Deprescribing in older patients with advanced cancer referred to palliative care.

OBJECTIVES: This study aimed to explore the prevalence of potentially inappropriate medications (PIMs) in a cohort of older adults with advanced cancer referred to palliative care. Secondary objectives were to describe the categories of identified PIMs and assess risk factors associated with their presence in this population. METHODS: This retrospective, observational study evaluated patients with advanced cancer admitted to a tertiary university hospital in Madrid, Spain and referred to palliative care between 1 January 2020 and 30 June 2020. Demographic, clinical, and pharmacotherapeutic data were obtained from the electronic medical records and regional databases. PIMs were assessed using the Screening Tool of Older Persons Prescriptions in Frail adults (STOPPFrail) criteria, V1. RESULTS: Among 123 patients (median age 80 years (IQR 73.5-87), 64.2% male), 74% presented at least one PIM according to the STOPPFrail criteria. The most common categories of inappropriate medications were lipid-lowering therapies, proton pump inhibitors, calcium supplements, and oral antidiabetics. The number of chronic comedications was significantly associated with PIM presence. CONCLUSIONS: Our study found a high prevalence of PIM among a cohort of older adults with advanced cancer and short life expectancy. This underlines the need for a comprehensive medication review to optimise pharmacotherapy in this population.

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.

Stability of meropenem in portable elastomeric infusion devices: which protocol should be implemented in clinical practice?

Meropenem has an excellent activity against gram-positive and gram-negative bacteria, including multi-resistant microorganisms. Even though meropenem is a great candidate for outpatient parenteral antimicrobial therapy (OPAT), its physicochemical stability is a major challenge. This work aimed to demonstrate the suitability of including meropenem in OPAT by elucidating its physicochemical stability in a range of commonly prescribed concentrations within portable elastomeric infusion devices. Physical and chemical stability were evaluated at two concentrations commonly used in clinical practice (2 and 25 mg/mL), and three temperatures (2°C-8°C, 25°C, and 32°C) using Accufuser portable elastomeric infusion devices. Drug adsorption onto portable elastomeric infusion devices was also determined at the end of the experiment. Meropenem stability significantly decreased at higher temperatures and when higher drug solution concentrations were used. Meropenem solutions at 2 mg/mL kept the drug content above 95% over 24 h at 2°C-8°C but just for 8 h at 25°C. Nevertheless, solutions containing 25 mg/mL of meropenem showed a dramatic decrease in chemical stability after 8 h 2°C-8°C and just after 4 h at 25°C or 32°C. However, physical stability was kept favorable during this period. The drug adsorption on the material of the elastomeric infusion device was below 1%, indicating the suitability of the chosen device. We propose several administration protocols for meropenem in portable elastomeric infusion devices in clinical practice, according to the results obtained in our study. The results obtained in this study open up the possibility of administering meropenem in an OPAT setting despite its short stability.IMPORTANCEAlthough outpatient parenteral antibiotic therapy can be a good approach to treating infections, a lack of data regarding antibiotic stability in portable elastomeric infusion devices restricts its safe and effective use. Actually, meropenem is used for prolonged periods above 24 h, and it is not physicochemically stable, which can compromise efficacy and toxicity. This work is of high importance to show the clinicians the real shelf life of meropenem when administered in portable elastomeric infusion devices. We propose several administration protocols for meropenem in portable elastomeric infusion devices in clinical practice, according to the stability drug results obtained in our study.

Stability of meropenem in portable elastomeric infusion devices: which protocol should be implemented in clinical practice?

IMPORTANCE: Although outpatient parenteral antibiotic therapy can be a good approach to treating infections, a lack of data regarding antibiotic stability in portable elastomeric infusion devices restricts its safe and effective use. Actually, meropenem is used for prolonged periods above 24 h, and it is not physicochemically stable, which can compromise efficacy and toxicity. This work is of high importance to show the clinicians the real shelf life of meropenem when administered in portable elastomeric infusion devices. We propose several administration protocols for meropenem in portable elastomeric infusion devices in clinical practice, according to the stability drug results obtained in our study.

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.

[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.

Real-world effectiveness and factors associated with increased mortality in non-critically ill patients with COVID-19 pneumonia receiving remdesivir.

