Proton pump inhibitors decrease efficacy of palbociclib in patients with metastatic breast.

OBJECTIVES: The objective of this investigation was to assess the impact of concurrent proton pump inhibitors (PPIs) on progression-free survival (PFS) in patients with hormone receptor-positive and HER2-negative metastatic breast cancer (mBC) who received palbociclib as first-line or successives therapy. MATERIALS AND METHODS: A retrospective observational study was conducted, enrolling patients diagnosed with estrogen receptor-positive, human epidermal growth factor receptor 2-negative mBC, and eligible for palbociclib treatment. Patients were categorized as "concurrent PPIs" if they received PPIs for at least two-thirds of the palbociclib therapy duration, and as "no concurrent PPIs" if they did not receive PPIs during the course of palbociclib treatment. RESULTS: A total of 165 patients were included in the study. Among first-line patients treated with palbociclib, those using concurrent PPIs exhibited a PFS of 8.88 months, while patients using palbociclib without concurrent PPIs had a PFS of 67.81 months (p < 0.0001). In second-line or subsequent treatments, patients on palbociclib with concurrent PPIs had a PFS of 7.46 months, whereas those using palbociclib without concurrent PPIs had a PFS of 17.29 months (p = 0.122). CONCLUSION: This study demonstrates that the concurrent use of PPIs in mBC patients receiving palbociclib negatively affects PFS, particularly in the first-line setting. Nevertheless, further investigation is warranted to explore the impact of PPIs on cycle-dependent kinase 4/6 inhibitors.

[Translated article] Compounding training programme for pharmacy technicians using a digital platform and simulation techniques.

OBJECTIVE: To describe a compounding training plan in a tertiary hospital pharmacy service. The project aimed pharmacy assistant technicians to use a digital training platform and simulation techniques. METHODS: Two training programs were designed, one for sterile and the other for non-sterile drugs. Each programme consists of several phases: a basic online training course (digital e-learning platform), a practical simulation workshop, a supervised practice in real conditions, and a final verification by the pharmacist to qualify the technician. Both programs include continuous and accredited evaluation by the hospital's Continued Education Commission. A satisfaction survey on training (e-lerning platform) was designed and conducted for pharmacy technicians (sterile and non-sterile). RESULTS: The project has been running for 3 years. Six specialist pharmacists from different areas involved in compounding are responsible for training and continuous evaluation. Twenty-one technicians have been trained, and nineteen have obtained qualifications. Two of them were found to be unfit. Currently, we employ13 pharmacy technicians who were initially trained. The participation rate in the satisfaction survey on training (e-learning platform) was 61.5% (n=8) out of a total number of current developers (n=13). Overall, 62.5% of technicians reported being satisfied or very satisfied, while the remaining 37.5% were indifferent. CONCLUSIONS: Compounding training program is currently in its third year. It has been crucial in delegating tasks to pharmacy technicians. The use of digital technology is essential in this training. We consider that, specific training in compounding, is indispensable and should be included in the academic plan for pharmacy technicians.

Green hospital pharmacy: A sustainable approach to the medication use process in a tertiary hospital. / [Artículo traducido] Farmacia hospitalaria ecológica: un enfoque sostenible del proceso de utilización de medicamentos en un hospital de tercer nivel.

BACKGROUND: Sustainable management of healthcare waste has a positive impact on the global environment. In order to reduce it, the sustainable practice of the pharmacotherapeutic process in all its stages is essential. OBJECTIVE: To analyse the sustainability strategies proposed by the pharmacy service to reduce drug waste derived from the pharmacotherapeutic process. SECONDARY OBJECTIVES: To analyse the stage of the pharmacotherapeutic process and the number and type of drugs involved. METHODS: The study was carried out in a tertiary-level hospital. To coordinate the proposals, a referent pharmacist from every pharmacy department area was selected. Four stages of the process were evaluated (management, validation, dispensing and compounding), patients concerned were classified as outpatients or inpatients, and drugs potentially involved were analysed by the administration route: Into oral or parenteral. RESULTS: Twenty eight ideas were proposed, which could affect more than 1200 drugs. 39.3% would affect the validation process, 17.9% the procurement management, 17.9% dispensing, and 7.1% the compounding. Implementation feasibility and acceptability of these proposals were evaluated. Those with the greatest potential were: Limiting the duration of treatments when possible, favouring the implementation of computer prescription order entry, favouring the use of the oral route over the parenteral route, and implementing computers in the preparation areas to avoid the use of paper guides. DISCUSION: In our study, many ideas have been proposed by hospital pharmacists to improve the sustainability of the medication use process. When assessing these proposals by impact and feasibility, according to our results, shorten as much as possible the duration of treatments, computerization of the medication use process, and oral administration over intravenous should be prioritized in order to reduce environmental impact.

