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Biomedical subjects

P Impicciatore

Publications and source records attributed to P Impicciatore.

16 recordsLinked to original sources
PubMed2002

Off-label use of drugs in Italy: a prospective, observational and multicentre study.

UNLABELLED: The aims of the study were to measure the paediatric, off-label use of drugs in the Italian hospital setting and to reveal areas for priority intervention by investigating the therapeutic indications most involved. Prescriptions given to all children admitted to nine general paediatric hospital wards from December 1998 to February 1999 were analysed. In total, 4265 prescriptions were given to 1461 children, 10 of which were unlicensed and excluded from further analysis. Sixty percent of prescriptions (range between centres: 44-71%) were off-label and concerned 89% of children receiving medications (80-96%). The main drug classes were antibacterials, antiasthmatics and analgesics, and represented 56% of off-label prescriptions. Paracetamol (385 prescriptions) and beclomethasone (339) were the generic substances most often used off-label. The most common off-label categories were dosage/frequency (50% of prescriptions), indication and lack of paediatric licence (7% each). Fifty-four per cent of all indications that led to off-label prescribing involved only respiratory problems, fever, respiratory tract infections and bronchospasm. CONCLUSIONS: Despite prescription profile differences among centres, off-label use was high everywhere. Immediate action for more rational drug use is necessary and requires not only regulatory intervention but also a more evidence-based, therapeutic approach.

Child↗
PubMed2001

Incidence of adverse drug reactions in paediatric in/out-patients: a systematic review and meta-analysis of prospective studies.

AIMS: To explore the usefulness of data derived from observational studies on adverse drug reactions (ADRs) in defining and preventing the risk of pharmacological interventions in children in different health care settings. METHODS: A systematic review of studies on ADRs in hospitalized children, in outpatient children, and on ADRs causing paediatric hospital admissions was performed. Studies were identified through a search of the MEDLINE and EMBASE databases. The inclusion criteria required that the population was not selected for particular conditions or drug exposure and prospective monitoring was used for identifying ADRs. Data were analysed by a random-effects model. RESULTS: Seventeen prospective studies were included. In hospitalized children, the overall incidence of ADRs was 9.53% (95% confidence interval [CI], 6.81, 12.26); severe reactions accounted for 12.29% (95%CI, 8.43,16.17) of the total. The overall rate of paediatric hospital admissions due to ADRs was 2.09% (95%CI, 1.02, 3.77); 39.3% (95%CI, 30.7,47.9) of the ADRs causing hospital admissions were life threatening reactions. For outpatient children the overall incidence of ADRs was 1.46% (95%CI, 0.7, 3.03). CONCLUSIONS: The results show that ADRs in children are a significant public health issue. The completeness and accuracy of prescription reporting as well as clinical information from studies was a rarity, making it difficult for health practitioners to implement evidence based preventive strategies. Further, methodologically sound drug surveillance studies are necessary for an effective promotion of a safer use of drugs in children.

Adolescent↗
PubMed2000

Survey of unlicensed and off label drug use in paediatric wards in European countries. European Network for Drug Investigation in Children.

OBJECTIVE: To determine the extent of use of unlicensed and off label drugs in children in hospital in five European countries. DESIGN: Prospective study of drugs administered to children in general paediatric medical wards over four weeks. SETTING: Children's wards in five hospitals (one each in the United Kingdom, Sweden, Germany, Italy, and the Netherlands). SUBJECTS: Children aged 4 days to 16 years admitted to general paediatric medical wards. MAIN OUTCOME MEASURE: Proportion of drugs that were used in an unlicensed or off label manner. RESULTS: 2262 drug prescriptions were administered to 624 children in the five hospitals. Almost half of all drug prescriptions (1036; 46%) were either unlicensed or off label. Of these 1036, 872 were off label and 164 were unlicensed. Over half of the patients (421; 67%) received an unlicensed or off label drug prescription. CONCLUSIONS: Use of off label or unlicensed drugs to treat children is widespread. This problem is likely to affect children throughout Europe and requires European action.

