Notificación de reacciones adversas a la vacuna frente al virus del papiloma humano en la Comunidad Valenciana (2007-2011) / Adverse reactions to human papillomavirus vaccine in the Valencian Community (2007-2011)

INTRODUCCIÓN: En 2009, 2 casos de convulsiones en adolescentes tras la administración de la vacuna tetravalente frente al virus del papiloma humano (VPH) generaron impacto mediático y afectaron negativamente la confianza del público en esta vacuna. Nuestros objetivos fueron describir las sospechas de reacciones adversas (SRA) notificadas al Centro Autonómico de Farmacovigilancia de la Comunidad Valenciana (CAFCV) tras la administración de la vacuna frente al VPH y comparar la tasa de notificación de síncope y convulsiones de esta vacuna con la de otras vacunas administradas en adolescentes. MATERIAL Y MÉTODOS: Estudio descriptivo de las notificaciones de SRA relacionadas con esta vacuna recibidas por el CAFCV entre 2007 y 2011. RESULTADOS: Las manifestaciones clínicas más comunicadas fueron mareos, cefalea y síncope. Las tasas de notificación de síncope o pérdida de conciencia y convulsiones con la vacuna frente al VPH fueron de 17 y 3,2 por 100.000 dosis administradas, respectivamente, y de 15 y 1,6 para síncope o pérdida de conciencia y convulsiones sincopales ocurridas el día de la vacunación. Las tasas de notificación de síncope o pérdida de conciencia y convulsiones fueron de 6,4 y 0,4 para otras vacunas. CONCLUSIONES: Las tasas de notificación de síncope o pérdida de conciencia y convulsiones fueron mayores para la vacuna frente al VPH que para otras vacunas administradas en adolescentes; esto es consistente con la atención mediática originada por la vacuna y con hallazgos de estudios previos. No obstante, la información obtenida sobre las SRA a la vacuna sugiere un buen perfil de seguridad

INTRODUCTION: In 2009, two cases of seizures in adolescents following quadrivalent human papillomavirus vaccine (qHPV) administration, generated important media attention, and adversely affected public trust in this vaccine. Our objectives were to describe suspected adverse reactions (SARs) reported to the Pharmacovigilance Centre in the Valencian Community (PCVC) after administration of HPV vaccine, and to compare reporting rates of syncope and seizures following this vaccine with those of other vaccines administered to girls aged 13-15 years. MATERIAL AND METHODS: Descriptive study of SARs reported following this vaccine to the PCVC between 2007 and 2011. RESULTS: The clinical symptoms most frequently reported were dizziness, headache, and syncope. Reporting rates of syncope or loss of consciousness and seizures with qHPV vaccine were 17 and 3.2 per 100,000 doses administered, respectively, and 15 and 1.6 for syncope or loss of consciousness and syncopal seizures occurred on the day of vaccination. The reporting rates of syncope or loss of consciousness and seizures were 6.4 and 0.4, for the other vaccines. CONCLUSIONS: Consistent with the media attention generated, and with results from other studies, the reporting rates of syncope or loss of consciousness and seizures were higher for the HPV vaccine than for other vaccines given in adolescence. Nevertheless, the overall information obtained on SARs following the qHPV vaccine suggests a good safety profile

Vigilancia pasiva de la seguridad postautorización de las vacunas frente a rotavirus: sensibilidad de la notificación de invaginación intestinal / Post-licensure passive safety surveillance of rotavirus vaccines: Reporting sensitivity for intussusception

INTRODUCCIÓN: Los objetivos de este estudio fueron describir las notificaciones de sospechas de reacciones adversas relacionadas con las vacunas frente a rotavirus y valorar la sensibilidad de la notificación para invaginación intestinal. MATERIAL Y MÉTODOS: Estudio descriptivo, a partir de las notificaciones de sospechas de reacciones adversas relacionadas con las vacunas frente a rotavirus, ocurridas en niños menores de diez meses, registradas en el Centro de Farmacovigilancia de la Comunidad Valenciana durante el periodo 2007-2011.Se comparó la tasa de notificación de invaginaciones con la tasa de invaginaciones en vacunados obtenida utilizando la base de datos de altas hospitalarias (CMBD) y el registro nominal de vacunaciones autonómico. RESULTADOS: La tasa de notificación de eventos adversos fue de 20 por 100.000 dosis administradas. El 74% de las notificaciones se clasificaron como no graves, siendo la fiebre, los vómitos y la diarrea las sospechas más frecuentes. Dos casos de invaginación, ocurridos en los siete primeros días tras la vacunación, fueron notificados como asociados temporalmente a la vacunación. La sensibilidad de la notificación de invaginación intestinal para el periodo de riesgo de uno a siete días fue del 50%. CONCLUSIONES: Los resultados sugieren que las vacunas frente a rotavirus presentan un perfil de seguridad en general adecuado, y que el Centro de Farmacovigilancia de la Comunidad Valenciana, comparado con otros sistemas de vigilancia pasiva, es igualmente sensible para detectar señales de posible asociación con invaginación intestinal. Este riesgo requiere ser investigado con estudios epidemiológicos bien diseñados y comparado con los evidentes beneficios que estas vacunas proporcionan

