Dolutegravir-Based Dual Therapies in HIV Pretreated Patients: A Real-Life Study in Madrid.

BACKGROUND: Few studies describe the use of dolutegravir (DTG)-based dual therapies under routine clinical practice. OBJECTIVES: To report real-life data on the use of DTG-based dual therapies in treatment-experienced patients. METHODS: This was an observational, retrospective study. It included all treatment-experienced HIV patients starting a DTG-based dual therapy from 2014 to 2018. The primary end point was to identify the incidence and reasons for the switch. The secondary end points were to assess the effectiveness, safety, adherence, and costs after 48 weeks of treatment (W48). RESULTS: The incidence of the switch to a DTG-based dual therapy increased from 1.6 patients per 1000 patient-years in 2014 to 38.6 in 2018. A total of 241 patients initiated this therapy: 113 (46.9%) patients started DTG plus rilpivirine (RPV), 72 (29.9%), DTG plus lamivudine (3TC), and 68 (28.2%), DTG plus boosted-darunavir (b-DRV). A total of 170 patients completed W48 of follow-up. By intention-to-treat analysis, 89.3% of virologically suppressed (VS) patients (94.3% with DTG plus b-DRV, 91.3% with DTG plus 3TC, and 87.2% with DTG plus RPV) and 56.7% of non-VS patients (71.4% with DTG plus RPV and 52.2% with DTG plus b-DRV) achieved a viral load <50 copies/mL at W48. The protocol-defined virological failure was 6.5%. Overall, 8.8% of patients had early discontinuation. The annual cost increased by €800 per patient ($916). CONCLUSIONS AND RELEVANCE: The use of DTG-based dual therapies has increased in real life, showing a favorable effectiveness and safety profile. Treatment costs increased, except for the switch to DTG plus 3TC.

Effectiveness, Safety, and Costs of Dolutegravir/Abacavir/Lamivudine Single-Tablet Regimen in a Real-Life Cohort of HIV-1 Adult Infected Patients.

Background: Real-life data on single-tablet regimen (STR) dolutegravir/abacavir/lamivudine (DTG/ABC/3TC) is scarce, and concerns about DTG neuropsychiatric adverse events (NP-AEs) have recently arisen. Objective: To explore the effectiveness and safety, in particular NP-AEs, of DTG/ABC/3TC in a cohort of HIV-1 adult infected patients. Pill burden, adherence to this STR, and the impact of switching on costs were also evaluated. Methods: This was an observational, retrospective study. The study population included antiretroviral therapy (ART)-naive and treatment-experienced (TE) patients who started DTG/ABC/3TC between February 1, 2016, and October 31, 2016. Effectiveness and safety were analyzed at week 48 (W48) by intention-to-treat analysis. The Cox regression model was used to investigate predictors of DTG/ABC/3TC discontinuation. Results: A total of 253 patients were included (44 ART naïve, 209 TE). At W48, the proportion of patients with virological suppression was 72.7% (95% CI = 58.4-87.0) in ART-naive patients, 85.6% (95% CI = 80.3-90.9) in previously suppressed TE patients, and 86.4% (95% CI = 65.1-97.1) in previously not suppressed TE patients. The rate of protocol-defined virological failure was 4.3%. The incidence of AEs was higher in the subgroup of ART-naive patients (56.1% vs 39.0%), with a rate of interruptions for this reason of 13.6% and 7.6%, respectively. The incidence of NP-AEs was 20.6%, with 3.9% of patients requiring discontinuation. Patients who had switched from a raltegravir-containing regimen discontinued DTG/ABC/3TC because of AEs more frequently (relative risk = 2.83; 95% CI = 1.04-7.72; P = 0.041) in the multivariate analysis. After switching to DTG/ABC/3TC, the median pill burden was reduced from 3 to 1 and the proportion of patients with an adherence <90%, from 20.1% to 12.0%. The annual per-patient ART costs increased by €48 (0.6% increase). Conclusion and Relevance: DTG/ABC/3TC is an effective strategy as first-line and switching ART. Our data suggest a worse tolerance in ART-naive patients, although the rate of discontinuation resulting from NP-AEs was relatively low. In the short-term, the adherence was slightly improved without significant changes in costs.

Repeated antifungal use audits are essential for selecting the targets for intervention in antifungal stewardship.