OBJECTIVES: Evidence on the effectiveness of remdesivir when used in real-life clinical practice is controversial. This study aims to analyse its effectiveness and the factors associated with increased mortality in non-critically ill patients with COVID-19 pneumonia who require supplemental low-flow oxygen and received remdesivir. METHODS: A retrospective cohort study was conducted at Ramón y Cajal University Hospital (Madrid, Spain) which included all patients treated with remdesivir in our institution during the second pandemic breakout in Spain, from August to November 2020. Treatment with remdesivir was limited to non-critically ill patients with COVID-19 pneumonia requiring low-flow supplemental oxygen, with a treatment duration of 5 days. RESULTS: A total of 1757 patients were admitted with COVID-19 pneumonia during the study period, of which 281 non-critically ill patients were treated with remdesivir and included in the analysis. Mortality at 28 days after initiation of treatment was 17.1%. The median (IQR) time to recovery was 9 days (6-15). 104 (37.0%) patients had complications during hospitalisation, with renal failure being the most frequent (31 patients; 36.5%). After adjustment for confounding factors, high-flow oxygen therapy was associated with increased 28-day mortality (HR 2.77; 95% CI 1.39 to 5.53; p=0.004) and decreased 28-day clinical improvement (HR 0.54; 95% CI 0.35 to 0.85; p=0.008). A significant difference in survival and clinical improvement was identified between patients treated with high and low-flow oxygen. CONCLUSION: The 28-day mortality rate in patients treated with remdesivir needing low-flow oxygen therapy was higher than that published in clinical trials. Age and increased oxygen therapy needed after the beginning of treatment were the main risk factors associated with mortality.

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)

Optimisation of the quality of care for patients with severe asthma: ASfarMA project.

Severe asthma has an important impact on patients and healthcare resources. Recently, the new specific treatments have defined a new scenario in which person-focused care and specialist multidisciplinary teams are necessary. Our Severe Asthma Unit (SAU) started the ASfarMA project along with an external human-centered design company to understand patients' vision of their illness, treatment, and healthcare experience, and to define the ideal SAU by performing a core group session, in-depth semistructured interviews and co-creation workshop. Herein, a series of tips classified as either 'transformative solutions' or 'quick wins', according to a value versus effort matrix are presented. Successful implementation of the proposed solutions will be valuable for patients and healthcare professionals, optimising patient care and resources. These findings can also be helpful to other SAUs or other humanisation projects involving complex, chronic and multidisciplinary pathologies.

SARS-CoV-2 Virus in Cancer Patients: A New Unknown in an Unsolved Equation.

INTRODUCTION: Cancer patients are more susceptible to infections, and infection can be more severe than in patients without cancer diagnosis. We conducted this retrospective study in patients admitted for SARS-CoV-2 infection in order to find differences in inflammatory markers and mortality in cancer patients compared to others. METHODS: We reviewed the electronic records of patients admitted for SARS-CoV-2 infection confirmed by PCR from March to September 2020. Data on socio-demographics, comorbidities, inflammatory makers, and cancer-related features were analyzed. RESULTS: 2,772 patients were admitted for SARS-CoV-2, to the Hospital Universitario Ramón y Cajal in Madrid during this period. Of these, 2,527 (91%) had no history of neoplastic disease, 164 (5.9%) patients had a prior history of cancer but were not undergoing oncological treatment at the time of infection, and 81 (2.9%) were in active treatment. Mortality in patients without a history of cancer was 19.5%, 28.6% for patients with a prior history of cancer, and 34% in patients with active cancer treatment. Patients in active oncology treatment with the highest mortality rate were those diagnosed with lung cancer (OR 5.6 95% CI: 2.2-14.1). In the multivariate study, active oncological treatment (OR 2.259 95% CI: 1.35-3.77) and chemotherapy treatment (OR 3.624 95% CI: 1.17-11.17), were statistically significant factors for the risk of death for the whole group and for the group with active oncological treatment, respectively. CONCLUSION: Cancer patients on active systemic treatment have an increased risk of mortality after SARS-CoV-2 infection, especially with lung cancer or chemotherapy treatment.

