ABSTRACT
Objetivo determinar la prevalencia de errores de conciliación (EC) al ingreso hospitalario en la población pediátrica onco-hematológica para comprobar si ésta presenta una susceptibilidad similar a la de los adultos para ser afectados por estos EC y describir las características de los pacientes en los que se producen.Métodoestudio prospectivo y multicéntrico de 12 meses de duración, de conciliación de medicación al ingreso en la población pediátrica onco-hematológica para evaluar la incidencia de EC y describir las características de los pacientes en los que se producen.Resultadosse concilió la medicación de 157 pacientes. En 96 pacientes se detectó al menos una discrepancia de la medicación. De las discrepancias detectadas, el 52,1% fueron justificadas por la nueva situación clínica del paciente o por el médico responsable mientras que el 48,9% se consideraron EC. El tipo de EC más frecuente fue la «omisión de algún medicamento», seguido por «una dosis, frecuencia o vía de administración diferente». Se efectuaron un total de 77 intervenciones farmacéuticas, de las que se aceptaron el 94,2%. En el grupo de pacientes con un número igual o mayor a 4 fármacos en tratamiento domiciliario se observó un incremento de 2,1 veces la probabilidad de experimentar un EC.Conclusionespara evitar o reducir los errores en uno de los puntos críticos de seguridad como son las transiciones asistenciales, existen medidas, como la conciliación de la medicación. En el caso de los pacientes pediátricos crónicos complejos, como los pacientes onco-hematológicos, el número de fármacos como parte del tratamiento domiciliario es la variable que se ha asociado a la presencia de EC al ingreso hospitalario, siendo la omisión de algún medicamento la causa principal de estos errores. (AU)
Objective To determine the prevalence of reconciliation errors (RE) on admission to hospital in the paediatric onco-haematological population in order to check whether they are similarly susceptible to these RE as adults and to describe the characteristics of the patients who suffer them.MethodsA 12-month prospective, multicentre study of medication reconciliation on admission in the paediatric onco-haematological population to assess the incidence of RE and describe the characteristics of the patients in whom they occur.ResultsMedication reconciliation was performed in 157 patients. At least 1 medication discrepancy was detected in 96 patients. Of the discrepancies detected, 52.1% were justified by the patient's new clinical situation or by the physician, while 48.9% were determined to be RE. The most frequent type of RE was the "omission of a medication", followed by "a different dose, frequency or route of administration". A total of 77 pharmaceutical interventions were carried out, 94.2% of which were accepted. In the group of patients with a number equal to or greater than 4 drugs in home treatment, there was a 2.1-fold increase in the probability of suffering a RE.ConclusionsIn order to avoid or reduce errors in one of the critical safety points such as transitions of care, there are measures such as medication reconciliation. In the case of complex chronic paediatric patients, such as onco-haematological patients, the number of drugs as part of home treatment is the variable that has been associated with the presence of medication RE on admission to hospital, with the omission of some medication being the main cause of these errors. (AU)
Subject(s)
Humans , Medication Reconciliation , Medication Errors , Pediatrics/instrumentation , Medical Oncology , Hematology , PrevalenceABSTRACT
INTRODUCTION: Medication reconciliation (MC) is one of the main strategies to reduce medication errors in care transitions. In Spain, several guidelines have been published with recommendations for the implementation and development of MC aimed at the adult population, although paediatric patients are not included. In 2018, a study was carried out that led to the subsequent publication of a document with criteria for selecting paediatric patients in whom CM should be prioritised. OBJECTIVES: To describe the characteristics of paediatric patients most likely to suffer from errors of reconciliation (EC), to confirm whether the results of a previous study can be extrapolated. METHODOLOGY: Prospective, multicentre study of paediatric inpatients. We analysed the CE detected during the performance of the CM on admission. The best possible pharmacotherapeutic history of the patient was obtained using different sources of information and confirmed by an interview with the patient/caregiver. RESULTS: 1043 discrepancies were detected, 544 were identified as CD, affecting 317 patients (43%). Omission of a drug was the most common error (51%). The majority of CD were associated with drugs in groups A (31%), N (23%) and R (11%) of the ATC classification. Polymedication and onco-haematological based disease were the risk factors associated with the presence of CD with statistical significance. CONCLUSIONS: The findings of this study allow prioritisation of CM in a specific group of paediatric patients, favouring the efficiency of the process. Onco-haematological patients and polymedication are confirmed as the main risk factors for the appearance of CD in the paediatric population.
