Severe neutropenia probably caused by enzalutamide and abiraterone in a prostate cancer patient.

INTRODUCTION: Abiraterone and enzalutamide are two androgen receptor pathway inhibitors approved, among others, for the treatment of metastatic castration-resistant prostate cancer in adult men whose disease has progressed on or after a docetaxel-based regimen. Although hematological effects, especially neutropenia, are one of the main complications of other oral antineoplastic drugs, these adverse effects are infrequent in the case of androgen receptor pathway inhibitors. CASE REPORT: We report the case of a patient diagnosed with metastatic castration-resistant prostate cancer who discontinued an androgen receptor pathway inhibitor due to drug-related grade 4 neutropenia. His control blood counts before enzalutamide starting were normal. After one month of treatment, he developed a grade 4 neutropenia, with complete neutrophil count recovery four weeks later. He underwent a bone marrow aspiration, which revealed normocelullar results, and enzalutamide was restarted. Three weeks later, the treatment was eventually discontinued due to neutropenia reappearance. Neutrophil count recovery was achieved one month later. Then, he started treatment with abiraterone, but two weeks later neutropenia reappeared. Abiraterone was withdrawn, and the patient recovered from neutropenia 2 weeks later. MANAGEMENT AND OUTCOMES: This case exposes not only the occurrence of rare toxicity of two individual drugs but also the description of a probable drug-class adverse event not reported before. The patient recovered from neutropenia after the androgen receptor pathway inhibitor was withdrawn, thereby supporting the diagnosis of probable drug-induced neutropenia. DISCUSSION: There is scarce evidence in the literature concerning androgen receptor pathway inhibitor-related neutropenia. However, its life-threatening potential cannot be ignored, so healthcare professionals should be warned of the possibility of the occurrence of such adverse reactions.

Impact of preoperative pharmaceutical care consultation on medication errors in surgical patients: a comprehensive analysis.

OBJECTIVE: Assessing the impact of introducing preoperative pharmaceutical care consultations by analyzing the severity of prevented medication errors (MEs) and their potential effects on the surgical process. METHODS: Preoperative pharmaceutical care consultation was implemented in our hospital to assess the preoperative medication management of surgical patients between the pre-anesthesia consultation and the day of surgery. Pharmacists evaluated the appropriateness of medication management based on a consensus multidisciplinary institutional protocol. All errors identified between 2016 and 2020 were analyzed, and their severity and potential impact on surgery were standardized. A list of therapeutic groups was created to prioritize patients for consultations. RESULTS: During the study period, 3,105 patients attended the consultations and 1,179 MEs were prevented. According to severity, 30.6% of MEs were classified as category E and 26.2% as D. The Number Needed to Treat to prevent a category E or higher ME (indicating potential harm to patients) was 5 patients. About 14.84% of MEs belonged to the prioritized drug groups. One hundred and thirteen errors would have resulted in a surgery delay of more than 24 h, and 175 errors were classified as G-H (irreversible damage). CONCLUSIONS: This study highlights the effectiveness of pharmaceutical care consultations in preventing MEs and improving surgical outcomes.

Remdesivir and SARS-CoV-2 monoclonal antibodies to prevent COVID-19 progression in hematological patients: an observational study.

BACKGROUND: Patients with hematological malignancies (HM) are at high risk of COVID-19 progression. Hence, early treatments to prevent progression are needed. The aim of our work was to evaluate the effectiveness and safety of remdesivir (RDV) and SARS-CoV-2 monoclonal antibodies (mAb) in patients with HM and mild-to-moderate disease in real clinical practice. METHODS: We conducted a prospective study in a tertiary hospital in 55 HM patients with mild-to-moderate SARS-CoV-2 disease diagnosed between August 2021 and July 2022 and who received RDV or mAb to prevent COVID-19 progression (related death or hospitalization). The primary endpoint was COVID-19 progression on day 28. Other outcomes were COVID-19 progression beyond day 28 and viral load evolution. RESULTS: RDV was administered to 44 (80.0%) patients and mAb to 11 (20.0%) patients. Death occurred in 1 (1.8%) patient and hospitalization in 9 (16.4%) patients by day 28, respectively; 3 patients (5.5%) required intensive care and 8 (14.5%), oxygen support. Of note, 5 additional patients [15, (27.3%) in total] died or required hospitalization after day 28. Two hazard Cox regression models yielded the absence of anti-SARS-CoV-2 antibodies, age over 65 years, and ECOG-performance status ≥ 2 as the main risk factors for COVID-19-related death or hospitalization. CONCLUSION: Our results from clinical practice suggest that RDV and SARS-CoV-2 mAb therapies elicit worse outcomes in hematological patients than those reported for high-risk population in clinical trials.

