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Introduction: The Community Pharmacy Survey on Patient Safety Culture (CPSOPSC) is a tool created by the Agency for Healthcare Research and Quality and used in the United States to assess the patient safety culture among community pharmacy workers. This survey has been adapted for use in hospital pharmacies in other countries. However, it has not yet been implemented in Spanish hospital pharmacies due to the lack of an applicable version in Spain. This project aims to adapt and reach a consensus on the CPSOPSC for its subsequent use as a tool to improve patient safety in hospital pharmacies in Spain., Methods: This non-clinical study will be developed in different phases: obtaining the necessary permissions, reviewing the literature to identify studies on the use of the CPSOPSC in hospital pharmacies, adapting the survey's questions to the sociocultural context, reaching a consensus on the questions using the Delphi-Rand/UCLA methodology with a panel of patient safety experts. These experts, who are hospital pharmacists, will evaluate the adapted survey in several rounds, using a Likert scale and telematic workshops to adjust the questions. Finally, a software application will be developed for the implementation, completion, and data management of the survey., Discussion: Adapting the CPSOPSC to hospital pharmacies in Spain may be a useful tool for measuring the patient safety culture in this context. Through the Delphi-Rand/UCLA methodology, expert consensus and the relevance of the survey are ensured. Additionally, the creation of a computer application will facilitate data collection and analysis, promoting its use among professionals. The resulting survey from this project can identify specific needs and areas for improvement in Spanish hospital pharmacies, being useful for future actions aimed at improving patient safety., (Copyright © 2024. Publicado por Elsevier España, S.L.U.)

Purpose: To compare the frequency of electronic prescription errors when the prescription was validated by the clinical pharmacist vs. when it was not., Methods: This prospective randomised controlled study was conducted in three phases. A randomised phase, in which patients were divided into control and intervention groups, and a pre- and post-intervention phase were consecutively performed to analyse the impact of pharmaceutical validation of prescriptions in a neonatal intensive care unit (NICU). This study was performed at a highly complex NICU at a tertiary hospital. All patients born during the study period who were admitted to the NICU, with a stay lasting ≥24 h, and received active pharmacological treatment were included in the study. Pharmaceutical validation was performed according to the paediatric pharmaceutical care model. A high level of validation was selected for this study. In the intervention group, discrepancies found during the review process were communicated to the medical team responsible for the patients and resolved on the same day., Results: In total, 240 patients were included in this study. Sixty-two patients were allocated to the pre-intervention ( n  = 38) or post-intervention ( n  = 24) groups, and 178 patients were randomly sorted into two groups, control ( n  = 82 newborns) and intervention ( n  = 96 newborns). During the randomisation phase, the number of prescription errors detected was significantly lower in the intervention group than that in the control group (129 vs. 270; p  < 0.001). Similarly, prescription errors reaching the patient were significantly reduced from 40% ( n  = 108) in the control group to 1.6% ( n  = 2) in the intervention group. In the pre- and post-intervention periods, the prescription lines containing prescription errors decreased from 3.4% to 1.5% ( p  = 0.005)., Conclusions: This study showed that the pharmaceutical validation process decreased both the number of errors in the electronic prescribing tools and the number of prescription errors reaching the patient., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2024 Canales-Siguero, García-Muñoz, Caro-Teller, Piris-Borregas, Martín-Aragón, Ferrari-Piquero, Moral-Pumarega and Pallás-Alonso.)

Objective: The aim of the study was to evaluate the safety profile of nirmatrelvir-ritonavir (NMV-r) in real clinical practice and to analyse the clinical relevance of drug-drug interactions in the development of adverse events., Methods: Observational, retrospective study in which safety data of patients treated with NMV-r between April and July 2022 in an outpatient setting were evaluated. The duration of follow-up was 28 days and the number of adverse reactions reported, as well as whether they were managed on an outpatient basis or required health care, and the presence of renal and hepatic function impairment were assessed. Concomitant treatment was reviewed, identifying theoretical drug-drug interactions (TDDIs) whose severity was defined using the Lexi-interact classification., Results: The study included 146 patients. 82 (56.16%) were women, whose median age was 65 years (22-95). the number of TDDIs detected and maintained during treatment with NMV-r was 164, with the percentage of patients with at least 1 interaction being 62.33%. The median number of TDDIs per patient was 1 (0-5). At least 1 adverse event (AE) was reported in 18 patients (11.84%). 11 AEs were potentially related to any TDDI. 7 patients required contact with hospital assistance for AE management. 8 patients had impaired renal function and 2 had impaired liver function at 28 days. The main groups of drugs implicated in the occurrence of an AE were oral anticoagulants and calcium antagonists., Conclusions: Our results show a high number of TDDIs detected were detected between NMV-r and other drugs. This study provides greater knowledge of the drugs involved in such interactions and their potential relationship with the occurrence of adverse events., Competing Interests: Conflicts of interest None declared., (Copyright © 2023 Sociedad Española de Farmacia Hospitalaria (S.E.F.H). Publicado por Elsevier España, S.L.U. All rights reserved.)