Subject(s)
Medication Reconciliation , Patient Admission , Child , Humans , Medication Errors/prevention & control , Medication Reconciliation/methods , Prospective Studies , Risk FactorsABSTRACT
OBJECTIVE: To determine the prevalence of reconciliation errors on admission to hospital in the pediatric onco-hematological population in order to check whether they are similarly susceptible to these reconciliation errors as adults and to describe the characteristics of the patients who suffer them. METHODS: A 12-month prospective, multicentre study of medication reconciliation on admission in the pediatric onco-hematological population to assess the incidence of reconciliation errors and to describe the characteristics of the patients. RESULTS: Medication reconciliation was performed in 157 patients. At least a medication discrepancy was detected in 96 patients. Of the discrepancies detected, 52.1% were related to patient's new clinical situation or by the physician, while 48.9% were determined to be reconciliation errors. The most frequent type of reconciliation error was the "omission of a medication", followed by "a different dose, frequency or route of administration". A total of 77 pharmaceutical interventions were carried out, 94.2% of which were accepted. In the group of patients with a number equal to or greater than 4 drugs in home treatment, there was a 2.1-fold increase in the probability of suffering a reconciliation error. CONCLUSIONS: In order to avoid or reduce errors in one of the critical safety points such as transitions of care, there are measures such as medication reconciliation. In the case of complex chronic pediatric patients, such as onco-hematological patients, the number of drugs as part of home treatment is the variable that has been associated with the presence of medication reconciliation errors on admission to hospital, and the omission of some medication was the main cause of these errors.
Subject(s)
Medication Errors , Medication Reconciliation , Adult , Humans , Child , Prospective Studies , Medication Errors/prevention & control , Patient Admission , HospitalsABSTRACT
Objetivos: la seguridad de los medicamentos en pediatría supone un verdadero reto. Se dispone de escasos estudios que hayan analizado los errores de medicación en los pacientes pediátricos que acuden a los servicios de urgencias. El objetivo de este estudio ha sido caracterizar los errores detectados en estos pacientes, determinando su gravedad, los procesos afectados, los medicamentos implicados y los tipos de errores y causas asociados. Métodos: estudio multicéntrico observacional prospectivo realizado en los servicios de urgencias de 8 hospitales públicos españoles durante 4 meses. Los errores de medicación detectados por los pediatras de urgencias en pacientes entre 0 y 16 años fueron evaluados por un farmacéutico y un pediatra. Los errores de medicación fueron analizados utilizando la Taxonomía Española de Errores de Medicación actualizada. Resultados: en 99.797 visitas a urgencias se detectaron 218 (0,2%) errores de medicación, de los cuales 74 (33,9%) causaron daños (eventos adversos por medicamentos). Los preescolares fueron el grupo poblacional con mayor número de errores de medicación (126/218). Los errores se originaron mayoritariamente en la prescripción (66,1%), por automedicación (16,5%) y por administración equivocada por parte de los familiares (15,6%). Los tipos de errores más frecuentes fueron: «dosis incorrectas» (51,4%) y «medicamento inapropiado» (46,8%). Los antiinfecciosos (63,5%) fueron los fármacos más comúnmente implicados en los errores con daño. Las causas subyacentes asociadas a una mayor proporción de errores de medicación fueron: «falta de conocimiento del medicamento» (63,8%), «falta de seguimiento de los procedimientos» (48,6%) y «falta de información del paciente» (30,3%). Conclusiones: los errores de medicación en la población pediátrica que acude a urgencias se producen en la prescripción, por automedicación y en la administración, provocando daños a los pacientes en un tercio de las ocasiones. ...(AU)
