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.
The evolving availability of health information on social media, regardless of its credibility, raises several questions about its impact on our health decisions and social behaviors, especially during health crises and in conflict settings where compliance with preventive measures and health guidelines is already a challenge due to socioeconomic factors. For these reasons, we assessed compliance with preventive measures and investigated the role of infodemic in people’s non-compliance with COVID-19 containment measures in Yemen. To this purpose and to triangulate our data collection, we executed a mixed method approach in which raw aggregated data were taken and analyzed from multiple sources (COVID-19 Government Response Tracker and Google COVID-19 Community Mobility Reports), then complemented and verified with In-depth interviews. Our results showed that the population in Yemen had relatively complied with the governmental containment measures at the beginning of the pandemic. However, containment measures were not supported by daily COVID-19 reports due to low transparency, which, together with misinformation and lack of access to reliable sources, has caused the population not to believe in COVID-19 and even practice social pressure on those who showed some compliance with the WHO guidelines. Those results indicate the importance of adopting an infodemic management approach in response to future outbreaks, particularly in conflict settings.
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