Drug burden index in people living with HIV over 50 years of age in a real clinical practice cohort.

OBJECTIVES: To determine DBI and its relationship with polypharmacy and pharmacotherapeutic complexity (PC) in a cohort of PLWH over 50 years of age at follow-up of pharmacotherapy in a tertiary hospital. METHODS: Observational and retrospective study that included PLWH in active antiretroviral treatment over 50 years of age who have been followed up in outpatient pharmacy services. Pharmacotherapeutic complexity was estimated through Medication Regimen Complexity Index (MRCI). Collected variables included comorbidities, current prescriptions and its classification according to anticholinergic and sedative activity and associated risk of falls. RESULTS: Studied population included 251 patients (85.7% men; median age: 58 years, interquartile range: 54-61). There was a high prevalence of high DBI scores (49.2%). High DBI was significantly correlated with a high PC, polypharmacy, psychiatric comorbidity and substances abuse (p<0.05). Among sedative drugs, the most prescribed were anxiolytic drugs (N05B) (n=85), antidepressant drugs (N06A) (n=41) and antiepileptic drugs (N03A) (n=29). For anticholinergic drugs, alpha-adrenergic antagonist drugs (G04C) were the most prescribed (n=18). Most frequent drugs associated with risk of falls were anxiolytics (N05B) (n=85), angiotensin-converting enzyme inhibitors (C09A) (n=61) and antidepressants (N06A) (n=41). CONCLUSION: The DBI score in older PLWH is high and it is related to PC, polypharmacy, mental diseases and substance abuse as is the prevalence of fall-related drugs. Control of these parameters as well as the reduction of the sedative and anticholinergic load should be included in the lines of work in the pharmaceutical care of people living with HIV+.

[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.

Simplification and Multidimensional Adaptation of the Stratification Tool for Pharmaceutical Care in People Living With HIV.

BACKGROUND: People living with human immunodeficiency virus (HIV) require specific pharmaceutical care (PC). Although the 2017 Capacity-Motivation-Opportunity (CMO) PC model allows a multidisciplinary approach that focuses on patient needs, it is too complex and presents room for improvement. OBJECTIVE: The aim of this study is to simplify and adapt the previous 2017 PC tool through a multidimensional approach to improve HIV patient care, to prove the validity of the model in real-life patients. METHODS: The new PC tool was generated by keeping some of the variables of the 2017 document and conducting a literature search. Content validity was determined by a 2-round Delphi methodology with an expert panel of 42 pharmacists. Consensus for the first and second rounds was defined as ≥70% agreement. The tool generated was validated in 407 real-life patients. RESULTS: Thirty-seven experts completed the first round of the Delphi survey and 36 the second. No consensus was reached for 3 variables, any of the frequency options and 4 interventions, while the experts agreed not to include 1 intervention in round 1. Consensus to include them was found for all but 1 variable and 1 intervention in round 2. The final tool obtained to select and stratify HIV-positive patients was composed of 9 dimensions divided into 17 variables. The new tool was validated with real-life patients and 3 priority levels were defined. CONCLUSIONS AND RELEVANCE: We created a new pyramid of score thresholds to classify patients into priority levels. The new tool simplifies the 2017 model and improves its utility to help HIV-positive patients, owing to its multidimensional approach.

Prevalence of polypharmacy and associated factors among patients living with HIV infection in Spain: The POINT study.

