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.

Comparison of the traditional pharmaceutical validation method versus an assisted pharmaceutical validation in hospitalized patients.

OBJECTIVE: To analyze pharmaceutical interventions that have been carried out with the support of an automated system for validation of treatments vs. the traditional method without computer support. METHOD: The automated program, ALTOMEDICAMENTOS® version 0, has 925 052 data with information regarding approximately 20 000 medicines, analyzing doses, administration routes, number of days with such a treatment, dosing in renal and liver failure, interactions control, similar drugs, and enteral medicines. During eight days, in four different hospitals (high complexity with over 1 000 beds, 400-bed intermediate, geriatric and monographic), the same patients and treatments were analyzed using both systems. RESULTS: 3,490 patients were analyzed, with 42 155 different treatments. 238 interventions were performed using the traditional system (interventions 0.56% / possible interventions) vs. 580 (1.38%) with the automated one. Very significant pharmaceutical interventions were 0.14% vs. 0.46%; significant was 0.38% vs. 0.90%; non-significant was 0.05% vs. 0.01%, respectively. If both systems are simultaneously used, interventions are performed in 1.85% vs. 0.56% with just the traditional system. Using only the traditional model, 30.5% of the possible interventions are detected, whereas without manual review and only the automated one, 84% of the possible interventions are detected. CONCLUSIONS: The automated system increases pharmaceutical interventions between 2.43 to 3.64 times. According to the results of this study the traditional validation system needs to be revised relying on automated systems. The automated program works correctly in different hospitals.

Objetivo: Analizar las intervenciones farmacéuticas realizadas con el apoyo de un sistema automático de validación de tratamientos vs. el método tradicional sin apoyo informático. Metodos: El programa automatizado, ALTOMEDICAMENTOS ® version 0, cuenta con 925.052 celdas con información de aproximadamente 20.000 medicamentos, analizando dosis, vías de administración, días de tratamiento, dosificación en insuficiencia renal y hepática, control de interacciones, de medicamentos semejantes y de medicamentos por vía enteral. Durante ocho días distribuidos en cuatro hospitales diferentes (alta complejidad con más de 1.000 camas, intermedio de 400 camas, geriátrico y monográfico), los mismos pacientes y tratamientos se analizaron mediante los dos sistemas. Resultados: Se han analizado 3.490 pacientes diferentes con 42.155 tratamientos. Por el sistema tradicional se han realizado 238 intervenciones (0,56% intervenciones/posibles intervenciones) vs. 580 (1,38%) con el automatizado. Las intervenciones farmacéuticas muy significativas fueron 0,14 vs. 0,46%, las significativas 0,38 vs. 0,90%, las no significativas 0,05 vs. 0,01%. Las intervenciones fueron del 1,85% al utilizar los dos sistemas vs. 0.56% usando solo el sistema tradicional. El sistema tradicional detectó el 30,5% de las posibles intervenciones, sin embargo con el sistema automático se detectaron el 84% de dichas intervenciones. Conclusiones: La automatización multiplica entre 2,43 a 3,64 veces las intervenciones farmacéuticas. En base a los resultados de este estudio el sistema tradicional de validación debería ser modificado, apoyándose en sistemas automatizados. El programa automático funciona en diferentes hospitales.

[Treatment with urea as an alternative to tolvaptan for the syndrome of inappropriate secretion of antidiuretic hormone]. / Tratamiento con urea como alternativa al tolvaptán en el síndrome de secreción inadecuada de la hormona antidiurética.

El síndrome de secreción inadecuada de la hormona antidiurética (SIADH) es una afectación que cursa con hiponatremia entre otros síntomas. Actualmente la familia de fármacos de elección para este síndrome son los vaptanes, entre ellos el tolvaptán, antagonistas de la vasopresina. La urea actúa como diurético osmótico produciendo la retención de sodio. Se presenta un caso en el que el cambio desde el tratamiento con tolvaptán a urea en el SIADH permitió mantener la respuesta, a un coste muy inferior. La paciente tenía 83 años, ingresó en nuestro Hospital al diagnosticarle una hiponatremia grave (108 mEq/L) durante una exploración por una caída en su casa. Durante el ingreso ante la sospecha de SIADH se le prescribió sucesivamente tres tipos de tratamientos: Restricción hídrica y suero salino, seguido de tolvaptán 15 mg y para finalizar se le prescribió 15 gr de urea cada 12 horas. Durante el primer tratamiento los niveles de sodio sérico no aumentaron lo suficiente, por lo que se cambió al tolvaptán, durante el cual los niveles de sodio sérico subieron a rangos normales. Al considerar que el tratamiento iba a ser de larga duración se decidió cambiar a la urea, durante el mismo los niveles de sodio sérico tuvo un ligero aumento. La paciente es dada de alta con la pauta de urea de forma indefinida. El coste diario del tratamiento de tolvaptán es de 66,91 euros; el de urea supone 0,30 euros. En casos como el descrito, el uso de urea preparada como fórmula magistral por el área de farmacotécnia del Servicio de Farmacia, es una alternativa al tolvaptán con un coste marcadamente inferior.