Objectives: Medication safety represents an important challenge in children. There are limited studies on medication errors in pediatric patients visiting emergency departments. To help bridge this gap, we characterized the medication errors detected in these patients, determining their severity, the stages of the medication process in which they occurred, the drugs involved, and the types and causes associated with the errors. Methods: We conducted a multicenter prospective observational study in the pediatric emergency departments of 8 Spanish public hospitals over a 4-month period. Medication errors detected by emergency pediatricians in patients between 0 and 16 years of age were evaluated by a clinical pharmacist and a pediatrician. Each medication error was analyzed according to the updated Spanish Taxonomy of Medication Errors. Results: In 99,797 visits to pediatric emergency departments, 218 (0.2%) medication errors were detected, of which 74 (33.9%) resulted in harm (adverse drug events). Preschoolers were the age group with the most medication errors (126/218). Errors originated mainly in the prescribing stage (66.1%), and also by self-medication (16.5%) and due to wrong administration of the medication by family members (15.6%). Dosing errors (51.4%) and wrong/improper drugs (46.8%) were the most frequent error types. Anti-infective drugs (63.5%) were the most common drugs implicated in medication errors with harm. Underlying causes associated with a higher proportion of medication errors were medication knowledge deficit (63.8%), deviation from procedures/guidelines (48.6%) and lack of patient information (30.3%). Conclusions: Medication errors presented by children attending emergency departments arise from prescriptions, self-medication, and administration, and lead to patient harm in one third of cases. Developing effective interventions based on the types of errors and the underlying causes identified will improve patient safety. (AU)
Subject(s)
Humans , Infant, Newborn , Infant , Child, Preschool , Child , Adolescent , Medication Errors/adverse effects , Medication Errors/statistics & numerical data , Emergency Medical Services/statistics & numerical data , Patient Safety , Pediatrics , Spain , Multicenter Studies as Topic , Prospective StudiesABSTRACT
OBJECTIVE: To determine the prevalence of reconciliation errors (RE) on admission to hospital in the paediatric onco-haematological population in order to check whether they are similarly susceptible to these RE as adults and to describe the characteristics of the patients who suffer them. METHODS: A 12-month prospective, multicentre study of medication reconciliation on admission in the paediatric onco-haematological population to assess the incidence of RE and describe the characteristics of the patients in whom they occur. RESULTS: Medication reconciliation was performed in 157 patients. At least 1 medication discrepancy was detected in 96 patients. Of the discrepancies detected, 52.1% were justified by the patient's new clinical situation or by the physician, while 48.9% were determined to be RE. The most frequent type of RE was the "omission of a medication", followed by "a different dose, frequency or route of administration". A total of 77 pharmaceutical interventions were carried out, 94.2% of which were accepted. In the group of patients with a number equal to or greater than 4 drugs in home treatment, there was a 2.1-fold increase in the probability of suffering a RE. CONCLUSIONS: In order to avoid or reduce errors in one of the critical safety points such as transitions of care, there are measures such as medication reconciliation. In the case of complex chronic paediatric patients, such as onco-haematological patients, the number of drugs as part of home treatment is the variable that has been associated with the presence of medication RE on admission to hospital, with the omission of some medication being the main cause of these errors.
Subject(s)
Medication Errors , Medication Reconciliation , Child , Humans , Hospitals , Medication Errors/prevention & control , Patient Admission , Prospective StudiesABSTRACT
Objetivo: Determinar la incidencia, gravedad y evitabilidad de los incidentes por medicamentos detectados en los pacientes que acuden a losservicios de urgencias pediátricas, e identificar los grupos de edad demayor riesgo y los medicamentos implicados.Método: Estudio multicéntrico observacional prospectivo, realizadoentre marzo y junio de 2017, en pacientes entre 0 y 16 años que acudieron a los servicios de urgencias pediátricas de ocho hospitales públicosespañoles. Se recogieron tres tipos de incidentes: eventos adversos pormedicamentos, errores de medicación e intoxicaciones accidentales. Losincidentes se caracterizaron atendiendo a su gravedad, evitabilidad, grupos de edad afectados y medicamentos implicados.Resultados: Durante el periodo de estudio se registraron 99.797 visitasa los servicios de urgencias pediátricas y se recogieron 334 incidentes pormedicamentos en 334 pacientes, de los cuales el 52,4% fueron varones,con una media de edad de 47,1 ± 44,4 meses. La incidencia de pacientes con incidentes fue del 0,3%. Del total de incidentes, 264 (79%) fueronconsiderados prevenibles y 158 (47,3%) produjeron daño a los pacientes.Los incidentes detectados fueron 144 (43,1%) eventos adversos por medicamentos, 218 (65,2%) errores de medicación (74 de ellos errores con daño,que se incluyen asimismo como eventos adversos prevenibles) y 46 (13,7%)intoxicaciones accidentales. Los preescolares (edad: 1-5 años) presentaronel 60,8% de los incidentes, siendo también el grupo de edad con un mayorporcentaje de incidentes prevenibles (64%). Un total de 351 medicamentosestuvieron implicados en los incidentes y pertenecieron mayoritariamentea tres grupos terapéuticos: antiinfecciosos de uso sistémico (171; 48,7%),sistema nervioso (66; 18,8%) y sistema respiratorio (41; 11,7%). (AU)
