Más no siempre es mejor. Pauta individual o calendario sistemático en vacuna antineumocócica / More is not always better. Individual guideline or systematic vaccination against pneumococcus

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Seguridad de las vacunas antigripales en grupos de riesgo: análisis de las sospechas de reacciones adversas notificadas en Comunidad Valenciana entre 2005 y 2011 / Safety of influenza vaccines in risk groups: analysis of adverse events following immunization reported in Valencian Community from 2005 to 2011

Objetivo. Evaluar las notificaciones de sospechas de reacciones adversas a las vacunas administradas frente a la gripe, por sexo, grupos de riesgo y por grupos de edad en la Comunidad Valenciana desde el año 2005 a 2011. Métodos. Se ha realizado un estudio farmacoepidemiológico de diseño observacional descriptivo y transversal, basado en las notificaciones de sospechas de reacciones adversas a las vacunas (NRAV) frente a la gripe, registradas a través del Sistema de Información Vacunal (SIV) de la Comunidad Valenciana, de 1 de enero de 2005 hasta 31 de diciembre de 2011. Resultados. Durante el periodo de estudio se registraron 5.107.790 dosis de vacuna frente a la gripe, con una tasa de notificación de NRAV de 1,94 por 100.000 (IC95% 1,59-2,36) y 228.094 dosis de vacuna de gripe A(H1N1)pdm09 (tasa 96,45 por 100.000; IC95% 84,52-110,06). El 70,71% (70) y el 64,55% (142), respectivamente, de las NRAV correspondieron a mujeres. El grupo de riesgo de trabajadores sociosanitarios presentó una mayor tasa de notificación para la gripe estacional (25,35 por 100.000; IC95%: 17,65-36,40) así como para gripe A(H1N1)pdm09 (864,13 por 100.000; IC95% 714,38-1044,93) durante el periodo de estudio. Conclusiones. Las vacunas frente a la gripe administradas durante el periodo de estudio muestran un elevado perfil de seguridad tanto en población con patología de riesgo como en otros grupos diana susceptibles de la vacunación. Las reacciones registradas durante el estudio coinciden en su mayoría con las descritas en las fichas técnicas de las vacunas (AU)

Objective. To evaluate reports of adverse events following influenza immunization by sex, risk and age groups in Valencian Community from 2005 to 2011. Methods. A pharmacoepidemiological descriptive cross-sectional observational study based on the reports of adverse events following immunization (AEFI) against influenza, registered through the Vaccination Information System (SIV) of Valencian Community from 1 January 2005 until 31 December 2011 was done. Results. During the study period 5,107,790 doses of vaccine against influenza were reported, with an AEFI incidence of 1.94 per 100,000 (95% CI 1.59 to 2.36), and 228,094 doses of vaccine for influenza A (H1N1) pdm09 (96.45 per 100,000, 95%CI 84.52-110.06). The 70.71% (70) and 64.55% (142), respectively, of AEFI were in women. The healthcare workers group had a higher reporting rate for seasonal influenza (25.35 per 100,000; 95%CI: 17.65-36.40) and for influenza A(H1N1) pdm09 (864.13 per 100,000; 95%CI 714.38-1044.93) during the study period. Conclusions. Vaccines against influenza administered during the study had a high safety profile in both populations with disease risk and other susceptible target groups of vaccination. Adverse reactions reported during the study mostly coincide with those described in the summary of product characteristics of vaccines (AU)

[Safety of influenza vaccines in risk groups: analysis of adverse events following immunization reported in Valencian Community from 2005 to 2011]. / Seguridad de las vacunas antigripales en grupos de riesgo: análisis de las sospechas de reacciones adversas notificadas en Comunidad Valenciana entre 2005 y 2011.

OBJECTIVE: To evaluate reports of adverse events following influenza immunization by sex, risk and age groups in Valencian Community from 2005 to 2011. METHODS: A pharmacoepidemiological descriptive cross-sectional observational study based on the reports of adverse events following immunization (AEFI) against influenza, registered through the Vaccination Information System (SIV) of Valencian Community from 1 January 2005 until 31 December 2011 was done. RESULTS: During the study period 5,107,790 doses of vaccine against influenza were reported, with an AEFI incidence of 1.94 per 100,000 (95% CI 1.59 to 2.36), and 228,094 doses of vaccine for influenza A (H1N1) pdm09 (96.45 per 100,000, 95%CI 84.52-110.06). The 70.71% (70) and 64.55% (142), respectively, of AEFI were in women. The healthcare workers group had a higher reporting rate for seasonal influenza (25.35 per 100,000; 95%CI: 17.65-36.40) and for influenza A(H1N1) pdm09 (864.13 per 100,000; 95%CI 714.38-1044.93) during the study period. CONCLUSIONS: Vaccines against influenza administered during the study had a high safety profile in both populations with disease risk and other susceptible target groups of vaccination. Adverse reactions reported during the study mostly coincide with those described in the summary of product characteristics of vaccines.

[Variability in the reporting of adverse reactions to the pandemic and seasonal influenza vaccine: seasons 2009-2010 and 2010-2011. Valencian community, Spain]. / Variabilidad en la notificación de reacciones adversas a las vacunas de la gripe pandémica y estacional: Temporadas 2009-2010 y 2010-2011, Comunitat Valenciana.