Subacute cutaneous lupus erythematosus following ribociclib therapy for metastatic breast cancer.

INTRODUCTION: Drug-induced subacute cutaneous lupus erythematosus (DI-SCLE) has been associated with drugs with different mechanisms of action, including anti-hypertensives, tumour necrosis factor-α inhibitors and even some chemotherapy medicines. In the last years, a few reports have been described in patients treated with cyclin-dependent kinase (CDK) 4/6 inhibitors, palbociclib and abemaciclib. CASE REPORT: Here, we describe a case of DI-SCLE in association with ribociclib and exemestane in a woman diagnosed with metastatic breast cancer. MANAGEMENT AND OUTCOME: Topical mometasone was prescribed for two weeks with complete resolution of lesions, also abemaciclib was substituted for ribociclib, and the patient had stable disease with no relapse of DI-SCLE. DISCUSSION: To our knowledge, this is the first report of ribociclib-induced SCLE but based on the DI-SCLE reported cases associated others CDK4/6 inhibitors, the role of this family of drugs in dermatopathology must be further investigated.

Real-world Performance of a New Strategy for Off-Label Use of Guselkumab in Moderate to Severe Psoriasis: Super-Responder Patients as the Epitome of Efficacy and Optimisation.

BACKGROUND: Guselkumab is a drug used to treat moderate to severe plaque psoriasis. However, real-life clinical data on its off-label use are limited, especially regarding the optimal drug dosage regimen for different patient profiles. OBJECTIVE: The main objective of this real-world, single-centre, retrospective study was to identify the off-label guselkumab dosing regimen used in clinical practice. The study also aimed to evaluate the drug's efficacy, safety, and survival, as well as the proportion of super-responders (SR) based on a newly proposed definition. METHODS: The study included 69 patients who started treatment with guselkumab between March 2019 and July 2021. Patients were followed up until April 2022, during which time their efficacy, safety, persistence, and use of guselkumab were recorded. Patients were aged ≥  18 years and had moderate to severe plaque psoriasis. RESULTS: The mean disease duration was 18.6 years, and 59% of patients had received at least one biologic treatment before guselkumab with a mean of 1.3 biologics per patient. The initial absolute Psoriasis Area and Severity Index (PASI) was 10.1 and decreased to 2.1 between Week 11-20 without significant changes in the PASI value throughout the 90 weeks of follow-up. The cumulative probability of drug survival was 93.5% at Week 52. No differences were found in terms of efficacy and survival associated with the off-label drug dosage regimens compared to the doses described in the Summary of Product Characteristics (SmPC). The greatest adjustments in the drug administration regimen were achieved in the subgroups of bio-naïve and SR patients, with a reduction in the number of administrations by 40% and 47% compared to the regimen described in the SmPC. Super-response to guselkumab was mainly associated with patients naïve to previous biologic treatment. CONCLUSION: The study demonstrated that off-label use of guselkumab was safe and effective in real-life clinical practice. The findings suggest that adjustments to the drug administration regimen may be necessary to optimise its use in different patient profiles, especially in SR and bio-naïve patients. Further studies are needed to confirm these findings.

Development of a telematic pharmaceutical care app (Haemoassist) for multidisciplinary follow-up of patients with congenital coagulopathies.

BACKGROUND: Guidelines for congenital coagulopathies recommend that patients record treatment administrations and bleeding episodes to help healthcare professionals monitor the disease. RESEARCH DESIGN AND METHODS: We studied over two years which patient profiles (age, treatment regimen, treatment compliance) were most likely to accept the use of an app to collect this information. We validated the quality of patient-reported data by comparing it with data obtained from hospital electronic records, pharmacy dispensing records and patient interview, collected in an access database used as a reference. Patient and professional opinions were solicited through open-ended interviews. RESULTS: The app was used by 52% of 315 patients studied. Younger patients were the most frequent users. Patients with better treatment compliance used the app more, although data collection was incomplete for most patients. The best rated by patients were the reminders of days of administration and the minimum stock alerts at home. Healthcare professionals rated the app positively. CONCLUSIONS: Healthcare professionals valued the app as useful for managing treatment of congenital coagulopathies. Patients need support and time to use the app and improve the quality of the data entered. Patients who used the app rated it positively. The treatment compliance improved.

Real-world outcomes of abiraterone and enzalutamide in first-line treatment of metastatic castration-resistant prostate cancer: which patients benefit most?

