RESUMO
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.
Assuntos
Infecções por HIV , Prescrição Inadequada , Humanos , Idoso , Infecções por HIV/complicações , Infecções por HIV/tratamento farmacológico , Polimedicação , Europa (Continente) , PrescriçõesRESUMO
Despite in vitro activity of interferon-ß (IFN-ß) against SARS-CoV-2 infection, its clinical efficacy remains controversial. We evaluated the impact of IFN-ß treatment in a cohort of 3590 patients hospitalized with COVID-19 during March−April 2020. The primary endpoint was a composed variable of admission to intensive care unit (ICU)/death. Overall, 153 patients (4%) received IFN-ß. They were significantly more severely ill, with a worse clinical and analytical situation, explaining a higher ICU admission (30% vs. 17%; p < 0.01), and a shorter time to the composed variable. In a Cox regression analysis, older age, lymphopenia, renal failure, or increased neutrophil-to-lymphocyte ratio were associated with a greater hazard ratio (HR) of admission at ICU/death. Notably, the HR of IFN-ß for the outcome variable was no longer significant after adjustment (HR, 1.03; 95% CI, 0.82−1.30), and different sensitivity analysis (early IFN use, ICU admission) showed no changes in the estimates. A propensity score matching analysis showed no association of IFN-ß therapy and outcome. In conclusion, in this large cohort of hospitalized COVID-19 patients, IFN-ß was used mainly in patients with advanced disease, reflecting an important bias of selection. After adjusting by severity, IFN-ß was not associated with a higher rate of ICU admission or mortality.
RESUMO
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.
Assuntos
Ensaios Clínicos como Assunto , Prescrições de Medicamentos , Drogas em Investigação/uso terapêutico , Erros de Medicação/estatística & dados numéricos , Segurança do Paciente , Hospitais , Humanos , Estudos Prospectivos , Medição de Risco , EspanhaRESUMO
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.