Objective: To determine the incidence, severity, and preventabilityof medication-related incidents in patients visiting pediatric emergencydepartments, and to identify the highest-risk age groups and the drugsmost frequently involved.Method: This is a multicenter prospective observational study carriedout between March and June 2017 in patients between 0 and 16 yearsof age who visited the pediatric emergency department of eight Spanishpublic hospitals. We recorded and assessed three different types of incidents: adverse drug events, medication errors, and accidental self-poisoning. Incidents were characterized according to severity, preventability,age groups affected, and drugs involved.Results: During the study period, a total of 99,797 visits were recordedto the pediatric emergency departments following 334 drug-related incidents in as many patients, of whom 52.4% were male, with a mean age of47.1 ± 44.4 months. The incidence of patients with drug-related incidents was 0.3%. Of the total incidents, 264 (79%) were considered preventable and 158 (47.3%) had caused harm to patients. Incidents detectedincluded 144 (43.1%) adverse drug events, 218 (65.2%) medication errors(74 of them leading to harm; these are also included as preventable drugrelated adverse events), and 46 (13.7%) cases of accidental self-poisoning. Preschoolers (1-5 years of age) represented 60.8% of incidents andwere the age group with the highest percentage of preventable incidents(64%). A total of 351 drugs were involved in the 334 incidents detected,most of which fell into one of three therapeutic groups: anti-infectives forsystemic use (171; 48.7%), nervous system (66; 18.8%) and respiratorysystem (41; 11.7%). (AU)
Subject(s)
Humans , Child , Pharmaceutical Preparations , Emergencies , Pediatrics , IncidenceABSTRACT
Objetivo: Determinar la incidencia, gravedad y evitabilidad de los incidentes por medicamentos detectados en los pacientes que acuden a los servicios de urgencias pediátricas, e identificar los grupos de edad de mayor riesgo y los medicamentos implicados.Método: Estudio multicéntrico observacional prospectivo, realizado entre marzo y junio de 2017, en pacientes entre 0 y 16 años que acudieron a los servicios de urgencias pediátricas de ocho hospitales públicos españoles. Se recogieron tres tipos de incidentes: eventos adversos por medicamentos, errores de medicación e intoxicaciones accidentales. Los incidentes se caracterizaron atendiendo a su gravedad, evitabilidad, grupos de edad afectados y medicamentos implicados.Resultados: Durante el periodo de estudio se registraron 99.797 visitas a los servicios de urgencias pediátricas y se recogieron 334 incidentes por medicamentos en 334 pacientes, de los cuales el 52,4% fueron varones, con una media de edad de 47,1 ± 44,4 meses. La incidencia de pacientes con incidentes fue del 0,3%. Del total de incidentes, 264 (79%) fueron considerados prevenibles y 158 (47,3%) produjeron daño a los pacientes. Los incidentes detectados fueron 144 (43,1%) eventos adversos por medicamentos, 218 (65,2%) errores de medicación (74 de ellos errores con daño, que se incluyen asimismo como eventos adversos prevenibles) y 46 (13,7%) intoxicaciones accidentales. Los preescolares (edad: 1-5 años) presentaron el 60,8% de los incidentes, siendo también el grupo de edad con un mayor porcentaje de incidentes prevenibles (64%). Un total de 351 medicamentos estuvieron implicados en los incidentes y pertenecieron mayoritariamente a tres grupos terapéuticos: antiinfecciosos de uso sistémico (171; 48,7%), sistema nervioso (66; 18,8%) y sistema respiratorio (41; 11,7%).Conclusiones: La incidencia de incidentes por medicamentos en los pacientes pediátricos que acudieron a servicios de urgencias fue inferior a la referida en pacientes adultos, si bien prácticamente la mitad de los incidentes detectados causaron daños a los pacientes. Los niños preescolares (1-5 años) fueron identificados como el grupo de edad con mayor riesgo. Los incidentes registrados estuvieron causados por un número reducido de medicamentos. Un elevado porcentaje de los incidentes fueron prevenibles, lo que confirma la imperiosa necesidad de implementar medidas de prevención de incidentes en esta población.