OBJECTIVES: Abiraterone and enzalutamide are two oral novel androgen receptor axis-targeted agents approved for the treatment of castration-resistant prostate cancer (mCRPC). Despite the availability of multiple treatments, there is a need to improve the knowledge and management of these drugs in the real-world setting, especially in patient groups under-represented in clinical trials. Our aim was to review the outcome of patients with chemotherapy-naïve mCRPC treated with abiraterone or enzalutamide in routine clinical practice in order to identify factors that are predictive for response. METHODS: This observational retrospective study was performed in a Spanish tertiary hospital and included men with chemotherapy-naïve mCPRC who started treatment with abiraterone or enzalutamide between September 2012 and November 2018. The study end date was 30 October 2020. RESULTS: Ninety patients with mCRPC were included, 57 with abiraterone and 33 with enzalutamide. Median overall survival (OS) was 26.87 months (95% CI 19.68 to 34.05), with no difference found between the two treatment groups. Nine variables were related to increased OS in the univariate analysis: Eastern Cooperative Oncology Group (ECOG) performance status (0-1 vs 2), pain (need of opioids for cancer pain), visceral disease, ≥3 bone lesions, exclusively lymph node metastases, baseline prostate specific antigen (PSA) (<50 vs ≥50 ng/dL and <20 vs ≥20 ng/dL), haemoglobin (<12 vs ≥12 g/dL) and alkaline phosphatase (≤116 vs >116 IU/L). A PSA response >50% was observed in 65 patients (76.5%). In the multivariate analysis, ECOG performance status, pain, visceral disease and alkaline phosphatase provided independent prognostic information. Median OS by Kaplan-Meier analysis was significantly longer for patients with a PSA response (32.1 vs 17.9 months; HR 0.46, 95% CI 0.27 to 0.78; p=0.003). CONCLUSIONS: This study assessed the efficacy of abiraterone and enzalutamide in a real-world setting, including patients under-represented in pivotal studies. Some clinical factors were correlated with improved OS in chemotherapy-naïve men with mCPRC treated with these drugs.

Training program in compounding for pharmacy technicians through a digital platform and simulation techniques. / Programa de formación en elaboración de medicamentos para técnicos de farmacia utilizando una plataforma digital de formación y técnicas de simulación.

OBJECTIVE: To describe a compounding training plan in a tertiary hospital Pharmacy Service. The project aimed to train Pharmacy Assistant Technicians using a digital training platform and simulation techniques. METHODS: Two training programmes were designed, one for sterile and the other for non-sterile drugs. Each programme consists of several phases: a basic online training course (digital e-learning platform), a practical simulation workshop, a supervised practice in real conditions and a final examination by the pharmacist to qualify the technician. Both programmes include a continuous and accredited evaluation by the hospital's Continuing Education Commission. A satisfaction survey on training (e-learning platform) was designed and conducted for pharmacy technicians (sterile and non-sterile). RESULTS: The project has been running for three years. Six specialist pharmacists from the different areas involved in compounding are responsible for training and continuous evaluation. Twenty-one technicians were trained, 19 were qualified, and two of them were unsuccessful. Nowadays, we have 13 pharmacy technicians out of those who were originally trained. Participation in the training satisfaction survey (e-learning platform) was 61.5% (n = 8) of the total number of current developers (n = 13). Overall satisfaction was good with 62.5% of technicians satisfied or very satisfied and the remainder were indifferent (37.5%). CONCLUSIONS: The compounding training program is now in its third year. It has been crucial in delegating tasks to Pharmacy technicians. The use of digital technology is essential in training. We believe that specific training in compounding, is essential and should be included in the pharmacy technician curriculum.

Influence of statin treatment in a cohort of patients admitted for COVID-19.

Aims and objectives: Statins have been proposed as potentially useful agents for modulating the host response in COVID-19. However, solid evidence-based recommendations are still lacking. Our aim was to study the association between statin use and clinical outcomes in a large cohort of hospitalized patients with SARS-CoV-2 infection, as well as the specific consequences of chronic treatment withdrawal during hospital admission. Material and methods: Retrospective observational study including 2191 hospitalized patients with confirmed SARS-CoV-2 infection. Results: Mean age was 68.0±17.8 years and 597 (27.3%) patients died during follow-up. A total of 827 patients (37.7% of the whole sample), received chronic treatment with statins. Even though they underwent more frequent admissions in critical care units, chronic treatment with statins was not independently associated with all-cause mortality [HR 0.95 (0.72-1.25)]. During the whole hospital admission, 371 patients (16.9%) received at least one dose of statin. Although these patients had a significantly worse clinical profile, both treatment with statins during admission [HR 1.03 (0.78-1.35)] and withdrawal of chronic statin treatment [HR 1.01 (0.78-1.30)] showed a neutral effect in mortality. However, patients treated with statins presented more frequently hepatic cytolysis, rhabdomyolysis and thrombotic/hemorrhagic events. Conclusions: In this large cohort of hospitalized COVID-19 patients, statins were not independently associated with all-cause mortality during follow-up. Clinically relevant statin-associated adverse effects should be carefully monitored during hospital admission.

