Sara Ibañez García

Heart transplantation (HT) poses high bleeding risks, especially for patients on anticoagulation. This study evaluates the use of idarucizumab for dabigatran (DBG) reversal compared to vitamin K antagonist (VKA) strategies in HT. A retrospective analysis of HT patients from January 2018 to December 2022, excluding those requiring ECMO immediately before or after surgery, was conducted. Outcomes included transfusion needs, re-surgery due to bleeding, ICU stay lengths, and 30-day survival. A cost analysis compared the direct expenses of each strategy. Among 34 patients, 20 were on DBG and 14 on VKAs or not anticoagulated. Idarucizumab significantly reduced the number of patients requiring transfusion (p = 0.034) and ICU stay lengths (p = 0.014), with no significant impact on re-surgery rates (p = 0.259) or survival (p = 0.955). Despite higher initial costs, overall expenses for idarucizumab were comparable to VKA reversal due to reduced transfusion needs and shorter ICU stays. Idarucizumab offers a viable and potentially cost-neutral anticoagulation reversal option for HT patients on DBG, presenting an alternative to VKA strategies. However, due to the retrospective nature of the study and the small sample size, further prospective studies are needed to confirm these findings.

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.

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.

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.

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 cause root 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.

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.

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 \ud 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 prevente these apps from becoming a safety problem rather than a useful tool for patients, regulation should be put in place\u

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. 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. 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 P <0.005). Pharmacists add important value in preventing PE, and their interventions are financially beneficial for the institution.