Acuerdo de riesgo compartido basado en resultados de salud para el tratamiento de psoriasis moderada-grave con certolizumab pegol / Risk-sharing agreement based on health outcomes for the treatment of moderate-severe psoriasis with certolizumab pegol

Objetivo: aportar evidencia de la efectividad de certolizumab pegol (CZP) en la práctica clínica real en pacientes adultos afectados por psoriasis (PsO) en placas moderada-grave, dentro del contexto de un acuerdo de riesgo compartido (ARC). Métodos: estudio observacional retrospectivo a partir de las variables recogidas en un ARC en los pacientes adultos con PsO en placas moderada-grave tratados con CZP. Participaron 10 hospitales españoles donde se estableció el ARC. Se evaluó el porcentaje de pacientes que alcanzaron la respuesta clínica objetivo del ARC en la visita de seguimiento (semana 16): valor de Psoriasis Area and Severity Index (PASI) absoluto ≤3 para la población naive a biológicos, y ≤5 ante el fracaso previo a un único fármaco biológico. Además, se analizó la mejora en la puntuación de otras escalas: Body Surface Area (BSA), Dermatology Life Quality Index (DLQI), Physician’s Global Assesment (PGA) y Nail Psoriasis Severity Index (NAPSI). Se realizó un análisis descriptivo del total de la población y por subgrupos de pacientes (naive vs. no naive a biológico, hombre vs. mujer, y con vs. sin interrupción). Resultados: se incluyeron 66 pacientes, 12 hombres y 54 mujeres. El 90,9% alcanzaron la respuesta clínica objetivo, con una reducción media de 8 (−78,4%) puntos de PASI absoluto. Se observó una mejora en BSA, PGA, NAPSI y DLQI, con una reducción de 11,3 (−80,6%), 1,9 (−65,5%), 3,3 (−30,7%) y 9,0 (−66,4%) puntos del valor absoluto, respectivamente. Pese a no alcanzar el objetivo terapéutico establecido en el ARC en 6 pacientes (9%) (el coste del fármaco fue asumido por el laboratorio), solo 2 (3%) interrumpieron el tratamiento. Conclusión: nuestro estudio muestra que CZP resulta efectivo en la práctica clínica real en los pacientes con PsO en placas moderada-grave con una mejora de PASI absoluto y DLQI, así como de otras escalas, tanto para el total de la población como en los subgrupos analizados...(AU)

Objective: To provide evidence of the effectiveness of certolizumab pegol (CZP) in real clinical practice in adult patients with moderate-to-severe plaque psoriasis (PsO) in the context of a risk-sharing agreement (RSA). Methods: Retrospective observational study based on variables collected in the RSA for treatment with CZP of adult patients with moderate-severe plaque PsO. Ten Spanish hospitals where the RSA was implemented participated. The percentage of patients who achieved the target clinical response of the RSA at the follow-up visit (week 16) was evaluated: absolute Psoriasis Area and Severity Index (PASI) value ≤3 for biologic naïve population, and ≤5 in case of previous failure to a single biologic drug. In addition, the improvement in the scores of other scales included in the study was analyzed: Body Surface Area (BSA), Dermatology Life Quality Index (DLQI), Physician's Global Assessment (PGA), and Nail Psoriasis Severity Index (NAPSI). A descriptive analysis was performed for the total population and by patient subgroups (naive vs. non-naive to biologic, male vs. female, and with vs. without discontinuation). Results: Sixty-six patients were included, 12 men and 54 women. 90.9% achieved the target clinical response, with a mean reduction of 8 (−78.4%) absolute PASI points. Improvement was observed in BSA, PGA, NAPSI and DLQI, with a reduction of 11.3 (−80.6%), 1.9 (−65.5%), 3.3 (−30.7%) and 9.0 (−66.4%) absolute value points, respectively. Despite not achieving the therapeutic target set in the RSA in six patients (9%) (the cost of the drug was assumed by the laboratory), only two (3%) discontinued treatment. Conclusion: Our study shows that CZP is effective in real clinical practice in patients with moderate-severe plaque PsO, with an improvement in absolute PASI and DLQI, as well as other scales, both for the total population and in the subgroups analyzed. Nearly 91% of patients reached the therapeutic target fixed in the RSA...(AU)

