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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

[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.

Hospital Pharmacy Service: Facing the logistics of medicines procurement.

COVID crisis has abruptly broken into our hospitals, and many difficulties have  emerged, including those related to supply logistics. A huge number of new  patients, a fast internal reorganization process and many other changes were  suddenly established. These circumstances revealed the need to increase stocks  of drugs, both for basic treatment as well as for specific SARS-CoV-2 infection  management. At the same time, other problems (shortages, new and complex  purchasing procedures, etc.) surfaced, so they could risk safety along the  pharmacotherapeutic process. The main objective was to develop and implement all the necessary measures within the logistics circuit in order to ensure the  availability of medicines for patients, as safely and effectively as possible, during the Coronavirus crisis. Firstly, two pharmacists were appointed to coordinate the whole process, and a preliminary analysis of the following aspects was carried  out an estimation of needs to make an initial drug provisioning, a storage  feasibility study and a global analysis of the logistics process to detect critical  points. Three different circuits for medicines supply were established as some  drugs were operated by Agencia Española de Medicamentos y Productos  Sanitarios (AEMPS) or Servicio Madrileño de Salud (SERMAS), and others were  under no restrictions. For stocks control, inventory was frequently reviewed and  monitoring of prescription trends was implemented. For all new medicinal  products, compliance with security standards was reviewed and relabeling was  carried out if necessary. Criteria were defined for the storage of overstocks and  it was placed an isolated area for quarantined drugs. Shortages inevitably  occurred but their effects were partly mitigated by AEMPS and SERMAS. After  all, we consider that the implemented procedure for logistics management may  be reproducible, and the key points we have identified are the following: to  enhance our quality management system, to develop an Action Plan for  Healthcare Emergencies and to ensure the adequate training for all pharmacy  staff. Furthermore, we also should address other aspects: to establish storage  optimization strategies, to focus on a more advanced logistics management  model, as well as to take advantage of the extraordinary multidisciplinary  network, which has been consolidated during this COVID pandemic.

La crisis COVID ha irrumpido en los hospitales de forma abrupta, y ha planteado  muchas dificultades de partida a todos los niveles, incluyendo la logística de  adquisiciones. El aumento radical de pacientes, una aceleradísima reorganización interna y otros cambios pusieron de manifiesto un drástico incremento de  necesidades, tanto de medicamentos básicos, como de aquellos específicos para  soporte y tratamiento de la infección por SARSCoV-2. Paralelamente, surgieron  otras dificultades como desabastecimientos, procedimientos de compra nuevos y más complejos, etc., que podían comprometer la seguridad del proceso de  utilización de medicamentos. Nuestro objetivo consistió en establecer todas las  medidas necesarias dentro del proceso logístico para garantizar de forma segura y eficaz la disponibilidad de los medicamentos para los pacientes durante la  crisis COVID. En primer lugar, se designaron los farmacéuticos responsables del  proceso, y se realizó un análisis preliminar de los siguientes aspectos:  estimación de necesidades para realizar una compra inicial, estudio de viabilidad de almacenamiento y análisis logístico global para detectar puntos críticos. Se establecieron tres circuitos de adquisiciones, según se tratase de medicamentos intervenidos por la Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), por el Servicio Madrileño de  Salud (SERMAS) o medicamentos no sujetos a restricciones. Para el control de stocks se implementaron revisiones frecuentes de inventario y seguimiento de las tendencias de prescripción. En las especialidades nuevas  recibidas se revisó el cumplimiento de los estándares de seguridad y se realizó  reetiquetado en caso necesario. Se establecieron unos criterios para el  almacenamiento de los sobrestocks y se destinó un área independiente para  medicamentos en cuarentena. Los desabastecimientos fueron inevitables pero  amortiguados por la gestión del SERMAS y la AEMPS. Una vez superada la crisis, consideramos que el procedimiento implantado para la gestión logística es  reproducible, y sus puntos clave para aplicabilidad futura son: mantener y  potenciar nuestro sistema de gestión de calidad, elaborar un plan de actuación  para emergencias sanitarias y garantizar la adecuada formación de todo el  personal. Asimismo, existen otros aspectos que debemos abordar: establecer  estrategias de optimización del almacenamiento, enfocarnos hacia un modelo de  gestión logística más avanzado, así como aprovechar la extraordinaria red  multidisciplinar consolidada durante la crisis.

Pharmacy Department management and organization.