Humanization Guide of the Spanish Society of Hospital Pharmacy for patients with inflammatory immune-mediated diseases.

OBJECTIVE: This study reports on the results of a project conducted by the Spanish Society of Hospital Pharmacy with patients with immune-mediated inflammatory diseases, with the following objectives: to understand  the experience of patients living with these diseases and the role of healthcare workers in such experience, and to identify opportunities to promote or boost humanization in hospital pharmacy units. METHOD: A user-centered design methodology was used, implementing exploratory and qualitative research tools. Led by a managing  team made up of experts in the methodology, a variety of people participated  in this project. The team comprised representatives of patients with  immunemediated inflammatory diseases, healthcare workers responsible for  their care, members of the immune-mediated inflammatory disease working  group of the Spanish Society of Hospital Pharmacy, and members of two patient advocacy organizations (Spanish Association of Persons with Chronic Immune-Mediated Inflammatory Diseases and the Spanish  association of Patients with Psoriasis). The research tools used included  indepth interviews, patients' diaries, ethnographic studies, and co-creation workshops. RESULTS: Five initiatives were identified as best practices to be implemented: The creation of functional or comprehensive care units; shared  medical records; integration of patient-reported outcomes with patient  experiences; implementation of the "capacity, motivation, opportunity"  pharmaceutical care model; and a closer interaction with patient advocacy  organizations. Six opportunities to improve the current situation were selected  as priority areas for hospital pharmacy departments: spreading knowledge  about immune-mediated inflammatory diseases; promoting a multidisciplinary  approach to these diseases; generating awareness on the  role of hospital pharmacists; revisiting the internal organization of pharmacy  departments; establishing closer relationships with patients; and seeing things  from the patients' point of view. Ten smart humanization initiatives were  proposed and classified in an impact-effort matrix: "Demystifying IMID", "IMID  teen challenge", "Patient­care academy", "Satellite consultation", "IMID  network", "A click away from the pharmacy", Medicines poker", "Patient-to- patient consultation", "Pharma-friendly consultation", and "Patient-centered  IMID sessions". CONCLUSIONS: This Annex to the Spanish Society of Hospital Pharmacy's Guidelines for the Humanization of Hospital Pharmacy Units intends  to promote a humanizing culture, bringing to the fore the unique value  of every single patient suffering from an immune-mediated  inflammatory disease, including their family and friends and their beliefs and  needs, preserving their dignity.

OBJETIVO: Describir el proyecto de humanización para los pacientes con  enfermedades inflamatorias mediadas por la inmunidad de la Sociedad  Española de Farmacia Hospitalaria encaminado a comprender la experiencia de  los pacientes con enfermedades inmunomediadas inflamatorias,  comprender el papel de los profesionales en la experiencia del paciente e  identificar oportunidades para impulsar la humanización desde los servicios de  farmacia hospitalaria.Método: Se empleó la metodología del diseño centrado en las personas, aplicando herramientas de investigación cualitativa y exploratoria. Participaron pacientes con enfermedades inflamatorias mediadas  por la inmunidad, profesionales de todos los perfiles que les atienden, el Grupo de trabajo de Enfermedades Inmunomediadas Inflamatorias de la  Sociedad Española de Farmacia Hospitalaria y representantes de pacientes (Asociación de personas con enfermedades crónicas inflamatorias  inmunomediadas y Asociación de pacientes Acción Psoriasis). Todo ello con la dirección de un equipo experto en diseño centrado en las personas. Entre las  dinámicas empleadas se encuentran: entrevistas en profundidad, diarios de  pacientes, observaciones etnográficas y talleres de cocreación. RESULTADOS: Se identificaron cinco iniciativas consideradas buenas prácticas a  implementar (creación de unidades funcionales o de atención integrada,  historia clínica compartida, integración de los resultados reportados por los  pacientes y de su experiencia, modelo "capacidad, motivación y oportunidad"  de atención farmacéutica y acercamiento a las asociaciones de pacientes). Se  seleccionaron seis oportunidades sobre las que diseñar soluciones en los  servicios de farmacia (favorecer el conocimiento de estas enfermedades,  impulsar su abordaje multidisciplinar, difundir las atribuciones del farmacéutico  de hospital, revisar la organización interna del servicio,  establecer el vínculo con el paciente y adoptar la visión del paciente). Se  propusieron diez grandes ideas para humanizar clasificadas en una matriz de  impacto-esfuerzo ("Remitente IMID", "IMID teen challenge", "Escuela de  familiares", "Consulta satélite", "Redemid", "A un botón de farmacia", "Póquer  de fármacos", "Consulta de paciente a paciente", "Farma friendly", "Sesiones  IMID Patient-Centric"). CONCLUSIONES: Con este anexo a la Guía de Humanización de la Sociedad  Española de Farmacia Hospitalaria se pretende promover una cultura de  humanización, que ponga en valor a la persona que hay detrás de todo  paciente con enfermedades inmunomediadas inflamatorias, teniendo en  consideración su familia, entorno, creencias y necesidades y preservando su  dignidad.

