Effectiveness and safety of direct-acting antivirals in hepatitis C infected patients with mental disorders: Results in real clinical practice.

The aim of this study is to analyze the effectiveness and safety of direct-acting antivirals (DAAs) in psychiatric patients with chronic hepatitis C (CHC). Secondary objectives included adherence and drug-drug interaction (DDIs) evaluations. Prospective observational comparative study carried out during 3 years. Psychiatric patients were included and mental illness classified by a psychiatric team based on clinical records. Main effectiveness and safety variables were sustained virologic response (SVR) at posttreatment week 12 (SVR12) and rate of on-treatment serious drug-related adverse events (AEs), respectively. A total of 242 psychiatric and 900 nonpsychiatric patients were included. SVR12 by intention-to-treat (ITT) analysis of psychiatric vs nonpsychiatric patients was 92.6% (95% confidence interval [CI], 89.1-96.1) vs 96.2% (95% CI, 94.9-97.5) (P = .02). SVR12 by modified-ITT analysis was 97.8% (95% CI, 95.0-99.3) vs 98.4% (95% CI, 97.5-99.3) (P = .74). 92.2% of psychiatric patients with mental disorders secondary to multiple drug use (MDSDU) and 93.0% of psychiatric patients without MDSDU vs 96.2% of nonpsychiatric patients reached SVR12 (P = .05 and P = .20, respectively). The percentage of adherent patients to DAAs did not show differences between cohorts (P = .08). 30.2% of psychiatric patients and 27.6% of nonpsychiatric patients presented clinically relevant DDIs (P = .47). 1.7% vs 0.8% of psychiatric vs nonpsychiatric patients developed serious AEs (P = .39); no serious psychiatric AEs were present. DAAs have shown a slightly lower effectiveness in psychiatric patients with CHC, as a result of loss of follow up, which justifies the need for integrated and multidisciplinary health care teams. DAAs safety, adherence, and DDIs, however, are similar to that of nonpsychiatric patients.

Teleconsultation for the Pharmaceutical Care of HIV Outpatients in Receipt of Home Antiretrovirals Delivery: Clinical, Economic, and Patient-Perceived Quality Analysis.

Background/Introduction:Pharmacist teleconsultations, combined with home drug delivery or mail-order pharmacy (MOP), can help hospital outpatients with difficulties accessing treatment. The objectives of this study are to describe a teleconsultation protocol and to evaluate clinical, economic, and patient-perceived quality results.Materials and Methods:A cohort observational study was carried out for 3 years on HIV outpatients. Clinical variables were adherence, plasma HIV-RNA, and CD4+ levels. A pharmacoeconomic analysis was carried out through a cost-minimization study. Patient-perceived quality was assessed through a satisfaction survey. Simple random sampling was performed for 95% safety, accuracy ±1%, and losses ±20%.Results:The 38 participants (sample size) consisted of 82% male patients, aged 44.7 ± 8.4 years. There were 854 teleconsultations and 100% treatment adherence. All HIV outpatients kept virally suppressed (p = 1.00) and maintained a controlled immunological level (p = 0.87). The economic evaluation revealed 137 ± 23 € patient/year costs-saved and 18.5 ± 7.2 h/patient/year working time gained. Patient-perceived quality average score was >9.4 out of 10 in all items; the most valued factors were the saving of direct costs and reconciliation with work commitments (45%) and the least valued attributes were making the payment for the shipment and having to adjust to a telephone appointment (41%).Discussion/Conclusions:A teleconsultation protocol associated with home antiretrovirals delivery or MOP obtains a high degree of satisfaction from the HIV hospital outpatients receiving treatment, without repercussions on the therapeutic objectives and with the saving of important direct costs for the patient and indirect costs in relation to labor productivity.

Prioritization of initiatives 2024-2027 of the strategic map of pharmaceutical outpatient care of the Spanish Society of Hospital Pharmacy. / Priorización de iniciativas 2024­2027 del mapa estratégico de atención farmacéutica al paciente externo de la Sociedad Española de Farmacia Hospitalaria.

OBJECTIVE: To prioritize the initiatives to be developed for the development of the Strategic Map of Outpatient Care (MAPEX) project to improve the quality of care and Pharmaceutical Care for patients seen in Hospital Pharmacy outpatient clinics in the period 2024-2027 in Spain. METHOD: The study was carried out in 4 phases between January and December 2023. For phase 1, a literature review of the evolution of the project was carried out by the coordinating committee with the aim of establishing a basis on which to define a new proposal for initiatives. In addition, an analysis was made of the health trends that will have an impact in the coming years. In phase 2, a working group of 19 specialists from all the autonomous communities was created, who were called regional ambassadors. They all made a preliminary proposal of initiatives and established revisions for their adjustment and final version both online and in telematic meetings. In phase 3, a consensus was established based on the Delphi-Rand/UCLA methodology with two rounds of online voting to select the initiatives classified as: priority and key or breakthrough. Between the first and second round of voting, a face-to-face "Consensus Conference" was held, where the results of the first round were presented. In phase 4, a public presentation was made in scientific forums and through the web. RESULTS: Ten trends in the health sector were identified. A list of 34 initiatives grouped into five lines of work was established. A total of 103 panelists participated in the first round and 76 in the second. Finally, five initiatives were established as priority and 29 as key. Among those prioritized were external visibility, adaptations to the CMO methodology, strengthening certification and improving training. CONCLUSIONS: The initiatives agreed upon as priorities were aimed at improving professional visibility, broadening the methodology of care work, expanding the quality of care, enhancing the training of professionals and the voice of patients.

