Potentially inappropriate prescriptions and potential prescription omissions in older people living with HIV.

OBJECTIVES: This study aimed to determine the prevalence of potentially inappropriate prescriptions (PIPs) and potential prescription omissions (PPOs) in a Spanish cohort of people living with HIV (PLWH) aged ≥65 years and to identify risk factors for the presence of PIPs and PPOs. METHODS: This retrospective cross-sectional study was conducted across 10 public hospitals in the Autonomous Community of Madrid, Spain. Clinical and demographic data were cross-checked against hospital and community pharmacy dispensation registries. PIPs and PPOs were assessed using the American Geriatrics Society (AGS)/Beers and Screening Tool of Older Persons' Prescriptions (STOPP)/Screening Tool to Alert Doctors to Right Treatment (START) criteria. Risk factors for PIPs and PPOs and agreement between AGS/Beers and STOPP/START criteria were statistically analysed. RESULTS: This study included 313 PLWH (median age 72 years), of whom 80.5% were men. PIP prevalence rates were 29.4% and 44.4% based on the AGS/Beers and STOPP criteria, respectively. The concordance between AGS/Beers and STOPP criteria was moderate. Benzodiazepines and proton pump inhibitors were the chronic comedications most commonly involved in PIPs. PPOs were observed in 61.4% of the patients. The leading omissions were insufficient influenza and pneumococcal vaccine coverage and inadequate bone health-related treatments. The number of chronic comedications, female sex, neuropsychiatric disorders, and cancer diagnosis were risk factors for PIPs, whereas osteopenia and osteoporosis were risk factors for PPOs. CONCLUSIONS: A high prevalence of PIPs and PPOs was observed in our cohort of older PLWH. These findings emphasize the importance of comprehensive medication reviews in this population to reduce inappropriate medication use and address their specific and underserved therapeutic needs.

Potentially Inappropriate Prescribing in Older People Living With HIV: A Scoping Review.

BACKGROUND: Antiretroviral therapy has transformed HIV from a progressive and often fatal infection to a chronic disease. Currently, people living with HIV (PLHIV) have near-normal life expectancy; however, they face accelerated ageing and a rise in non-AIDS-defining HIV-associated conditions. Comorbidities increase the number of prescribed drugs and, therefore, the risk of polypharmacy and prescribing potentially inappropriate medications (PIMs). Still, there are no specific tools to identify PIMs in older PLHIV, which opens a pathway to investigate the particularities in the prescription of medication in this population. METHODS: We conducted a scoping review in 5 electronic databases for studies reporting the use of tools to identify PIMs in older PLHIV. No language or date restrictions were applied. To complete the search, abstracts published in the most relevant HIV Conferences and Events in their editions from 2010 to 2022 were screened. RESULTS: Of 50,193 records returned (13,701 of the databases and 36,492 of the Congresses), 39 studies met the inclusion criteria. Most studies were single-centre and conducted in Europe. Twenty-eight studies were cross-sectional, and most researchers used explicit criteria, mainly Beers and STOPP-START criteria, to identify PIMs. CONCLUSIONS: Potentially inappropriate prescribing is frequent among older PLHIV. Explicit conventional tools to identify PIMs in older populations may need to be adapted to tackle the needs of PLHIV. Implicit tools may be more valid, although their use is more time-consuming, and standardization is complex.

Versión en español de los criterios STOPP/START 3. Avances en la detección de la prescripción inapropiada de medicamentos en personas mayores / Spanish version of the STOPP/START 3 criteria: Advances in the detection of inappropriate prescribing medication in the older people

Los criterios STOPP/START son criterios explícitos basados en sistemas fisiológicos que resumen la evidencia sobre problemas de prescripción relevantes clínicamente relacionados con el uso de medicamentos potencialmente inapropiados (criterios STOPP) y con potenciales omisiones de prescripción (criterios START). Las dos versiones anteriores de los criterios STOPP/START se publicaron en 2008 y en 2015, y sus versiones en español, en 2009 y en 2015. En 2023 se acaba de publicar la versión3 de dichos criterios. El objetivo de este artículo es presentar la versión traducida al español, así como revisar la utilización y el impacto que ha tenido la versión2 del año 2015 en nuestro idioma. Se realizó una traducción del inglés al español por profesionales expertos y con alto nivel de inglés de la versión3 de los criterios STOPP/START, que incorporan la evidencia publicada desde abril de 2014 hasta marzo de 2022. Además, se hizo una revisión sistemática de las publicaciones que han usado la traducción española de la versión previa (versión2 de 2015) de los criterios STOPP/START. La nueva versión, presentada en este artículo, cuenta con 190 criterios STOPP/START (133 criterios STOPP y 57 criterios START), lo que supone un aumento del 40% en el número de criterios en comparación con la versión anterior. En la revisión se encontraron 37 estudios (21 observacionales, 11 de intervención y 5 de otro tipo) que han usado la versión española en lugar de la internacional. La versión3 en español de los criterios STOPP/START es una lista explícita actualizada de medicamentos potencialmente inapropiados y posibles omisiones en la prescripción que tienen el objetivo de optimizar la medicación y minimizar las reacciones adversas a los medicamentos durante la revisión de la medicación en las personas mayores, en particular aquellas con multimorbilidad y polifarmacia (AU)