Medicines in exceptional circumstances for solid tumours: focusing on evidence, effectiveness, and toxicity profiles.

OBJECTIVE: To analyse the applications for drugs in special situations (compassionate use, off-label use and foreign drugs) for solid  tumours, and to assess the level of evidence supporting these applications, as  well as the effectiveness and safety of most frequent drugs. METHOD: We performed a cross-sectional study of all applications for drugs in  special situations during 2018 and 2019 in a representative third-level centre.  We collected data about generic names of drugs, clinical indications, and level  of evidence provided on the application form. Furthermore, tumour response  was assessed according to the Response Evaluation Criteria in Solid Tumours  version 1.1., Progression Free Survival and Overall Survival. Safety was  evaluated with the National Cancer Institute Common Terminology Criteria for  Adverse Events, version 5.0. RESULTS: 2,273 drugs in special situations were approved between January  2018 and December 2019. In 431 cases (19%), they were used to treat solid  tumours. Out of 431, 291 (67.5%) applications were offlabel drugs, 76 (18%)  foreign drugs, and 64 (15%) were compassionate use of drugs. Most of them  were supported by phase 3 (47%) or phase 2 (33%)  clinical trials. The  majority of adverse effects were grade 1 and only in 6/67 cases the treatment  was discontinued due to toxicity. CONCLUSIONS: A significant number of drugs in special situations are prescribed  to Oncology patients. The majority of applications of these drugs was supported by clinical trials. The real-life experience showed an effectiveness and tolerance profile similar to those described in randomised  clinical trials.

OBJETIVO: Analizar las solicitudes de medicamentos en situaciones especiales (uso compasivo, uso fuera de indicación y medicamentos  extranjeros) para tumores sólidos, y evaluar el nivel de evidencia que avala  dichas solicitudes, así como la efectividad y seguridad de los medicamentos  más frecuentes.Método: Estudio transversal que incluyó las solicitudes de medicamentos en  situaciones especiales durante el período 2018-2019 en un centro representativo español de tercer nivel. Se recogieron datos sobre  principios activos, indicaciones clínicas y nivel de evidencia aportado en la  solicitud. Asimismo, la respuesta tumoral fue evaluada mediante criterios  Response Evaluation Criteria in Solid Tumours versión 1.1, supervivencia libre  de progresión y supervivencia global. La seguridad fue evaluada con la versión 5.0 de los criterios de toxicidad Common Terminology Criteria for  Adverse Events del National Cancer Institute de Estados Unidos. RESULTADOS: Un total de 2.273 medicamentos en situaciones especiales fueron aprobados entre enero de 2018 y diciembre de 2019. El 19% (431) se  aprobaron para el tratamiento de tumores sólidos. De estos 431, 291 (67,5%)  solicitudes fueron de medicamentos fuera de indicación, 76 (18%) extranjeros  y 64 (15%) en uso compasivo. La mayoría son avaladas por estudios clínicos  aleatorizados en fase III (47%) o fase II (33%). La mayor parte de los efectos  adversos fueron de grado 1 y solo en 6/67 casos el tratamiento fue  interrumpido por toxicidad. CONCLUSIONES: Un porcentaje importante de medicamentos en usos especiales se prescriben a pacientes oncológicos. La mayoría de las solicitudes fueron  avaladas por algún estudio clínico aleatorizado. La experiencia en vida real  mostró un perfil de efectividad y tolerancia similar al descrito en los estudios  clínicos aleatorizados.