Analysing Early Diagnosis Strategies for HIV Infection: A Retrospective Study of Missed Diagnostic Opportunities.

Early diagnosis of a Human Immunodeficiency Virus (HIV)-infected person represents a cornerstone of HIV prevention, treatment, and care. Numerous publications have developed recommendations where HIV serology is indicated to reduce missed diagnostic opportunities (MDOs). This retrospective study analyses new HIV infection diagnoses and the relationship between late diagnosis (LD)/advanced HIV disease (AHD), baseline characteristics, and MDOs. Sociodemographic data and data related to contact with the health system in the 5 years before diagnosis were collected. Most of the 273 diagnoses were made in primary care (48.5%). Approximately 50.5% and 34.4% had LD and AHD criteria, respectively. Female sex was associated with a higher incidence of LD. Persons infected through the heterosexual route and those at an older age had a higher risk for LD and AHD. People with previous HIV serology presented a lower percentage of LD and AHD. In total, 10% of the health contact instances were classified as MDOs, mostly occurring in primary care. A significant increase in the median of MDOs was observed in patients with LD/AHD. Female sex and hepatitis C virus co-infection were associated with an increase in the number of MDOs. The high percentage of LD and AHD and the significant number of MDOs show that the current screening system should be improved.

Prevalence of adverse drug reactions associated with emergency department visits and risk factors for hospitalization. / [Artículo traducido] Prevalencia de reacciones adversas a medicamentos asociadas a visitas al servicio de urgencias y factores de riesgo de hospitalización.

OBJECTIVE: Adverse drug reactions increase morbidity and mortality, prolong hospital stay and increase healthcare costs. The primary objective of this study was to determine the prevalence of emergency department visits for adverse drug reactions and to describe their characteristics. The secondary objective was to determine the predictor variables of hospitalization for adverse drug reactions associated with emergency department visits. METHODS: Observational and retrospective study of adverse drug reactions registered in an emergency department, carried out from November 15th to December 15th, 2021. The demographic and clinical characteristics of the patients, the drugs involved and the adverse drug reactions were described. Logistic regression was performed to identify factors related to hospitalization for adverse drug reactions. RESULTS: 10,799 patients visited the ED and 216 (2%) patients with adverse drug reactions were included. The mean age was 70 ± 17.5 (18-98) years and 47.7% of the patients were male. A total of 54.6% of patients required hospitalization and 1.6% died from adverse drug reactions. The total number of drugs involved was 315 with 149 different drugs. The pharmacological group corresponding to the nervous system constituted the most representative group (n = 81). High-risk medications, such as antithrombotic agents (n = 53), were the subgroup of medications that caused the most emergency department visits and hospitalization. Acenocumarol (n = 20) was the main drug involved. Gastrointestinal (n = 62) disorders were the most common. Diarrhea (n = 16) was the most frequent adverse drug reaction, while gastrointestinal bleeding (n = 13) caused the highest number of hospitalizations. Charlson comorbidity index behaved as an independent risk factor for hospitalization (aOR 3.24; 95% CI: 1.47-7.13; p=0.003, in Charlson comorbidity index 4-6, and aOR 20.07; 95% CI: 6.87-58.64; p = 0.000, in Charlson comorbidity index ≥ 10). CONCLUSIONS: The prevalence of emergency department visits for adverse drug reactions continues to be a non-negligible health problem. High-risk drugs such as antithrombotic agents were the main therapeutic subgroup involved. Charlson comorbidity index was an independent factor in hospitalization, while gastrointestinal bleeding was the adverse drug reaction with the highest number of hospital admissions.

Lipid profile changes associated with antiretroviral therapies in a real-world cohort. / [Artículo traducido] Cambios en el perfil lipídico asociados con las terapias antirretrovirales en una cohorte de vida real.

OBJECTIVE: To compare lipid profile changes and cardiovascular events among HIV naïve and experienced patients from a real-world cohort treated with elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide fumarate or dolutegravir/abacavir/lamivudine. METHOD: A retrospective cohort study in HIV naïve and experienced people at a reference hospital in Spain was done. During the follow-up (March 2015-June 2019), patients were treated with elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide fumarate or dolutegravir/abacavir/lamivudine. Epidemiological, clinical and immunovirological variables were recorded. A statistical analysis of the lipid profile at baseline, 48 and 120 weeks after initiating the study therapy, cardiovascular events (myocardial infarction, heart failure, cerebrovascular accident, deep venous thrombosis, myocardiopathy, non-ST- segment elevation acute coronary syndrome, and ST-segment elevation myocardial infarction) and cardiovascular risks factors was performed. Data were analysed in naïve and experienced patients from each of the study treatments. The data was obtained from the medical history. The statistical analysis was performed with SPSS v.24 software. RESULTS: A total of 266 and 191 patients receiving treatment with elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide fumarate and dolutegravir/abacavir/lamivudine were included in the study, respectively. After 120 weeks of treatment, a worsening of the lipid profile was found in the elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide fumarate group, both in naïve and experienced patients, whereas not so conspicuously observed in the dolutegravir/abacavir/lamivudine group. Statistically significant differences between both groups were found in experienced patients favoring dolutegravir/abacavir/lamivudine; in total cholesterol (204.1 ± 38.2 vs. 187.3 ± 29.4, p < 0.001) and LDL-C (126.1 ± 31.9 vs. 113.5 ± 28.5, p = 0.001) at week 48, and in total cholesterol (201.1 ± 33.4 vs. 188.7 ± 33.9, p = 0.013) and HDL-C (54.2 ± 15.6 vs. 48.3 ± 14.3, p = 0.01) at week 120. No significant differences in cardiovascular events were found, neither in naïve nor in experienced patients. CONCLUSIONS: The lipid profile among elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide fumarate group worsened throughout the follow-up, both in naïve and experienced patients, not so remarkable in the dolutegravir/abacavir/lamivudine group. Both regimens were well tolerated, with similar rates of cardiovascular events.