The STOPP/START criteria are explicit physiologic systems-based criteria that summarize evidence on clinically relevant prescribing problems related to the use of potentially inappropriate medications (STOPP criteria) and potential prescribing omissions (START criteria). The two previous versions of the STOPP/START criteria were published in 2008 and 2015, and their Spanish versions in 2009 and 2015. Version3 of these criteria has just been published in 2023. The aim of this article is to present the Spanish translated version, and to review the use and impact that version2 of 2015 has had in our language. A translation from English to Spanish was performed by expert professionals with a high level of English of version3 of the STOPP/START criteria, which incorporates the evidence published from April 2014 to March 2022. In addition, a systematic review of publications that have used the Spanish translation of the previous version (version2 of 2015) of the STOPP/START criteria was performed. The new version, presented in this article, has 190 STOPP/START criteria (133 STOPP criteria and 57 START criteria), which is a 40% increase in the number of criteria compared to the previous version. The review found 37 studies (21 observational, 11 interventional and 5 other) that used the Spanish version instead of the international version. The Spanish version 3 of the STOPP/START criteria is an updated explicit list of potentially inappropriate medications and possible omissions in prescribing that aims to optimize medication and minimize adverse drug reactions during medication review in the elderly, particularly those with multimorbidity and polypharmacy (AU)

[Spanish version of the STOPP/START 3 criteria: Advances in the detection of inappropriate prescribing medication in the older people]. / Versión en español de los criterios STOPP/START 3. Avances en la detección de la prescripción inapropiada de medicamentos en personas mayores.

The STOPP/START criteria are explicit physiologic systems-based criteria that summarize evidence on clinically relevant prescribing problems related to the use of potentially inappropriate medications (STOPP criteria) and potential prescribing omissions (START criteria). The two previous versions of the STOPP/START criteria were published in 2008 and 2015, and their Spanish versions in 2009 and 2015. Version3 of these criteria has just been published in 2023. The aim of this article is to present the Spanish translated version, and to review the use and impact that version2 of 2015 has had in our language. A translation from English to Spanish was performed by expert professionals with a high level of English of version3 of the STOPP/START criteria, which incorporates the evidence published from April 2014 to March 2022. In addition, a systematic review of publications that have used the Spanish translation of the previous version (version2 of 2015) of the STOPP/START criteria was performed. The new version, presented in this article, has 190 STOPP/START criteria (133 STOPP criteria and 57 START criteria), which is a 40% increase in the number of criteria compared to the previous version. The review found 37 studies (21 observational, 11 interventional and 5 other) that used the Spanish version instead of the international version. The Spanish version 3 of the STOPP/START criteria is an updated explicit list of potentially inappropriate medications and possible omissions in prescribing that aims to optimize medication and minimize adverse drug reactions during medication review in the elderly, particularly those with multimorbidity and polypharmacy. With this new version, the original criteria are intended to be more widely disseminated within the Spanish-speaking healthcare community. The Spanish version2 of the STOPP/START has been widely used, so we consider that the translation into Spanish has helped to improve pharmacotherapy in older patients with polypharmacy and multimorbidity in our linguistic environment.

HIV and HCV screening by non-infectious diseases physicians: can we improve testing and hidden infection rates?

Background: Missed opportunities for Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV) testing remain high. We aimed to ascertain the knowledge of screening guidelines and attitudes of non-infectious disease (ID) hospital physicians and assess the impact of a 1-h session on screening rates and diagnoses. Methods: This interventional study consisted of a 1-h training session on HIV and HCV epidemiology and testing guidelines for non-ID physicians. Pre-and post-session questionnaires compared the knowledge of the guidelines and attitudes toward screening before and after the session. Rates of screening and diagnoses were compared in three 6 months periods: before, immediately after, and 24 months ±4 after the session. Results: A total of 345 physicians from 31 departments participated in these sessions. Before the session, 19.9% (28% medical, 8% surgical) and 17.9% (30% medical, 2.7% surgical) were aware of HIV and HCV testing guidelines, respectively. The willingness to routinely test increased from 5.6 to 22%, whereas not ordering tests decreased from 34.1 to 2.4%. HIV screening rates significantly increased by 20% after the session (7.7 vs. 9.3 tests per 103 patients; p < 0.001), and the effect persisted until the long-term period. The HIV diagnosis rate increased globally (3.6 vs. 5.2 HIV diagnoses per 105 patients; p = 0.157), mainly because of medical services (4.7 vs. 7.7 per 105 patients; p = 0.082). The HCV screening rate increased significantly immediately and in the long term only in medical services (15.7 and 13.6%, respectively). The new active HCV infection rates increased immediately and declined steeply thereafter. Conclusion: A short session for non-ID physicians can improve HIV/HCV screening, increase diagnosis, and contribute to disease elimination.

Impact of COVID-19 on the Care of Patients with HIV Infection.

The COVID-19 pandemic and associated lockdown measures have been associated with substantial disruptions to health care services, including screening for human immunodeficiency virus (HIV) and management of people living with HIV (PLWH). Data from 3265 patients were examined in a retrospective cohort study. We compared outpatient follow-up for PLWH, the number of new patients, treatment adherence, hospitalizations, and deaths during the "pandemic period" (March 2020 to February 2021), the "pre-pandemic period" (the equivalent time frame in 2019), and the "post-pandemic period" (March to September 2021). During the pandemic period, the number of new patients seen at the HIV clinic (116) as well as the requested viral load tests (2414) decreased significantly compared to the pre-pandemic (204 and 2831, respectively) and post-pandemic periods (146 and 2640, respectively) (p < 0.01 for all the comparisons). However, across the three study periods, the number of drug refills (1385, 1330, and 1411, respectively), the number of patients with undetectable viral loads (85%, 90%, and 93%, respectively), and the number of hospital admissions among PLWH remained constant. Despite the COVID-19 pandemic's impact, our findings show stability in the retention of clinical care, adherence to treatment, and viral suppression of PLWH, with no significant impact on hospitalization rates or all-cause mortality.