BACKGROUND: The loss of confidence in the safety of vaccines derived from alarm conditions, as in the case of the flu pandemic may affect both vaccination coverage and the sensitivity to the reporting of suspected adverse reactions associated vaccines (SRAAV). The aim of the study is to describe the adverse effects reported to the vaccine against pandemic influenza in the 2009-2010 season and against seasonal influenza in 2009-2010 and 2010-2011 seasons, by type of vaccine, risk groups and by age group in the Valencian Community (CV). METHODS: A retrospective descriptive study has been made of the individuals presenting suspected adverse reactions to the influenza vaccine reported through the Vaccine Information System during the seasons 2009-2010 and 2010-2011 in the Valencian Community. 95% confidence intervals were calculated. RESULTS: During the period 2009-2010 the reporting rate of suspected reactions for seasonal influenza vaccine was 0.020 per thousand doses administered, for the pandemic vaccine 0.95. The reporting rate for seasonal influenza vaccine in the period 2010-2011 was 0.04 per thousand. CONCLUSIONS: There was an increase in the number of reported suspected adverse reactions to the pandemic vaccines compared with the rest of influenza vaccines, during the seasons. The highest suspected adverse reaction reporting rate was for the group of health professionals partner for both vaccines against seasonal and pandemic influenza.

Variabilidad en la notificación de reacciones adversas a las vacunas de la gripe pandémica y estacional. Temporadas 2009-2010 y 2010-2011, Comunitat Valenciana / Variability in the reporting of adverse reactions to the pandemic and seasonal inluenza vaccine. Seasons 2009-2010 and 2010-2011. Valencian Community, Spain

Fundamentos: La pérdida de confianza en la seguridad de las vacunas derivada de situaciones de alarma, como en el caso de la gripe pandémica, puede afectar tanto a las coberturas vacunales como a la sensibilidad frente a la notificación de las sospechas de reacciones adversas asociadas a vacunas (SRAAV). El objetivo del trabajo es describir los efectos adversos a la vacuna frente a la gripe pandémica notificados en la temporada 2009-2010 y comparar si existen diferencias con los descritos con la vacuna de la gripe estacional en las temporadas 2009-2010 y 2010-2011 en la Comunitat Valenciana (CV). Métodos: Se realizó un estudio descriptivo de los individuos vacunados frente a la gripe que presentaron alguna SRAAV a la vacuna antigripal y que fue notificada a través del Sistema de Información Vacunal, durante las temporadas 2009-2010 (incluyendo la vacunación pandémica) y 2010-2011 en CV. se calcularon las tasas de notificación de sospechas de reacciones adversas asociadas a vacunas por cada mil dosis de vacunas administradas y sus intervalos de confianza al 95%. Resultados: Durante el periodo 2009-2010 la tasa de notificación de SRAAV para la vacuna de la gripe estacional fue de 0,02 por mil dosis administradas, para la vacuna pandémica de 0,95. En el periodo 2010-2011 la tasa para la vacuna de la gripe estacional fue de 0,04 por mil. Conclusiones: Durante las temporadas analizadas se incrementó el número de notificaciones de SRAAV para las vacunas pandémicas en comparación con el resto de vacunas antigripales. La mayor tasa de notificación de SRAAV correspondió al grupo de profesionales sociosanitarios, tanto para las vacunas frente a la gripe estacional como pandémica(AU)

Background: The loss of confidence in the safety of vaccines derived from alarm conditions, as in the case of the flu pandemic may affect both vaccination coverage and the sensitivity to the reporting of suspected adverse reactions associated vaccines (SRAAV). The aim of the study is to describe the adverse effects reported to the vaccine against pandemic influenza in the 2009-2010 season and against seasonal influenza in 2009-2010 and 2010-2011 seasons, by type of vaccine, risk groups and by age group in the Valencian Community(CV). Methods: A retrospective descriptive study has been made of the individuals presenting suspected adverse reactions to the influenza vaccine reported through the Vaccine Information System during the seasons 2009-2010 and 2010-2011 in the Valencian Community. 95% confidence intervals were calculated. Results: During the period 2009-2010 the reporting rate of suspected reactions for seasonal influenza vaccine was 0.020 per thousand doses administered, for the pandemic vaccine 0.95. The reporting rate for seasonal influenza vaccine in the period 2010-2011 was 0.04 per thousand. Conclusions: There was an increase in the number of reported suspected adverse reactions to the pandemic vaccines compared with the rest of influenza vaccines, during the seasons. The highest suspected adverse reaction reporting rate was for the group of health professionals partner for both vaccines against seasonal and pandemic influenza(AU)

[Public health service prescriptions of vaccines not included in systematic vaccination programs in Valencian community, Spain, during the period 2004-2009]. / Prescripción de vacunas no incluidas en el calendario vacunal en la Comunitat Valenciana durante el período 2004-2009.