Risk-sharing agreement based on health outcomes for the treatment of moderate–severe psoriasis with certolizumab pegol / Acuerdo de riesgo compartido basado en resultados de salud para el tratamiento de psoriasis moderada-grave con certolizumab pegol

Objetivo: aportar evidencia de la efectividad de certolizumab pegol (CZP) en la práctica clínica real en pacientes adultos afectados por psoriasis (PsO) en placas moderada-grave, dentro del contexto de un acuerdo de riesgo compartido (ARC). Métodos: estudio observacional retrospectivo a partir de las variables recogidas en un ARC en los pacientes adultos con PsO en placas moderada-grave tratados con CZP. Participaron 10 hospitales españoles donde se estableció el ARC. Se evaluó el porcentaje de pacientes que alcanzaron la respuesta clínica objetivo del ARC en la visita de seguimiento (semana 16): valor de Psoriasis Area and Severity Index (PASI) absoluto ≤3 para la población naive a biológicos, y ≤5 ante el fracaso previo a un único fármaco biológico. Además, se analizó la mejora en la puntuación de otras escalas: Body Surface Area (BSA), Dermatology Life Quality Index (DLQI), Physician’s Global Assesment (PGA) y Nail Psoriasis Severity Index (NAPSI). Se realizó un análisis descriptivo del total de la población y por subgrupos de pacientes (naive vs. no naive a biológico, hombre vs. mujer, y con vs. sin interrupción). Resultados: se incluyeron 66 pacientes, 12 hombres y 54 mujeres. El 90,9% alcanzaron la respuesta clínica objetivo, con una reducción media de 8 (−78,4%) puntos de PASI absoluto. Se observó una mejora en BSA, PGA, NAPSI y DLQI, con una reducción de 11,3 (−80,6%), 1,9 (−65,5%), 3,3 (−30,7%) y 9,0 (−66,4%) puntos del valor absoluto, respectivamente. Pese a no alcanzar el objetivo terapéutico establecido en el ARC en 6 pacientes (9%) (el coste del fármaco fue asumido por el laboratorio), solo 2 (3%) interrumpieron el tratamiento. Conclusión: nuestro estudio muestra que CZP resulta efectivo en la práctica clínica real en los pacientes con PsO en placas moderada-grave con una mejora de PASI absoluto y DLQI, así como de otras escalas, tanto para el total de la población como en los subgrupos analizados...(AU)

Objective: To provide evidence of the effectiveness of certolizumab pegol (CZP) in real clinical practice in adult patients with moderate-to-severe plaque psoriasis (PsO) in the context of a risk-sharing agreement (RSA). Methods: Retrospective observational study based on variables collected in the RSA for treatment with CZP of adult patients with moderate-severe plaque PsO. Ten Spanish hospitals where the RSA was implemented participated. The percentage of patients who achieved the target clinical response of the RSA at the follow-up visit (week 16) was evaluated: absolute Psoriasis Area and Severity Index (PASI) value ≤3 for biologic naïve population, and ≤5 in case of previous failure to a single biologic drug. In addition, the improvement in the scores of other scales included in the study was analyzed: Body Surface Area (BSA), Dermatology Life Quality Index (DLQI), Physician's Global Assessment (PGA), and Nail Psoriasis Severity Index (NAPSI). A descriptive analysis was performed for the total population and by patient subgroups (naive vs. non-naive to biologic, male vs. female, and with vs. without discontinuation). Results: Sixty-six patients were included, 12 men and 54 women. 90.9% achieved the target clinical response, with a mean reduction of 8 (−78.4%) absolute PASI points. Improvement was observed in BSA, PGA, NAPSI and DLQI, with a reduction of 11.3 (−80.6%), 1.9 (−65.5%), 3.3 (−30.7%) and 9.0 (−66.4%) absolute value points, respectively. Despite not achieving the therapeutic target set in the RSA in six patients (9%) (the cost of the drug was assumed by the laboratory), only two (3%) discontinued treatment. Conclusion: Our study shows that CZP is effective in real clinical practice in patients with moderate-severe plaque PsO, with an improvement in absolute PASI and DLQI, as well as other scales, both for the total population and in the subgroups analyzed. Nearly 91% of patients reached the therapeutic target fixed in the RSA...(AU)

Risk-sharing agreement based on health outcomes for the treatment of moderate-severe psoriasis with certolizumab pegol. / Acuerdo de riesgo compartido basado en resultados de salud para el tratamiento de psoriasis moderada-grave con certolizumab pegol.

