Clinical evaluation of pulmonary hypertension using patient-reported outcomes: a cross-sectional study.

BACKGROUND: Patients with pulmonary hypertension (PH) have progressive and disabling symptoms, as well as a burden of treatments and a difficult clinical evaluation that make health-related quality of life a particularly relevant endpoint in this disease. The objective of the study was to evaluate patient-reported outcomes of patients receiving specific treatment for PH in a tertiary hospital using a specific questionnaire (Cambridge Pulmonary Hypertension Outcome Review-CAMPHOR) in the pharmacy consultation. METHODS: A cross-sectional, observational, descriptive study was conducted. It included all patients receiving specific treatment for PH in a tertiary hospital in Madrid, Spain. The inclusion period comprised between August to December 2019. CAMPHOR questionnaires containing three domains: symptoms, activities and quality of life were completed by the patients at the pharmacy consultation. Demographic and clinical variables, including WHO Functional Class (WHO FC), PH-specific tests and hemodynamic parameters, were recorded. Non-parametric analyses to assess relations between variables and CAMPHOR domains were performed. RESULTS: Thirty-six patients consented to participate in the study and completed the questionnaire. Median scores for symptoms, activities, and quality of life domains were 5.5 (2.5-10), 8.0 (4.5-10.5) and 3.5 (1-7.5), respectively. Statistically significant differences were found in the three domains when comparing by WHO FC, in the activities domain for 6-m walking test and in the quality of life domain for patients who had emergency visits or hospitalizations in the last year. CONCLUSIONS: The CAMPHOR questionnaire could be useful as a complementary test to achieve an integrated evaluation of PH patients, who could complete it easily during their routine pharmacy visits.

Cancellations of elective surgical procedures due to inadequate management of chronic medications.

WHAT IS KNOWN AND OBJECTIVES: Inadequate management of chronic medication puts patients at risk and causes unnecessary suspension of surgical procedures. The objective of the study was to calculate the rate of cancellation of elective surgical procedures due to inadequate management of chronic medications and to analyse the underlying causes of cancellation. METHODS: We designed an analytic, observational, retrospective study of all elective surgical procedures performed from July to October 2017 in a tertiary hospital. The main variable was the percentage of surgeries cancelled owing to inadequate management of chronic medications. Other variables recorded included demographic characteristics, time between the preanaesthesia evaluation and surgery, drug involved, and the reason for incorrect management of the medication. RESULTS: During the study period, 5415 surgical procedures were programmed, and 793 (14.6%) were cancelled. Cancellations due to inadequate patient preparation accounted for 5.3% (42 cases), and 19 were related to incorrect medication management (2.4% of the total number of cancellations). The 19 patients, who were mostly men (73.7%), had a median age of 76 years (IQR 68-81). The drugs involved were acenocoumarol (6), enoxaparin (4), clopidogrel (4), direct-acting oral anticoagulants (2), acetylsalicylic acid (1), tocilizumab (1) and leflunomide (1). The reasons for drug mishandling were poor understanding of the anaesthesiology recommendations (15) and lack of a preanaesthesia evaluation (4). WHAT IS NEW AND CONCLUSION: Inadequate management of chronic medications (2.4%) is not the most frequent reason for cancellation, although it is one of the easiest to avoid. Based on our results, starting in October 2017, the Pharmacy Department began to offer a pharmaceutical service to patients with doubts about the preoperative management of chronic medications.

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.

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.

[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.

Medication guide for dose adjustment and management of cardiotoxicity and lipid metabolic adverse events of oral antineoplastic therapy.

