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1.  Drug use profile in outpatient children and adolescents in different Italian regions 
BMC Pediatrics  2013;13:46.
Background
Large differences exist in the prevalence rate of drugs prescribed to children and adolescents between and within countries. The aim of this study was to evaluate child and adolescent drug prescription patterns in Italy in an extra-hospital setting at the regional and Local Health Unit (LHU) levels.
Methods
Data sources were three regional prescription databases. Data concerning the year 2008 were evaluated. A total of 3.3 million children and adolescents were included. Drug prevalence and prescription rates were evaluated at the regional and LHU levels. The correlation between mean latitude, average annual income, hospitalisation rate, number of paediatricians per 1,000 resident children, and prevalence rate was evaluated by LHU using a linear multiple regression analysis.
Results
Large differences were found across Italian regions and LHUs. The mean prevalence rate was 56.4% (95% CI 56.3-56.5%; 51.2-65.4% among regions) and, at the LHU level, ranged from 43.1% to 70.0% (higher in the South). A total of 878 drugs were prescribed, 175 of which were shared by all LHUs. Amoxicillin clavulanate was the most used drug in all regions and in 31 of 33 LHUs. Amoxicillin was the drug with the highest variability in use between LHUs (9.1-52.1% of treated children). An inverse correlation was found between prevalence rate and both latitude (p < 0.0001) and average annual income (p = 0.0002).
Conclusions
The use of drugs in children and adolescents is higher in southern Italy and is inversely related to latitude and average annual income. More efforts should be devoted to informing physicians, patients and policy makers in order to plan effective initiatives to improve the situation.
doi:10.1186/1471-2431-13-46
PMCID: PMC3623731  PMID: 23557352
Children; Adolescent; Drug utilisation; Prescription; Outpatient
2.  Ocular medicines in children: the regulatory situation related to clinical research 
BMC Pediatrics  2012;12:8.
Background
Many ocular medications are prescribed for paediatric patients, but the evidence for their rational use is very scant. This study was planned to compare the availability and the licensing status of ocular medications marketed in Italy, the United Kingdom (UK), and the United States of America (USA) related to the amount of published and un-published RCTs testing these drugs in the paediatric population.
Methods
A quantitative analysis was performed to evaluate the number of ocular medications with a paediatric license in Italy, the UK, and the USA. A literature search was also performed in MEDLINE, EMBASE, and The Cochrane Central Register of Controlled Trials for randomized controlled trials (RCTs) on ophthalmic pharmacological therapy in children aged < 18 years, published up to December 2010. A search in the international clinical trial registries, the list of paediatric investigation plans (PIPs) approved by European Medicines Agency (EMA), and the table of medicines with new paediatric information approved by Food and Drug Administration (FDA) was also performed.
Results
In all, of 197 drugs identified, 68 (35%) single drugs are licensed for paediatric use at least in one considered country, while 23 (12%) were marketed in all three countries. More specifically, in Italy 43 single drugs (48% of those marketed) had a paediatric license, while 39 (64%) did in the UK and 22 (54%) did in the USA. Only 13 drugs were marketed with a paediatric license in all countries.
The percentage of drugs licensed for paediatric use and for which at least one RCT had been performed ranged between 51% in Italy and 55% in the USA. No published RCTs were found for 11 (48%) drugs licensed for paediatric use in all three countries. In all, 74 (35%) of the retrieved RCTs involved mydriatic/cycloplegic medications.
A total of 62 RCTs (56% completed) on 46 drugs were found in the international clinical trial registries. Cyclosporin and bevacizumab were being studied in many ongoing trials. Twenty-six drugs had new paediatric information approved by FDA based on new paediatric clinical trials, while only 4 PIPs were approved by EMA.
Conclusions
There is a pressing need for further research and clinical development in the pediatric ophthalmic area, where effective up-to-date treatments, and additional research and education on use in children, remain priorities.
doi:10.1186/1471-2431-12-8
PMCID: PMC3335368  PMID: 22264311
review; ocular medicines; eye diseases; drug therapy; paediatrics
3.  Antidepressant and antipsychotic use in an Italian pediatric population 
BMC Pediatrics  2011;11:40.
Background
The safety and effectiveness of psychotropic drug use in the paediatric population is widely debated, in particular because of the lack of data concerning long term effects.