Objective: The aim of the study was to evaluate the safety profile of nirmatrelvir-ritonavir (NMV-r) in real clinical practice and to analyze the clinical relevance of drug-drug interactions in the development of adverse events., Methods: Observational, retrospective study in which safety data of patients treated with NMV-r between April and July 2022 in an outpatient setting were evaluated. The duration of follow-up was 28 days and the number of adverse reactions reported, as well as whether they were managed on an outpatient basis or required health care, and the presence of renal and hepatic function impairment were assessed. Concomitant treatment was reviewed, identifying theoretical drug-drug interactions (TDDIs) whose severity was defined using the Lexi-interact classification., Results: The study included 146 patients, 82 (56,16%) were women, whose median age was 65 years (22-95). The number of TDDIs detected and maintained during treatment with NMV-r was 164, with the percentage of patients with at least one interaction being 62,33%. The median number of TDDIs per patient was 1 (0-5). At least 1 adverse event (AE) was reported in 18 patients (11,84%). Eleven AEs were potentially related to any TDDI. Seven patients required contact with hospital assistance for AE management. Eight patients had impaired renal function and 2 had impaired liver function at 28 days. The main groups of drugs implicated in the occurrence of an AE were oral anticoagulants and calcium antagonists., Conclusions: Our results show a high number of TDDIs detected were detected between NMV-r and other drugs. This study provides greater knowledge of the drugs involved in such interactions and their potential relationship with the occurrence of adverse events., (Copyright © 2023 Sociedad Española de Farmacia Hospitalaria (S.E.F.H). Publicado por Elsevier España, S.L.U. All rights reserved.)

Infection is a common complication in kidney transplant recipients (KTRs). The usefulness of antimicrobial stewardship programs (ASP) and hospital-acquired infection control (HAIC) initiatives in the general inpatient population is well established. We performed a quasi-experimental study to evaluate a joint ASP/HAIC initiative focused on KTRs. A dedicated ASP team optimized antimicrobial prescriptions in consecutive KTRs during the intervention period (June 2015-March 2016). A multifaceted, evidence-based HAIC program was concurrently implemented. Results were compared with the preceding period (June 2014-March 2015). We included 96 and 100 KTRs in the intervention and preintervention periods, respectively. There was a reduction in the consumption of meropenem (rate ratio [RR]: 0.63; 95% confidence interval [CI]: 0.53-0.75; P <.0001), ceftazidime (RR: 0.31; 95% CI: 0.21-0.45; P <.0001), vancomycin (RR: 0.65; 95% CI: 0.53-0.8; P <.0001), and ciprofloxacin (RR: 0.66; 95% CI: 0.55-0.81; P <.0001) and an increase of fosfomycin (RR: 1.80; 95% CI: 1.17-2.76; P =.008) during the intervention period. The incidence of cystitis (RR: 0.30; 95% CI: 0.28-0.33; P <.001) and upper urinary tract infection (RR: 0.56; 95% CI: 0.33-0.95; P =.04) decreased. A specific ASP/HAIC initiative was effective in optimizing antimicrobial use and reducing the incidence of common bacterial infections among KTRs., (Copyright © 2023 American Society of Transplantation & American Society of Transplant Surgeons. Published by Elsevier Inc. All rights reserved.)

