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FUNDAMENTOS: Los inhibidores de la integrasa se han posicionado recientemente en todas las Guías Clínicas de VIH como tratamiento antirretroviral de primera línea para el VIH. Sin embargo, dos de estos fármacos se han asociado también a efectos adversos a nivel del sistema nervioso central, concretamente con alteraciones del sueño. El objetivo del trabajo fue analizar la influencia de bictegravir y dolutegravir en la calidad del sueño en personas que viven con VIH (PVIH). MÉTODOS: Se realizó un estudio observacional y transversal entre los meses de diciembre de 2020 y enero de 2021 en las PVIH de las consultas de atención farmacéutica del hospital. Se recogieron variables demográficas y de adherencia. La calidad del sueño se midió mediante el Cuestionario de Pittsburgh o PSQI. Las PVIH se clasificaron en 2 grupos: el grupo estudio, constituido por participantes con bictegravir o dolutegravir en su tratamiento, y el grupo control, integrado por el resto de PVIH. Se analizó la influencia de las variables recogidas sobre el resultado del PSQI mediante la prueba de chi cuadrado/odds ratio para variables categóricas y el de t de Student o U de Mann Whitney para variables continuas. RESULTADOS: Se incluyeron 119 PVIH, de las cuales un 64% en el grupo estudio y un 67% en el grupo control sufrían trastornos del sueño según el PSQI (p=0,788). Tampoco hubo diferencias estadísticamente significativas cuando se compararon los diferentes componentes del sueño entre los dos grupos. CONCLUSIONES: Un elevado porcentaje de PVIH, independientemente de si el TAR incluye bictegravir o dolutegravir, tienen problemas relacionados con la calidad del sueño. No se encuentra correlación entre la calidad del sueño y el tratamiento con bictegravir o dolutegravir comparado con el resto de tratamientos.(AU)

BACKGROUND: HIV Clinical Guidelines have positioned integrase inhibitors recently as first-line treatment. However, two of these drugs have also been associated with adverse side effects on the central nervous system, especially with sleep disturbances. The objective was to analyse the influence of bictegravir and dolutegravir on the sleep quality in HIV patients. METHODS: An observational, cross-sectional study was carried out between December 2020 and January 2021 in HIV patients attended in a pharmacy care clinic. Demographic and adherence variables were collected. Sleep quality was measured using the Pittsburgh questionnaire or PSQI. We classified patients into two groups: patients with bictegravir or dolutegravir in their treatment (study group) and the rest (control group). The influence of the variables collected on the PSQI result was analysed using the Chi-Square test for categorical variables and the student t-test or Mann-Whitney U test for continuous variables. RESULTS: One hundred and nineteen patients were included. 64% in the study group and 67% in the control group suffered from sleep disorders according to the PSQI questionnaire (p=0.788). Neither were statistical differences found when the different components of sleep were analysed between the two groups. CONCLUSIONS: A high percentage of patients, regardless of whether their treatment includes bictegravir or dolutegravir, have problems with their sleep quality. We didn’t find a correlation between sleep quality and treatment with bictegravir or dolutegravir compared to the other treatments.(AU)

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OBJECTIVE: HIV Clinical Guidelines have positioned integrase inhibitors recently as first-line treatment. However, two of these drugs have also been associated with adverse side effects on the central nervous system, especially with sleep disturbances. The objective was to analyse the influence of bictegravir and dolutegravir on the sleep quality in HIV patients. METHODS: An observational, cross-sectional study was carried out between December 2020 and January 2021 in HIV patients attended in a pharmacy care clinic. Demographic and adherence variables were collected. Sleep quality was measured using the Pittsburgh questionnaire or PSQI. We classified patients into two groups: patients with bictegravir or dolutegravir in their treatment (study group) and the rest (control group). The influence of the variables collected on the PSQI result was analysed using the Chi-Square test for categorical variables and the student t-test or Mann-Whitney U test for continuous variables. RESULTS: One hundred and nineteen patients were included. 64% in the study group and 67% in the control group suffered from sleep disorders according to the PSQI questionnaire (p=0.788). Neither were statistical differences found when the different components of sleep were analysed between the two groups. CONCLUSIONS: A high percentage of patients, regardless of whether their treatment includes bictegravir or dolutegravir, have problems with their sleep quality. We didn't find a correlation between sleep quality and treatment with bictegravir or dolutegravir compared to the other treatments.

