Presence of metallic components in transdermal drug delivery systems and risk of skin burns. / [Artículo traducido] Presencia de partículas metálicas en parches transdérmicos de medicamentos y riesgo de quemaduras.

OBJECTIVE: Skin burns are associated with the presence of metallic components in transdermal drug delivery systems during Magnetic Resonance Imaging, cardioversion or defibrillation procedures. The aim of the study was to review the presence of metallic components in marketed products of transdermal drug delivery systems in Spain. METHOD: For each presentation, the summary of product characteristics was reviewed. If the information was not provided, manufacturers were contacted. RESULTS: We identified 59 marketed products of transdermal drug delivery systems of 12 different active substances. 59.3% of patches contained metallic components or their presence could not be ruled out. Information regarding the need to remove the patch was only included in 8 summaries of product characteristics (13.6%). A table was elaborated and included the following aspects: product, active substance, manufacturer, need to remove the patch before the exposure to magnetic or electric fields and references. CONCLUSION: More than a half of the patches at the time of the study contained metals or their absence could not be confirmed by the manufacturer. However, this information was only included in 13.6% of summaries of product characteristics.

Presence of metallic components in transdermal drug delivery systems and risk of skin burns.

OBJECTIVE: Skin burns are associated with the presence of metallic components in transdermal drug delivery systems during Magnetic Resonance Imaging, cardioversion, or defibrillation procedures. The aim of the study was to review the presence of metallic components in marketed products of transdermal drug delivery systems in Spain. METHOD: For each pharmaceutical form, the summary of product characteristics was reviewed. If the information was not provided, manufacturers were contacted. RESULTS: We identified 59 marketed products of transdermal drug delivery systems of 12 different active substances. 59.3% of patches contained metallic components or their presence could not be ruled out. Information regarding the need to remove the patch was only included in 8 summaries of product characteristics (13.6%) A table was elaborated and included the following aspects: product, active substance, manufacturer, need to remove the patch before the exposure to magnetic or electric fields, and references. CONCLUSION: More than a half of the patches at the time of the study contained metals or their absence could not be confirmed by the manufacturer. However, this information was only included in 13.6% of summaries of product characteristics.

Pharmacist care in hospital emergency departments: a consensus paper from the Spanish hospital pharmacy and emergency medicine associations. / Atención farmacéutica en los servicios de urgencias: documento de posicionamiento de la Sociedad Española de Farmacia Hospitalaria (SEFH) y la Sociedad Española de Medicina de Urgencias y Emergencias (SEMES).

OBJECTIVES: To draft a list of actions and quality indicators for pharmacist care in hospital emergency departments, based on consensus among a panel of experts regarding which actions to prioritize in this setting. MATERIAL AND METHODS: A panel of experts from the Spanish Society of Hospital Pharmacy (SEFH) and the Spanish Society of Emergency Medicine (SEMES) evaluated a preliminary list of potential actions and quality of care indicators. The experts used a questionnaire to assess the proposals on the basis of available evidence. In the first round, each expert individually assessed the importance of each proposed action based on 4 dimensions: evidence base, impact on clinical response and patient safety, ease of implementation, and priority. In the second round the experts attended a virtual meeting to reach consensus on a revised list of proposals; suggestions and comments that had been made anonymously in the first round were included. The group then prioritized each action as basic, intermediate, or advanced. RESULTS: The experts evaluated a total of 26 potential actions and associated quality indicators. No items were eliminated in the analysis of scores and comments from the first round. After the second round, 25 actions survived. Nine were considered basic, 10 intermediate, and 6 advanced. CONCLUSION: The expert panel's list of pharmacist actions and care quality indicators provides a basis for developing a pharmacist care program in Spanish emergency departments on 3 levels of priority. The list can serve as a guide to pharmacists, managers, physicians, and nurses involved in the effort to improve drug therapy in this hospital setting.