[Sleep disorders related to HIV treatment.] / Trastornos en la calidad del sueño asociados a los inhibidores de la integrasa en el tratamiento del VIH.

OBJECTIVE: HIV Clinical Guidelines have positioned integrase inhibitors recently as first-line treatment. However, two of these drugs have also been associated with adverse side effects on the central nervous system, especially with sleep disturbances. The objective was to analyse the influence of bictegravir and dolutegravir on the sleep quality in HIV patients. METHODS: An observational, cross-sectional study was carried out between December 2020 and January 2021 in HIV patients attended in a pharmacy care clinic. Demographic and adherence variables were collected. Sleep quality was measured using the Pittsburgh questionnaire or PSQI. We classified patients into two groups: patients with bictegravir or dolutegravir in their treatment (study group) and the rest (control group). The influence of the variables collected on the PSQI result was analysed using the Chi-Square test for categorical variables and the student t-test or Mann-Whitney U test for continuous variables. RESULTS: One hundred and nineteen patients were included. 64% in the study group and 67% in the control group suffered from sleep disorders according to the PSQI questionnaire (p=0.788). Neither were statistical differences found when the different components of sleep were analysed between the two groups. CONCLUSIONS: A high percentage of patients, regardless of whether their treatment includes bictegravir or dolutegravir, have problems with their sleep quality. We didn't find a correlation between sleep quality and treatment with bictegravir or dolutegravir compared to the other treatments.

OBJETIVO: Los inhibidores de la integrasa se han posicionado recientemente en todas las Guías Clínicas de VIH como tratamiento antirretroviral de primera línea para el VIH. Sin embargo, dos de estos fármacos se han asociado también a efectos adversos a nivel del sistema nervioso central, concretamente con alteraciones del sueño. El objetivo del trabajo fue analizar la influencia de bictegravir y dolutegravir en la calidad del sueño en personas que viven con VIH (PVIH). METODOS: Se realizó un estudio observacional y transversal entre los meses de diciembre de 2020 y enero de 2021 en las PVIH de las consultas de atención farmacéutica del hospital. Se recogieron variables demográficas y de adherencia. La calidad del sueño se midió mediante el Cuestionario de Pittsburgh o PSQI. Las PVIH se clasificaron en 2 grupos: el grupo estudio, constituido por participantes con bictegravir o dolutegravir en su tratamiento, y el grupo control, integrado por el resto de PVIH. Se analizó la influencia de las variables recogidas sobre el resultado del PSQI mediante la prueba de chi cuadrado/odds ratio para variables categóricas y el de t de Student o U de Mann Whitney para variables continuas. RESULTADOS: Se incluyeron 119 PVIH, de las cuales un 64% en el grupo estudio y un 67% en el grupo control sufrían trastornos del sueño según el PSQI (p=0,788). Tampoco hubo diferencias estadísticamente significativas cuando se compararon los diferentes componentes del sueño entre los dos grupos. CONCLUSIONES: Un elevado porcentaje de PVIH, independientemente de si el TAR incluye bictegravir o dolutegravir, tienen problemas relacionados con la calidad del sueño. No se encuentra correlación entre la calidad del sueño y el tratamiento con bictegravir o dolutegravir comparado con el resto de tratamientos.

Trastornos en la calidad del sueñoasociados a los inhibidores dela integrasa en el tratamiento del VIH / Sleep disorders related to HIV treatment

FUNDAMENTOS: Los inhibidores de la integrasa se han posicionado recientemente en todas las Guías Clínicas de VIH como tratamiento antirretroviral de primera línea para el VIH. Sin embargo, dos de estos fármacos se han asociado también a efectos adversos a nivel del sistema nervioso central, concretamente con alteraciones del sueño. El objetivo del trabajo fue analizar la influencia de bictegravir y dolutegravir en la calidad del sueño en personas que viven con VIH (PVIH). MÉTODOS: Se realizó un estudio observacional y transversal entre los meses de diciembre de 2020 y enero de 2021 en las PVIH de las consultas de atención farmacéutica del hospital. Se recogieron variables demográficas y de adherencia. La calidad del sueño se midió mediante el Cuestionario de Pittsburgh o PSQI. Las PVIH se clasificaron en 2 grupos: el grupo estudio, constituido por participantes con bictegravir o dolutegravir en su tratamiento, y el grupo control, integrado por el resto de PVIH. Se analizó la influencia de las variables recogidas sobre el resultado del PSQI mediante la prueba de chi cuadrado/odds ratio para variables categóricas y el de t de Student o U de Mann Whitney para variables continuas. RESULTADOS: Se incluyeron 119 PVIH, de las cuales un 64% en el grupo estudio y un 67% en el grupo control sufrían trastornos del sueño según el PSQI (p=0,788). Tampoco hubo diferencias estadísticamente significativas cuando se compararon los diferentes componentes del sueño entre los dos grupos. CONCLUSIONES: Un elevado porcentaje de PVIH, independientemente de si el TAR incluye bictegravir o dolutegravir, tienen problemas relacionados con la calidad del sueño. No se encuentra correlación entre la calidad del sueño y el tratamiento con bictegravir o dolutegravir comparado con el resto de tratamientos.(AU)