A previous audit to assess the quality of antifungal use was performed in our hospital in 2011. After 5 years of antifungal stewardship program (AFS), we performed a follow-up audit in order to describe the long-term effect of such program. Using a predefined score, we evaluated the antifungal use in 100 consecutive adult inpatients receiving systemic antifungals. Results of the present audit were compared with those of a previous one, performed in 2011, before the implementation of our AFS. After 5 years, AFS program has induced a change in the population who received antifungal drugs in our hospital with a reduction in medical patients and a relative higher prescription among hematological ones. As for indications, empirical use decreased very significantly (from 62 to 30%, p < 0.001), while tailored treatment (from 20 to 41%, p = 0.001) and prophylaxis (from 15 to 27%, p = 0.03) increased. Compared to 2011, we also observed an improvement in the optimal choice of antifungal drug, route of administration, and microbiological adjustment. However, no significant improvement was observed regarding adequacy of length of therapy or optimal dosage or administration route. Although we observed an increase in the number of optimal DOTs used, the potential estimated savings continued to be high (~ €44,199 for every 100 patients receiving antifungals). Our study is the first to show the impact on the use of antifungal drugs exerted by a prolonged non-coercive AFS program. We also demonstrate the utility of a periodic audit of antifungal use in order to point out new goals for future interventions.

Effectiveness, Safety, and Costs of a Treatment Switch to Dolutegravir Plus Rilpivirine Dual Therapy in Treatment-Experienced HIV Patients.

BACKGROUND: Evidence about the use of dolutegravir (DTG) and rilpivirine (RPV) as an antiretroviral therapy (ART) in treatment-experienced patients is scarce. OBJECTIVE: To explore the effectiveness, safety, and costs of switching to a DTG plus RPV regimen in this population. METHODS: This observational, prospective study included all treatment-experienced patients who switched to DTG plus RPV between November 2014 and July 2016. Patients were excluded if resistance mutations to integrase inhibitors or RPV were found. The effectiveness endpoint was the proportion of patients who achieved virological suppression (viral load [VL] <50 copies/mL) at week 48 (W48). Safety (incidence of adverse events leading to discontinuation and laboratory abnormalities), adherence, and costs were analyzed. RESULTS: A total of 35 patients were included, and 91.4% were virologically suppressed at baseline. Patients were treated with ART for a median of 14 years (interquartile range = 7-20). At W48, 91.4% of patients were virologically suppressed (95% CI = 77.0-98.2). Two of the 3 patients not suppressed at baseline achieved undetectable VL at W48, and 2 patients discontinued DTG plus RPV (intolerance and a drug-drug interaction). None of the virologically suppressed patients at baseline showed virological rebound through W48. There were no significant changes in lipid, liver, and renal profiles. The proportion of patients with an ART adherence >90% increased from 65.6% to 93.8% ( P = 0.004). The annual per-patient ART costs dropped by €665 ( P = 0.265). CONCLUSIONS: Switching to DTG plus RPV seems to be an effective and safe strategy. Significant improvements in patients' adherence and costs were achieved.

Improving pharmacotherapy outcomes in patients with hepatitis C virus infection treated with direct-acting antivirals: The GRUviC project.

BACKGROUND/OBJECTIVE: Pharmaceutical care is needed in hepatitis C virus (HCV)-infected patients treated with direct-acting antivirals (DAA). We describe the implementation of a comprehensive pharmaceutical care programme (CPCP) for HCV-infected patients treated with DAA in a tertiary-care hospital and provide data about health outcomes and costs. METHODS: Quasi-experimental study between 1 April 2015 and 30 June 2016. A group of hospital pharmacists collaborating on HCV infection implemented interventional measures for validation of drug prescriptions, detection of clinically relevant drug-drug interactions and adverse drug events (ADEs), and patient education. Quality, health and cost-effectiveness outcomes were evaluated. RESULTS: A total of 1070 patients were enrolled. Pharmacists made 327 interventions that led to the prevention of 299 (91.4%) medication errors, 16 of which were grade G-H (NCC MERP classification). The main reasons for the pharmacist's intervention were management of 143 drug-drug interactions. The overall sustained virologic response at week 12 posttreatment (SVR12) rate was 93.0% (95% CI 91.4-94.6). The SVR12 was higher than 90.0% in all populations, except in genotype 3 patients (86.0%, 95% CI 78.7-93.9), decompensated cirrhotic patients (81.1%, 95% CI 69.7-92.6) and transplant recipients (86.8%, 95% CI 76.7-96.9). ADEs occurred in 85.5% of the study patients, but only 1.0% (11 patients) experienced an ADE that led to premature discontinuation. The total cost of treatment was €18 279 225 (€17 083 per patient). The most cost-effective treatment was selected in 93.1% of patients. CONCLUSIONS: The implementation of a CPCP developed by hospital pharmacists in patients treated with DAAs for HCV infection is an effective approach that improves patient safety and education. The active involvement of the pharmacist in improving adherence to local guidelines promoted the selection of the most cost-effective treatment in the majority of cases.