OBJETIVO: Los inhibidores de la integrasa se han posicionado recientemente en todas las Guías Clínicas de VIH como tratamiento antirretroviral de primera línea para el VIH. Sin embargo, dos de estos fármacos se han asociado también a efectos adversos a nivel del sistema nervioso central, concretamente con alteraciones del sueño. El objetivo del trabajo fue analizar la influencia de bictegravir y dolutegravir en la calidad del sueño en personas que viven con VIH (PVIH). METODOS: Se realizó un estudio observacional y transversal entre los meses de diciembre de 2020 y enero de 2021 en las PVIH de las consultas de atención farmacéutica del hospital. Se recogieron variables demográficas y de adherencia. La calidad del sueño se midió mediante el Cuestionario de Pittsburgh o PSQI. Las PVIH se clasificaron en 2 grupos: el grupo estudio, constituido por participantes con bictegravir o dolutegravir en su tratamiento, y el grupo control, integrado por el resto de PVIH. Se analizó la influencia de las variables recogidas sobre el resultado del PSQI mediante la prueba de chi cuadrado/odds ratio para variables categóricas y el de t de Student o U de Mann Whitney para variables continuas. RESULTADOS: Se incluyeron 119 PVIH, de las cuales un 64% en el grupo estudio y un 67% en el grupo control sufrían trastornos del sueño según el PSQI (p=0,788). Tampoco hubo diferencias estadísticamente significativas cuando se compararon los diferentes componentes del sueño entre los dos grupos. CONCLUSIONES: Un elevado porcentaje de PVIH, independientemente de si el TAR incluye bictegravir o dolutegravir, tienen problemas relacionados con la calidad del sueño. No se encuentra correlación entre la calidad del sueño y el tratamiento con bictegravir o dolutegravir comparado con el resto de tratamientos.

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PURPOSE: To define the signals that a new artificial intelligence (AI) system must emit to improve adverse drug events (ADEs) management in oral antineoplastic agents (OAA). METHODS: A multidisciplinary group of experts in patient safety was set up to define what signals the new AI system must emit to improve ADEs management in OAAs. The baseline data for the new AI system were generated through an observational and ambispective study carried out in a university hospital. All patients who met the inclusion criteria were selected consecutively every working day for 6 months. The ADEs were collected by interview and by the review of health records. The ADEs were categorised according to how they could be detected: patient, analysis, examination. RESULTS: The group defined what signals the AI system must emit to improve ADEs management in OAAs: a signal to educate the patient when the possible ADEs were categorised as patient, a signal as a reminder to request a blood test or a microbiological culture when the possible ADEs were categorised as analysis, and a signal as a reminder for the necessity of a clinical examination when the possible ADEs were categorised as examination. A total of 1652 ADEs were reported in the interviews (ADE-interview) with the pharmacist, and doctors noted 1989 ADEs in the health record (ADE-HR). The most frequent ADEs were identified in the patient category. CONCLUSION: This study opens a new way for better management of ADEs and is the first step in the development of a future technology, which will improve the quality of life of patients.

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INTRODUCCIÓN: La prescripción de tratamiento antirretroviral (TAR) que contiene potenciadores farmacocinéticos como ritonavir y cobicistat es frecuente. El objetivo de este estudio fue analizar las interacciones potenciales del TAR que incluyen estas moléculas en su formulación con la medicación domiciliaria del paciente, así como el manejo clínico de aquellas potencialmente graves. MÉTODOS: Estudio prospectivo en la consulta de atención farmacéutica de un hospital de tercer nivel entre enero y diciembre de 2018. Se incluyeron en el estudio aquellos pacientes VIH + con un TAR que contuviera cobicistat o ritonavir. Se analizaron las interacciones potenciales entre el TAR y la medicación concomitante en tres bases de datos (Micromedex(R), Drugs.com y Liverpool), se detallaron las intervenciones realizadas, y se analizaron las reacciones adversas encontradas. RESULTADOS: Se incluyeron 968 pacientes con un total de 2.148 prescripciones (274 principios activos diferentes). Se realizaron un total de 86 intervenciones relativas a interacciones potenciales en los pacientes. Las más frecuentes fueron sustituciones de tratamientos corticoideos, supensiones de tratamiento y monitorizaciones más estrechas. Se analizaron un total de doce sospechas de reacción adversa. El grado de concordancia en la clasificación de la gravedad de las interacciones para cobicistat y ritonavir fue buena entre las tres bases de datos. Resultó destacable Micromedex(R) como la más completa por tener más principios activos registrados. CONCLUSIÓN: Las interacciones entre el TAR con potenciadores farmacocinéticos en su composición y la medicación concomitante es frecuente y requiere de una importante variedad de intervenciones. El chequeo de interacciones en distintas bases de datos es recomendable ya que pueden ocasionar reacciones adversas a medicamentos

