Pediatric Population In Spain Research Articles

[Translated article] Current situation and evolution of the availability of drugs in the pediatric population in Spain

ObjectiveTo analyze the characteristics of the new medicines approved in the pediatric population in the last 3 years, both those with studies only in the pediatric population and those that extend their indication in this population group, as well as the current situation in relation to their marketing and financing. MethodsDescriptive observational study of all drugs that include an indication in the pediatric population in Spain (by extension of the indications of drugs already authorized or because they are new drugs that already include an indication in this population group), from January 2019 to March 2022. ResultsDuring the study period, 129 drugs included their indication in the pediatric population. 13.9% of them are not marketed, 46.5% are in a situation of non-financing, under study or without a request for financing, and 4.6% are financed for a specific pediatric subpopulation. 52.7% are original drugs, 4.7% are generic, 38.8% are biological, 3.8% are biosimilar, and 17.8% are orphan drugs. 57.36% of these medicines obtain the pediatric indication due to extension of the indication and 42.64% obtain it because they are new medicines that already include their studies in the pediatric population. ConclusionsDrugs with authorized indications are increasingly available in the pediatric population and the trend is to extend the indication of authorized drugs to the adult population. However, barriers in terms of financing and marketing need to be expedite and overcome to facilitate access to them.

Situación actual y evolución de la disponibilidad de medicamentos en la población pediátrica en España

ObjectiveTo analyze the characteristics of the new medicines approved in the pediatric population in the last three years, both those with studies only in the pediatric population and those that extend their indication in this population group, as well as the current situation in relation to their marketing and financing. MethodsDescriptive observational study of all drugs that include an indication in the pediatric population in Spain (by extension of the indications of drugs already authorised or because they are new drugs that already include an indication in this population group), from January 2019 to March 2022. ResultsDuring the study period, 129 drugs included their indication in the pediatric population. 13,9% of them are not marketed, 46,5% are in a situation of non-financing, under study, or without a request for financing, and 4,6% are financed for a specific pediatric subpopulation. 52,7% are original drugs, 4,7% are generic, 38,8% are biological, 3,8% are biosimilar and 17,8% are orphan drugs. 57,36% of these medicines obtain the pediatric indication due to extension of the indication and 42,64% obtain it because they are new medicines that already include their studies in the pediatric population. ConclusionsDrugs with authorised indications are increasingly available in the paediatric population and the trend is to extend the indication of authorised drugs to the adult population. However, barriers in terms of financing and marketing need to be expedited and overcome to facilitate access to them.

Characteristics of enterovirus infection associated neurologic disease associated in a pediatric population in Spain

IntroductionEnteroviruses are a type of RNA-strained virus with more than 100 different genotypes. Infection can be asymptomatic, and, if any, symptoms can range from mild to severe. Some patients can develop neurological involvement, such as aseptic meningitis, encephalitis, or even cardiorespiratory failure. However, in children, the risk factors for developing severe neurological involvement are not well understood. The aim of this retrospective study was to analyze some characteristics associated with severe neurological involvement in children hospitalized for neurological disease after enterovirus infection. Methodsretrospective observational study analyzing clinical, microbiological and radiological data of 174 children hospitalized from 2009 to 2019 in our hospital. Patients were classified according to the World Health Organization case definition for neurological complications in hand, foot and mouth disease. ResultsOur findings showed that, in children between 6 months old and 2 years of age, the appearance of neurological symptoms within the first 12h from infection onset—especially if associated with skin rash—was a significant risk factor for severe neurological involvement. Detection of enterovirus in cerebrospinal fluid was more likely in patients with aseptic meningitis. By contrast, other biological samples (e.g., feces or nasopharyngeal fluids) were necessary to detect enterovirus in patients with encephalitis. The genotype most commonly associated with the most severe neurological conditions was EV-A71. E-30 was mostly associated with aseptic meningitis. ConclusionsAwareness of the risk factors associated with worse neurological outcomes could help clinicians to better manage these patients to avoid unnecessary admissions and/or ancillary tests.

