Effect of a Structured Pharmaceutical Care Intervention Versus Usual Care on Cardiovascular Risk in HIV Patients on Antiretroviral Therapy: INFAMERICA Study.

BACKGROUND: HIV+ patients have increased their life expectancy with a parallel increase in age-associated comorbidities. OBJECTIVE: To determine the effectiveness of an intensive pharmaceutical care follow-up program in comparison to a traditional model among HIV-infected patients with moderate/high cardiovascular risk. METHOD: This was a multicenter, prospective, randomized study of a structured health intervention conducted between January-2014 and June-2015 with 12 months of follow-up at outpatient pharmacy services. The selected patients were randomized to a control group (usual care) or intervention group (intensive pharmaceutical care). The interventional program included follow-up of all medication taken by the patient to detect and work toward the achievement of pharmacotherapeutic objectives related to cardiovascular risk and making recommendations for improving diet, exercising, and smoking cessation. Individual motivational interview and periodic contact by text messages about health promotion were used. The primary end point was the percentage of patients who had reduced the cardiovascular risk index, according to the Framingham-score. RESULTS: A total of 53 patients were included. As regards the main variable, 20.7% of patients reduced their Framingham-score from high/very high to moderate/low cardiovascular risk versus 12.5% in the control group ( P=0.016). In the intervention group, the number of patients with controlled blood pressure increased by 32.1% ( P=0.012); 37.9% of patients overall stopped smoking ( P=0.001), and concomitant medication adherence increased by 39.4% at the 48-week follow-up ( P=0.002). Conclusion and Relevance: Tailored pharmaceutical care based on risk stratification, motivational interviewing, and new technologies might lead to improved health outcomes in HIV+ patients at greater cardiovascular risk.

Treatment adherence to oral chemotherapy in patients with locally advanced or metastatic non-small cell lung cancer: Protocol for a hospital pharmacy-based real-world study.

OBJECTIVE: This article describes a study protocol for evaluating adherence to oral chemotherapy (OCT) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) in Spain. METHODS: This multicenter, observational, prospective study will be conducted by 6 hospital pharmacists from 6 Spanish hospitals. The study will include men and women aged 18 years or older with a diagnosis of locally advanced or metastatic NSCLC who are being treated or have been prescribed OCT. Once included, the patient will be active and prospectively followed up for 3 months, including 4 study visits to record information on sociodemographic variables, antineoplastic treatment and adherence, pharmaceutical care, clinical variables, and patient-reported outcomes (PRO) (the 3-level version of EQ-5D, the EORTC Core Quality of Life Questionnaire, the Brief Illness Perception Questionnaire, the Treatment Satisfaction with Medicines Questionnaire, and the PRO version of Common Terminology Criteria for Adverse Events). Twelve months after patient inclusion, we will record information on the disease progression status and dispensed prescriptions. The primary outcome is the percentage of treatment adherence that will be calculated based on the pill count as follows: the difference between the number of pills dispensed minus the number of unused pills will be divided by the number of days of treatment multiplied by the number of pills/day prescribed by the oncologist; this quotient will be multiplied by 100 to obtain the percentage of adherence. Based on the that pill count reconciliation, those with a percentage adherence >80% will be primarily categorized as adherent. Secondarily, treatment adherence will be also calculated based on the proportion of days covered and the 4-items Morisky Green Levine Medication Adherence Scale. To analyze the impact of patients' and treatment characteristics on adherence, bivariate analyses will be performed using different adherence cut-off points. To evaluate the impact of adherence on treatment efficacy as evaluated by progression-free survival, we will be using the Kaplan-Meier method and compare it with the log-rank test and univariate Cox regression analysis. CONCLUSIONS: We expect that our study will provide initial information on key aspects of adherence to OCT (i.e., measurement, facilitators, and barriers) and its relationship with patients' and clinically relevant outcomes in the setting of NSCLC, and that this information will help in designing pharmaceutical interventions to improve adherence.

Complementary and alternative medicine in HIV care: frequency of consumption, risks and interactions with antiretroviral therapy.