Lipid profile changes associated with antiretroviral therapies in a real-world cohort.

OBJECTIVE: To compare lipid profile changes and cardiovascular events among HIV naïve and experienced patients from a real-world cohort treated with elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide fumarate or dolutegravir/abacavir/lamivudine. METHOD: A retrospective cohort study in HIV naïve and experienced people at a reference hospital in Spain was done. During the follow-up (March 2015-June 2019), patients were treated with elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide fumarate or dolutegravir/abacavir/lamivudine. Epidemiological, clinical, and immunovirological variables were recorded. A statistical analysis of the lipid profile at baseline, 48, and 120 weeks after initiating the study therapy, cardiovascular events (myocardial infarction, heart failure, cerebrovascular accident, deep venous thrombosis, myocardiopathy, non-ST-segment elevation acute coronary syndrome, and ST-segment elevation myocardial infarction), and cardiovascular risks factors was performed. Data were analysed in naïve and experienced patients from each of the study treatments. The data were obtained from the medical history. The statistical analysis was performed with SPSS v. 24 software. RESULTS: A total of 266 and 191 patients receiving treatment with elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide fumarate and dolutegravir/abacavir/lamivudine were included in the study, respectively. After 120 weeks of treatment, a worsening of the lipid profile was found in the elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide fumarate group, both in naïve and experienced patients, whereas not so conspicuously observed in the dolutegravir/abacavir/lamivudine group. Statistically significant differences between both groups were found in experienced patients favouring dolutegravir/abacavir/lamivudine; in total cholesterol (204.1±38.2 vs. 187.3±29.4, P < .001) and LDL-C (126.1±31.9 vs. 113.5±28.5, P = .001) at week 48, and in total cholesterol (201.1±33.4 vs. 188.7±33.9, P = .013) and HDL-C (54.2±15.6 vs. 48.3±14.3, P = .01) at week 120. No significant differences in cardiovascular events were found, neither in naïve nor in experienced patients. CONCLUSIONS: The lipid profile among elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide fumarate group worsened throughout the follow-up, both in naïve and experienced patients, not so remarkable in the dolutegravir/abacavir/lamivudine group. Both regimens were well tolerated, with similar rates of cardiovascular events.

Medication reconciliation for patients after their discharge from intensive care unit to the hospital ward.

OBJECTIVES: The aim of this study was to determine whether the transition of care from the intensive care unit to the ward would pose a high risk for reconciliation errors. The primary outcome of this study was to describe and quantify the discrepancies and reconciliation errors. Secondary outcomes included classification of the reconciliation errors by type of medication error, therapeutic group of the drugs involved and grade of potential severity. METHODS: We conducted a retrospective observational study of reconciliated adult patients discharged from the Intensive Care Unit to the ward. Before a patient was discharged from the intensive care unit, their last intensive care unit's prescriptions were compared with their proposed medication list in the ward. The discrepancies between these were classified as justified discrepancies or reconciliation errors. Reconciliation errors were classified by type of error, potential severity, and therapeutic group. RESULTS: We found that 452 patients were reconciliated. At least one discrepancy was detected in 34.29% (155/452), and 18.14% (82/452) had at least one reconciliation errors. The most found error types were a different dose or administration route (31.79% (48/151)) and omission errors (31.79% (48/151)). High alert medication was involved in 19.20% of reconciliation errors (29/151). CONCLUSIONS: Our study shows that intensive care unit to non-intensive care unit transitions are high-risk processes for reconciliation error. They frequently occur and occasionally involve high alert medication, and their severity could require additional monitoring or cause temporary harm. Medication reconciliation can reduce reconciliation errors.

Medication reconciliation for patients after their discharge from intensive care unit to the hospital ward. / [Artículo traducido] Conciliación de la medicación en el alta desde la unidad de cuidados intensivos a la planta de hospitalización.

OBJECTIVES: The aim of this study was to determine whether the transition of care from the intensive care unit to the ward would pose a high risk for reconciliation errors. The primary outcome of this study was to describe and quantify the discrepancies and reconciliation errors. Secondary outcomes included classification of the reconciliation errors by type of medication error, therapeutic group of the drugs involved and grade of potential severity. METHODS: We conducted a retrospective observational study of reconciliated adult patients discharged from the Intensive Care Unit to the ward. Before a patient was discharged from the intensive care unit, their last intensive care unit's prescriptions were compared with their proposed medication list in the ward. The discrepancies between these were classified as justified discrepancies or reconciliation errors. Reconciliation errors were classified by type of error, potential severity, and therapeutic group. RESULTS: We found that 452 patients were reconciliated. At least one discrepancy was detected in 34.29% (155/452), and 18.14% (82/452) had at least one reconciliation errors. The most found error types were a different dose or administration route (31.79% [48/151]) and omission errors (31.79% [48/151]). High alert medication was involved in 19.20% of reconciliation errors (29/151). CONCLUSIONS: Our study shows that intensive care unit to non-intensive care unit transitions are high-risk processes for reconciliation error. They frequently occur and occasionally involve high alert medication, and their severity could require additional monitoring or cause temporary harm. Medication reconciliation can reduce reconciliation errors.

