Effects of a pharmacist designed clinical decision support system on antimicrobial stewardship.

Background Clinical decision support systems (CDSS) are computer applications, which can be applied to give guidance to practitioners in antimicrobial stewardship (AS) activities, however, further information is needed for their optimal use. Objectives To analyze the implementation of a CDSS program in a primary-care hospital, describing alerts, recommendations, and the effect on consumption and clinical outcomes. Methods In October 2020, a pharmacist-driven CDSS designed for AS was implemented in a second-level hospital. The program provides a list of alerts related to antimicrobial treatment and microbiology, which were automatized for revision by the AS professionals. To analyze the implementation of the CDSS, a pre-post intervention, retrospective study was designed. AS triggered alerts and recommendations (total number and rate of acceptance) were compiled. The effect of the CDSS was measured using antimicrobial consumption, duration of antimicrobial treatments, in-hospital mortality and length of stay (LOS) for patients admitted for infectious causes. Results The AS team revised a total of 7,543 alerts and 772 patients had at least one recommendation, with an acceptance rate of 79.3%. Antimicrobial consumption decreased from 691.1 to 656.8 daily defined doses (DDD)/1,000 beds-month (P = 0.04) and the duration of antimicrobial treatment from 3.6 to 3.3 days (P <0.01). In-hospital mortality decreased from 6.6% to 6.2% (P=0.46) and mean LOS from 7.2 to 6.2 days (P<0.01) Conclusion The implementation of a CDSS resulted in a significant reduction of antimicrobial DDD, duration of antimicrobial treatments and hospital LOS. There was no significant difference in mortality.

Transcriptomic landscape of granulosa cells and peripheral blood mononuclear cells in women with PCOS compared to young poor responders and women with normal response.

STUDY QUESTION: Are transcriptomic profiles altered in ovarian granulosa cells (GCs) and peripheral blood mononuclear cells (PBMNCs) of women with polycystic ovary syndrome (PCOS) compared to young poor responders (YPR) and women with normal response to ovarian stimulation? SUMMARY ANSWER: RNA expression profiles in ovarian GCs and PBMNCs were significantly altered in patients with PCOS compared with normoresponder controls (CONT) and YPR. WHAT IS KNOWN ALREADY: PCOS is characterised by a higher number of follicles at all developmental stages. During controlled ovarian hyperstimulation, PCOS women develop a larger number of follicles as a result of an exacerbated response, with an increased risk of ovarian hyperstimulation syndrome. Despite the number of developing follicles, they are often heterogeneous in both size and maturation stage, with compromised quality and retrieval of immature oocytes. Women with PCOS appear to have a longer reproductive lifespan, with a slightly higher menopausal age than the general population, in addition to having a higher antral follicular count. As a result, the ovarian follicular dynamics appear to differ significantly from those observed in women with poor ovarian response (POR) or diminished ovarian reserve. STUDY DESIGN, SIZE, DURATION: Transcriptomic profiling with RNA-sequencing and validation using quantitative reverse transcription PCR (qRT-PCR). Women with PCOS (N = 20), YPR (N = 20) and CONT (N = 20). Five patients for each group were used for sequencing and 15 samples per group were used for validation. PARTICIPANTS/MATERIALS, SETTING, METHODS: PCOS was defined using the revised Rotterdam diagnostic criteria for PCOS. The YPR group included women <35 years old with <4 mature follicles (at least 15 mm) on the day of the trigger. According to internal data, this group represented the bottom 15th percentile of patients' responses in this age group. It was consistent with Patient-Oriented Strategies Encompassing Individualize D Oocyte Number (POSEIDON) criteria for POR (Group 3). The young CONT group included women <35 years without PCOS or anovulation, who developed >14 mature follicles (at least 15 mm on transvaginal ultrasound). According to internal data, a threshold of >14 mature follicles was established to represent the top 25% of patients in this age group in this clinic.Overall, n = 60 GCs and PBMNCs samples were collected and processed for total RNA extraction. To define the transcriptomic cargo of GCs and PBMNCs, RNA-seq libraries were successfully prepared from samples and analysed by RNA-seq analysis. Differential gene expression analysis was used to compare RNA-seq results between different groups of samples. Ingenuity pathway analysis was used to perform Gene Ontology and pathways analyses. MAIN RESULTS AND THE ROLE OF CHANCE: In PBMNCs of PCOS, there were 65 differentially expressed genes (DEGs) compared to CONT, and 16 compared to YPR. In GCs of PCOS, 4 genes showed decreased expression compared to CONT, while 58 genes were differentially expressed compared to YPR. qRT-PCR analysis confirmed the findings of the RNA-seq. The functional enrichment analysis performed revealed that DEGs in GCs of PCOS compared to CONT and YPR were prevalently involved in protein ubiquitination, oxidative phosphorylation, mitochondrial dysfunction and sirtuin signaling pathways. LARGE SCALE DATA: The data used in this study is partially available at Gene Ontology database. LIMITATIONS, REASONS FOR CAUTION: The analysis in PBMNCs could be uninformative due to inter-individual variability among patients in the same study groups. Despite the fact that we considered this was the best approach for our study's novel, exploratory nature. WIDER IMPLICATIONS OF THE FINDINGS: RNA expression profiles in ovarian GCs and PBMNCs were altered in patients with PCOS compared with CONT and YPR. GCs of PCOS patients showed altered expression of several genes involved in oxidative phosphorylation, mitochondrial function and sirtuin signaling pathways. This is the first study to show that the transcriptomic landscape in GCs is altered in PCOS compared to CONT and YPR. STUDY FUNDING/COMPETING INTEREST(S): This study was partially supported by grant PI18/00322 from Instituto de Salud Carlos III, and European Regional Development Fund (FEDER), 'A way to make Europe' awarded to S.H. M.C., S.H., S.T., L.R., M.R., I.R., A.P. and R.C. declare no conflict of interests concerning this research. E.S. is a consultant for and receives research funding from the Foundation for Embryonic Competence. TRIAL REGISTRATION NUMBER: N/A.

