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m La asistencia farmaceutica al paciente pediatrico presenta una serie de peculiaridades tanto clinicas como metodologicas, que derivan principalmente de los siguientes aspectos: los condicionantes farmacocineticos y farmacodinamicos en las diferentes subpoblaciones pediatricas, la insuficiente investigacion clinica en pediatria, la falta de formas farmaceuticas adaptadas a pediatria y un mayor riesgo de sufrir errores de medicacion con resultados daninos para la salud. Los principales motivos son1, por un lado, el hecho de que la mayor parte de los medicamentos que se emplean en ninos estan acondicionados para su uso en adultos, de forma que previa administracion en pediatria deben ser formulados en diferentes volumenes y concentraciones. Esta manipulacion incluye muchas veces la realizacion de calculos que inducen a error en un alto porcentaje de las ocasiones. Los ninos, sobre todo los mas jovenes, pequenos y enfermos, toleran peor un error de medicacion, puesto que sus funciones renales, inmunes y hepaticas estan en continuo desarrollo.

Drug administration is one of the main sources of errors in pediatric intensive care units (PICUs). An available guide for intravenous drug administration might be useful. The aim of this article is to present the methodology and results for the development of a guide for intravenous drug administration in a PICU. A total of 116 drugs were included. Standard concentrations, diluents, technique for reconstitution and dilution, stability, rate of administration, and relevant observations were defined for each drug according to a review of the most commonly used literature resources. The main unique feature of this article is that it includes standard concentrations for each drug.

The aim of the study was to develop and implement a protocol for the prevention and treatment of catheter related intraluminal thrombosis in a paediatric intensive care unitA computerised search was carried out on MEDLINE, through PubMed, using the medical subject heading 'central venous catheter', 'central venous access device', 'central venous line' associated with 'occlusion', 'obstruction', 'catheter-related thrombosis', 'critically ill patients' and 'thrombolytic therapy'. References of reviewed articles were also searched for relevant titles as well as non-randomised controlled trials and series of cases when no information of higher level of evidence was available.With the information gathered, a protocol for the prevention and treatment of catheter related intraluminal thrombosis was elaborated and those recommendations that best suit our environment were included. They were agreed upon by a broad panel of professionals working in the Pediatric Intensive Care Unit and the Pharmacy Department.Due to the variety of options available for the pharmacotherapeutic management of intraluminal catheter thrombosis, one measure to improve the quality of the therapy and to diminish the variability in the prescription could be the implementation of a protocol as described in this paper.

PurposeThe impact of smart infusion pumps on the interception of errors in the programming of i.v. drug administrations on a pediatric intensive care unit (PICU) is investigated.MethodsA prospective observational intervention study was conducted in the PICU of a hospital in Madrid, Spain, to estimate the patient safety benefits resulting from the implementation of smart pump technology (Alaris System, CareFusion, San Diego, CA). A systematic analysis of data stored by the devices during the designated study period (January 2010–June 2011) was conducted using the system software (Guardrails CQI Event Reporter, CareFusion). The severity of intercepted errors was independently classified by a group of four clinical pharmacists and a group of four intensive care pediatricians; analyses of intragroup and intergroup agreement in perceptions of severity were performed.ResultsDuring the 17-month study period, the overall rate of user compliance with the safety software was 78%. The use of smart pump technology resulted in the interception of 92 programming errors, 84% of which involved analgesics, antiinfectives, inotropes, and sedatives. About 97% of the errors resulted from user programming of doses or infusion rates above the hard limits defined in the smart pump drug library. The potential consequences of the intercepted errors were considered to be of moderate, serious, or catastrophic severity in 49% of cases.ConclusionThe use of smart pumps in a PICU improved patient safety by enabling the interception of infusion programming errors that posed the potential for severe injury to pediatric patients.