BACKGROUND: HIV Clinical Guidelines have positioned integrase inhibitors recently as first-line treatment. However, two of these drugs have also been associated with adverse side effects on the central nervous system, especially with sleep disturbances. The objective was to analyse the influence of bictegravir and dolutegravir on the sleep quality in HIV patients. METHODS: An observational, cross-sectional study was carried out between December 2020 and January 2021 in HIV patients attended in a pharmacy care clinic. Demographic and adherence variables were collected. Sleep quality was measured using the Pittsburgh questionnaire or PSQI. We classified patients into two groups: patients with bictegravir or dolutegravir in their treatment (study group) and the rest (control group). The influence of the variables collected on the PSQI result was analysed using the Chi-Square test for categorical variables and the student t-test or Mann-Whitney U test for continuous variables. RESULTS: One hundred and nineteen patients were included. 64% in the study group and 67% in the control group suffered from sleep disorders according to the PSQI questionnaire (p=0.788). Neither were statistical differences found when the different components of sleep were analysed between the two groups. CONCLUSIONS: A high percentage of patients, regardless of whether their treatment includes bictegravir or dolutegravir, have problems with their sleep quality. We didn’t find a correlation between sleep quality and treatment with bictegravir or dolutegravir compared to the other treatments.(AU)

The Negative Impact of COVID-19 in HCV, HIV, and HPV Surveillance Programs During the Different Pandemic Waves.

Background: The coronavirus disease 2019 (COVID-19) pandemic has been a worldwide stress test for health systems. 2 years have elapsed since the description of the first cases of pneumonia of unknown origin. This study quantifies the impact of COVID-19 in the screening program of chronic viral infections such as human papillomavirus (HPV), human immunodeficiency virus (HIV), and hepatitis C virus (HCV) along the six different pandemic waves in our population. Each wave had particular epidemiological, biological, or clinical patterns. Methods: We analyzed the number of samples for screening of these viruses from March 2020 to February 2022, the new infections detected in the pandemic period compared to the previous year, the time elapsed between diagnosis and linking to treatment and follow-up of patients, and the percentage of late HIV diagnosis. Moreover, we used the origin of the samples as a marker for quantifying the restoration of activity in primary care. Results: During the first pandemic year, the number of samples received was reduced by 26.7, 22.6, and 22.5% for molecular detection of HPV or serological HCV and HIV status respectively. The highest decrease was observed during the first wave with 70, 40, and 26.7% for HPV, HCV, and HIV. As expected, new diagnoses also decreased by 35.4, 58.2, and 40.5% for HPV, HCV, and HIV respectively during the first year of the pandemic. In the second year of the pandemic, the number of samples remained below pre-pandemic period levels for HCV (-3.6%) and HIV (-9.3%) but was slightly higher for HPV (8.0%). The new diagnoses in the second year of the pandemic were -16.1, -46.8, and -18.6% for HPV, HCV, and HIV respectively. Conclusions: Undoubtedly, an important number of new HPV, HCV, and HIV infections were lost during the COVID-19 pandemic, and surveillance programs were disrupted as a consequence of collapse of the health system. It is a priority to reinforce these surveillance programs as soon as possible in order to detect undiagnosed cases before the associated morbidity-mortality increases. New pandemic waves could increase the risk of reversing the achievements made over the last few decades.

Clinical Impact of the Capacity-Motivation-Opportunity Pharmacist-Led Intervention in People Living with HIV in Spain, 2019-2020.

Background: People living with HIV (PLWH) have significantly enhanced their life expectancy. Consequently, age-associated comorbidities and related health conditions are increasingly found in PLWH complicating their clinical management. Objective: To determine the effect of the capacity-motivation-opportunity (CMO) structured pharmaceutical care intervention for improving clinical health-care results frequently associated to PLWH. Methods: Multicenter, prospective, pre-post intervention study evaluating the CMO pharmacist-led program in adult PLWH was conducted between September 2019 and September 2020 with six months of follow-up. The primary objective of this study was to determine differences in clinical outcomes (total cholesterol, triglycerides, HDL, blood pressure and glycosylated hemoglobin) and variation in the patient's activation measure before and after the intervention. Results: A total of 61 patients were included, 72% were men with a median age of 53 years. After the implementation of the pharmacist-driven program, the percentage of patients with high levels of total cholesterol decreased significantly (18% to 4.9%; p < 0.001). Similarly, the prevalence of patients with high levels of triglycerides, HDL or with hypertension was significantly lower post intervention (13.1% to 6.6%, p < 0.001; 47.5% to 6.6%, p = 0.019 and 24% to 4%, p = 0.009, respectively). The number of patients who achieved the highest activation level increased from 69% to 77.6% (p < 0.001). Conclusion: The CMO program resulted in significantly better health outcomes during the six months following the pharmacist-led intervention as well as improved activation in PLWH.

Safety and tolerability of inhaled antibiotics in patients with bronchiectasis.