Antecedentes y objetivos: Se ha especulado que las estatinas pueden ser de utilidad en el tratamiento de pacientes con COVID-19, pero no existen evidencias clínicas sólidas. El objetivo de este trabajo es conocer su utilidad en una cohorte de gran tamaño de pacientes hospitalizados por COVID-19, así como si su retirada se asocia con un peor pronóstico. Material y métodos: Estudio retrospectivo observacional. Se incluyeron 2.191 pacientes hospitalizados con infección confirmada con SARS-CoV-2. Resultados: La edad media fue de 68,0 ± 17,8 años y fallecieron un total de 597 (27,3%) pacientes. Un total de 827 pacientes (37,7% de la muestra) estaban tratados previamente con estatinas. Aunque precisaron con mayor frecuencia de ingreso en camas de críticos, dicho grupo terapéutico no resultó un factor predictor independiente de muerte en el seguimiento [HR 0,95 (0,72-1,25)]. Un total de 371 pacientes (16,9%) recibió al menos una dosis de estatina durante el ingreso. A pesar de ser una población con un perfil clínico más desfavorable, tanto su uso [HR 1,03 (0,78-1,35)] como la suspensión durante el ingreso en pacientes que las recibían crónicamente [HR 1,01 (0,78-1,30)] presentaron un efecto neutro en la mortalidad. No obstante, el grupo con estatinas desarrolló con mayor frecuencia datos de citolisis hepática, rabdomiolisis y más eventos trombóticos y hemorrágicos. Conclusiones: En nuestra muestra, las estatinas no se asociaron de forma independiente a una menor mortalidad en pacientes con COVID-19. En aquellos pacientes que tengan indicación de recibirlas por su patología previa es necesario monitorizar estrechamente sus potenciales efectos adversos durante el ingreso hospitalario.

Influence of statin treatment in a cohort of patients admitted for COVID-19. / Influencia del tratamiento con estatinas en una cohorte de pacientes ingresados por COVID-19.

AIMS AND OBJECTIVES: Statins have been proposed as potentially useful agents for modulating the host response in COVID-19. However, solid evidence-based recommendations are still lacking. Our aim was to study the association between statin use and clinical outcomes in a large cohort of hospitalized patients with SARS-CoV-2 infection, as well as the specific consequences of chronic treatment withdrawal during hospital admission. MATERIAL AND METHODS: Retrospective observational study including 2191 hospitalized patients with confirmed SARS-CoV-2 infection. RESULTS: Mean age was 68.0±17.8 years and 597 (27.3%) patients died during follow-up. A total of 827 patients (37.7% of the whole sample), received chronic treatment with statins. Even though they underwent more frequent admissions in critical care units, chronic treatment with statins was not independently associated with all-cause mortality [HR 0.95 (0.72-1.25)]. During the whole hospital admission, 371 patients (16.9%) received at least one dose of statin. Although these patients had a significantly worse clinical profile, both treatment with statins during admission [HR 1.03 (0.78-1.35)] and withdrawal of chronic statin treatment [HR 1.01 (0.78-1.30)] showed a neutral effect in mortality. However, patients treated with statins presented more frequently hepatic cytolysis, rhabdomyolysis and thrombotic/hemorrhagic events. CONCLUSIONS: In this large cohort of hospitalized COVID-19 patients, statins were not independently associated with all-cause mortality during follow-up. Clinically relevant statin-associated adverse effects should be carefully monitored during hospital admission.

Real-World Experience with Two-Drug Regimens in HIV-1-Infected Patients Beyond the Indication of Clinical Trials: 48 Weeks' Results.

Data on two-drug regimens (2DRs) have shown high efficacy and tolerability in treatment-naive and treatment-experienced HIV-1 patients. Current guidelines recommend 2DRs as alternative to three-drug regimens (3DRs) to reduce long-term drug exposure and costs. Nevertheless, real-world experience with 2DR is limited. This study assessed the use of 2DR in routine clinical practice in a tertiary hospital. A retrospective, observational, descriptive study was performed on the use of dual therapy in adult HIV-1 patients. Individuals on antiretroviral treatment (ART) with dolutegravir plus lamivudine or dolutegravir plus rilpivirine who started 2DR between November 1, 2018, and April 30, 2019, were eligible for our study. Follow-up period was 48 weeks. Overall, 112 patients started 2DR; median age was 51 years and 88.4% were men. Most patients (97.3%) were treatment experienced before dual therapy, with 9.6 ± 8.0 years of prior ART on average. Around 96.4% of patients were virologically suppressed before 2DR. Most common reasons to start dual therapy were treatment simplification (49.5%), avoidance of long-term toxicities (21.1%), and intolerance to previous ART (18.3%). The main regimen used in dual therapy was dolutegravir plus lamivudine (98.2%). Only eight patients discontinued dual therapy; the main reason for discontinuation was toxicity. All patients who did not discontinue 2DR were virologically suppressed at week 48. ART simplification saved €130,117.58 during the study period. In our cohort, dual therapy was mainly used for virologically suppressed patients, before availability of the single-tablet 2DR. Switching to a 2DR may be a key option for treatment simplification and avoidance of long-term toxicities. Furthermore, 2DR could provide a more cost-effective alternative to 3DR.

