Impacto de la implantación de la prescripción electrónica asistida en la seguridad del paciente pediátrico / Impact of introducing assisted electronic prescription on paediatric patient safety

OBJETIVO: El efecto de la implantación de la prescripción electrónica asistida en la seguridad de los pacientes pediátricos ha sido poco estudiado. El objetivo de este estudio es comparar los errores de medicación antes y después de su implantación en un hospital terciario. MATERIAL Y MÉTODOS: Estudio cuasiexperimental comparativo de los errores de medicación detectados antes y después de la implantación de la prescripción electrónica. Se analizaron todas las líneas de tratamiento y se recogió el punto de la cadena donde ocurrió el error, el tipo de error y su causa. Se realizó un estudio Delphi sobre la importancia de cada error en el que participaron médicos, enfermeros y farmacéuticos. RESULTADOS: Se incluyeron 166 pacientes (83 en cada etapa). Se detectó algún error en el 92% de los pacientes en la etapa preimplantacional (2,8 ± 2,1 errores/paciente) y en el 7,2% en la etapa postimplantacional (0,1 ± 0,4 errores/paciente). La prescripción electrónica asistida supuso una reducción absoluta del riesgo de error de un 40% (intervalo de confianza del 95% = 35,6-44,4%). Los lapsus/despistes fueron la principal causa de error en ambos grupos. En la etapa preimplantacional se consideraron graves el 9,5% de los errores, y en la etapa postimplantacional todos fueron leves o moderados. CONCLUSIONES: La implantación de la prescripción electrónica con sistemas de ayuda a la prescripción, validación y administración de medicamentos reduce de forma significativa los errores de medicación y elimina los errores graves

OBJECTIVE: There have been very few studies on the effect of assisted electronic prescription on paediatric patient safety. The objective of this study is to compare medication errors that occurred before and after its introduction in a tertiary hospital. MATERIAL AND METHODS: A quasi-experimental comparative study of medication errors detected before and after assisted electronic prescription introduction. All treatment lines were analysed in order to detect the point in the chain where the medication error occurred, as well as its type and cause. A Delphi study was conducted on the importance of each medication error involving doctors, nurses, and pharmacists. RESULTS: The study included 166 patients (83 at each stage). At least one medication error was detected in 92% in the pre-introduction phase patients (2.8 ± 2.1 errors/patient) and 7.2% of post-introduction phase patients (0.1 ± 0.4 errors/patient). The assisted electronic prescription led to an absolute risk reduction of 40% (95% confidence interval = 35.6-44.4%). The main cause of error was lapses and carelessness in both stages. Medication errors were considered serious in 9.5% of cases in the pre-introduction phase, while all of them were mild or moderate in the post-introduction phase. CONCLUSIONS: The assisted electronic prescription implementation with prescription, validation and medication administration assistance systems significantly reduces medication errors and eliminates serious errors

[Impact of introducing assisted electronic prescription on paediatric patient safety]. / Impacto de la implantación de la prescripción electrónica asistida en la seguridad del paciente pediátrico.

OBJECTIVE: There have been very few studies on the effect of assisted electronic prescription on paediatric patient safety. The objective of this study is to compare medication errors that occurred before and after its introduction in a tertiary hospital. MATERIAL AND METHODS: A quasi-experimental comparative study of medication errors detected before and after assisted electronic prescription introduction. All treatment lines were analysed in order to detect the point in the chain where the medication error occurred, as well as its type and cause. A Delphi study was conducted on the importance of each medication error involving doctors, nurses, and pharmacists. RESULTS: The study included 166 patients (83 at each stage). At least one medication error was detected in 92% in the pre-introduction phase patients (2.8±2.1 errors/patient) and 7.2% of post-introduction phase patients (0.1±0.4 errors/patient). The assisted electronic prescription led to an absolute risk reduction of 40% (95% confidence interval=35.6-44.4%). The main cause of error was lapses and carelessness in both stages. Medication errors were considered serious in 9.5% of cases in the pre-introduction phase, while all of them were mild or moderate in the post-introduction phase. CONCLUSIONS: The assisted electronic prescription implementation with prescription, validation and medication administration assistance systems significantly reduces medication errors and eliminates serious errors.