INTRODUCTION: Bronchiectasis is typically treated with inhaled antibiotics in clinical practice. However, there is a striking lack of standardised procedures for the preparation of noncommercial solutions. We used biochemical parameters to analyse the safety and tolerability of inhaled antibiotics in patients with bronchiectasis, and determined potential associations between the inhaled antibiotics used and adherence to the medications and quality of life. METHODS: We conducted a literature review, biochemical testing, and a pilot study of patients admitted to our hospital with noncystic fibrosis bronchiectasis. The MEDLINE database was searched for studies involving inhaled antibiotics to treat bronchiectasis. We analysed the pH, osmolality, and sodium and chloride ion concentrations of the antibiotics used. The pilot study included patients receiving inhaled antibiotic treatment. Demographic data, adherence, and quality of life were recorded and assessed. We determined potential associations between the study variables. RESULTS: The literature review identified 429 articles: 106 included precise instructions for diluting antibiotics, and 18 reported data on the biochemical parameters analysed. Laboratory results showed that some antibiotic dilutions were outside the range of tolerability, especially those involving dry powders for intravenous infusion, which must be diluted for their inhalation. Adherence was good in more than 80% of the patients, and higher in men and older patients. Men reported better quality of life. No associations were found between the antibiotics used and the other variables. CONCLUSION: Regarding the biochemical parameters analysed, there is a lack of information on the tolerability and biochemical safety of noncommercial dilutions of inhaled antibiotics used to treat bronchiectasis.

Application of the CMO methodology to the improvement of primary adherence to concomitant medication in people living with-HIV. The PRICMO Project.

OBJECTIVE: To determine the effectiveness of a pharmaceutical care intervention based on the CMO methodology (Capacity, Motivation  and Opportunity) in improving primary adherence to concomitant  treatment in HIV+ patients on antiretroviral treatment. METHOD: This was a longitudinal prospective multicenter study carried out  between September 2019 and September 2020, which included HIV+  patients older than 18 years who were on antiretroviral treatment and  were taking concomitant medications. Demographic, clinical, and pharmacotherapeutic variables were collected. As required by the CMO methodology, all patients were followed for 6 months and stratified  into three levels of care. Individualized pharmaceutical care was provided according to the interventions established for each level. At every consultation, a motivational interview was conducted based on each  patient's alignment with and achievement of their pharmacotherapeutic  objectives. A website was developed to deal with the opportunity pillar.  The main variable was the percentage of patients considered primary  adherents to the prescribed concomitant medication. Adherence over the  six months prior to the study was compared to adherence at the end of the study. Additionally, the percentage of patients considered secondary  adherents to concomitant treatment and antiretroviral treatment during  the 6 months prior to the start of the study was compared to the  percentage of such patients at the end of the study. Adherence was  measured based on dispensation records and specific validated  questionnaires. Patients were only considered adherent if they were  deemed adherent by both methods. RESULTS: A total of 61 patients were included in the study, 72% male. Median age was 53 years and the median number of concomitant drugs prescribed was 7. A total of 60.6% of patients were polymedicated. The percentage of patients considered primary non-adherent was 52.5% at baseline (n = 32) and 4.9% (n = 3, p < 0.001) at the end of the study. Secondary adherence to both concomitant medication (41.6% vs 88.3%) and antiretroviral treatment (85.2% vs 95.1%) improved at the end of the study (p < 0.0001). CONCLUSIONS: Pharmaceutical care based on the CMO methodology significantly improved both primary and secondary  dherence to concomitant drugs and to antiretroviral treatment.

Objetivo: Determinar la efectividad de una intervención farmacéutica, basada en la metodología CMO (Capacidad, Motivación,  portunidad), para mejorar la adherencia primaria al tratamiento  concomitante en pacientes VIH+ en tratamiento antirretroviral.Método: Estudio longitudinal, prospectivo, multicéntrico, realizado entre septiembre de 2019 y septiembre de 2020. Se incluyeron pacientes VIH+ mayores de 18 años, en tratamiento antirretroviral y  prescripción de fármacos concomitantes. Se recogieron variables  demográficas, clínicas y farmacoterapéuticas. Se realizó atención  farmacéutica durante 6 meses según el modelo CMO en cada paciente,  basado en su nivel de estratificación y las intervenciones establecidas para cada umbral. En cada consulta se realizó una entrevista motivacional  basada en el alcance de los objetivos farmacoterapéuticos para cada  paciente. Para desarrollar el pilar de oportunidad se creó y desarrolló la  web: www.proyecto-pricmo.com. La variable principal fue el porcentaje de  pacientes considerados adherentes primarios a la medicación concomitante  prescrita, comparando los 6 meses previos al estudio, frente al mismo valor al finalizar el estudio. Adicionalmente, se comparó el  porcentaje de pacientes adherentes secundarios al tratamiento  concomitante y al tratamiento antirretroviral durante los 6 meses previos  al inicio del estudio frente al mismo valor en los pacientes al finalizar el  estudio. Para medir la adherencia se consideraron dos métodos: registros  y cuestionarios validados específicos. Solo se consideraron adherentes si lo fueron a ambos métodos.Resultados: Se incluyeron 61 pacientes. El 72,0% fueron hombres, con una mediana de edad de 53 años. La mediana de fármacos  oncomitantes fue de 7. El 60,6% de los pacientes tenían presencia de  polifarmacia. El porcentaje de pacientes considerados no adherentes  primarios basalmente fue del 52,5% (n = 32), mientras que a la  finalización fue del 4,9% (n = 3, p < 0,001). Tanto la adherencia  secundaria a la medicación concomitante (41,6% versus 88,3%) como al  tratamiento antirretroviral (85,2% versus 95,1%) mejoraron al finalizar el  estudio (p < 0,001).Conclusiones: La intervención farmacéutica basada en la metodología CMO mejoró significativamente tanto la adherencia primaria  como secundaria a la medicación concomitante y la secundaria al  tratamiento antirretroviral.