Renal profile of patients treated with elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide fumarate and dolutegravir/abacavir/lamivudine: 120-week results from a real-world cohort.

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide fumarate (EVG/c/FTC/TAF) and dolutegravir/abacavir/lamivudine (DTG/ABC/3TC) are currently available for HIV patients. OBJECTIVES: This study evaluated modifications in the renal safety profile in a large real-world cohort of patients who had received EVG/c/FTC/TAF or DTG/ABC/3TC. METHODS: A retrospective observational study of HIV-infected patients who received EVG/c/FTC/TAF or DTG/ABC/3TC between March 2015 and June 2019 at a reference hospital in north-western Spain was conducted. Epidemiological, clinical, immunovirological data and information regarding antiretroviral therapy were recorded. The statistical differences between treatments were calculated. RESULTS: A total of 457 patients were evaluated, 266 using EVG/c/FTC/TAF and 191 using DTG/ABC/3TC. Up to week 120, serum creatinine improved in both study groups among experienced patients (EVG/c/FTC/TAF 1.01±0.24 vs 0.91±0.19, p<0.001; DTG/ABC/3TC 1.08±0.24 vs 1.02±0.31, p<0.001), while in naïve patients serum creatinine remained stable compared with baseline. Statistically significant differences were found in serum creatinine when comparing both treatments at week 48 in experienced (0.94±0.21 vs 1.09±0.28, p<0.001) and naïve patients (0.89±0.16 vs 1.06±0.20, p=0.001), and among experienced patients at week 120 (0.91±0.19 vs 1.02±0.31, p=0.015) for the EVG/c/FTC/TAF and DTG/ABC/3TC groups, respectively. During the follow-up, 39 patients in EVG/c/FTC/TAF and 33 in DTG/ABC/3TC (p=0.449) discontinued treatment. The main reason for stopping treatment was adverse events, which were similar in both groups. CONCLUSIONS: During the follow-up, patients experienced changes that were not clinically relevant in both treatment groups. Differences in renal events were not found.

Discontinuation due to neuropsychiatric adverse events with efavirenz- and dolutegravir-based antiretroviral therapy: a comparative real-life study.

OBJECTIVES: Despite the high efficacy of antiretroviral treatment, no drug is free from adverse events (AEs). Efavirenz (EFV) and dolutegravir (DTG) are antiretroviral drugs for which neuropsychiatric adverse events (NPAEs) have been described. This study evaluated the safety and tolerability of DTG-based and EFV-based antiretroviral regimens in HIV-infected patients. METHODS: A retrospective observational study was carried out in HIV-infected patients who started DTG- or EFV-based antiretroviral treatment from January 2008 to December 2018 at a reference hospital in north-western Spain. Epidemiological, clinical and immunovirological data were recorded. A statistical analysis was performed with SPSS software. RESULTS: A total of 282 DTG- and 148 EFV-based therapies were initiated. During follow-up, statistically significant differences have been found between the rate of patients who discontinued DTG and EFV due to AEs (12.1% vs 35.8%, p<0.001) and the main AEs in both groups, NPAEs (8.2% vs 25.0%, p<0.001). Female gender (OR 2.610 (95% CI 1.327 to 5.133), p=0.005) was associated with discontinuations due to AEs. Patients with documented psychiatric disorders were at higher risk of discontinuation due to NPAEs (OR 4.782 (95% CI 1.190 to 19.220), p=0.027). The multivariate analysis showed a 61.2% risk reduction in benzodiazepine prescriptions in patients treated with DTG. In both groups, patients needed consultation and follow-up in the psychiatry unit (16.9% in the EFV group and 8.9% in the DTG group, p=0.021). CONCLUSIONS: We found a high rate of discontinuations due to AEs and NPAEs, prescription of benzodiazepines and a requirement for consultation in a psychiatric unit in both treatment groups, especially with EFV.

Telepharmacy scorecard: Activity and quality indicators for the pharmaceutical care in a hospital pharmacy service.

OBJECTIVE: Telepharmacy, as a complementary activity to face-to-face pharmaceutical care in a Hospital pharmacy service, must have specific activity, effectiveness and quality indicators. The objectives of the  project were to design a scorecard of activity, effectiveness and quality  indicators that will make it possible to assess the situation and progress of Telepharmacy and enable continuous improvement. A tool is also provided to measure the indicators, and some recommendations are given for its  implementation. METHOD: The project, led by a panel of expert pharmacists, was developed in  2021 in four phases: a literature review, preliminary identification of quality  criteria and indicators, evaluation of indicators, adjustment of the proposal and definition of priority indicators, and drafting of descriptive files, as well as the  development and validation of a scorecard. The indicators were prioritized  based on their appropriateness, usefulness, relevance and feasibility. Finally,  the scorecard was submitted for evaluation by the members and Patient  Committee of the Spanish Hospital Pharmacy Society. RESULTS: The resulting scorecard consists of 50 indicators grouped into five  areas: General aspects (18); pharmacotherapeutic follow-up (12); home drug  delivery (15); patient information and education (2); and coordination with the  care team (3). A total of 31 were considered priority or essential  indicators, which are initially recommended for the implementation of a  Telepharmacy program. In contrast, 15 are general indicators, including  measurement of patient and professional satisfaction; 6 indicators refer to  pharmacotherapeutic follow-up; 1 is related to patient information and  education, and 2 correspond to care team coordination. CONCLUSIONS: The scorecard developed is a management tool for the implementation and evaluation of Telepharmacy in the Hospital pharmacy service. This tool enables assessing the initial situation, monitoring  implementation progress, measuring quality and performance, facilitating  decision-making and establishing an improvement plan.