Effectiveness and Safety of Ombitasvir-Paritaprevir/Ritonavir and Dasabuvir With or Without Ribavirin for HCV Genotype 1 Infection for 12 Weeks Under Routine Clinical Practice.

BACKGROUND: No previous studies exist examining the effectiveness and safety in real clinical practice of the combination of ombitasvir/paritaprevir/ritonavir and dasabuvir (OBV/PTV/r+DSV). OBJECTIVE: To evaluate the effectiveness and safety in real clinical practice of the combination of OBV/PTV/r+DSV with or without ribavirin for 12 weeks in treatment-naïve and previously treated adult patients with chronic hepatitis C virus (HCV) genotype 1 infection. METHODS: This was an observational study of a prospective cohort of treatment-naïve and pretreated adult patients who received 12 weeks of OBV/PTV/r (25/150/100 mg once daily) and DSV (250 mg twice daily) with or without ribavirin. The primary effectiveness outcome was sustained virological response 12 weeks after the end of treatment (SVR12). Safety outcomes were presented by the incidence of adverse events. RESULTS: A total of 116 of 121 patients achieved a SVR12 (95.9%, 95% CI = 90.6-98.6). The SVR12 rate was 93.8% (95% CI = 86.0-97.9) in cirrhotic patients and 100% (95% CI = 91.4-100.0) in noncirrhotic patients. Adverse events occurred in 91.7% of patients, of which 81.8% were grade 1/2, and none led to premature discontinuation. Grade 3 adverse events were reported in 9.9% of patients. The most frequent adverse event was anemia (52.1%), although only 1.6% had a hemoglobin level below 8 g/dL. The incidence of any adverse event was higher in the group of patients who received ribavirin (96.5% vs 80.0%, P = 0.002). CONCLUSIONS: The combination of OBV/PTV/r+DSV with or without ribavirin for 12-week settings achieved a high rate of SVR12, with an acceptable safety profile in routine clinical care.

[Cost-effectiveness and safety of telaprevir and boceprevir for chronic hepatitis C in real-world clinical practice]. / Coste-efectividad y seguridad de telaprevir y boceprevir para el tratamiento de la hepatitis C crónica en la práctica clínica.

INTRODUCTION: Triple therapy with telaprevir or boceprevir has proven to be effective in the treatment of chronic hepatitis C with response rates of up to 88%. However, the treatment may be associated with important adverse effects and a high economic impact. OBJECTIVE: To assess the cost-effectiveness and safety of triple therapy with telaprevir or boceprevir for the treatment of chronic hepatitis C. METHODS: Retrospective observational study. We included all patients who had started treatment with protease inhibitors before July 31(st), 2013. We evaluated sustained virological response, the cost per patient achieving sustained virological response, and the cost of the supportive treatment for adverse events associated with triple therapy. RESULTS: Fifty-nine patients were included; 35 had been treated with telaprevir (59.3%) and 24 with boceprevir (40.7%). Sustained virological response was achieved by 38 (64.4%) patients: 24 (68.6%) patients in the telaprevir treatment arm and 14 (58.3%) patients in the boceprevir treatment arm. The cost per patient with sustained virological response was 43,555 € (95% CI 35,389-51,722 €). There were no statistically significant differences between the overall costs of therapy with telaprevir, 43,494 € (95% CI 34,795 €-55,092 €) versus boceprevir, 42,005 € (95% CI 32,122-64,243€). The mean cost of supportive care per patient was 1,500 €, while the maximum cost was 11,374 €. Due to adverse events, 8 (13.6%) patients required hospital admission, 22 (37.3%) patients attended the accident and emergency department, and 26 (44.1%) patients needed additional medical consultations. CONCLUSIONS: The treatment of triple therapy with telaprevir or boceprevir resulted in high cost per patient with sustained virological response. Due to adverse events, a high number of patients required supportive care, whose costs should be added to those of triple therapy.