The WHO declared the SARS- CoV-2 outbreak a pandemic in March 11, 2020.  Spain has been the third country with the highest number of reported cases of  COVID-19. In the face of the pandemic, the authorities of the Autonomous  Community of Madrid led an unprecedented transformation of hospital services  by increasing the number of beds available, setting up temporary field hospitals  in fairgrounds, and transforming hotels into support centers for patients with  mild symptoms of COVID-19. In the light that this crisis will continue to be a real threat for the years to come, our hospital pharmacies need to be better prepared for similar outbreaks in the future. During the COVID-19 pandemic, the  Department of Hospital Pharmacy of Hospital General Universitario Gregorio  Marañón has faced four challenges: an exponential increase in the demand for  resources, constant changes to therapeutic protocols and approaches, regulatory changes, and a dramatic impact on hospital staff (strain on human resources  and psychological impact). This article is aimed at describing the main  organizational changes implemented to the Department of Hospital Pharmacy of  Hospital GU Gregorio Marañón and its relationship with other hospital  pharmacies of the Community of Madrid. An account is provided of the strategies to be adopted for reorganizing a Department of Hospital Pharmacy and achieve a safe and effective use of medications. Strategies range from the creation of  integral hospital task groups (COVID-crisis task group, protocolization task  group, research task group) to the adaptation of the internal organization of the  Department of Hospital Pharmacy, which encompasses aspects related to  management and leadership; a communication plan (internal and external);  staff management, and the reorganization and adaptation of processes. People,  patients and professionals are at the core of these strategies. This paper is a  reflection on key factors of "humanization in COVID times".

Con fecha 11 de marzo de 2020 la Organización Mundial de la Salud declaró el  estado de pandemia por SARS-CoV-2. En algunos momentos de la crisis, España fue el tercer país del mundo en número de casos. Las autoridades de la  Comunidad de Madrid, una de las más afectadas, han respondido con una  transformación hospitalaria sin precedentes, aumentando el número de camas  disponibles, creando hospitales de campaña en recintos feriales y transformando hoteles en centros de apoyo para pacientes leves. Dado que la aparición de  estas crisis continuará siendo una amenaza real en los próximos años, es  necesario revisar la preparación de nuestros servicios de farmacia para afrontar  este tipo de situaciones. El reto al que se ha enfrentado el Servicio de Farmacia  del Hospital General Universitario Gregorio Marañón durante la crisis de la  pandemia COVID-19 ha venido determinado por cuatro circunstancias:  incremento exponencial de la demanda de recursos, cambios constantes en los  protocolos y decisiones terapéuticas, cambios regulatorios y gran impacto en las personas (gestión de recursos y gestión de las emociones). En este trabajo  se describen los principales cambios organizativos de un servicio de farmacia a  través de la experiencia del Hospital General Universitario Gregorio Marañón y  sus relaciones con otros servicios de farmacia de la Comunidad de Madrid. Se  detallan los procedimientos que deben contemplarse para la reorganización de  un servicio de farmacia para lograr un uso seguro y eficiente de los  medicamentos. Se detallan desde la participación en los comités globales de  hospital (comité de crisis COVID, comité de protocolización y comité de  investigación) hasta la organización interna del servicio de farmacia, que  incluyen: gestión y liderazgo, plan de comunicación (interna y externa), gestión  de las personas, reorganización y adaptación de los procesos. Las personas,  pacientes y profesionales son los grandes protagonistas de esta actuación, por lo  que incluimos una reflexión sobre los factores clave para la "humanización en  tiempos de COVID".

Grading the potential safety risk of medications used in hospital care.

OBJECTIVE: The aim of this study was to stratify medications used in hospital  care according to their potential risk. METHOD: The RAND/UCLA Appropriateness Method was used. Anatomical Therapeutic Chemical subgroups were classified according to their potential risk. A literature search, bulletins, and alerts issued by patient safety organizations were used to identify the potential safety risk of  these subgroups. Nine experts in patient/medication safety were selected to score the subgroups for their appropriateness in the classification. Two evaluation rounds were conducted: the first by email and the second by a  panel meeting. RESULTS: A total of 298 Anatomical Therapeutic Chemical subgroups were  evaluated. They were classified into three scenarios (low, medium, and high  risk). In the first round, 266 subgroups were classified as appropriate to the  assigned scenario, 32 were classified as uncertain, and none were classified as  inappropriate. In the second round, all subgroups were classified as appropriate.  The most frequent subgroups in the low-risk scenario belonged to  group A "Alimentary tract and metabolism" (44%); the most frequent in the  medium-risk scenario belonged to group J "Antiinfectives for systemic use"  (32%); and the most frequent in the high-risk scenario belonged to group L  "Antineoplastic and immunomodulating agents" (29%) and group N "Nervous  system" (26%). CONCLUSIONS: Based on the RAND/UCLA appropriateness method, Anatomical  Therapeutic Chemical subgroups used in hospital care were classified according  to their potential risk (low, medium, or high). These lists can be incorporated  into a risk-scoring tool for future patient/medication safety studies.