Potential Development of Vitrified Immature Human Oocytes: Influence of the Culture Medium and the Timing of Vitrification.

How does the in vitro maturation (IVM) medium and the vitrification procedure affect the survival of germinal vesicle (GV) oocytes obtained from stimulated cycles and their development to the blastocyst stage? In total, 1085 GV human oocytes were obtained after women underwent a cycle of controlled ovarian stimulation, and these oocytes were subjected to IVM before or after their vitrification. IVM was carried out in two commercial culture media not specifically designed for maturation. MII oocytes were then activated and embryo development until day 6 was evaluated. According to the results, a higher percentage of oocytes reach the MII stage if they are vitrified before they undergo IVM. Nevertheless, the medium used and the sample size determine whether these differences become significant or not. Similar survival rates and development to blastocysts were observed in all the conditions studied.

Haemorrhagic complications in patients with renal insufficiency during treatment or prophylaxis with dalteparin.

OBJECTIVES: Low-molecular-weight heparins are widely used in clinical practice for the treatment or prophylaxis of venous thromboembolism (VTE). As these drugs are eliminated mainly by renal means, any renal function impairment may lead to higher plasma concentrations and increase the risk of bleeding. This study aims to evaluate whether in clinical practice there is an increase in the occurrence of bleeding in patients with renal insufficiency (RI) during treatment or prophylaxis with dalteparin, and to analyse the risk factors potentially influencing the appearance of such bleeding events. METHODS: Patients were sampled from the Universitary Severo Ochoa Hospital, Leganés, Spain. This was a retrospective cohort study with a 1 year inclusion period, conducted at a Spanish university hospital with 400 beds, on patients undergoing treatment or prophylaxis for VTE with dalteparin for a minimum of 3 days. The main outcome measure was the number of patients who had bleeding events, independently of their severity, during dalteparin administration in patients with RI. RESULTS: 367 patients were included in the study. Bleeding occurred in 17.9% of patients in the group with RI and in 7.3% of patients with normal renal function (NRF). Most haemorrhages in both cohorts were grade 2 on the WHO scale (64.7% in the RI group and 69.2% in the NRF group). Logistic regression analysis allowed the presence of RI (MDRD-4 (Modification of Diet in Renal Disease) <50 mL/min) to be identified as a risk factor. CONCLUSION: Patients with RI treated with dalteparin face a higher risk of bleeding than those with NRF, which seems to make it necessary to monitor and seek new dosage adjustments for these patients.Impact on practice statements: This study yields new data on dalteparin in RI, which has not been widely studied before.

Assessment of exposure-response relationship for bevacizumab in patients with metastatic colorectal cancer.

