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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.)

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.)

Objective: To study immune-related adverse events (irAEs) in non-small cell lung cancer (NSCLC) patients treated with nivolumab, as well as to assess whether these reactions could be predictors of further effectiveness of therapy., Methods: Retrospective, observational and longitudinal study. All NSCLC patients who received nivolumab between February 2015-May 2020 were included. In terms of safety, irAEs and their severity were registered and to evaluate the effectiveness, overall survival (OS) and progression free survival (PFS) were calculated., Results: 75 patients were included. 32 patients (43%) were reported irAES. Mainly the irAEs affected the skin (36%). Followed by pneumonitis (20%), gastrointestinal reactions (12%), endocrine (12%) and hepatitis (12%). Regarding severity, 92% were moderate. The median PFS was 9.49 months on the group with irAEs versus 1.99 months on the group without irAEs group (p < 0.0001). The median OS was 17.44 months versus 7.67 months respectively (p = 0.0001). According to the incidence of irAEs developed ( = > 2 vs. 1 vs. 0), the median PFS was 20.53 versus 5.35 versus 1.99 months respectively (p < 0.0001). The median OS was 23.41 versus 15.80 versus 7.67 months, respectively (p = 0.0002)., Conclusion: In a significant number of patients irAEs occur, generally of grade 1-2 severity, affecting mainly the skin, lungs and gastrointestinal system. We confirm that the development of irAEs in patients with NSCLC treated with nivolumab is a strong predictor of treatment effectiveness in both PFS and OS, with statistically significant results. On those patients who experience two or more immunorelated adverse events the greatest benefit has been observed.

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: 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 literature has described the interaction between valproic acid  and carbapenems. This interaction leads to decreases in plasma concentrations  of valproic acid. The main objectives of this study were  to assess its relevance in clinical practice, to identify variables associated with  increased seizure episode rates, and to analyse the impact of pharmaceutical intervention on avoiding the effects of this interaction., Method: An observational retrospective study of inpatients with epilepsy  admitted between 2016 and 2020. Their pharmacological treatment throughout  admission was recorded, and the presence of other interactions  leading to decreased plasma concentrations of valproic acid was reviewed. The  seizure rate during the year prior to admission was compared to that during  the interaction period. For every episode in which the interaction was detected, an intervention was conducted by providing the prescriber with information on  the interaction and suggesting a change of antibiotherapy as well as the  pharmacokinetic monitoring of valproic acid., Results: 37 episodes were included. 58.1% of the patients were male and  median age was 70 years. In total, 56.8% of the patients received meropenem  and 43.2% received ertapenem. The median duration of  concomitant treatment with valproic acid and carbapenem was 4 days. The  incidence rate ratio was 2.60 (95% confidence interval: 1.61-4.21). Thus, this  interaction was associated with a higher seizure rate. A statistically significant  association was found between higher seizure rates and patients treated with  more than one anti-epileptic drug. Hospital pharmacists detected 24 episodes  (64.9%). In total, 17 interventions (70.8%) were accepted and 13  combinations were discontinued. Pharmacokinetic monitoring was conducted in  13 episodes (35.1%) and infratherapeutic levels were found in all of them., Conclusions: The interaction between valproic acid and meropenem or ertapenem is clinically relevant. It is recommended that this combination should be avoided provided that a viable alternative is available.  Pharmaceutical intervention may contribute to preventing seizures associated with this combination., (Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.)

