Impact of pharmaceutical validation on prescribing errors in a neonatal intensive care unit. Randomised and controlled study.

Purpose: To compare the frequency of electronic prescription errors when the prescription was validated by the clinical pharmacist vs. when it was not. Methods: This prospective randomised controlled study was conducted in three phases. A randomised phase, in which patients were divided into control and intervention groups, and a pre- and post-intervention phase were consecutively performed to analyse the impact of pharmaceutical validation of prescriptions in a neonatal intensive care unit (NICU). This study was performed at a highly complex NICU at a tertiary hospital. All patients born during the study period who were admitted to the NICU, with a stay lasting ≥24 h, and received active pharmacological treatment were included in the study. Pharmaceutical validation was performed according to the paediatric pharmaceutical care model. A high level of validation was selected for this study. In the intervention group, discrepancies found during the review process were communicated to the medical team responsible for the patients and resolved on the same day. Results: In total, 240 patients were included in this study. Sixty-two patients were allocated to the pre-intervention (n = 38) or post-intervention (n = 24) groups, and 178 patients were randomly sorted into two groups, control (n = 82 newborns) and intervention (n = 96 newborns). During the randomisation phase, the number of prescription errors detected was significantly lower in the intervention group than that in the control group (129 vs. 270; p < 0.001). Similarly, prescription errors reaching the patient were significantly reduced from 40% (n = 108) in the control group to 1.6% (n = 2) in the intervention group. In the pre- and post-intervention periods, the prescription lines containing prescription errors decreased from 3.4% to 1.5% (p = 0.005). Conclusions: This study showed that the pharmaceutical validation process decreased both the number of errors in the electronic prescribing tools and the number of prescription errors reaching the patient.

[Incidence of intravenous colistin nephrotoxicity in hospitalized patients]. / Incidencia de nefrotoxicidad inducida por colistina intravenosa en pacientes hospitalizados.

OBJECTIVE: The increase in infections with multidrug resistant bacteria has forced to return to the use of colistin, antibiotic with known nephrotoxicity. The aim of the study is to determine the incidence of colistin nephrotoxicity nowadays. METHODS: Retrospective-observational-unicentric study was collected hospitalized patients in intravenous colistin treatment during the years 2018-2019. Nephrotoxicity was defined according to the RIFLE scale. The variables to determine it were serum creatinine (sCr) and glomerular filtration (GF). The variables analyzed were age, sex, treatment duration, loading and cumulative dose, empirical/targeted treatment, chronic kidney disease, concomitant use of intravenous contrast and nephrotoxic drugs. RESULTS: A total of 90 patients (60% men) were included, with an average age of 58.2±18.1 years. The mean duration of treatment was 9±8.3 days, with an average cumulative dose of 69.8±71MU. There were no differences between sCr and GF at the beginning and end of treatment. The incidence of nephrotoxicity was 1.73 cases/100 days of treatment (prevalence of 15.56%). CONCLUSIONS: Colistin nephrotoxicity has an important incidence, without developing severe illness.

[Implementation of the Lean Six Sigma in the improvement of the medication dispensing circuit]. / Implementación Lean Six Sigma en la mejora del circuito de dispensación de medicación.

OBJECTIVE: Lean Six Sigma (LSS) methodology is used to increase productivity and to improve performance, by eliminating processes that do not add value to the customer, as well as reducing variability. In recent years, its application in healthcare sector is increasing in order to improve the efficiency of processes. The aim of this study was to evaluate the results obtained in terms of efficiency in the medication dispensing circuit, after application of LSS methodology. MATERIAL AND METHODS: A multidisciplinary team was created in order to analyse and improve the medication dispensing circuit. The main tools used in LSS methodology were the DMAIC cycle (Define, Measure, Analyse, Improve and Control), SIPOC diagram (Suppliers, Inputs, Process, Outputs, and Customers), a root-cause analysis; a survey to determine the "Customer's voice" about the circuit; and the cost of each task in terms of staff time. Two Pilot Nursing Units (Thoracic Surgery and Cardiology) were selected to introduce the improvement actions. The main analysed variables were: urgent medication orders per day, and percentage of medication orders made online. RESULTS: After the application of LSS methodology, a significant reduction was found in urgent medicament orders per day in both nursing units, and a significant improvement in the electronic processing of urgent orders. The performance of medication dispensing circuit was increased from 60% (1.76 sigma) during initial data analysis, to 93% (3 sigma) in Thoracic Surgery, and from 71% (2.11 sigma) to 81% (2.4 sigma) in Cardiology. Six months after the implementation of improvements, the performance values were increased to 94% (3.1 sigma) and 93% (3 sigma), respectively. Estimated cost savings related to staff were 798.2 € (266 € per month) after implementation, ascending to 2, 228.5 € (371.4 € per month) after 6months. CONCLUSION: The use of LSS methodology has improved the performance of medication dispensing circuits, reducing costs in terms of staff time, and obtaining satisfactory results.