Antibiotic stability in portable elastomeric infusion devices: A systematic review.

PURPOSE: Although outpatient parenteral antibiotic therapy (OPAT) can be a good approach to treatment of infections, a lack of data regarding antibiotic stability in portable elastomeric infusion devices restricts its safe, appropriate, and effective use. The objective of this work was to complete a systematic peer-reviewed analysis of published articles about antibiotic stability in elastomeric infusion devices that provide evidence supporting their use in OPAT. SUMMARY: A systematic review following PRISMA guidelines was conducted in January 2021 to identify published articles about antibiotic stability in portable elastomeric infusion devices. The databases used were PubMed, Embase, Web of Science, and a Cochrane database. A total of 1,615 original studies and conference communications were found. After title, abstract, and full-text review, 33 articles met the inclusion criteria. The data obtained included information about the stability of 30 different antibiotics. To our knowledge, this is the first review to summarize the available published data on the stability of antibiotics in portable elastomeric infusion devices. The results highlight the poor stability of some antibiotics in solution and the variability of the laboratory conditions in the included studies. CONCLUSION: This systematic review can serve as a useful resource for healthcare professionals involved in providing OPAT using portable elastomeric infusion devices. However, further stability studies should be performed, especially high-quality studies simulating real-life time and temperature conditions.

Medicamentos en situaciones especiales paratumores sólidos: profundizando en la evidencia y los perfiles de efectividad y toxicidad / Medicines in exceptional circumstances for solid tumours: focusing on evidence, effectiveness, and toxicity profiles

Objetivo: Analizar las solicitudes de medicamentos en situaciones especiales(uso compasivo, uso fuera de indicación y medicamentos extranjeros) paratumores sólidos, y evaluar el nivel de evidencia que avala dichas solicitudes,así como la efectividad y seguridad de los medicamentos más frecuentes.Método: Estudio transversal que incluyó las solicitudes de medicamentosen situaciones especiales durante el período 2018-2019 en un centrorepresentativo español de tercer nivel. Se recogieron datos sobre principiosactivos, indicaciones clínicas y nivel de evidencia aportado en la solicitud.Asimismo, la respuesta tumoral fue evaluada mediante criterios ResponseEvaluation Criteria in Solid Tumours versión 1.1, supervivencia libre de progresióny supervivencia global. La seguridad fue evaluada con la versión5.0 de los criterios de toxicidad Common Terminology Criteria for AdverseEvents del National Cancer Institute de Estados Unidos.Resultados: Un total de 2.273 medicamentos en situaciones especialesfueron aprobados entre enero de 2018 y diciembre de 2019. El19% (431) se aprobaron para el tratamiento de tumores sólidos. De estos431, 291 (67,5%) solicitudes fueron de medicamentos fuera de indicación,76 (18%) extranjeros y 64 (15%) en uso compasivo. La mayoría son avaladas por estudios clínicos aleatorizados en fase III (47%) o fase II(33%). La mayor parte de los efectos adversos fueron de grado 1 y soloen 6/67 casos el tratamiento fue interrumpido por toxicidad.Conclusiones: Un porcentaje importante de medicamentos en usosespeciales se prescriben a pacientes oncológicos. La mayoría de lassolicitudes fueron avaladas por algún estudio clínico aleatorizado. Laexperiencia en vida real mostró un perfil de efectividad y tolerancia similaral descrito en los estudios clínicos aleatorizados.