Resumen: La prevalencia del asma ha aumentado en las últimas décadas, especialmente en los países desarrollados, por motivos no bien esclarecidos. En los últimos años se ha observado una asociación entre el uso de paracetamol en distintas etapas de la vida, incluyendo la gestación y la infancia, y la prevalencia de asma. El carácter observacional de los estudios publicados no permite establecer una relación causal. Sería necesario realizar ensayos clínicos para comprobar la naturaleza de la asociación, que podría deberse a la presencia de diversos factores de confusión. Las sociedades pediátricas españolas firmantes de este artículo consideran que los datos disponibles hasta la fecha no son suficientes para desaconsejar el uso de paracetamol durante la gestación ni en niños asmáticos o con riesgo de asma. Abstract: Asthma prevalence has increased over the last few decades, especially in developed countries, and possibly due to different reasons. An association between paracetamol use or exposure at different periods of life, including gestation and childhood, and asthma prevalence has been observed in the last few years. Causality can not be established from observational reports, due to the arguable presence of many confounding factors and biases. Randomised trials are needed to elucidate the nature of this association. The Spanish Paediatric societies subscribing to this paper consider that current evidence is insufficient to discourage the use of paracetamol during gestation or in children with or at risk of asthma.

The Spanish Network for the Study of Paediatric Tuberculosis has shown a lack of national consensus on the treatment of tuberculosis in children, partly due to the unavailability of paediatric presentations of antituberculosis drugs. The harmonisation of tuberculosis treatment in children is a priority in Spain. A joint action is proposed by a group of Spanish experts in childhood tuberculosis and in the area of Paediatric Pharmacology. To this end, a pTBred-led workgroup of members from five scientific bodies has been created. Drug pharmaceutical compounding in oral suspensions or oral solutions are recommended as follows: isoniazid 50 mg/mL, pyrazinamide 100 mg/mL, and ethambutol 50 mg/mL. Raw materials, period of validity, and storage conditions are specified. Recommendations for the use of fixed-dose combination drugs are also established. If oral solutions/suspensions or fixed-dose combination drugs are not appropriate, the use of crushed tablets is recommended. Adherence to treatment and optimal dosing of antituberculosis drugs are critical in the control and eradication of TB. This multidisciplinary document provides an opportunity to promote the appropriate treatment of paediatric tuberculosis in Spain, and should become a useful tool for paediatricians and pharmacists. Resumen: La Red Española de Estudio de la Tuberculosis Pediátrica ha evidenciado una falta de consenso nacional en la administración de antituberculosos en niños, propiciada por la escasez de presentaciones pediátricas específicas. Es prioritario homogeneizar el tratamiento de la tuberculosis en niños en nuestro país. Un grupo de expertos españoles en tuberculosis infantil y en el área de medicamentos pediátricos proponen una actuación conjunta, con la finalidad de mejorar esta situación en nuestro medio. Para ello se constituye un Grupo de Trabajo, liderado por pTBred, en el que participan otras 5 sociedades e instituciones científicas. Se proponen las siguientes fórmulas magistrales en forma de suspensión o solución oral para el tratamiento de la tuberculosis en niños: isoniacida 50 mg/ml, pirazinamida 100 mg/ml y etambutol 50 mg/ml. Se especifican materias primas, periodo de validez y condiciones de conservación y administración. Se establecen recomendaciones para el uso de fármacos combinados a dosis fijas. Si no se consigue la dosis apropiada mediante fármacos combinados a dosis fijas, y no se dispone de fórmula magistral, se recomienda la administración mediante comprimidos triturados. El adecuado cumplimiento terapéutico y la administración de dosis óptimas de los fármacos antituberculosos constituyen pilares fundamentales en el control y erradicación de la enfermedad. La oportunidad de disponer de este documento multidisciplinar en España favorecerá el correcto tratamiento de la tuberculosis pediátrica, y será una guía útil para todos los pediatras y farmacéuticos que lo precisen.

The main goal of clinical pharmacists is to improve patient care quality by providing individualised care. This is achieved by validating prescriptions and performing pharmacotherapeutic follow-up, leading to effective, safe and efficient drug therapy. However, there is no specific model for medication order validation in paediatrics addressing the distinct issues of paediatric drug use or the greater susceptibility of medication errors occurring in this patient group. For this reason we intended to design and reach consensus on a paediatric pharmaceutical care model by applying a two-round Delphi technique. In order to define the levels of complexity in reaching consensus for the model, three variables were taken into account: level of access to patient medical and drug records (partial vs. total), access to medical and nursing staff attending the patient (on-site vs. off-site) and the pharmacist available time (limited vs. adequate). In order to describe the minimum items to be included in the validation process at each of the three levels of complexity, we analysed the safety profile in the medication order prescription previously defined in an epidemiological study in eight hospitals with a total capacity of 1565 paediatric beds. A panel of experts was recruited (50 experts from 20 different hospitals) and the questionnaire was completed. Consensus was established at 70% of agreement by experts for an item. Following debate on the items that did not obtain consensus, a second round was performed, after which the final consensus model was defined. After two rounds of consultation, consensus was obtained for 39 out of the 41 items that were surveyed. Of these, 17 were then used for the basic validation model (e.g. weight/age check, dose/weight check), 13 were implemented in the intermediate level (e.g. identification of adverse effects from excipients) and 9 were incorporated at advanced level (e.g. reconciliation at discharge for patients at risk). By applying the model, based on homogenous criteria for action, the clinical pharmacist's role will improve, and in turn, this will doubtlessly reduce drug errors through medication order validation.