Safety and effectiveness of a four-factor prothrombin complex concentrate for vitamin K antagonist reversal following a fixed-dose strategy.

OBJECTIVES: Early reversal of anticoagulation improves outcomes in major bleeding and emergency surgery. To reverse vitamin K antagonists (VKA), vitamin K in addition to prothrombin complex concentrate (PCC) is recommended. Dosing recommendations for VKA reversal provided by the manufacturer are 25-50 IU/kg depending on the baseline international normalised ratio (INR). Nevertheless, we recommend an initial fixed dose of 1000 IU, and additional 500 IU doses evaluated on a case-by-case basis. As there is a paucity of clinical data demonstrating the efficacy and safety of this strategy, we designed this study to assess the effectiveness and safety of a four-factor (4F)-PCC for VKA reversal following a fixed-dose strategy. METHODS: This was a retrospective study of adult patients who received 4F-PCC for VKA reversal. The primary outcome was INR correction. INR correction was achieved if the first INR draw after 4F-PCC was ≤1.5. Safety outcome was any confirmed thromboembolic event within 3 months after 4F-PCC. Secondary outcomes included activated partial thromboplastin time (aPTT) correction, as well as haemostatic effectiveness for bleeding patients. RESULTS: A total of 145 patients were included: 106 (73.1%) in the bleeding group and 39 (26.9%) in the emergency surgery group. The INR target was reached in 102 (70.3%) patients (p<0.0001). In one case, a thromboembolic complication was possibly related to 4F-PCC. The aPTT ratio target was reached in 113 (77.9%) patients (p<0.0001), and 79 of the 106 (74.5%) patients reversed for bleeding achieved haemostatic effectiveness. CONCLUSIONS: After 4F-PCC, the majority of patients achieved the target INR, meaning 4F-PCC is a useful modality for rapid INR reduction. The safety profile may be considered acceptable. Fixed-dose 4F-PCC was able to restore haemostasis rapidly while minimising the risk of adverse events and optimising available resources.

Defibrotide for the treatment of severe hepatic sinusoidal obstruction syndrome: a single-centre experience.

OBJECTIVES: Determine the effectiveness and cost of defibrotide in patients with severe hepatic sinusoidal obstruction syndrome following haematopoietic stem cell transplantation in a tertiary hospital. METHODS: A retrospective observational study. Adults or children treated with defibrotide at a mean dose of 6.8 mg/kg every 6 hours, until the total bilirubin levels are normalised, were included. Main endpoint was complete response, defined as normalised total serum bilirubin levels and resolution of multiple organ failure. Secondary endpoints were survival by 100 days post-transplant, influence of risks factors in effectiveness and cost of treatment. RESULTS: 51 patients (36 adults and 15 children) received defibrotide; median dose of defibrotide administered was 25.19 mg/kg/day (10.0-100.3). Complete response was achieved in 19 (37.3%) patients. By 100 days post-transplant complete response was achieved in 18 (35.3%) patients and the survival rate was 29 (56.9%) patients. There were no significant differences in effectiveness between adults versus paediatrics and between patients who presented risk factors. The mean cost of treatment per patient was €32 916, mean costs in adults was €104 292 and €17 394 in children. CONCLUSION: Regarding the results of our study, it is convenient to identify the patients who will be able to benefit from this treatment according to clinical conditions, medical history and prognosis. Given the great economic impact of defibrotide, we consider that more cost-effectiveness studies are required. TRIAL REGISTRATION NUMBER: EPA-OD, number LBM-DEF-2016-01.

Intraocular minocycline for the treatment of ocular pythiosis.