Characteristics of enterovirus infection associated neurologic disease in a pediatric population in Spain

IntroductionEnteroviruses are a type of RNA-strained virus with more than 100 different genotypes. Infection can be asymptomatic, and, if any, symptoms can range from mild to severe. Some patients can develop neurological involvement, such as aseptic meningitis, encephalitis, or even cardiorespiratory failure. However, in children, the risk factors for developing severe neurological involvement are not well understood. The aim of this retrospective study was to analyze some characteristics associated with severe neurological involvement in children hospitalized for neurological disease after enterovirus infection. Methodsretrospective observational study analyzing clinical, microbiological and radiological data of 174 children hospitalized from 2009 to 2019 in our hospital. Patients were classified according to the World Health Organization case definition for neurological complications in hand, foot and mouth disease. ResultsOur findings showed that, in children between 6 months old and 2 years of age, the appearance of neurological symptoms within the first 12h from infection onset—especially if associated with skin rash—was a significant risk factor for severe neurological involvement. Detection of enterovirus in cerebrospinal fluid was more likely in patients with aseptic meningitis. By contrast, other biological samples (e.g., feces or nasopharyngeal fluids) were necessary to detect enterovirus in patients with encephalitis. The genotype most commonly associated with the most severe neurological conditions was EV-A71. E-30 was mostly associated with aseptic meningitis. ConclusionsAwareness of the risk factors associated with worse neurological outcomes could help clinicians to better manage these patients to avoid unnecessary admissions and/or ancillary tests.

A Spanish case-control study in

Novel human astroviruses (HAstV) were discovered 10 years ago and have been associated with fatal cases of central nervous system infections. Their role in gastroenteritis is controversial, as they have been identified in symptomatic and asymptomatic subjects. The aim of the study was to investigate novel HAstV in a gastroenteritis case-control study including a pediatric population in Spain over a one-year period. We included stool samples from patients with gastroenteritis and negative results for viruses screened by routine diagnostics, and stool samples of control subjects who sought for a routine medical consultation. All samples were screened by real-time RT-PCR assays for novel HAstV. An additional screening for rotavirus, norovirus GI, GII, sapovirus, classic HAstV and adenovirus was also performed for the control group. Overall, 23/363 stool samples from case patients (6.3%) and 8/199 stool samples from control patients (4%) were positive for ≥1 novel HAstV. MLB1 was predominant (64.5% of positives). Seasonality was observed for the case group (p = 0.015), but not the control group (p = 0.95). No difference was observed in the prevalence of novel HAstV between the case and control groups (OR 1.78, 95% CI 0.68–5.45; p = 0.30). Nevertheless, MLB genome copy numbers/ml of fecal suspension was significantly higher in the control group than in the case group (p = 0.008). In our study, we identified a lack of association between novel HAstV and gastroenteritis in the studied population, which could indicate a potential role of reservoir for children, especially given the higher viral load observed in the asymptomatic group for some of them.

Management of small intestinal bacterial overgrowth by pediatric gastroenterologists in Spain.

small intestinal bacterial overgrowth (SIBO) is a heterogeneous condition with nonspecific symptoms. This study aimed to report its management by pediatric gastroenterologists in Spain. a descriptive study was performed by means of a survey sent to 184 active members of the Spanish Society of Pediatric Gastroenterology, Hepatology and Nutrition (SEGHNP). one hundred and forty-eight responses (80.4 %) were received. Forty-four patients had no predisposing condition, 31.1 % used antibiotics followed by probiotics, 33.1 % antibiotherapy concomitant with probiotics, 24.3 % only antibiotics and 10.8 % only probiotics. The diagnosis was established via clinical parameters in 73.8 % of participants and the therapeutic response was checked only by clinical data in 90 %. there is high variability in the management of SIBO among pediatric population in Spain.