Pediatric patients admitted to intensive care units are likely candidates for intravenous drug administration. These patients may sometimes have limited vascular access, so availability of compatibility charts for intravenous Y-site administration may help daily clinical practice. A 2-dimensional table with the 47 intravenous drugs more commonly administered in the authors' pediatric intensive care unit was drawn up based on a review of 4 databases routinely used for checking drug compatibilities. The level of concordance between the various sources used for the review was strong (κ>0.8). However, an awareness of the limitations of each of these databases will help to optimize search results.

Objective To assess the impact of pharmacist intervention in reducing prescribing errors in paediatrics, and to analyse the clinical significance and reasons behind the errors detected. Methods Cross-sectional epidemiological study analysing the activities of the paediatric pharmacist in a maternity and children9s hospital with 180 paediatric beds, between January 2007 and December 2009. The following variables were analysed: impact of the pharmacist9s recommendation on patient care, reason for the intervention, clinical significance, type of negative outcome associated with the medication, acceptance rate, medication involved, intervention detection date and observations. Results A total of 1475 interventions in medical orders for 14 713 paediatric patients were recorded (40 (2.9%) extremely significant interventions and 155 (11.1%) very significant interventions). There were 1357 prescribing errors, 833 of which were dosing errors. 2.2% of the errors detected were potentially fatal (30 cases) and 14.3% (194 cases) were clinically serious. The main reason for interventions was detection of a dosage between 1.5 and 10 times higher than that recommended. The overall rate of acceptance of the pharmacist9s suggestions was 94.3%. The pharmacist carried out an average of 0.019 interventions per patient day throughout the study period. Conclusion Interventions by a clinical pharmacist had a major impact on reducing prescribing errors in the study period, thus improving the quality and safety of care provided.

To assess the main differences in clinical significance of the prescribing errors intercepted by clinical pharmacists in paediatrics and obstetrics and the reasons for these prescribing errors, as well as the differences in pharmacists’ activity indicators. The was a cross-sectional epidemiological study analysing the activities of paediatric pharmacists in a maternity and children's hospital with 180 paediatric beds and 138 obstetrics and gynaecology beds between January 2007 and December 2009. The following variables were analysed: clinical significance of prescribing errors intercepted, reason for the error, impact of the intervention by pharmacist, acceptance rate of the recommendation made, medication involved, intervention detection date and observations. A total of 2,449 interventions in medical orders were recorded. Interventions that were not accepted by doctors were excluded, leaving 43 cases (2.1%) of extremely significant interventions and 170 (8.4%) very significant interventions. Interventions in what were deemed to be error-free situations were excluded. Significance testing (based on 2,035 errors detected) showed that 1.7% of the detected errors were potentially lethal (35 cases), while 10.2% (210 cases) were clinically serious. The main reason for the interventions was the detection of a dosage between 1.5- and tenfold higher than the recommended dosage. The overall rate of acceptance of the pharmacist's suggestions was 92.2%. Pharmacists carried out an average of 0.016 interventions/patient-day throughout the study period. Paediatric patients had a fourfold higher risk of serious errors than the maternity population. Pharmacist intervention had a major impact on reducing prescribing errors in the study period, thus improving the quality and efficiency of care provided.

Many studies have reported increased pediatric susceptibility to the development of errors; children are more vulnerable, so it is very important to guarantee the best therapeutic results at the lowest risk. There are many studies related to prescription of drugs in pediatrics under conditions other than those authorized. Studies show that approximately 50% of the drugs used in children are off label or unlicensed, and in about 70% of pediatric patients at least one drug is prescribed under those conditions.