Objective: To assess the degree of implementation of medication error prevention practices in Spanish hospitals., Method: Descriptive multicenter study of the degree of implementation of the safety practices included in the "Medication use-system safety self-assessment for hospitals. Version. II". Spanish hospitals that completed the questionnaire between October, 2021 and September, 2022 participated. The survey contains 265 items for evaluation grouped into 10 key elements. Mean score and mean percentages based on the maximum possible values for the overall survey, for the key elements, and for each individual item of evaluation were calculated. The results were compared with those of the previous 2011 study., Results: A total of 131 hospitals from 15 autonomous regions participated in the study. The mean score of the overall questionnaire in all hospitals was 898.2 (57.4% of the maximum possible score). No differences were found according to dependency, size, or type of hospital, either in the overall questionnaire or in the key elements. The lowest values were found for key elements VIII, I and VI, on competence and training of health professionals in safety practices (45.1%), availability and accessibility of essential information on patients (48%), and devices for administering drugs (52.3%). With respect to 2011, significant increases were found both in the overall questionnaire and in the key elements, except V and VII, referring to standardization, storage, and distribution of medications, and environmental factors and human resources. Several evaluation items on the safe management of high-risk drugs, medication reconciliation, incorporation of clinical pharmacists into the healthcare teams, and implementation of technologies that allow full traceability throughout the medication system, showed low percentages., Conclusions: There has been appreciable progress in the degree of implementation of some medication error prevention practices in Spanish hospitals, but many proven efficacy practices recommended by the World Health Organization and safety organizations are still poorly implemented. The information obtained can be useful for prioritizing the practices to be addressed and as a new baseline for monitoring progress., Competing Interests: Conflict of interest All the authors state that they have no conflicts of interest., (Copyright © 2023 Sociedad Española de Farmacia Hospitalaria (S.E.F.H). Publicado por Elsevier España, S.L.U. All rights reserved.)

Objective: To assess the degree of implementation of medication error prevention practices in Spanish hospitals., Method: Descriptive multicenter study of the degree of implementation of the safety practices included in the "Medication use-system safety self-assessment for hospitals. Version. II". Spanish hospitals that completed the questionnaire between October/2021 and September/2022 participated. The survey contains 265 items for evaluation grouped into 10 key elements. Mean score and mean percentages based on the maximum possible values for the overall survey, for the key elements and for each individual item of evaluation were calculated. The results were compared with those of the previous 2011 study., Results: A total of 131 hospitals from 15 autonomous regions participated in the study. The mean score of the overall questionnaire in all hospitals was 898.2 (57.4% of the maximum possible score). No differences were found according to dependency, size or type of hospital, either in the overall questionnaire or in the key elements. The lowest values were found for key elements 8, 1 and 6, on competence and training of health professionals in safety practices (45.1%), availability and accessibility of essential information on patients (48%), and devices for administering drugs (52.3%). With respect to 2011, significant increases were found both in the overall questionnaire and in the key elements, except 5 and 7, referring to standardization, storage and distribution of medications, and environmental factors and human resources. Several evaluation items on the safe management of high-risk drugs, medication reconciliation, incorporation of clinical pharmacists into the healthcare teams and implementation of technologies that allow full traceability throughout the medication system, showed low percentages CONCLUSIONS: There has been appreciable progress in the degree of implementation of some medication error prevention practices in Spanish hospitals, but many proven efficacy practices recommended by the World Health Organization and safety organizations are still poorly implemented. The information obtained can be useful for prioritizing the practices to be addressed and as a new baseline for monitoring progress., (Copyright © 2023 Sociedad Española de Farmacia Hospitalaria (S.E.F.H). Publicado por Elsevier España, S.L.U. All rights reserved.)