[Translated article] Achieving excellence in the pharmaceutical care of the surgical patient.

The perioperative setting is one of the hospital areas with the highest prevalence of medication errors. Despite the wide experience of hospital pharmacists in developing medication safety programs and improvement initiatives, the perioperative setting has remained one of the areas in which there is less experience. Clinical pharmacist should be integrated into the multidisciplinary care team so that they can be involved in the different surgical phases of care, which include from the preoperative assessment to inpatient stay, and finally discharge from hospital. Their work will consist of coordinating and implementing strategies that have been demonstrated to reduce medication errors during the perioperative process. The aim of this paper is to introduce a specialized pharmaceutical care program to achieve excellence in the pharmaceutical care of surgical patients. This program is especially aimed at promoting the figure of the clinical pharmacist in the perioperative setting to guarantee the highest quality and safety in pharmacotherapeutic care throughout all the surgical phases of care.

Achieving excellence in the pharmaceutical care of the surgical patient. / Hacia la excelencia en la atención farmacéutica al paciente quirúrgico.

The perioperative setting is one of the hospital areas with the highest prevalence of medication errors. Despite the wide experience of hospital pharmacists in developing medication safety programs and improvement initiatives, the surgical environment has remained one of the areas in which there is less experience. Clinical pharmacist should be integrated into the multidisciplinary care teams so that they can be involved in the different surgical phases of care, which include from the preoperative assessment to inpatient stay, and finally discharge from hospital. Their work will consist of coordinating and implementing strategies that have been demonstrated to reduce medication errors throughout the perioperative process. The aim of this paper is to introduce a specialized pharmaceutical care program to achieve excellence in the pharmaceutical care of surgical patients. This program is especially aimed at promoting the figure of the clinical pharmacist in the perioperative setting to guarantee the highest quality and safety in pharmacotherapeutic care throughout all the surgical phases of care.

A smartphone app to improve the safety of patients undergoing treatment with oral antineoplastic agents: 4 years of experience in a university hospital.

Objective: This study aims to analyze the impact of the eOncosalud app on the management and follow-up of adverse effects (AE) in patients receiving oral antineoplastic agents. Material and methods: We performed an observational, prospective study of cancer outpatients treated with oral antineoplastic agents (OAA), monitored by the eOncosalud app between August 2017 and October 2021. Safety variables were collected from eOncosalud: the number of AE; severity of the AE according to CTCAE, version 4.03; timelapse from app installation to first recorded AE; automatic recommendations issued; and the patient's acceptance of the recommendations made. To assess the impact of the recommendations generated by the algorithm, we calculated the positive predictive value (PPV) as the number of recommendations accepted out of the total number of recommendations generated. Safety-related patient messages were also analyzed (AE, drug-drug interactions, drug administration). Result: The app was downloaded and used by 186 patients (58.0% women), with a mean age of 59.0 years. A total of 1,368 AE were recorded, the most frequent being fatigue (19.37%), diarrhea (18.20%), and skin changes (9.21%). Regarding the recommendations issued by the app algorithm, 102 patients received 344 information brochures, 39 patients received 51 recommendations for supportive care to control AE, 60 patients received 240 recommendations to visit their primary care doctor, 14 patients received 16 recommendations to contact their specialist pharmacist or oncologist-hematologist, and 34 patients received 73 recommendations to go to the emergency room. The suggestion to go to the emergency room and contact the specialist pharmacist or oncologist-hematologist had a PPV of 0.51 and 0.35, respectively. Half of the patients (50.4%) used the messaging module. A total of 1,668 messages were sent. Of these, 47.8% were related to treatment safety: AE, 22.7%; drug-drug interactions, 20.6%; drug administration, 3.6%; and missing a dose, 1.0%. Conclusions: The eOncosalud app enables close, real-time monitoring of patients treated with OAA. The automatic recommendations through the app's algorithm have optimized available healthcare resources. The app facilitated early detection of AE, thus enabling patients themselves to improve the safety of their treatment.