Aim of the review The therapeutic management of pediatric idiopathic nephrotic syndrome is still a challenge due to the large number of potentially effective pharmacological alternatives and the insufficient scientific evidence available. A bibliographic review was performed in order to identify the available pharmacological alternatives, as well as their place in therapy, and to analyze whether the treatment algorithm developed by the pediatric nephrology department of our hospital is consistent with the evidence published to date. Method A literature search was carried out on MEDLINE, through PubMed, using the medical subject heading (MeSH) nephrotic syndrome. The search was limited to review papers, meta-analyses, clinical practice guidelines, and randomized controlled trials performed on pediatric populations up to September 2009. Results The treatment algorithm established in our hospital is consistent with the evidence available. Prednisone constitutes the first line treatment with evidence level Ia. When corticosteroids do not achieve remission, there are other therapeutic options that are not clearly positioned yet and further studies that provide more information on their comparative efficacy and safety are needed. These alternative therapeutic options are cyclosporine, mycophenolate mofetil, levamisol, cyclophosphamide and methylprednisolone, as independent strategies or as part of “Mendoza Protocol”, tacrolimus and rituximab. Their sequence of introduction in the therapeutic scheme of NS is classified as evidence level IV and grade D recommendation. Conclusion The wide range of options available for the pharmacotherapeutic management of NS and the lack of evidence about the comparative efficacy and safety of the different therapeutic strategies, make its positioning rather difficult. Therefore each hospital needs to draw up protocols based not only on the small amount of evidence available, but also on the authorized indications, availability of the drugs, clinical experience, associated costs, and patient preferences with regard to the duration of treatment, incidence and type of adverse effects. Development of new randomized controlled trials should be encouraged and setting up national plans for the treatment of this pathology might be a good approach for this problem.

Background Meeting chronic patient needs is essential to improve health outcomes. Purpose To design a pharmaceutical care plan for chronic paediatric patients using a risk stratification tool. Material and methods The care plan was developed in 4 steps from April to June 2014: 1. Literature review. 2.4 workshops were held with experts. The chronic conditions and the variables of each patient with their corresponding relative weights were defined, varying from 1(low) to 4(high risk) in ascending order of risk, and resulted in a risk matrix with increasing levels, which included the pharmaceutical care actions to be carried out in each level. 3. pre-test was developed and used in 195 patients from 7 hospitals. 4.5 case studies were performed. Results The care plan was applied to patients with different chronic conditions, classified into 15 groups (autoimmune, gastrointestinal, oncology, etc.). 13 variables divided into 3 categories were defined: demographic (age, obesity/malnutrition, social/cognitive problems); clinical (visits to the emergency room), comorbidities, clinical conditions that require special monitoring);and drug treatment (polypharmacy, complex patterns, changes in regular regimen, suspected non-adherence, suspicion/risk of medication-related problem, high-risk medicine). Afterwards, 4 risk levels were defined according to the total variable score: level 4, for patients with ≤17 points; level 3, 18 to 22 points; level 2, 23 to 26 points; and level 1, for ≥27 points. For each risk level 3 types of care actions were defined: pharmacotherapy monitoring, training/education to patient/parent/caregiver, and coordination activities with the care team. We evaluated the distribution of 195 real patients into the defined risk levels: 60% were scored into level 4, 20% into level 3, 13% into level 2 and 7 into level 1. This was considered an adequately stratified population distribution. Conclusion The pharmaceutical care plan adequately stratified chronic paediatric patients into different risk levels and can be used to prioritise those patients that will benefit more from our interventions. References and/or Acknowledgements We would like to thank Abbvie and Ascendo consulting for their logistic support. No conflict of interest.

Background Previous studies have reported an error rate between 11.7% and 49.0% in the medication process for hospitalised children. Off-label use and diluting medicines increase the risk of error in paediatric patients, in addition to developmental differences among children. Health care organisations are developing strategies in an attempt to reduce those errors, caused by many factors involving many people. Purpose To determine the overall incidence and incidence at different stages of medication errors (transcription, storage, preparation and administration stages) in a paediatric hemato-oncology ward. Materials and methods We conducted a descriptive observational study of drug administrations in a paediatric hemato-oncology ward of a large teaching tertiary hospital in Spain. Data were collected on 21 days, including weekends, between February and March of 2013 and they were analysed by SPSS statistical software. Medication errors were classified according with the updated classification of the Ruiz-Jarabo group (Otero et al ., 2008). The error rate was calculated considering the number of doses with one or more errors as numerator and total opportunities of error (TOE) as denominator. TOE is defined as the total number of doses given, whether correct or incorrect, plus omitted doses. Results 23 patients (52.2% female, 47.8% male, average age 6.0 [3.0–10.0] years old) were observed. Of 1116 doses administrated, 302 had at least one error, so error rate was 27.1% (95%, CI: 24,1%-30.3%) or 24.1% excluding wrong-time errors. Stages with higher error rates were preparation (43.8%) and storage (32.3%). Most common errors were related to photoprotection (66.7%), timing errors (15.8%) and incorrect preparation of suspensions (10.5%). Pharmacological groups with higher error rates were cardiovascular (100.0%), gastrointestinal (61.9%) and nervous system (49.3%). Conclusions The error rates we obtained were similar to those published before. Most common errors were related to failures in working protocols because medicines were never protected against light. No conflict of interest.