Intervención farmacéutica basada en la metodología CMO para la mejora de la adherencia primaria a la medicación concomitante en pacientes con infección por VIH: Proyecto PRICMO / Application of the CMO methodology to the improvement of primary adherence to concomitant medication in people living with-HIV. The PRICMO Project

Objetivo: Determinar la efectividad de una intervención farmacéutica,basada en la metodología CMO (Capacidad, Motivación, Oportunidad), para mejorar la adherencia primaria al tratamiento concomitante enpacientes VIH+ en tratamiento antirretroviral.Método: Estudio longitudinal, prospectivo, multicéntrico, realizado entreseptiembre de 2019 y septiembre de 2020. Se incluyeron pacientesVIH+ mayores de 18 años, en tratamiento antirretroviral y prescripción defármacos concomitantes. Se recogieron variables demográficas, clínicasy farmacoterapéuticas. Se realizó atención farmacéutica durante 6 mesessegún el modelo CMO en cada paciente, basado en su nivel de estratificación y las intervenciones establecidas para cada umbral. En cadaconsulta se realizó una entrevista motivacional basada en el alcance de losobjetivos farmacoterapéuticos para cada paciente. Para desarrollar el pilarde oportunidad se creó y desarrolló la web: www.proyecto-pricmo.com. a variable principal fue el porcentaje de pacientes considerados adherentes primarios a la medicación concomitante prescrita, comparandolos 6 meses previos al estudio, frente al mismo valor al finalizar el estudio. Adicionalmente, se comparó el porcentaje de pacientes adherentessecundarios al tratamiento concomitante y al tratamiento antirretroviraldurante los 6 meses previos al inicio del estudio frente al mismo valor enlos pacientes al finalizar el estudio. Para medir la adherencia se consideraron dos métodos: registros y cuestionarios validados específicos. Solose consideraron adherentes si lo fueron a ambos métodos. (AU)

Objective: To determine the effectiveness of a pharmaceutical careintervention based on the CMO methodology (Capacity, Motivation andOpportunity) in improving primary adherence to concomitant treatment inHIV+ patients on antiretroviral treatment.Method: This was a longitudinal prospective multicenter study carriedout between September 2019 and September 2020, which includedHIV+ patients older than 18 years who were on antiretroviral treatmentand were taking concomitant medications. Demographic, clinical, andpharmacotherapeutic variables were collected. As required by the CMOmethodology, all patients were followed for 6 months and stratified intothree levels of care. Individualized pharmaceutical care was providedaccording to the interventions established for each level. At every consultation, a motivational interview was conducted based on each patient’salignment with and achievement of their pharmacotherapeutic objectives. A website was developed to deal with the opportunity pillar. The mainvariable was the percentage of patients considered primary adherents tothe prescribed concomitant medication. Adherence over the six monthsprior to the study was compared to adherence at the end of the study.Additionally, the percentage of patients considered secondary adherentsto concomitant treatment and antiretroviral treatment during the 6 monthsprior to the start of the study was compared to the percentage of suchpatients at the end of the study. Adherence was measured based ondispensation records and specific validated questionnaires. Patients wereonly considered adherent if they were deemed adherent by both methods. (AU)

Healthcare failure mode and effect analysis in the chemotherapy preparation process.

PURPOSE: To conduct a Health Care Failure Mode and Effects Analysis (HFMEA) of the chemotherapy preparation process to identify the steps with the potential to cause errors, and to develop further strategies to improve the process and thus minimize the risk of errors. METHODS: An HFMEA was conducted to identify and reduce preparation errors during the chemotherapy preparation process. A multidisciplinary team mapped the preparation process, formally identified all the steps, and then conducted a brainstorming session to determine potential failure modes and their potential effects. A severity and probability score for each failure mode, a hazard score (HS) and a total HS were calculated. A hazard analysis was conducted for each HS equal to or more than 8. Finally, an action plan was identified for each failure mode. After the action plan was implemented, failure modes were revaluated and a new HS score was calculated as well as the percentage decrease in risk. RESULTS: The team identified five main steps in the chemotherapy preparation process and nine potential failure modes. After implementing the control measures, all the HSs decreased. The total HS associated with the chemotherapy preparation process decreased from 54 to 26 (-52%). This reduction in the total HS was mainly achieved by updating the Standard Operating Procedures (SOPs) and implementing bar code and gravimetric control system. CONCLUSION: The application of HFMEA to the chemotherapy preparation process in centralized chemotherapy units can be very useful in identifying actions aimed at reducing errors in the healthcare setting.

Prevention of adverse drug reactions in hospitalized older patients with multi-morbidity and polypharmacy: the SENATOR* randomized controlled clinical trial.