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: Lean Six Sigma (LSS) methodology is used to increase productivity and to improve performance, by eliminating processes that do not add value to the customer, as well as reducing variability. In recent years, its application in healthcare sector is increasing in order to improve the efficiency of processes. The aim of this study was to evaluate the results obtained in terms of efficiency in the medication dispensing circuit, after application of LSS methodology., Material and Methods: A multidisciplinary team was created in order to analyse and improve the medication dispensing circuit. The main tools used in LSS methodology were the DMAIC cycle (Define, Measure, Analyse, Improve and Control), SIPOC diagram (Suppliers, Inputs, Process, Outputs, and Customers), a root-cause analysis; a survey to determine the "Customer's voice" about the circuit; and the cost of each task in terms of staff time. Two Pilot Nursing Units (Thoracic Surgery and Cardiology) were selected to introduce the improvement actions. The main analysed variables were: urgent medication orders per day, and percentage of medication orders made online., Results: After the application of LSS methodology, a significant reduction was found in urgent medicament orders per day in both nursing units, and a significant improvement in the electronic processing of urgent orders. The performance of medication dispensing circuit was increased from 60% (1.76 sigma) during initial data analysis, to 93% (3 sigma) in Thoracic Surgery, and from 71% (2.11 sigma) to 81% (2.4 sigma) in Cardiology. Six months after the implementation of improvements, the performance values were increased to 94% (3.1 sigma) and 93% (3 sigma), respectively. Estimated cost savings related to staff were 798.2 € (266 € per month) after implementation, ascending to 2, 228.5 € (371.4 € per month) after 6months., Conclusion: The use of LSS methodology has improved the performance of medication dispensing circuits, reducing costs in terms of staff time, and obtaining satisfactory results., (Copyright © 2020 FECA. Publicado por Elsevier España, S.L.U. All rights reserved.)

Background and Objectives: Medication errors are the most common adverse events in healthcare. Pharmaceutical validation (PV) seeks to reduce them. The aims of this study were to assess the impact of the introduction of an automated tool for the validation (VPAT) of the high clinical relevance drugs prescription (HCRD) over time of pharmaceutical intervention (PI), and to quantify the number of medication errors detected before and after its implementation., Material and Methods: A two phase retrospective-observational single centre study was designed. A pre-intervention phase (Pre-P): PV of beds with Unit Dose Dispensing (October 2015 - February 2016), was followed by a post-intervention phase (Post-P): PV using a VPAT of HCRD in hospital patients (October 2016 - February 2017). HCRD were selected from the list of high-risk drugs of Institute for Safe Medication Practices. The data was obtained from the PI record (Access®) and the computerised prescription. The variables collected were: age and gender of the patients included, data of drugs prescription, and time to PI., Results: A total of 477 PI were analysed in 404 patients, with a mean age of 65.9±19.5 years (53.22% women). The mean time up to PI was 25.6±24.72h in the Pre-P, and 18.87±20.44h in the Post-P (P=0.01). In Pre-P, 106 PI were performed (35.85% prevention of adverse reactions) compared to 371 PI (39.62% medication reconciliation) in Post-P., Conclusions: The VPAT enabled a greater number of medication errors to be detected and intervened in hospitalised patients, with a significantly reduced time to PI., (Copyright © 2020 FECA. Publicado por Elsevier España, S.L.U. All rights reserved.)

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.

Introduction: Introduction: a black precipitate was observed in the filter during the infusion of a parenteral nutrition without lipids. There are similar findings published in which copper and sulphur (from cysteine) were found in the composition of the precipitate. Objective: to determine if copper and cysteine are involved in the formation of the precipitate. Methods: samples of the parenteral nutrition solution were taken before and after its passage through the filter. Amino acids concentrations were analysed in both samples by ion exchange chromatography and post-column derivatization with ninhydrin in a Biochrom 30 device. Copper concentrations were measured by atomic absorption spectrometry in a PerkinElmer AAnalyst™ 200 device. Results: a decrease in cysteine concentration of 29.3% was found. The concentration of copper decreased by 75.9%. Conclusions: the decrease in the concentrations of cysteine and copper in the filtered solution suggest that both are involved in the formation of the black precipitate observed in the filter.

Objective: to determine if precipitation processes occur in parenteral nutrition solutions (PNs) with calcium gluconate and sodium glycerophosphate in the precipitation threshold limits of the Spanish SENPE/SEGHNP/SEFH 2008 consensus document of PN preparation., Methods: seven PNs with different composition were prepared in triplicate: five 100 ml PNs with different concentrations of amino acids, calcium and phosphorus similar to consensus document maximum concentrations for precipitation, and two control PNs: one without calcium and phosphorus and other with high calcium and phosphorus content and low concentration of amino acids. All PNs did not contain lipids to allow correct detection of precipitates. The no lipid PNs were stored at room temperature for 20 hours, and at 35 °C for four hours. Subsequently, they filtered through a 0.2 μm filter, which was observed by electron microscopy. Because a large amount of not expected precipitates was observed, complementary studies were carried out., Results: precipitates were observed in all PNs except in the control solution without calcium and phosphorus; many of them were greater than 10 μm. However, according to our studies, these crystals were produced after filtration and calcium was found in their composition, but not phosphorus. Particles from the preparation of parenteral nutrition were also observed., Conclusions: in our study we did not find calcium phosphate precipitates in the limits included in the consensus document SENPE/SEGHNP/ SEFH. However, it is possible that micro precipitates with calcium are formed. It is important to filter PNs prior to their administration.