Background Ivabradine is authorised for the treatment of coronary artery disease and chronic heart failure with systolic dysfunction in adult patients, but there is little information on its efficacy and safety in children. Purpose To assess the use, efficacy and safety of ivabradine in paediatric patients. Materials and methods Observational study of the children treated with ivabradine in a university tertiary hospital. Patients’ clinical records were reviewed and the following data were collected: date of birth, sex, weight, diagnosis and concomitant conditions, treatment duration and ivabradine dosing. Heart rate was used to assess effectiveness. Treatment was considered effective if the heart rate decreased below 130 bpm. Safety was assessed by the occurrence of any adverse events described in the summary of product characteristics. Results Four children were treated with ivabradine in our institution, all of them for the indication of inappropriate sinus tachycardia as an off-label use. The median age at the start of treatment was 5.6 years (1.1–15.5). Three patients had undergone a heart transplant before treatment and the fourth started ivabradine before he had received a heart transplant. Median starting dose was 0.08 mg/kg/12 h (0.05–0.14). Median heart rate before treatment was 155 bpm (140–160). Ivabradine was effective for three patients, with a median of 110 bpm (110–128) after treatment, though one of them was considered a partial responder because the dose had to be doubled to maintain the desired heart rate. Treatment was ineffective for the remaining patient (median heart rate 147 bpm) and was discontinued. Overall, ivabradine was well tolerated. However, the dose had to be reduced to a half in one patient due to QT prolongation but was normalised after dose adjustment. Conclusions Ivabradine seemed to be an effective and safe treatment for inappropriate sinus tachycardia in most of our paediatric patients. Nonetheless, more studies are required to confirm these results. No conflict of interest.

Background Placing central venous access devices (CVADs) is essential in the management of critically ill children. Used for the administration of fluids, medicines, total parenteral nutrition or blood products they may, however, also cause thrombotic complications. Purpose To develop and implement a protocol for the prevention and treatment of catheter-related intraluminal thrombosis in a Paediatric Intensive Care Unit (PICU). Materials and Methods A computerised search was carried out on MEDLINE using the medical subject heading ‘central venous catheter’ associated with ‘occlusion’,’ ‘thrombosis’, ‘critically ill patients’ and ‘fibrinolytic’. The protocol development process was guided by the goal of weighing evidence regarding effectiveness, safety and cost. Algorithms were developed in order to reduce the complexity of the protocol, aid comprehension, and facilitate successful implementation. Results With the information gathered, a protocol was drawn up and those recommendations that best suit our environment were included. They were agreed upon by a broad panel of professionals working in the PICU and the Pharmacy Department. Facts to highlight: Prevention of intraluminal catheter thrombosis: Prevention of intraluminal CVAD thrombosis with continuous heparin infusion: To keep intravenous catheters patent for drug administration, haemodynamic monitoring and blood sampling. Prevention of intraluminal CVAD thrombosis with heparin lock solutions: To maintain catheters not being used for the administration of continuous infusion fluids. Prevention of intraluminal CVAD thrombosis with fibrinolytic lock solutions: If prior intraluminal thrombosis has occurred. The fibrinolytic agent used should be the same as that used for thrombosis resolution. Treatment of intraluminal CVAD thrombosis Normal saline : Flush with 5–10 mL. If after 3 attempts the problem is not solved, administration of fibrinolytic therapy is recommended. Urokinase at a concentration of 5,000 U/mL (first line). Alteplase at a concentration of 1 mg/mL (second line). Conclusions Due to the variety of options available for the pharmacotherapeutic management of intraluminal catheter thrombosis, one measure to improve the quality of the treatment and reduce the variability in prescriptions could be to implement a protocol as described. No conflict of interest.