OBJETIVO: La Telefarmacia, como actividad complementaria de la atención farmacéutica presencial en un servicio de farmacia de hospital, debe disponer de indicadores de calidad, actividad y efectividad específicos. Los objetivos del proyecto fueron definir los indicadores de calidad, actividad y efectividad de un cuadro de mando que permitan conocer la  situación y evolución de la Telefarmacia y ayuden a la toma de decisiones de mejora continua, además de diseñar una herramienta que permita medir los indicadores y establecer recomendaciones para su implantación.Método: El proyecto liderado por un grupo de expertos farmacéuticos se desarrolló durante el año 2021 en cuatro fases: revisión bibliográfica,  elaboración preliminar de criterios de calidad e indicadores, valoración de los indicadores y definición de indicadores prioritarios, la elaboración de fichas descriptivas, y el desarrollo y validación de una herramienta de cuadro de mando. Los indicadores se priorizaron en función de su adecuación, utilidad, pertinencia y factibilidad. Finalmente, el cuadro de mando fue sometido a la evaluación de los socios y del Comité de Pacientes de la Sociedad Española de Farmacia Hospitalaria. RESULTADOS: El cuadro de mando consta de 50 indicadores agrupados en cinco ámbitos: 18 de ellos sobre aspectos generales, 12 en el ámbito del  seguimiento farmacoterapéutico, 15 relacionados con la dispensación y entrega informada de medicamentos a distancia, 2 sobre formación e información a los  pacientes y 3 en relación con la coordinación con el equipo asistencial. Se  consideraron 31 de ellos prioritarios, siendo los recomendados inicialmente en  la implantación de un programa de Telefarmacia. De ellos, 15 son generales  (incluyendo la medida de satisfacción del paciente y el profesional), 6 son  indicadores de seguimiento, 1 de formación e información y 2 de coordinación  asistencial. CONCLUSIONES: El cuadro de mando desarrollado es una herramienta de  gestión para implantar y evaluar la Telefarmacia en los servicios de farmacia  hospitalaria, que permite conocer la situación inicial, monitorizar la  implantación, medir la calidad y el desempeño, facilitar la toma de decisiones y  establecer un plan de mejora.

Patient Experience Evaluation of the CMO-Based Pharmaceutical Care Model vs Usual Care in People Living with HIV.

Objective: To compare patient experience in a real-life population of people living with HIV (PLWH) who received pharmaceutical care (PC) based on the Capacity-Motivation-Opportunity (CMO) model versus the traditional model. Methods: Prospective cohort study in PLWH receiving either CMO-based PC or traditional PC in Spain between October 2019 and June 2021 (24 weeks), performed by the pharmacy department of 14 Spanish hospitals. Participants were adult patients with a clinical diagnosis of HIV treated with antiretrovirals who had been monitored in the participating hospital pharmacies for >1 year. Patient experience (IEXPAC questionnaire), clinical outcomes (cholesterol, triglycerides, HDL, glycated haemoglobin, and blood pressure), adherence to treatment, virologic control and patient satisfaction were determined. Results: Patient experience in the CMO group at week 24 was significantly better (7.6 vs 6.9) than in the traditional group, with a higher mean improvement. Adherence was better in the CMO group, particularly with regard to concomitant medications (53.2% to 91.7%, p<0.001); no changes were observed in the traditional group. Patient satisfaction improved in the CMO group vs the traditional group (48 vs 44, p<0.001). Conclusion: To our knowledge, this is the first study to compare CMO vs traditional methodology. The CMO model showed an overall improvement in real-life patient experience, satisfaction, and adherence to treatment compared to the traditional methodology.

e-Interconsultations between a hospital pharmacy service and primary care pharmacy units in Spain.

PURPOSE: To analyse the profile of consultations made using an electronic platform system (e-Interconsultation) of communication between the hospital pharmacy service and primary care pharmacy units. METHOD: Descriptive and retrospective analysis of the number and type of e-Interconsultations for 3 years in a health area. DATA SOURCE: data mining of the e-Interconsultation platform (Microsoft Sharepoint software). RESULTS: A total of 1152 interconsultations have been made and 90.6% (88.9%-92.4% 95% CI) solved. 477 (41.1%) of them were referrals from hospital care to primary care in addition to 675 (58.6%) from primary to hospital care. The validation of prescriptions and the need for drug monitoring in primary care are among the main reasons for consultation. CONCLUSION: This two-way electronic platform of communication is a good mechanism that collaborates in patients' transit between different healthcare levels because it allows us to facilitate, normalise and document consults, referrals and pharmaceutical interventions between hospital care and primary care. Therefore, it helps us provide better quality pharmaceutical care to our patients.

Development of the @Antidotos_bot chatbot tool for poisoning management.

OBJECTIVE: To describe the development of the Antidotos_bot chatbot tool, which is used to facilitate the search for information in the Antidote Administration Guide and to perform useful calculations in the use of antidotes. METHOD: In January 2019, we proposed developing a freely accessible chatbot on Telegram® using Xenioo®. Software development  defined the way it interacts with users and incorporated calculation  functionalities. Internal validation was conducted and it was presented as  Antidotos_bot in June 2019. RESULTS: Antidotos_bot included information in Spanish on 49 antidotes and 57 poisonings. Three types of calculations were provided  and two treatment algorithms could be consulted. Consultation was  possible through 332 questions. Internal validation needed five sets of  training over 2 months. By July 2020, it had 415 users. The most  frequently consulted antidotes were glucagon, penicillin G, protamine, n- acetylcysteine and flumazenyl. Regarding monthly activity, there was an  average of 29 calculations and an average of three new users and three  queries per user. CONCLUSIONS: Antidotos_bot is a poisoning management decisionmaking tool that provides up-to-date information in a user-friendly manner. It could contribute to improving the quality and safety of care in  emergency situations.