INTRODUCTION: The prescription of antiretroviral treatment (ART) that contains pharmacokinetic enhancers such as ritonavir and cobicistat is frequent. The objective of this stdy was to analyze the potential interactions of ART that include these molecules in their formulation with the patient's home medication, as well as the clinical management of those potentially serious. METHODS: Prospective study conducted in the pharmacy care clinic of a third level hospital between January and December of 2018. Those HIV+patients with an ART containing cobicistat or ritonavir were included in the study. Potential interactions between ART and concomitant medication were analysed in three databases (Micromedex(R), Drugs.com and Liverpool), the interventions carried out were detailed, and adverse drug reactions analysed. RESULTS: 968 patients were included with a total of 2,148 prescriptions (274 different medications). A total of 86 interventions were performed regarding potential interactions in patients. The most frequent were substitutions of corticoid treatments, treatment suspensions and closer monitoring of treatments. A total of possible adverse drug reactions were analysed. The degree of agreement in the severity classification of the interactions for cobicistat and ritonavir was good among the three databases. It was remarkable Micromedex(R) as the most complete because it has more registered medications. CONCLUSIÓN: The interactions between ART with pharmacokinetic enhancers in its composition and concomitant medication is frequent and requires a significant variety of interventions. The check of interactions in different databases is recommended since they can cause adverse drug reactions

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Introduction: Satisfaction and knowledge among patients with HIV after switching from tenofovir to tenofovir/alafenamide remain unexplored. Given that both parameters are associated with better health outcomes it is relevant to measure them in patients during routine clinical practice. Objective: To evaluate the degree of knowledge and satisfaction in patients who had their antiretroviral regimen switched from rilpivirine (RPV)/emtricitabine (FTC)/TDF to RPV/FTC/TAF. Materials and methods: We conducted a prospective study in a third-level hospital between September, 2018, and November, 2018. We included patients who had previously been treated with RPV/FTC/TDF and collected their RPV/FTC/TAF treatment in the second visit. A 5-point Likert-type agreement/disagreement scale was used to assess satisfaction and knowledge regarding the medication switch. Results: We included 116 patients in the study of whom 75% were satisfied and 64% had a high-level of knowledge. Young patients were less satisfied with the way in which the change was explained (p=0.0487). Concerning the new medication, the patients were better informed about its renal (85% of them) and bone benefits (82%) than about its adverse effects on the lipid profile (40%). Conclusions: The patients were generally satisfied with the change in medication and well nformed about the dosage and advantages of TAF over TDF, but less well informed about the possible adverse effects of TAF.