Limited literature is available for bevacizumab exposure-response relationship and there is not a concentration threshold associated with an optimal disease control. This prospective observational study in patients with metastatic colorectal cancer (mCRC) aims to evaluate, in a real-life setting, the relationship between bevacizumab through concentrations at steady state (Ctrough, SS) and disease control. Ctrough, SS were drawn, coinciding with the radiological evaluation of the response (progression or clinical benefit). Generalized estimating equations (GEE) analysis was performed. To test the association between Ctrough, SS in each patient with overall survival (OS) or progression-free survival (PFS), Cox proportional hazard models were developed. Data included 50 bevacizumab Ctrough, SS from 27 patients. The GEE model did not suggest any positive association between bevacizumab Ctrough, SS and clinical benefit (OR 0.99, 95% CI: 0.98-1.02, p = 0.863). The Cox regression showed association between higher median Ctrough, SS with better OS (HR 0.86, 95% CI: 0.73-1.01, p = 0.060), but not with PFS. We cannot confirm a relationship between bevacizumab Ctrough, SS and clinical benefit but this is the first real-world study trying to show a relationship between bevacizumab Ctrough, SS and disease control in mCRC. It was conducted in a small sample size which reduces the level of evidence. Further controlled randomized studies with a sufficient number of patients are required.

Impact of Maturation and Vitrification Time of Human GV Oocytes on the Metaphase Plate Configuration.

The combination of in vitro maturation (IVM) techniques and oocyte vitrification (OV) could increase the number of useful oocytes in different types of patients. IVM and subsequent OV is the most widely used clinical strategy. Would the results improve if we reverse the order of the techniques? Here, we evaluated survival, in vitro maturation, time to extrude the first polar body (PB), and the metaphase plate configuration of human prophase I (GV) oocytes before or after their vitrification. Specific, 195 GV oocytes from 104 patients subjected to controlled ovarian stimulation cycles were included. We stablished three experimental groups: GV oocytes vitrified and IVM (Group GV-Vit), GV oocytes IVM and vitrified at MII stage (Group MII-Vit), and GV oocytes IVM (Group not-Vit). All of them were in vitro matured for a maximum of 48 h and fixed to study the metaphase plate by confocal microscopy. According to our results, the vitrification of immature oocytes and their subsequent maturation presented similar survival, maturation, and metaphase plate conformation rates, but a significantly higher percentage of normal spindle than the standard strategy. Additionally, the extension of IVM time to 48 h did not seem to negatively affect the oocyte metaphase plate configuration.

Error Detection and Cost Savings With an Image-Based Workflow Management System Connected to a Computerized Prescription Order Entry Program for Antineoplastic Compounding.

OBJECTIVE: The aim of the study was to analyze both the prevalence of errors with the implementation of an image-based workflow management system during the antineoplastic compounding process, and the estimated costs associated with the negative clinical outcome if the errors had not been intercepted. METHODS: Three months after the implementation of Phocus Rx system at a hospital pharmacy department, the identification, classification (type, preparation stage, and cause), and potential severity degree (from negligible to catastrophic) of the errors intercepted were determined. The probability of an error causing an adverse event if it had reached the patient (from nil [0] to high [0.6]) and its consequences was estimated by a team of clinical pharmacists and physicians. Cost-effectiveness analysis from the hospital's perspective was performed. RESULTS: Overall, 9872 antineoplastic medications were prepared using Phocus Rx. The total compounding error rate was 0.8% (n = 78, 56 [69.2%] were related to incorrect dose, 20 [28.2%] to incorrect drug preparation or conditioning technique, and 2 [2.6%] were wrong drugs). Approximately 70% of the detected errors were classified as undetectable via the previous verification practice, with 11.55% judged to be potentially severe (n = 9) and 51.3% moderate (n = 29). Likelihood of occurrence of an adverse event was medium (0.4) to high (0.6) for 37.2% of the errors. Estimated cost ratio and return on investment were €4.21 and 321%, respectively. CONCLUSIONS: The implementation of Phocus Rx prevented antineoplastic preparation errors that would have reached the patient otherwise. In addition, acquisition of this technology was estimated to be cost-effective.

Potentially inappropriate medication in acute hospitalized elderly patients with polypharmacy: an observational study comparing PRISCUS, STOPP, and Beers criteria.

PURPOSE: To compare the prevalence of potentially inappropriate medication (PIM) in the elderly according to the PRISCUS list, STOPP criteria, and Beers criteria. Secondary, to describe the differences using the three criteria focused on the inappropriate prescription of psychotropic drugs in the elderly. METHODS: A retrospective study was performed at Severo Ochoa University Hospital. The study included 365 patients, aged 80 years and older, living in Madrid, Spain. RESULTS: 93.42% of patients received at least one PIM during hospitalization. Using the PRISCUS list, this changed from 32.6 to 2.7% at discharge. Applying STOPP criteria lowered the percentage from 65.20 to 10.95%, and with Beers criteria from 80.27 to 10.13. Lower Barthel index at admission was associated with an increased relative risk for receiving at least one PIM (OR 1.79, 95% CI 1.15-2.80, p = 0.024) using PRISCUS list as a tool in conjunction with STOPP criteria (OR 1.44, 95% CI 0.89-2.33, p = 0.037). Polypharmacy at admission predicted the presence of PIMs with STOPP criteria (OR 1.74, 95% CI 1.07-2.84, p = 0.001). Regarding psychotropic medicines, 208 patients (56.98%) received at least one psychotropic medicine during hospitalization. A total of 26.30% of patients were treated with psychotropic medicines, detected by the PRISCUS list, and 53.97% and 29.85% with STOPP and Beers, respectively. CONCLUSIONS: Explicit criteria are a useful tool for identifying during hospitalization of the elderly patients. As indicated by the results, new research is needed to carry out an adaptation in our country that includes an evaluation of the strengths of the three tools to decrease PIMs and improve prescription in the elderly.