Objetivo: Determinar la incidencia, gravedad y evitabilidad de los incidentes por medicamentos detectados en los pacientes que acuden a los servicios de urgencias pediátricas, e identificar los grupos de edad de mayor riesgo y los medicamentos implicados.Método: Estudio multicéntrico observacional prospectivo, realizado entre marzo y junio de 2017, en pacientes entre 0 y 16 años que acudieron a los servicios de urgencias pediátricas de ocho hospitales públicos españoles. Se recogieron tres tipos de incidentes: eventos adversos por medicamentos, errores de medicación e intoxicaciones accidentales. Los incidentes se caracterizaron atendiendo a su gravedad, evitabilidad, grupos de edad afectados y medicamentos implicados.Resultados: Durante el periodo de estudio se registraron 99.797 visitas a los servicios de urgencias pediátricas y se recogieron 334 incidentes por medicamentos en 334 pacientes, de los cuales el 52,4% fueron varones, con una media de edad de 47,1 ± 44,4 meses. La incidencia de pacientes con incidentes fue del 0,3%. Del total de incidentes, 264 (79%) fueron considerados prevenibles y 158 (47,3%) produjeron daño a los pacientes. Los incidentes detectados fueron 144 (43,1%) eventos adversos por medicamentos, 218 (65,2%) errores de medicación (74 de ellos errores con daño, que se incluyen asimismo como eventos adversos prevenibles) y 46 (13,7%) intoxicaciones accidentales. Los preescolares (edad: 1-5 años) presentaron el 60,8% de los incidentes, siendo también el grupo de edad con un mayor porcentaje de incidentes prevenibles (64%). Un total de 351 medicamentos estuvieron implicados en los incidentes y pertenecieron mayoritariamente a tres grupos terapéuticos: antiinfecciosos de uso sistémico (171; 48,7%), sistema nervioso (66; 18,8%) y sistema respiratorio (41; 11,7%).Conclusiones: La incidencia de incidentes por medicamentos en los pacientes pediátricos que acudieron a servicios de urgencias fue inferior a la referida en pacientes adultos, si bien prácticamente la mitad de los incidentes detectados causaron daños a los pacientes. Los niños preescolares (1-5 años) fueron identificados como el grupo de edad con mayor riesgo. Los incidentes registrados estuvieron causados por un número reducido de medicamentos. Un elevado porcentaje de los incidentes fueron prevenibles, lo que confirma la imperiosa necesidad de implementar medidas de prevención de incidentes en esta población.
ABSTRACT
BACKGROUND: Electroanatomical mapping systems (EMS) reduce fluoroscopy dose for the ablation. Higher costs and longer procedure times are the drawbacks associated with EMS. Our objective was to validate the efficiency of the EMS. OBJECTIVE: To demonstrate that using EMS is more efficient and as secure as the traditional system of ablation. METHODS: From April 2013 to June 2018, all patients were included into two groups, according to the intention of ablation with or without fluoroscopy. Right, left, supraventricular and ventricular ablation were included. We compared procedure variables (fluoroscopy, radiofrequency and procedure times, ablation results, complication rates and costs of the procedure) that included material and detrimental effect of fluoroscopy. RESULTS: A total of 105 were included in the fluoroscopy group and 287 in the without fluoroscopy group. We found an important reduction in time and radiation dose in all the ablation procedures studied, without increasing the procedure time. No differences in ablation results nor complications rate were found. We found lower costs in the flutter ablation without fluoroscopy, similar costs in the right focal tachycardia ablation group and higher costs in the without fluoroscopy group for the AVNRT and left accessory pathway. When detrimental effect of fluoroscopy was added, all procedures without fluoroscopy were significantly more efficient than the ones performed with it. CONCLUSIONS: Ablation without fluoroscopy is a technique as safe and effective as the conventional technique. Our study suggests that the radiation dose delivered to the patient and staff might be reduced, without increasing the total procedure time, being even more efficient.
Subject(s)
Catheter Ablation/methods , Electrophysiology/methods , Fluoroscopy/methods , Female , Humans , Male , Middle Aged , Treatment OutcomeABSTRACT
Ninguno de estos antimicrobianos son novedades terapéuticas, y ambos son ampliamente utilizados en Atención Primaria. Sin embargo el interés por cada uno de ellos es radicalmente distinto desde el punto de vista pediátrico. Por un lado, las quinolonas, usadas en exceso en la patología infecciosa en adultos y restringida en población infantil. Por otro, la combinación de amoxicilina con ácido clavulánico, con diferentes formulaciones, alguna de ellas prácticamente olvidada y denostada por los pediatras, es uno de los antibióticos de mayor uso en Pediatría. Viejos conocidos, de los que es posible se desconozcan ciertas características que merece la pena actualizar. La selección del agente adecuado, junto con la dosis, la pauta y la duración serán esenciales tanto para un adecuado tratamiento como para evitar resistencias bacterianas, así como el conocimiento de sus restricciones y posibles efectos adversos. Por lo tanto, profundizar en el conocimiento de estos fármacos potenciará uno de los elementos de la lucha frente al aumento de resistencias de los microorganismos. El objetivo final será fomentar el uso racional de estos fármacos antimicrobianos, siguiendo las indicaciones de guías y consensos actuales