Molecular Characterization of Streptococcus pyogenes Causing Invasive Disease in Pediatric Population in Spain A 12-year Study.

To perform a comprehensive description of the epidemiology of Streptococcus pyogenes invasive disease in the pediatric population in 2 regions of Spain (Catalonia and Gipuzkoa) through 12 years. All S. pyogenes isolates causing invasive disease in pediatric patients between 2005 and 2016 were included. The emm-type and the presence of 13 exotoxin genes (speA, speB, speC, speF, speG, speH, speI, speJ, speK, speL, speM, smeZ, ssa and slo) were determined in all 93 available isolates and the Multi Locus Sequece Typing in 10% of isolates of each different emm-type. Overall, 103 cases of S. pyogenes invasive infections were detected: 77 in Catalonia and 26 in Gipuzkoa, being 50.5% females. The incidence rate per 100,000 children was 2.5 for Gipuzkoa and 2.6 for Catalonia, with no significant temporal trends. The median age was 30 months. The most frequent clinical presentations were: pneumonia (26.2%), bacteremia/sepsis (23.3%), septic arthritis/osteomyelitis (22.3%), cellulitis/mastoiditis (12.6%) and meningitis (6.8%). Eight children developed streptococcal toxic shock syndrome. Nine cases were preceded by varicella infection. The associated mortality rate was 3.9%. Three isolates were resistant to erythromycin, being one of them also resistant to clindamycin and 4 isolates were resistant to levofloxacine. Forteen different emm-types were detected being emm1/ST28 (40.9%) the most frequent clone in both regions followed by emm12/ST36-ST242, emm6/ST382, emm3/ST15, emm75/ST150 and emm4/ST38-39. speA gene was only detected in emm1 and emm3 isolates. Eight exotoxins were enough to assign an emm-type with a very high degree of accuracy (95%). The 30-valent vaccine would include 96.8% of isolates.

C-72Wisconsin Card Sorting Test: Normative Data for a Pediatric Population in Spain

C-72Wisconsin Card Sorting Test: Normative Data for a Pediatric Population in Spain

C-74D2 Attention Test: Normative Data for a Pediatric Population in Spain

C-74D2 Attention Test: Normative Data for a Pediatric Population in Spain

C-73Symbol Digit Modalities Test: Normative Data for a Pediatric Population in Spain

C-73Symbol Digit Modalities Test: Normative Data for a Pediatric Population in Spain

Tendencia de la obesidad infantil y el bajo peso por año de nacimiento y edad en España, 1983-2011

Introduction and objectivesThe prevalences of child obesity and overweight are increasing worldwide and are a significant public health issue, particularly in terms of long-term cardiovascular risk profiles, which continue into adulthood unless obesity is reversed. Accurately identifying trends and at-risk subgroups is crucial to correctly target public health initiatives. The objective of this study was to examine changes in the prevalences of child obesity and underweight in Spain from 1983 to 2011 taking into consideration both age and birth year. MethodsA series of cross-sectional studies representative of the pediatric population in Spain between 1987 and 2011 was used to calculate the prevalence and trends of excess weight and underweight in girls and boys aged 2 to 14 years per survey year and per birth year. ResultsThe overall prevalence of overweight and obesity remained relatively stable. The prevalence of overweight in boys aged 10 to 14 years increased from 13.9% to 22.2%. The prevalence of obesity in girls aged 2 to 5 years decreased from 30% to 19.8%, whereas the prevalence of underweight in this group increased from 13.7% to 22.6%. ConclusionsChild obesity trends in Spain over the last 2 decades appear to be stable with some fluctuations, but the trends differ depending on age and sex, and have stabilized at too high a level. The prevalence of underweight also appears to have increased and should be considered alongside excess weight when designing and implementing child health and weight measures.Full English text available from:www.revespcardiol.org/en

Trends in Child Obesity and Underweight in Spain by Birth Year and Age, 1983 to 2011

