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Background and Objective: The safety profile of Janus Kinase (JAK) inhibitors has acquired attention due to post-marketing observed adverse drug reactions. The study focuses on the analysis of adverse reactions related to tofacitinib, baricitinib, upadacitinib, and filgotinib in rheumatoid arthritis patients, including identifying predictive factors linked to their occurrence., Patients and Methods: Observational retrospective study. Adult patients with rheumatoid arthritis from a university hospital receiving JAK inhibitor treatment between September 2017 and January 2024 were included. The cumulative incidence of each adverse reaction was calculated using the Naranjo scale. Risk factors for developing adverse reactions were identified through logistic regression analyses., Results: Two hundred twenty-three patients were included, with 28.7% presenting adverse reaction related to JAK inhibitor treatment. The adverse drug reactions with the highest cumulative incidence were infections and gastrointestinal disorders. Infections included: upper respiratory tract (4.5%), cellulitis (3.1%), urinary tract (2.7%), herpes zoster (1.8%). Gastrointestinal disorders comprised: abdominal pain (4.0%), diarrhea (3.6%), nausea and vomiting (3.6%), gastrointestinal perforation (1.3%), diverticulitis (0.9%). Classified at 0.5% were: headache, paresthesias, skin rash, severe neutropenia, insomnia, dyspnea, hypertensive crisis. As risk factors, were identified: the treatment with a non-selective JAK inhibitor (OR adjusted: 4.03; 95% CI: 1.15-14.10; P=.029) and older age (OR adjusted: 1.03; 95% CI: 1.00-1.05; P=.036)., Conclusions: Infections and gastrointestinal disorders represented the adverse reactions related to JAK inhibitor treatment with the highest cumulative incidence, with risk factors for their occurrence being non-selective JAK inhibitor treatment and older age of the patient., (Copyright © 2024 Elsevier España, S.L.U. All rights reserved.)

Introduction: The aim of this study was to assess the implementation of safe medication practices in hospital emergency services, in order to understand the points of greatest risk as well as the safety challenges faced by these departments, and to plan collaboratively improvement initiatives., Method: Multicentric and descriptive study based on completion of the "Medication safety self-assessment of emergency services" from 5/16/2023 to 11/16/2023, at voluntarily participating emergency services. The survey contained 93 items 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 assessed., Results: A total of 72 emergency services completed the questionnaire. The mean score obtained for the overall questionnaire was 428.3 points (51.1% of the maximum score). Results showed a large variation among the scores of the participating services (range: 164-620.5). Four key elements had values below 50%, corresponding to competence and training of professionals in safety practices (38.4%); incorporation of pharmacists in emergency departments (42.1%), availability and accessibility of information about patients (43.1%), and patient education (48.1%). The highest values corresponded to labeling, packaging, and naming of medications (69.2%) and communication of prescriptions and other medication information (64%). No differences were found between emergency services in the key elements according to the dependency or size of the hospital, or the type of service, except for the item referring to the incorporation of pharmacists in the emergency service, where differences were observed between hospitals with less than 200 beds (28.9%) and those with more than 500 (52.2%)., Conclusion: The application of the specific self-assessment questionnaire has made it possible to identify safety practices that are insufficiently implemented into emergency services in our country and to identify critical points for improvement for which planning collaborative initiatives to reduce medication errors in these departments should become a priority., (Copyright © 2024. Publicado por Elsevier España, S.L.U.)