Effect of a Mobile App for the Pharmacotherapeutic Follow-Up of Patients With Cancer on Their Health Outcomes: Quasi-Experimental Study.

BACKGROUND: Oral antineoplastic agents (OAAs) have revolutionized cancer management. However, they have been reported with adverse side effects and drug-drug interactions. Moreover, patient adherence to OAA treatment is critical. Mobile apps can enable remote and real-time pharmacotherapeutic monitoring of patients, while also promoting patient autonomy in their health care. OBJECTIVE: The primary objective was to analyze the effect of using a mobile app for the follow-up of patients with oncohematological malignancies undergoing treatment with OAAs on their health outcomes. The secondary objectives were to analyze the role of the app in communication with health care professionals and patient satisfaction with the app. METHODS: We performed a comparative, quasi-experimental study based on a prepost intervention with 101 patients (control group, n=51, traditional pharmacotherapeutic follow-up vs intervention group, n=50, follow-up through e-OncoSalud, a custom-designed app that promotes follow-up at home and the safety of patients receiving OAAs). The effect of this app on drug safety, adherence to treatment, and quality of life was evaluated. RESULTS: With regard to drug safety, 73% (37/51) of the patients in the control group and 70% (35/50) of the patients in the intervention group (P=.01) presented with drug-related problems. The probability of detecting an insufficiently treated health problem in the intervention group was significantly higher than that in the control group (P=.04). The proportion of patients who presented with side effects in the intervention group was significantly lower than that in the control group (P>.99). In the control group, 49% (25/51) of the patients consumed some health resources during the first 6 months of treatment compared with 36% (18/50) of the patients in the intervention group (P=.76). Adherence to treatment was 97.6% (SD 7.9) in the intervention group, which was significantly higher than that in the control group (92.9% [SD 10.0]; P=.02). The EuroQol-5D in the intervention group yielded a mean (SD) index of 0.875 (0.156), which was significantly higher than that in the control group (0.741 [0.177]; P<.001). Approximately 60% (29/50) of the patients used the messaging module to communicate with pharmacists. The most frequent types of messages were acknowledgments (77/283, 27.2%), doubts about contraindications and interactions with OAAs (70/283, 24.7%), and consultations for adverse reactions to treatment (39/283, 13.8%). The satisfaction with the app survey conducted in the intervention group yielded an overall mean (SD) score of 9.1 (0.4) out of 10. CONCLUSIONS: Use of e-OncoSalud for the real-time follow-up of patients receiving OAAs facilitated the optimization of some health outcomes. The intervention group had significantly higher health-related quality of life and adherence to treatment than the control group. Further, the probability of the intervention group presenting with side effects was significantly lower than that of the control group.

Exposición a fármacos asociados a agravamiento de síntomas en pacientes con miastenia grave / Drug exposure associated with exacerbation of symptoms in patients with myasthenia gravis

INTRODUCCIÓN: Numerosos fármacos se han relacionado con el agravamiento de síntomas en pacientes con miastenia grave, pero hasta la fecha no existen estudios sobre la exposición a fármacos en estos pacientes. OBJETIVOS: Describir el consumo de fármacos y calcular la tasa anual de episodios de exacerbación en una cohorte de pacientes con miastenia grave, y explorar posibles factores de riesgo de exacerbaciones graves. PACIENTES Y MÉTODOS: Estudio observacional longitudinal retrospectivo que incluye a pacientes adultos con miastenia grave seguidos en consulta. Cálculo de frecuencias, tasas y construcción de modelo de eventos repetidos. RESULTADOS: De 91 pacientes incluidos, el 94,51% estuvo expuesto al menos a un fármaco durante el período de estudio (siete años y un mes). De ellos, 51 tuvieron al menos una prescripción de un fármaco contraindicado en la ficha técnica (56,04%). Se contabilizaron 145 exacerbaciones en 50 pacientes. La tasa anual de incidencia fue de 0,35 exacerbaciones por paciente y año. De estas exacerbaciones, 48 fueron graves (en 18 pacientes), con una tasa anual de incidencia de 0,12. Se halló una posible asociación entre diagnóstico de miastenia grave generalizada y timectomía, con un aumento del riesgo de episodios de exacerbación graves. CONCLUSIONES: En esta cohorte se encontró una amplia exposición a fármacos, pero no asociación con el riesgo de episodios de exacerbación graves. Algo más de la mitad de pacientes tuvo al menos un episodio de exacerbación durante el período de estudio, la mayoría leves. Son necesarios estudios que corroboren estas conclusiones y puedan estudiar posibles correlaciones entre fármacos y el riesgo de episodios de exacerbación