Objectives: Linezolid is an oxazolidin commonly related to the development of haematological toxicity, being renal clearance the major factor involved in the drug clearance. The aim of this study is to evaluate the influence of increased filtration rates in the incidence of linezolid-induced haematological toxicity by comparing augmented renal clearance (ARC) patients versus normal renal function patients., Material and Methods: A retrospective, observational study was conducted on hospitalized patients treated with linezolid for 5 days or more during 2014-2019 period. Patients with a filtration rate of ≥130 mL/min versus reference patients (60-90 mL/min) were compared. Haematological toxicity was defined as a decrease of 25% in platelets, of 25% in haemoglobin, and/or 50% in neutrophils from baseline. Toxicity relevance was classified according to Common Terminology Criteria for Adverse Events v5. Incidence of haematological toxicity between groups was studied by chi-square and Fisher test. Furthermore, percentage diminution of all 3 parameters was calculated and compared by Mann-Whitney test and treatment interruption and transfusion requirements were registered., Results: 30 ARC patients and 38 reference patients were included. Haematological toxicity was observed in 16.66% of ARC patients vs 44.74% of reference patients (P=.014); thrombocytopenia in 13.33% vs 36.84% (P=.051), anaemia in 3.3% vs 10.52% (P=.374) and neutropenia in 10% vs 23.68% (P=.204). Median percentage of platelets decrease in ARC patients was -10.36 (-193.33-62.03) vs 2.68 (-163.16-82.71) in reference patients (P=.333), while haemoglobin decrease was 2.50 (-12.12-25.93) vs 9.09 (-17.72-30.63) (P=.047) and neutrophils decrease was 9.14 (-73.91-76.47) vs 27.33 (-86.66-90.90) (P=.093). 10.5% of normal renal function patients reported at least 1 adverse event grade 3 or superior while 2.6% of them interrupted treatment and 5.2% had transfusion requirements. No major events or interruptions were reported in ARC patients., Conclusion: Our findings suggest a lower incidence and clinical relevance of haematological toxicity in augmented renal clearance patients. Thrombocytopenia was the major event in both populations. This might be related to a lower exposure to the drug due to the higher clearance and likely lower therapeutic efficiency. These results suggest a potential benefit of therapeutic drug monitoring on high risk patients., Competing Interests: Conflicts of interest None declared., (Copyright © 2023 Sociedad Española de Farmacia Hospitalaria (S.E.F.H). Publicado por Elsevier España, S.L.U. All rights reserved.)

Objectives: Linezolid is an oxazolidin commonly related to the development of hematological toxicity, being renal clearance the major factor involved in the drug clearance. The aim of this study is to evaluate the influence of increased filtration rates in the incidence of linezolid-induced hematological toxicity by comparing augmented renal clearance (ARC) patients versus normal renal function patients., Material and Methods: A retrospective, observational study was conducted on hospitalized patients treated with linezolid for 5 days or more during 2014-2019 period. Patients with a filtration rate of ≥130 mL/min versus reference patients (60-90 mL/min) were compared. Hematological toxicity was defined as a decrease of 25% in platelets, of 25% in hemoglobin and/or 50% in neutrophils from baseline. Toxicity relevance was classified according to Common Terminology Criteria for Adverse Events v5. Incidence of hematological toxicity between groups was studied by chi-square and Fisher test. Furthermore, percentaje disminution of all three parameters was calculated and compared by Mann-Whitney test and treatment interruption and tranfusion requirements were registered., Results: 30 ARC patients and 38 reference patients were included. Hematological toxicity was observed in 16.66% of ARC patients vs 44.74% of reference patients (p = 0.014); thrombocytopenia in 13.33% vs 36.84% (p = 0.051), anemia in 3.3% vs 10.52% (p = 0.374) and neutropenia in 10% vs 23.68% (p = 0.204). Median percentaje of platelets decrease in ARC patients was -10.36 (-193.33-62.03) vs 2.68 (-163.16-82.71) in reference patients (p = 0.333), while hemoglobin decrease was 2.50 (-12.12-25.93) vs 9.09 (-17.72-30.63) (p = 0.047) and neutrophils decrease was 9.14 (-73.91-76.47) vs 27.33 (-86.66-90.90) (p = 0.093). 10.5% of normal renal function patients reported at least one adverse event grade 3 or superior while 2.6% of them interrupted treatment and 5.2% had tranfusion requirements. No major events or interruptions were reported in ARC patients., Conclusion: Our findings suggest a lower incidence and clinical relevance of hematological toxicity in augmented renal clearance patients. Thrombocytopenia was the major event in both populations. This might be related to a lower exposure to the drug due to the higher clearance and likely lower therapeutic efficiency. These results suggest a potential benefit of therapeutic drug monitoring on high risk patients., (Copyright © 2023 Sociedad Española de Farmacia Hospitalaria (S.E.F.H). Publicado por Elsevier España, S.L.U. All rights reserved.)