Objective: To develop a panel of indicators to monitor antimicrobial stewardship programs activity in the emergency department., Methods: A multidisciplinary group consisting of experts in the management of infection in emergency departments and the implementation of antimicrobial stewardship programs (ASP) evaluated a proposal of indicators using a modified Delphi methodology. In the first round, each expert classified the relevance of each proposed indicators in two dimensions (healthcare impact and ease of implementation) and two attributes (prioritisation level and frequency). The second round was conducted based on the modified questionnaire according to the suggestions raised and new indicators suggested. Experts modified the prioritisation order and rated the new indicators in the same manner as in the first round., Results: 61 potential indicators divided into four groups were proposed: consumption indicators, microbiological indicators, process indicators, and outcome indicators. After analysing the scores and comments from the first round, 31 indicators were classified as high priority, 25 as intermediate priority, and 5 as low priority. Moreover, 18 new indicators were generated. Following the second round, all 61 initially proposed indicators were retained, and 18 new indicators were incorporated: 11 classified as high priority, 3 as intermediate priority, and 4 as low priority., Conclusions: The experts agreed on a panel of ASP Indicators adapted to the emergency services prioritised by level of relevance. This is as a helpful tool for the development of these programs and will contribute to monitoring the appropriateness of the use of antimicrobials in these units., Competing Interests: Declaration of Competing Interest None declared., (Copyright © 2023 Sociedad Española de Farmacia Hospitalaria (S.E.F.H). All rights reserved.)

Objective: To develop a panel of indicators to monitor antimicrobial stewardship programs activity in the emergency department., Methods: A multidisciplinary group consisting of experts in the management of infection in emergency departments and the implementation of antimicrobial stewardship programs (ASP) evaluated a proposal of indicators using a modified Delphi methodology. In the first round, each expert classified the relevance of each proposed indicators in two dimensions (healthcare impact and ease of implementation) and two attributes (prioritization level and frequency). The second round was conducted based on the modified questionnaire according to the suggestions raised and new indicators suggested. Experts modified the prioritization order and rated the new indicators in the same manner as in the first round., Results: 61 potential indicators divided into four groups were proposed: consumption indicators, microbiological indicators, process indicators, and outcome indicators. After analyzing the scores and comments from the first round, 31 indicators were classified as high priority, 25 as intermediate priority, and 5 as low priority. Moreover, 18 new indicators were generated. Following the second round, all 61 initially proposed indicators were retained, and 18 new indicators were incorporated: 11 classified as high priority, 3 as intermediate priority, and 4 as low priority., Conclusions: The experts agreed on a panel of ASP indicators adapted to the emergency services prioritized by level of relevance. This is as a helpful tool for the development of these programs and will contribute to monitoring the appropriateness of the use of antimicrobials in these units., (Copyright © 2023 Sociedad Española de Farmacia Hospitalaria (S.E.F.H). All rights reserved.)

Objectives: To assess the usefulness of a tool based on ICD-10 diagnostic codes to identify patients who consult an emergency department for adverse drug events (ADE)., Methods: Prospective observational study, in which patients discharged from an emergency department during May to August 2022 with a diagnosis coded with one of the 27 ICD-10 diagnoses considered as triggers were included. ADE confirmation was carried out by analyzing drugs prescribed prior to admission, and through a discussion among experts and a phone interview with patients after hospital discharge., Results: 1143 patients with trigger diagnoses were evaluated, of which 310 (27.1%) corresponded to patients whose emergency visit was attributed to an ADE. A 58.4% of ADE consultations were found with three diagnostic codes: K59.0-Constipation (n = 87; 28.1%), I16.9-Hypertensive Crisis (n = 72; 23.2%) and I95.1-Orthostatic hypotension (n = 22; 7.1%). The diagnoses with the highest degree of association with consultations attributed to ADE were E16.2-Hypoglycemia, unspecified (73.7%) and E11.65-Type 2 diabetes mellitus with hyperglycemia (71.4%), while diagnoses D62-Acute posthemorrhagic anemia and I74.3-Embolism and thrombosis of arteries of the lower limbs were not attributed to any case of ADE., Conclusions: The ICD-10 codes associated with trigger diagnoses are a useful tool to identify patients who consult the emergency services with ADE and could be used to apply secondary prevention programs to avoid new consultations to the health care system., Competing Interests: Conflicts of interest No conflicts of interest are declared., (Copyright © 2023 Sociedad Española de Farmacia Hospitalaria (S.E.F.H). Publicado por Elsevier España, S.L.U. All rights reserved.)