Introduction and objectivesThe prevalences of child obesity and overweight are increasing worldwide and are a significant public health issue, particularly in terms of long-term cardiovascular risk profiles, which continue into adulthood unless obesity is reversed. Accurately identifying trends and at-risk subgroups is crucial to correctly target public health initiatives. The objective of this study was to examine changes in the prevalences of child obesity and underweight in Spain from 1983 to 2011 taking into consideration both age and birth year. MethodsA series of cross-sectional studies representative of the pediatric population in Spain between 1987 and 2011 was used to calculate the prevalence and trends of excess weight and underweight in girls and boys aged 2 to 14 years per survey year and per birth year. ResultsThe overall prevalence of overweight and obesity remained relatively stable. The prevalence of overweight in boys aged 10 to 14 years increased from 13.9% to 22.2%. The prevalence of obesity in girls aged 2 to 5 years decreased from 30% to 19.8%, whereas the prevalence of underweight in this group increased from 13.7% to 22.6%. ConclusionsChild obesity trends in Spain over the last 2 decades appear to be stable with some fluctuations, but the trends differ depending on age and sex, and have stabilized at too high a level. The prevalence of underweight also appears to have increased and should be considered alongside excess weight when designing and implementing child health and weight measures.

Analysis of comorbidities and therapeutic approach for allergic rhinitis in a pediatric population in Spain

Allergic rhinitis (AR) is the most common chronic disease in children. The main objective of this study was to analyze the comorbidities and therapeutic approaches for AR in a Spanish pediatric population. Children aged 6 to 12years with AR were included in an observational, cross-sectional, multicenter study. 1,275 children were recruited from 271 centers. AR was intermittent in 59.5% of cases, persistent in 40.5%, seasonal in 60.7%, and perennial in 39.3% of patients. The most frequent comorbidities were conjunctivitis (53.6%), asthma (49.5%), atopic dermatitis (40%), rhinosinusitis(26.1%), otitis media (23.8%), and adenoid hypertrophy (17.3%). Overall, patients with persistent, moderate or severe, AR were more likely to present comobidities, except for food allergy and urticaria. The most common drugs used for treatment of AR were oral antihistamines(76%), nasal corticosteroids(49%) and a combination of both (45%). Antihistamines and nasal corticosteroids were used on demand (<18days) in 38 and 41% of patients, respectively; for 18-30days in 22 and 27%; for 1-3months in 31 and 29%; and for more than 3months in 8 and 3%, respectively. Eye drops were used in 32% and specific immunotherapy in 21% of patients. Comorbidities are frequent in children with AR, supporting the notion of allergy as a systemic disease. Severity and duration of AR were significantly associated with presence of most of comorbidities. The most common drugs used for AR treatment were oral antihistamines, followed by nasal corticosteroids and a combination of both used on demand.

Infecciones neonatales por Staphylococcus aureus de inicio en la comunidad

IntroductionStaphylococcus aureus is a major cause of neonatal community-onset infections. The emergence of methicillin-resistant S. aureus infections in this age group has been reported in USA in the last few years; however there are no studies in Spain. The aim of this study is to describe the epidemiological, clinical and microbiological characteristics of S. aureus community-onset infections in neonates. MethodsWe prospectively reviewed the S. aureus infections in neonates over a three year period (2007-2009) in the Pediatric Emergency Department of Hospital 12 de Octubre in Madrid (Spain). ResultsWe recorded 30 cases of neonatal S. aureus community-onset infections. Only one isolated (3.3%) was resistant to methicillin, and two (6.7%) were PVL(+). ConclusionsDespite the emergence of MRSA outside the hospital in pediatric population in Spain, CA-MRSA and SA PVL(+) infections are not frequent in neonates.