PURPOSE: A case of ocular pythiosis successfully treated with surgery and intraocular and oral minocycline is reported. SUMMARY: A 30-year-old man who wore corrective contact lenses traveled to Brazil and Colombia where he swam in salt and fresh waters while wearing contact lenses. He sought treatment at an emergency department after 2 weeks of suffering with a painful corneal ulcer, redness, and loss of vision in his right eye that had been treated at other centers with ophthalmic moxifloxacin for 10 days and with fortified topical antibiotics (amikacin and vancomycin) for 2 days. Examination using a slit lamp revealed a deep central corneal ulcer with surrounding white infiltrate, endothelial plaque, and hypopyon. Due to infection severity, the patient was admitted and received empirical antibiotic therapy and i.v. and topical antifungals. During the first corneal transplantation, the patient's original infection relapsed and was treated with voriconazole and liposomal amphotericin B intraocular injections. A subsequent infection developed, and a second keratoplasty was performed. One month after hospital admission, the patient was diagnosed with ocular pythiosis and therapy with oral minocycline was initiated. After severe infection relapse in the anterior chamber, the patient underwent a third penetrating keratoplasty, where minocycline intraocular injection was administered. After this intervention, complete infection control was achieved, and the patient was discharged 45 days after admission with oral minocycline and 1% cyclosporine and 0.3% ofloxacin eye drops. CONCLUSION: A patient with ocular pythiosis was successfully treated with penetrating keratoplasty and 2 months of treatment with intracameral and oral minocycline.

Perception survey on the value of the hospital pharmacist at the emergency department.

OBJECTIVE: To determine the perception and evaluation of the Emergency pharmacist by the medical and nursing staff at the Emergency department. METHODS: A multicenter study based on a survey sent to the Spanish Society of Hospital Pharmacists (SEFH) for Emergency pharmacists (EPh) to distribute among the Emergency staff. Descriptive statistics were used, with a 95% confidence interval. RESULTS: 102 (12%) questionnaires were completed by 73 Emergency Physicians (71.6%) and 29 Emergency Nurses (28.4%), out of 835 surveys sent. The most common pharmaceutical activities, and perceived as more relevant for patient safety, were: consultation solution, prescription validation, and medication reconciliation. 63% of respondents supported the prospective review of high-risk medications, while 89% believed that the Pharmacist improves the quality of care. EPh are considered useful for training healthcare staff and patients, and 77% of respondents considered them as an integral member of the team. They would resort more to Pharmacists if they were present at the hospital department. CONCLUSIONS: The results show the acceptance of Hospital Pharmacists in the Emergency Department; their functions are known and valued. They are considered an integral member of the team, who will provide safety and improve patient care. Medication reconciliation and prescription validation are highlighted because of their relevance in terms of safety. Further studies are needed to assess health outcomes and their economic impact.

Objetivo: Determinar la percepción y valoración del farmacéutico de Urgencias por el personal médico y de enfermería de este servicio.Métodos: Estudio multicéntrico basado en una encuesta que se envió a la SEFH para que los farmacéuticos de Urgencias lo dirigieran al personal de esta unidad. Se aplica una estadística descriptiva con intervalos de confianza del 95%.Resultados: 102 (12%) encuestas cumplimentadas por 73 médicos (71,6%) y 29 enfermeras (28,4%) de Urgencias, de un total de 835 enviadas. Se aprecian como actividades farmacéuticas más comunes y relevantes para la seguridad del paciente: la resolución de consultas, la validación de prescripciones y la conciliación de la medicación. El 63% apoya la validación prospectiva de los medicamentos de alto riesgo. Para el 89% el farmacéutico mejora la calidad de la atención. Lo consideran útil en la formación del personal sanitario y de los pacientes y, para un 77% del total, es parte integral del equipo. Recurren más a él si está presente en el servicio. Conclusiones: Los resultados muestran la aceptación del farmacéutico de hospital en Urgencias; se conocen y valoran sus funciones. Es considerado parte integral del equipo, aporta seguridad y mejora la atención de los pacientes. Se refuerzan la conciliación de la medicación y la validación de las prescripciones por su relevancia en la seguridad. Su visibilidad facilita que recurran a sus servicios, si bien un reciente informe de la SEFH refleja una reducida presencia en las Urgencias hospitalarias. Hacen falta más estudios que valoren los resultados en salud y su repercusión económica.

Pharmacotherapy follow-up of patients under treatment with biologic agents for chronic inflammatory systemic conditions: an agreement among hospital pharmacists for the standardized collection of a minimum set of data.

BACKGROUND AND OBJECTIVE: The objective of this study was to reach a consensus on the minimum set of data that would allow to optimize the pharmacotherapy follow-up of patients on biologic agents for chronic systemic inflammatory conditions, through structured and standardized collection with an electronic tool in the hospital pharmacy. MATERIALS AND METHOD: A scientific committee was formed (n = 5 hospital pharmacists). The Delphi Technique was used, 2 rounds of consultation by e-mail for hospital pharmacists. A structured questionnaire was used, based on a bibliographic review and recommendations by the scientific committee; 37 statements were assessed with the Likert 5-point scale (1= "Strongly Disagree"; 5= "Strongly Agree"). Consensus was reached when 75% or more of panel members assigned a score of 1-2 (rejection consensus) or 4-5 (agreement consensus) to the matter reviewed. Descriptive statistical analyses were conducted. RESULTS: The study included 21 hospital pharmacists (70 were invited, there was 70% response). Consensus was reached for 100% of statements. The minimum set of data was agreed upon, as well as the recommendations that the pharmacist had to collect and make during visits: to document the health status, health-related quality of life, changes in treatment compliance and in patient autonomy, as well as the conditions to make feasible the systematic collection of the minimum data set. CONCLUSIONS: There is consensus among hospital pharmacists about a minimum data set to be collected, through an electronic tool, which will order, standardize and structure the pharmacotherapy follow-up of patients with chronic inflammatory conditions on treatment with biologic agents in the spanish public health system.