Introducción. La satisfacción y el conocimiento del cambio de tenofovir por tenofovir-alafenamida en pacientes con HIV no se han estudiado aún. Estos dos parámetros se relacionan con mejores resultados en salud y, por lo tanto, es importante medirlos durante la práctica clínica habitual. Objetivo. Evaluar el grado de conocimiento y satisfacción de los pacientes positivos para HIV ante el cambio de tratamiento antirretroviral con rilpivirina, emtricitabina y tenofovir (RPV-FTC-TDF) por rilpivirina, emtricitabina y tenofovir-alafenamida (RPV-FTC-TAF). Materiales y métodos. Se llevó a cabo un estudio prospectivo en un hospital de tercer nivel entre los meses de septiembre y noviembre de 2018. Se incluyeron pacientes previamente tratados con RPV-FTC-TDF que acudían por segunda vez a consulta para recibir el tratamiento con RPV-FTC-TAF. La satisfacción y el grado de conocimiento se analizaron mediante nueve preguntas, usando una escala de tipo Likert de 5 puntos para evaluar el grado de acuerdo. Resultados. Se incluyeron 116 pacientes en el estudio. El 75 % de ellos se mostró satisfecho con el cambio y se consideró que el 64 % conocía lo que implicaba. Los pacientes jóvenes se mostraron menos satisfechos con el modo en que se les explicó el cambio (p=0,0487). Los pacientes estaban mejor informados sobre las ventajas renales (85 % de conocimiento) y óseas (82 %) de la nueva medicación, que sobre sus inconvenientes para el perfil lipídico (40 %). Conclusiones. En general, los pacientes se mostraron satisfechos con el cambio de medicación y conocían la posología del medicamento y las ventajas de la tenofovir-alafenamida frente al tenofovir, pero no sus posibles efectos adversos.

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Introducción. La satisfacción y el conocimiento del cambio de tenofovir por tenofovir- alafenamida en pacientes con HIV no se han estudiado aún. Estos dos parámetros se relacionan con mejores resultados en salud y, por lo tanto, es importante medirlos durante la práctica clínica habitual. Objetivo. Evaluar el grado de conocimiento y satisfacción de los pacientes positivos para HIV ante el cambio de tratamiento antirretroviral con rilpivirina, emtricitabina y tenofovir (RPV-FTC-TDF) por rilpivirina, emtricitabina y tenofovir-alafenamida (RPV-FTC-TAF). Materiales y métodos. Se llevó a cabo un estudio prospectivo en un hospital de tercer nivel entre los meses de septiembre y noviembre de 2018. Se incluyeron pacientes previamente tratados con RPV-FTC-TDF que acudían por segunda vez a consulta para recibir el tratamiento con RPV-FTC-TAF. La satisfacción y el grado de conocimiento se analizaron mediante nueve preguntas, usando una escala de tipo Likert de 5 puntos para evaluar el grado de acuerdo. Resultados. Se incluyeron 116 pacientes en el estudio. El 75 % de ellos se mostró satisfecho con el cambio y se consideró que el 64 % conocía lo que implicaba. Los pacientes jóvenes se mostraron menos satisfechos con el modo en que se les explicó el cambio (p=0,0487). Los pacientes estaban mejor informados sobre las ventajas renales (85 % de conocimiento) y óseas (82 %) de la nueva medicación, que sobre sus inconvenientes para el perfil lipídico (40 %). Conclusiones. En general, los pacientes se mostraron satisfechos con el cambio de medicación y conocían la posología del medicamento y las ventajas de la tenofovir- alafenamida frente al tenofovir, pero no sus posibles efectos adversos.

Introduction: Satisfaction and knowledge among patients with HIV after switching from tenofovir to tenofovir/alafenamide remain unexplored. Given that both parameters are associated with better health outcomes it is relevant to measure them in patients during routine clinical practice. Objective: To evaluate the degree of knowledge and satisfaction in patients who had their antiretroviral regimen switched from rilpivirine (RPV)/emtricitabine (FTC)/TDF to RPV/FTC/TAF. Materials and methods: We conducted a prospective study in a third-level hospital between September, 2018, and November, 2018. We included patients who had previously been treated with RPV/FTC/TDF and collected their RPV/FTC/TAF treatment in the second visit. A 5-point Likert-type agreement/disagreement scale was used to assess satisfaction and knowledge regarding the medication switch. Results: We included 116 patients in the study of whom 75% were satisfied and 64% had a high-level of knowledge. Young patients were less satisfied with the way in which the change was explained (p=0.0487). Concerning the new medication, the patients were better informed about its renal (85% of them) and bone benefits (82%) than about its adverse effects on the lipid profile (40%). Conclusions: The patients were generally satisfied with the change in medication and well informed about the dosage and advantages of TAF over TDF, but less well informed about the possible adverse effects of TAF.