OBJECTIVE: To provide evidence of the effectiveness of certolizumab pegol (CZP) in real clinical practice in adult patients with moderate-to-severe plaque psoriasis (PsO) in the context of a risk-sharing agreement (RSA). METHODS: Retrospective observational study based on variables collected in the RSA for treatment with CZP of adult patients with moderate-severe plaque PsO. Ten Spanish hospitals where the RSA was implemented participated. The percentage of patients who achieved the target clinical response of the RSA at the follow-up visit (week 16) was evaluated: absolute Psoriasis Area and Severity Index (PASI) value ≤3 for biologic naïve population, and ≤5 in case of previous failure to a single biologic drug. In addition, the improvement in the scores of other scales included in the study was analyzed: Body Surface Area (BSA), Dermatology Life Quality Index (DLQI), Physician's Global Assessment (PGA), and Nail Psoriasis Severity Index (NAPSI). A descriptive analysis was performed for the total population and by patient subgroups (naive vs. non-naive to biologic, male vs. female, and with vs. without discontinuation). RESULTS: Sixty-six patients were included, 12 men and 54 women. 90.9% achieved the target clinical response, with a mean reduction of 8 (-78.4%) absolute PASI points. Improvement was observed in BSA, PGA, NAPSI and DLQI, with a reduction of 11.3 (-80.6%), 1.9 (-65.5%), 3.3 (-30.7%) and 9.0 (-66.4%) absolute value points, respectively. Despite not achieving the therapeutic target set in the RSA in six patients (9%) (the cost of the drug was assumed by the laboratory), only two (3%) discontinued treatment. CONCLUSION: Our study shows that CZP is effective in real clinical practice in patients with moderate-severe plaque PsO, with an improvement in absolute PASI and DLQI, as well as other scales, both for the total population and in the subgroups analyzed. Nearly 91% of patients reached the therapeutic target fixed in the RSA. Implementing this type of agreement can provide a direct or indirect benefit for all the agents involved in the process, providing valuable information for decision-making.

Consensus of Spanish Society of Hospital Pharmacy on optimal medication therapy management of atopic dermatitis / Consenso de la Sociedad Española de Farmacia Hospitalaria en manejo fármacoterapéutico óptimo de la dermatitis atópica

Aim: This study's aims are: 1) To use the Delphi method to determine the level of consensus among hospital pharmacists (HPs) as regards the factors involved in the current approach to patients with atopic dermatitis (AD); 2) To identify potential areas for improvement in hospital pharmacy in terms of dealing with patients with severe AD; and 3) To contribute to adequate pharmaceutical care for patients with AD by drawing up recommendations. Methods: A two-round Delphi survey with participation from HPs from all over Spain. Three theme-based blocks were set out: 1) AD; 2) Management of patients with severe AD in the Hospital Pharmacy setting; and 3) Unmet needs (pathology, patient, treatment and management). Results: The 42 HPs participating reached a consensus in recognising the impact of severe AD on the patients suffering from it, the need to encourage adherence and the recommendations to use scales that take into account the patient's quality of life and indicators of the patient's experience. It has also been demonstrated that it is worthwhile evaluating the results in real clinical practice in consensus with other specialists from the multidisciplinary team. Finally, it is advisable to use drugs that have demonstrated long-term effectiveness and safety for patients with severe AD, given the disease's chronic nature. Conclusions: This Delphi consensus highlights the impact of severe AD on patients, the importance of a multidisciplinary and holistic approach, in which HP play a major role. It also highlights the importance of increased access to new drugs to improve health outcomes. (AU)