Patient-reported outcomes and mobile applications. A review of their impact on patients' health outcomes.

OBJECTIVE: To review the evidence of the mobile apps in collection patient- reported outcomes and their impact on health outcomes. Method: A review was conducted of the literature on apps aimed at collecting  patient-reported outcomes. Selected articles were required to consider the  apps' impact on patients' health outcomes. The search was carried out during  April 2021 in Pubmed and Embase using the search terms "app", "mobile  applications" , "patient-reported outcomes", "outcome assessment, health  care", and "quality of life", To be included articles had to be written in English  or Spanish and they were required to dwell on apps used by patients, family  members and/or caregivers that measured at least one health outcome. No  time restrictions were applied. RESULTS: Of the 26 articles reviewed, 19 (73.1%) were clinical trials, 4  (15.4%) were quasi-experimental studies, and 3 (11.5%) were observational studies. A pharmacy department was involved in 4 studies  (15.4%), and 3 (11.5%), were carried out in Spain. The sample size ranged  from 14 to 411. Depending on the study population, the most frequent studies included cancer patients (42.3%) and patients with cardiovascular  diseases (26.9%). Most of the studies focused on measuring the impact of the app on the patients' quality of life (50.0%), control of clinical parameters  (46.2%), adherence (38.5%), and management of symptoms and/or reduction  of complications (26.9%). Overall efficacy in terms of the  percentage of studies where apps were found to result in a significant  improvement was 73.1%. The most heavily impacted patient-reported  outcomes were adherence, health-related quality of life and satisfaction. CONCLUSIONS: There is emerging evidence that apps have a positive impact on  patients' health outcomes. These tools have shown to lead to an improvement  in the management of different conditions, with results showing a reduction in  complications rates and in the consumption of resources as well as better  adherence to medication and enhanced patient quality of life.

OBJETIVO: Realizar una revisión sobre la evidencia de las aplicaciones móviles  en el registro de los patient-reported outcomes y su impacto en los resultados  en salud.Método: Revisión de la literatura sobre los estudios de aplicaciones orientadas  al registro de patient-reported outcomes y que analizaran su impacto en los  resultados en salud de los pacientes. La búsqueda se realizó en abril de 2021  en Pubmed y Embase con los términos "App", "Mobile Applications"; "Patient  Reported Outcomes"; "Outcome Assessment, Health Care"; "Quality of Life". Se  incluyeron artículos publicados en inglés o español sin límite de tiempo y  que incluyeran aplicaciones cuyos participantes fueran pacientes, familiares y/o  cuidadores y que midieran algún tipo de resultado en salud. RESULTADOS: De los 26 artículos revisados, 19 (73,1%) fueron ensayos clínicos, 4 (15,4%) estudios cuasiexperimentales y 3 (11,5%) estudios  observacionales. En 4 estudios (15,4%) estaba implicado un servicio  de farmacia y en 3 (11,5%) el estudio fue realizado en España. El tamaño  muestral varió de 14 a 411. En función de la población de estudio, los más  frecuentes incluyeron pacientes oncológicos (11 [42,3%] estudios) y pacientes  con patologías cardiovasculares (7 [26,9%] estudios). La mayoría de los  estudios se centraron en la medición del impacto de las aplicaciones en  términos de calidad de vida (50,0%), control de parámetros clínicos (46,2%),  adherencia (38,5%) y manejo de los síntomas y/o reducción de complicaciones (26,9%). La eficacia global en términos del porcentaje en los que se observó una mejoría significativa con el uso de las aplicaciones fue del 73,1%. Los patient-reported outcomes en los que se observó un mayor impacto fueron la adherencia, la calidad de vida relacionada con la salud y la satisfacción. CONCLUSIONES: Existe evidencia emergente de que las aplicaciones tienen un  impacto positivo en los resultados en salud de los pacientes. Estas herramientas están demostrando una mejora en el manejo de diferentes patologías, con resultados que muestran una reducción de  complicaciones y consumo de recursos y mejoras en la adherencia y calidad de  vida de los pacientes.

Mobile Apps for Hematological Conditions: Review and Content Analysis Using the Mobile App Rating Scale.