[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.

[Lapatinib plus transtuzumab for HER-2 positiva metastatic breast cancer: experience of use]. / Lapatinib en combinación con trastuzumab en el tratamiento del cáncer de mama metastásico HER2 positivo: Experiencia de uso.

OBJECTIVE: To describe the outcomes produced by concomitant use of HER2-receptor inhibitors Lapatinib and Trastuzumab for the treatment of HER 2-positive metastatic breast cancer. METHOD: Retrospective observational study. Patients treated with Trastuzumab and Lapatinib between January of 2010 and May of 2012 were selected. Demographical and clinical data were gathered. RESULTS: 23 patients with metastatic breast cancer (mean age 59.3 ± 13.3 years) were included. All of them had received an average of 5 treatment lines with at least one of them including Trastuzumab. The median progression-free survival rate with combined Lapatinib + Trastuzumab, with or without associated chemotherapy was 7 months (95% CI: 2.78-11.21) and 3 months for the patients only receiving Lapatinib and Trastuzumab. Seven patients experienced adverse events and in four patients the treatment was stopped due to toxicity. CONCLUSIONS: The treatment with HER2-receptor inhibitors in our patients resulted in progression-free survival rates similar to those published in clinical trials with patients receiving Lapatinib + Trastuzumab not combined with any other anti-cancer therapy, with good treatment tolerability.

Objetivo: Describir los resultados obtenidos con la utilización conjunta de dos inhibidores del receptor HER2 (lapatinib y trastuzumab) en el tratamiento del cáncer de mama metastático HER 2 positivo. Método: Estudio observacional retrospectivo. Se seleccionaron pacientes en tratamiento con trastuzumab y lapatinib entre enero de 2010 y mayo de 2012. Se recogieron datos demográficos y clínicos. Resultados: Se incluyeron 23 pacientes con cáncer de mama metastático (edad media de 59,3 ± 13,3 años). Todos ellos habían recibido una media de 5 líneas de tratamiento previo con al menos una línea de tratamiento con trastuzumab. La mediana de supervivencia libre de progresión con lapatinib + trastuzumab combinado con o sin otra quimioterapia asociada fue de 7 meses (IC 95%: 2,78-11,21) y de 3 meses para las pacientes que sólo recibieron lapatinib y trastuzumab. Siete pacientes tuvieron efectos adversos y en cuatro pacientes se suspendió el tratamiento por toxicidad. Conclusiones: El tratamiento con dos inhibidores del receptor HER2 en nuestras pacientes ha resultado en una supervivencia libre de progresión similar a la de los ensayos clínicos publicados cuando las pacientes recibieron lapatinib + trastuzumab y no se combinó con otra terapia antineoplásica, con buena tolerancia al tratamiento.

[Satisfaction perceived by outpatients and pharmacy auxiliaries in a Hospital Pharmacy Department, as a method of improving quality]. / Satisfacción percibida por los pacientes y por el personal auxiliar de farmacia del área de atención a pacientes externos como método de mejora de la calidad.

OBJECTIVES: To evaluate the satisfaction of pharmacy auxiliaries, and patients attending the Outpatient Pharmacy, after the restructuring of the physical space and the process of dispensing drugs. METHODS: Three months after the restructuring of the Area (January 2009), we gave satisfaction surveys (anonymously and voluntarily) over 2 weeks, to a sample of the 3,300 patients who came per month and another to pharmacy auxiliaries who had worked in the area. The surveys consisted of eight closed questions with a Likert-type format about the physical space and organization, dispensing process and overall satisfaction (primary endpoint). In addition, there was an open question to gather suggestions. RESULTS: A total of 265 patients received the questionnaire (response rate 94%). The most valued aspect was the confidentiality (4.2 ± 0.7) and the worst was the waiting area (3.2 ± 1). There was a 100% response rate from the 26 pharmacy auxiliaries who received the questionnaire. The highest score was obtained by the installation of the bar-code reader (3.9 ± 0.6) and the lowest for organization of the stores (3.1 ± 1.2). They added comments about the lack of personnel, computer systems, organization of space and the lack of clarity of the prescription. The overall patient satisfaction was 4.2 ± 0.6 and that of the auxiliaries was 3.7 ± 0.7. CONCLUSIONS: The results of patients and employees satisfaction surveys have been useful information to assess changes in the area and identify points for improvement. In most of the issues the satisfaction was greater in patients than employees. We believe it is necessary to carry out actions for improving physical space and organization.