[Impact of a quality improvement plan on the validation of drug prescriptions on the safety of the hospitalised patient]. / Impacto de un plan de mejora de calidad en la validación de la prescripción de fármacos sobre la seguridad de los pacientes hospitalizados.

BACKGROUND AND OBJECTIVES: Medication errors are the most common adverse events in healthcare. Pharmaceutical validation (PV) seeks to reduce them. The aims of this study were to assess the impact of the introduction of an automated tool for the validation (VPAT) of the high clinical relevance drugs prescription (HCRD) over time of pharmaceutical intervention (PI), and to quantify the number of medication errors detected before and after its implementation. MATERIAL AND METHODS: A two phase retrospective-observational single centre study was designed. A pre-intervention phase (Pre-P): PV of beds with Unit Dose Dispensing (October 2015 - February 2016), was followed by a post-intervention phase (Post-P): PV using a VPAT of HCRD in hospital patients (October 2016 - February 2017). HCRD were selected from the list of high-risk drugs of Institute for Safe Medication Practices. The data was obtained from the PI record (Access®) and the computerised prescription. The variables collected were: age and gender of the patients included, data of drugs prescription, and time to PI. RESULTS: A total of 477 PI were analysed in 404 patients, with a mean age of 65.9±19.5 years (53.22% women). The mean time up to PI was 25.6±24.72h in the Pre-P, and 18.87±20.44h in the Post-P (P=0.01). In Pre-P, 106 PI were performed (35.85% prevention of adverse reactions) compared to 371 PI (39.62% medication reconciliation) in Post-P. CONCLUSIONS: The VPAT enabled a greater number of medication errors to be detected and intervened in hospitalised patients, with a significantly reduced time to PI.

[Usage, effectiveness and safety of abiraterone in prostate cancer]. / Uso, efectividad y seguridad de abiraterona en cáncer de próstata.

BACKGROUND AND OBJECTIVE: After the marketing of Abiraterone, an androgen synthesis inhibitor, the aim of the study was to analyze its use, response, and safety in the population of a tertiary care level hospital. MATERIALS AND METHODS: A retrospective observational study was carried out including all patients that were started on Abiraterone within a 21-month period. Demographical, diagnostic, therapeutic, and clinical variables were gathered. The response was assessed through the decreased of PSA as compared to baseline values. To assess the safety, all treatment-related adverse events were recorded. RESULTS: A total of 45 patients were included of which 88.89% could be assessed for the drug effectiveness. The median baseline PSA value was 457.31 (range 9032-2.81). PSA decrease was ≥ 50%, ≥ 90% and < 30% in 16 (40%), 3 (7.5%) y 20 (50%), respectively. The most common grade 1-2 adverse events were fatigue (35.6%), increased liver enzymes (28.9%), hipokalemia (13.3%) and fluid retention (11.1%). CONCLUSIONS: Abiraterone was a well tolerated drug that has shown to be active in prostate cancer patients previously treated with taxans, so it has been postulated as an alternative in this pathology.

Fundamento y objetivo: Tras la comercialización de abiraterona, inhibidor de la síntesis de andrógenos, el objetivo del estudio fue analizar el uso, la respuesta y la seguridad de abiraterona en la población de un hospital de tercer nivel. Material y métodos: Se realizó un estudio observacional retrospectivo en el que se incluyeron todos los pacientes que iniciaron tratamiento con abiraterona en un periodo de 21 meses. Se recogieron variables demográficas, diagnósticas, terapéuticas y clínicas. La respuesta se evaluó de acuerdo con la reducción del PSA con respecto al basal. Para evaluar la seguridad se registraron todas las reacciones adversas secundarias al tratamiento. Resultados: Se incluyó un total de 45 pacientes de los que, fueron evaluables con respecto a la efectividad del fármaco el 88,89%. La mediana de PSA basal era de 457,31 (rango 9032- 2,81). La reducción de PSA fue ≥50%, ≥90% y.