Neither of these antimicrobials are innovations; both are widely spread therapeutic tools at primary health care. However, the interest for each of them is dramatically different from the pediatric point of view. On the one hand, the quinolones, overused in adults ́ infectious patologies and restricted for children. On the other hand, the combination of amoxicillin with clanulanic acid, using different formulations, some of which has been almost forgotten and disdained by peditricians, is one of the most useful antibiotics in pediatrics. Old acquaintances, whose characteristics are worth updating. The selection of the right agent, along with the dose, the pattern and the duration will be essential both for an adequate treatment and to avoid bacterial resistences, and also to know their restrictions and possible adverse effects. Therefore, to deepen in the knowledge of these drugs will boost one of the elements of the fight against the increase of microbial resistances. The final goal will be to encourage the use of this antimicrobials, following the indications of guidelines and actual consensus
Subject(s)
Humans , Child , Drug Resistance, Microbial , Anti-Bacterial Agents/therapeutic use , Communicable Diseases/drug therapy , Amoxicillin-Potassium Clavulanate Combination/therapeutic use , Amoxicillin/therapeutic use , Clavulanic Acid/therapeutic use , Quinolones/therapeutic use , Anti-Bacterial Agents/adverse effects , Primary Health Care , Drug Prescriptions/statistics & numerical dataABSTRACT
No disponible
Subject(s)
Humans , Electrocardiography , Atrial Premature Complexes/diagnosis , Atrioventricular Block/diagnosis , Diagnosis, DifferentialABSTRACT
No disponible
Subject(s)
Humans , Middle Aged , Bradycardia/etiology , Sick Sinus Syndrome/diagnosis , Atrial Fibrillation/complications , ElectrocardiographyABSTRACT
Objective: To describe off-label and unlicensed drugs in clinical practice in a Neonatal Intensive Care Unit (NICU). Method: The design of the study was a descriptive and retrospective three months research in a NICU of a Spanish University Hospital. All prescriptions were classified as approved, off-label and unlicensed drug used, according to the information available on the Summary of Product Characteristics. Off-label drugs prescriptions were divided into four groups (dose, frecuency, age and indication of use) depending on the reason of disconformity. Results: Forty-one neonates were included (46.3% premature patients) and a total of 273 drug prescriptions were evaluated. Of them, 53.1% (145) were classified as an approved drug prescriptions, 41.4% (113) were off-label use and 5.5% (15) were unlicensed drugs. 90.2% of the patients (37/41) received at least one off label prescription, with a median of 3 (range 1-7). Age was the foremost reason for off-label use (42.5%), followed by dose (31.0%), frecuency (16.8%) and dose-frecuency off-label drug use (8.8%). The last place was reserved for off-label drug use by indication (0.9%). Group J (corresponding with antiinfectives for systemic use) was the most frecuently prescribed, with ampicillin (18.6%) and gentamicin (16.8%) as the drugs most commonly use as off-label prescriptions. Finally, caffeine citrate was the unlicensed drug most frecuently prescribed. Conclusion: Off-label and unlicensed drug use prescriptions in our NICU clinical practice are highly frecuent as other authors have previously published in other countries where they were studied. Although there are few studies in newborn patients, both off-label and unlicensed drug prescriptions are commonly recomended in Paediatrics Guidelines (AU)
Objetivo: Describir la utilización de medicamentos fuera de ficha técnica (FFT) y sin licencia en una Unidad de Cuidados Intensivos Neonatales (UCIN). Método: Estudio descriptivo y retrospectivo realizado durante tres meses en la UCIN de un hospital público español. Las prescripciones se clasificaron según la ficha técnica oficial en tres grupos: dentro de ficha técnica, FFT y sin licencia. Las prescripciones FFT se clasificaron según la razón por la que no se ajustaban a ella en cuatro grupos: dosis, frecuencia, edad e indicación. Resultados: Se incluyeron 41 neonatos (46,3% prematuros) y 273 prescripciones. De ellas, el 53,1% (145) se prescribieron según ficha técnica, el 41,4% (113) FFT y el 5,5% (15) sin licencia. El 90,2% de los pacientes (37/41) recibieron al menos un tratamiento FFT, con una media de 3 (rango 1-7). En el 42,5% de los casos la razón por la cual se consideró al fármaco FFT fue la edad, en el 31,0% la dosis, en el 16,8% la frecuencia, en el 8,8% la dosis y la frecuencia y en el 0,9% la indicación. El grupo terapéutico prescrito con más frecuencia fue el J (antiinfecciosos para uso sistémico), con ampicilina (18,6%) y gentamicina (16,8%) como fármacos más prescritos FFT. El fármaco sin licencia con mayor número de prescripciones fue la cafeína citrato. Conclusiones: En nuestra UCIN la utilización de fármacos FFT y sin licencia es muy habitual y similar a la de otros países. La mayoría de las prescripciones analizadas no disponen de estudios específicos en neonatos, aunque sí está ampliamente recomendado su uso en las guías de práctica clínica pediátricas (AU)