[Insulin therapy at the hospital setting]. / Insulinoterapia en el medio hospitalario.

Hyperglycemia is defined in different studies as a poor prognostic factor relating with higher risk for post-surgical infections, neurological complications, increased hospital staying, and admission to intensive care units. Appropriate use of insulin therapy is one of the key factors assuring the best management of hospitalized patients. The aim of this review was to discuss the most important aspects of insulin use at the hospital setting. We analyzed the different types of insulin commercially available and the factors determining their efficacy, as well as the different regimens and administration routes available at the hospital according to the type of patient and the type of feeding or exogenous intake of carbohydrates. The fear of inducing hypoglycemic episodes at the hospital contributes to an inappropriate prescription of the programmed insulin doses, the use of flexible rapid insulin doses in monotherapy, and setting excessively high glycemia levels. Currently, individualized management of hospital hyperglycemias should replace obsolete insulin regimens in order to reach more stringent glycemia goals and decreasing the number of complications in the hospitalized patient.

[Types of insulin therapy]. / Tipos de insulinoterapia.

Diabetes mellitus is a chronic disease associated with a series of long-term microvascular and macrovascular complications that requires continuing therapeutic control. In recent years, the pharmaceutical industry has developed new types of insulin and administration systems in order to more closely mimic human insulin secretion. In this way, insulin therapy is divided into conventional and intensive regimens according to their complexity. In type 1 diabetes mellitus (T1DM) patients, the treatment of choice is the one which achieves intensive glycemic control. In type 2 diabetes mellitus, we can start with a simplified conventional regimen which could progress into an intensive one similar to that of T1DM treatment. Both types of diabetes require an individualized treatment prescription based on the needs and characteristics of each patient.

[Intervention of a pharmacy department following the 11-M terrorist attack]. / Actuación de un servicio de farmacia en el atentado terrorista del 11-M.

OBJECTIVE: To describe the intervention of a pharmacy department, as well as medication requirements, in the healthcare emergency situation brought about by the terrorist attack of March 11, 2004 in Madrid. To compare this intervention with other similar experiences reported in the medical literature. METHOD: A compilation of actions carried out by pharmacists directly involved in the management of this incident. A literature search of Medline, Cochrane Library, and Spanish Index Medicus databases. RESULTS: The pharmacy department acted to ensure the availability of all medication needed in the management of casualties by placing urgent orders in pharmaceutical laboratories, simplifying distribution networks, and staying in permanent contact with the medical and nursing staff of the emergency department, as well as with people in charge of emergency coordination. Most commonly used medications included plasma expanders, fluid therapy, blood-derived products, pain killers, antiseptics, peripheral myorelaxants, and antibiotics, which are consistent with those employed by other Madrid hospitals for this same attack. CONCLUSIONS: The pharmacy department, as any other department in a hospital, should be ready to rapidly and effectively cope with any emergency situation. Having a protocol available including major intervention guidelines is advisable to reduce reaction times, anticipate potential complications, and effectively solve such situations.

[Ambulatory mouth surgery. Experience at a buccal-dental health unit in primary care]. / Cirugía oral ambulatoria. Experiencia en una unidad de salud bucodental en atención primaria.

OBJECTIVES: To describe the results obtained from conducting non-hospital mouth surgery in a buccal-dental health unit, to evaluate the quality of care and to monitor its evolution over two years. DESIGN: Descriptive, retrospective study with quality assessment methodology. PARTICIPANTS: Oral surgery interventions conducted during 1998 and 1999. SETTING: Primary care. Buccal-Dental Health Unit at Villanueva de la Serena. MEASUREMENTS AND MAIN RESULTS: 140 interventions took place in 1998 and 1999. 12 descriptive variables were analysed. 10 explicit standard quality criteria were worked out. Scientific and technical quality was measured through compliance rates. The radicular remains (28.6%) and the cordal remains included or retained (24.3%) were the most common diagnoses. The most frequently employed surgical procedures were: residual root extraction (28.6%) and the surgical extraction of included tooth (24.3%). 100% of users had signed an informed consent. In 9.9% of procedures a biopsy was performed: it gave 92.8% concordance with the diagnosis. In 1998, 6 of the 10 criteria scored above 90%. The mean of criteria satisfied per intervention was 7.4. There were clear deficiencies in anamnesis data collection (9.24%) and recording of post-operative complications (0% compliance). 60% of criteria did not achieve the standard. In 1999, 40% of criteria had a figure between 99 and 100%. 70% of criteria achieved the standard. The quantification of the improvement was significant in anamnesis (p < 0.001), analysis (p < 0.001) and post-operative complications (p < 0.001). CONCLUSIONS: Performing mouth surgery is a feasible non-hospital service. The quality cycle installed was highly effective.