Objetivos: Los objetivos de este estudio son: 1) Determinar, mediante el método Delphi, el grado de consenso existente entre los farmacéuticos de hospital (FH) en cuanto a los factores que intervienen en el abordaje actual de los pacientes con dermatitis atópica (DA); 2) Identificar posibles áreas de mejora en la farmacia hospitalaria en cuanto al abordaje de los pacientes con DA grave; y 3) Contribuir a una adecuada atención farmacéutica a los pacientes con DA mediante la elaboración de recomendaciones. Método: Una encuesta Delphi con participación de FHs de toda España. Se establecieron tres bloques temáticos: 1) DA; 2) Manejo de pacientes con DA grave desde Farmacia Hospitalaria; y 3) Necesidades no cubiertas (patología, paciente, tratamiento y manejo). Resultados: Los 42 FHs participantes llegaron a un consenso en el reconocimiento del impacto de la DA grave en los pacientes, la necesidad de fomentar la adherencia y las recomendaciones de utilizar escalas que tengan en cuenta la calidad de vida del paciente e indicadores de la experiencia. También se muestra la conveniencia de evaluar los resultados en la práctica clínica real en consenso con otros especialistas del equipo multidisciplinar. Por último, es aconsejable utilizar fármacos que hayan demostrado eficacia y seguridad a largo plazo para los pacientes con DA grave, dado el carácter crónico de la enfermedad. Conclusiones: Este consenso Delphi pone de manifiesto el impacto de la DA grave en los pacientes, la importancia del abordaje multidisciplinar y holístico, en el que el FH juega un papel de gran importancia. También se resalta la importancia de un mayor acceso a nuevos fármacos que permitan mejorar resultados en salud. (AU)

A computer architecture based on disruptive information technologies for drug management in hospitals.

The drug management currently carried out in hospitals is inadequate due to several factors, such as processes carried out manually, the lack of visibility of the hospital supply chain, the lack of standardized identification of medicines, inefficient stock management, an inability to follow the traceability of medicines, and poor data exploitation. Disruptive information technologies could be used to develop and implement a drug management system in hospitals that is innovative in all its phases and allows these problems to be overcome. However, there are no examples in the literature that show how these technologies can be used and combined for efficient drug management in hospitals. To help solve this research gap in the literature, this article proposes a computer architecture for the whole drug management process in hospitals that uses and combines different disruptive computer technologies such as blockchain, radio frequency identification (RFID), quick response code (QR), Internet of Things (IoT), artificial intelligence and big data, for data capture, data storage and data exploitation throughout the whole drug management process, from the moment the drug enters the hospital until it is dispensed and eliminated.

Consensus of Spanish Society of Hospital Pharmacy on optimal medication therapy management of atopic dermatitis. / [Artículo traducido] Consenso de la Sociedad Española de Farmacia Hospitalaria sobre el manejo fármacoterapéutico óptimo de la dermatitis atópica.

AIM: This study's aims are: 1) To use the Delphi method to determine the level of consensus among HPs as regards the factors involved in the current approach to patients with AD; 2) To identify potential areas for improvement in hospital pharmacy in terms of dealing with patients with severe AD; and 3) To contribute to adequate pharmaceutical care for patients with AD by drawing up recommendations. METHODS: A two-round Delphi survey with participation from HPs from all over Spain. Three theme-based blocks were set out: 1) AD; 2) Management of patients with severe AD in the Hospital Pharmacy setting; and 3) Unmet needs (pathology, patient, treatment and management). RESULTS: The 42 HPs participating reached a consensus in recognizing the impact of severe AD on the patients suffering from it, the need to encourage adherence and the recommendations to use scales that take into account the patient's quality of life and indicators of the patient's experience. It has also been demonstrated that it is worthwhile evaluating the results in real clinical practice in consensus with other specialists from the multidisciplinary team. Finally, it is advisable to use drugs that have demonstrated long-term effectiveness and safety for patients with severe AD, given the disease´s chronic nature. CONCLUSIONS: This Delphi consensus highlights the impact of severe AD on patients, the importance of a multidisciplinary and holistic approach, in which HP play a major role. It also highlights the importance of increased access to new drugs to improve health outcomes.

