[Ethics Committee experience during COVID-19 emergency. A brief report.] / Experiencia de un Comité de Ética de la Investigación durante la pandemia por COVID-19.

OBJECTIVE: The health crisis caused by COVID-19 required the prompt launch of research in order to generate scientific evidence pertaining to the new disease oriented to control its devastating effects and continuous spread. Therefore, it was essential to adapt the work flow of Research Ethics Committees, to prioritize and to accelerate the evaluation of projects related to this disease. METHODS: This work analyses the evaluation conducted by our Regional Ethics Committees during the initial period of the health emergency (between 13th March and 28th May 2020). RESULTS: 81 research projects were evaluated, 73 of them of regional scope (62 single-centre), 4 national and 4 international. 57 projects obtained a favourable opinion, 4 were withdrawn by the sponsors, 6 did not require ethics approval and 14 did not respond to the clarifications requested up to the date of the study's closure. CONCLUSIONS: The most important research procedures to be analysed in this context are those related to the methodology and informed consent process. It is also essential to address aspects related to the privacy of personal data, and to take into account the workload of the researchers. As an improvement proposal, we think that greater collaboration between the different research teams should be encourage to obtain more robust results.

OBJETIVO: La crisis sanitaria motivada por la COVID-19 hace necesaria la puesta en marcha, con celeridad, de investigaciones encaminadas a generar evidencias científicas que incidan en el control de sus devastadores efectos. Por ello, fue necesario realizar ajustes en la dinámica de trabajo de los Comités de Ética de la Investigación, así como priorizar y agilizar la evaluación de los proyectos relacionados con dicha enfermedad. Este trabajo pretendió analizar la actividad la actividad evaluadora del Comité de Ética de la Investigación con Medicamentos de Galicia (CEIm-G) durante dicho período de emergencia sanitaria. METODOS: Se evaluaron 81 proyectos de investigación, 73 de ellos de ámbito autonómico (62 unicéntricos), 4 nacionales y 4 internacionales. RESULTADOS: En 57 proyectos el dictamen fue favorable, 4 fueron retirados por los promotores, en 6 no procedía dictamen y 14 no respondieron a las aclaraciones solicitadas hasta la fecha del cierre del estudio. CONCLUSIONES: Las causas más frecuentes de solicitud de aclaraciones están relacionadas con la metodología y, a continuación, con la hoja de información al paciente y el consentimiento informado. También es imprescindible abordar los aspectos relacionados con la intimidad de los datos personales y las muestras, e igualmente tener en cuenta la carga de trabajo de los investigadores. Como propuesta de mejora, consideramos que se debe incidir en una mayor coordinación entre los diferentes equipos de investigación para tratar de obtener resultados más robustos.

Influence of health warnings on the use of rosiglitazone and pioglitazone in an area of Spain: A time-series study.

BACKGROUND: Throughout 2007 and January 2008, several glitazones health warnings were published on rosiglitazone myocardial infarction risk. The impact of such warnings on glitazones prevalence of utilization has been extensively studied in the United States but only in one European country (England), which has showed different pattern from US studies. The aim of this study is to evaluate the impact of such safety warnings on glitazones utilization in an area of another European country. METHODS: We calculated the number of defined daily doses per thousand inhabitants per day of glitazones each month during the period from 2006 to 2008 in a health area of Spain. We analyzed the data graphically and through a segmented regression analysis. RESULTS: Rosiglitazone defined daily doses per thousand inhabitants per day were growing before the safety warnings, after the warnings a change in trend occurred and rosiglitazone utilization showed a downturn slope. Pioglitazone defined daily doses per thousand inhabitants per day were stable before the safety warnings, and a linear growth was observed after the safety warnings. Throughout the study period, rosiglitazone defined daily doses per thousand inhabitants per day were higher than pioglitazone defined daily doses per thousand inhabitants per day until near the end of 2008. CONCLUSION: Despite the fact that cardiovascular warnings affected rosiglitazone and not pioglitazone, rosiglitazone was more utilized than pioglitazone until near the end of 2008 which is a pattern similar to the one found in another European studies in England, but very different from studies in the United States, where rosiglitazone was less utilized than pioglitazone from the first month after rosiglitazone cardiovascular safety warnings.

Impact of a health safety warning and prior authorisation on the use of piroxicam: a time-series study.

BACKGROUND: The aim of this study was to assess the quantitative changes in systemic use of piroxicam after the issue of a health safety warning about its risks and the subsequent implementation of prior authorisation. METHODS: We determined the number of monthly daily defined doses/1000 inhabitants/day (DHDs) of piroxicam in the period 2005-2008 in a health area in Spain. The data were analysed graphically, and the impact of the safety warning and introduction of prior authorisation were estimated by using segmented regression analysis. RESULTS: The graph showed that the number of DHDs of piroxicam was stable both before and after the health safety warning but registered a very marked decrease after implementation of prior authorisation, after which DHDs of piroxicam remained stable at a 98% inferior level compared with previous to prior authorisation. Segmented regression analysis showed no statistically significant immediate jump in piroxicam utilisation after the safety warning nor a change in the slope afterwards, but it did show a significant immediate jump after prior authorisation. CONCLUSION: Population exposure to systemic piroxicam remained unaffected by a previous health safety warning but declined sharply after the introduction of prior authorisation.

