Drug utilization study on immediate release Fentanyl in Spain. Prevalence, incidence, and indication.

PURPOSE: We aimed to characterize the trends of immediate release fentanyl (IRF) use in Spain between 2012 and 2017 and indication for its use. IRF drugs are rapid-acting opioids approved to treat breakthrough cancer pain (BTCP) in patients already receiving maintenance opioid therapy for chronic cancer pain. A substantial increase in consumption of IRF has been observed with emerging cases of abuse and dependence, most of them in noncancer patients. METHODS: An ecological descriptive consumption study with aggregated data from drug dispensed by community pharmacies and reimbursed by the National Health System in which Defined Daily Doses per 10 000 inhabitants (DID) were calculated and a retrospective cohort study using data from the Spanish Database for Pharmacoepidemiological Research in Primary Care in which participants entered the cohort study after 1 year with the Primary Care Practitioners were performed. Annual prevalence and incidence rate of IRF use were estimated by sex and calendar year. Potential indication was also assessed. RESULTS: IRF use in Spain increased from 2.1 DID in 2012 to 3.8 DID in 2017. The incidence rate and prevalence increased in 53% and 74%, respectively. Patients without previous cancer or BCTP diagnosis represented 27% of incident users, predominantly women. Half of patients with noncancer-related diagnosis had a musculoskeletal disorder linked to the first IRF prescription. CONCLUSIONS: National consumption and new IRF users in Spain increased over the study period and one quarter of patients did not have a BTCP or cancer diagnosis registered in their clinical record.

An imported case of vaccine-derived poliovirus type 2, Spain in the context of the ongoing polio Public Health Emergency of International Concern, September 2021.

The monthly retrospective search for unreported acute flaccid paralysis (AFP) cases conducted as a complementary component of the Spanish AFP surveillance system identified a case of AFP in a child admitted in Spain from Senegal during August 2021. Vaccine-derived poliovirus 2 was identified in the stool in September 2021. We present public health implications and response undertaken within the framework of the National Action Plan for Polio Eradication and the Public Health Emergency of International Concern.

[Eradication of poliomyelitis in Spain: What has happened in the last decade?] / Erradicación de la poliomielitis en España: ¿qué ha pasado en la última década?

On the 60th anniversary of the initiation of the polio vaccination campaign in Spain, the significant milestone in achieving disease control is highlighted. There has been a shift from an incidence of over 2,000 yearly cases in the 1960s to a sustained absence of wild poliovirus (WPV) since 1988. Despite the observed negative impact on polio vaccination coverage at the onset of the COVID-19 pandemic, these rates gradually recovered, reaching 98.2% in primary vaccination in 2022. Over the past decade, two essential elements have been identified to maintain the goal of polio elimination and that reinforces the importance of sustaining high vaccination coverage: robust epidemiological surveillance systems and a swift response to alerts to protect the vulnerable population and prevent virus reintroduction. In order to achieve eradication, it is crucial to interrupt international transmission and maintain continuous high-quality surveillance and effective coordination across different levels in response to any detection of PV, wild or vaccine derived. This article aimed to provide a comprehensive view of the polio eradication situation in Spain, focusing on the key events that occurred in the last decade and the present and future challenges.

hito en el control de la enfermedad que ha supuesto el cambio desde una incidencia de más de 2.000 casos anuales en la década de los 60 a una ausencia mantenida de poliovirus (PV) salvaje desde 1988. A pesar del impacto negativo observado en las coberturas de vacunación de poliomielitis al inicio de la pandemia de la COVID-19, estas se fueron recuperando, alcanzando un 98,2% en la primovacunación en 2022. En la última década se han identificado dos elementos esenciales para mantener el objetivo de eliminación de la poliomielitis y que, además, refuerzan la importancia de mantener altas coberturas de vacunación: los sistemas de vigilancia epidemiológica robustos y la respuesta rápida a las alertas para proteger a la población vulnerable y evitar la circulación del virus. Es crucial interrumpir la transmisión a nivel internacional para lograr la erradicación, manteniendo una vigilancia continua de alta calidad y una coordinación efectiva entre los diferentes niveles frente a cualquier detección de PV, ya sea salvaje o derivado de la vacuna. Este artículo tuvo como objetivo proporcionar una visión integral sobre la situación de erradicación de la poliomielitis en España, centrándose en los eventos clave ocurridos en la última década y en los retos presentes y futuros.

[Updated cost of vaccinating throughout life in Spain in 2023]. / Actualización del coste de vacunar a lo largo de toda la vida en España para el año 2023.