PURPOSE: Survival in people living with HIV (PLWH) has increased and thus people are aging with HIV, increasing the frequency of multimorbidity and polypharmacy. This cross-sectional study was conducted to evaluate the prevalence of polypharmacy among PLWH who were on antiretroviral treatment and were followed in an outpatient setting by the pharmacy department of several hospitals across Spain. In addition, we aimed to evaluate factors associated with polypharmacy and treatment complexity among this population. MATERIAL AND METHODS: We recorded information on demographic data, data on disease control including viral load and CD4 count at the time of inclusion, comorbidities, pharmacologic treatment and drugs interactions. Polypharmacy was defined as the use of 6 or more different drugs, including antiretroviral medication; major polypharmacy was defined as the use of ≥11 different drugs. RESULTS: Overall, 1225 PLWH were eligible in the study. The median (IQR) age was 49 (40-54). Comorbidities were present in 819 (67%) PLWH and 571 (47%) had two or more comorbidities. Overall, 397 (32.4%, 95% CI 29.8-34.9) PLWH met the criteria for polypharmacy, and 67 (5.5%, 95% CI, 4.2-6.7) had major polypharmacy. Several factors were associated with polypharmacy such as type of antiretroviral treatment, presence of potential interactions, the use of several types of medications and the number of comorbidities. Treatment complexity was also a factor strongly associated with polypharmacy; for each point increase in the medication regimen complexity index (MRCI), the likelihood of polypharmacy increased 2.3-fold. CONCLUSIONS: Polypharmacy is frequent among PLWH in Spain and contributes to a relevant extent to treatment complexity.

Prevalence of polypharmacy and associated factors among patients living with HIV infection in Spain: The POINT study.

PURPOSE: Survival in people living with HIV (PLWH) has increased and thus people are aging with HIV, increasing the frequency of multimorbidity and polypharmacy. This cross-sectional study was conducted to evaluate the prevalence of polypharmacy among PLWH who were on antiretroviral treatment and were followed in an outpatient setting by the pharmacy department of several hospitals across Spain. In addition, we aimed to evaluate factors associated with polypharmacy and treatment complexity among this population. MATERIAL AND METHODS: We recorded information on demographic data, data on disease control including viral load and CD4 count at the time of inclusion, comorbidities, pharmacologic treatment and drugs interactions. Polypharmacy was defined as the use of 6 or more different drugs, including antiretroviral medication; major polypharmacy was defined as the use of ≥11 different drugs. RESULTS: Overall, 1225 PLWH were eligible in the study. The median (IQR) age was 49 (40-54). Comorbidities were present in 819 (67%) PLWH and 571 (47%) had two or more comorbidities. Overall, 397 (32.4%, 95% CI 29.8-34.9) PLWH met the criteria for polypharmacy, and 67 (5.5%, 95% CI, 4.2-6.7) had major polypharmacy. Several factors were associated with polypharmacy such as type of antiretroviral treatment, presence of potential interactions, the use of several types of medications and the number of comorbidities. Treatment complexity was also a factor strongly associated with polypharmacy; for each point increase in the medication regimen complexity index (MRCI), the likelihood of polypharmacy increased 2.3-fold. CONCLUSIONS: Polypharmacy is frequent among PLWH in Spain and contributes to a relevant extent to treatment complexity.

Prevalence of polypharmacy and pharmacotherapy complexity in elderly people living with HIV in Spain. POINT study.

