Adverse drug reactions in Ghanaian children: review of reports from 2000 to 2012 in VigiBase

Objective: The aim of this article is to describe adverse drug reactions (ADRs) reported for children aged 0 - 17 years in Ghana. Methods: Paediatric reports submitted by the Ghana National Centre for Pharmacovigilance to the World Health Organisation (WHO) Global ADR database, VigiBase up to December 2012 were extracted. The data were analysed for number of reports per year, types of reporters and suspected ADRs and drugs. Results: A total of 343 reports for children were received during the period. The drug classes most frequently reported were vaccines (115, 31%), antimalarials (106, 28%) and antibiotics (57, 15%). Of the top 20 individual drugs, 19 were anti-infectives. The most frequently reported ADRs were injection site infection, fever and rash. There were 23 deaths reported, and antimalarials were implicated in 12 cases. Conclusions: Vaccines, antimalarials and antibiotics are the leading medicines reported to cause ADRs in Ghanaian children. There was a high mortality rate, with many of the deaths due to causes explained in the individual case safety reports

Clinical Studies in Infants (Pediatric Pharmacology)

Treatment of children with effective and safe medicines is crucial to improve their outcome. Despite this relevance, it is still common practice in children to administer medicines outside their market authorization. Even if authorized, pediatric medicines may not be age-appropriate for a broad range of therapeutic areas. This has been recognized as very unsatisfactory by all stakeholders involved and makes clinical pharmacological studies in children an obvious need. However, clinical trials of medicines in children come with their specific burdens. These burdens can be qualified as either related to the specific aspects of pediatric pharmacokinetics (PK) and pharmacodynamics (PD) or relate to the logistics of clinical trials of medicines in children. This is followed by a stakeholder’s analysis, discussing specific aspects related to parents and their children (International Children’s Advisory Network, iCAN), recruitment challenges, and research capacity building. We hereby tried to focus on recent evolutions, including initiatives to further develop this research capacity (Institute for Advanced Clinical Trials, iACT for children; Innovative Medicines Initiative, IMI2). Perhaps progress is slower than anticipated, but pediatric medicines research is evolving, and we should keep this momentum. A further structured collaboration between the different stakeholders involved (the society, parents and children, sponsors, regulatory authorities) at the international level is crucial to use the available, but limited, resources as effective as possible to further improve pharmaceutical care in children.</p