Fundamento y objetivo: El objetivo de este estudio fue consensuar un conjunto mínimo de datos cuya recopilación sistemática y estandarizada, mediante una herramienta electrónica en la farmacia hospitalaria, permitiera optimizar el seguimiento farmacoterapéutico de los pacientes tratados con agentes biológicos por enfermedades sistémicas inflamatorias crónicas. Material y método: Se constituyó un comité científico (n = 5 farmacéuticos hospitalarios). Se empleó la técnica Delphi, 2 rondas de consulta, por correo electrónico entre farmacéuticos hospitalarios. Se utilizó un cuestionario estructurado basado en una revisión bibliográfica y en recomendaciones del comité científico, valorándose 37 afirmaciones en una escala Likert de 5 puntos (1 = "En total desacuerdo"; 5 = "Totalmente de acuerdo"). Se alcanzó consenso cuando el 75% o más de los panelistas puntuaron 1-2 (consenso-rechazo) o 4-5 (consenso- acuerdo) la cuestión planteada. Se realizaron análisis estadísticos descriptivos. Resultados: Participaron 21 farmacéuticos hospitalarios (70 invitados, 70% respuesta). Se logró consenso en el 100% de las afirmaciones. Se acordó el conjunto mínimo de datos y de recomendaciones que el farmacéutico debe recoger y hacer en las visitas; documentar el estado de salud, la calidad de vida relacionada con la salud, los cambios en la adherencia al tratamiento y en la autonomía de los pacientes, así como las condiciones para hacer factible la recopilación sistemática del conjunto mínimo de datos. Conclusiones: Existe consenso entre los farmacéuticos hospitalarios en un conjunto mínimo de datos cuya recopilación, mediante una herramienta electrónica, ordenará, estandarizará y sistematizará el seguimiento farmacoterapéutico de los pacientes con enfermedades inflamatorias crónicas en tratamiento con agentes biológicos en el entorno sanitario público español.

Analysis of antiretroviral therapy modification in routine clinical practice in the management of HIV infection.

OBJECTIVES: The main goal was to assess the reasons for antiretroviral therapy (ART) change in patients with HIV in a hospital setting in routine clinical practice. The economic impact of ART modification was also analysed. METHODS: Patients with HIV who changed their ART between 24 November and 24 December 2014 were registered. Length of initial therapy, type of ART before and after therapy modification, and reasons for the ART change were analysed. To assess the economic impact, antiretroviral drug costs at the time of the study were recorded. RESULTS: Of a cohort of 3850 patients with HIV, 1976 attended for pharmaceutical care consultation at Hospital Universitario La Paz during the study period. Ninety-two patients (4.7%) had their ART modified. The median length of the previous therapy was 26 months (range 1-144). The most common initial therapy regimen was 2 nucleoside reverse transcriptase inhibitors (NRTI)+1 non-nucleoside reverse transcriptase inhibitor (NNRTI) (29.4%), and the most common one after modification was 2 NRTI+1 integrase strand transfer inhibitor (INSTI) (40.2%). Forty-three modifications were made because of toxicity and adverse effects (46.7%), 25 because of therapy simplification (27.2%), 16 because of treatment failure (17.4%), and 8 because of drug-drug interactions (8.7%). ART costs increased by a mean of €14 (SD €216; range -€528 to +€831) per month per patient after therapy modification at the time of study. CONCLUSIONS: Toxicity and adverse effects were the most common reason for ART alteration in patients with HIV in routine clinical practice in a hospital setting. Better knowledge about factors that motivate these changes may contribute to decreased toxicity and increased treatment success. ART modification had a variable but not very substantial economic impact.

Analysis of an electronic medication reconciliation and information at discharge programme for frail elderly patients.