Background: Currently, there is no validated method for estimating antimicrobial consumption in the neonatal population, as it exists for adults using Defined Daily Doses (DDD). In neonatology, although there are different methods, each one with advantages and disadvantages, there is no unified criterion for use. The aim of this study is to validate the neonatal DDD designed as a new standardised form of antimicrobial consumption over this population., Methods: The validation of the neonatal DDD, Phase II of the research project, was carried out through a descriptive observational study. Periodic cut-offs were performed to collect antimicrobial prescriptions of neonates admitted to the neonatology and intensive care units of nine Spanish hospitals. The data collected included demographic variables (gestational age, postnatal age, weight and sex), antimicrobial dose, frequency and route of administration. The selection of the optimal DDD value takes into account power value, magnitude obtained from the differences in the DDD, statistical significance obtained by the Wilcoxon test and degree of agreement in the stipulated doses., Results: Set of 904 prescriptions were collected and finally 860 were analysed based on the established criteria. The antimicrobials were mostly prescribed in the intensive care unit (63.1%). 32 different antimicrobials were collected, and intravenous administration was the most commonly used route. Neonatal DDD were defined for 11 different antimicrobials. A potency > 80% was obtained in 7 antibiotics. The 57.1% of the selected DDD correspond to phase I and 21.4% from phase II., Conclusion: DDD validation has been achieved for the majority of intravenously administered antimicrobials used in clinical practice in the neonatal population. This will make it possible to have an indicator that will be used globally to estimate the consumption of antimicrobials in this population, thus confirming its usefulness and applicability.

The SARS-CoV-2 pandemic has caused an increase in antibiotic use in different settings. We describe the antibiotic prescribing prevalence, associated factors and trends, as well as concomitant bacterial infections in children hospitalized with COVID-19 or multisystemic inflammatory syndrome related to SARS-CoV-2 in Spain., (© The Author(s) 2022. Published by Oxford University Press on behalf of The Journal of the Pediatric Infectious Diseases Society. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Objective: Medications errors are a major problem that can cause a harm to inpatients. The main objective of the study was to compared medication errors in pharmacotherapeutic process before and after to carried out an intervention: to implant an automated dispensing cabine with to use Lean Six Sigma methodology. The secondary objective was to assess process performance, sigma level and defects per one million opportunities for medication error., Methods: Quasi-experimental and randomized study carried out in a Thoracic Surgery Unit of a Spanish Hospital. A pharmaceutic recorded and assesed the medication errors detected during pre-intervention period (july-august 2017) and post-intervention period (march-april 2018). The steps analyzed were dispensing, storage and compounding/administration. The pharmacist observed a third of the medication dispensed, stored and compounded/administered during the study period. The observed medication was randomly selected using AleatorMetod.xls software. To perform the statistical analysis, Student's t test and Mann-Whitney U test were used to compare quantitative variables, and Chi-square test for qualitative variables. A significance level of p<0.05 was considered., Results: The pharmaceutic recorded 4,538 drugs. After intervention, medication errors were decreased a 49% in total pharmacotherapeutic process (12.06% vs 6.15%; p<0.001). In addition, errors were decreased a 91.6% (4.27% vs 0.36%; p=0.004) in the step of medication storage; and a 75.8% (22.52% vs 5.46%; p<0.001) in the step of drugs compounding/administration. However, medication errors were increased in the step of medication dispensing (4.51% vs 15.29%; p<0.001). The process performance increased a 6% (87.9% vs 93.9%), sigma level increased from 2.67 to 3.04 and defects per one million opportunities for medication error decreased a 49%., Conclusions: To implant an automated dispensing cabinet with Lean Six Sigma methodology helps create a safer environment for the inpatient, reducing medication errors in the steps of storage and preparation/administration, as well as improving the total process performance and sigma level., Competing Interests: Disclosure The authors report no conflicts of interest in this work.