Objective: The management of cardiotoxicity concerning the use of oral antineoplastic agents (OAAs) is a challenge for healthcare professionals. Our objective was to create a comprehensive medication management guide with dose adjustment recommendations on OAAs concerning cardiotoxic and lipid metabolic adverse events (AEs) to assist healthcare professionals when prescribing OAAs. Materials and methods: A review of the available information on all dose adjustments necessary to safely prescribe and dispense OAAs concerning cardiotoxicity was conducted. In January 2023, we identified all OAAs authorized by the European Medicines Agency (EMA). For each drug, the latest summary of product characteristics (SPC) approved by the EMA and the tertiary data source Lexicomp® were reviewed. Cardiotoxic AEs were recorded, namely, QT interval prolongation, decrease in left ventricular ejection fraction (LVEF), imbalances in blood pressure (hypertension and hypotension), alterations in heart rate (tachycardia and bradycardia), and thrombosis. Any available dose adjustment recommendations in case of an occurrence of these adverse events were collected. Results: In all, 93 different OAAs had been approved by the EMA and were reviewed. Among them, 51.6% have recognized cardiotoxic AEs and 10.8% can cause alterations in lipid metabolism. A total of 27 (29.0%) OAAs had specific recommendations regarding QT prolongation; 88.9% were listed in the SPC and 59.3% in Lexicomp®. Eight OAAs (9.68%) have reported a decrease in LVEF, and four of these drugs, namely, encorafenib, lorlatinib, ripretinib, and sunitinib, have specific management recommendations. Almost half (49.5%) of currently approved OAAs can potentially alter blood pressure; 34 (36.6%) of them have been reported to cause hypertension and 12 (12.9%) are related to hypotension. Tachycardia and/or bradycardia are associated with 22.6% and 8.6% of the evaluated drugs, respectively. Regarding thrombosis, 30 (32.3%) of the drugs analyzed included the appearance of a thrombus as a possible AE. Conclusions: More than half of the OAAs can produce cardiotoxic effects, with the most frequent being blood pressure alteration and QT interval prolongation with a non-depreciable incidence of LV dysfunction or thrombosis. Before starting the treatment, it is necessary to stratify baseline cardiovascular risk, plan a surveillance schedule, and consider referral to cardio-oncology units.

PCSK9 inhibitors revisited: Effectiveness and safety of PCSK9 inhibitors in a real-life Spanish cohort.

INTRODUCTION: Proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) have emerged as a therapeutic option for patients with hypercholesterolemia who do not attain low-density lipoprotein cholesterol (LDL-C) goals and/or are intolerant to other lipid-lowering drugs. Our aim was to analyze the effectiveness and safety of PCSK9i in routine clinical practice and factors related to poor outcomes. MATERIALS AND METHODS: We conducted an ambispective study in 115 patients who recieved alirocumab or evolocumab, in a tertiary level hospital. From February 2017 to April 2020, patients were recruited and followed up for a median of 20.4 months. The main outcomes were relative reduction in LDL-C, percentage of patients achieving the therapeutic goals established by 2016 ESC/EAS guidelines, incidence of major cardiovascular events (MACEs) and drug-related adverse events (ADRs). RESULTS: The median LDL-C achieved was 57.0 mg/dL (relative reduction of 59.9% from baseline, p< 0.001). After adjusting for confounders, smaller LDL-C reductions were related to female sex, absence of concomitant lipid-lowering therapy and treatment with alirocumab. Overall, 84.6% of the patients achieved the therapeutic goals. During follow-up, 7 MACEs were detected. ADRs, generally considered mild, affected 38.1% of the participants (mainly mialgias and arthralgias) and triggered discontinuations in 8.7% of cases. CONCLUSIONS: PCSK9i are effective and safe, although certain factors may influence their effectiveness. Interestingly, our results suggest that alirocumab and evolocumab may not be therapeutic equivalents, as initially suggested.

Levels of tacrolimus after treatment for chronic hepatitis C with direct antiviral agents in solid organ transplant recipients.

Background and objective The main objective was to evaluate the impact of Hepatitis C Virus treatment with direct-acting antiviral agents on tacrolimus blood levels in recipients of kidney and heart allografts. Method We analysed Hepatitis C Virus infected adult patients who received tacrolimus as immunosuppressive maintenance therapy and received direct-acting antiviral agents treatment in a tertiary hospital with solid transplant multidisciplinary program in Madrid, Spain. Liver and renal function, tacrolimus dose and blood levels were analysed before and 12 weeks after the end of treatment. Results We identified 7 kidney and 2 heart transplant recipients. All patients achieved sustained virologic response at 24 weeks. At week 12 after treatment, all liver functionality tests improved significantly with no significant changes in renal function. A decrease in the tacrolimus blood level/dose ratio for every patient was observed (370.04 ± 253.93 vs. 186.44 ± 123.74 ng/mL per mg/kg; p < 0.05). The requirements of tacrolimus dose increased after Hepatitis C Virus treatment (0.03 ± 0.04 vs. 0.04 ± 0.03 mg/kg/day, p < 0.05) to reach lower blood levels than before treatment (6 ± 2.25 vs. 4.67 ± 1.51 ng/mL, p < 0.05). Conclusion Caution is advised to clinicians; close monitoring of tacrolimus levels after direct-acting antiviral agents is recommended in order to avoid infradosification that could pose a risk of graft rejection.