OBJECTIVE: To determine the prevalence of polypharmacy in persons living with  HIV of at least 65 years of age receiving antiretroviral treatment. A  characterization of antiretroviral treatment, as well as a determination of the  prevalence of comorbidities; of the most common types of concomitant medication; of adherence rates; of the pharmacotherapeutic  complexity; and of drug-drug interactions were also among the goals of the  study. METHOD: This was a multi-center, cross-sectional observational study that  included persons living with HIV aged 65 years or more who were on active  antiretroviral treatment. Demographic, clinical (viral load, CD4 count and  comorbidities) and pharmacotherapeutic (type of antiretroviral treatment: single tablet regimen, polypharmacy [six active ingredients or more] and major  polypharmacy [11 active ingredients or more] variables were considered).  Adherence to antiretroviral treatment was measured by dispensation records and the Simplified Medication Adherence Questionnaire, while adherence to  concomitant medication was measured using dispensation records and the  Morisky-Green questionnaire. The Medication Regimen Complexity Index was  calculated. Drug-drug interactions were analyzed using the Liverpool and  Lexicomp databases. RESULTS: Seventy-four patients (86.5% male) were included, with a median age  of 69 years (66.7-72.0). The sexual route was the most common route of  transmission of the disease (67.6%). The virus was undetectable in 89.2% of  patients; the CD4 count was over 200/mL in 94.6% of the sample. The median  number of comorbidities was 3.5 (2.0-5.0), 52.7% of them being cardiovascular; 50.0% related to the central nervous system; 17.6% hepatic; and 8.1%  consisting in chronic pulmonary disease. A total of 81.1% of patients received  triple therapy and 48.6% single tablet regimen. The median number of  concomitant drugs administered was 5.0 (2.0-7.0), polypharmacy was observed  in 71.6% of cases and major polypharmacy in 25.7%. Antihypertensive and  cardiovascular drugs were prescribed to 56.8% of patients, lipid-lowering drugs  to 50.0%, antiulcer agents to 33.8% and psychoactive drugs to 32.4%.  According to dispensation records, adherence to antiretroviral treatment was  85.1% and to concomitant medication 62.8%. The median Medication Regimen Complexity Index for the whole treatment was 13.0 (8.0-17.6). Potential drug- drug interactions were observed in 55.4% of patients and contraindicated interactions in 12.2%. CONCLUSIONS: Elderly persons living with HIV exhibit a high prevalence of  polypharmacy, pharmacotherapeutic complexity, poor adherence and drug-drug  interactions. For that reason, pharmacotherapeutic optimization must be a  priority in these patients.

Objetivo: Determinar la prevalencia de polifarmacia en personas que viven con  VIH de al menos 65 años en tratamiento antirretroviral. Describir el tratamiento  antirretroviral, determinar la prevalencia de comorbilidades, el tipo de  medicación concomitante más frecuente, la adherencia, la complejidad farmacoterapéutica y las interacciones.Método: Estudio observacional, transversal y multicéntrico en el que se incluyeron a personas que viven con VIH de al menos 65 años con  tratamiento antirretroviral activo. Se recogieron variables demográficas, clínicas (carga viral, linfocitos CD4 y comorbilidades) y farmacoterapéuticas (tipo  de tratamiento antirretroviral, regímenes con single- tablet-regimen, polifarmacia ­seis principios activos incluyendo tratamiento  antirretroviral­, polifarmacia mayor ­11 principios activos incluyendo  tratamiento antirretroviral­). Se midió la adherencia al tratamiento  antirretroviral con los registros de dispensación y con el Simplified Medication  Adherence Questionnaire, y la adherencia al tratamiento concomitante mediante  los registros de dispensación y el cuestionario Morisky-Green. Se calculó el  índice de complejidad farmacoterapéutica a través del Medication Regimen  Complexity Index. Se revisaron las interacciones con la base de datos de  Liverpool y Lexicomp. Resultados: Se incluyeron 74 pacientes (86,5% hombres) con una mediana de  edad de 69 (66,7-72,0) años. La vía sexual fue la forma más frecuente de  adquisición (67,6%). Presentaron indetectabilidad del virus el 89,2% de los  pacientes y con una cifra de linfocitos CD4 de más de 200/ml el 94,6%. La  mediana de comorbilidades fue de 3,5 (2,0-5,0): cardiovascular 52,7%, sistema  nervioso central 50,0%, hepática 17,6% y enfermedad pulmonar crónica 8,1%.  Recibieron triple terapia el 81,1% y single-tablet-regimen el 48,6%. La mediana  de fármacos concomitantes fue 5,0 (2,0-7,0), polifarmacia 71,6% y polifarmacia mayor 25,7%. Medicamentos antihipertensivos y del sistema cardiovascular  fueron prescritos en un 56,8% de los pacientes, hipolipemiantes 50,0%,  antiulcerosos 33,8% y psicofármacos 32,4%. La adherencia según registros de  dispensación del tratamiento antirretroviral fue del 85,1% y de la medicación  concomitante del 62,8%. La mediana del Medication Regimen Complexity Index  del tratamiento completo fue 13,0 (8,0-17,6). Tenían al menos una interacción potencial el 55,4% y al menos una contraindicada el 12,2% de los pacientes.Conclusiones: Las personas mayores que viven con VIH tienen una alta  prevalencia de polifarmacia, complejidad farmacoterapéutica, baja adherencia al  tratamiento e interacciones, por lo que la optimización farmacoterapéutica debe  ser una prioridad en este tipo de pacientes.

