Antibiotic prescriptions in acute otitis media and pharyngitis in Italian pediatric outpatients.

BACKGROUND: Acute otitis media (AOM) and pharyngitis are very common infections in children and adolescents. Italy is one of the European countries with the highest rate of antibiotic prescriptions. The aim of this study is to describe first-line treatment approaches for AOM and pharyngitis in primary care settings in Italy over six years, including the prevalence of 'wait and see' for AOM, where prescription of antibiotics is delayed 48 h from presentation, and differences in prescribing for pharyngitis when diagnostic tests are used. METHODS: The study is a secondary data analysis using Pedianet, a database including data at outpatient level from children aged 0-14 in Italy. Prescriptions per antibiotic group, per age group and per calendar year were described as percentages. "Wait and see" approach rate was described for AOM and pharyngitis prescriptions were further grouped according to the diagnostic test performed and test results. RESULTS: We identified 120,338 children followed by 125 family pediatricians between January 2010 and December 2015 for a total of 923,780 person-years of follow-up. Among them 30,394 (mean age 44 months) had at least one AOM diagnosis (n = 54,943) and 52,341 (mean age 5 years) had at least one pharyngitis diagnosis (n = 126,098). 82.5% of AOM diagnoses were treated with an antibiotic within 48 h (mainly amoxicillin and amoxicillin/clavulanate) and the "wait and see" approach was adopted only in 17.5% of cases. The trend over time shows an increase in broad spectrum antibiotic prescriptions in the last year (2015). 79,620 (63%) cases of pharyngitis were treated and among GABHS pharyngitis confirmed by rapid test 56% were treated with amoxicillin. The ones not test confirmed were treated mainly with broad spectrum antibiotics. CONCLUSIONS: Despite guidance to use the 'wait and see' approach in the age group analyzed, this strategy is not often used for AOM, as previously noted in other studies in hospital settings. Broad-spectrum antibiotic prescription was more frequent when pharyngitis was not confirmed by rapid test, in keeping with evidence from other studies that diagnostic uncertainty leads to overuse of antibiotics.

Community-Acquired Rotavirus Gastroenteritis Compared with Adenovirus and Norovirus Gastroenteritis in Italian Children: A Pedianet Study.

Background. Rotavirus (RV) is the commonest pathogen in the hospital and primary care settings, followed by Adenovirus (AV) and Norovirus (NV). Only few studies that assess the burden of RV gastroenteritis at the community level have been carried out. Objectives. To estimate incidence, disease characteristics, seasonal distribution, and working days lost by parents of RV, AV, and NV gastroenteritis leading to a family pediatrician (FP) visit among children < 5 years. Methods. 12-month, observational, prospective, FP-based study has been carried out using Pedianet database. Results. RVGE incidence was 1.04 per 100 person-years with the highest incidence in the first 2 years of life. Incidences of AVGEs (1.74) and NVGEs (1.51) were slightly higher with similar characteristics regarding age distribution and symptoms. Risk of hospitalisation, access to emergency room (ER), and workdays lost from parents were not significantly different in RVGEs compared to the other viral infections. Conclusions. Features of RVGE in terms of hospitalisation length and indirect cost are lower than those reported in previous studies. Results of the present study reflect the large variability of data present in the literature. This observation underlines the utility of primary care networks for AGE surveillance and further studies on community-acquired gastroenteritis in children.

Incidence and clinical presentation of acute otitis media in children aged <6 years in European medical practices.

We conducted an epidemiological, observational cohort study to determine the incidence and complications of acute otitis media (AOM) in children aged <6 years. Data on physician-diagnosed AOM were collected from retrospective review of medical charts for the year preceding enrolment and then prospectively in the year following enrolment. The study included 5776 children in Germany, Italy, Spain, Sweden, and the UK. AOM incidence was 256/1000 person-years [95% confidence interval (CI) 243-270] in the prospective study period. Incidence was lowest in Italy (195, 95% CI 171-222) and highest in Spain (328, 95% CI 296-363). Complications were documented in <1% of episodes. Spontaneous tympanic membrane perforation was documented in 7% of episodes. Both retrospective and prospective study results were similar and show the high incidence during childhood in these five European countries. Differences by country may reflect true differences and differences in social structure and diagnostic procedures.

In-label and off-label use of respiratory drugs in the Italian paediatric population.

AIM: To evaluate the prescription rate of respiratory drugs (ATC code R03) in an Italian community setting and to estimate the extent of off-label use by both age and indication. METHODS: A cohort study aimed at evaluating prescriptions of drugs with ATC code R03 was conducted for the period 2002-2006. Data source was the PEDIANET Database. RESULTS: Ninety percent of R03 prescriptions are covered by 11 active substances or combinations, corresponding to 67 medicinal products. Inhaled corticosteroids are the most prescribed anti-asthmatic agents, followed by short-acting beta2 mimetics. The mean off-label rate is 19 and 56%, by age and indication respectively. The majority of off-label uses is among children under the age of 2. Five active substances are used at dosages not supported by adequate dose-finding studies. CONCLUSION: 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.