Objective: To analyse the applications for drugs in special situations(compassionate use, off-label use and foreign drugs) for solid tumours, andto assess the level of evidence supporting these applications, as well asthe effectiveness and safety of most frequent drugs.Method: We performed a cross-sectional study of all applications fordrugs in special situations during 2018 and 2019 in a representativethird-level centre. We collected data about generic names of drugs,clinical indications, and level of evidence provided on the applicationform. Furthermore, tumour response was assessed according to the ResponseEvaluation Criteria in Solid Tumours version 1.1., Progression FreeSurvival and Overall Survival. Safety was evaluated with the NationalCancer Institute Common Terminology Criteria for Adverse Events, version5.0.Results: 2,273 drugs in special situations were approved betweenJanuary 2018 and December 2019. In 431 cases (19%), they were usedto treat solid tumours. Out of 431, 291 (67.5%) applications were offlabeldrugs, 76 (18%) foreign drugs, and 64 (15%) were compassionate use ofdrugs. Most of them were supported by phase 3 (47%) or phase 2 (33%) clinical trials. The majority of adverse effects were grade 1 and only in6/67 cases the treatment was discontinued due to toxicity.Conclusions: A significant number of drugs in special situations areprescribed to Oncology patients. The majority of applications of thesedrugs was supported by clinical trials. The real-life experience showed aneffectiveness and tolerance profile similar to those described in randomisedclinical trials.

Analysis of adverse drug events as a way to improve cancer patient care.

PURPOSE: To define the signals that a new artificial intelligence (AI) system must emit to improve adverse drug events (ADEs) management in oral antineoplastic agents (OAA). METHODS: A multidisciplinary group of experts in patient safety was set up to define what signals the new AI system must emit to improve ADEs management in OAAs. The baseline data for the new AI system were generated through an observational and ambispective study carried out in a university hospital. All patients who met the inclusion criteria were selected consecutively every working day for 6 months. The ADEs were collected by interview and by the review of health records. The ADEs were categorised according to how they could be detected: patient, analysis, examination. RESULTS: The group defined what signals the AI system must emit to improve ADEs management in OAAs: a signal to educate the patient when the possible ADEs were categorised as patient, a signal as a reminder to request a blood test or a microbiological culture when the possible ADEs were categorised as analysis, and a signal as a reminder for the necessity of a clinical examination when the possible ADEs were categorised as examination. A total of 1652 ADEs were reported in the interviews (ADE-interview) with the pharmacist, and doctors noted 1989 ADEs in the health record (ADE-HR). The most frequent ADEs were identified in the patient category. CONCLUSION: This study opens a new way for better management of ADEs and is the first step in the development of a future technology, which will improve the quality of life of patients.

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.

Patient and health practitioner perceptions about the role of hospital pharmacists along the care continuum: the Fharmaconectados Project.

OBJECTIVE: To determine the perception of patients and practitioners regarding the role of the hospital pharmacist along the care  continuum. METHOD: This was a multicenter cross-sectional observational analytical study, carried out in two phases between 15 October and 31  December 2020. In the first phase, a literature search was carried out to  identify specific questionnaires that measured the overall satisfaction of  patients in relation to the work of hospital pharmacists. Subsequently, a  specific consensus-based questionnaire was developed, structured into  three areas: care, relationships, and capacity-building and training. The  study included patients treated in the participating centers and served by  patient associations. They had to be older than 18 years, present with a  chronic condition, and be treated with medication for hospital use. In the  second phase, a qualitative study was carried out using focus group  discussions to analyze how hospital pharmacists are perceived and how  they would like to be recognized by patients. Four meetings were held in  different territories of Spain. Previously, the research team agreed on the  questions to be asked, which were grouped into four sections: healthcare,  relational, training and information. RESULTS: A total of 482 surveys were obtained. The percentage of patients  who expressed a positive view of the role of the hospital  pharmacist was 88.0% (n = 424). In the multivariate analysis, the most  positive  opinions about these professionals were expressed by women and by patients who had received previous care in the hospital, those who had  a high opinion of the coordination of these professionals with the rest of  the care team, and those who had received the greatest amount of  emotional support. Integration of the pharmacist with the healthcare team  was found to vary across different hospitals and the hospitals' public image  we seen to be related to the way they were pharmacoeconomically  managed. In the sections related to capacity-building and training and  challenges for the future, respondents emphasized the need to promote  the introduction of new patient monitoring technologies. CONCLUSIONS: Patients have a good opinion of the service provided by hospital pharmacists, although many are unaware of the significance of  their role.