Uso de medicamentos en condiciones no aprobadas en cuidados intensivos neonatales / Use of off-label drugs in neonatal intensive care

Objetivo: Evaluar la prevalencia de prescripciones en condiciones no autorizadas (off-label y unlicensed) en una Unidad de Cuidados Intensivos Neonatales (UCIN) y definir qué características de los neonatos se asocian a un mayor uso de fármacos en estas condiciones. Material y métodos: Estudio observacional prospectivo en una UCIN nivel III-C durante un periodo de 6 meses. Se evaluó la condición de uso de cada fármaco, tomando como referencia su ficha técnica. Se utilizó un algoritmo secuencial para la clasificación de las prescripciones en: aprobadas, unlicensed u off-label (por edad, por indicación, por vía de administración, y por dosis). Resultados: Se incluyeron 84 pacientes y 564 prescripciones. Un total de 127 prescripciones fueron consideradas off-label y 45 unlicensed; lo cual supuso el 22,5% y el 8% del total, respectivamente. El 59,5% de los pacientes recibieron al menos un fármaco en una de estas condiciones, ascendiendo este porcentaje al 100% en los grandes prematuros y en los pacientes quirúrgicos (p < 0,001). Se encontró una correlación lineal positiva entre la estancia en UCIN y el número de prescripciones off-label (coeficiente de correlación 0,6 p < 0,001). Conclusiones: La prescripción de fármacos en condiciones no autorizadas es habitual en UCIN, siendo especialmente frecuente en los pacientes con mayor vulnerabilidad. Estos resultados ponen de manifiesto la necesidad de avanzar en la investigación y homogeneizar la información existente sobre los fármacos en neonatología, con el objetivo de realizar una prescripción eficaz y segura

Objective: To evaluate the prevalence of non-approved prescriptions (off-label and unlicensed) in a Neonatal Intensive Care Unit (NICU), and to describe factors of the neonate associated with its use. Materials and methods: Observational prospective study in a level III NICU during a 6-month period. Every prescription was analysed using the summary of product characteristics as a reference. A sequential algorithm was used to create a classification of prescriptions based on current status: approved, unlicensed, off-label (by age, route of administration, dosage, or indication). Results: The study included 84 patients and 564 prescriptions. A total of 127 (22.5%) prescriptions were considered off-label, and 45 (8%) were considered unlicensed. More than half (59.5%) of the patients received at least one of these drugs, and this increases to 100% among very preterm neonates and surgical patients (P < .001). A positive linear correlation was found between duration of NICU stay and the number of off-label prescriptions (correlation coefficient 0.6; P < .001). Conclusions: Non-licensed drugs are frequently prescribed in NICU, especially in the most vulnerable patients. Our results show the need to move forward on clinical research in order to homogenise the existing data about neonatology drugs, with the aim of making an efficient and safe prescription

[Use of off-label drugs in neonatal intensive care]. / Uso de medicamentos en condiciones no aprobadas en cuidados intensivos neonatales.

OBJECTIVE: To evaluate the prevalence of non-approved prescriptions (off-label and unlicensed) in a Neonatal Intensive Care Unit (NICU), and to describe factors of the neonate associated with its use. MATERIALS AND METHODS: Observational prospective study in a level III NICU during a 6-month period. Every prescription was analysed using the summary of product characteristics as a reference. A sequential algorithm was used to create a classification of prescriptions based on current status: approved, unlicensed, off-label (by age, route of administration, dosage, or indication). RESULTS: The study included 84 patients and 564 prescriptions. A total of 127 (22.5%) prescriptions were considered off-label, and 45 (8%) were considered unlicensed. More than half (59.5%) of the patients received at least one of these drugs, and this increases to 100% among very preterm neonates and surgical patients (P<.001). A positive linear correlation was found between duration of NICU stay and the number of off-label prescriptions (correlation coefficient 0.6; P<.001). CONCLUSIONS: Non-licensed drugs are frequently prescribed in NICU, especially in the most vulnerable patients. Our results show the need to move forward on clinical research in order to homogenise the existing data about neonatology drugs, with the aim of making an efficient and safe prescription.

Experience with levosimendan in 32 paediatric patients.

The aim of this study was to describe the off-label conditions of use for levosimendan in the paediatric population of a tertiary referral hospital. This is a retrospective observational study conducted between January 2007 and January 2014. Inclusion criteria were as follows: 100 % of paediatric patients who received intravenous perfusions of levosimendan during the study period. The following data were gathered: age, sex, diagnosis, dose administered, duration and date of the perfusion, number of perfusions per patient, previous inotropic and concomitant treatment, side effects and survival. A total of 32 patients were included in the study (56 % male). The mean age at the moment of administration was 4 months (range 2 days-15 years). During the study period, a total of 70 infusions were recorded. Fifteen of the 32 patients (46.9 %) received repeat doses, with a mean interval between doses of 8 days (range 3-37 days). The doses used were between 0.05 and 0.2 mcg/kg/min. Loading doses were not used in any cases. At the moment of receiving the infusion, all of the patients were receiving conventional treatment without any response, including inotropic support in 88 % of the cases. The administration of levosimendan was only suspended in one case due to the appearance of severe hypotension. In the rest of the administrations, it was well tolerated, without registering any severe side effect during the infusion process. Levosimendan proved to be a safe, effective strategy in our paediatric population. The good tolerance observed may be related to the absence of an initial bolus or loading dose.