OBJETIVO: Desarrollar un conjunto de actividades e indicadores de atención farmacéutica en los servicios de urgencias hospitalarios mediante un consenso colectivo de un panel de expertos que permita priorizar las actividades a realizar por los farmacéuticos en estas unidades. METODO: Un comité formado por miembros de la Sociedad Española de Farmacia Hospitalaria (SEFH) y de la Sociedad Española de Medicina de Urgencias y Emergencias (SEMES) evaluó una propuesta inicial de actividades e indicadores potenciales, basados en la evidencia científica disponible, en formato de cuestionario. En una primera ronda, cada uno de los expertos del panel clasificó de forma individual la relevancia de cada una de las actividades propuestas en cuatro dimensiones: evidencia científica, impacto en la respuesta clínica y seguridad para el paciente, facilidad de implementación y grado de prioridad. La segunda ronda se realizó mediante una reunión grupal de forma virtual, a partir del cuestionario modificado de acuerdo con las sugerencias planteadas, así como los comentarios vertidos por los participantes del panel de forma anónima. En esta ronda, cada actividad fue clasificada por consenso como básica, intermedia o avanzada en función del grado de prioridad de implantación considerado por el grupo de expertos. RESULTADOS: Se propusieron un total de 26 potenciales actividades a los expertos, con indicadores asociados. Tras el análisis de las puntuaciones y los comentarios realizados en la primera ronda, no se eliminó ninguna de las actividades propuestas. Tras la segunda ronda, se mantuvieron 25 actividades, de las cuales se puntuaron 9 como actividades básicas, 10 actividades como intermedias y 6 actividades como avanzadas. CONCLUSIONES: El desarrollo del conjunto de actividades e indicadores de atención farmacéutica en urgencias, priorizados por grado de relevancia para la unidad, es la base para el desarrollo de esta cartera de servicios en los hospitales españoles, y sirve como guía tanto para farmacéuticos como para gestores, médicos y enfermeros de la unidad a fin de mejorar la farmacoterapia los pacientes atendidos en los servicios de urgencias.

[Translated article] Achieving excellence in the pharmaceutical care of the surgical patient.

The perioperative setting is one of the hospital areas with the highest prevalence of medication errors. Despite the wide experience of hospital pharmacists in developing medication safety programs and improvement initiatives, the perioperative setting has remained one of the areas in which there is less experience. Clinical pharmacist should be integrated into the multidisciplinary care team so that they can be involved in the different surgical phases of care, which include from the preoperative assessment to inpatient stay, and finally discharge from hospital. Their work will consist of coordinating and implementing strategies that have been demonstrated to reduce medication errors during the perioperative process. The aim of this paper is to introduce a specialized pharmaceutical care program to achieve excellence in the pharmaceutical care of surgical patients. This program is especially aimed at promoting the figure of the clinical pharmacist in the perioperative setting to guarantee the highest quality and safety in pharmacotherapeutic care throughout all the surgical phases of care.

Appropriateness of Empirical Antibiotic Therapy for Cervicitis and Urethritis Prescribed in the Emergency Department.

Objectives: Sexually transmitted infections are a prevalent global health care problem. Treatment guidelines have recently been updated as a result of antimicrobial resistance and public health trends. The aim of the study was to assess the appropriateness of empirical antibiotic therapy prescribed for cervicitis and urethritis in the emergency department. Methods: We designed a retrospective observational cohort study. We included adult patients with suspected cervicitis or urethritis who attended the emergency department of a tertiary hospital in 2020. We excluded patients with suspected pelvic inflammatory disease, pregnancy or prostatitis and those requiring admission to hospital. Appropriateness of empirical antibiotic therapy was evaluated taking into account 4 aspects: indication, dosing, duration of therapy, and route of administration. Data were obtained from the electronic medical record, the electronic prescription program, and the discharge summary. Results: The study population comprised 176 patients; mean age was 28.9 years (SD = 7.7), and 90.9% were men. The most prescribed treatment was the combination of ceftriaxone and azithromycin (83.0%). Treatment was inappropriate in 71.6% of patients. A total of 159 drug errors were recorded. The most frequent cause was undertreatment (36.4%) related to underdosing (46.5%), particularly with regard to ceftriaxone. The percentage of errors was 11.9% for indication, 84.9% for dosing, 3.1% for duration, and 0% for route of administration. Conclusions: A high percentage of patients who attended the emergency department for suspected cervicitis or urethritis received an inappropriate empirical antibiotic regimen. The main reason was undertreatment due to underdosing.

Achieving excellence in the pharmaceutical care of the surgical patient. / Hacia la excelencia en la atención farmacéutica al paciente quirúrgico.