Background: Controversy remains about the efficacy of tocilizumab (TCZ) for the treatment of severe COVID-19. We aimed to analyze the profile of TCZ-respondent patients., Methods: We retrospectively analyzed a cohort of patients with severe COVID-19 who received off-label TCZ after recommendation by a local committee and were admitted to the University Hospital "12 de Octubre" until May 2020. The primary end point was a significant clinical improvement (SCI) on day 14 after administration of TCZ. Factors independently related to SCI were analyzed by multivariate logistic regression models., Results: Of 428 (63.3%) patients treated with TCZ, 271 (63.3%) experienced SCI. After adjustment for factors related to unfavorable outcomes, TCZ administration within the first 48 hours from admission (odds ratio [OR]: 1.98, 95% confidence Interval [95% CI]: 1.1-3.55; P = 0.02) and ALT levels >100 UI/L at day 0 (OR: 3.28; 95% CI: 1.3-8.1; P = 0.01) were independently related to SCI. The rate of SCI significantly decreased according to the time of TCZ administration: 70.2% in the first 48 hours from admission, 58.5% on days 3-7, and 45.1% after day 7 (P = 0.03 and P = 0.001, respectively)., Conclusion: TCZ improves the prognosis of patients with COVID-19 the most if treatment starts within the first 48 hours after admission., Competing Interests: Conflicts of interest All the authors declare no potential conflict of interest regarding this study., (Copyright © 2022 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Background: Patient education on pharmacological treatment could reduce readmissions. Our objective was to carry out a pharmacist intervention focused on providing information about high-risk medications to chronic patients and to analyse its influence on readmissions and costs., Methods: A single-centre study with an intervention group and a retrospective control group was conducted. The intervention was carried out in all polymedicated patients ≥ 65 years who were admitted to internal medicine and signed the informed consent between June 2017 and February 2018. Patients discharged to nursing homes or long-term hospitals were excluded. The control group were all the patients who were admitted during the same months of 2014 who met the same inclusion criteria. The patients were classified according to the HOSPITAL score as having a low, intermediate, or high risk of potentially avoidable readmission. Outcome measures were 30-day readmission and cost data. To analyse the effect of the intervention on readmission, a logistic regression was performed., Results: The study included 589 patients (286 intervention group; 303 control group). The readmission rate decreased from 20.13% to 16.43% in the intervention group [OR = 0.760 95% CI (0.495-1.166); p = 0.209)]. The incremental cost for the intervention to prevent one readmission was €3,091.19, and the net cost saving was €1,301.26. In the intermediate- and high-risk groups, readmissions were reduced 10.91% and 10.00%, and the net cost savings were €3,3143.15 and €3,248.71, respectively., Conclusions: The pharmacist intervention achieved savings in the number of readmissions, and the net cost savings were greater in patients with intermediate and high risks of potentially avoidable readmission according to the HOSPITAL score., (© 2022. The Author(s).)

Objectives: Dalbavancin is approved for the treatment of complicated skin and soft tissue infections. However, there is growing evidence that other gram-positive infections could be treated with this antibiotic. A study was undertaken in a tertiary hospital in Spain to evaluate the effectiveness and safety of dalbavancin in off-label indications and the potential healthcare cost savings., Methods: A retrospective observational study including all patients treated with dalbavancin in our hospital from October 2016 to August 2019 was carried out. Demographic, clinical and safety variables were collected. Effectiveness was assessed using the clinical and microbiological resolution of the infection and the absence of hospital admissions due to the same infection in the following 3 months., Results: A total of 102 patients were included (69.9% men, n=71; median age 72.5 years (range 56.0-84.0)). Treatment was off label in 71 cases (69.6%). The most frequent off-label indications were catheter-related bacteraemia (15.7%, n=16) and endocarditis (13.6%, n=14). All patients had previously received antibiotics. The main reason for switching to dalbavancin was patient discharge (79.4%, n=81). Dalbavancin was administered during hospitalisation in 66.7% of the patients and in the outpatient setting in 13.7%. The median reduction in length of hospital stay was 14 days per patient. A saving of about 4550 Euros per patient was estimated. 89 patients (93.7%) had clinical and microbiological resolution of the infection at the end of the study. One patient did not finish the dalbavancin infusion due to an allergic reaction., Conclusions: Our results suggest that dalbavancin is a safe and effective alternative to the off-label treatment of gram-positive infections. Its dosage facilitates early discharge and outpatient management of these patients., Competing Interests: Competing interests: None declared., (© European Association of Hospital Pharmacists 2022. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: The combination of selective serotonin reuptake inhibitors with  rivaroxaban may result in a dual interaction (pharmacokinetic and pharmacodynamic) depending on the type of selective serotonin reuptake inhibitor employed (CYP3A4-inhibiting vs. non-CYP3A4 inhibiting).  The purpose of this study was to use real world data to determine if the type of  selective serotonin reuptake inhibitor used plays a role in the risk and severity of bleeding in patients receiving rivaroxaban. Method: This was a single-center retrospective longitudinal observational study carried out between January 2016 and February 2020 in patients aged 18 years or older treated concurrently with rivaroxaban (prescribed for treatments) and a selective serotonin reuptake  nhibitor. Patients were divided into two groups according to the selective  serotonin reuptake inhibitor they received, i.e., a CYP3A4 inhibitor (group 1):  sertraline, fluoxetine and paroxetine, or a non-CYP3A4 inhibitor (group 2): citalopram and escitalopram. We analyzed the bleeding events and  everity, the daily dose of rivaroxaban used and the medication administered concomitantly., Results: A total of 146 patients were included (89 in group 1 and 57 in group  2) and 35 bleeding events (24% of patients) were identified, of  which 12 were  major and 23 were minor. The bleeding rate was higher in group 1  (25.8% vs 21.0%) but there were no differences in major bleeding (10.1% vs  5.3%; p = 0.235) or minor bleeding (13.5% vs 15.8%; p = 0.496). The  bleeding rate with a daily rivaroxaban dose of 20 mg was 9% (8/89) in group 1  and 14% (8/57) in group 2 (p = 0.2137), as compared with 16.9% (15/89)  in group 1 versus 7% (4/57) in group 2 (p = 0.042) for a daily 15 mg dose., Conclusions: Although the type of selective serotonin reuptake inhibitor used  concurrently with rivaroxaban was not found to influence the patients' bleeding  risk, a significant increase in the risk of bleeding was  bserved based on the dose of rivaroxaban used., (Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.)