Consensus of Spanish Society of Hospital Pharmacy on optimal medication therapy management of atopic dermatitis.

AIM: This study's aims are: 1) To use the Delphi method to determine the level of consensus among hospital pharmacists (HPs) as regards the factors involved in the current approach to patients with atopic dermatitis (AD); 2) To identify potential areas for improvement in hospital pharmacy in terms of dealing with patients with severe AD; and 3) To contribute to adequate pharmaceutical care for patients with AD by drawing up recommendations. METHODS: A two-round Delphi survey with participation from HPs from all over Spain. Three theme-based blocks were set out: 1) AD; 2) Management of patients with severe AD in the Hospital Pharmacy setting; and 3) Unmet needs (pathology, patient, treatment and management). RESULTS: The 42 HPs participating reached a consensus in recognising the impact of severe AD on the patients suffering from it, the need to encourage adherence and the recommendations to use scales that take into account the patient's quality of life and indicators of the patient's experience. It has also been demonstrated that it is worthwhile evaluating the results in real clinical practice in consensus with other specialists from the multidisciplinary team. Finally, it is advisable to use drugs that have demonstrated long-term effectiveness and safety for patients with severe AD, given the disease's chronic nature. CONCLUSIONS: This Delphi consensus highlights the impact of severe AD on patients, the importance of a multidisciplinary and holistic approach, in which HP play a major role. It also highlights the importance of increased access to new drugs to improve health outcomes.

Therapeutic Drug Monitoring in Oncohematological Patients: A Fast and Accurate HPLC-UV Method for the Quantification of Nilotinib in Human Plasma and Its Clinical Application.

Nilotinib, a second-generation tyrosine kinase inhibitor, has demonstrated clinical activity in chronic myeloid leukemia. As an exposure-response relationship has been observed for nilotinib, its therapeutic drug monitoring could be a valuable tool in clinical practice. Therefore, the aim of this study was to develop and validate a selective and precise high performance liquid chromatography-ultraviolet method for the measurement of nilotinib in plasma from patients with cancer. After protein precipitation extraction with acetonitrile, nilotinib and rilpivirine were separated using isocratic elution on a Tracer Excel 120 ODS C18 column using a mobile phase consisting of a mixture of potassium dihydrogen phosphate-buffered solution (pH 5.5; 0.037 M)-methanol-acetonitrile (45:45:10, v/v/v), pumped at a flow rate of 1.7 mL·min-1. A wavelength of 254 nm was selected for the quantification of the analyte and the internal standard (IS). The technique was validated following the guidelines for the validation of analytical methods of regulatory agencies (Food and Drug Administration (FDA) and the European Medicines Agency (EMA)). Linearity was established in a concentration range between 125 and 7000 ng/mL. The detection limit was 90 ng/mL, and the lower limit of quantification was 125 ng/mL. For all concentrations in the calibration curve, the intraday and interday coefficients of variation were less than 4.1%. Median recovery of nilotinib from plasma was ≥65.1% (±21.4%). The method described is sensitive, selective, reproducible, and rapid, and can be used for the accurate determination of nilotinib in human plasma for pharmacokinetics studies and for therapeutic drug monitoring (TDM) of nilotinib in routine clinical practice.

Six months multicentre pilot open label single-arm study to evaluate patient experience, acceptability and satisfaction of switching certolizumab pegol from a prefilled syringe or autoinjection pen to an AVA® e-Device in rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis patients.

WHAT IS KNOWN AND OBJECTIVE: The study aimed to assess acceptability and patient experience of Certolizumab (CZP) self-injection with AVA® and clarify patient device preference after switching CZP from the syringe or auto-injection pen to AVA® in rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA) patients. METHOD: A multicentre open-label, cross-sectional and prospective study among four Spanish hospitals was performed. Adult RA, PsA, axSpA patients treated for at least 6 months with the CZP syringe or pen were recruited. At the first visit, patients completed Pre-AVA® questionnaire. Patients were instructed on proper administration of CZP by AVA®. After 2 and 6 months of CZP self-injections using the AVA®, patient experience, adherence, preference and safety of each administration was assessed using post-AVA® questionnaire. RESULTS AND DISCUSSION: Thirty four patients were included (28 women). All patients self-administered CZP AVA® the full dose of CZP was injected. Patients reported >90% adherence to CZP AVA® assessed with the injection log. Pain at the injection site was reduced after switching to AVA®. Twenty nine patients preferred CZP AVA® and five patients preferred the CZP pen. No safety-related findings related to AVA® CZP administration were identified. WHAT IS NEW AND CONCLUSION: The AVA® is an advantageous delivery option for CZP in patients with RA, PsA, axSpA.