Objetivo: Determinar la percepción de los pacientes y profesionales  especto al papel del farmacéutico de hospital en el proceso asistencial  sanitario.Método: Estudio multicéntrico, observacional, analítico y transversal,  realizado en dos fases entre el 15 de octubre y el 31 de  diciembre de 2020. En la primera fase se realizó una búsqueda  bibliográfica para identificar cuestionarios específicos que midieran la  satisfacción global de los pacientes en relación con la actividad asistencial  de los farmacéuticos de hospital. Al no identificarse ninguno validado y  adaptado, se elaboró un cuestionario específico. Se estructuró en tres  áreas: asistencial, relacional y de capacitación y formación. Se incluyeron  pacientes atendidos en los centros participantes y asociaciones de  pacientes colaboradoras en el proyecto, mayores de 18 años, con patología  crónica y tratamiento con medicación de uso hospitalario. En la  segunda fase se llevó a cabo un estudio cualitativo en formato focus group para analizar cómo son percibidos y cómo les gustaría ser reconocidos a  los farmacéuticos de hospital por parte de los pacientes. Se realizaron  cuatro reuniones en diferentes territorios de España. Previamente el  equipo investigador acordó el guion y las preguntas a llevar a cabo,  incluyéndose 13, agrupadas por bloques: asistencial, relacional, formación  e información. Resultados: Se obtuvieron un total de 482 encuestas. El porcentaje de  pacientes que valoraron positivamente el papel del farmacéutico de Abstract hospital fue del 88,0% (n = 424). Se identificó que tienen  mejor opinión sobre los farmacéuticos hospitalarios las mujeres, los  pacientes que habían recibido atención previa en el hospital, los que  valoraron mejor la coordinación de estos profesionales con el resto del  equipo y aquellos con mayor apoyo emocional previo recibido. En la  segunda fase se identificó que la integración del farmacéutico con el  equipo varía en función de los centros y que la imagen que se tiene es la  relacionada con la gestión farmacoeconómica. En el bloque de capacitación  y formación, así como retos de futuro, se identificó la  necesidad de fomentar la introducción de nuevas tecnologías para el  seguimiento de los pacientes.Conclusiones: Los pacientes tienen una buena opinión del servicio prestado por el farmacéutico de hospital, aunque muchos  desconocen su papel.

Percepción de pacientes y profesionales respecto al papel del farmacéutico de hospital en el proceso asistencial. Proyecto Fharmaconectados / Patient and health practitioner perceptions about the role of hospital pharmacists along the care continuum: the Fharmaconectados Project

Objetivo: Determinar la percepción de los pacientes y profesionales respecto al papel del farmacéutico de hospital en el proceso asistencial sanitario.Método: Estudio multicéntrico, observacional, analítico y transversal,realizado en dos fases entre el 15 de octubre y el 31 de diciembre de2020. En la primera fase se realizó una búsqueda bibliográfica paraidentificar cuestionarios específicos que midieran la satisfacción global delos pacientes en relación con la actividad asistencial de los farmacéuticosde hospital. Al no identificarse ninguno validado y adaptado, se elaboróun cuestionario específico. Se estructuró en tres áreas: asistencial, relacional y de capacitación y formación. Se incluyeron pacientes atendidos enlos centros participantes y asociaciones de pacientes colaboradoras en elproyecto, mayores de 18 años, con patología crónica y tratamiento conmedicación de uso hospitalario. En la segunda fase se llevó a cabo unestudio cualitativo en formato focus group para analizar cómo son percibidos y cómo les gustaría ser reconocidos a los farmacéuticos de hospitalpor parte de los pacientes. Se realizaron cuatro reuniones en diferentesterritorios de España. Previamente el equipo investigador acordó el guiony las preguntas a llevar a cabo, incluyéndose 13, agrupadas por bloques: asistencial, relacional, formación e información.Resultados: Se obtuvieron un total de 482 encuestas. El porcentajede pacientes que valoraron positivamente el papel del farmacéutico de hospital fue del 88,0% (n = 424). Se identificó que tienen mejor opinión sobre los farmacéuticos hospitalarios las mujeres, los pacientes quehabían recibido atención previa en el hospital, los que valoraron mejorla coordinación de estos profesionales con el resto del equipo y aquellos con mayor apoyo emocional previo recibido. (AU)

