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Maurizio Bonati

Publications and source records attributed to Maurizio Bonati.

At least 19 recordsLinked to original sources
PubMed2006

The awareness among paediatricians of off-label prescribing in children: a survey of Italian hospitals.

OBJECTIVE: To investigate paediatricians' perception and awareness of off-label (OL) and unlicensed drug usage in clinical practice. METHODS: We conducted a questionnaire-based, observational study involving 28 departments/specialty units of four tertiary paediatrics Italian hospitals. The questionnaire was sent to a designated paediatrician in each department/specialty unit with the request that they summarise their awareness of OL prescriptions after a group discussion with all paediatricians working in the same department/unit. RESULTS: A total of 95 drugs were identified. The most common perceived reasons detected for OL use were age and formulation. Corticosteroids, ACE-inhibitors, beta-blockers and calcium-antagonists were most frequently indicated as OL for formulation, while ACE-inhibitors, new generation anti-epilepsy drugs, immunosuppressants, ketorolac and propofol as OL for age. Adrenaline, midazolam and ACE-inhibitors were indicated as unlicensed for route of administration. We found a high concordance between the OL drugs identified by physicians and those reported in the "Italian Summary Product Characteristics". CONCLUSIONS: Italian paediatricians perceived different drugs as unlicensed/OL from those identified by existing prescriptions studies. These perceived drugs may represent a priority in tackling the problem of OL usage in the hospital practice. The review of the Italian Summary Product Characteristics of some of the drugs identified, together with the monitoring of permanent clinical practice and with new clinical research, may be a step forward to reduce OL use in children.

Attitude of Health Personnel↗
PubMed2006

Use of psychotropic medications in Italian children and adolescents.

INTRODUCTION: The evidence of psychotropic drug safety and efficacy in the pediatric population is scant and widely debated. Yet, the prescription prevalence and incidence are increasing. A drug utilization study, based on a multiregional prescription database was therefore carried out in a sample of 1,484,770 Italian children and adolescents younger than 18 years during the year 2004. Furthermore, the trend of psychotropic prescription prevalence was evaluated from 1998 to 2004. During 2004, 4,316 children and adolescents received psychotropic drugs (2.91 per thousand youths). Antidepressants were prescribed to 3,503 youths (2.36 per thousand), antipsychotics to 1,005 (0.68 per thousand), and lithium to 73 (0.05 per thousand). A total of 265 youths received drugs from more than one psychotropic class. The prevalence rate of psychotropic drug prescriptions increased with increasing age, with a statistically significant trend ([Formula: see text]; p<0.0001), and it increased in the period 1998-2004 with a statistically significant trend ([Formula: see text]; p<0.0001), reaching its highest value in 2002 (3.08 per thousand). The trend for antidepressants was similar ([Formula: see text]; p<0.0001), while the prevalence of antipsychotics did not increase. CONCLUSION: Even though the prevalence of psychotropic drug prescriptions in Italian children is lower than that reported in other countries (e.g. United States, Canada, Netherlands, UK), the increase in antidepressant prescriptions raises some concerns. Data concerning safety and efficacy of these antidepressants in pediatrics are still limited and further studies are needed to guarantee evidence based therapeutic approaches in children, adolescents and their families.

Adolescent↗
PubMed2006

DEC-net: the development of the European register of clinical trials on medicines for children.

BACKGROUND: The need to register a clinical trial in a public database has been widely discussed in the last few years. Several general clinical trial registers have been developed, but none are dedicated to children. A web-based register of trials on drug therapy in children was therefore developed. PURPOSE: The general objective of the project, called DEC-NET (European register of clinical trials on medicines for children - drug evaluation in children) and supported by the European Community, is to provide the scientific community with a flexible tool for promoting communication and collaboration among researchers, disseminating clinical trial results and facilitating patient access and recruitment to trials. METHODS: We identified a set of trial data to be collected, including general trial information, recruitment information, eligibility criteria, clinical trial characteristics, location and contact information, study drugs, study sponsor and results. The system was set up to allow authorized users (working in Italy, Spain, France and UK) to enter, handle and monitor the trial information. Medical data dictionaries (ie, ICD-9 and ATC) were used in order to make the data-entry and the search and data analysis procedures easier. A multilingual approach in data handling and presentation made accessing trial information in English and in the language of the country where the study is located feasible. Search and browsing tools were set up to allow investigators, researchers, and citizens to freely search and browse the entire register and access the details of trials meeting the search criteria. RESULTS: The DEC-net register (http://www.dec-net.org) was opened for trial notification and consultation. LIMITATIONS: DEC-net currently involves four European countries and is a pilot project. CONCLUSIONS: It is hoped that what has been achieved so far represents only the beginning of a long-term project, and the next step will be to extend the register's use to other European countries.