Evaluation of antifungal use in a tertiary care institution: antifungal stewardship urgently needed.

OBJECTIVES: To assess the quality of antifungal use, to propose a point score for this evaluation and to estimate the potential economic savings of an antifungal stewardship programme. METHODS: From December 2010 to January 2011, we identified 100 adult inpatients receiving systemic antifungals. Antifungal use was evaluated by means of a predefined score that considered indication, drug selection, dosage, adjustments after microbiology results, switching to an oral agent and length of treatment. Total antifungal prescriptions [in defined daily doses (DDDs) and days of therapy (DOTs)] and potential cost savings were calculated. RESULTS: Overall, 43% of prescriptions came from medical departments, 25% from haematology/oncology and 17% from intensive care units. The main reasons for starting antifungals were empirical (42%), pre-emptive (20%) and targeted treatment (20%). Antifungals were unnecessary in 16% of cases. Inadequacies in other aspects of antifungal prescription were: drug selection, 31%; dosing, 16%; no switch from intravenous to oral administration, 20%; no adjustment after microbiological results, 35%; and length of therapy, 27%. The number of antifungal DDDs per 1000 patient-days was 65.1. The total number of DOTs was 1556, which added a direct cost of €219 364. Only 51.3% of DOTs were considered optimal. The potential estimated savings would be €50 536. CONCLUSIONS: Major efforts should be made to improve the selection and duration of antifungal therapy. Our study demonstrated the potential cost savings that could be achieved by optimizing antifungal therapy. A stewardship programme should include an instrument to objectively evaluate the adequacy of antifungal use.

Effects of a Pharmacist-Designed Clinical Decision Support System on Antimicrobial Stewardship.

BACKGROUND: Clinical decision support systems (CDSSs) 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: Our objective was to analyze the implementation of a CDSS program in a second-level hospital, describing alerts, recommendations, and the effects 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 defined daily 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.

Implementation and evaluation of a home pharmaceutical care model through Telepharmacy.

OBJECTIVE: To describe the impact of a Specialized Pharmaceutical Care model  that includes pharmacotherapeutic monitoring of patients through an  Telepharmacy platform and home medication dispensing. METHOD: A descriptive and retrospective study conducted in the Pharmacy Service of a tertiary hospital, between 23 March 2020 and 31  December 2021. A new pharmaceutical care model for chronic ambulatory  patients was developed, including: (i) definition of criteria for selecting  Telepharmacy candidate patients; (ii) stratification of patients by risk level; (iii)  definition of individualized pharmacotherapeutic monitoring; (iv)  adaptation of the Pharmacy Service app platform to ensure continuous pharmacotherapeutic monitoring and patient monitoring (e- Oncohealth, e-Midcare and farMcuida), (v) implementation of an appointment  system; and (vi) development of a software module for the management of  home medication delivery. The impact of this pharmaceutical care model was assessed by analyzing indicators of activity, safety, adherence and  perceived quality. Moreover, an additional study on the impact of COVID­19 was developed in order to assess the accessibility of medical care  and continuity of treatment through a survey conducted on a random sample of 100 patients. RESULTS: During the study period, 2,737 patients benefited from the new  remote pharmaceutical care model. A total of 7,758 Telepharmacy consultations were performed. Pharmacotherapeutic monitoring  prevented 1,043 adverse drug reactions, which affected 10.4% of patients  (3.6 adverse drug reactions/patient). Mean adherence to treatment  was 95.2%. Overall satisfaction with the new model was 9.8/10. All patients would recommend this model to other patients. CONCLUSIONS: The new Pharmaceutical care model increases patient safety and  improves treatment adherence, with a high perceived quality. Patient  stratification and individualized follow-up via an Telepharmacy platform were  crucial to the development of this model.