BACKGROUND: Hematological conditions are prevalent disorders that are associated with significant comorbidities and have a major impact on patient care. Concerning new tools for the care of these patients, the number of health apps aimed at hematological patients is growing. Currently, there are no quality analyses or classifications of apps for patients diagnosed with hematological conditions. OBJECTIVE: The aim of this study is to analyze the characteristics and quality of apps designed for patients diagnosed with hematological conditions by using the Mobile App Rating Scale (MARS). METHODS: We performed an observational, cross-sectional descriptive study of all smartphone apps for patients diagnosed with hematological conditions. A search was conducted in March 2021 using the following terms: anemia, blood cancer, blood disorder, hematological cancer, hematological malignancy, hematological tumor, hematology, hemophilia, hemorrhage, lymphoma, leukemia, multiple myeloma, thalassemia, thrombocytopenia, and thrombosis. The apps identified were downloaded and evaluated by 2 independent researchers. General characteristics were registered, and quality was analyzed using MARS scores. Interrater reliability was measured by using the Cohen κ coefficient. RESULTS: We identified 2100 apps in the initial search, and 4.19% (88/2100) of apps met the inclusion criteria and were analyzed. Of the 88 apps, 61% (54/88) were available on Android, 30% (26/88) were available on iOS, and 9% (8/88) were available on both platforms. Moreover, 7% (6/88) required payment, and 49% (43/88) were updated in the last year. Only 26% (23/88) of the apps were developed with the participation of health professionals. Most apps were informative (60/88, 68%), followed by preventive (23/88, 26%) and diagnostic (5/88, 6%). Most of the apps were intended for patients with anemia (23/88, 26%). The mean MARS score for the overall quality of the 88 apps was 3.03 (SD 1.14), ranging from 1.19 (lowest-rated app) to 4.86 (highest-rated app). Only 47% (41/88) of the apps obtained a MARS score of over 3 points (acceptable quality). Functionality was the best-rated section, followed by aesthetics, engagement, information, and app subjective quality. The five apps with the highest MARS score were the following: Multiple Myeloma Manager, Hodgkin Lymphoma Manager, Focus On Lymphoma, ALL Manager, and CLL Manager. The analysis by operating system, developer, and cost revealed statistically significant differences in MARS scores (P<.001, P<.001, and P=.049, respectively). The interrater agreement between the 2 reviewers was substantial (k=0.78). CONCLUSIONS: There is great heterogeneity in the quality of apps for patients with hematological conditions. More than half of the apps do not meet acceptable criteria for quality and content. Most of them only provide information about the pathology, lacking interactivity and personalization options. The participation of health professionals in the development of these apps is low, although it is narrowly related to better quality.

Chimeric Antigen Receptor T Cell Therapy Management and Safety: A Practical Tool From a Multidisciplinary Team Perspective.

PURPOSE: The use process for chimeric antigen receptor T (CAR-T) cell drugs is complex and has been associated with a number of potentially severe complications, which requires management by a multidisciplinary team. Pharmacists are a key element in the team and have roles and responsibilities. Our objective was to develop a structured and practical guide that supports hospital pharmacist responsibilities and defines specific activities in a CAR-T cell therapy program, specifically in Europe. METHODS: A literature review was performed, and the recommendations related to pharmacy practice in CAR-T therapy programs were analyzed. A multidisciplinary team was assembled, and meetings were held to address the key tasks in the CAR-T cells' management process and to create the guide, based on national and international recommendations and in expert's opinions. RESULTS: The multidisciplinary team defined the following key tasks and issued recommendations to improve patient safety, treatment efficacy, and quality: patient selection and evaluation, CAR-T cell drug order to manufacturer, apheresis and material shipment, reception of CAR-T cell drug and storing, CAR-T cell drug prescription and pharmacy verification, CAR-T cell drug thawing and dispensing, CAR-T cell drug administration, patient education, pharmacovigilance and monitoring and outcomes' record and evaluation. In each task the pharmacist's role and how it can improve patient care are defined. A checklist was created to guarantee the compliance of standard operating procedures approved in the institution to manage CAR-T cell therapy and as a tool to collect required data for outcomes' record and evaluation. CONCLUSION: This article provides a consensus set of safety recommendations regarding CAR-T therapy management in clinical practice, easily implementable by other institutions in the European setting. The guide identifies key steps where the involvement of hospital pharmacists would improve the safety and quality of the process and is a support guide to standardize hospital pharmacists' responsibilities within the multidisciplinary team.

Tocilizumab as salvage treatment of refractory pulmonary acute graft-versus-host disease.