Objetivo: Describir el desarrollo del simulador conversacional Antidotos_bot, para facilitar la búsqueda de información en la Guía de  administración de Antídotos y realizar cálculos útiles en el uso de  antídotos.Método: En enero de 2019 planteamos el desarrollo de un simulador conversacional de libre acceso en Telegram®, empleando la  plataforma Xenioo®. En el desarrollo del software se definió la forma de  interacción con el usuario y se incorporaron funcionalidades de cálculo. Se  realizó una validación interna y en junio de 2019 se presentó  Antidotos_bot.Resultados: Antidotos_bot incorporó información en castellano sobre 49  antídotos en 57 intoxicaciones, permitiendo realizar tres tipos de cálculos y consultar dos algoritmos de tratamiento. La consulta fue posible mediante  332 preguntas. La validación interna precisó cinco entrenamientos diferentes durante 2 meses. En julio 2020, Antidotos_bot  tenía 415 usuarios y los antídotos más consultados fueron glucagón,  penicilina G, protamina, n-acetilcisteína y flumazenilo. Mensualmente  fueron realizados 29 cálculos, el número medio de nuevos usuarios fue de  3 y el número medio de consultas por usuario fue de 3.Conclusiones: Antidotos_bot es una herramienta de apoyo en la toma de  decisiones en intoxicaciones, que proporciona información actualizada de  forma ágil, y podría contribuir a mejorar la calidad y seguridad asistencial  en situaciones de emergencia.

Outpatients' Opinion And Experience Regarding Telepharmacy During The COVID-19 Pandemic: The Enopex Project.

BACKGROUND: Telepharmacy, as a remote pharmaceutical care procedure, is being used worldwide during the COVID-19 pandemic, with the aim of preserving the health of patients and professionals. Its future development should incorporate the assessment of patient perception, but no research study has investigated it. OBJECTIVE: The objective was to poll the opinions and experiences of outpatients with telepharmacy through a purpose-developed questionnaire and to assess it's quality through an internal validity and reliability analysis. METHODS: Cross-sectional observational study of adult patients who used telepharmacy services during the COVID-19 lockdown period in Spain. The subjects answered a 24-item questionnaire, after giving their informed consent. Place of delivery, informed pharmacotherapeutic follow-up, opinion about telepharmacy, future development, ethics/satisfaction, and coordination constituted the six questionnaire categories. After assessing the adequate sample size with the Kaiser-Meyer-Olkin test, the Bartlett sphericity test analyzed the validity of the questionnaire. The intraclass correlation coefficient and Cronbach's α coefficient calculations verified the reliability and internal consistency. RESULTS: A total of 9442 interviews were administered to patients from 81 hospitals, of which 8079 were valid (52.8% female). A 54.1% were aged between 41-65 years; 42.7% had been in treatment for more than 5 years; 42.8% lived between 6-31 miles from the hospital. As many as 96.7% of patients were "satisfied" or "very satisfied" with telepharmacy, 97.5% considering it complementary to their usual follow-up; 55.9% expressed a preference for being followed up face to face when visiting the hospital. 75.6% said they had rather receive their medication at home. The sample size obtained was deemed appropriate [the Kaiser-Meyer-Olkin test (0.789) and Bartlett's sphericity test (p<0.005)]. The reliability analysis resulted in a Cronbach α = 0.7. CONCLUSION: Patients have shown high satisfaction with telepharmacy and the ENOPEX questionnaire is a tool with sufficient validity and reliability to be used in the evaluation of the care that patients receive through telepharmacy.

Influence of drug-drug interactions on effectiveness and safety of direct-acting antivirals against hepatitis C virus.

OBJECTIVES: Direct-acting antivirals are the recommended treatment for hepatitis C-infected patients. Drug-drug interactions with concomitant treatments can cause lack of effectiveness and/or safety. The objective of this study is to characterise drug-drug interactions of direct-acting antivirals and to analyse their influence both on the effectiveness of antiviral treatment and on the overall safety of pharmacological treatment in hepatitis C-infected patients. METHODS: Observational and prospective cohort study for 3 years in the pharmaceutical care outpatient consultation of a general hospital, undertaking detection, evaluation and management of drug-drug interactions by clinical pharmacists and physicians. The main outcome measures were sustained virologic response at week 12 for effectiveness and serious drug-related adverse events for safety. Multivariate statistical analysis applied to: (a) patient basal characteristics related to presence of drug-drug interactions; (b) previous antiviral treatments, viral genotype, cirrhosis, decompensations and presence of drug-drug interactions related to the effectiveness of direct-acting antivirals. RESULTS: Of a total of 1092 patients, the majority of them were men, around 60 years old and HCV-genotype 1 mono-infected, with a high basal viral load, naive to antiviral treatment, treated with ledipasvir/sofosbuvir and without cirrhosis. 24.5% had drug-drug interactions. Proton pump inhibitors were the concomitant drugs that caused the most drug-drug interactions. Age ≥65 years and direct-acting antivirals based on protease inhibitors were independently related to the presence of drug-drug interactions (p≤0.012). All (100%) of the therapeutic recommendations based on detected drug-drug interactions were implemented; 97.7% of patients with interactions versus 99.0% without them reached sustained virologic failure (p=0.109). The serious adverse events rates were 1.5% and 1.3% in patients with and without drug-drug interactions, respectively (p=0.841). CONCLUSIONS: Drug-drug interactions are frequent among hepatitis C-infected patients receiving treatment with direct-acting antivirals. However, the collaboration between physicians and clinical pharmacists makes it possible to detect, evaluate, avoid or clinically manage these drug-drug interactions, in order to maintain whole treatment therapeutic safety and the effectiveness of direct-acting antivirals.