Influencia de una alerta sanitaria sobre la utilización de telitromicina / Influence of a regulatory safety warning on the use of telithromycin

No disponible

Impacto de una alerta sanitaria sobre la utilización de ranelato de estroncio / Impact of a health safety warning on strontium ranelate utilization

ObjetivoEvaluar la evolución del uso de ranelato de estroncio tras la publicación de una alerta sanitaria en noviembre de 2007 sobre los riesgos de desarrollo de DRESS (Drug Rash with Eosinophilia and Sistemic Symptoms) por este medicamento.MétodoSe calculan las DHD (dosis diarias definidas/1.000 habitantes/día) mensuales de ranelato de estroncio entre 2006 y 2008 en un área sanitaria de España. Se analizan los datos gráficamente y mediante un modelo de regresión múltiple.ResultadosLa representación gráfica muestra una tendencia a largo plazo creciente durante todo el periodo de estudio, aunque el ritmo de crecimiento es inferior después de la emisión de la alerta. El modelo de regresión múltiple muestra que la alerta sanitaria resulta ser estadísticamente significativa.ConclusiónLa utilización de ranelato de estroncio sigue creciendo después de la emisión de la alerta sanitaria, aunque a un ritmo menor que antes(AU)

ObjectiveTo evaluate changes in the use of strontium ranelate following a health safety warning in November 2007 on the risks of the development of DRESS (Drug Rash with Eosinophilia and Systemic Symptoms) with the use of this medicine.MethodMonthly strontium ranelate DHD (daily defined doses/1,000 inhabitants/day) were calculated between 2006 and 2008 in a health area of Spain. The data were analyzed graphically and through a multiple regression model.ResultsGraphical representation showed a long-term rising trend throughout the study period, although growth slowed after the safety warning was issued. The multiple regression model showed that the health warning was statistically significant.ConclusionThe use of strontium ranelate continues to grow after the issue of the health safety warning, although at a slower pace than previously(AU)

[Impact of a health safety warning on strontium ranelate utilization]. / Impacto de una alerta sanitaria sobre la utilización de ranelato de estroncio.

OBJECTIVE: To evaluate changes in the use of strontium ranelate following a health safety warning in November 2007 on the risks of the development of DRESS (Drug Rash with Eosinophilia and Systemic Symptoms) with the use of this medicine. METHOD: Monthly strontium ranelate DHD (daily defined doses/1,000 inhabitants/day) were calculated between 2006 and 2008 in a health area of Spain. The data were analyzed graphically and through a multiple regression model. RESULTS: Graphical representation showed a long-term rising trend throughout the study period, although growth slowed after the safety warning was issued. The multiple regression model showed that the health warning was statistically significant. CONCLUSION: The use of strontium ranelate continues to grow after the issue of the health safety warning, although at a slower pace than previously.

Metformina también como primera elección en pacientes con peso normal. ¿Se ha incrementado su uso? / Metformin also as first choice in patients with normal weight. Has its use increased?

ObjetivoEvaluar si tras la publicación en agosto de 2006 de los nuevos algoritmos de consenso con la recomendación de utilizar metformina de elección también en pacientes con normopeso se ha producido un aumento en la utilización de este medicamento en el periodo inmediatamente posterior.DiseñoEstudio longitudinal-retrospectivo.EmplazamientoÁrea Sanitaria de Santiago de Compostela, A Coruña.Participantesusuarios del Servicio Gallego de Salud en el Área Sanitaria de Santiago de Compostela.MétodosSe estudia la evolución de las dosis diarias definidas/1.000 habitantes/día (DHD) mensuales de metformina desde principios de 2003 hasta 12 meses después de la publicación de los nuevos algoritmos, analizando los datos gráficamente y mediante un modelo de regresión múltiple.ResultadoLa representación gráfica de la serie temporal de las DHD de metformina muestra un crecimiento lineal para el periodo, y se aprecia aumento de la tendencia de crecimiento tras la publicación del nuevo algoritmo de consenso. La regresión múltiple muestra que el aumento es estadísticamente significativo.ConclusionesTras la publicación de los nuevos algoritmos de consenso, se observa a corto plazo un aumento de la tendencia de crecimiento en la utilización de metformina(AU)

ObjectiveTo assess whether the release of the new consensus algorithms in August 2006, along with the consensus recommendation of also using metformin as first choice in patients with normal weight, has led to an increase in the use of this drug in the period immediately after.DesignRetrospective longitudinal Study.SitesSantiago de Compostela Health District (A Coruña).ParticipantsUsers of the Galician health service in the Santiago de Compostela Health District.MethodsThe evolution of the monthly number of DHD (Daily Defined Doses/1000 inhabitants/day) of metformin from early 2003 until 12 months after the issuing of new algorithms was analysed graphically and using a multiple regression model.ResultsThe graphical representation of the DHD of metformin over time shows a linear growth for the period, but there is an increasing trend after the publication of the new consensus algorithm. The multiple regression showed that the increase is statistically significant.ConclusionsFollowing the publication of the new consensus algorithm an increasing trend in the use of metformin is observed in the short term(AU)

[Metformin also as first choice in patients with normal weight. Has its use increased?]. / Metformina también como primera elección en pacientes con peso normal. ¿Se ha incrementado su uso?

OBJECTIVE: To assess whether the release of the new consensus algorithms in August 2006, along with the consensus recommendation of also using metformin as first choice in patients with normal weight, has led to an increase in the use of this drug in the period immediately after. DESIGN: Retrospective longitudinal Study. SITES: Santiago de Compostela Health District (A Coruña). PARTICIPANTS: Users of the Galician health service in the Santiago de Compostela Health District. METHODS: The evolution of the monthly number of DHD (Daily Defined Doses/1000 inhabitants/day) of metformin from early 2003 until 12 months after the issuing of new algorithms was analysed graphically and using a multiple regression model. RESULTS: The graphical representation of the DHD of metformin over time shows a linear growth for the period, but there is an increasing trend after the publication of the new consensus algorithm. The multiple regression showed that the increase is statistically significant. CONCLUSIONS: Following the publication of the new consensus algorithm an increasing trend in the use of metformin is observed in the short term.