INTRODUCTION: Numerous drugs have been related to exacerbation of myasthenia gravis. So far there are no studies examining the extent of use of drugs related to exacerbation of myasthenia gravis. AIMS: We sought to assess the extent of use of drugs related to exacerbations and the annual incidence rate of exacerbations in a cohort of myasthenia gravis patients. We explored possible risk factors of severe exacerbations. PATIENTS AND METHODS: We performed a retrospective cohort study. We included adult patients followed in neurology department. We estimated frequencies, rates and built a recurrent events model. RESULTS: We included 91 patients. 94.51% of patients had at least one prescription of a drug. 51 patients had at least one prescription of a drug contraindicated according to its drug label. 145 exacerbation episodes were reported in 50 patients. The annual incidence rate of exacerbation episodes was 0.35. 48 exacerbations were severe (in 18 patients). The annual incidence rate of severe exacerbation episodes was 0.12. Generalized myasthenia gravis and thymectomy were associated with a higher risk of severe exacerbation episodes. CONCLUSIONS: Our patients were extensive and widespread exposed to drugs during the follow-up period but we did not find and association with severe exacerbation episodes. Just over half of the patients had at least one exacerbation episode during the study period, most of them were mild. Further studies with larger sample sizes are necessary to corroborate these conclusions and to study possible correlations between the use of drugs and the risk of exacerbation episodes

Novel mobile application for direct communication between pharmacists and patients treated with oral antineoplastic agents.

PURPOSE: Initial experience with use of a smartphone application to enhance communication with and home monitoring of hematology/oncology patients under treatment with oral antineoplastic agents (OAAs) is described. SUMMARY: Broad use of OAAs is changing the landscape of hematology/oncology patient care, with this form of therapy giving patients greater autonomy but also raising concerns about correct OAA administration and management of adverse effects (AEs) or interactions. Information and communication technologies, specifically mobile health technologies, are ideal tools in this new environment. A multidisciplinary team at a large hospital in Spain developed a smartphone application for patients receiving OAA therapy that consists of 5 modules or functionalities: (1) a treatment agenda, or electronic journal of patient activity, including medication use; (2) a treatment record; (3) continuous recording of vital signs (blood pressure and temperature), health-related quality of life, and AEs, with management of AEs based on an algorithm that displays different recommendations according to AE severity; (4) 2-way messaging capability; and (5) information and links to websites of interest. From June through November 2017, 37 patients downloaded and used the application. About two-thirds (68%) of the patients sent a total of 182 messages to the pharmacist on duty; 58% of the patients registered at least 1 AE. The mean time of registration of the first AE after initiation of OAA therapy was 8 days. As a result of patient use of the application, 2 emergency room visits were avoided and 3 patients were referred to a general practitioner. CONCLUSION: The application has allowed real-time monitoring of patients treated with OAAs. This new patient-pharmacist communication channel has facilitated the early detection of AEs, contributing to the safety of treatment and patient satisfaction with healthcare.

Necesidades sociosanitarias en pacientes con intolerancia hereditaria a la fructosa en España / Social and health care needs in patients with hereditary fructose intolerance in Spain