OBJECTIVES: People living with HIV (PLWH) are common users of complementary and alternative medicine (CAM). The main objective of this study was to study the frequency and patterns of CAM natural products use in a large cohort of PLWH and to identify potential drug-drug interactions (DDIs) and the impact on their antiretroviral treatment (ART) adherence and efficacy. METHODS: This was a cross-sectional multicenter survey including 420 PLWH from different Spanish hospitals. Participants completed a face-to-face questionnaire on CAM consumption and different sociodemographic and clinical data were collected. DDIs between CAM and ART were identified and classified according to the Liverpool University Database and patient factors related to CAM consumption were assessed. RESULTS: 420 participants were included (82.6% male, mean age 47 years); 209 patients (49.8%) were taking at least one CAM. The most consumed CAM were green, black and red tea (n=146, 25.4%), ginger (n=26, 4.5%), fish oil (n=25, 4.4%) and cannabis (n=24, 4.2%). An ART based on integrase inhibitors was the only factor independently associated with CAM consumption (OR 1.54, 95% CI 1.04 to 2.26). 50 potential CAM-ART interactions in 43 (20.6%) patients taking CAM were identified, being clinically significant in 80% of the cases. CAM products most frequently involved with a potential significant DDI were supplements containing divalent cations (n=11) and garlic (n=7). No differences in ART efficacy and adherence were observed between patients with and without CAM consumption. CONCLUSIONS: Almost 50% of patients were taking at least one CAM product and its use was associated with an integrase inhibitor based ART. One out of every six patients was at risk of presenting with an interaction between a CAM and their ART, confirming the need to review continuously the use of CAM as part of the medication review process.

[Translated article] 2022 update of the indicators for quality of care and pharmaceutical care for people living with human immunodeficiency virus.

OBJECTIVE: To update and define indicators for improving the quality of care and Pharmaceutical Care for people living with HIV infection in Spain. METHOD: The present project, which updates the previous version of the 2013 document, was developed in four work phases carried out between January and June 2022. In phase 1, the organization phase, a working group was created, made up of seven hospital pharmacy specialists with extensive experience in pharmaceutical care and from different SFHs in Spain. In addition, another 34 specialists participated in the evaluation of the indicators through two rounds of online evaluation to generate consensus. For phase 2, initially, a review of the identified reference literature was carried out with the aim of establishing a basis from which to define a proposal for quality criteria and indicators. Then, a preliminary proposal of criteria was made and revisions were established for their adjustment in several telematic work meetings. In phase 3, consensus was established based on the Delphi-Rand/UCLA consensus methodology. In addition, all the indicators classified as appropriate and necessary were grouped according to two levels of monitoring recommendation, so as to guide the hospital pharmacy services in the priority of their measurement: key and advanced. Finally, in phase 4, the final project document was prepared, along with the corresponding descriptive sheets for each indicator in order to facilitate the measurement and evaluation of the indicators by the hospital pharmacy services. RESULTS: Following the consensus methodology used, a list of items made up of 79 appropriate and necessary indicators was drawn up to establish a follow-up and monitoring of the quality and activity of Pharmaceutical Care for people living with HIV. Of these, 60 were established as key and 19 advanced. CONCLUSIONS: The indicators defined and updated, since the previous version of 2013, are intended to be a tool for professionals to guide decision-making and facilitate the measurement and assessment of the most relevant aspects of the quality and pharmaceutical care of people living with HIV.

2022 update of the indicators for quality of care and pharmaceutical care for people living with human immunodeficiency virus. / Actualización 2022 de los indicadores para la calidad asistencial y la atención farmacéutica a las personas que viven con el virus de la inmunodeficiencia humana.

OBJECTIVE: To update and define indicators for improving the quality of care and pharmaceutical care for people living with HIV infection in Spain. METHOD: The present project, which updates the previous version of the 2013 document, was developed in four work phases carried out between January and June 2022. In phase 1, the organization phase, a working group was created, made up of seven hospital pharmacy specialists with extensive experience in pharmaceutical care and from different SFHs in Spain. In addition, another 34 specialists participated in the evaluation of the indicators through two rounds of online evaluation to generate consensus. For phase 2, initially, a review of the identified reference literature was carried out with the aim of establishing a basis from which to define a proposal for quality criteria and indicators. Then, a preliminary proposal of criteria was made and revisions were established for their adjustment in several telematic work meetings. In phase 3, consensus was established based on the Delphi-Rand/UCLA consensus methodology. In addition, all the indicators classified as appropriate and necessary were grouped according to two levels of monitoring recommendation, so as to guide the hospital pharmacy services in the priority of their measurement: key and advanced. Finally, in phase 4, the final project document was prepared, along with the corresponding descriptive sheets for each indicator in order to facilitate the measurement and evaluation of the indicators by the hospital pharmacy services. RESULTS: Following the consensus methodology used, a list of items made up of 79 appropriate and necessary indicators was drawn up to establish a follow-up and monitoring of the quality and activity of pharmaceutical care for people living with HIV. Of these, 60 were established as key and 19 advanced. CONCLUSIONS: The indicators defined and updated, since the previous version of 2013, are intended to be a tool for professionals to guide decision-making and facilitate the measurement and assessment of the most relevant aspects of the quality and pharmaceutical care of people living with HIV.