The perioperative setting is one of the hospital areas with the highest prevalence of medication errors. Despite the wide experience of hospital pharmacists in developing medication safety programs and improvement initiatives, the surgical environment has remained one of the areas in which there is less experience. Clinical pharmacist should be integrated into the multidisciplinary care teams so that they can be involved in the different surgical phases of care, which include from the preoperative assessment to inpatient stay, and finally discharge from hospital. Their work will consist of coordinating and implementing strategies that have been demonstrated to reduce medication errors throughout the perioperative process. The aim of this paper is to introduce a specialized pharmaceutical care program to achieve excellence in the pharmaceutical care of surgical patients. This program is especially aimed at promoting the figure of the clinical pharmacist in the perioperative setting to guarantee the highest quality and safety in pharmacotherapeutic care throughout all the surgical phases of care.

Hacia la excelencia en la atención farmacéutica al paciente quirúrgico / Achieving excellence in the pharmaceutical care of the surgical patient

El proceso quirúrgico es una de las áreas del hospital con más prevalencia de errores de medicación. A pesar de la amplia experiencia del farmacéutico en el desarrollo de prácticas seguras de utilización de los medicamentos, el bloque quirúrgico ha sido una de las áreas en las que menos experiencia existe.El farmacéutico especialista debe integrarse en el equipo multidisciplinar, de tal forma que pueda estar presente en todas las etapas de atención al enfermo (prehospitalización, precirugía, intracirugía, postcirugía y alta). Su función será coordinar y diseñar la puesta en marcha de diferentes estrategias que han demostrado reducir el riesgo de errores de medicación durante todo el proceso perioperatorio.El objetivo del presente trabajo es presentar un programa de atención farmacéutica especializada para alcanzar la excelencia en la atención farmacéutica del paciente quirúrgico. Este programa está dirigido especialmente a visibilizar la figura del farmacéutico en el entorno perioperatorio, para que pueda colaborar en garantizar una atención farmacoterapéutica de máxima calidad y seguridad en todas las etapas. (AU)

The perioperative setting is one of the hospital areas with the highest prevalence of medication errors. Despite the wide experience of hospital pharmacists in developing medication safety programs and improvement initiatives, the surgical environment has remained one of the areas in which there is less experience.Clinical pharmacist should be integrated into the multidisciplinary care teams so that they can be involved in the different surgical phases of care, which include from the preoperative assessment to inpatient stay, and finally discharge from hospital. Their work will consist of coordinating and implementing strategies that have been demonstrated to reduce medication errors throughout the perioperative process.The aim of this paper is to introduce a specialized pharmaceutical care program to achieve excellence in the pharmaceutical care of surgical patients. This program is especially aimed at promoting the figure of the clinical pharmacist in the perioperative setting to guarantee the highest quality and safety in pharmacotherapeutic care throughout all the surgical phases of care. (AU)

Mobile Health Apps Providing Information on Drugs for Adult Emergency Care: Systematic Search on App Stores and Content Analysis.

BACKGROUND: Drug-referencing apps are among the most frequently used by emergency health professionals. To date, no study has analyzed the quantity and quality of apps that provide information on emergency drugs. OBJECTIVE: This study aimed to identify apps designed to assist emergency professionals in managing drugs and to describe and analyze their characteristics. METHODS: We performed an observational, cross-sectional, descriptive study of apps that provide information on drugs for adult emergency care. The iOS and Android platforms were searched in February 2021. The apps were independently evaluated by 2 hospital clinical pharmacists. We analyzed developer affiliation, cost, updates, user ratings, and number of downloads. We also evaluated the main topic (emergency drugs or emergency medicine), the number of drugs described, the inclusion of bibliographic references, and the presence of the following drug information: commercial presentations, usual dosage, dose adjustment for renal failure, mechanism of action, therapeutic indications, contraindications, interactions with other medicinal products, use in pregnancy and breastfeeding, adverse reactions, method of preparation and administration, stability data, incompatibilities, identification of high-alert medications, positioning in treatment algorithms, information about medication reconciliation, and cost. RESULTS: Overall, 49 apps were identified. Of these 49 apps, 32 (65%) were found on both digital platforms; 11 (22%) were available only for Android, and 6 (12%) were available only for iOS. In total, 41% (20/49) of the apps required payment (ranging from €0.59 [US $0.64] to €179.99 [US $196.10]) and 22% (11/49) of the apps were developed by non-health care professionals. The mean weighted user rating was 4.023 of 5 (SD 0.71). Overall, 45% (22/49) of the apps focused on emergency drugs, and 55% (27/49) focused on emergency medicine. More than half (29/47, 62%) did not include bibliographic references or had not been updated for more than a year (29/49, 59%). The median number of drugs was 66 (range 4 to >5000). Contraindications (26/47, 55%) and adverse reactions (24/47, 51%) were found in only half of the apps. Less than half of the apps addressed dose adjustment for renal failure (15/47, 32%), interactions (10/47, 21%), and use during pregnancy and breastfeeding (15/47, 32%). Only 6% (3/47) identified high-alert medications, and 2% (1/47) included information about medication reconciliation. Health-related developer, main topic, and greater amount of drug information were not statistically associated with higher user ratings (P=.99, P=.09, and P=.31, respectively). CONCLUSIONS: We provide a comprehensive review of apps with information on emergency drugs for adults. Information on authorship, drug characteristics, and bibliographic references is frequently scarce; therefore, we propose recommendations to consider when developing an app of these characteristics. Future efforts should be made to increase the regulation of drug-referencing apps and to conduct a more frequent and documented review of their clinical content.