BACKGROUND: Multi-morbidity and polypharmacy increase the risk of non-trivial adverse drug reactions (ADRs) in older people during hospitalization. Despite this, there are no established interventions for hospital-acquired ADR prevention. METHODS: We undertook a pragmatic, multi-national, parallel arm prospective randomized open-label, blinded endpoint (PROBE) controlled trial enrolling patients at six European medical centres. We randomized 1,537 older medical and surgical patients with multi-morbidity and polypharmacy on admission in a 1:1 ratio to SENATOR software-guided medication optimization plus standard care (intervention, n = 772, mean number of daily medications = 9.34) or standard care alone (control, n = 765, mean number of daily medications = 9.23) using block randomization stratified by site and admission type. Attending clinicians in the intervention arm received SENATOR-generated advice at a single time point with recommendations they could choose to adopt or not. The primary endpoint was occurrence of probable or certain ADRs within 14 days of randomization. Secondary endpoints were primary endpoint derivatives; tertiary endpoints included all-cause mortality, re-hospitalization, composite healthcare utilization and health-related quality of life. RESULTS: For the primary endpoint, there was no difference between the intervention and control groups (24.5 vs. 24.8%; OR 0.98; 95% CI 0.77-1.24; P = 0.88). Similarly, with secondary and tertiary endpoints, there were no significant differences. Among attending clinicians in the intervention group, implementation of SENATOR software-generated medication advice points was poor (~15%). CONCLUSIONS: In this trial, uptake of software-generated medication advice to minimize ADRs was poor and did not reduce ADR incidence during index hospitalization.

Satisfaction and knowledge among patients with HIV after switching from tenofovir to tenofovir alafenamide in regimens containing emtricitabine and rilpivirine / [Grado de satisfacción y conocimiento de pacientes positivos para HIV ante el cambio de tenofovir a tenofovir-alafenamida en tratamientos con emtricitabina y rilpivirina].

Introduction: Satisfaction and knowledge among patients with HIV after switching from tenofovir to tenofovir/alafenamide remain unexplored. Given that both parameters are associated with better health outcomes it is relevant to measure them in patients during routine clinical practice. Objective: To evaluate the degree of knowledge and satisfaction in patients who had their antiretroviral regimen switched from rilpivirine (RPV)/emtricitabine (FTC)/TDF to RPV/FTC/TAF. Materials and methods: We conducted a prospective study in a third-level hospital between September, 2018, and November, 2018. We included patients who had previously been treated with RPV/FTC/TDF and collected their RPV/FTC/TAF treatment in the second visit. A 5-point Likert-type agreement/disagreement scale was used to assess satisfaction and knowledge regarding the medication switch. Results: We included 116 patients in the study of whom 75% were satisfied and 64% had a high-level of knowledge. Young patients were less satisfied with the way in which the change was explained (p=0.0487). Concerning the new medication, the patients were better informed about its renal (85% of them) and bone benefits (82%) than about its adverse effects on the lipid profile (40%). Conclusions: The patients were generally satisfied with the change in medication and well nformed about the dosage and advantages of TAF over TDF, but less well informed about the possible adverse effects of TAF.

Introducción. La satisfacción y el conocimiento del cambio de tenofovir por tenofovir-alafenamida en pacientes con HIV no se han estudiado aún. Estos dos parámetros se relacionan con mejores resultados en salud y, por lo tanto, es importante medirlos durante la práctica clínica habitual. Objetivo. Evaluar el grado de conocimiento y satisfacción de los pacientes positivos para HIV ante el cambio de tratamiento antirretroviral con rilpivirina, emtricitabina y tenofovir (RPV-FTC-TDF) por rilpivirina, emtricitabina y tenofovir-alafenamida (RPV-FTC-TAF). Materiales y métodos. Se llevó a cabo un estudio prospectivo en un hospital de tercer nivel entre los meses de septiembre y noviembre de 2018. Se incluyeron pacientes previamente tratados con RPV-FTC-TDF que acudían por segunda vez a consulta para recibir el tratamiento con RPV-FTC-TAF. La satisfacción y el grado de conocimiento se analizaron mediante nueve preguntas, usando una escala de tipo Likert de 5 puntos para evaluar el grado de acuerdo. Resultados. Se incluyeron 116 pacientes en el estudio. El 75 % de ellos se mostró satisfecho con el cambio y se consideró que el 64 % conocía lo que implicaba. Los pacientes jóvenes se mostraron menos satisfechos con el modo en que se les explicó el cambio (p=0,0487). Los pacientes estaban mejor informados sobre las ventajas renales (85 % de conocimiento) y óseas (82 %) de la nueva medicación, que sobre sus inconvenientes para el perfil lipídico (40 %). Conclusiones. En general, los pacientes se mostraron satisfechos con el cambio de medicación y conocían la posología del medicamento y las ventajas de la tenofovir-alafenamida frente al tenofovir, pero no sus posibles efectos adversos.

Grado de satisfacción y conocimiento de pacientes positivos para HIV ante el cambio de tenofovir a tenofovir-alafenamida en tratamientos con emtricitabina y rilpivirina / Satisfaction and knowledge among patients with HIV after switching from tenofovir to tenofovir alafenamide in regimens containing emtricitabine and rilpivirine