Adolescent↗
PubMed2000

Mothers as active partners in the prevention of childhood diseases: maternal factors related to immunization status of preschool children in Italy.

BACKGROUND: We examined how maternal socio-demographic factors, together with mother's education, knowledge, and perception of immunizations, can affect the uptake of optional vaccinations of preschool children in Italy. METHODS: Interviews of Italian mothers were performed using a structured questionnaire administered by trained interviewers with no specific medical competence. RESULTS: A convenience sample of 1,035 mothers were interviewed. Fifty-nine percent of the respondents reported to have had their child immunized with the MMR vaccine and 54% reported to have had their child immunized against pertussis. In logistic regression analysis, three variables were significantly associated with both the immunization outcomes: mother's positive attitude toward immunization (OR = 1.69; IC 1.13-2.52 for pertussis; OR = 1.86, IC 1. 17-2.96 for MMR); mothers' residency in the North of the country (OR = 1.74; IC 1.32-2.30 for pertussis; OR = 1.63, IC 1.18-2.24 for MMR); and mother's receipt of satisfactory information on immunization (OR = 1.67; IC 1.15-2.21 for pertussis; OR = 2.25, IC 1. 47-3.43 for MMR). An immunization performed in recent years (after 1994), probably following the widespread use of acellular vaccine, was the most significant predictor for pertussis immunization (OR = 3.21; IC 2.43-4.24). CONCLUSIONS: The findings suggest that mothers' attitudes, educational level, and socio-demographic characteristics, as well as socio-economic factors and local health policies, can influence children's immunization uptake. Health promotion, based on a partnership between parents and health professionals, should become a priority in Italian vaccination policies.

Analysis of Variance↗
PubMed2000

Parents on the web: risks for quality management of cough in children.

BACKGROUND: Health information on the Internet, with respect to common, self-limited childhood illnesses, has been found to be unreliable. Therefore, parents navigating on the Internet risk finding advice that is incomplete or, more importantly, not evidence-based. The importance that a resource such as the Internet as a source of quality health information for consumers should, however, be taken into consideration. For this reason, studies need to be performed regarding the quality of material provided. Various strategies have been proposed that would allow parents to distinguish trustworthy web documents from unreliable ones. One of these strategies is the use of a checklist for the appraisal of web pages based on their technical aspects. OBJECTIVE: The purpose of this study was to assess the quality of information present on the Internet regarding the home management of cough in children and to examine the applicability of a checklist strategy that would allow consumers to select more trustworthy web pages. METHODS: The Internet was searched for web pages regarding the home treatment of cough in children with the use of different search engines. Medline and the Cochrane database were searched for available evidence concerning the management of cough in children. Three checklists were created to assess different aspects of the web documents. The first checklist was designed to allow for a technical appraisal of the web pages and was based on components such as the name of the author and references used. The second was constructed to examine the completeness of the health information contained in the documents, such as causes and mechanism of cough, and pharmacological and nonpharmacological treatment. The third checklist assessed the quality of the information by measuring it against a gold standard document. This document was created by combining the policy statement issued by the American Academy of Pediatrics regarding the pharmacological treatment of cough in children with the guide of the World Health Organization on drugs for children. For each checklist, the web page contents were analyzed and quantitative measurements were assigned. RESULTS: Of the 19 web pages identified, 9 explained the purpose and/or mechanism of cough and 14 the causes. The most frequently mentioned pharmacological treatments were single-ingredient suppressant preparations, followed by single-ingredient expectorants. Dextromethorphan was the most commonly referred to suppressant and guaifenesin the most common expectorant. No documents discouraged the use of suppressants, although 4 of the 10 web documents that addressed expectorants discouraged their use. Sixteen web pages addressed nonpharmacological treatment, 14 of which suggested exposure to a humid environment and/or extra fluid. In most cases, the criteria in the technical appraisal checklist were not present in the web documents; moreover, 2 web pages did not provide any of the items. Regarding content completeness, 3 web pages satisfied all the requirements considered in the checklist and 2 documents did not meet any of the criteria. Of the 3 web pages that scored highest in technical aspect, 2 also supplied complete information. No relationship was found, however, between the technical aspect and the content completeness. Concerning the quality of the health information supplied, 10 pages received a negative score because they contained more incorrect than correct information, and 1 web page received a high score. This document was 1 of the 2 that also scored high in technical aspect and content completeness. No relationship was found, however, among quality of information, technical aspect, and content completeness. CONCLUSIONS: As the results of this study show, a parent navigating the Internet for information on the home management of cough in children will no doubt find incorrect advice among the search results. (ABSTRACT TRUNCATED)