INTRODUCTION: Acute graft-versus-host disease GVHD (aGVHD) is the main complication during the first months after bone transplantation. Steroid therapy is clearly the upfront established treatment for aGVHD. However, there are patients with partial response to steroid treatment and steroid-refractory cases. For those patients, a vast number of therapeutic options have emerged, although the evidence is scarce. CASE REPORT: We report the use of tocilizumab as salvage treatment in a patient with corticosteroid refractory pulmonary aGVHD that was admitted to the critical care unit for respiratory support measures. MANAGEMENT & OUTCOME: We decided to use tocilizumab as rescue treatment, after failure of corticosteroid treatment, standard treatment with broad-spectrum antibiotics and etanercept. The patient showed a remarkable clinical improvement two days after first infusion and a total resolution of the symptomatology with normalization of the spirometry tests after 4 weeks of the administration of tocilizumab. DISCUSSION: To the authors' knowledge, this is the first case that describes the effective and safe use of tocilizumab as a rescue treatment in a patient with steroid-refractory pulmonary aGVHD. It showed a rapid onset of action and a favorable safety profile, which could make it an interesting option for the treatment of this potentially fatal complication.

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.

Assessing Apps for Patients with Genitourinary Tumors Using the Mobile Application Rating Scale (MARS): Systematic Search in App Stores and Content Analysis.

BACKGROUND: The large number of available cancer apps and their impact on the population necessitates a transparent, objective, and comprehensive evaluation by app experts, health care professionals, and users. To date, there have been no analyses or classifications of apps for patients with genitourinary cancers, which are among the most prevalent types of cancer. OBJECTIVE: The objective of our study was to analyze the quality of apps for patients diagnosed with genitourinary cancers using the Mobile Application Rating Scale (MARS) and identify high-quality apps. METHODS: We performed an observational cross-sectional descriptive study of all smartphone apps for patients diagnosed with genitourinary cancers available on iOS and Android platforms. In July 2019, we searched for all available apps for patients with genitourinary cancers (bladder, prostate, cervical, uterine, endometrial, kidney, testicular, and vulvar) or their caregivers. Apps were downloaded and evaluated, and the general characteristics were entered into a database. The evaluation was performed by 2 independent researchers using the MARS questionnaire, which rates 23 evaluation criteria clustered in 5 domains (Engagement, Functionality, Esthetics, Information, and Subjective Quality) on a scale from 1 to 5. RESULTS: In total, 46 apps were analyzed. Of these, 31 (67%) were available on Android, 6 (13%) on iOS, and 9 (20%) on both platforms. The apps were free in 89% of cases (41/46), and 61% (28/46) had been updated in the previous year. The apps were intended for prostate cancer in 30% of cases (14/46) and cervical cancer in 17% (8/46). The apps were mainly informative (63%, 29/46), preventive (24%, 11/46), and diagnostic (13%, 6/46). Only 7/46 apps (15%) were developed by health care organizations. The mean MARS score for the overall quality of the 46 apps was 2.98 (SD 0.77), with a maximum of 4.63 and a minimum of 1.95. Functionality scores were quite similar for most of the apps, with the greatest differences in Engagement and Esthetics, which showed acceptable scores in one-third of the apps. The 5 apps with the highest MARS score were the following: "Bladder cancer manager," "Kidney cancer manager," "My prostate cancer manager," "Target Ovarian Cancer Symptoms Diary," and "My Cancer Coach." We observed statistically significant differences in the MARS score between the operating systems and the developer types (P<.001 and P=.01, respectively), but not for cost (P=.62). CONCLUSIONS: MARS is a helpful methodology to decide which apps can be prescribed to patients and to identify which features should be addressed to improve these tools. Most of the apps designed for patients with genitourinary cancers only try to provide data about the disease, without coherent interactivity. The participation of health professionals in the development of these apps is low; nevertheless, we observed that both the participation of health professionals and regular updates were correlated with quality.

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.

Potential drug interactions between targeted oral antineoplastic agents and concomitant medication in clinical practice.