INTRODUCCIÓN: La intolerancia hereditaria a la fructosa es una enfermedad metabólica debida a una deficiencia en la aldolasa B. Nuestro objetivo es conocer las necesidades sociosanitarias del colectivo. METODOLOGÍA: Estudio observacional prospectivo en el que se difundió una encuesta de necesidades sociosanitarias a pacientes con intolerancia hereditaria a la fructosa residentes en España. RESULTADOS: La mayoría disponían de diagnóstico, confirmado principalmente por análisis genético en menores y sobrecarga de fructosa en adultos, no padecían secuelas (72,34%) ni discapacidad (64%) y el 83,33% de niños tomaban medicamentos frente al 52,38% de adultos (p < 0,05) (2,06 medicamentos de media). La mayoría acudieron a consultas en los dos últimos años, principalmente unidades de enfermedades metabólicas (42,5%) y/o nutricionista (42,5%), aunque menos de la mitad eran atendidos en centros de referencia (mayoritariamente niños [p < 0,05]). El 48% estaban satisfechos con la atención sanitaria aunque se sintieron discriminados en actividades de ocio, escolares, sanitarias y/o cotidianas. Las fuentes más fiables de información fueron el médico de atención especializada (69,39%) y la asociación de pacientes (59,18%). El 54% no indicaron ningún problema en ninguna de las dimensiones de calidad de vida, aunque algunos tuvieron problemas en actividades cotidianas, dolor y ansiedad. CONCLUSIONES: Aunque su perfil no sea tan discapacitante como el de otras enfermedades raras, es importante conocer las necesidades del paciente con intolerancia hereditaria a la fructosa. Aunque se han reducido los tiempos en el diagnóstico, la menor atención y satisfacción sanitaria en adultos hace necesario incidir en las necesidades de esta población, siendo clave la formación e información de los profesionales sanitarios

INTRODUCTION: Hereditary fructose intolerance is a metabolic disease due to an aldolase B deficiency. Our objective was to ascertain the social and health care needs of those with this deficiency. MATERIAL AND METHODS: A prospective, observational study was performed. A survey of social and health care needs was conducted to hereditary fructose intolerance patients living in Spain. RESULTS: Most patients had been diagnosed, mainly by genetic analysis in children and based on fructose overload in adults. Population surveyed had no sequelae (72.34%) or disability (64%), and 83.33% of children and 52.38% of adults were taking drugs (p < .05) (2.06 drugs on average). Most patients had attended medical visits in the past two years, mainly in metabolic disease units (42.5%) and/or nutrition units (42.5%), but less than a half attended reference centers (mostly children [p < 0.05]). Although 48% were satisfied with health care, they felt discriminated in recreational activities, school, health and/or daily activities. The most reliable sources of information were the specialized care physician (69.39%) and patients' association (59.18%). Fifty-five percent reported no problem in any quality of life dimension, although some had problems in daily activities, pain, and anxiety. CONCLUSIONS: Although hereditary fructose intolerance is less disabling than other rare diseases, it is important to know the needs of those who suffer from it. Although time to diagnosis has shortened, the poorer health care and satisfaction with it perceived in adults makes it necessary to emphasize the needs of this population, and the critical need of training and information of health care professionals

Risks and medication errors analysis to evaluate the impact of a chemotherapy compounding workflow management system on cancer patients' safety.

A failure modes, effects and criticality analysis was supported by an observational medication error rate study to analyze the impact of Phocus Rx®, a new image-based workflow software system, on chemotherapy compounding error rates. Residual risks that should be a target for additional action were identified and prioritized and pharmacy staff satisfaction with the new system was evaluated. In total, 16 potential failure modes were recognized in the pre-implementation phase and 21 after Phocus Rx® implementation. The total reduction of the criticality index was 67 percent, with a reduction of 46 percent in material preparation, 76 percent in drug production and 48 percent in quality control subprocesses. The relative risk reduction of compounding error rate was 63 percent after the implementation of Phocus Rx®, from 0.045 to 0.017 percent. The high-priority recommendations defined were identification of the product with batch and expiration date from scanned bidimensional barcodes on drug vials and process improvements in image-based quality control. Overall satisfaction index was 8.30 (SD 1.06) for technicians and 8.56 (SD 1.42) for pharmacists (p = 0.655). The introduction of a new workflow management software system was an effective approach to increasing safety in the compounding procedures in the pharmacy department, according to the failure modes, effects and criticality analysis method.

Social and health care needs in patients with hereditary fructose intolerance in Spain. / Necesidades sociosanitarias en pacientes con intolerancia hereditaria a la fructosa en España.

INTRODUCTION: Hereditary fructose intolerance is a metabolic disease due to an aldolase B deficiency. Our objective was to ascertain the social and health care needs of those with this deficiency. MATERIAL AND METHODS: A prospective, observational study was performed. A survey of social and health care needs was conducted to hereditary fructose intolerance patients living in Spain. RESULTS: Most patients had been diagnosed, mainly by genetic analysis in children and based on fructose overload in adults. Population surveyed had no sequelae (72.34%) or disability (64%), and 83.33% of children and 52.38% of adults were taking drugs (p <.05) (2.06 drugs on average). Most patients had attended medical visits in the past two years, mainly in metabolic disease units (42.5%) and/or nutrition units (42.5%), but less than a half attended reference centers (mostly children [p <0.05]). Although 48% were satisfied with health care, they felt discriminated in recreational activities, school, health and/or daily activities. The most reliable sources of information were the specialized care physician (69.39%) and patients' association (59.18%). Fifty-five percent reported no problem in any quality of life dimension, although some had problems in daily activities, pain, and anxiety. CONCLUSIONS: Although hereditary fructose intolerance is less disabling than other rare diseases, it is important to know the needs of those who suffer from it. Although time to diagnosis has shortened, the poorer health care and satisfaction with it perceived in adults makes it necessary to emphasize the needs of this population, and the critical need of training and information of health care professionals.