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

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

Comparison of a polypharmacy-based scale with Charlson comorbidity index to predict 6-month mortality in chronic complex patients after an ED visit.

AIMS: The aim of this study was to test whether a newly designed polypharmacy-based scale would perform better than Charlson's Comorbidity Index (CCI) to predict outcomes in chronic complex adult patients after a reference Emergency Department (ED) visit. METHODS: We built a polypharmacy-based scale with prespecified drug families. The primary outcome was 6-month mortality after the reference ED visit. Predefined secondary outcomes were need for hospital admission, 30-day readmission, and 30-day and 90-day mortality. We evaluated the ability of the CCI and the polypharmacy-based scale to independently predict 6-month mortality using logistic regression, receiver operating characteristic (ROC) curves, and cumulative survival curves using Kaplan-Meier estimates and the log-rank test for three-category distributions of the polypharmacy-based scale and the CCI. Finally, we sought to replicate our results in two different external validation cohorts. RESULTS: We included 201 patients (53.7% women, mean age = 81.4 years), 162 of whom were admitted to the hospital at the reference ED visit. In separate multivariable analyses accounting for gender, age and main diagnosis at discharge, both the polypharmacy-based scale (P < .001) and the CCI (P = .005) independently predicted 6-month mortality. The polypharmacy-based scale performed better in the ROC analyses (area under the curve [AUC] = 0.838, 95% confidence interval [CI] = 0.780-0.896) than the CCI (AUC = 0.628, 95% CI = 0.548-0.707). In the 6-month cumulative survival analysis, the polypharmacy-based scale showed statistical significance (P < .001), whereas the CCI did not (P = .484). We replicated our results in the validation cohorts. CONCLUSIONS: Our polypharmacy-based scale performed significantly better than the CCI to predict 6-month mortality in chronic complex patients after a reference ED visit.

Promoting clinical pharmacy services through advanced medication review in the emergency department.

Objectives: To determine if an advanced medication review carried out in the emergency department (ED) increases the number of pharmacotherapy recommendations (PR) and the severity of the detected prescribing errors. Methods: We designed an analytic observational prospective cohort study with preintervention assessment (PRE) and postintervention assessment (POST). In PRE, prescription review was done by pharmacists located in the pharmacy department; they took into account only the information provided by the computerised physician order entry system. In POST, pharmacists were physically present in the ED and performed an advanced medication review. The main variables were number of PR and the severity of detected prescribing errors according to the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) severity index. Clinical variables were number of calls to physicians on duty during the first 48 hours of admission, readmissions at 30 days, visits to the ED at 30 days, inhospital mortality and length of stay. Results: The study population comprised 102 patients (51 in PRE and 51 in POST). In PRE, the number of PR per patient was 1.1; in POST, this value increased by 53% (1.7 PR per patient; P=0.014), especially in the case of PR related to home medications. The severity of prescribing errors was higher in POST (P=0.004). There was a trend towards better results for all clinical outcomes in POST although statistical significance was not reached. Conclusions: An advanced medication review in the ED increases the number of PR and the severity of the detected prescribing errors.

Thromboprophylaxis Management in Surgical Patients: The Efficacy of a Protocol in the Electronic Prescription Program.