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.

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.

Multidisciplinary strategy to reduce errors with the use of medical gases.

OBJECTIVE: Lack of awareness of the risks associated with the use of medical  gases amongst health professionals and health organizations is concerning. The  objective of this study is to redefine the use process of medical gases in a  hospital setting. METHOD: A sentinel event took place in a clinical unit, the incorrect administration of a medical gas to an inpatient. A multidisciplinary  causeroot analysis of the sentinel event was carried out. Different improvement points were identified for each error detected and so we defined a  good strategy to ensure the safe use of these drugs. RESULTS: 9 errors were identified and the following improvement actions were  defined: storage (gases of clinical use were separated from those of industrial  use and proper identification signs were placed), prescription (6 protocols were  included in the hospital´s Computerized Physician Order Entry software),  validation (pharmacist validation of the prescription to ensure appropriate use of  these), dispensation (a new protocol for medical gases dispensation and  transportation was designed and implemented) and administration (information  on the pressure gauges used for each type of gas was collected and reviewed).  72 Signs with recommendations for medical gases identification and  administration were placed in all the clinical units. Specific training on the safe  use of medical gases and general safety training was imparted. CONCLUSIONS: The implementation of a process that integrates all phases of use  of medical gases and applies to all professionals involved is presented here as a  strategy to increase safety in the use of these medicines.

Objetivo: Existe una falta de concienciación sobre los riesgos asociados al uso  de los gases medicinales tanto por parte de los profesionales como por parte de  las organizaciones sanitarias, que no han definido estrategias que garanticen la  seguridad en su utilización. Nuestro objetivo fue redefinir el circuito de  utilización de los gases medicinales en el ámbito hospitalario.Método: En una unidad de hospitalización tuvo lugar un evento centinela, la  administración incorrecta de un gas medicinal a un paciente ingresado. Un  equipo multidisciplinar realizó el análisis causa-raíz del evento. Se propusieron áreas de mejora encaminadas a actuar sobre los errores detectados y así definir un programa que garantizara la seguridad en el uso de los gases medicinales.Resultados: Se identificaron nueve errores y se definieron acciones de mejora  en: almacenamiento (separación e identificación de los gases de uso clínico y de  los de uso industrial); prescripción (inclusión de seis protocolos en el programa  de prescripción electrónica); validación (revisión de la prescripción de los gases  medicinales por un farmacéutico); dispensación (implantación de un protocolo  de traslados), y administración (información sobre los manómetros utilizados  para cada tipo de gas). Además, se impartió formación relativa al uso de los  gases medicinales. Se colocaron 72 pósteres en las unidades clínicas con  recomendaciones para su uso seguro. Conclusiones: La implantación de un circuito que integra todas las fases de  utilización de los gases medicinales e implica a todos los profesionales involucrados se presenta como la estrategia dirigida a aumentar la seguridad en  la utilización de estos medicamentos.

Adding value through pharmacy validation: a safety and cost perspective.