OBJECTIVES: Our objective was to analyze potential drug interactions (PDIs) between targeted OAAs and concomitant therapy in clinical practice. METHODS: A cross-sectional observational study was performed in cancer outpatients who started treatment with a targeted OAA between 1 December 2015 and 31 May 2019. PDIs were analyzed using the Lexicomp® and the database About Herbs®. PDIs were classified according to severity, risk, and reliability ratings and their underlying mechanism. Univariate and multivariate analysis were performed to identify risk factors associated with PDIs. RESULTS: A total of 881 patients were included, of whom 50.9% had at least 1 PDI between the OAA and the concomitant medication. The factors associated with a higher risk of PDIs were polypharmacy (≥5 concomitant medicines) (OR = 3.64 (2.54-5.20), p < 0.001), type of tumor (prostate cancer [OR = not available, p < 0.001], chronic myelogenous leukemia [OR = 5.10 (1.08-24.05), p = 0.040], sarcoma [OR = 4.97 (1.05-23.55), p = 0.043]), and treatment with hormone therapies (OR = not available, p < 0.001). CONCLUSION: A search of PDIs should be prioritized, especially in patients receiving targeted OAAs with risk factors, such as polymedication, prostate cancer, chronic myelogenous leukemia, sarcoma, and treatment with hormone therapies.

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.

Design of the functional requirements of a smartphone app for patients receiving oral antineoplastic agents: The e-OncoSalud® app.

OBJECTIVE: To design a mobile app based on the needs of the onco-hematological patient receiving oral antineoplastic agents. METHODS: A multidisciplinary working group (pharmacy-oncology-hematology) was created to design the app. The study was developed in three phases: first, we analyzed the features of patients receiving oral antineoplastic agents. We then analyzed available apps for cancer patients. Finally, we designed the app's functionalities. RESULTS: We included 51 patients with middle-advanced age (68.7 years (SD=10.7)). They were polymedicated (mean: 5.3 (SD = 2.7), with numerous drug-drug interactions and adverse effects (all patients presented adverse effects). We then analyzed 166 apps. Most apps had more than one use, the most frequent being information (39.8%) and diagnosis (38.6%). Ten apps (6%) were for registering and monitoring treatment and adverse effects. Almost half of the apps (48.8%) were developed by healthcare organizations. Finally, we designed an app (e-OncoSalud®) with the following functionalities: (a) agenda; (b) treatment and drug interactions checker; (c) continuous recording of self-controls (weight, blood pressure, general condition) and adverse effects. The management of the adverse effects are based on an algorithm which provides different recommendations according to the adverse effects severity; (d) patient-pharmacist messaging in real-time; (e) education. CONCLUSIONS: After analysis of the main problems affecting these patients and the needs not covered by the existing apps, we designed e-OncoSalud®. It integrates relevant information about their treatment, focused on drug interactions identification and the prevention, and management of adverse effects.

Oral antineoplastic agents: assessment of safety and dose adjustments in clinical practice.

Objectives: Although the safety profile of oral antineoplastic agents (OAAs) is better than that of classic chemotherapy, the rate of severe adverse events (AEs) is high. The objective was to assess the reasons for adjustments to treatment with OAAs during the first 100 days of treatment. Methods: The authors performed a prospective observational study of cancer outpatients who initiated OAAs between November 2015 and October 2017. Dose reductions and treatment interruptions were closely followed-up during the first 100 days after the beginning of treatment with an OAA. The authors described the different safety profile of different OAA classes. Results: The authors included 443 patients (31 different OAA assessed), of whom 53.0% required their OAA to be adjusted during the first 100 days of treatment. A total of 151 patients required dose reductions and/or interruptions of OAAs owing to AEs. The authors identified 203 AEs in these patients. Treatment with sorafenib, lower ECOG performance status, and first-line treatment were associated with a higher proportion of treatment adjustments due to AEs. Conclusion: These results in clinical practice could be a first approach to help healthcare professionals to design patient monitoring programs by identifying priority patients and drugs, and remarks the importance of pharmacovigilance in OAAs.

Trends in hospital consumption of analgesics after the implementation of a pain performance improvement plan / Tendências no consumo hospitalar de analgésicos após a implantação de plano de melhoria do controle da dor