Antitussive Agents↗
PubMed1999

Status of new medicines approved by the European Medicines Evaluation Agency regarding paediatric use.

AIMS: To evaluate the activity of the European Medicines Evaluation Agency with regard to the registration for paediatric use of new medicines granted a marketing authorization. METHODS: European Public Assessment Reports published on the Internet from January 95 until April 98 have been analysed using the browser Microsoft Explorer and the software Adobe Acrobat Reader. RESULTS: Of the 45 new substances licensed since January 95, 29 (64%) were of possible use in children but only 10 were licensed for paediatric use. For the 19 drugs of possible use in children, but not approved for such a use, in nine instances (47%) their summary of product characteristics reported that their use in children has not been established. CONCLUSIONS: A change of practice by pharmaceutical companies and regulatory authorities is imperative so that children are not precluded from having the same rights to medicines as adults.

Child↗
PubMed1997

Reliability of health information for the public on the World Wide Web: systematic survey of advice on managing fever in children at home.

OBJECTIVE: To assess the reliability of healthcare information on the world wide web and therefore how it may help lay people cope with common health problems. METHODS: Systematic search by means of two search engines, Yahoo and Excite, of parent oriented web pages relating to home management of feverish children. Reliability of information on the web sites was checked by comparison with published guidelines. MAIN OUTCOME MEASURES: Minimum temperature of child that should be considered as fever, optimal sites for measuring temperature, pharmacological and physical treatment of fever, conditions that may warrant a doctor's visit. RESULTS: 41 web pages were retrieved and considered. 28 web pages gave a temperature above which a child is feverish; 26 pages indicated the optimal site for taking temperature, most recommending rectal measurement; 31 of the 34 pages that mentioned drug treatment recommended paracetamol as an antipyretic; 38 pages recommended non-drug measures, most commonly tepid sponging, dressing lightly, and increasing fluid intake; and 36 pages gave some indication of when a doctor should be called. Only four web pages adhered closely to the main recommendations in the guidelines. The largest deviations were in sponging procedures and how to take a child's temperature, whereas there was a general agreement in the use of paracetamol. CONCLUSIONS: Only a few web sites provided complete and accurate information for this common and widely discussed condition. This suggests an urgent need to check public oriented healthcare information on the internet for accuracy, completeness, and consistency.

Analgesics, Non-Narcotic↗
PubMed1997

Thyroid function in children treated for acute lymphoblastic leukemia.

To determine the late effects of treatment on thyroid function in children who survive acute lymphoblastic leukemia, we assessed plasma levels of thyroid hormones in 24 children (15 girls and 9 boys) who had received combination of chemotherapy along with 18-24 Gy of irradiation to the cranium. The children were aged between 1 and 10.5 years (mean 3.1) at diagnosis and thyroid status was investigated between 1.3 and 13 years (mean 6.8) after completion of therapy. Six children showed a low peak of plasma thyroid stimulating hormone (TSH), after stimulation with thyrotrophin-releasing hormone (TRH). Three children showed a low basal plasma TSH concentration. Serum levels of thyroxine (T4, fT4) and triiodothyronine (T3, fT3) were normal in all patients. The frequency of thyroid hypofunction (low peak response of TSH to TRH) was more common in children receiving 24 compared to 18 Gy cranial irradiation (50% vs 14%; odds ratio = 7) and those who had completed therapy more than 5 years ago (31.3% vs 12.5%, odds ratio 3.18) although no significant association could be found (95% IC: 0.27-65.8 and 0.24-90 respectively). Because of the low mean age at diagnosis of our population no significant association could be found between children younger than 3 years of age at diagnosis and thyroid hypofunction (odds ratio = 0.14; 95% IC: 0.01-1.48). We conclude that treatment for acute lymphoblastic leukemia including cranial irradiation may lead to TRH/TSH dysfunction and therefore long term survivors should be followed for a long period after completion of therapy.