In Italy the prevalence of psychotropic drug prescriptions increased in the early 2000s and decreased afterwards. In such a context, a study with the aim to estimate the incidence and prevalence of psychotropic drug prescription in the paediatric population and to describe diagnostic and therapeutic approaches was performed.
Methods
The study population was composed of 76,000 youths less than 18 years and living in the area covered by the local health unit of Verona, Italy. The data source was the Verona local health unit's administrative prescription database. Prevalence and incidence of antidepressant and/or antipsychotic drug prescriptions in the 2004-2008 period were estimated. Children and adolescents receiving antidepressant and/or antipsychotic drug prescriptions between 1 January 2005 and 31 December 2006 were identified and questionnaires were sent to the prescribers with the aim to collect data concerning diagnostic and therapeutic approaches, and care strategies.
Results
The prevalence of psychotropic drug prescriptions did not change in the 2004-2008 period, while incidence slightly increased (from 7.0 in 2005 to 8.3 per 10,000 in 2008). Between 1 January 2005 and 31 December 2006, 111 youths received at least one psychotropic drug prescription, 91 of whom received antidepressants. Only 28 patients attended child and adolescent psychiatry services. Information concerning diagnostic and therapeutic approaches, and care strategies was collected for 52 patients (47%). Anxiety-depressive syndrome and attention disorders were the diseases for which psychotropic drugs were most commonly prescribed. In all, 75% youths also received psychological support and 20% were prescribed drugs for 2 or more years.
Conclusions
Despite the low drug prescription prevalence, the finding that most children were not cared for by child and adolescent psychiatric services is of concern and calls for a systematic, continuous monitoring of psychopharmacological treatments.
doi:10.1186/1471-2431-11-40
PMCID: PMC3120679  PMID: 21605367
4.  Oral ondansetron versus domperidone for symptomatic treatment of vomiting during acute gastroenteritis in children: multicentre randomized controlled trial 
BMC Pediatrics  2011;11:15.
Background
Vomiting in children with acute gastroenteritis (AG) is not only a direct cause of fluid loss but it is also a major factor of failure of oral rehydration therapy (ORT). Physicians who provide care to paediatric patients in the emergency department (ED) usually prescribe intravenous fluid therapy (IVT) for mild or moderate dehydration when vomiting is the major symptom. Thus, effective symptomatic treatment of vomiting would lead to an important reduction in the use of IVT and, consequently, of the duration of hospital stay and of frequency of hospital admission. Available evidence on symptomatic treatment of vomiting shows the efficacy of the most recently registered molecule (ondansetron) but a proper evaluation of antiemetics drugs largely used in clinical practice, such as domperidone, is lacking.
Objectives
To compare the efficacy of ondansetron and domperidone for the symptomatic treatment of vomiting in children with AG who have failed ORT.
Methods/Design
Multicentre, double-blind randomized controlled trial conducted in paediatric EDs. Children aged from 1 to 6 years who vomiting, with a presumptive clinical diagnosis of AG, and without severe dehydration will be included. After the failure of a initial ORS administration in ED, eligible children will be randomized to receive: 1) ondansetron syrup (0,15 mg/Kg of body weight); 2) domperidone syrup (0,5 mg/Kg of body weight); 3) placebo. The main study outcome will be the percentage of patients needing nasogastric or IVT after symptomatic oral treatment failure, defined as vomiting or fluid refusal after a second attempt of ORT. Data relative to study outcomes will be collected at 30 minute intervals for a minimum of 6 hours. A telephone follow up call will be made 48 hours after discharge. A total number of 540 children (i.e. 180 patients in each arm) will be enrolled.
Discussion
The trial results would provide evidence on the efficacy of domperidone, which is largely used in clinical practice despite the lack of proper evaluation and a controversial safety profile, as compared to ondansetron, which is not yet authorized in Italy despite evidence supporting its efficacy in treating vomiting. The trial results would contribute to a reduction in the use of IVT and, consequently, in hospital admissions in children with AG. The design of this RCT, which closely reflect current clinical practice in EDs, will allow immediate transferability of results.
Trial Registration
ClinicalTrials.gov: NCT01257672
doi:10.1186/1471-2431-11-15
PMCID: PMC3045958  PMID: 21310051

Results 1-4 (4)