Abstract Background: Pain management committee established a pain performance improvement plan in 2012. Objectives: The aim of the study was to assess the trends in analgesic consumption in a tertiary teaching hospital and the associated economic impact. Methods: A descriptive, retrospective study was conducted between 2011 and 2015. The analysis included: anti-inflammatory and antirheumatic products non-steroids, opioid analgesics and other analgesics and antipyretics. Data are converted into DDD/100 bed-days to analyze consumption trends. Main outcome measure: assessment of the analgesic consumption after the implementation of a pain performance improvement plan. Results: Overall, non-steroidal anti-inflammatory and antirheumatic products consumption decreased in 24.8 DDD/100 bed-days (-28.3%), accounting for most of the total analgesic consumption decrease (-13%) and total cost (-44.3%). Opioid consumption increased markedly from 22.3 DDD/100 bed-days in 2011 to 26.5 DDD/100 bed-days in 2015 (+18.9%). In 2011, the most consumed opioid was morphine (8.6 DDD/100 bed-days). However, there was an increasing trend in fentanyl consumption (from 8.1 to 12.1 DDD/100 bed-days in 2015), which resulted in fentanyl replacing morphine from the most consumed opioid in 2015 (12.1 DDD/100 bed-days). In 2015, the group of other analgesics and antipyretics represented 46.2% of the total analgesic consumption. Acetaminophen was the most commonly consumed analgesic drug (53.2 DDD/100 bed-days in 2015) and had the highest total cost, it represented 55.4% of the overall cost in 2015. Conclusion: Opioid consumption showed an increasing trend during the 5 year period, with fentanyl replacing morphine as the most used opioid. In general, analgesics diminished use was due to the decreasing trend of consumption of non-steroidal anti-inflammatory and antirheumatic products.

Resumo Justificativa: A Comissão para o Manejo da Dor estabeleceu um plano de melhoria no controle da dor em 2012. Objetivo: Avaliar as tendências do consumo de analgésicos em um hospital de ensino terciário e o impacto econômico associado. Métodos: Estudo descritivo, retrospectivo, feito entre 2011 e 2015. A análise incluiu: produtos anti-inflamatórios e antirreumáticos não esteroides, analgésicos opioides e outros analgésicos e antipiréticos. Os dados foram convertidos em DDD/100 leitos-dia para analisar as tendências de consumo. Principal medida do desfecho: avaliação do consumo de analgésicos após o estabelecimento de um plano de melhoria no controle da dor. Resultados: O consumo total de produtos anti-inflamatórios e antirreumáticos não esteroides diminuiu em 24,8 DDD/100 leitos-dia (-28,3%), representando a maior parte da redução total do consumo de analgésicos (-13%) e o custo total (-44,3%). O consumo global de opioides aumentou acentuadamente de 22,3 DDD/100 leitos-dia em 2011 para 26,5 DDD/100 leitos-dia em 2015 (+18,9%). Em 2011, o opioide mais consumido foi a morfina (8,6 DDD/100 leitos-dia). No entanto, houve uma tendência crescente no consumo de fentanil (de 8,1 para 12,1 DDD/100 leitos-dia em 2015), o que resultou na substituição de morfina por fentanil como o opioide mais consumido em 2015 (12,1 DDD/100 leitos-dia). Em 2015, o grupo dos outros analgésicos e antipiréticos representou 46,2% do consumo total de analgésicos. Acetaminofeno foi o analgésico mais consumido (53,2 DDD/100 leitos-dia em 2015) e teve o maior custo total, representou 55,4% do custo total em 2015. Conclusão: O consumo de opioides mostrou uma tendência crescente durante o período de cinco anos, fentanil substituiu morfina como o opioide mais usado. Em geral, o uso diminuído de analgésicos foi devido à tendência decrescente do consumo de produtos anti-inflamatórios e antirreumáticos não esteroides.

A comparative study of contamination in three closed systems for the preparation of hazardous drugs through simulations with fluorescein.

OBJECTIVE: The objective of this study was to compare the environmental contamination generated during the preparation of cytostatic  agents using three different methods through simulations using fluorescein, and  the time required for preparation of each method. METHOD: A comparative study of the processing of fluorescein mixtures using three types of closed systems was conducted at the centralized unit for  hazardous drugs of the Pharmacy Department of a General Teaching Hospital. Environmental contamination was detected in critical points of  connection, and in splashes produced at any other points. The main variable was  qualitative detection of contamination through ultraviolet light when three  methods were compared (method A: ChemoClave®, method B: SmartSite®  valve and Texium® connector, method C: PhaSealTM with BD luer extension). A  final number of 60 mixtures were prepared to detect differences of at least 5%. RESULTS: Qualitative contamination at the critical points during preparation, was  seen in groups A and B for every mixture that was processed. No contamination  at all in critical points was seen in any of the mixtures prepared using  PhaSealTM. Statistically significant differences were found between arms A and  C (p < 0.001) and arms B and C (p < 0.001); no differences were found  between arms A and B. CONCLUSIONS: The combination of PhaSealTM system in conjunction with the BD  luer extension for administering hazardous drugs from a tree modality system  has been shown to be the system with the lowest level of contamination during  processing without increasing the time required for preparation of the mixture.