Survey on the situation of telepharmacy as applied to the outpatient care in hospital pharmacy departments in Spain during the COVID-19 pandemic.

OBJECTIVE: To analyze the status of the implementation and development of  telepharmacy as applied to the pharmaceutical care of outpatients treated at  hospital pharmacy services in Spain during the COVID-19 pandemic. METHOD: Six weeks after the beginning of the confinement period, an online 10- question survey was sent to all members of the Spanish Society of Hospital  Pharmacists. A single response per hospital was requested. The survey included  questions on the provision of remote pharmaceutical care prior to the onset of  the health crisis, patient selection criteria, procedures for home delivery of  medications and the means used to deliver them, the number of patients who  benefited from telepharmacy, and the number of referrals made. Finally,  respondents were asked whether a teleconsultation was carried out before  sending patients their medication and whether these deliveries were recorded. RESULTS: A total of 39.3% (n = 185) of all the hospitals in the National Health  System (covering all of Spain's autonomous regions) responded to the survey.  Before the beginning of the crisis, 83.2% (n = 154) of hospital pharmacy  services did not carry out remote pharmaceutical care activities that included  telepharmacy with remote delivery of medication. During the study period,  119,972 patients were treated, with 134,142 deliveries of medication being  completed. Most hospitals did not use patient selection criteria. A total of 30.2%  of hospitals selected patients based on their personal circumstances. Home  delivery and informed delivery (87%; 116,129 deliveries) was the option used in most cases. The means used to deliver the medication mainly included the use  of external courier services (47.0%; 87 hospitals) or the hospital's own transport services (38.4%; 71 hospitals). As many as 87.6% of hospitals carried out  teleconsultations prior to sending out medications and 59.6% recorded their  telepharmacy activities in the hospital pharmacy appointments record. CONCLUSIONS: The rate of implementation of telepharmacy in outpatient care in  Spain during the study period in the pandemic was high. This made it possible to guarantee the continuity of care for a large number of patients.

Objetivo: Analizar la situación de la implantación y desarrollo de la telefarmacia aplicada a la atención farmacéutica a pacientes externos de los servicios de  farmacia hospitalaria en España durante la pandemia por la COVID-19.Método: Se envió una encuesta online de 10 preguntas a todos los socios de la  Sociedad Española de Farmacia Hospitalaria a las seis semanas del inicio del  periodo de confinamiento por la pandemia. Se solicitó una única respuesta por  hospital. Se incluyeron preguntas sobre la realización de atención farmacéutica  no presencial con dispensación a distancia previa al inicio de la crisis sanitaria,  los criterios de selección de pacientes, los procedimientos de envío de  medicación y los medios utilizados, el número de pacientes que se han  beneficiado de la telefarmacia y el número de envíos realizados. Por último, se  identificó la realización o no de teleconsulta previa al envío de medicación y si la  actividad quedó registrada.Resultados: Un 39,3% (n = 185) del total de hospitales públicos del Sistema  Nacional de Salud pertenecientes a todas las comunidades autónomas  respondieron a la encuesta. El 83,2% (n = 154) de los servicios de farmacia  hospitalarios no realizaban actividades de atención farmacéutica no presencial  con telefarmacia que incluyeran envío de medicación antes del inicio de la crisis  sanitaria. En el periodo de estudio se atendieron 119.972 pacientes y se  realizaron 134.142 envíos de medicación. La mayoría de los hospitales no  utilizaron criterios de selección de pacientes. El 30,2% de los centros  seleccionaron en función de las circunstancias personales del paciente. La  dispensación domiciliaria y entrega informada (87%; 116.129 envíos) fue la  opción utilizada de forma mayoritaria para el envío. Los medios para hacer llegar la medicación fueron, principalmente, la mensajería externa (47%; 87 centros) o medios propios del hospital (38,4%; 71 centros). Un 87,6% de los hospitales realizaron teleconsulta previa al envío de medicación y el 59,6% registró la actividad de telefarmacia en la agenda de citación. Conclusiones: La implantación de la telefarmacia aplicada a la atención a  pacientes externos en España durante la pandemia ha sido elevada. Así se ha  podido garantizar la continuidad de los tratamientos de un elevado número de  pacientes.

Effectiveness and safety of sofosbuvir/velpatasvir ± ribavirin vs glecaprevir/pibrentasvir in genotype 3 hepatitis C virus infected patients.