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.

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)

Effect of Early Peripheral Parenteral Nutrition Support in an Enhanced Recovery Program for Colorectal Cancer Surgery: A Randomized Open Trial.

BACKGROUND: Peripheral parenteral nutrition allows repletion of acute nutrient deficiencies and could prevent further nutrition deficits before and after colorectal surgery. A randomized open study was performed to evaluate the effect of perioperative peripheral parenteral nutrition (PPN) support on postoperative morbidity after colorectal cancer surgery within an enhanced recovery program. METHODS: Patients were randomized into two groups: peripheral parenteral nutrition (PPN) (with Peri-Olimel N4-E) versus conventional fluid therapy (FT). Ninety-day postoperative complications, laboratory parameters, length of hospital stay, and compliance with the ERAS protocol were assessed. RESULTS: A total of 158 patients were analysed. The overall 90-day complication rate was 38.6% (61 patients), and 24 patients had major complications (Clavien-Dindo III-V) (15.2%). In the multivariate analysis, the intervention (PPN vs. FC) showed a protective effect against postoperative complications (p = 0.0031, OR = 0.2 (CI: 0.08-0.87)). Following ordinal regression, PPN and early oral tolerance showed a protective effect, being less likely to develop complications or to move from minor to major complications. In patients with low compliance to ERAS during the first postoperative day, PPN showed a protective effect, preventing 28% of morbidity. CONCLUSIONS: Perioperative peripheral parenteral nutrition (PPN) support with Peri-Olimel N4-E in colorectal cancer surgery associated with early oral intake could reduce postoperative complications.

Health and economic impact of the correct diagnosis of transthyretin cardiac amyloidosis in Spain.

Objective: To estimate the health and economic impact of the reduction in mortality and cardiovascular hospitalizations, associated with correct diagnosis of cardiac transthyretin amyloidosis (ATTR-CM), from the Spanish National Health System (NHS) perspective.Methods: A costs and effects analysis were performed (probabilistic Markov model) with time horizons between 1 and 15 years, comparing the correct diagnosis of ATTR-CM versus the non-diagnosis. Transition probabilities were obtained from the ATTR-ACT study (placebo arm) and from the literature. Costs and healthcare resources were obtained from Spanish sources (€ 2019) and from a panel of Spanish clinical experts.Results: After 1, 5, 10 and 15 years, the diagnosis of ATTR-CM would generate a gain of 0.031 (95%CI 0.025; 0.038); 0.387 (95%CI 0.329; 0.435); 0.754 (95%CI 0.678; 0.781) and 0.944 (95%CI 0.905; 0.983) life years per patient, respectively, with savings of € 212 (95%CI € -632; 633), € 2,289 (95%CI € 2,250; 2,517), € 2,859 (95%CI € 2,584; 3,149) and € 2,906 (95%CI € 2,669; 3,450) per patient, respectively, versus the non-diagnosis.Conclusions: Just by correctly diagnosing ATTR-CM, years of life would be gained, cardiovascular hospitalizations would be avoided, and savings would be generated for the NHS, compared to the non-diagnosis of the disease.

Consensus to identify the dangerous drugs risks in hospital pharmacy services.