Guselkumab in moderate-to-severe plaque psoriasis: effectiveness in real clinical practice / Guselkumab en placa de moderada a grave psoriasis: eficacia en la práctica clínica real

Introducción: La psoriasis es una enfermedad cutánea inflamatoria crónica inmunomediada que afecta a casi el 1-2% de la población mundial. El tratamiento biológico de la psoriasis moderada a grave ha cambiado el paradigma de manejo de la enfermedad, permitiendo un mejor control de la misma. Métodos: Se llevo a cabo un estudio observacional retrospectivo que incluyó a pacientes con psoriasis moderada a grave que fueron tratados durante al menos 36 semanas con guselkumab. La eficacia se evaluó mediante la estimación de pacientes que alcanzaron las respuestas PASI 75, PASI 90 y PASI 100 en las semanas 16, 24 y 36. Se utilizó la prueba T de Student para muestras pareadas para determinar la significación estadística entre PASI al inicio y respuesta PASI en las semanas 16, 24 y 36. Resultados: Se incluyeron 22 pacientes, 14 mujeres (63, 6%), con una edad media de 48, 7 ± 15, 5 años. El tratamiento con guselkumab redujo el PASI medio de 10, 3 ± 6 al inicio del estudio a 2, 4 ± 2 (p = 0,003), 1, 3 ± 1, 8 (p = 0,001) y 0, 3 ± 0, 6 (p = 0,001) a las 16, 24 y 36 semanas, respectivamente. Discusión: El primer fármaco en unirse al arsenal terapéutico anti-IL23 fue guselkumab. La eficacia obtenida fue superior a la observada en estudios fase III para PASI 90 y 100 a la semana 36. Existen algunos estudios que han evaluado la eficacia a corto plazo de guselkumab en la práctica clínica real; sin embargo, este fármaco se ha comercializado recientemente, limitando la posibilidad de evaluación durante períodos de tiempo más prolongados. Conclusión: Guselkumab presenta buenos resultados en el manejo de la psoriasis en adultos. La práctica clínica real a medio y largo plazo será fundamental, con un mayor tamaño muestral y período de seguimiento.

Introduction: Psoriasis is a chronic immune­ mediated inflammatory skin disease that affects nearly 1­2% of the population worldwide. Biologic treatment of moderate-to-severe psoriasis has changed the disease management paradigm, allowing for better disease control. Methods: A retrospective observational study including patients with moderate-to-severe psoriasis who were treated for at least 36 weeks with guselkumab. Efficacy was evaluated by estimating the proportion of patients achieving PASI 75, PASI 90 and PASI 100 responses at weeks 16, 24 and 36. The Student t-test for paired samples was used to determine the significant difference in outcome of patients between PASI at baseline and PASI response at weeks 16, 24 and 36. Reslts: 22 patients were included, 14 women (63.6%), with mean age of 48.7±15.5. Guselkumab treatment decreased mean PASI from 10.3±6 at baseline to 2.4±2 (p=0.003), 1.3±1.8 (p=0.001) and 0.3±0.6 (p=0.001) at 16, 24 and 36 weeks, respectively. Discussion: The first anti-IL23 drug family to join the therapeutic arsenal is guselkumab. The efficacy obtained is higher than that observed in phase III studies for PASI 90 and 100 at week 36. There are some studies that have evaluated the short-term effectiveness of guselkumab in real clinical practice; however, this drug has only recently been marketed, limiting the possibility of as yet longer treatment periods. Conclusion: Guselkumab shows great results in the management of psoriasis in adults. Medium- and long-term real clinical practice will be essential, with a larger sample size and longer follow-up period.

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.