Antimicrobial stewardship programs (ASPs) have been shown to be effective and safe, contributing to reducing and adjusting antimicrobial use in clinical practice. Such programs not only reduce antibiotic selection pressure and therefore the selection of multidrug-resistant strains, but also reduce the potential deleterious effects for individual patients and even improve the prognosis by adjusting the choice of drug and dosage, and lessening the risk of adverse effects and interactions. Gram-negative bacilli (GNB), particularly multidrug-resistant strains (MDR-GNB), represent the main infectious problem in the Intensive Care Unit (ICU), and are therefore a target for ASPs. The present review provides an update on the relationship between ASPs and MDR-GNB., (Copyright © 2022 Elsevier España, S.L.U. and SEMICYUC. All rights reserved.)

Objective: Adverse drug events are a well-known cause of emergency department admissions. FARM-URG is a project promoted by  the REDFASTER working group of the Spanish Society of Hospital  Pharmacy. Its aim is to evaluate these adverse events through regular  prevalence measurements. The present study shows the results of the first observations. The goal was to determine the prevalence of adverse drug  events with respect to the total number of patients treated in emergency  departments and carry out a description of the different events identified., Method: This is a multicenter cross-sectional study carried out in the emergency room of 13 Spanish hospitals. The identification and  registration of patients were obtained from the emergency department  patient census at the time of the first prevalence measurement (16 June  2020). The REDCap® platform was used for patient registration., Results: The 2020 FARM-URG registry, which included 13 hospitals, evaluated 772 patients, of whom 57 (7.4%) consulted for  adverse drug events. Antithrombotic drugs were responsible for most of  these episodes, acenocoumarol being the main drug involved (22.8%).  Nine (15.8%) adverse drug events were caused by inappropriate drug  prescriptions according to the STOPP-START criteria. Nineteen (33.0%)  patients returned to the emergency service within 30 days from discharge., Conclusions: Adverse drug events are a frequent cause of emergency department visits and are commonly associated with a  significant percentage of re-visits. The FARM-URG project has been created with the purpose of obtaining dynamic and updated information on such  events., (Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.)

Objective: To describe the current situation of the hospital pharmacist in intensive care units and their activity in care, in teaching  and in research., Method: Multicenter and prospective study through a survey  disseminated by the Spanish Society of Hospital Pharmacy, which  consisted of several sections: personal and hospital's data, hospital's  characteristics, pharmacist's involvement in intensive care units and  teaching., Results: A number of 58 completed surveys were obtained. The  number of pharmacists involved in intensive care units was 1 in 77.6%  of cases, assisting an average of 30.8 beds (5-70). Experience of  pharmacists in the intensive care unit was 5 years on average (2  months-25 years). Visitor's pass assistance and shift changes were  between "never" by 36.2% to "daily" by 22.4%. Out of respondents,  93.1% reported a part-time intensive care unit involvement. Regarding  activities undertaken, between 40-60% of pharmacists manage  narcotics, teaching at intensive care unit, conciliation and safety.  Between 60-80%, pharmacists cover clinical nutrition, notarization,  optimization of pharmacokinetics and antibiotics; and 84.5% perform  pharmacotherapy follow-up. Out of the surveyed pharmacists, 77.6%  have specialized medical training, rotating intensive care unit residents  in 86% of cases., Conclusions: Most of the surveyed hospitals have one part-time  pharmacist in these units. In order to improve the quality of  pharmaceutical care of critically ill patients, it would be necessary to  extend the involvement in time and staff, regarding the current  situation, and a greater number of hospitals should include pharmacists  in hospital intensive care units., (Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.)

Objective: Antimicrobial Stewardship Programs (ASPs) have appeared as very useful tools in order to improve the use of antimicrobial agents. The objective of this study is to assess the impact of an ASP on haematological patients hospitalized in an Intensive Care Unit (ICU)., Methods: A quasi-experimental pre-post intervention study, which included haematological patients admitted to an ICU and assessed by the ASP program during 3 years. The impact of the program on patient evolution was assessed by comparison between the previous period and the intervention period in terms of mortality, mean stay, number of re-hospitalizations, and duration of mechanical ventilation for intubated patients., Results: The ASP team assessed 324 antimicrobial agents in 169 patients; they recommended 121 modifications, including 55 treatment discontinuations. Compared with the pre-intervention period, there were no significant differences in the variables assessed. No variation was observed in colonization by multi-resistant bacteria., Conclusions: The implementation of an APS on critical haematological patients will lead to a relevant number of treatment modifications, without any impact on the clinical evolution of patients., (Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.)