BACKGROUND AND OBJECTIVE: Venous thromboembolism (VTE) continues to be a problem in surgical patients, but thromboprophylactic measures are not always implemented. This study aimed to evaluate thromboprophylaxis practice in surgical patients at our institution by assessing appropriateness during admission and discharge; 60-day clinical outcomes are analyzed, and finally further interventions are discussed for continued improvement. METHODS: A cross-sectional, observational study was conducted in patients undergoing orthopedic and abdominal surgical procedures. Initially, the institution protocol was updated and embedded in the Computerized Physician Order Entry system. We then assessed prospective adequacy of thromboprophylaxis as per established in the protocol. The primary endpoint was thromboprophylaxis initiation and, secondarily, the quality of related prescriptions during hospitalization and at discharge. RESULTS: A total of 114 patients were included in the study. According to VTE risk, thromboprophylaxis was initiated in 85.1% of the patients as needed during hospitalization and 94.8% at discharge. The following inadequacies versus the protocol were found: no duration information in the discharge summary (32.5%), incorrect postsurgical administration time of pharmacological prophylaxis (15.8%), omission of mechanical prophylaxis (13.7%), misdosing (9.6%), and omission of pharmacological prophylaxis (2.6%). No VTE events occurred 60 days postdischarge. CONCLUSION: The electronic protocol was an effective tool, as evidenced by the fact that thromboprophylaxis was initiated in the majority of surgical patients in our institution during hospitalization and at discharge. Still, some aspects leave room for improvement (duration, dosing, and timing), and further measures such as implementation of Electronic Medication Administration Records and new functionalities in the Clinical Decision Support systems are proposed.

Drug safety surveillance within a strategy for the management of non-chemotherapy drug-induced neutropenia.

Background Severe non-chemotherapy drug-induced neutropenia is a rare idiosyncratic drug reaction that is considered potentially fatal. Objective To report, in terms of drug safety surveillance, the results of an institutional strategy for NCDIN. Method An observational and prospective study including all adult patients who received filgrastim for the treatment of NCDIN from June 2015 to December 2017 was carried out by hematologists and clinical pharmacists. Results 13 patients with severe NCDIN were included in the study. The median age was 51 (range 24-80) years old and 46.2% were male. Seven patients had one or more negative prognostic factors (age > 65 years, renal impairment, autoimmune diseases and/or a neutrophil count at diagnosis < 0.1 × 109 cells/L). A single drug was identified as causative in 3 patients, while in 10 cases, 2-3 drugs were considered as potentially causative. The most frequent drugs were metamizole, piperacillin/tazobactam, dexketoprofen and linezolid, among others. Seven patients developed NCDIN during their hospital stay while 6 were admitted to the emergency department. Patients were using a median of 11 drugs (IQR 8-15) at the time of diagnosis. No deaths were recorded. Conclusion Metamizole and piperacillin/tazobactam are the most common drugs linked to non-chemotherapy drug-induced neutropenia in our cohort.

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

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

Twelve weeks of ombitasvir/paritaprevir/r and dasabuvir without ribavirin is effective and safe in the treatment of patients with HCV genotype 1b infection and compensated cirrhosis: results from a real-world cohort study.

OBJECTIVE: To explore the effectiveness and safety of ombitasvir/paritaprevir/ritonavir and dasabuvir (OBV/PTV/r+DSV) for 12 weeks without ribavirin in adults with chronic HCV genotype 1b infection and compensated cirrhosis. METHODS: Observational study of a prospective cohort of adult patients with HCV genotype 1b infection and compensated cirrhosis who received 12 weeks of OBV/PTV/r and DSV without ribavirin. Effectiveness was assessed by recording the percentage of patients achieving sustained virological response at week 12 post-treatment (SVR12). Safety outcomes were based on the incidence of adverse events. RESULTS: Seventy-eight patients were included. The SVR12 rate was 96.1% (95%CI 89.2-99.2). Adverse events were recorded in 78.0% of patients. Of these, 97.7% were grade 1/2. One patient discontinued treatment prematurely owing to adverse events. Eighty-six interactions were detected in 43 patients (55.1%). Overall, 81.4% of interactions required close monitoring, alteration of drug dosage, or timing of administration. In 7.0% of cases, the interactions arose from contraindications that required the suspension of the concomitant drug. In 11.6% of cases, medicinal plants or foods were withdrawn. CONCLUSIONS: The simplified regimen of OBV/PTV/r+DSV administered for 12 weeks is effective and safe in patients with chronic HCV genotype 1b infection and compensated cirrhosis. No adverse reactions related to drug-drug interactions were recorded.