Objetivo: Estratificar los medicamentos utilizados en el ámbito hospitalario según el riesgo de provocar daño al paciente.Método: Se utilizó la metodología RAND/UCLA para clasificar los subgrupos terapéuticos del código Anatómica, Terapéutica, Química según el  riesgo de provocar daño al paciente. Para ello se realizó una revisión de la  evidencia disponible en publicaciones, boletines y alertas de organismos de  seguridad del paciente. A continuación se seleccionaron nueve expertos en  seguridad del paciente/medicamento para evaluar la clasificación de los  subgrupos terapéuticos: una primera ronda de evaluación por vía telemática y  una segunda ronda en una reunión presencial en la que se presentaron y  discutieron los resultados de la primera.Resultados: Se evaluaron 298 subgrupos terapéuticos. Se clasificaron en tres  escenarios (riesgo bajo, medio y alto). En la primera ronda se clasificaron 266  subgrupos como adecuados al escenario asignado, 32 subgrupos fueron  clasificados como inciertos y ninguno fue clasificado como inapropiado. En la  segunda ronda, todos los subgrupos fueron clasificados como adecuados. Los  subgrupos más frecuentes en el escenario de riesgo bajo pertenecieron al Grupo  A: "Tracto alimentario y metabolismo" (44%), en el de riesgo medio al Grupo J:  "Antiinfecciosos para uso sistémico" (32%), y en el de riesgo alto al Grupo L:  "Agentes antineoplásicos e inmunomoduladores" (29%) y al Grupo N: "Sistema  nervioso" (26%).Conclusiones: La metodología RAND/UCLA ha permitido estratificar los  subgrupos utilizados en el ámbito hospitalario según el riesgo potencial de  provocar daño al paciente. Esta estratificación puede servir como herramienta  para futuros estudios de seguridad en la utilización de medicamentos.

A continuous usability evaluation of an electronic medication administration record application.

RATIONALE, AIMS, AND OBJECTIVES: The complexity of an electronic medication administration record (eMAR) has been underestimated by most designers in the past. Usability issues, such as poorly designed user application flow in eMAR, are therefore of vital importance, since they can have a negative impact on nursing activities and result in poor outcomes. The purpose of this study was to evaluate the usability of an eMAR application during its development. METHODS: A usability evaluation was conducted during the development of the eMAR application. Two usability methods were used: a heuristic evaluation complemented by usability testing. Each eMAR application version provided by the vendor was evaluated by 2 hospital pharmacists, who applied the heuristic method. They reviewed the eMAR tasks, detected usability problems and their heuristic violations, and rated the severity of the usability problems. Usability testing was used to assess the final application version by observing how 3 nurses interacted with the application. RESULTS: Thirty-four versions were assessed before the eMAR application was considered usable. During the heuristic evaluation, the usability problems decreased from 46 unique usability problems in version 1 (V1) to 9 in version 34 (V34). In V1, usability problems were categorized into 154 heuristic violations, which decreased to 27 in V34. The average severity rating also decreased from major usability problem (2.96) to no problem (0.23). During usability testing, the 3 nurses did not encounter new usability problems. CONCLUSION: A thorough heuristic evaluation is a good method for obtaining a usable eMAR application. This evaluation points key areas for improvement and decreases usability problems and their severity.

Effect of an electronic medication administration record application on patient safety.

RATIONALE, AIMS, AND OBJECTIVES: To evaluate the effect of an electronic medication administration record (eMAR) application on the rate of medication errors in medication administration recording (ME-MAR). METHODS: A before-and-after, quasiexperimental study was conducted in a university hospital that implemented the eMAR application in March 2014. Data collection was conducted in April 2012 (pre-) and June 2014 (post-) by two pharmacists. The ME-MARs were analysed by the staff involved to identify their cause. The two pharmacists independently classified the ME-MARs. In the case of disagreement, a research team examined the ME-MARs and categorized them by consensus. Three classifications were used: A classic medication error taxonomy and 2 technology-induced error taxonomies. RESULTS: The pharmacists analysed 2835 (pre-) and 2621 (post-) medication administration records (MAR), respectively. Overall, the ME-MAR rate decreased from 48.0% (pre-) to 36.9% (post-) (P < .05). The same types of ME-MAR were observed in both phases except for "MAR with incomplete information," which was not observed in the postimplementation phase. In both phases, the most frequent ME-MAR was "MAR at the wrong time" (MAR before or after medication administration) (31.6% vs 30.2%). The main cause of ME-MARs in both phases was the failure to follow work procedures. The potential future risk of ME-MARs significantly decreased after the eMAR implementation (P < .05). All ME-MARs were "use errors" because of human factors. New ME-MARs (1.24%; n = 12) were observed in the postimplementation phase. CONCLUSION: Use of the eMAR application significantly reduces the rate of ME-MAR and their potential risk. The main cause of ME-MAR was the failure to follow work procedures.