Child↗
PubMed2005

A literature review on off-label drug use in children.

UNLABELLED: The aim was to compare results of studies performed in different settings worldwide and identify common therapeutic areas to allow for focused interventions, because off-label drug use can be a measure of the lack of knowledge concerning paediatric treatments. A secondary objective was to provide a brief review of efforts to date. A literature review of articles on off-label and unlicensed drug use in children involving general prescription samples was performed using Medline and Embase. In all, 30 studies from 1985-2004 were included. Eleven involved paediatric hospital wards, seven neonatal hospital wards, and 12 the community setting. The off-label and unlicensed classification methods varied, making results difficult to compare. In general, off-label/unlicensed prescription rates ranged from 11%-80%, and higher rates were found in younger versus older patients and in the hospital versus community settings. On the paediatric hospital wards, off-label/unlicensed prescriptions ranged from 16%-62% and most often concerned acetaminophen, cisapride, chloral hydrate, and salbutamol. In the neonatal wards, rates ranged from 55%-80% and often involved caffeine. In the community setting, rates ranged from 11%-37% and the most commonly implicated drugs were salbutamol and amoxicillin. CONCLUSION: A lack of harmonization between the evidence, the information available to doctors, and its use in clinical practice exists and this is part of the reason off-label therapies are so common. Attempts have been made to improve knowledge concerning paediatric treatments, but more focused interventions are needed, also taking into consideration this lack of harmonization.

Adolescent↗
PubMed2005

Italian paediatricians and off-label prescriptions: loyal to regulatory or guideline standards?

AIM: To evaluate the reason off-label use exists in paediatric general practice and to distinguish between non-compliance with respect to regulatory standards and non-compliance with respect to guidelines in order to determine what this difference means in terms of rational prescribing. METHODS: Information on patients visited by 35 general paediatricians in southern Italy was collected and their prescriptions analysed for off-label status. Off-label drug use in the Italian paediatric community setting was assessed. A sample indication, pharyngotonsillitis, was chosen and the related prescriptions analysed, distinguishing between non-compliance with regulatory standards (i.e. off-label use) and non-compliance with guidelines, in order to determine the appropriateness of prescribing. RESULTS: Information was collected on 9917 patients (8476 prescriptions). In all, 17% of prescriptions were off label. When the 1675 pharyngotonsillitis prescriptions were analysed, 8% were off label and 63% were not in accordance with the guidelines. On the other hand, 55% of these prescriptions did not adhere to the guidelines, but were not off label either. CONCLUSION: The results of this study were surprising because off-label drug use for pharyngotonsillitis, a common paediatric condition, was low, while non-adherence to guidelines was high. In cases such as this one, in which guidelines exist, physicians' prescribing habits were irrational because they did not follow the evidence. Physicians should keep up to date with new knowledge and should be provided with updated product information.

Child↗
PubMed2003

Inappropriate use of anti-asthmatic drugs in the Italian paediatric population.

OBJECTIVE: To evaluate anti-asthmatic drug prescriptions in a large Italian paediatric population. METHODS: Prescriptions involving 417,559 children younger than 14 years old dispensed during 2000 by the retail pharmacies of 17 Italian local health units participating in the ARNO project were analysed. RESULTS: In the study, 92,890 children (22.2%) received at least one anti-asthmatic drug prescription. The prevalence of prescriptions was higher in children less than 1 year old, significantly decreased with increasing age, and was higher in boys than in girls. Of children treated with anti-asthmatic drugs, 71.5% received prescriptions of less than three boxes. Beclomethasone, salbutamol, flunisolide and fluticasone were the most prescribed drugs. Beclomethasone and flunisolide were prescribed mostly as nebulised suspension. CONCLUSIONS: The data suggest that anti-asthmatic drugs are often prescribed for diseases different from asthma and that many children are exposed to treatments for which there is no evidence of efficacy.

Anti-Asthmatic Agents↗