Drug utilization and off-label drug use in Spanish pediatric gastroenterology outpatients.

BACKGROUND AND OBJECTIVES: The clinical use of medicines outside the conditions authorized in their Summary of Product Characteristics (SPC) (off-label use) is a common practice in pediatrics. The aim of the present study was to describe and quantify the medicines received by children attended in the pediatric gastroenterology department, their off-label use, and compliance with accepted rules for said use. METHODS: A retrospective observational study was performed on all of the patients who had their first consultation in pediatric gastroenterology between January 1 and October 31, 2010. All of the clinical information and medicines prescribed were analyzed. Off-label use was defined as the use of medicines in indications not included in the officially approved SPC or in ages not included or recommended in the SPC as well as the use of doses, intervals, or administration routes different from those considered in the SPC. RESULTS: A total of 695 patients (52.8% male) were included, 48.2% younger than 2 years. Two-hundred seven patients (29.8%) received 331 prescriptions. The most commonly used medicines were anti-H2 and proton pump inhibitors. Of all the prescriptions, 33.2% were considered off-label, and up to 47.3% of the prescribed patients had at least 1 medicine under off-label conditions. The medical records contained no documentation on information given to the parents regarding off-label use. CONCLUSIONS: The study found a high percentage of off-label use of medicines in the Pediatric Gastroenterology outpatient setting, especially in children younger than 2 years. Several initiatives were derived from the present study and implemented in our hospital.

Effect of nutritional status on Tuberculin skin testing.

OBJECTIVES: To evaluate Tuberculin skin test (TST) results in a population of immigrants and internationally adopted children from several geographical areas; to analyze whether nutritional status can modify TST results. METHODS: This cross-sectional observational study included adopted children and immigrants evaluated in the authors' unit between January 2003 and December 2008. Children diagnosed with tuberculosis, or vaccinated with live attenuated virus 2 mo earlier, HIV-infected, chronically ill or under treatment with immunosuppressive agents were excluded. TST was considered as dependent variable. Independent variables were gender, age, geographical origin, BCG scar, nutritional status, immune status and intestinal parasitism. RESULTS: One thousand seventy four children were included; 69.6 % were girls. There was a BCG scar in 79 % of children. Mantoux = 0 mm was found in 84.4 %, <10 mm in 4.1 %, and ≥10 mm in 11.4 % of children. Nutrition (McLaren's classification) was normal (≥90 %) in 26.7 % of the subjects, with mild malnutrition (80-89 %) in 36 %, moderate (70-79 %) in 23.2 % and severe (≤69 %) in 14.1 %. There was no difference in TST results among different nutritional status children. CONCLUSIONS: The nutritional status, measured by McLaren's classification, does not changes the results of TST. McLaren's classification only grades protein-caloric malnutrition, so in authors' experience this type of malnutrition does not interfere with TST results. Implementing other nutritional parameters could help to determine whether nutritional status should be taken into account when interpreting TST results.

Tuberculin skin test in bacille Calmette-Guérin-vaccinated children: how should we interpret the results?

BACKGROUND: The tuberculin skin test (TST) is the most useful method for the diagnosis of tuberculosis (TB). There is no evidence about the effect of bacillus Calmette-Guerin (BCG) vaccine on the interpretation of TST results. OBJECTIVE: The aim of this study was to evaluate TST results in a population of immigrants and adopted children, analyzing the effect of the vaccine on TST. METHODS: Cross-sectional observational study including immigrants or adopted children evaluated in our unit between January 2003 and December 2008 was made. Children diagnosed with TB, live attenuated virus vaccinated 2 months earlier, HIV-infected, chronically ill, or under treatment with immunosuppressive agents were excluded. TST was considered the dependent variable. Independent variables were gender, age, geographical origin, BCG scar, nutritional status, immune status, and intestinal parasites infestation. RESULTS: One thousand seventy-four children were included, 69.6 % are female; their origin includes China (34.7 %), Latin America (20.8 %), India/Nepal (19.4 %), Eastern Europe (15.7 %), and Africa (9.3 %). BCG scar was present in 79 % of children. Mantoux = 0 mm in 84.4 %, <10 mm in 4.1 %, and ≥10 mm in 11.4 %. Only two variables, age and BCG scar, influenced TST result. Risk of a TST false-positive due to BCG disappears 3 years after vaccine administration. CONCLUSIONS: A history of BCG vaccination at birth does not interfere with TST results in children >3 years old. Under 3 years of age, BCG does interfere with and may cause a false-positive TST result. In these cases, the use of interferon-gamma release assays (IGRAs) is recommended. If IGRAs are not available or when results are indeterminate, ignoring the antecedent of the vaccine is recommended.

Pandemic H1N1 influenza-associated hospitalizations in children in Madrid, Spain.

OBJECTIVE: To describe the epidemiological and clinical characteristics of children hospitalized with 2009 pandemic influenza (pH1N1) in Madrid, Spain. PATIENTS/METHODS: We included patients less than 14 years of age admitted to one of 18 hospitals in Madrid, Spain, between May 1 and November 30, 2009 and diagnosed with pH1N1 by polymerase chain reaction. A retrospective chart review was conducted and data were compared by age, presence of high-risk medical conditions, and pediatric intensive care unit (PICU) admission. RESULTS: A total of 517 pH1N1 cases were included for final analysis. One hundred and forty-two patients (27·5%) had predisposing underlying illnesses, with immunosuppression (36 children, 7%) and moderate persistent asthma (34, 6·6%) being the most common ones. Patients with underlying medical conditions had longer hospital stays [median 5, interquartile range (IQR) 3-8 days, versus median 4, IQR 3-6, P < 0·001] and required intensive care (20·4% versus 5·9%, P < 0·001) and mechanical ventilation more frequently than previously healthy children. Globally, intensive care was required for 51 patients (10%) and invasive mechanical ventilation for 12 (2%). Pediatric intensive care unit admission was significantly associated with abnormal initial chest X-ray [Odds Ratio (OR) 3·5, 95% confidence interval (CI) 1·5-8·5], underlying neurological condition (OR 3·1, CI 1·2-7·5) and immunosuppression (OR 2·9, 1·2-6·8). Five patients (0·9%) died; two with severe neurological disease, two with leukemia, and one with a malignant solid tumor. CONCLUSIONS: Children with underlying medical conditions experienced more severe pH1N1 disease. Risk factors for admission to the PICU included underlying neurological conditions, immunosuppression and abnormal initial chest X-ray.