Impacto de la intervención farmacéutica realizada a pacientes oncológicos en farmacia comunitaria / Impact of the pharmaceutical intervention performed on cancer patients in community pharmacy

INTRODUCCIÓN: Los pacientes oncológicos en tratamiento ambulatorio con antineoplásicos orales constituyen una población susceptible de beneficiarse de la Atención Farmacéutica. Conseguir un óptimo resultado de la terapia farmacológica es fundamental para la mejora de la calidad de vida de estos pacientes. OBJETIVO: Llevar a cabo un estudio de atención farmacéutica en pacientes con cáncer en tratamiento ambulatorio de dispensación en farmacia comunitaria con el objetivo de realizar asistencia al paciente, dispensación y seguimiento de un tratamiento farmacoterapéutico registrando y documentando la intervención farmacéutica. MÉTODO: Se trata de un estudio cuasi-experimental antes-después, con seguimiento longitudinal, prospectivo y con finalidad analítica. Se recogió la información directa de cada paciente a través de una entrevista, un total de 95, analizando todos los aspectos relacionados con su medicación. Se realizaron intervenciones a distintos niveles siempre que fue necesario. Se valoró la adherencia al tratamiento por el Test Morinsky-Gren-Levine, y la efectividad de la intervención sobre la sintomatología mediante el test estadístico de McNemar. RESULTADOS: Un 88,9 % de pacientes no adherentes pasaron a serlo tras la intervención farmacéutica. La intervención enfocada a controlar la sintomatología resultó significativa estadísticamente. CONCLUSIÓN: En paciente oncológico, la atención farmacéutica integral incide en una mejora del cumplimiento terapéutico y en la calidad de vida del paciente

INTRODUCTION: An optimal result of pharmacological therapy is essential to achieve the improvement in the quality of life of these patients. OBJECTIVE: To carry out a study of pharmaceutical care in patients with cancer in outpatient dispensing treatment in community pharmacy, evaluating the effectiveness of this program. To this end, the evaluation of the adherence to the pharmacological treatment and the control of the symptomatology of the disease are done, recording and documenting the obtained data. METHOD: This is a quasi-experimental, before-after study with longitudinal, prospective and analytical monitoring. The direct information of each patient was collected through an interview (a total of 95 interviews were conducted) analyzing all aspects related to their medication. Interventions were performed at different levels whenever necessary. Adherence to treatment was assessed by the Morinsky-Green-Levine Test whereas the effectiveness of the intervention on symptomatology was determined using the McNemar statistical test. RESULTS: The total number of patients included in the study were 95. Out of the total, 88.9% of non-adherent patients became adherent after the intervention. The intervention focused on minimizing adverse reactions was significant statistically. CONCLUSION: In oncological patients, pharmaceutical advice has an impact on therapeutic accomplishment improvement but also in the quality of life of the patient

Measure of adherence to direct-acting antivirals as a predictor of the effectiveness of hepatitis C treatment.

Background Adherence to direct-acting antivirals could be a predictor response to these treatments in hepatitis C. Objective To assess the ability of three methods of measuring adherence to direct-acting antivirals [pill counts, pharmacy dispensing record and Simplified Medication Adherence Questionnaire (SMAQ)] as predictors of their effectiveness. Setting Study conducted by the pharmacy department of the hospital. Methods: A retrospective study was performed. Patients ≥ 18 years with hepatitis C that started and completed treatment with direct-acting antivirals between the 1st-April-2015 and 28st-February-2016 were enrolled. To evaluate the predictive ability to obtain a response to treatment, Chi squared test, Mann-Whitney-U test and ROC-curves were used. Main outcome measure Adherence to antivirals was assessed by three methods and response to treatment, which was defined as obtaining a viral load of hepatitis C virus ≤ 15UI/ml at week 12 after the end of treatment. Results 128 patients were enrolled. The overall average adherence obtained with SMAQ (99.09%) was similar to the pill counts (96.40%, p = 0.043) and pharmacy dispensing record (91.10%, p = 0.02). There was no correlation between the percentage of patients considered as adherent by SMAQ (99.09%) and the achievement of response to treatment (96.40%, p = 0.999). The ROC-curve obtained for the pill count method shows a global area under the curve of 0.53. For pharmacy dispensing record method, patients with an adherence ≤ 66.66% have a high probability of not achieving response (sensitivity and specificity of 79.00% and 100.00%, respectively). Conclusions Pharmacy dispensing record is shown as the best indicator of adherence to predict therapeutic failure in our study.