Trends in Drug Resistance Prevalence in HIV-1–infected Children in Madrid

Drug resistance mutations compromise antiretroviral treatment (ART) effectiveness in HIV-1-infected children. Trends in drug resistance prevalence have not been previously evaluated in HIV-infected children in Spain. HIV-1 variants, drug resistance prevalence dynamics and drug susceptibility were analyzed from 1993 to 2010 in HIV-infected children with available pol sequence, sample or drug resistance profile. HIV-1 variants were characterized by phylogenetic analysis. Resistance mutations in pretreated and naive patients were identified according to International AIDS Society-2010 and the World Health Organization list, respectively. In 232 patients, genotypic resistance profiles (n = 11) or pol sequences (n = 128) were recovered or newly generated from infected samples (n = 93). Patients were mainly in care at pediatric units (63%), were mostly Europeans (84%), with moderate AIDS symptoms (65%), on ART (91%) and infected by HIV-1 subtype B (89%). Transmitted major drug resistance mutations were selected in 6 (13.6%) of the 44 ART-naive children: 4.8%, 9.3% and 11.6%, for protease inhibitors, nucleoside reverse transcriptase inhibitors and nonnucleoside reverse transcriptase inhibitors, respectively. Overall resistance prevalence was higher (71.8%) among ART-exposed children: 39.9%, 66.5% and 35.3% for protease inhibitors, nucleoside reverse transcriptase inhibitors and nonnucleoside reverse transcriptase inhibitors, respectively. Resistance prevalence among ART-exposed children was higher in 2009 to 2010 relative to 1993 to 1999 for nonnucleoside reverse transcriptase inhibitors (42% versus 6%; P = 0.006), protease inhibitors (39% versus 13%; P = 0.004) and nucleoside reverse transcriptase inhibitors (63% versus 44%; P = NS). Susceptibility to each drug in resistant viruses was predicted. The rate of non-B infections increased in the last years, mainly caused by recombinant viruses. The increasing resistance prevalence among the HIV-infected pediatric population in Spain highlights the importance of specific drug resistance and drug susceptibility surveillance in long-term pretreated children to optimize treatment regimens.

Análisis multinivel del uso de servicios de salud bucodental por población infanto-juvenil

Objectives To analyze the variables associated with the use of oral health services in the last year by the population aged 6 to 15 years living in Spain and to determine whether there is variability in the use of these services among autonomous regions and, if so, whether this variability could be explained by variables related to the care model of the distinct autonomous regions. Methods A cross-sectional study of the Spanish National Health Survey (2006) was carried out. Independent variables were individual (sociodemographic, dental disease, habits and socioeconomic) and contextual (type of dental care model and prevalence of unemployment in the autonomous region). Association was estimated by multilevel logistic regression. Results Variance in the use of oral health services among autonomous regions was 0.16 (SE: 0.07), and 4.8% of the total variability was attributable to the autonomous region. The variables included in the model explained 83.11% of the variance. Individual variables associated with an increased likelihood of using dental services were the presence of disease and the frequency of brushing. Individual variables associated with a lower likelihood were age, origin, intake of sugary soft drinks and socioeconomic status. The contextual variables of being covered by a dental care model (of the type Childhood Dental Care Plan) older than 10 years doubled the likelihood of using oral health services compared with those without such coverage (OR = 2.47, CI = 2.04-2.99). Conclusions The use of oral health services during the last year by the pediatric population in Spain is lower than recommended. This use is associated with individual variables (demographic, dental health, habits and socioeconomic factors) and contextual variables (dental care model).

Epidemiology of pneumococcal meningitis hospitalizations in pediatric population in Spain (1998–2006)

The burden of hospital admissions for pneumococcal meningitis in pediatric population in Spain during a 9-year period was estimated. Data were obtained from the national information system (computerized hospital discharge data). There were 770 hospital admissions with an annual incidence of 1.44 cases per 100,000 population. Rate of death and case-fatality rate were 0.11 per 100,000 population and 7.92%, respectively. The higher incidence and rate of death was found in children up to 12 months of age and the higher case-fatality rate in children of 10–14 years of age. Further studies assessing the incidence of pneumococcal meningitis in post-vaccination period are needed.