Objectives: Sofosbuvir/velpatasvir±ribavirin (SOF/VEL±RBV) and glecaprevir/pibrentasvir (GLE/PIB) are the drug combinations of choice for treating individuals with genotype 3 hepatitis C virus (G3-HCV) infection. The objective of this study was to evaluate the effectiveness and safety of SOF/VEL±RBV compared with GLE/PIB for treating G3-HCV infection under routine clinical practice conditions. Methods: We conducted a prospective observational cohort study of individuals with G3-HCV infection who initiated treatment with SOF/VEL +/-RBV or GLE/PIB between April 2017 and July 2018. Prisoners and children were excluded. The outcome variable of effectiveness was sustained virological response 12 weeks after completing treatment (SVR12). The safety variable was withdrawal secondary to severe adverse events (SAEs). Covariates included sex, age, HIV co-infection, previous liver transplant, cirrhosis, hepatic fibrosis and previous antiviral treatment. Statistical significance was calculated using Fisher's exact test or the Mann-Whitney U-test. Results: A total of 76 patients were included in the analysis, of whom 46 were treated with SOF/VEL±RBV and 30 were treated with GLE/PIB. No baseline differences were observed between treatment groups with respect to age, sex, HIV co-infection, fibrosis stage, cirrhosis and previous antiviral treatment. Of the patients treated with SOF/VEL±RBV and GLE/PIB, 95.7% and 96.7% reached SVR12, respectively (P=0.7). Of patients with and without cirrhosis, 83.3% and 98.4% reached SVR12, respectively (P=0.09). Of the patients with low-grade hepatic fibrosis (F0-2) and advanced fibrosis (F3-4), 100% and 85.7% reached SVR12, respectively (P=0.03). In treatment-naïve and treatment-experienced patients, 95.7% and 100% reached SVR12, respectively (P=0.57), without significant differences independent of the treatment group (P=0.28 for SOF/VEL±RBV; P=0.18 for GLE/PIB). The incidence of AEs was 21.1% (95% CI 11.3% to 30.9%). None of the patients developed an SAE or required antiviral treatment withdrawal. Conclusions: SOF/VEL±RBV or GLE/PIB are safe and effective for treating G3-HCV-infections, with a lower effectiveness in patients with advanced fibrosis F3-4.

Spanish Society of Hospital Pharmacy Position Statement on Telepharmacy: Recommendations for its implementation and development.

The use of information and communication technologies have nowadays become  part and parcel of hospital pharmacy practice. Against this background, it is  hardly surprising that Telepharmacy has sparked the interest of a large number  of stakeholders. In this respect, the Spanish Society of Hospital Pharmacy has  developed a definition of the concept and outlined the conditions under which  Telepharmacy should operate. It has also shared its institutional stance on the  subject through a position statement that states that Telepharmacy is the  provision of pharmaceutical care at a distance through information and  communication technologies. Telepharmacy practice includes activities such as  therapeutic validation, drafting of clinical documents, provision of  pharmaceutical care, therapeutic follow-up, adherence monitoring, drug  education and information, coordination between healthcare providers and  evaluation of health outcomes. The clinical tasks performed as part of  Telepharmacy practice must adhere to a standardized procedure and revolve  around the patient's clinical record. Access to Telepharmacy must be provided without discrimination. The service comprises four main activities:  pharmacotherapeutic follow-up; patient and caregiver-directed education and information-dissemination; coordination with healthcare providers from the  same or different hospitals; and remote informed home drug delivery. Implementation of Telepharmacy requires an adjustment of human (training and capacity-building) and technological resources (validation, interoperability, confidentiality). It must also comply with the laws and regulations in force both  at a regional and a national level. Telepharmacy procedures must also be  adapted to the relevant ethical standards and codes of good practice.  Appropriate indicators must be used to evaluate the performance of  Telepharmacy and its impact on health outcomes. According to Spanish Society  of Hospital Pharmacy Telepharmacy is a necessary complementary tool to  provide specialized pharmaceutical care and thereby improve health outcomes  and maximize patient safety and satisfaction.

En la práctica asistencial de los farmacéuticos de hospital resulta imprescindible la utilización de las tecnologías de la información y comunicación en el ámbito de la Telefarmacia. Por lo tanto, la Sociedad Española e Farmacia Hospitalaria considera oportuno definir el término y condiciones de  Telefarmacia y comunicar su posicionamiento institucional a través de este  documento de posicionamiento: "La Telefarmacia es la práctica farmacéutica a  distancia a través del uso de las tecnologías de la información y comunicación".  La Telefarmacia incluye como principales actividades: validación terapéutica,  documentación clínica, consulta de atención farmacéutica, monitorización  terapéutica, seguimiento de la adherencia, formación/información sobre  medicamentos, coordinación con profesionales sanitarios y evaluación de  resultados en salud. Los procedimientos asistenciales en el ámbito de la  Telefarmacia deben regirse por un Procedimiento Normalizado de Trabajo, con  documentación en la historia clínica y sin discriminación de acceso a pacientes  candidatos. Se consideran cuatro procedimientos principales de Telefarmacia:  seguimiento farmacoterapéutico; información y/o formación a pacientes y  cuidadores; coordinación con el equipo multidisciplinar a nivel intra y  extrahospitalario; dispensación y entrega informada de medicamentos a  distancia. La implantación de la Telefarmacia requiere adecuación de medios  humanos (formación, capacitación) y tecnológicos (validación, interoperatividad, confidencialidad). Asimismo, debe dar cumplimiento a la legalidad y normativa  vigente, tanto a nivel autonómico como estatal. Los procedimientos de  Telefarmacia deben también ajustarse a las consideraciones éticas y los códigos  deontológicos pertinentes. Debe fomentarse la evaluación de la Telefarmacia a  través del uso de indicadores y de la investigación de su repercusión sobre los  resultados en salud. Por tanto, la Sociedad Española de Farmacia Hospitalaria  considera que la Telefarmacia es una herramienta complementaria y necesaria  para la provisión de una Atención Farmacéutica Especializada con el objetivo  final de mejorar los resultados en salud y maximizar la seguridad y satisfacción  de los pacientes.