OBJETIVO: Describir el impacto de un modelo de atención farmacéutica especializada que incluye el seguimiento farmacoterapéutico de  los pacientes mediante una plataforma de Telefarmacia y la dispensación de  la medicación en el domicilio.Método: Estudio descriptivo, retrospectivo, llevado a cabo en un servicio de  farmacia de un hospital terciario entre el 23 marzo de 2020 y el 31 de  diciembre de 2021. Se desarrolló un nuevo modelo de atención farmacéutica para la atención de los pacientes crónicos ambulatorios, que incluye: i) definición de los criterios de selección de los pacientes  candidatos a Telefarmacia, ii) estratificación de los pacientes según el nivel de riesgo, iii) definición del seguimiento farmacoterapéutico individualizado, iv)  adaptación de la plataforma de apps del servicio de  farmacia para garantizar el seguimiento farmacoterapéutico continuo y la  monitorización de los pacientes (e-Oncosalud, e-Midcare y farMcuida), v)  implantación de un sistema de citación, y vi) el desarrollo de un módulo  informático para la gestión de la dispensación y entrega de la medicación en el  domicilio. El impacto de este modelo de atención se evaluó mediante el análisis  de indicadores de actividad, seguridad, adherencia y calidad percibida.  Asimismo, se incluyó un estudio adicional sobre el impacto de la  COVID­19 en  la accesibilidad de la atención médica y la continuidad de los  tratamientos, mediante una encuesta a una muestra aleatoria de 100  pacientes. RESULTADOS: Durante el periodo de estudio, 2.737 pacientes se han beneficiado del nuevo modelo de atención farmacéutica a distancia. El número de consultas de Telefarmacia realizadas fue 7.758. El seguimiento  farmacoterapéutico evitó 1.043 eventos adversos asociados a la  medicación, que afectaron al 10,4% de los pacientes atendidos (3,6 eventos  adversos asociados a la medicación/paciente). La adherencia media al  tratamiento de los pacientes fue del 95,2%. La satisfacción global con el nuevo  modelo de atención farmacéutica fue de 9,8/10. El 100% de los  pacientes lo recomendaría a otros pacientes. CONCLUSIONES: Este nuevo modelo de atención farmacéutica aumenta la  seguridad del paciente y mejora su adherencia al tratamiento, con unos índices  de calidad percibida elevados. La estratificación de pacientes y el  seguimiento personalizado mediante la plataforma Telefarmacia resultaron clave en su desarrollo.

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.

Utility of 1,3 ß-d-Glucan Assay for Guidance in Antifungal Stewardship Programs for Oncologic Patients and Solid Organ Transplant Recipients.

The implementation of 1,3 ß-d-glucan (BDG) has been proposed as a diagnostic tool in antifungal stewardship programs (ASPs). We aimed to analyze the influence of serum BDG in an ASP for oncologic patients and solid organ transplant (SOT) recipients. We conducted a pre-post study. In the initial period (PRE), the ASP was based on bedside advice, and this was complemented with BDG in the post-period (POST). Performance parameters of the BDG assay were determined. Antifungal (AF) use adequacy was evaluated using a point score. Clinical outcomes and AF costs were also compared before and after the intervention. Overall, 85 patients were included in the PRE-period and 112 in the POST-period. Probable or proven fungal infections were similar in both groups (54.1% vs. 57.1%; p = 0.67). The determination of BDG contributed to improved management in 75 of 112 patients (66.9%). The AF adequacy score improved in the POST-period (mean 7.75 vs. 9.29; p < 0.001). Median days of empiric AF treatment was reduced in the POST-period (9 vs. 5 days, p = 0.04). All-cause mortality (44.7% vs. 34.8%; p = 0.16) was similar in both periods. The cost of AF treatments was reduced in the POST-period with a difference of 779.6 €/patient. Our data suggest that the use of BDG was a cost-effective strategy that contributed to safely improving the results of an ASP for SOT and oncologic patients.

COVID-19 in hospitalised patients in Spain: a cohort study in Madrid.

Few large series describe the clinical characteristics, outcomes and costs of COVID-19 in Western countries. This cohort reports the first 1255 adult cases receiving anti-COVID-19 treatment at a Spanish hospital (1-24 March 2020). Treatment costs were calculated. A logistic regression model was used to explore risk factors on admission associated with ARDS. A bivariate Cox proportional hazard ratio (HR) model was employed to determine the HR between individual factors and death. We included 1255 patients (median age 65 years; 57.8% male), of which 92.3% required hospitalisation. The prevalence of hypertension, cardiovascular disease and diabetes mellitus (DM) was 45.1%, 31.4% and 19.9%, respectively. Lymphocytopenia (54.8%), elevated alanine aminotransferase (33.0%) and elevated lactate dehydrogenase (58.5%) were frequent. Overall, 36.7% of patients developed ARDS, 10.0% were admitted to an ICU and 21.3% died. The most frequent antiviral combinations were lopinavir/ritonavir plus hydroxychloroquine (44.2%), followed by triple therapy with interferon beta-1b (32.7%). Corticosteroids and tocilizumab were used in 25.3% and 12.9% of patients, respectively. Total cost of anti-COVID-19 agents was €511 825 (€408/patient). By multivariate analysis, risk factors associated with ARDS included older age, obesity, DM, severe hypoxaemia, lymphocytopenia, increased creatine kinase and increased C-reactive protein. In multivariate Cox model, older age (HR 1.07, 95% CI 1.06-1.09), cardiovascular disease (HR 1.34, 95% CI 1.01-1.79), DM (HR 1.45, 95% CI 1.09-1.92), severe hypoxaemia (HR 2.01, 95% CI 1.49-2.72), lymphocytopenia (HR 1.62, 95% CI 1.20-2.20) and increased C-reactive protein (HR 1.04, 95% CI 1.02-1.06) were risk factors for mortality.