Background During care transitions, discrepancies and medication errors often occur, putting patients at risk, especially older patients with polypharmacy. Objective To assess the results of a medication reconciliation and information programme for discharge of geriatric patients conducted through hospital information systems. Setting A 1300-bed university hospital in Madrid, Spain. Method A prospective observational study. Geriatricians selected candidates for medication reconciliation at discharge, and sent an electronic inter-consultation request to the pharmacy department. Pharmacists reviewed the medication list, comparing it with electronic prescriptions, medication previously prescribed by primary care physicians and other medical records, and resolved any discrepancies. An individualized and tailored drug information at discharge sheet was sent to geriatricians and made available to primary care physicians. Main outcome measure The number and type of discrepancies, the number, type and severity of errors, and the main pharmacological groups involved. Results Medication reconciliation was performed for 118 patients with a mean age of 87 years (SD 5.9), involving a total of 2054 medications, or 17.4 per patient. Discrepancies were found in 723 (35 %) drugs, 105 of which were considered medication errors (15 %); 66 patients (56 %) had at least one error. This gave 0.9 reconciliation errors per patient reviewed and 1.6 per patient with errors. Of the 105 errors, 14 (13 %) were considered serious. The most frequent errors were incomplete prescriptions (40 %) and omissions (35 %). Conclusion An electronic medication reconciliation programme helps pharmacists detect serious medication errors in frail elderly patients and provides complete and up-to-date written information to prevent additional errors at home.

Objective quantification of adherence to prophylaxis in haemophilia patients aged 12 to 25years and its potential association with bleeding episodes.

BACKGROUND: The treatment of choice for patients with severe haemophilia is prophylaxis with clotting factor. Effective prophylaxis requires optimal adherence. Most published studies are based on surveys and interviews with patients or their parents. However, studies based on objective measurements of adherence are few and inconclusive. OBJECTIVE: The main purpose of this study was to assess adherence to prophylaxis using an objective method in patients with haemophilia aged 12 to 25years as well as to assess its potential association with bleeding episodes. Secondary objectives included comparing objective and subjective adherence (questionnaire) and identifying factors potentially associated with treatment adherence. METHODS: A retrospective observational study was designed to collect data on treatment adherence and clinical course of patients in 2013. The study included haemophilia patients on prophylaxis with clotting factor concentrate; the age range was 12 to 25years. Objective adherence to treatment was measured through pharmacy dispensing records. Dispensing dates within 2013 were used for calculation. Adherence (%) was calculated by dividing the total number of International Units (IU) of factor dispensed by the total estimated number of IU and multiplying by 100. Subjective adherence was measured using an ad hoc questionnaire which was completed by the patient. The number of bleeding episodes (joint, muscle and others) was obtained from interviews with the patient at the consultation with the pharmacist and was subsequently confirmed with the patient's clinical history. Other parameters were also evaluated. RESULTS: We included 52 patients in the study. Average adherence of patients resulting from the analysing of dispensing records was 85.72 (SD=23.76%). The global average of bleeding episodes was 2.2 (SD=2.69). 32.6% (seventeen) patients presented with at least one joint bleeding episode versus 67.3% (thirty five) who showed no joint bleeding episodes. Likewise, only 10% (five) patients presented with one muscle bleeding episode. Even though a significant association between the rate of objective adherence and the number of bleeding episodes was not observed, a higher number of hemarthrosis was observed in less-adherent patients. Subjective adherence perceived by patients as reported by the questionnaire showed that 36 (83.7%) of the 43 patients who completed the questionnaire considered their adherence as good, whereas 7 (16.3%) of the 43 patients considered it as fair. A statistically significant relationship was found between objective adherence expressed as a percentage using dispensing records, and subjective adherence perceived by the patient (p=0.004). The other parameters evaluated were not associated with adherence to prophylaxis. CONCLUSIONS: Measuring objective adherence using pharmacy dispensing records is a simple and useful tool. No significant correlation was found between the rate of objective adherence observed and the number of bleeding episodes; however, a higher number of hemarthrosis was observed in less-adherent patients.

Spanish Rheumatology Society and Hospital Pharmacy Society Consensus on recommendations for biologics optimization in patients with rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis.

OBJECTIVE: The aim of this study was to establish guidelines for the optimization of biologic therapies for health professionals involved in the management of patients with RA, AS and PsA. METHODS: Recommendations were established via consensus by a panel of experts in rheumatology and hospital pharmacy, based on analysis of available scientific evidence obtained from four systematic reviews and on the clinical experience of panellists. The Delphi method was used to evaluate these recommendations, both between panellists and among a wider group of rheumatologists. RESULTS: Previous concepts concerning better management of RA, AS and PsA were reviewed and, more specifically, guidelines for the optimization of biologic therapies used to treat these diseases were formulated. Recommendations were made with the aim of establishing a plan for when and how to taper biologic treatment in patients with these diseases. CONCLUSION: The recommendations established herein aim not only to provide advice on how to improve the risk:benefit ratio and efficiency of such treatments, but also to reduce variability in daily clinical practice in the use of biologic therapies for rheumatic diseases.