INTRODUCTION: The aims of this study were to describe the reports of suspected adverse events due to rotavirus vaccines, and assess the reporting sensitivity for intussusception. MATERIAL AND METHODS: Descriptive study performed using the reports of suspected adverse events following rotavirus vaccination in infants aged less than 10 months, as registered in the Pharmacovigilance Centre of the Valencian Community during 2007-2011.The reporting rate for intussusception was compared to the intussusception rate in vaccinated infants obtained using the hospital discharge database (CMBD), and the regional vaccine registry. RESULTS: The adverse event reporting rate was 20 per 100,000 administered doses, with the majority (74%) of the reports being classified as non-serious. Fever, vomiting, and diarrhea were the adverse events reported more frequently. Two intussusception cases, which occurred within the first seven days post-vaccination, were reported as temporarily associated to vaccination. The reporting sensitivity for intussusception at the Pharmacovigilance Centre in the 1-7 day interval following rotavirus vaccination was 50%. CONCLUSIONS: Our results suggest that rotavirus vaccines have, in general, a good safety profile. Intussusception reporting to the Pharmacovigilance Centre shows sensitivity similar to other passive surveillance systems. The intussusception risk should be further investigated using well-designed epidemiological studies, and evaluated in comparison with the well-known benefits provided by these vaccines

[Adverse reactions to human papillomavirus vaccine in the Valencian Community (2007-2011)]. / Notificación de reacciones adversas a la vacuna frente al virus del papiloma humano en la Comunidad Valenciana (2007-2011).

INTRODUCTION: In 2009, two cases of seizures in adolescents following quadrivalent human papillomavirus vaccine (qHPV) administration, generated important media attention, and adversely affected public trust in this vaccine. Our objectives were to describe suspected adverse reactions (SARs) reported to the Pharmacovigilance Centre in the Valencian Community (PCVC) after administration of HPV vaccine, and to compare reporting rates of syncope and seizures following this vaccine with those of other vaccines administered to girls aged 13-15 years. MATERIAL AND METHODS: Descriptive study of SARs reported following this vaccine to the PCVC between 2007 and 2011. RESULTS: The clinical symptoms most frequently reported were dizziness, headache, and syncope. Reporting rates of syncope or loss of consciousness and seizures with qHPV vaccine were 17 and 3.2 per 100,000 doses administered, respectively, and 15 and 1.6 for syncope or loss of consciousness and syncopal seizures occurred on the day of vaccination. The reporting rates of syncope or loss of consciousness and seizures were 6.4 and 0.4, for the other vaccines. CONCLUSIONS: Consistent with the media attention generated, and with results from other studies, the reporting rates of syncope or loss of consciousness and seizures were higher for the HPV vaccine than for other vaccines given in adolescence. Nevertheless, the overall information obtained on SARs following the qHPV vaccine suggests a good safety profile.

[Post-licensure passive safety surveillance of rotavirus vaccines: reporting sensitivity for intussusception]. / Vigilancia pasiva de la seguridad postautorización de las vacunas frente a rotavirus: sensibilidad de la notificación de invaginación intestinal.

INTRODUCTION: The aims of this study were to describe the reports of suspected adverse events due to rotavirus vaccines, and assess the reporting sensitivity for intussusception. MATERIAL AND METHODS: Descriptive study performed using the reports of suspected adverse events following rotavirus vaccination in infants aged less than 10 months, as registered in the Pharmacovigilance Centre of the Valencian Community during 2007-2011. The reporting rate for intussusception was compared to the intussusception rate in vaccinated infants obtained using the hospital discharge database (CMBD), and the regional vaccine registry. RESULTS: The adverse event reporting rate was 20 per 100,000 administered doses, with the majority (74%) of the reports being classified as non-serious. Fever, vomiting, and diarrhea were the adverse events reported more frequently. Two intussusception cases, which occurred within the first seven days post-vaccination, were reported as temporarily associated to vaccination. The reporting sensitivity for intussusception at the Pharmacovigilance Centre in the 1-7 day interval following rotavirus vaccination was 50%. CONCLUSIONS: Our results suggest that rotavirus vaccines have, in general, a good safety profile. Intussusception reporting to the Pharmacovigilance Centre shows sensitivity similar to other passive surveillance systems. The intussusception risk should be further investigated using well-designed epidemiological studies, and evaluated in comparison with the well-known benefits provided by these vaccines.

