA OPP project, which is funded by the H2020 program. The study aimed to investigate different aspects of the collection of images through web surveys. To do this, we implemented a mobile web survey in an opt-in online panel in Spain. The survey had various questions, some of which were about the books that the participants have at their main residence. The questions related to books were asked in three different ways: regular survey questions showing visual examples of how different numbers of books fit in a 74 centimetre wide shelf depending on their thickness, regular survey questions without the visual examples, and questions where participants were asked to send photos of the books at their home. This report explains how the study was designed and conducted. It covers important aspects such as the experimental design, the questionnaire used, the characteristics of the participants, ethical considerations, and plans for disseminating the results.

This document presents the protocol of our study asking respondents for information about the books they have at home. This information was solicited through conventional types of questions ( i.e., typing in answers or choosing one answer category), and/or through asking respondents to take and send photos of the books. This study has methodological and substantive objectives. The former involves investigating respondents' preference, evaluation of the questions, participation levels, compliance, and data quality. The latter focuses on exploring the impact of the number of books on the academic achievement of children and examining other factors that might influence these relations. We conducted a mobile web survey, assigning respondents to four groups:    â€¢   Choice: Respondents could choose their preferred answering method.    â€¢   Text-TextPlus: Respondents answered conventional questions first, and later received illustrations of how different numbers of books looked like to help respondents provide accurate answers.    â€¢   TextPlus-Images: Respondents answered conventional questions with the illustrations and then submitted photos of the books at home.    â€¢   Images-Text: Respondents shared photos of the books and then answered the conventional questions. Respondents were asked to evaluate their respective answering methods. The questionnaire had up to 65 questions covering various dimensions, including respondents' sociodemographic characteristics, children's academic performance, literacy-related activities, and camera usage. Data were collected using the Netquest opt-in online panel in Spain. The tool WebdataVisual was used to capture and share the photos. The target population included parents of children living with them and who attended the first, third, or fifth year of primary school. The sample size was 1,202 cases. We expect this study to provide valuable insights regarding visual data collection through web surveys. Further, we expect to gain a better understanding of the data on the books respondents have at home when such data are collected through different methods.

Home learning environment and out-of-home activities: their relations to prosocial behaviour and peer relationships in primary school children.

There is consensus that child socio-emotional development is influenced by various contexts, such as the family one. Research on influencing factors on child socio-emotional skills mainly investigated the effects of home learning environment, whereas the effects of out-of-home activities were often analysed mainly in samples of adolescents. The present study aimed to shed light on effects of preschool home learning environment and out-of-home activities on two facets of socio-emotional skills at the beginning of primary school: Prosocial behaviour and peer relationships. The information on the child prosocial behaviour and peer relationships at preschool age was included with the aim to control for most of the differences across children. Using data from a large sample of children (N = 1,818; M age = 7.08 years, SD = 0.15; 49.9% girls), results of regression analyses show significant effects of out-of-home activities on prosocial behaviour after controlling a range of child- and family-related influencing factors on prosocial behaviour as well as prosocial behaviour at preschool age. The effects of home learning environment were significant after controlling a range of child- and family-related influencing factors on both facets of socio-emotional skills but became nonsignificant after taking into account respective behaviour at preschool age. The results of the present study suggest that fostering participation in out-of-home activities might contribute to an increase of prosocial behaviour in primary school children.

Comprehension of Connectives: Development Across Primary School Age and Influencing Factors.

Language development is not completed when children enter primary school. As the comprehension of connectives (such as although, despite) is important for understanding and producing academic texts and, thus, relevant for school success, we investigated its development and influencing factors across primary school age on the basis of a newly developed and validated test instrument. Using a German sample of 627 students (n = 361 language minority learners) in primary school, results of growth curve models showed students' initial level of the comprehension of connectives to be negatively related to its growth rate. Additional analyses revealed this association to be mainly due to parental socioeconomic status (SES) rather than students' language background. In particular, parental SES and students' receptive grammar impacted initial level as well as growth rate of connective comprehension. Our results point to the necessity of a continuous and early sensitization for the register of academic language especially in the group of students from a low socioeconomic background.

Development of academic vocabulary across primary school age: Differential growth and influential factors for German monolinguals and language minority learners.