Prospective study of the burden of acute gastroenteritis and rotavirus gastroenteritis in children less than 5 years of age, in Padova, Italy.

BACKGROUND: Data on the burden of rotavirus gastroenteritis in Europe are needed to help understand the potential impact of introducing new rotavirus vaccines. MATERIALS AND METHODS: As part of prospective observational study (Rotavirus gastroenteritis Epidemiology and Viral types in Europe Accounting for Losses in Public Health and Society Study, REVEAL) conducted in 2004--2005 in seven European countries, we studied, the characteristics of acute gastroenteritis and rotavirus gastroenteritis in children less than 5 years in primary care, emergency room and hospital settings (Padova, Italy). RESULTS: A total of 757 children with acute gastroenteritis were included and enzyme-linked immunoabsorbent assay (ELISA) results were available for 725 cases. The overall estimated annual incidence for rotavirus gastroenteritis was 4.7%. Overall, rotavirus gastroenteritis was estimated to account for 43.6% of acute gastroenteritis cases. Among children with acute gastroenteritis (AGE) aged 6-23 months, 61.2% were rotavirus positive. Rotavirus gastroenteritis (RVGE) was responsible for 68.8% of hospitalizations, 61% of emergency consultations, and 33% of primary care consultations. The most prevalent serotype was G9 (84.4%) followed by G1 (11.8%). The relative risk for rotavirus gastroenteritis of being referred to hospital after an initial consultation in primary care was 3.37 (95% CI: 1.77-6.43) and 3.38 (95% CI: 2.28-5.01) for emergency room referral. Children with rotavirus gastroenteritis generally had more severe disease than children with rotavirus-negative gastroenteritis. CONCLUSION: Rotavirus accounts for a significant proportion of acute gastroenteritis cases in children less than 5 years in Italy, many of whom require frequent primary care consultations, or care in emergency room or hospital settings.

Cost effectiveness of sublingual immunotherapy in children with allergic rhinitis and asthma.

BACKGROUND: Economic evaluations are increasingly relevant in order to provide support for decision makers when judging about alternative ways to allocate public funds. Aim of this study was to evaluate the economic effect of treatment with high dose sublingual immunotherapy (SLIT) in children. METHODS: The study involved one allergy center, located in the north of Milan, Italy. From the existing records of patients seen for allergic disease, we extracted all children and adolescents with allergic disease, who had 1-year data prior to receiving SLIT and 3-year data on SLIT. Outcome measures (number of exacerbations, visits, absence from nursery or school), direct costs (euros spent on drugs, specialist visits, SLIT) and indirect costs (costs resulting from children school and parental work loss) were analysed. A second analysis compared a sub-group of allergic asthmatic children with a control group for costs, based on records of patients not SLIT-treated, extracted from a network-database of paediatricians. RESULTS: 135 patients were extracted, of which 46 had perennial, and 89 had seasonal allergy with comparable gender and age distribution. A substantial reduction was found in all outcome measures during SLIT compared with the before period. The average annual cost/patient was 2672 before SLIT initiation and _629/year during SLIT. Similar results were found for allergen subgroups. The asthma sub-analysis involved 41 children with SLIT and 35 controls. Again, SLIT patients showed a substantial reduction in outcome measures; the direct cost/patient over the whole follow-up (4 years) was _1182 for SLIT patients and _1100 for controls. CONCLUSION: High dose SLIT may be effective in reducing the cost of allergic rhinitis and asthma and comparably expensive to conventional treatment in children with allergic asthma over a 4 years follow-up.

Asthma prevalence and drug prescription in asthmatic children.

A cross-sectional study was conducted on among 28,856 children aged from birth to 14 years to determine the prevalence of asthma and assess its treatment in a sample of asthmatic children. Children diagnosed with asthma were identified by a sensitive algorithm applied to the information stored in the computerized medical records between 1997 and 1998. Pediatricians then reviewed and validated the diagnosis. Specific information was obtained, after age stratification under 5 yrs and over 6 ys, from the medical records and by interview regarding their personal details and treatment of asthmatic patients. In all, 1,263 cases of asthma were identified (64% males) with a prevalence of 6.3% among males and 4% among females in under 5 year-olds, and 3.9% for males and 2.1% for females in over 6 year-olds. The prevalence of asthma diagnosed directly by the pediatrician was consequently higher among under 5 year-olds, in both genders, than among the older children. Contrary to the international guidelines, pediatricians prescribed more oral corticosteroids and nebulized short-acting beta-2 agonists for children under 5 ys olds than for over 6 year-olds (13.3% Vs 4.8% and 25% Vs 10.9%, respectively, p < 0.001). For the > or = 6 year-olds, the most commonly prescribed treatments were oral antihistamines (13.9% Vs 12.6%), inhaled corticosteroids via metered-dose inhaler (30.8% Vs 28.7%) and sodium cromoglycate (12.1% Vs 4.8%, p < 0.001).

Active monitoring of adverse drug reactions in children. Italian Paediatric Pharmacosurveillance Multicenter Group.

An active monitoring system of adverse drug reactions (ADR) in children was developed through a network of family paediatricians. The reported Incidence of ADRs was 15.1 per 1000 children.