OBJECTIVE: To identify the hazards and define the theoretical  occupational risks arising from the process of handling hazard drugs in  hospital pharmacy services on the basis of expert consensus. METHOD: An expert consensus was conducted (nominal group and documentary techniques) using a mixed method of two face-to-face rounds (meeting of participants and approval of proposals) and  three masked rounds (individualized review). The analysis was applied  to the field of hospital pharmacy. The stages of the process were  designed using the standardized graphical Business Process Model and Notation. RESULTS: A specific flowchart was obtained for the management and  traceability of hazardous drugs. All general process phases were  characterized. A management chart included operations addressing the  reception and storage, compounding, conservation, and dispensation of  hazardous drugs in hospital pharmacy services. This chart provides a  description of the chemical hazards and exposure routes. CONCLUSIONS: The hazardous drug process should be integrated in a standard management system to improve the safety of patients and  healthcare professionals. Efficiency can maximized and procedural  incidents minimized, thereby ensuring the quality and the safety of  hazardous drugs handling in hospital pharmacy services. Once hazards  are identified, risk assessment should be implemented using a  systematic and preventative methodology to minimize the risk and  severity of any adverse event.

Objetivo: Identificar los peligros y definir los riesgos laborales teóricos derivados del proceso de manipulación de los medicamentos  peligrosos en los servicios de farmacia hospitalaria mediante un  consenso de expertos.Método: Se realizó un consenso de expertos (grupo nominal y técnicas documentales) utilizando un método mixto mediante dos  rondas presenciales (reunión de los participantes y aprobación de  propuestas) y tres rondas enmascaradas (revisión del material de forma individual). El análisis se aplicó al ámbito de la farmacia hospitalaria y  las etapas del proceso se diseñaron mediante notación gráfica  normalizada Business Process Modeling Notation.Resultados: Se obtuvo el diagrama de flujo específico para la gestión y trazabilidad de los medicamentos peligrosos, caracterizándose cada  una de las fases del proceso general, recopiladas en un cuadro de  gestión de etapas y operaciones de recepción y almacenamiento,  elaboración, conservación y dispensación de medicamentos peligrosos  en los servicios de farmacia hospitalaria, que sirvió para la posterior  descripción de riesgos químicos y vías de exposición.Conclusiones: Los medicamentos peligrosos deben integrarse en un sistema normalizado de gestión con el fin de mejorar la seguridad del paciente y de los profesionales sanitarios, a la vez que se maximizan la eficiencia de los recursos y minimizan los incidentes procesales,  garantizando la calidad y la seguridad del proceso de manipulación de  medicamentos peligrosos en los servicios de farmacia. Sería deseable,  una vez se han identificado los peligros, llevar a cabo una evaluación de  los riesgos siguiendo una metodología sistemática y de abordaje  preventivo que permita calibrar la probabilidad de ocurrencia y la  gravedad de cualquier suceso adverso.

Availability of Authorizations from EMA and FDA for Age-Appropriate Medicines Contained in the WHO Essential Medicines List for Children 2019.

Lack of age-appropriate commercially drug products availability is a common problem in pediatric therapeutics; this population needs improved and safer drug delivery. In addition, biopharmaceutic aspects, dosage requirements, and swallowing abilities demand pediatric forms different to adult formulations. The objective of this study was to evaluate the authorization availability from United States Food and Drug Administration (FDA) and European Medicines Agency (EMA) of oral essential medicines for children and analyze its age-appropriateness for oral administration in children. All oral drugs from 7th List of Essential Medicines for Children by World Health Organization (WHO) were selected. Availability of commercial drug products was collected from OrangeBook, Spanish drug product catalogue, British electronic Medicines Compendium, and the International Vademecum. Tablets, effervescent tablets, and capsules were considered as not age-appropriate forms. Liquid forms, powder for oral suspension, mini tablets, granules, and soluble films were considered as age-appropriate forms due to their flexibility. More than 80% of the studied drugs possess a commercial authorization in oral forms in both EMA and FDA. Nevertheless, around 50% of these formulations are not age-appropriate for most pediatric groups. This study shows the lack of age-appropriate medicines for children. More efforts are needed to improve development and approval of pediatric medicines.