Lactulose enemas in the treatment of hepatic encephalopathy. Do we help or harm?

The administration of lactulose enemas instead of or in combination with oral lactulose is common practice in patients with hepatic encephalopathy. Lactulose is a non-absorbable disaccharide that is catabolized by the bacterial flora to short chain fatty acids (e.g., lactic acid and acetic acid) which lower the colonic pH. This pH favors the formation of non-absorbable NH4+ from NH3, trapping NH4+ in the colon and thus reducing plasma ammonia concentrations. Lactulose therapy is considered as a first-line treatment and can be administered both orally and rectally.

Improving pharmacotherapy outcomes in patients with hepatitis C virus infection treated with direct-acting antivirals: The GRUviC project.

BACKGROUND/OBJECTIVE: Pharmaceutical care is needed in hepatitis C virus (HCV)-infected patients treated with direct-acting antivirals (DAA). We describe the implementation of a comprehensive pharmaceutical care programme (CPCP) for HCV-infected patients treated with DAA in a tertiary-care hospital and provide data about health outcomes and costs. METHODS: Quasi-experimental study between 1 April 2015 and 30 June 2016. A group of hospital pharmacists collaborating on HCV infection implemented interventional measures for validation of drug prescriptions, detection of clinically relevant drug-drug interactions and adverse drug events (ADEs), and patient education. Quality, health and cost-effectiveness outcomes were evaluated. RESULTS: A total of 1070 patients were enrolled. Pharmacists made 327 interventions that led to the prevention of 299 (91.4%) medication errors, 16 of which were grade G-H (NCC MERP classification). The main reasons for the pharmacist's intervention were management of 143 drug-drug interactions. The overall sustained virologic response at week 12 posttreatment (SVR12) rate was 93.0% (95% CI 91.4-94.6). The SVR12 was higher than 90.0% in all populations, except in genotype 3 patients (86.0%, 95% CI 78.7-93.9), decompensated cirrhotic patients (81.1%, 95% CI 69.7-92.6) and transplant recipients (86.8%, 95% CI 76.7-96.9). ADEs occurred in 85.5% of the study patients, but only 1.0% (11 patients) experienced an ADE that led to premature discontinuation. The total cost of treatment was €18 279 225 (€17 083 per patient). The most cost-effective treatment was selected in 93.1% of patients. CONCLUSIONS: The implementation of a CPCP developed by hospital pharmacists in patients treated with DAAs for HCV infection is an effective approach that improves patient safety and education. The active involvement of the pharmacist in improving adherence to local guidelines promoted the selection of the most cost-effective treatment in the majority of cases.

Clinical and Economic Impact of a Multisciplinary Intervention to Reduce Bleeding Risk in Patients With Acute Coronary Syndrome.

INTRODUCTION AND OBJECTIVES: To evaluate the clinical and economic impact of a multidisciplinary program to reduce bleeding events in patients with acute coronary syndrome through optimization of antithrombotic therapy. METHODS: We designed a preintervention (PRE) and postintervention (POST) quasi-experimental study using a retrospective analysis of 2 cohorts. The first cohort was analyzed to detect correctable measures contributing to bleeding (PRE). Afterward, a quality improvement intervention with a bundle of recommendations was implemented. Finally, a second cohort of patients was evaluated to investigate the impact of the measures on bleeding reduction (POST). The impact on health outcomes was evaluated through comparison of the percentage of in-hospital bleeding events and 30-day readmissions between the 2 cohorts. The economic analysis took into account the costs associated with the implementation of the program and the cost-savings associated with the prevention of bleeding events and 30-day readmissions. RESULTS: A total of 677 patients were included (377 in PRE and 300 in POST). The total bleeding rate was reduced after the implementation of the bundled intervention by 29.2% (31.6% in POST vs 22.3% in PRE; OR, 0.62; 95%CI, 0.44-0.88) while 30-day readmission rates were 7.7% in PRE and 5% in POST (P=.20). The estimated avoided cost was €95 113.6 per year, meaning that €10.1 would be obtained in return for each euro invested during the first year and €36.3 during the following years. CONCLUSIONS: This multidisciplinary program has proven to be effective in reducing bleeding events and is economically attractive.