In Italy, many respiratory drugs are approved for the treatment of paediatric respiratory diseases, but a remarkable percentage of their prescriptions is off-label. This pharmaco-utilization study demonstrates that there is a need to perform clinical studies aimed at increasing the current knowledge on marketed paediatric drugs, and to revise and re-label the existing regulatory documents to reduce their off-label uses.

Thanks to their features, these methods represent a reliable way of ultimately improving paediatric care.

BackgroundThe incidence of acute otitis media (AOM) vary from country to country. Geographical variations together with differences in study designs, reporting and settings play a role. We assessed the incidence of AOM in Italian children seen by primary care paediatricians (PCPs), and described the methods used to diagnose the disease.MethodsThis secondary data analysis from the Pedianet database considered children aged 0 – 6 years between 01/2003 and 12/2007. The AOM episodes were identified and validated by means of patient diaries. Incidence rates/100 person-years (PY) were calculated for total AOM and for single or recurrent AOM.ResultsThe 92,373 children (52.1% males) were followed up for a total of 227,361 PY: 23,039 (24.9%) presented 38,241 episodes of AOM (94.6% single episodes and 5.4% recurrent episodes). The total incidence rate of AOM in the 5-year period was 16.8 episodes per 100 PY (95% CI: 16.7-16.9), including single AOM (15.9 episodes per 100 PY; 95% CI: 15.7-16.1) and recurrent AOM (0.9 episodes per 100 PY; 95% CI: 0.9-0.9). There was a slight and continuously negative trend decrease over time (annual percent change −4.6%; 95%CI: -5.3, -3.9%). The AOM incidence rate varied with age, peaking in children aged 3 to 4 years (22.2 episodes per 100 PY; 95% CI 21.8-22.7). The vast majority of the AOM episodes (36,842/38,241, 96.3%) were diagnosed using a static otoscope; a pneumatic otoscope was used in only 3.7%.ConclusionsOur data fill a gap in our knowledge of the incidence of AOM in Italy, and indicate that AOM represents a considerable burden for the Italian PCP system. Educational programmes concerning the diagnosis of AOM are needed, as are further studies to monitor the incidence in relation to the introduction of wider pneumococcal conjugate vaccines.

Pharmacogenetics is a newly emerging research area confronted with obvious scientific and ethical concerns not only from an academic and social perspective, but also on a regulatory level.An overview of ongoing and planned pharmacogenetic studies is needed to evaluate the current status and focus of research and to appraise the alignment of research themes relative to the unmet medical needs of the paediatric population.The objective of this review was to explore the current status, limitations and perspectives of pharmacogenomic and pharmacogenetic clinical research in the paediatric population from an academic, regulatory and industrial perspective.Results show a rather equal distribution of activities across the different research categories throughout the world. More than 50% of the research activities are related to exploratory studies aimed at establishing the connection between a given genetic trait and the risk associated with a pathology or disease.Based on this situation, we advocate for more translational and conformational studies. Moreover, there is a strong need to give appropriate attention to the methodological requirements for clinical research, which lack the scientific and statistical rigour and make study findings unsuitable for clinical purposes and often impossible to interpret.

Antibiotics are the most prescribed drugs in children, often administered without any specific diagnosis. In Italy, Family Pediatricians prescribe antibiotics more frequently than in other Europe countries, the commonest being amoxicillin, amoxicillin/clavulanate and cefaclor. We conducted a retrospective cohort study of children up to 12 years old, included in the database Pedianet, who received at least one prescription of amoxicillin, amoxicillin/clavulanate or cefaclor during the period 1S 1 January 2003 to 30lh June 2007. 335,352 antibiotics prescriptions in 110.747 children were included in the study. There were 168.458 prescriptions of amoxicillin, amoxicillin/clavulanate or cefaclor, amounting to 50.2% of antibiotic prescriptions. The main indication was unspecified-upper respiratory tract infection (26.5%). Overall, amoxicillin/clavulanate was the most commonly prescribed antibiotic in older children, while amoxicillin was the most prescribed in younger patients. Amoxicillin was the most prescribed antibiotic in all age groups (p < 0.0001) for upper respiratory tract infections, otitis media and acute bronchitis. A therapeutic switch occurred in 0.6% of cases, and was most frequent in pneumonia. This was a retrospective study carried out using software designed for the routine practice and not for specific studies; therefore several limitations on the data interpretation need to be considered especially on the diagnosis. However, the study shows that antibiotic consumption in the Italian pediatric population exceeds the European average, with three beta-lactam drugs accounting for over half of all antibiotic prescriptions.