Consenso para identificar los riesgos de los medicamentos peligrosos en los servicios de farmacia hospitalaria / Consensus to identify the dangerous drugs risks in hospital pharmacy services

OBJETIVO: Identificar los peligros y definir los riesgos laborales teóricos derivados del proceso de manipulación de los medicamentos peligrosos en los servicios de farmacia hospitalaria mediante un consenso de expertos. MÉTODO: Se realizó un consenso de expertos (grupo nominal y técnicas documentales) utilizando un método mixto mediante dos rondas presenciales (reunión de los participantes y aprobación de propuestas) y tres rondas en-mascaradas (revisión del material de forma individual). El análisis se aplicó al ámbito de la farmacia hospitalaria y las etapas del proceso se diseñaron mediante notación gráfica normalizada Business Process Modeling Notation. RESULTADOS: Se obtuvo el diagrama de flujo específico para la gestión y trazabilidad de los medicamentos peligrosos, caracterizándose cada una de las fases del proceso general, recopiladas en un cuadro de gestión de etapas y operaciones de recepción y almacenamiento, elaboración, conservación y dispensación de medicamentos peligrosos en los servicios de farmacia hospitalaria, que sirvió para la posterior descripción de riesgos químicos y vías de exposición. CONCLUSIONES: Los medicamentos peligrosos deben integrarse en un sistema normalizado de gestión con el fin de mejorar la seguridad del paciente y de los profesionales sanitarios, a la vez que se maximizan la eficiencia de los recursos y minimizan los incidentes procesales, garantizando la calidad y la seguridad del proceso de manipulación de medicamentos peligrosos en los servicios de farmacia. Sería deseable, una vez se han identificado los peligros, llevar a cabo una evaluación de los riesgos siguiendo una metodología sistemática y de abordaje preventivo que permita calibrar la probabilidad de ocurrencia y la gravedad de cualquier suceso adverso

OBJECTIVE: To identify the hazards and define the theoretical occupational risks arising from the process of handling hazard drugs in hospital pharmacy services on the basis of expert consensus. METHOD: An expert consensus was conducted (nominal group and documentary techniques) using a mixed method of two face-to-face rounds (meeting of participants and approval of proposals) and three masked rounds (individualized review). The analysis was applied to the field of hospital pharmacy. The stages of the process were desig-ned using the standardized graphical Business Process Model and Notation. RESULTS: A specific flowchart was obtained for the management and traceability of hazardous drugs. All general process phases were characterized. A management chart included operations addressing the reception and storage, compounding, conservation, and dispensation of hazardous drugs in hospital pharmacy services. This chart provides a description of the chemical hazards and exposure routes. CONCLUSIONS: The hazardous drug process should be integrated in a standard management system to improve the safety of patients and health-care professionals. Efficiency can maximized and procedural incidents minimized, thereby ensuring the quality and the safety of hazardous drugs handling in hospital pharmacy services. Once hazards are identified, risk assessment should be implemented using a systematic and preventative methodology to minimize the risk and severity of any adverse evento

Adequacy of Parenteral Nutrition in Preterm Infants According to Current Recommendations: A Study in A Spanish Hospital.

BACKGROUND: In preterm infants, it is important to ensure adequate nutritional intake to accomplish foetal growth requirements. This study evaluated clinical practice regarding the prescription of parenteral nutrition in preterm infants in the neonatology unit of a tertiary hospital. METHODS: It was a retrospective observational study of a sample of preterm infants (n = 155) born between January 2015 and December 2017 who were prescribed parenteral nutrition. Compliance with the hospital's protocol and with the guidelines of the scientific societies American Society for Parenteral and Enteral Nutrition (ASPEN), European Society for Clinical Nutrition and Metabolism (ESPEN) and Spanish Society of Clinical Nutrition and Metabolism (SENPE) was evaluated. The differences in macronutrient intake and total duration of parenteral nutrition were analysed according to gestational age and birth weight. RESULTS: The established protocol was followed in a high percentage (95.5%-100%) except with respect to the initiation of supplying established trace elements (64.9%). Compliance with the recommendations set forth in the guidelines was between 82.1% and 100%, with the exception of the initial carbohydrate intake recommended by ASPEN and ESPEN, for which compliance was 8.3%. Lower gestational age and birth weight were correlated with longer duration of parenteral nutrition (p < 0.001). CONCLUSIONS: A lower gestational age and birth weight are related to a longer duration of parenteral nutrition. The results of this study demonstrate the importance of developing and evaluating protocols in clinical practice.