Clinical course of severe patients with COVID-19 treated with tocilizumab: report from a cohort study in Spain.

Background: We report the long-term outcomes, changes in laboratory parameters, the incidence of secondary nosocomial infections and treatment cost of a Spanish cohort of patients with severe COVID-19 that received tocilizumab (TCZ).Methods: Retrospective cohort of PCR confirmed adult patients who received TCZ from March 1 to 24, 2020 in a tertiary hospital was analyzed. Patients were followed up until 10 May 2020.Results: We included 162 patients (median age 64 years; 70.4% male). At time of TCZ administration, 48.1% of patients were on invasive mechanical ventilation (IMV). Over a median follow-up of 53 days, 46.9% of patients were discharge in good conditions and 19.8% were still hospitalized. The overall mortality was 33.3%, being higher in patients on IMV than those who did not (46.2% vs 26.7%, P < 0.001). A significant improvement in the lymphocyte count, C-reactive protein, lactate dehydrogenase, and D-dimer was observed. Overall, 43.2% patients presented nosocomial infections, causing death in 8%. Infections were more prevalent in ICU units (63.0% vs 17.1%, P < 0.001). The total cost of TCZ was €371,784.Conclusions: Among the patients who used TCZ, one third died, regardless the improvement in some inflammatory biomarkers. The incidence of secondary nosocomial infections was high.

Improving surgical antibiotic prophylaxis adherence and reducing hospital readmissions: a bundle of interventions including health information technologies.

OBJECTIVES: Infection following orthopaedic surgery is a feared complication and an indicator of the quality of the hospital. Surgical antibiotic prophylaxis (SAP) guidelines are not always properly followed. Our aim was to describe and evaluate the impact of a multidisciplinary intervention on antibiotic prophylaxis adherence to hospital guidelines and 30-day postoperative outcomes. METHODS: The study was carried out from January to May 2016 and consisted of creating a multidisciplinary team, updating institutional guidelines and embedding the recommendations in the computerised physician order entry system which is linked to dose and renal function alerts, educational activities and pharmaceutical bedside care of patients in the orthopaedic department. A prospective pre-post study was carried out in accordance with the Declaration of Helsinki. The following information was recorded: patient and surgery characteristics, adherence to SAP guidelines, surgical site infections, length of hospital stay and rate of readmission 30 days after discharge. Statistical analyses were performed using SPSS 18.0. RESULTS: Eighty three orthopaedic patients of mean±SD age 68.2±17.0 years (44.6% male, 40 in the pre-intervention group and 43 in the intervention group) were included. Cefazolin was the recommended and most commonly administered antibiotic agent. In the intervention group, an improvement in global adherence to guidelines was achieved (76.7% vs 89.9%; p=0.039): antibiotic duration (75.0% vs 97.7%), correct dosage post-surgery (55.0% vs 76.7%), timing of administration (57.5% vs 72.1%), antibiotic pre-surgery prescription (92.5% vs 97.7%). Three surgical site infections were detected in the pre-intervention group and none in the intervention group (p>0.05). Length of hospital stay was reduced by 1 day and readmission decreased by 15% (p=0.038). CONCLUSIONS: SAP is used in daily practice in most orthopaedic patients. The implementation of a multidisciplinary programme based on health technology improved the adherence to guidelines and appeared to reduce the readmission rate.

Pharmacy Department management and organization.