Background: A significant percentage of hospital readmissions within 30 days of discharge are a result of avoidable drug-related problems. Stratifying patients according to readmission risk is key to pharmaceutical intervention (PI) design strategies to improve treatment outcomes. Objective: To assess whether a pharmaceutical care (PC) program at discharge in polymedicated patients at high potentially avoidable readmission (PAR) risk, according to the HOSPITAL score, improves 30-day readmission rate (30-dRR). Methods: This prospective controlled, quasi-experimental, 11-month study included 163 chronic polymedicated patients (>5 medications) at high PAR risk according to the HOSPITAL score. We calculated the 30-dRR and number of medication variations and Medication Regimen Complexity Index-E (MRCI-E) after PI. Results were compared with a retrospective cohort of chronic patients at high PAR risk. Results: The 30-dRR was 18.4% in the intervention group and 25.6% in the control group (odds ratio [OR] = 0.66; 95% CI = 0.38 to 1.14). Total medication reduction (-1.28; 95% CI = -1.88 to -0.68), number of high-risk medications in chronic patients (-0.58; 95% CI = -0.9 to -0.26), and MRCI-E (-6.42; 95% CI = -8.07 to -4.76) were statistically significant ( P < .001). The number of medications at discharge was associated with an increased readmission risk (OR = 1.07; 95% CI = 1.01 to 1.14). Conclusions: The degree of polypharmacy and patients' treatment complexity after hospital discharge significantly reduced as a result of the PC program compared with the control group. This highlights the need for patient selection and prioritization strategies for implementing PIs focused on reducing polypharmacy and preventing drug-related problems that may cause PAR., Competing Interests: Declaration of Conflicting Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article., (© The Author(s) 2021.)

Objective: Intravenous (IV) tocilizumab has been used to stop the inflammatory phase of SARS-CoV-2 infection. To preserve the largest number of IV units for this use, the Spanish Agency for Medicines and Health Products (AEMPS) carried out a controlled supply of it and recommended the change to a subcutaneous presentation (SC) of tocilizumab or sarilumab in all those patients in IV tocilizumab treatment for rheumatologic indications. The objective of this study was to evaluate the change from IV tocilizumab to SC presentation due to its controlled supply during the COVID-19 pandemic., Methods: Retrospective observational study of adult patients (>18 years old) under treatment with IV tocilizumab follow-up by the Rheumatology Service of the Hospital 12 de Octubre. The follow-up period was 3 months (March 2020-June 2020) and 39 patients were included in the study. Variables related to the patients and their treatment were collected. A descriptive analysis of the data was carried out., Results: In 69.23% (n=27) of the patients, treatment was changed to SC tocilizumab (n=23) or sarilumab (n=4). 44% of patients (n=12) switched back to their original IV tocilizumab treatment. The reasons for stopping treatment with SC tocilizumab were: drug intolerance (n=4), disease worsening (n=4), and patient preference (n=1). Regarding sarilumab, the reasons were drug intolerance (n=2) and patient preference (n=1)., Conclusions: Almost half of the patients had to return to the original treatment. The main reason was intolerance to the new treatment, followed by ineffectiveness and patient preferences.