Objetivo: El objetivo de este estudio fue comparar la contaminación ambiental  generada durante la preparación de fluoresceína y el tiempo de preparación  usando tres sistemas cerrados de transferencia diferentes.Método: Estudio comparativo de elaboración de mezclas de fluoresceína con  tres tipos de sistemas cerrados en una unidad de mezclas peligrosas de un  Servicio de Farmacia de un Hospital General Universitario. Se consideró  contaminación ambiental la detectada en los puntos críticos de conexión y las  salpicaduras generadas en cualquier otro punto distinto. La variable principal fue  la detección cualitativa mediante luz ultravioleta de la contaminación  generada cuando se comparan tres sistemas (sistema A: ChemoClave®, sistema  B: válvula SmartSite® y conector Texium®, sistema C: PhaSealTM con  alargadera luer BD). Se prepararon 60 mezclas para poder detectar  diferencias de al menos el 5%.Resultados: Se detectó contaminación en los puntos críticos durante la  preparación en todas las mezclas de los grupos A y B. No se detectó contaminación en ninguna de las mezclas en las que se usó el sistema  cerrado PhaSealTM. Se encontraron diferencias estadísticas entre los grupos A y  C (p < 0,001) y entre los grupos B y C (p < 0,001); no se encontraron diferencias entre los grupos A y B.Conclusiones: La combinación del sistema PhaSealTM y la alargadera luer BD  para administrar fármacos peligrosos en la modalidad de árbol ha mostrado ser  el sistema con el menor nivel de contaminación durante la preparación, sin que  esto se traduzca en aumento en el tiempo de elaboración.

Oncology Patient Interest in the Use of New Technologies to Manage Their Disease: Cross-Sectional Survey.

BACKGROUND: Information and communication technologies (ICTs) in oncology can revolutionize the medical care of cancer patients. ICTs can promote patients' empowerment and real-time disease monitoring. There is limited information about the impact of ICTs in cancer patients or their level of interest in using these tools for greater management of their condition. OBJECTIVE: This study aimed to understand the ICT usage profile in hematology-oncology patients to identify their needs and determine their level of interest in these technologies as a means of managing their disease. METHODS: A 28-item questionnaire was drawn up by a multidisciplinary team including pharmacists and oncologists. The questions were organized into 3 blocks, which were as follows: block A-sociodemographic characteristics; block B-use of ICTs when searching for health-related information; and block C-usage preferences for health apps. Hematology-oncology patients receiving treatment between May and July 2017 were included. A paper copy of the questionnaire was handed over to patients in either the day hospital or the pharmaceutical care consultancy in pharmacy services. RESULTS: A total of 650 questionnaires were handed out, with a participation of 94.0% (611/650). Patient sociodemographic characteristics were as follows: mean age was 57.8 years (age range: 19-91). Of 611 participants, 40.7% (249/611) had a university education, and 45.1% (276/611) of participants reported their overall state of health to be good. Results from use of ICTs when searching for health-related information were as follows: 87.1% (532/611) of participants were interested in being informed about health-related matters. Of all participants, 75.5% (532/611) sought information from health professionals and 61.3% (375/611) on the internet. Before going to their doctor's appointment, 21.8% (133/611) of patients looked up information about their disease or treatment on the internet. This access to the internet rose to 50.9% (311/611) after their first medical appointment with their oncologist. Usage preferences for health apps were as follows: 82.7% (505/611) had a smartphone, whereas 20.3% (124/611) had a health app installed. Overall, 81.5% (498/611) would use an app if their health professional recommended it to them, but 39.6% (242/611) were not willing to pay for it. CONCLUSIONS: The hematology-oncology patients showed a great deal of interest in searching for health-related information by means of ICTs, especially using smartphones and apps. The issues that drew the most interest in terms of apps were appointment management, advice on disease management, and communication with health professionals. Free access to these features and the recommendation by a health professional are important factors when it comes to their use. Therefore, the health care provider is a key element in the recommendation of ICTs, providing their knowledge and experience concerning their correct usage.