Academic language has been shown to significantly contribute to success across school subjects. However, to date, there are no empirical studies addressing its development across primary school age. The present study investigated the growth of academic vocabulary and influential conditions from Grades 2 to 4 based on a newly developed and validated test instrument. Drawing on a German sample of 472 children (N = 281 language minority learners) we found evidence of a Matthew effect with the group of language minority learners showing both lower initial level and lower growth rates compared to their monolingual peers. In addition, results of simple and full conditional growth curve models underline the significant impact of family background (parental education, books at home) and of children's nonverbal cognitive abilities on the intercept as well as the growth of academic vocabulary, thereby supporting the assumption of an additional Matthew effect according to family background, particularly in monolingual majority language children. Our results indicate the need for an early promotion of the register of academic language in monolingual as well as language minority students. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

Drug utilization patterns and reported health status in ethnic German migrants (Aussiedler) in Germany: a cross-sectional study.

BACKGROUND: Inadequate utilization of healthcare services by migrant populations is an important public health concern. Inadequate drug consumption and poor compliance to the therapeutic regimen are common manifestations of low health-care seeking behavior present in migrants even in the countries with well-established healthcare systems. There are few studies on the use of medicines among the different groups of migrants in Germany. The objective of this study is to investigate drug consumption patterns of ethnic German migrants (Aussiedler) and their current health status. METHODS: A cross-sectional study nested into a cohort of 18,621 individuals aged 20-70 years who migrated to Germany from the former Soviet Union between 1990 and 2005 was conducted. Data on consumption of drugs, drug handling, major health risk factors, and one-year disease prevalence were obtained for 114 individuals through a self-administered questionnaire and phone interviews. Results were compared to the data on the German population derived from the Disease Analyzer database and Robert Koch Institute (RKI) annual reports. Direct age standardization, test of differences, Chi-square test, and descriptive statistics were applied as appropriate. For drug classification the Anatomical Therapeutic Chemical (ATC) system was used. RESULTS: Of the respondents, 97% reported to have at least one disease within a 12-month period. The one-year prevalence of asthma (6.9%), hypertension (26.7%), chronic bronchitis (8.6%), and diabetes (4.9%) in migrants was similar to the general German population. 51% regularly took either over-the-counter (OTC) medication or prescription medicines. Six ATC groups were analyzed. The highest drug consumption was reported for the ATC cardiovascular (22%), nervous (9%), and muskulo-skeletal system (8%). 30% used OTC medicines obtained in the country of origin. Difficulties with drug handling were rare. Alcohol consumption did not differ from the German population (p = 0.19 males and 0.27 females), however smoking prevalence was lower (p < 0.01) in both sexes. CONCLUSION: Ethnic German migrants seem to differ only slightly from Germans in health status, drug utilization, and disease risk factors, and if so, not in an extreme way. Country of origin remains a source of medicines for a substantial part of migrants. The study is limited by a small sample size and low response rate.

Corporate social responsibility in countries with mature and emerging pharmaceutical sectors / Responsabilidad social corporativa en países con sectores farmacéuticos maduros y emergentes

In recent decades the concept of Corporate Social Responsibility (CSR) has been adopted by many business sectors, including the pharmaceutical industry. However, in this and other sectors its application remains variable, particularly between mature and developing economies. Its stakeholders include pharmacy and medical students, their attitude to the involvement of companies in socially responsible activities will be important determinants of public response to the industry. Objective: To investigate the knowledge, attitudes and practices of senior medical and pharmacy students towards the CSR concept in the pharmaceutical sector in mature (Germany) and developing (Russia) markets. Methods: A questionnaire survey was carried out among senior pharmacy and medical students during the summer semester 2008 in two Russian and one German university. In each country 120 questionnaires were distributed. The response rate was 95% in Russia and 93% in Germany. Results: Although the relevance of CSR was widely acknowledged by the students, very few were aware of CSR practices currently performed by companies. The reputation of the pharmaceutical industry was generally poor: less than 15% of respondents gave credence to the information provided in advertisements and fully supported pricing strategies as well as policies towards the developing countries. When choosing an employer more than 90% of respondents consider the policies affecting an employee directly as pivotal. However, for a high proportion of students (59% in Russia and 64% in Germany) socially irresponsible behavior by companies has a significant negative impact. Conclusions: This paper identifies practices which students believe should be a part of the CSR programmes for the pharmaceutical industry, and also some that should be abandoned. It recommends that corporate communication on CSR should be expanded. Key differences are seen in perceptions of students in Germany and Russia towards the extent of irresponsible actions and the variation between them (AU)