Objective: To analyse the effectiveness and safety of oral antineoplastic drugs  (ANEOs) that are authorized in special situations in a third-level hospital and to  compare the results obtained with the clinical evidence used for this  authorization., Method: Descriptive observational and retrospective study. We included all  adult patients who started treatment with ANEO in special situations during the  year 2016. We collected demographic, treatment-related and clinical variables  (overall survival (OS), progression-free survival (PFS)). Adverse reactions and  detected interactions were collected. An unadjusted comparison was made  between the results of the available evidence and those of the study patients., Results: 34 patients were treated, 50% were men, the median age was 58  years (38-80) and they presented ECOG 1 in 64.7%. Most of the treated  patients were diagnosed with advanced colorectal cancer, treated with  trifluridine-tipiracil, followed by palbociclib in breast cancer, obtaining results  similar to those of the evidence. The median PFS was 2.8 months (95% CI 0.8- 4.8) and the 8-month SG (95% CI 3.4-12.5) for all patients. 26% of patients  required dose reduction because of treatment toxicity. We found 13 interactions,  which affected 15 patients, only two of category X., Conclusions: The effectiveness of ANEO in special situations in our center is  similar to that of available evidence. The impact on survival is low and adverse  effects are common., (Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.)

Purpose: To investigate the preference of HER2+ breast cancer patients and nursing professionals for subcutaneous (SC) versus intravenous (IV) trastuzumab and to evaluate the financial impact derived from the use of the SC formulation., Methods: A cross-sectional questionnaire-based study was carried out to investigate preferences of all patients who started treatment with SC trastuzumab while they had received the IV formulation before. The preference of nursing staff in charge of preparation and administration was also analysed. The financial impact was evaluated considering the number of preparations of SC trastuzumab and the cost of IV and SC trastuzumab, the consumables used for preparation and administration and nursing staff time for preparation., Results: 76 female patients were included, 84% completed the questionnaire. Of the patients, 94% declared to be satisfied with the SC route and 88% would prefer SC administration if they had to choose between IV and SC. Time saving was the main reason to justify satisfaction and preference (48 and 45% respectively). The most common adverse event related to SC trastuzumab was post-injection pain in the injection site, experienced by 77% of the patients. SC trastuzumab was preferred by 100% of the nursing staff. Total annual savings using SC formulation instead of the IV were 35.332€., Conclusions: SC trastuzumab is preferred by patients and the nursing staff versus the IV administration. The use of SC trastuzumab reduced the cost derived from trastuzumab administration.

Objective: To analyze pharmaceutical interventions that have been carried out with the support of an automated system for validation of treatments vs. the traditional method without computer support., Method: The automated program, ALTOMEDICAMENTOS® version 0, has 925 052 data with information regarding approximately 20 000 medicines, analyzing doses, administration routes, number of days with such a treatment, dosing in renal and liver failure, interactions control, similar drugs, and enteral medicines. During eight days, in four different hospitals (high complexity with over 1 000 beds, 400-bed intermediate, geriatric and monographic), the same patients and treatments were analyzed using both systems., Results: 3,490 patients were analyzed, with 42 155 different treatments. 238 interventions were performed using the traditional system (interventions 0.56% / possible interventions) vs. 580 (1.38%) with the automated one. Very significant pharmaceutical interventions were 0.14% vs. 0.46%; significant was 0.38% vs. 0.90%; non-significant was 0.05% vs. 0.01%, respectively. If both systems are simultaneously used, interventions are performed in 1.85% vs. 0.56% with just the traditional system. Using only the traditional model, 30.5% of the possible interventions are detected, whereas without manual review and only the automated one, 84% of the possible interventions are detected., Conclusions: The automated system increases pharmaceutical interventions between 2.43 to 3.64 times. According to the results of this study the traditional validation system needs to be revised relying on automated systems. The automated program works correctly in different hospitals., (Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.)