The WHO declared the SARS- CoV-2 outbreak a pandemic in March 11, 2020.  Spain has been the third country with the highest number of reported cases of  COVID-19. In the face of the pandemic, the authorities of the Autonomous  Community of Madrid led an unprecedented transformation of hospital services  by increasing the number of beds available, setting up temporary field hospitals  in fairgrounds, and transforming hotels into support centers for patients with  mild symptoms of COVID-19. In the light that this crisis will continue to be a real threat for the years to come, our hospital pharmacies need to be better prepared for similar outbreaks in the future. During the COVID-19 pandemic, the  Department of Hospital Pharmacy of Hospital General Universitario Gregorio  Marañón has faced four challenges: an exponential increase in the demand for  resources, constant changes to therapeutic protocols and approaches, regulatory changes, and a dramatic impact on hospital staff (strain on human resources  and psychological impact). This article is aimed at describing the main  organizational changes implemented to the Department of Hospital Pharmacy of  Hospital GU Gregorio Marañón and its relationship with other hospital  pharmacies of the Community of Madrid. An account is provided of the strategies to be adopted for reorganizing a Department of Hospital Pharmacy and achieve a safe and effective use of medications. Strategies range from the creation of  integral hospital task groups (COVID-crisis task group, protocolization task  group, research task group) to the adaptation of the internal organization of the  Department of Hospital Pharmacy, which encompasses aspects related to  management and leadership; a communication plan (internal and external);  staff management, and the reorganization and adaptation of processes. People,  patients and professionals are at the core of these strategies. This paper is a  reflection on key factors of "humanization in COVID times".

Con fecha 11 de marzo de 2020 la Organización Mundial de la Salud declaró el  estado de pandemia por SARS-CoV-2. En algunos momentos de la crisis, España fue el tercer país del mundo en número de casos. Las autoridades de la  Comunidad de Madrid, una de las más afectadas, han respondido con una  transformación hospitalaria sin precedentes, aumentando el número de camas  disponibles, creando hospitales de campaña en recintos feriales y transformando hoteles en centros de apoyo para pacientes leves. Dado que la aparición de  estas crisis continuará siendo una amenaza real en los próximos años, es  necesario revisar la preparación de nuestros servicios de farmacia para afrontar  este tipo de situaciones. El reto al que se ha enfrentado el Servicio de Farmacia  del Hospital General Universitario Gregorio Marañón durante la crisis de la  pandemia COVID-19 ha venido determinado por cuatro circunstancias:  incremento exponencial de la demanda de recursos, cambios constantes en los  protocolos y decisiones terapéuticas, cambios regulatorios y gran impacto en las personas (gestión de recursos y gestión de las emociones). En este trabajo  se describen los principales cambios organizativos de un servicio de farmacia a  través de la experiencia del Hospital General Universitario Gregorio Marañón y  sus relaciones con otros servicios de farmacia de la Comunidad de Madrid. Se  detallan los procedimientos que deben contemplarse para la reorganización de  un servicio de farmacia para lograr un uso seguro y eficiente de los  medicamentos. Se detallan desde la participación en los comités globales de  hospital (comité de crisis COVID, comité de protocolización y comité de  investigación) hasta la organización interna del servicio de farmacia, que  incluyen: gestión y liderazgo, plan de comunicación (interna y externa), gestión  de las personas, reorganización y adaptación de los procesos. Las personas,  pacientes y profesionales son los grandes protagonistas de esta actuación, por lo  que incluimos una reflexión sobre los factores clave para la "humanización en  tiempos de COVID".

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.

Use of the EFQM excellence model to improve hospital pharmacy performance.

BACKGROUND: Quality management systems are widely used to improve the quality and efficiency of healthcare services. However, evidence regarding the value of the European Foundation for Quality Management (EFQM) model in improving the performance of hospital departments is lacking. OBJECTIVE: To describe the value of the EFQM model as a quality framework for improving the performance of a hospital pharmacy department (PD). DESIGN: A case study describing the development of the Enablers' criteria of the model and the results achieved. SETTING: PD in a tertiary-care teaching hospital of the Madrid Public Health Service (Spain). INTERVENTIONS: Four self-assessments were conducted using the questionnaire "Perfil" during the period 2008-2017. A quality improvement plan was developed on the basis of the results of each self-assessment. A balanced scorecard was used to track progress. Improvement in quality management was externally evaluated by the Spanish Management Excellence Club in 2010, 2013, and 2017. MAIN OUTCOME MEASURES: Change in the scores obtained in the external assessments, the quality improvement initiatives implemented for each Enabler's criteria, and the results of key performance indicators. RESULTS: The EFQM was a useful framework for self-assessment and a good system for identifying improvement initiatives. The model progressively improved the services provided for patients, the safety and efficiency of pharmacotherapy, productivity of the PD, and customer and staff satisfaction. The external assessment scores exceeded 300 points in 2010, 400 points in 2013, and 500 points in 2017. Scores for all of the criteria progressively improved, particularly in 'people'. CONCLUSIONS: The EFQM was a practical tool for improvement of PD performance, especially in areas such as strategic planning, people management, and innovation. The main difficulties were the lack of decision-making capacity in relevant areas and benchmarking with other PDs.