Subject(s)
Humans , Infant, Newborn , Intensive Care, Neonatal/methods , Drug Approval , Drug Utilization/statistics & numerical data , Off-Label Use/statistics & numerical data , Intensive Care Units, Neonatal/trends , Compassionate Use Trials , Retrospective Studies , Pharmaceutical Services/methodsABSTRACT
Objetive: To describe off-label and unlicensed drugs in clinical practice in a Neonatal Intensive Care Unit (NICU). METHOD: The design of the study was a descriptive and retrospective three months research in a NICU of a Spanish University Hospital. All prescriptions were classified as approved, off-label and unlicensed drug used, according to the information available on the Summary of Product Characteristics. Off-label drugs prescriptions were divided into four groups (dose, frecuency, age and indication of use) depending on the reason of disconformity. RESULTS: Forty-one neonates were included (46.3% premature patients) and a total of 273 drug prescriptions were evaluated. Of them, 53.1% (145) were classified as an approved drug prescriptions, 41.4% (113) were off-label use and 5.5% (15) were unlicensed drugs. 90.2% of the patients (37/41) received at least one off label prescription, with a median of 3 (range 1-7). Age was the foremost reason for off-label use (42.5%), followed by dose (31.0%), frecuency (16.8%) and dose-frecuency off-label drug use (8.8%). The last place was reserved for off-label drug use by indication (0.9%). Group J (corresponding with antiinfectives for systemic use) was the most frecuently prescribed, with ampicillin (18.6%) and gentamicin (16.8%) as the drugs most commonly use as off-label prescriptions. Finally, caffeine citrate was the unlicensed drug most frecuently prescribed. CONCLUSION: Off-label and unlicensed drug use prescriptions in our NICU clinical practice are highly frecuent as other authors have previously published in other countries where they were studied. Although there are few studies in newborn patients, both off-label and unlicensed drug prescriptions are commonly recomended in Paediatrics Guidelines.
Objetivo: Describir la utilización de medicamentos fuera de ficha técnica (FFT) y sin licencia en una Unidad de Cuidados Intensivos Neonatales (UCIN).Método: Estudio descriptivo y retrospectivo realizado durante tres meses en la UCIN de un hospital público español. Las prescripciones se clasificaron según la ficha técnica oficial en tres grupos: dentro de ficha técnica, FFT y sin licencia. Las prescripciones FFT se clasificaron según la razón por la que no se ajustaban a ella en cuatro grupos: dosis, frecuencia, edad e indicación.Resultados: Se incluyeron 41 neonatos (46,3% prematuros) y 273 prescripciones. De ellas, el 53,1% (145) se prescribieron según ficha técnica, el 41,4% (113) FFT y el 5,5% (15) sin licencia. El 90,2% de los pacientes (37/41) recibieron al menos un tratamiento FFT, con una media de 3 (rango 1-7). En el 42,5% de los casos la razón por la cual se consideró al fármaco FFT fue la edad, en el 31,0% la dosis, en el 16,8% la frecuencia, en el 8,8% la dosis y la frecuencia y en el 0,9% la indicación. El grupo terapéutico prescrito con más frecuencia fue el J (antiinfecciosos para uso sistémico), con ampicilina (18,6%) y gentamicina (16,8%) como fármacos más prescritos FFT. El fármaco sin licencia con mayor número de prescripciones fue la cafeína citrato.Conclusiones: En nuestra UCIN la utilización de fármacos FFT y sin licencia es muy habitual y similar a la de otros países. La mayoría de las prescripciones analizadas no disponen de estudios específicos en neonatos, aunque sí está ampliamente recomendado su uso en las guías de práctica clínica pediátricas.
Subject(s)
Intensive Care Units, Neonatal/statistics & numerical data , Off-Label Use/statistics & numerical data , Female , Humans , Infant, Newborn , Intensive Care, Neonatal , Male , Retrospective Studies , Spain , Tertiary Care CentersABSTRACT
We present the case of a patient with syncope with repetition over 12 years, with a clinical profile not clearly related with a cardiogenic origin, who was studied by several medical specialties without any accurate diagnosis. After subcutaneous loop recorder implantation, we were able to demonstrate how seizures acted as a trigger in the genesis of an exaggerated cardio inhibitory reflex. A new entity has been described, known as "ictal asystole", in patients with focal epilepsy mostly from the temporal lobes and has been implicated as a cardiac cause of sudden unexplained death in epilepsy. We think this case could add new information about some patients who are at high risk of death but they are misdiagnosed.