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INTRODUCTION: The prescription of antiretroviral treatment (ART) that contains pharmacokinetic enhancers such as ritonavir and cobicistat is frequent. The objective of this stdy was to analyze the potential interactions of ART that include these molecules in their formulation with the patient's home medication, as well as the clinical management of those potentially serious. METHODS: Prospective study conducted in the pharmacy care clinic of a third level hospital between January and December of 2018. Those HIV+patients with an ART containing cobicistat or ritonavir were included in the study. Potential interactions between ART and concomitant medication were analysed in three databases (Micromedex®, Drugs.com and Liverpool), the interventions carried out were detailed, and adverse drug reactions analysed. RESULTS: 968 patients were included with a total of 2,148 prescriptions (274 different medications). A total of 86 interventions were performed regarding potential interactions in patients. The most frequent were substitutions of corticoid treatments, treatment suspensions and closer monitoring of treatments. A total of possible adverse drug reactions were analysed. The degree of agreement in the severity classification of the interactions for cobicistat and ritonavir was good among the three databases. It was remarkable Micromedex® as the most complete because it has more registered medications. CONCLUSION: The interactions between ART with pharmacokinetic enhancers in its composition and concomitant medication is frequent and requires a significant variety of interventions. The check of interactions in different databases is recommended since they can cause adverse drug reactions.

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RATIONALE, AIMS, AND OBJECTIVES: The complexity of an electronic medication administration record (eMAR) has been underestimated by most designers in the past. Usability issues, such as poorly designed user application flow in eMAR, are therefore of vital importance, since they can have a negative impact on nursing activities and result in poor outcomes. The purpose of this study was to evaluate the usability of an eMAR application during its development. METHODS: A usability evaluation was conducted during the development of the eMAR application. Two usability methods were used: a heuristic evaluation complemented by usability testing. Each eMAR application version provided by the vendor was evaluated by 2 hospital pharmacists, who applied the heuristic method. They reviewed the eMAR tasks, detected usability problems and their heuristic violations, and rated the severity of the usability problems. Usability testing was used to assess the final application version by observing how 3 nurses interacted with the application. RESULTS: Thirty-four versions were assessed before the eMAR application was considered usable. During the heuristic evaluation, the usability problems decreased from 46 unique usability problems in version 1 (V1) to 9 in version 34 (V34). In V1, usability problems were categorized into 154 heuristic violations, which decreased to 27 in V34. The average severity rating also decreased from major usability problem (2.96) to no problem (0.23). During usability testing, the 3 nurses did not encounter new usability problems. CONCLUSION: A thorough heuristic evaluation is a good method for obtaining a usable eMAR application. This evaluation points key areas for improvement and decreases usability problems and their severity.

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Background The introduction of new technologies in the prescribing process has seen the emergence of new types of medication errors. Objective To determine the prevalence and consequences of technology-induced prescription errors associated with a computerized provider order entry (CPOE) system in hospitalized older patients. Setting Patients 65 years or older admitted to the Departments of Internal Medicine, General Surgery, and Vascular Surgery of a tertiary hospital. Method Prospective observational 6-month study. Technology-induced errors were classified according to various taxonomies. Interrater reliability was measured. Consequences were assessed by interviewing patients and healthcare providers and classified according to their severity. Main outcome measure Prevalence of technology-induced errors. Results A total of 117 patients were included and 107 technology-induced errors were recorded. The prevalence of these errors was 3.65%. Half of the errors were clinical errors (n = 54) and the majority of these were classified as wrong dose, wrong strength, or wrong formulation. Clinical errors were 9 times more likely to be more severe than procedural errors (14.8 vs 1.9%; OR 9.04, 95% CI 1.09-75.07). Most of the errors did not reach the patient. Almost all errors were related to human-machine interactions due to wrong (n = 61) or partial (n = 41) entries. Conclusion Technology-induced errors are common and intrinsic to the implementation of new technologies such as CPOE. The majority of errors appear to be related to human-machine interactions and are of low severity. Prospective trials should be conducted to analyse in detail the way these errors occur and to establish strategies to solve them and increase patient safety.