BACKGROUND: In the context of the policies of rational use of medicine, and in order to achieve an efficient management of the vaccinations programs, we expect to know the number of packings and cost of prescribed vaccines not included in the vaccination programs of Valencian Community and its departments during 2009 and to analyze its evolution since 2004, focusing on an analysis of Heptavalent pneumococcal conjugate vaccine in children under two years old. METHODS: Retrospective descriptive study to analyze the prescriptions of vaccines in Valencian Community during 2009 and its evolution since 2004. VARIABLES: vaccine availability, number of packings, group of beneficiary (actives/pensioners), department, and cost of prescriptions. DATA SOURCES: Gestor de Prestación Farmacéutica (GAIA) and Sistema Información Poblacional (SIP). RESULTS: In 2009 prescribed vaccines on official national health system prescription forms that are not included in vaccination programs, supposed a cost of 683.445,71 € corresponding to 17.353 packings (87% of the total prescribed vaccines). Heptavalent pneumococcal conjugate vaccine generated 72% of the total cost of vaccines not included in the vaccination programs. The trend from 2004 to 2009 shows an increase in expenditure of 735.334 € (24,66%) in 2005 from which there takes place a marked and gradual decrease that reaches 1.562.650,67 € (-228.64%). The cost by departments of prescriptions per 1000 children under two years old of pneumococcal conjugate vaccine ranges between 17.377 and 324 €. CONCLUSIONS: The declining trend of prescriptions, mainly of pneumococcal conjugate vaccines, continues during 2009. A great interdepartmental variability is observed, nevertheless, in rates of prescription that should be corrected.

Prescripción de vacunas no incluidas en el calendario vacunal en la Comunitat Valenciana durante el período 2004-2009 / Public health service prescriptions of vaccines not included in systematic vaccination programs in valencian community, Spain, during the period 2004-2009

Fundamentos: En el marco de las políticas de uso racional del medicamento, y al objeto de conseguir una gestión eficiente de los programas de vacunaciones, el objetivo de este trabajo es conocer el número de envases de las vacunas prescritas no incluidas en los programas de vacunación en la Comunitat Valenciana y en sus departamentos de salud, así como el gasto que produjeron en 2009, y analizar la evolución desde 2004, centrando el análisis en la vacuna heptavalente conjugada frente al Streptococcus pneumoniae en menores de dos años. Método: Estudio descriptivo retrospectivo de las vacunas prescritas mediante receta en la Comunitat Valenciana durante el año 2009 y su evolución desde 2004. Variables: número de envases, tipo de beneficiario (activo/pensionista), departamento y gasto generado. Fuentes: Gestor de Prestación Farmacéutica (GAIA) y Sistema Información Poblacional (SIP). Resultados: En 2009 la prescripción mediante receta de vacunas no incluidas en los programas de vacunación generó un gasto de 683.445,71 ] correspondiente a 17.353 envases, lo que supuso el 87! del total del gasto en vacunas recetadas. La vacuna frente al S. pneumoniae generó el 72! del gasto total de las vacunas no incluidas en el calendario. La evolución 2004-2009 muestra un aumento del gasto de 735.334 ] (24,66!) en 2005 a partir del cual se produjo un descenso acusado y paulatino que alcanzó los 1.562.650,67 ] (-228.64!). El gasto por departamentos para la vacuna del neumococo conjugada heptavalente por mil niños/as menores de dos años osciló entre 17.377 y 324 ]. Conclusiones: La tendencia descendente del gasto en recetas prescritas se mantuvo durante 2009, fundamentalmente de vacunas conjugadas frente a neumococo. No obstante, se observó gran variabilidad interdepartamental en las tasas de prescripción que debe ser corregida(AU)

Background: In the context of the policies of rational use of medicine, and in order to achieve an efficient management of the vaccinations programs, we expect to know the number of packings and cost of prescribed vaccines not included in the vaccination programs of Valencian Community and its departments during 2009 and to analyze its evolution since 2004, focusing on an analysis of Heptavalent pneumococcal conjugate vaccine in children under two years old. Methods: Retrospective descriptive study to analyze the prescriptions of vaccines in Valencian Community during 2009 and its evolution since 2004. Variables: vaccine availability, number of packings, group of beneficiary (actives/pensioners), department, and cost of prescriptions. Data sources: Gestor de Prestación Farmacéutica (GAIA) and Sistema Información Poblacional (SIP). Results: In 2009 prescribed vaccines on official national health system prescription forms that are not included in vaccination programs, supposed a cost of 683.445,71 ] corresponding to 17.353 packings (87! of the total prescribed vaccines). Heptavalent pneumococcal conjugate vaccine generated 72! of the total cost of vaccines not included in the vaccination programs. The trend from 2004 to 2009 shows an increase in expenditure of 735.334 ] (24,66!) in 2005 from which there takes place a marked and gradual decrease that reaches 1.562.650,67 ] (-228.64!). The cost by departments of prescriptions per 1000 children under two years old of pneumococcal conjugate vaccine ranges between 17.377 and 324 ]. Conclusions: The declining trend of prescriptions, mainly of pneumococcal conjugate vaccines, continues during 2009. A great interdepartmental variability is observed, nevertheless, in rates of prescription that should be corrected(AU)