Robotic dispensing improves patient safety, inventory management, and staff satisfaction in an outpatient hospital pharmacy.

RATIONALE, AIMS AND OBJECTIVES: Implementation of robotic systems in outpatient hospital pharmacies is uncommon. Other than cost, 1 of the barriers to widespread adoption is the lack of definitive evidence that this technology actually reduces dispensing errors and improves inventory management. OBJECTIVE: To identify the frequency of medication dispensing errors before and after the implementation of a robotic original pack dispensing system in an outpatient hospital pharmacy and to analyse the impact of this system on the quality of stock management and staff satisfaction. METHODS: A prospective before-and-after medication error study was performed using a disguised observation technique. Several indicators of stock management and staff satisfaction were monitored. Drugs were dispensed manually by technicians using a barcode-controlled system (preimplementation phase) or the dispensing robot ROWA Vmax (ARX) (postimplementation phase). As not all drugs could be handled by the robot, residual manual dispensing was also used. RESULTS: The dispensing error rate was reduced from 1.31% of prescriptions (43/3284) to 0.63% (19/3004) (relative risk reduction [RRR], 51.7%; 95% CI, 17.3% to 71.8%). The error rate decreased up to 0.12% (3/2496) (RRR, 90.8%; 95% CI, 70.4% to 97.1%) if errors during residual manual dispensing were excluded. The stock-out ratio was reduced from 0.85% to 0.17% (RRR, 80.5%; 95% CI, 49.5% to 92.5%). Daily staff time (median) in stock management was reduced by 59.3% (from 1 hour 36 minutes to 39 minutes). High level of staff satisfaction with this technology was achieved, although it was slightly higher in the group of pharmacists compared to technicians (8.63 ± 0.7 vs 7.78 ± 0.7, P = .046). CONCLUSION: The implementation of a robotic original pack dispensing system substantially decreased the rate of dispensing errors and optimized stock management. Minimizing the number of drugs out of the dispensing robot is critical when attempting to maximize the benefits of its implementation.

Twelve weeks of ombitasvir/paritaprevir/r and dasabuvir without ribavirin is effective and safe in the treatment of patients with HCV genotype 1b infection and compensated cirrhosis: results from a real-world cohort study.

OBJECTIVE: To explore the effectiveness and safety of ombitasvir/paritaprevir/ritonavir and dasabuvir (OBV/PTV/r+DSV) for 12 weeks without ribavirin in adults with chronic HCV genotype 1b infection and compensated cirrhosis. METHODS: Observational study of a prospective cohort of adult patients with HCV genotype 1b infection and compensated cirrhosis who received 12 weeks of OBV/PTV/r and DSV without ribavirin. Effectiveness was assessed by recording the percentage of patients achieving sustained virological response at week 12 post-treatment (SVR12). Safety outcomes were based on the incidence of adverse events. RESULTS: Seventy-eight patients were included. The SVR12 rate was 96.1% (95%CI 89.2-99.2). Adverse events were recorded in 78.0% of patients. Of these, 97.7% were grade 1/2. One patient discontinued treatment prematurely owing to adverse events. Eighty-six interactions were detected in 43 patients (55.1%). Overall, 81.4% of interactions required close monitoring, alteration of drug dosage, or timing of administration. In 7.0% of cases, the interactions arose from contraindications that required the suspension of the concomitant drug. In 11.6% of cases, medicinal plants or foods were withdrawn. CONCLUSIONS: The simplified regimen of OBV/PTV/r+DSV administered for 12 weeks is effective and safe in patients with chronic HCV genotype 1b infection and compensated cirrhosis. No adverse reactions related to drug-drug interactions were recorded.