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.

Improvement of outpatient pharmacy through patient participation and Lean methodology.

OBJECTIVE: To improve the quality of the dispensing process and  pharmaceutical care in the Outpatient Pharmacy through patient participation and Lean methodology, and to analyse the results obtained in  terms of efficiency and patient satisfaction. METHOD: Prospective observational single-centre study. A working group was  organized with the health care staff involved in outpatient care to apply Lean  methodology and detect improvement opportunities. We used a focus group  technique to understand the patients' experience. The impact on patient  satisfaction was measured through a mass survey mailed out in December  2019 (before introducing the main measures) and in December 2020. RESULTS: More than 30 improvement actions were identified after surveying the opinions of the patients and health care staff involved. Nine actions were prioritized, which were mainly related to structural and circuit changes. Waiting times significantly improved (35% of patients waited for more than 30 minutes before the improvement actions vs 4.5% afterward). The results showed that waiting times and overall  satisfaction significantly improved in the period between the two surveys. In both cases, the degree of satisfaction was higher after introducing the improvement actions. CONCLUSIONS: We analysed the situation of our Outpatient Service and designed the most appropriate improvement actions according to the resources available. This initiative was achieved through patient  participation (via a focus group and mass surveys), the participation of health  care staff, and the application of Lean methodology.

Objetivo: Mejorar la calidad del proceso de dispensación y atención farmacéutica a pacientes externos mediante la participación del  paciente y la aplicación de la metodología Lean y analizar los resultados  obtenidos en cuanto a eficiencia e impacto en la satisfacción de los pacientes. Método: Estudio observacional, prospectivo y unicéntrico. Se creó un grupo de  trabajo con los diferentes profesionales implicados en la atención al  paciente externo para aplicar la metodología Lean y detectar oportunidades de  mejora. Para conocer la experiencia del paciente se utilizó la técnica del grupo  focal. El impacto en la satisfacción de los pacientes se midió mediante  encuestas de satisfacción que se enviaron a través del correo electrónico en  diciembre de 2019 (antes de implantar las principales medidas) y en diciembre  de 2020.Resultados: Teniendo en cuenta la perspectiva de los pacientes y de los  profesionales sanitarios, se identificaron más de 30 acciones de mejora de las  que se priorizaron 9, relacionadas fundamentalmente con cambios  estructurales y de circuitos. Se consiguió mejorar significativamente los  tiempos de espera (el 35% de los pacientes esperaban más de 30 minutos  frente al 4,5% en el análisis realizado después de las intervenciones). Los  aspectos que mostraron diferencias estadísticamente significativas en las  encuestas entre los dos periodos fueron el tiempo de espera y la satisfacción  global, en ambos casos el grado de satisfacción fue superior una vez  implantadas las acciones de mejora.Conclusiones: La participación del paciente, a través del grupo focal y  encuestas masivas, unido a la participación de los profesionales sanitarios implicados en el proceso, a través de la metodología Lean, ha permitido analizar la realidad de nuestro servicio y diseñar las acciones de  mejora más adecuadas en función de los recursos disponibles.

[Antiretroviral therapy of HIV infection: duration and reasons for changing the first therapeutic regimen in 518 patients]. / Tratamiento antirretroviral de la infección por el virus de la inmunodeficiencia humana: duración y motivos de cambio del primer esquema terapéutico en 518 pacientes.

BACKGROUND AND OBJECTIVE: Different combinations of antiretroviral drugs are used as initial HIV therapy but comparative studies between them are not frequent. The objectives of this study are to determine the median duration of different therapy combinations in naive patients between 1998-2000 and the main reasons for changing or stopping this first antiretroviral therapy (ARVT). PATIENTS AND METHOD: This study included a total of 518 naive patients who began antiretroviral therapy patients from 1998-2000. Using a Kaplan-Meier analysis the median duration of different combinations was determined. In addition, the main reasons for changing or stopping this first treatment were analysed. RESULTS: First ARVT median duration was 427 days (IQR: 114-890). 47% of patients stopped their first therapy due to adverse effects, 6% voluntarily withdrew from it, in 9% of patients the therapy was not effective and 15% of them were lost of follow up. Only 9% of them continued with the same ARVT at the end of the study but if we add 7% of treatment simplifications we can consider 16% of first ARVT successful. CONCLUSIONS: A median duration of 427 days, similar to other studies, is shorter than we would prefer for HIV, a condition that requires continuous treatment. On the other hand, the study corroborates that secondary effects are the principal problem associated with ARVT.