Development and Evaluation of a Clinical Decision Support System to Improve Medication Safety.

BACKGROUND: Clinical decision support systems (CDSSs) are a good strategy for preventing medication errors and reducing the incidence and severity of adverse drug events (ADEs). However, these systems are not very effective and are subject to multiple limitations that prevent their implementation in clinical practice. OBJECTIVES: The objective of this study was to evaluate the effectiveness of an advanced CDSS, HIGEA, which generates alerts based on predefined clinical rules to identify patients at risk of an ADE. METHODS: A multidisciplinary team defined the system and the clinical rules focusing on medication errors commonly encountered in clinical practice. Four intervention programs were defined: (1) dose adjustment in renal impairment; (2) adjustment of anticoagulation/antiplatelet therapy; (3) detection of biochemical/hematologic toxicities; and (4) therapeutic drug monitoring. We performed a 6-month observational prospective study to analyze the effectiveness of these clinical rules by calculating the positive predictive value (PPV). RESULTS: The team defined 211 clinical rules. During the study period, HIGEA generated 1,086 alerts (8.9 alerts per working day), which were reviewed by pharmacists. Fifty-one percent (554/1,086) of alerts generated an intervention to prevent a possible ADE; of these, 66% (368/554) required a documented modification to therapy owing to a real prescription error intercepted. The intervention program that induced the highest number of modifications to therapy was the dose adjustment in renal impairment program (PPV = 0.51), followed by the adjustment of anticoagulation/antiplatelet therapy program (PPV = 0.24). The percentage of accepted interventions was similar in surgical units (68%), medical units (67%), and critical care units (63%). CONCLUSION: Our study offers evidence that HIGEA is highly effective in preventing potential ADEs at the prescription stage.

Implementation of a pharmaceutical care program for patients with hepatitis C treated with new direct-action antivirals.

Background A pharmaceutical care program is necessary to improve the management of direct-acting antivirals in hepatitis C. Objective Describe health outcomes obtained with the implementation of a pharmaceutical care program in Hepatitis C patients treated with direct-acting antivirals. Setting This study was performed in a pharmacy department of a university hospital. Methods Retrospective study between 1st-April 2015 and 28st-February 2016. Hospital pharmacists implemented interventional measures for validation of antivirals prescriptions, detection of drug-interaction, adverse drug events, education and patient´s adherence to antiviral regimen. Main outcome measure Health and quality outcomes of the implementation of the pharmaceutical care program. Results A total 128 patients were enrolled. The overall sustained virologic response at week 12 post-treatment rate was 96.1% (95% CI 92.7-99.5). Adverse drug events occurred in 90.6% of the patients, and the majority were grade 1-2. Pharmacists made 334 pharmaceutical interventions. 35.5% of these interventions were aimed to resolve negative results of drugs. 80.9% of the negative results of drugs improved or were eliminated with the application of the measures proposed by the pharmacists (p ≤ 0.001). Pharmacists carried out 175 preventive interventions to avoid negative results of drugs. 97.3% of these interventions were accepted and managed to prevent the appearance of negative results of drugs (p = 0.453). Conclusion The implementation of a pharmaceutical care program in patients with hepatitis C treated with direct-acting antivirals has improved the safety in the use of these drugs.

Influence of particle size and intestinal conditions on in vitro lipid and protein digestibility of walnuts and peanuts.

A static in vitro model was used to assess walnuts and peanuts macronutrient digestion of with two different particle size. Nuts were digested under different intestinal conditions of pH (6 or 7), bile concentration (1-10 mM) and pancreatic concentration (1000 to 4000 LU/g fat) the matrix degradation index (MDI), proteolysis and lipolysis were analyzed. Results showed that nuts particle size affects proteolysis and MDI the most; intestinal pH was more relevant in free fatty acids release. Lipolysis extent was lower under suboptimal intestinal conditions of pH 6 and bile salts 1 mM, and in peanuts it was lower than walnuts (567, 585, 134 and 398 mg FFA/g fat in large and small walnuts, and large and small peanuts, respectively). The higher the pancreatic concentration the higher the proteolysis extent in walnuts; in peanuts, protein digestibility was limited even at high pancreatic concentration at pH 6 and bile concentration 1 mM.