RATIONALE, AIMS AND OBJECTIVES: Prescribing errors (PE) are frequent, cause significant harm to patients and prove costly. Few studies demonstrate the impact of pharmacist interventions. The objectives of this study were to characterize the severity and cost of the potential outcome of PE that pharmacists can prevent and to develop an economic analysis. METHOD: We performed a non-randomized, prospective, observational study of all prescriptions made to adult patients admitted to a 1300-bed tertiary teaching hospital in Madrid (Spain) by means of a computerized physician order entry tool combined with a clinical decision support system. We analysed PE intercepted through the pharmacist validation process between January and June 2013. An independent team determined the severity of the potential adverse drug event (ADE) and the probability of causing an ADE (PAE). We estimated the cost avoidance and performed an economic analysis. A kappa statistic was used to verify inter-observer agreement. RESULTS: 484 PE were intercepted: 36.2% of PE were classified as being of minor severity, 59.1% as moderate and 4.7% as serious. The most common type of moderate-serious PE found was excessive dose (30%, 94/309), followed by insufficient dose (20%, 62/309), and omission (19%, 58/309). The most frequent families of drugs involved in moderate-serious PE were antineoplastic agents (22.3%, 69/309) and antimicrobials (17.2%, 53/309). The PAE was higher than 40% in 49% of PE. We estimated a cost avoidance of €291,422 and a return on investment of €1.7 for each €1 spent on a pharmacist's salary. The overall inter-rater agreement for the participants was moderate for severity (κ = 0.57; P <0.005) and strong for the PAE (κ = 0.77; P <0.005). CONCLUSIONS: Pharmacists add important value in preventing PE, and their interventions are financially beneficial for the institution.

Smartphone applications for cancer patients; what we know about them?

BACKGROUND AND OBJECTIVE: one of the groups that can benefit most from healthcare applications, are cancer patients. However, not all applications have a sufficient level of evidence. Our objective is to analyze the characteristics of mobile healthcare applications for cancer patients and know the reliability of their information. MATERIAL AND METHODS: a descriptive observational study of mobile apps targeting cancer patients. In November 2014, we searched mobile applications for cancer patients in the App Store (iOS) and Google Play (Android), using the terms "cancer" and "oncology" (English and/or Spanish languages). Applications were downloaded and evaluated. We registered their general characteristics (classification of cancer, last date of actualization, language and others) and their purpose (whether were informative, diagnostic, or preventive purposes) on an Excel® chart. The analysis was completed with an internet search to analyze their scientific evidence. RESULTS: one hundred and sixty six applications were downloaded. 23.5% were destined for breast cancer. 52.4% upgraded their software in the last year. 98.2 % were in English. Most of the applications had more than one purpose. The most frequent were informative (39.8%), diagnostic (38.6%) and preventive (28.3%). 50.6% presented sufficient scientific evidence. CONCLUSIONS: there are many benefits that are expected from these applications. However, we detected a lack of validity of the information, as well as lack of update of the data. To prevent these apps from becoming a safety problem rather than a useful tool for patients, regulation should be put in place.

Fundamento y objetivo: uno de los grupos que más se pueden beneficiar de las aplicaciones en salud son los pacientes con cáncer. Sin embargo, no todas tienen un nivel de evidencia suficiente. El objetivo es analizar las características de las aplicaciones móviles destinadas a los pacientes con cáncer y conocer la fiabilidad de su información. Material y métodos: estudio observacional descriptivo de las aplicaciones móviles destinadas a los pacientes con cáncer. En noviembre de 2014 se realizó una búsqueda en los sistemas operativos App Store (iOS) y Google Play (Android), utilizando los términos "cancer" y "oncology" (idiomas inglés y/o español), se descargaron y evaluaron. En una tabla Excel® se registraron sus características generales (tipo de cáncer, fecha de última actualización e idioma, entre otras) y finalidad (informativa, diagnóstica y preventiva, entre otras). El análisis se completó con una búsqueda en internet para analizar su evidencia científica. Resultados: se descargaron 166 aplicaciones. El 23,5% estaban destinadas al cáncer de mama. El 52,4% actualizaron el software en el último año. El 98,2% estaban en inglés. La mayoría tenían más de una finalidad. Las más frecuentes fueron: informativa (39,8%), diagnóstica (38,6%) y preventiva (28,3%). El 50,6% presentaban una evidencia científica suficiente. Conclusiones: son muchos los beneficios que se esperan de estas aplicaciones. Sin embargo, se ha detectado una falta de validez de la información, así como falta de actualización de los datos. Para evitar que se conviertan en un problema de seguridad en lugar de una ayuda para el paciente, es necesaria su regulación.