ABSTRACT
BACKGROUND AND OBJECTIVE: To determine the incidence of adverse drug events (ADE) in hospitalized patients, identify those that were potentially preventable, and asses the drug classes involved, the clinical symptoms and the type of medication errors that led to the preventable ADE. PATIENTS AND METHOD: An observational study of ADE prevalence in hospitalized patients in internal medicine, pneumology, gastroenterology, nephrology and neurology wards, over a six-month period, at a tertiary university hospital. ADE were prospectively detected through physician and nurses reporting fostered by daily visits of a clinical research and retrospectively through review of medical records using event codes as defined by the IDC-9-CM system. RESULTS: In a total of 2,643 hospitalized patients, 191 (7.2%) ADE were detected. Of these, 38 cases (19.9%) were classified as preventable, of which 21.1% were mild; 60.5% moderate and 18.4% serious or life-threatening. Preventable ADE were frequently associated with anti-infective drugs (22.9%), diuretics (18.8%) and digoxin (16.7%). Inadequate therapy monitoring (28.3%), excessive dosage (21.7%), selection of an inappropriate drug according to patient characteristics and/or to diagnosis (15.0%), lack of prescription of a necessary drug (15.0%) and drug-drug interactions (11.7%) were the most common identified type of errors leading to preventable ADE. CONCLUSIONS: 1.4% of hospitalized patients in medical wards experienced potentially preventable ADE. Healthcare professionals and administrators must be made aware of the scope of this problem so that they will implement effective safety practices directed to reduce the incidence of medication errors, particularly prescription and monitoring errors.
Subject(s)
Drug-Related Side Effects and Adverse Reactions , Hospitalization/statistics & numerical data , Medication Errors , Humans , Medication Errors/statistics & numerical dataABSTRACT
Fundamento y objetivo: Determinar la incidencia de acontecimientos adversos causados por medicamentos (AAM) en pacientes hospitalizados, diferenciando los potencialmente prevenibles, y describir los medicamentos implicados, las manifestaciones clínicas y los tipos de errores de medicación asociados a los AAM prevenibles. Pacientes y método: Estudio observacional de 6 meses de duración que incluyó a los pacientes hospitalizados en los servicios de Medicina Interna, Neumología, Gastroenterología, Nefrología y Neurología de un hospital universitario. Los AAM se detectaron prospectivamente mediante comunicación fomentada y retrospectivamente mediante revisión de diagnósticos al alta utilizando códigos CIE-9. Resultados: Se detectaron AAM en 191 (7,2%) pacientes de los 2.643 que estuvieron ingresados en ese período. De estos casos, 38 (19,9%) se clasificaron como prevenibles; en el 21,1% fueron leves, en el 60,5%, moderados y en el 18,4%, graves o potencialmente mortales. Los medicamentos asociados con mayor frecuencia a los AAM prevenibles fueron antiinfecciosos (22,9%), diuréticos (18,8%) y digoxina (16,7%). Los principales tipos de errores que causaron los AAM prevenibles fueron la falta de seguimiento analítico o clínico del tratamiento (28,3%), la prescripción de dosis elevadas (21,7%), la prescripción de un medicamento inapropiado (15,0%) o la falta de prescripción de un medicamento necesario (15,0%) y las interacciones medicamentosas (11,7%). Conclusiones: Un 1,4% de los pacientes hospitalizados en unidades médicas presentó AAM potencialmente prevenibles. Es preciso concienciar a los profesionales y a las autoridades sanitarias de la trascendencia de este problema e implantar en los hospitales prácticas de seguridad efectivas para reducir los errores de medicación, especialmente los errores de prescripción y de seguimiento
Background and objective: To determine the incidence of adverse drug events (ADE) in hospitalized patients, identify those that were potentially preventable, and asses the drug classes involved, the clinical symptoms and the type of medication errors that led to the preventable ADE. Patients and method: An observational study of ADE prevalence in hospitalized patients in internal medicine, pneumology, gastroenterology, nephrology and neurology wards, over a six-month period, at a tertiary university hospital. ADE were prospectively detected through physician and nurses reporting fostered by daily visits of a clinical research and retrospectively through review of medical records using event codes as defined by the IDC-9-CM system. Results: In a total of 2,643 hospitalized patients, 191 (7.2%) ADE were detected. Of these, 38 cases (19.9%) were classified as preventable, of which 21.1% were mild; 60.5% moderate and 18.4% serious or life-threatening. Preventable ADE were frequently associated with anti-infective drugs (22.9%), diuretics (18.8%) and digoxin (16.7%). Inadequate therapy monitoring (28.3%), excessive dosage (21.7%), selection of an inappropriate drug according to patient characteristics and/or to diagnosis (15.0%), lack of prescription of a necessary drug (15.0%) and drug-drug interactions (11.7%) were the most common identified type of errors leading to preventable ADE. Conclusions: 1.4% of hospitalized patients in medical wards experienced potentially preventable ADE. Healthcare professionals and administrators must be made aware of the scope of this problem so that they will implement effective safety practices directed to reduce the incidence of medication errors, particularly prescription and monitoring errors