Introduction: Antiviral drugs for the treatment of hepatitis C virus (HCV) infections have a large number of interactions. The aim of this study was to describe the interactions of telaprevir, boceprevir and sofosbuvir with immunosuppressive drugs in liver transplant recipients., Methods: A retrospective observational study was performed in liver transplant patients with HCV infection who started treatment with telaprevir, boceprevir or sofosbuvir. Dose, regimens and plasma levels of tacrolimus, cyclosporine and sirolimus before and after antiviral treatment initiation were collected. Average variations in dose, dosing interval and immunosuppressive plasma levels after the start of treatment were calculated., Results: Thirty-five patients were included. In patients treated with telaprevir (n = 18), the cyclosporine dose was reduced by an average of 59.1% (SD = 14.6%), yielding an average reduction of 14.6% (18.8%) in plasma levels. The dose of tacrolimus was reduced by 34.3% (31.7%), increasing the dosing interval by a mean of 73.4 (38.2) hours. After this variation, tacrolimus levels were increased by an average of 59.7% (89.6%). In patients treated with boceprevir (n = 4), tacrolimus started with a reduction of 18.1% (9.8%) of the initial dose and an average increase in the dosing interval of 12.0 (16.9) hours, showing a mean reduction in plasma levels of 37.7% (21.8%). Sofosbuvir therapy (n = 13) showed no significant variations in immunosuppressive drug levels., Conclusions: The interaction of telaprevir and boceprevir with immunosuppressive drugs requires a substantial dose reduction at the beginning of treatment and close monitoring of plasma levels., (Copyright © 2014 Elsevier España, S.L.U. and AEEH y AEG. All rights reserved.)

Objective: To assess causes of suspension of hepatitis C treatment in patients receiving triple antiviral therapy (peginterferon+ ribavirin + protease inhibitor)., Methods: Retrospective observational study of patients who received triple antiretroviral therapy against hepatitis C between January 2012 - March 2013 and discontinued their treatment., Results: Of 156 patients who initiated therapy, 41 discontinued treatment: Nineteen due to adverse events, being dermatological events in seven patients ( 36.8 %), intolerance in six(31.6%) and hematologic toxicity in four (15.8%) . Sixteen patients discontinued treatment for being ineffectiveness.Patients with higher inefficacy failure rate were "null-responders"(32.3% ) while the group of "relapsers" were the one with the highest rate of toxicity suspensions (15.6%). Two patients died during treatment for pneumonia., Conclusions: Triple therapy with boceprevir and telaprevir is associated with a significant number of treatment failures due to toxicity and ineffectiveness., (Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.)

Purpose: To analyse the effectiveness of the use of Tolvaptan and the adequacy of Tolvaptan prescription at a tertiary level hospital., Methods: Prospective observational study of Tolvaptan prescrip - tion from October of 2010 to December of 2011., Results: 30 patients (60.0% males) were included, 50.0% of which were diagnosed with heart failure and 30.0% with SIADH. Tolvaptan allowed achieving sodium levels higher than 135 mEq/L in 53.3% of the patients with a mean baseline value of 125.3±7.3 mEq/L. The median treatment duration was 5.0 days (interquartile range=3-45). A significant increase of uric acid associated to Tolvaptan treatment was observed. The prescription was in agreement to what has been established in GFT in 63.3% of the cases., Conclusions: Tolvaptan increases sodium levels by 7.5 mEq/L, both in SIADH-associated hyponatremia and in heart failure, with an appropriate safety profile., (Copyright © 2013 SEFH. Published by AULA MEDICA. All rights reserved.)