Child↗
PubMedDate not supplied

Mother's knowledge of, attitudes toward, and management of fever in preschool children in Italy.

BACKGROUND: We examined mothers' knowledge of, attitudes toward, and management of fever in their children. METHODS: Interviews of mothers of preschool children were performed using a structured questionnaire administered by interviewers with no specific medical competence. RESULTS: Of a total of 1,237 mothers who were interviewed, data were analyzed for the 707 mothers who had coped with a febrile episode in their children during the previous month. Of these, 59% were concerned about fever in their children and 17% were very worried. At the onset of fever, 48% of the mothers gave their child an antipyretic and 18% called the physician immediately. In logistic regression analysis, five variables were significantly associated with mothers' concern: the absence of previous information on the management of fever, temperature > 39 degrees C, an only child, mother's low educational level, and mother's residency in the south of Italy. For the request for a physician's visit, of the variables entered, the only explanatory ones were the mother's concern and the absence of previous information on the management of fever. CONCLUSIONS: These findings suggest that informing mothers on the definition, consequences, and treatment of fever can significantly improve their confidence in managing fever, as reflected by fewer requests for physicians' visits.

Child, Preschool↗
PubMedDate not supplied

Effect of coexistent diseases on survival of patients undergoing dialysis.

A cohort retrospective study was used to analyze the effect of comorbidity on survival of end-stage renal disease (ESRD) patients undergoing dialysis. The authors analyzed the survival of 255 patients (144 men, 111 women; median age 54 years; range 8-81 years) followed at the District Hemodialysis Unit in Foggia, Italy, over a 15 year period (median follow-up 30 months; range 1-190 months). Two subscales assessing the overall severity of the identified coexistent diseases and overall physical impairment, and a composite four level index of coexistent diseases (ICED) were assembled using information recorded at the time of admission. The Cox proportional hazard model was applied to evaluate the association of various patient characteristics with the probability of death. Mortality risk was associated with patient age (RR = 3.4 for patients aged 42-61; RR = 4.8 for patients older than age 61 compared with patients younger than age 42), initial condition leading to renal failure (RR = 3.1 for diabetes compared with primary renal disease) and ICED (RR = 3.0 for patients with uncontrolled coexistent disease or severe impairment compared with patients with no coexistent disease and no or mild impairment). Gender and type of dialysis were not associated with mortality risk. It was concluded that, as is the case with other chronic conditions, co-morbidity is a powerful independent prognostic factor in determining the mortality of ESRD patients.

Adolescent↗
PubMedDate not supplied

[3 years of "new developments" in pharmacotherapy. An update which is also a proposal for participative experimentation].

The analysis of the contents of key national and international drug bulletins provides a comprehensive overview of what has been produced worldwide in the field of pharmacology and therapeutics over the last few years after the last publication in R d 1). The work presented, tries to avoid the risk of being a purely descriptive listing of true and false "new" information, and may be seen as an "experiment of information transfer": the available data are presented and summarised from various complementary points of view, to suggest also a methodology of permanent education, for which instruments are also proposed. Further, the text is tentatively proposed as an experiment of communication between nurses and pharmacists, to stimulate their dialogue and interaction both with respect to the use of drug literature and to the evaluation of daily needs of information in routine hospital practice.

Drug Therapy↗