En las últimas décadas, el concepto de responsabilidad social corporativa (RSC) ha sido adoptado por muchos sectores empresariales, incluyendo la industria farmacéutica. Sin embargo, tanto en este como en otros sectores, su aplicación es variable, particularmente entre las economías maduras y en desarrollo. Entre los decisores se encuentran los estudiantes de farmacia y medicina, y su actitud ante la participación de las empresas en actividades socialmente responsables será un determinante importante de la respuesta del público ante la industria. Objetivo: Investigar el conocimiento, actitudes y prácticas de los estudiantes de últimos años de farmacia y medicina sobre el concepto de RSC en los mercados farmacéuticos maduros (Alemania) y en desarrollo (Rusia). Métodos: Se realizó una investigación entre estudiantes de últimos años de farmacia y medicina durante el semestre de verano de 2008 en dos universidades rusas y una alemana. En cada país se distribuyeron 120 cuestionarios. La tasa de respuesta fue del 95% en Rusia y del 93% en Alemania. Resultados: Aunque la importancia de la RSC fue reconocida por los estudiantes, muy pocos conocía las prácticas de RSC actualmente realizadas por las empresas. La reputación de la industria farmacéutica era en general pobre: menos del 15% de los respondentes daba crédito a la información proporcionada en los anuncios y apoyaba completamente estrategias de precios así como políticas para países en desarrollo. Cuando seleccionaban un empleo, más del 90% de los respondentes consideró las políticas que afectan al empleador como críticas. Sin embargo, para una alta proporción de estudiantes (59% en Rusia y 64% en Alemania) las actitudes socialmente irresponsables de las empresas tenía un significativo impacto negativo. Conclusiones: Este artículo identifica las prácticas que los estudiantes creen que deberían formar parte de los programas de RSC de la industria farmacéutica, así como los que deberían abandonar. Se recomienda que se aumente la comunicación corporativa sobre la RSC. SE han visto diferencias clave en la percepción de los estudiantes en Alemania y Rusia sobre la extensión de las acciones irresponsables y la variedad de ellas (AU)

Corporate social responsibility in countries with mature and emerging pharmaceutical sectors.

UNLABELLED: In recent decades the concept of Corporate Social Responsibility (CSR) has been adopted by many business sectors, including the pharmaceutical industry. However, in this and other sectors its application remains variable, particularly between mature and developing economies. Its stakeholders include pharmacy and medical students, their attitude to the involvement of companies in socially responsible activities will be important determinants of public response to the industry. OBJECTIVE: To investigate the knowledge, attitudes and practices of senior medical and pharmacy students towards the CSR concept in the pharmaceutical sector in mature (Germany) and developing (Russia) markets. METHODS: A questionnaire survey was carried out among senior pharmacy and medical students during the summer semester 2008 in two Russian and one German university. In each country 120 questionnaires were distributed. The response rate was 95% in Russia and 93% in Germany. RESULTS: Although the relevance of CSR was widely acknowledged by the students, very few were aware of CSR practices currently performed by companies. THE REPUTATION OF THE PHARMACEUTICAL INDUSTRY WAS GENERALLY POOR: less than 15% of respondents gave credence to the information provided in advertisements and fully supported pricing strategies as well as policies towards the developing countries. When choosing an employer more than 90% of respondents consider the policies affecting an employee directly as pivotal. However, for a high proportion of students (59% in Russia and 64% in Germany) socially irresponsible behavior by companies has a significant negative impact. CONCLUSIONS: This paper identifies practices which students believe should be a part of the CSR programmes for the pharmaceutical industry, and also some that should be abandoned. It recommends that corporate communication on CSR should be expanded. Key differences are seen in perceptions of students in Germany and Russia towards the extent of irresponsible actions and the variation between them.