Objective: To determine the perception of patients and practitionersregarding the role of the hospital pharmacist along the care continuum.Method: This was a multicenter cross-sectional observational analyticalstudy, carried out in two phases between 15 October and 31 December2020. In the first phase, a literature search was carried out to identifyspecific questionnaires that measured the overall satisfaction of patientsin relation to the work of hospital pharmacists. Subsequently, a specific consensus-based questionnaire was developed, structured into threeareas: care, relationships, and capacity-building and training. The studyincluded patients treated in the participating centers and served by patientassociations. They had to be older than 18 years, present with a chroniccondition, and be treated with medication for hospital use. In the secondphase, a qualitative study was carried out using focus group discussionsto analyze how hospital pharmacists are perceived and how they wouldlike to be recognized by patients. Four meetings were held in differentterritories of Spain. Previously, the research team agreed on the questionsto be asked, which were grouped into four sections: healthcare, relational,training and information.Results: A total of 482 surveys were obtained. The percentage ofpatients who expressed a positive view of the role of the hospital pharmacist was 88.0% (n = 424). In the multivariate analysis, the most positive opinions about these professionals were expressed by women and bypatients who had received previous care in the hospital, those who had ahigh opinion of the coordination of these professionals with the rest of thecare team, and those who had received the greatest amount of emotionalsupport. (AU)

[Analysis of patient safety in the process of drug prescription in research.] / Análisis de la seguridad del paciente en el proceso de prescripción de medicamentos en investigación.

OBJECTIVE: The increasing complexity of clinical trial protocols and the very nature of investigational drugs increase the likelihood of prescribing errors and require comprehensive control and monitoring of treatments. The aim of this study was to measure and analyze the potential risks of prescribing errors in investigational drugs. METHODS: A prospective, descriptive, and observational study was carried out in a third-level hospital in Madrid, for one month in 2017. Manual prescribing errors (EP) in investigational drugs and potential risks of harm to the patient were analyzed. A descriptive statistical analysis was performed, including the absolute and relative frequency for the variables. RESULTS: A total of 254 medical orders corresponding to 327 lines of treatment and 274 different drugs were reviewed, of which 83% were categorized as "high-risk". Results showed 217 (85.4%) EP within the identification of the medical order and 1,045 (319,6%) in the treatment. The risk level of harm to the patient was high for all EP in patient identification and moderate for all EP in the clinical trial identification. The lines of treatment showed an especially high-risk potential for EP in dosage (25%) and frequency (41%). CONCLUSIONS: The high rate of EP found, along with the high-risk potential these entail, reflects the need for improving the security process when prescribing investigational drugs in our field.

OBJETIVO: La creciente complejidad de los protocolos de ensayo clínico y la propia naturaleza de los medicamentos en investigación aumentan la probabilidad de errores de medicación, a la par que exigen un control y seguimiento exhaustivo de los tratamientos. El objetivo de este artículo fue medir y analizar el riesgo potencial de los errores de prescripción de los medicamentos en investigación. METODOS: Se realizó un estudio prospectivo, descriptivo y observacional en un hospital de tercer nivel de Madrid, durante un mes en 2017. Se analizaron los errores de prescripción (EP) manual de medicamentos en investigación y el riesgo potencial de causar daño al paciente. Se realizó un análisis estadístico descriptivo, incluyendo la frecuencia absoluta y relativa para las variables. RESULTADOS: Se revisaron 254 órdenes médicas correspondientes a 327 líneas de tratamiento y 274 medicamentos distintos, de los cuales el 83% se categorizaron de riesgo alto. Se encontraron 217 (85,4%) EP en la identificación de la orden médica y 1.045 (319,6%) en el tratamiento. El nivel de riesgo de causar daño al paciente fue alto para todos los EP de identificación del paciente y moderado para todos los EP de identificación del ensayo clínico. En las líneas de tratamiento, el riesgo potencial fue alto, principalmente en los EP de dosis (25%) y frecuencia (41%). CONCLUSIONES: El elevado número de EP encontrados, junto con el alto riesgo potencial que supone la mayoría de ellos, refleja la necesidad de mejorar la seguridad del proceso de prescripción de medicamentos en investigación en nuestro entorno.