Objective: The increase in infections with multidrug resistant bacteria has forced to return to the use of colistin, antibiotic with known nephrotoxicity. The aim of the study is to determine the incidence of colistin nephrotoxicity nowadays., Methods: Retrospective-observational-unicentric study was collected hospitalized patients in intravenous colistin treatment during the years 2018-2019. Nephrotoxicity was defined according to the RIFLE scale. The variables to determine it were serum creatinine (sCr) and glomerular filtration (GF). The variables analyzed were age, sex, treatment duration, loading and cumulative dose, empirical/targeted treatment, chronic kidney disease, concomitant use of intravenous contrast and nephrotoxic drugs., Results: A total of 90 patients (60% men) were included, with an average age of 58.2±18.1 years. The mean duration of treatment was 9±8.3 days, with an average cumulative dose of 69.8±71MU. There were no differences between sCr and GF at the beginning and end of treatment. The incidence of nephrotoxicity was 1.73 cases/100 days of treatment (prevalence of 15.56%)., Conclusions: Colistin nephrotoxicity has an important incidence, without developing severe illness., (©The Author 2020. Published by Sociedad Española de Quimioterapia. This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0)(https://creativecommons.org/licenses/by-nc/4.0/).)

Objective: Immediate-release fentanyl is indicated in the treatment of breakthrough pain in cancer patients who already receive opioids as background chronic analgesia. According to an alert issued by the Spanish Agency of Medicines, its consumption under non-authorized conditions has alarmingly increased in recent years, with a greater risk of abuse and dependence. The main objective of this study is to compare the off-label use of immediate-release fentanyl in our hospital during 2014 and 2017., Methods: Retrospective cross-sectional descriptive study in which immediate-release fentanyl prescriptions were compared in adult patients admitted during 2014 and 2017 in a group 5 hospital. Variables were collected by the electronic medical record. The association study between qualitative variables was calculated using the χ 2 test, and quantitative variables with the t-student test., Results: In 2014, 0.43 immediate-release fentanyl prescriptions were made in our center for every 100 admissions, and in 2017 0.54/100 admissions. 22.1% (n=34) prescriptions were off-label in 2014, while in 2017 31.8% (n=76) (p=0.034). Both years, the most frequent off-label indications were healing of ulcers and wounds and non-cancer chronic pain., Conclusions: The use of immediate-release fentanyl in the hospital setting has considerably increased in comparison to 2014, as well as its off-label use., Competing Interests: Disclosure The authors report no conflicts of interest in this work.

Background and Objective: After the marketing of Abiraterone, an androgen synthesis inhibitor, the aim of the study was to analyze its use, response, and safety in the population of a tertiary care level hospital., Materials and Methods: A retrospective observational study was carried out including all patients that were started on Abiraterone within a 21-month period. Demographical, diagnostic, therapeutic, and clinical variables were gathered. The response was assessed through the decreased of PSA as compared to baseline values. To assess the safety, all treatment-related adverse events were recorded., Results: A total of 45 patients were included of which 88.89% could be assessed for the drug effectiveness. The median baseline PSA value was 457.31 (range 9032-2.81). PSA decrease was ≥ 50%, ≥ 90% and < 30% in 16 (40%), 3 (7.5%) y 20 (50%), respectively. The most common grade 1-2 adverse events were fatigue (35.6%), increased liver enzymes (28.9%), hipokalemia (13.3%) and fluid retention (11.1%)., Conclusions: Abiraterone was a well tolerated drug that has shown to be active in prostate cancer patients previously treated with taxans, so it has been postulated as an alternative in this pathology., (Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.)