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RATIONALE, AIMS, AND OBJECTIVES: To evaluate the effect of an electronic medication administration record (eMAR) application on the rate of medication errors in medication administration recording (ME-MAR). METHODS: A before-and-after, quasiexperimental study was conducted in a university hospital that implemented the eMAR application in March 2014. Data collection was conducted in April 2012 (pre-) and June 2014 (post-) by two pharmacists. The ME-MARs were analysed by the staff involved to identify their cause. The two pharmacists independently classified the ME-MARs. In the case of disagreement, a research team examined the ME-MARs and categorized them by consensus. Three classifications were used: A classic medication error taxonomy and 2 technology-induced error taxonomies. RESULTS: The pharmacists analysed 2835 (pre-) and 2621 (post-) medication administration records (MAR), respectively. Overall, the ME-MAR rate decreased from 48.0% (pre-) to 36.9% (post-) (P < .05). The same types of ME-MAR were observed in both phases except for "MAR with incomplete information," which was not observed in the postimplementation phase. In both phases, the most frequent ME-MAR was "MAR at the wrong time" (MAR before or after medication administration) (31.6% vs 30.2%). The main cause of ME-MARs in both phases was the failure to follow work procedures. The potential future risk of ME-MARs significantly decreased after the eMAR implementation (P < .05). All ME-MARs were "use errors" because of human factors. New ME-MARs (1.24%; n = 12) were observed in the postimplementation phase. CONCLUSION: Use of the eMAR application significantly reduces the rate of ME-MAR and their potential risk. The main cause of ME-MAR was the failure to follow work procedures.

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RATIONALE, AIMS AND OBJECTIVES: The aim of this study is to adapt and assess the interrater reliability of a potential future risk matrix for medication errors in medication administration recording (ME-MAR). METHODS: The study was carried out in a teaching hospital. It was conducted in two phases. In the first phase, a consensus method was used in order to adapt the potential future risk matrix published by the National Patient Safety and Otero et al. to the ME-MAR. The consensus method consisted in a nominal group formed by four pharmacists. In the second phase, a multidisciplinary group of experts in patient safety assessed the reliability of the adapted matrix. Five raters evaluated 100 ME-MAR. Its reliability was evaluated using the kappa statistic. RESULTS: In the first phase, two meetings were necessary until consensus was reached to adapt the potential future risk matrix to the ME-MAR. For this purpose, the two following categories were defined: likelihood of ME-MAR's recurrence and most likely consequences of ME-MAR. The definition of each grade of likelihood of recurrence was based on the incidence of ME-MAR from an unpublished study carried out in our hospital. In order to determine the most likely consequences of ME-MAR, a two-dimensional matrix was designed, with severity per type of ME-MAR on one axis and the class of medication on the other. In the second phase, the reliability of the matrix was tested. The overall interrater agreement for the five raters was substantial at 0.68 (Confidence interval 95% 0.60-0.76). CONCLUSION: The adapted matrix of potential future risk to ME-MAR is reliable and can serve as a guide for future studies.

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Identificar, cuantificar y comparar los errores de medicación (EM) de antineoplásicos que se producen con un sistema de prescripción manual y con un sistema de prescripción electrónica asistida (PEA). Estudio observacional, descriptivo, prospectivo, realizado en pacientes ingresados en una unidad de Hematología. Se analizaron los EM producidos antes y después de la implantación de la PEA. Se detectaron 184 EM y 53 de identificación de pacientes. La RRR fue del 92,03% y la RAR del 40,02%. Las disminuciones de los errores en las categorías de falta de prescripción de un medicamento necesario, dosis mayor, error de preparación/manipulación, vía de administración y velocidad de administración fueron estadísticamente significativas. La PEA de antineoplásicos disminuye el número de EM. Evita errores derivados de la omisión de información y disminuye los relacionados con la dosis y la estabilidad de las mezclas (AU)

To identify, quantify and compare medication errors (ME) of antineoplastic agents produced with manual prescriptions and with electronically assisted prescriptions (EAP). An observational, descriptive, prospective study in a haematological hospitalisation unit. Antineoplastic agents ME were determined before and after implementation of EAP. 184 ME and 53 identification errors were detected. A RRR of 92,03% and an AAR of 40,02% were obtained. Non-prescription medication errors, higher dose errors, wrong preparation or handling errors, administration route errors and rate of administration errors were significantly lower with EAP. Antineoplastic agents ME have decreased since computerising the prescription process. The decrease of omission errors, dosage-related errors and those related to the stability of the mixtures stands out (AU)

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