OBJECTIVE: Four modifications were introduced in the Lifetime Vaccination Schedule of the Interterritorial Council of the National Health System (CISNS) in 2023.The aim of this study was to estimate the cost of vaccinating a healthy person and people with certain risk conditions throughout life in Spain and to compare with a previous estimation from 2019. METHODS: A descriptive study of the cost of administering the vaccines included in the Lifetime Vaccination Schedule for the year 2023 and in the schedule for risk groups was carried out. RESULTS: The estimated cost to immunize a healthy person throughout life in 2023 is 1,541.56€ for a woman and 1,498.18€ for a men, which corresponds to an increase of 125% compared to the cost in 2019. The risk conditions with the highest cost are asplenia and complement deficiency and primary immunodeficiencies, with a cost of 3,159.82 euros and 2,566 euros respectively on average. The cost of vaccinating the whole healthy population in Spain in a year is around 565M€. Moreover, the cost of vaccinating the new-borns cohort of 2023 was estimated at 500M€. CONCLUSIONS: Despite the cost increase in 2023, immunization is still a very cheap intervention, considering the economic impact of immunopreventable diseases in the society. The relative low cost of immunization throughout life makes this health intervention useful and worthwhile.

OBJECTIVE: En el calendario de vacunación a lo largo de toda la vida del Consejo Interterritorial del Sistema Nacional de Salud (CISNS) se introdujeron cuatro modificaciones importantes en 2023. El objetivo de este estudio fue estimar el coste de la vacunación a lo largo de toda la vida a una persona sana y a ciertos grupos de riesgo tomando como referencia el calendario de 2023 y compararlo con una estimación previa de 2019. METHODS: Se realizo un estudio descriptivo del coste de administrar las vacunas incluidas en el calendario de vacunación a lo largo de toda la vida para el año 2023 y en el calendario para grupos de riesgo. RESULTS: El coste estimado de vacunar a una persona sana a lo largo de toda la vida en 2023 es de 1.541,56 euros en mujeres y 1.498,18 euros en hombres, lo que supondría un incremento del 125% con respecto al coste en 2019. Las condiciones de riesgo con el coste más alto son asplenia además de déficit del complemento e inmunodeficiencias primarias, suponiendo 3.159.82 euros y 2.566 euros, respectivamente, de media. Vacunar a toda la población sana en España en un año costaría unos 565 millones de euros y vacunar a la cohorte de recién nacidos de 2023 a lo largo de toda la vida unos 500 millones de euros. CONCLUSIONS: A pesar del incremento en el coste en 2023, considerando el impacto económico de las enfermedades prevenibles por vacunación en la sociedad, la vacunación sigue siendo una intervención barata que aporta múltiples beneficios.

[Non-inferiority studies efficacy and safety: review of methodological and statistical aspects in clinical trials and non-interventional studies with medicinal products.] / Estudios de no inferioridad de eficacia y seguridad: revisión e interpretación de aspectos metodológicos y estadísticos en ensayos clínicos y estudios observacionales con medicamentos.

Non-inferiority studies are increasingly more common for introducing new medicines in the market. Despite being situations where the use of this study design is justified, there is not a common analytical approach on how to conduct them. Pursuing a rigorous methodology, both in the study conduction and in its disseminations, is critical to ensure robust results to enable regulatory agencies and clinicians to reach valid conclusions and decisions which ultimately will benefit clinical practice. Most of the published reviews focus on the efficacy outcomes of non-inferiority clinical trials. We are unaware of other reviews that goes beyond and includes specific aspects for non-interventional designs and for studies focused on safety. Moreover, this review provides a simple and practical perspective with a minimum mathematical content on this complex type of studies.

Los estudios de no inferioridad son cada vez más frecuentes para introducir nuevos medicamentos en el mercado. Aunque existen situaciones en las que su uso está justificado, no existe un enfoque analítico único y conservador. Para arrojar resultados fiables y de calidad, deben seguir una estricta metodología, tanto en la ejecución como en la difusión de los resultados, la cual permita, tanto a las agencias reguladoras como a los clínicos, establecer conclusiones válidas y decisiones que repercutan en beneficio de la práctica clínica. La mayor parte de las revisiones publicadas se centran en los ensayos clínicos de no inferioridad de eficacia. En esta revisión se contemplan, además, los diseños observacionales y los aspectos específicos de los estudios de seguridad. Todo ello desde un punto de vista práctico y sencillo, con un contenido matemático mínimo.