Introducción. La satisfacción y el conocimiento del cambio de tenofovir por tenofovir- alafenamida en pacientes con HIV no se han estudiado aún. Estos dos parámetros se relacionan con mejores resultados en salud y, por lo tanto, es importante medirlos durante la práctica clínica habitual. Objetivo. Evaluar el grado de conocimiento y satisfacción de los pacientes positivos para HIV ante el cambio de tratamiento antirretroviral con rilpivirina, emtricitabina y tenofovir (RPV-FTC-TDF) por rilpivirina, emtricitabina y tenofovir-alafenamida (RPV-FTC-TAF). Materiales y métodos. Se llevó a cabo un estudio prospectivo en un hospital de tercer nivel entre los meses de septiembre y noviembre de 2018. Se incluyeron pacientes previamente tratados con RPV-FTC-TDF que acudían por segunda vez a consulta para recibir el tratamiento con RPV-FTC-TAF. La satisfacción y el grado de conocimiento se analizaron mediante nueve preguntas, usando una escala de tipo Likert de 5 puntos para evaluar el grado de acuerdo. Resultados. Se incluyeron 116 pacientes en el estudio. El 75 % de ellos se mostró satisfecho con el cambio y se consideró que el 64 % conocía lo que implicaba. Los pacientes jóvenes se mostraron menos satisfechos con el modo en que se les explicó el cambio (p=0,0487). Los pacientes estaban mejor informados sobre las ventajas renales (85 % de conocimiento) y óseas (82 %) de la nueva medicación, que sobre sus inconvenientes para el perfil lipídico (40 %). Conclusiones. En general, los pacientes se mostraron satisfechos con el cambio de medicación y conocían la posología del medicamento y las ventajas de la tenofovir- alafenamida frente al tenofovir, pero no sus posibles efectos adversos.

Introduction: Satisfaction and knowledge among patients with HIV after switching from tenofovir to tenofovir/alafenamide remain unexplored. Given that both parameters are associated with better health outcomes it is relevant to measure them in patients during routine clinical practice. Objective: To evaluate the degree of knowledge and satisfaction in patients who had their antiretroviral regimen switched from rilpivirine (RPV)/emtricitabine (FTC)/TDF to RPV/FTC/TAF. Materials and methods: We conducted a prospective study in a third-level hospital between September, 2018, and November, 2018. We included patients who had previously been treated with RPV/FTC/TDF and collected their RPV/FTC/TAF treatment in the second visit. A 5-point Likert-type agreement/disagreement scale was used to assess satisfaction and knowledge regarding the medication switch. Results: We included 116 patients in the study of whom 75% were satisfied and 64% had a high-level of knowledge. Young patients were less satisfied with the way in which the change was explained (p=0.0487). Concerning the new medication, the patients were better informed about its renal (85% of them) and bone benefits (82%) than about its adverse effects on the lipid profile (40%). Conclusions: The patients were generally satisfied with the change in medication and well informed about the dosage and advantages of TAF over TDF, but less well informed about the possible adverse effects of TAF.

Interacciones de cobicistat y ritonavir en pacientes con VIH y sus consecuencias clínicas / Interactions of cobicistat and ritonavir in patients with HIV and its clinical consequences

INTRODUCCIÓN: La prescripción de tratamiento antirretroviral (TAR) que contiene potenciadores farmacocinéticos como ritonavir y cobicistat es frecuente. El objetivo de este estudio fue analizar las interacciones potenciales del TAR que incluyen estas moléculas en su formulación con la medicación domiciliaria del paciente, así como el manejo clínico de aquellas potencialmente graves. MÉTODOS: Estudio prospectivo en la consulta de atención farmacéutica de un hospital de tercer nivel entre enero y diciembre de 2018. Se incluyeron en el estudio aquellos pacientes VIH + con un TAR que contuviera cobicistat o ritonavir. Se analizaron las interacciones potenciales entre el TAR y la medicación concomitante en tres bases de datos (Micromedex(R), Drugs.com y Liverpool), se detallaron las intervenciones realizadas, y se analizaron las reacciones adversas encontradas. RESULTADOS: Se incluyeron 968 pacientes con un total de 2.148 prescripciones (274 principios activos diferentes). Se realizaron un total de 86 intervenciones relativas a interacciones potenciales en los pacientes. Las más frecuentes fueron sustituciones de tratamientos corticoideos, supensiones de tratamiento y monitorizaciones más estrechas. Se analizaron un total de doce sospechas de reacción adversa. El grado de concordancia en la clasificación de la gravedad de las interacciones para cobicistat y ritonavir fue buena entre las tres bases de datos. Resultó destacable Micromedex(R) como la más completa por tener más principios activos registrados. CONCLUSIÓN: Las interacciones entre el TAR con potenciadores farmacocinéticos en su composición y la medicación concomitante es frecuente y requiere de una importante variedad de intervenciones. El chequeo de interacciones en distintas bases de datos es recomendable ya que pueden ocasionar reacciones adversas a medicamentos

INTRODUCTION: The prescription of antiretroviral treatment (ART) that contains pharmacokinetic enhancers such as ritonavir and cobicistat is frequent. The objective of this stdy was to analyze the potential interactions of ART that include these molecules in their formulation with the patient's home medication, as well as the clinical management of those potentially serious. METHODS: Prospective study conducted in the pharmacy care clinic of a third level hospital between January and December of 2018. Those HIV+patients with an ART containing cobicistat or ritonavir were included in the study. Potential interactions between ART and concomitant medication were analysed in three databases (Micromedex(R), Drugs.com and Liverpool), the interventions carried out were detailed, and adverse drug reactions analysed. RESULTS: 968 patients were included with a total of 2,148 prescriptions (274 different medications). A total of 86 interventions were performed regarding potential interactions in patients. The most frequent were substitutions of corticoid treatments, treatment suspensions and closer monitoring of treatments. A total of possible adverse drug reactions were analysed. The degree of agreement in the severity classification of the interactions for cobicistat and ritonavir was good among the three databases. It was remarkable Micromedex(R) as the most complete because it has more registered medications. CONCLUSIÓN: The interactions between ART with pharmacokinetic enhancers in its composition and concomitant medication is frequent and requires a significant variety of interventions. The check of interactions in different databases is recommended since they can cause adverse drug reactions