Sospecha de reacciones adversas a la vacuna triple vírica notificadas al Centro de Farmacovigilancia de la Comunidad Valenciana / Suspected adverse events to measles, mumps and rubella vaccine reported to the Community of Valencia Pharmacovigilance Centre

Introducción: El sistema de Farmacovigilancia de Medicamentos de Uso Humano constituye un importante mecanismo para el seguimiento postautorización de la seguridad de las vacunas. La vacuna triple vírica es una vacuna combinada de virus vivos atenuados de sarampión, rubéola y parotiditis. A pesar de que los episodios adversos asociados son considerados generalmente leves, la vacuna ha sido ampliamente cuestionada. Nuestro objetivo fue describir las notificaciones de sospecha de reacciones adversas relacionadas con esta vacuna, realizadas al Centro de Farmacovigilancia de la Comunidad Valenciana. Material y métodos: Estudio descriptivo a partir de los casos notificados entre el 15 de mayo de 2005 y el 15 de mayo de 2010.Tras agrupar las sospechas de reacciones adversas por criterios diagnósticos, fue realizado un análisis descriptivo de las variables. Resultados: Tras la administración de 545.830 dosis fueron notificadas 96 sospechas de reacciones adversas (1,76 notificaciones/100.000 dosis), que incluyeron un total de 181 reacciones. Las reacciones descritas con más frecuencia fueron fiebre (42,7%) e inflamación en la zona de inyección (36,5%). Fueron clasificadas como graves el 8,3% de las notificaciones. En todos los casos la recuperación fue completa. Conclusiones: Las sospechas de reacciones adversas notificadas coinciden con las reacciones descritas en las fichas técnicas de las vacunas. La frecuencia de notificaciones es notablemente inferior a la descrita en la literatura, no obstante, a pesar de las probables limitaciones y con los datos obtenidos podemos afirmar que la vacuna triple vírica ofrece un buen perfil de seguridad, acorde con los datos publicados hasta ahora (AU)

Introduction: A Pharmacovigilance system is an important tool for post-marketing monitoring on vaccine safety. Measles, mumps, rubella (MMR) vaccine is a combined vaccine of live attenuated virus. Since its approval, and although the adverse events are considered generally mild, the vaccine has been widely questioned for the controversies arising around its safety. Our objective was to describe suspected adverse events related to MMR vaccine reported to the Valencian Pharmacovigilance Centre. Material and methods: Descriptive study from cases reported between May 15th, 2005 and May 15th, 2010. After grouping the suspected adverse events by diagnostic criteria, a descriptive analysis of variables was performed. Results: After 545,830 doses administered, 96 notifications were reported (1.76 notifications/100,000 doses) including 181 adverse events. Fever (42.7%) and local inflammation (36.5%) were the most reported events. There were 8.3% notifications classified as severe. Recovery was complete in all cases. Conclusions: The suspected adverse events reported coincided with those described in the Summary of Product Characteristics of the vaccine. The frequency of reports was lower than previously published estimates. Despite the limitations, the data obtained allowed us to conclude that MMR vaccine has a good safety profile, according to previously published studies (AU)

[Suspected adverse events to measles, mumps and rubella vaccine reported to the Community of Valencia Pharmacovigilance Centre]. / Sospecha de reacciones adversas a la vacuna triple vírica notificadas al Centro de Farmacovigilancia de la Comunidad Valenciana.

INTRODUCTION: A Pharmacovigilance system is an important tool for post-marketing monitoring on vaccine safety. Measles, mumps, rubella (MMR) vaccine is a combined vaccine of live attenuated virus. Since its approval, and although the adverse events are considered generally mild, the vaccine has been widely questioned for the controversies arising around its safety. Our objective was to describe suspected adverse events related to MMR vaccine reported to the Valencian Pharmacovigilance Centre. MATERIAL AND METHODS: Descriptive study from cases reported between May 15th, 2005 and May 15th, 2010. After grouping the suspected adverse events by diagnostic criteria, a descriptive analysis of variables was performed. RESULTS: After 545,830 doses administered, 96 notifications were reported (1.76 notifications/100,000 doses) including 181 adverse events. Fever (42.7%) and local inflammation (36.5%) were the most reported events. There were 8.3% notifications classified as severe. Recovery was complete in all cases. CONCLUSIONS: The suspected adverse events reported coincided with those described in the Summary of Product Characteristics of the vaccine. The frequency of reports was lower than previously published estimates. Despite the limitations, the data obtained allowed us to conclude that MMR vaccine has a good safety profile, according to previously published studies.

Utilización de fármacos antipsicóticos atípicos en ancianos institucionalizados y prevalencia de alteraciones metabólicas / Utilisation of atypical antipsychotic drugs in institutionalised elderly persons and prevalence of metabolic alterations

Objetivos Describir y evaluar la utilización de antipsicóticos atípicos en la población anciana institucionalizada de la Comunidad Valenciana y la prevalencia de alteraciones metabólicas asociadas. Material y métodos Estudio multicéntrico, descriptivo y transversal de utilización de medicamentos y caso-control de la prevalencia de las alteraciones de la glucemia, colesterol y triglicéridos. El análisis estadístico de las alteraciones metabólicas se realiza a partir de la diferencia de prevalencia y su significación estadística entre el grupo control y estudio. Resultados Se incluyen 681 pacientes (grupo estudio: 344; grupo control: 337) de 20 centros sociosanitarios. El 18,5% de los pacientes institucionalizados está en tratamiento con antipsicóticos atípicos. Los diagnósticos más frecuentes son alteraciones de conducta asociada a la demencia (63,6%) y a la esquizofrenia (18,4%). La risperidona es el fármaco antipsicótico más utilizado (66,0%). En general, para todos los fármacos, las dosis utilizadas se ajustan a las recomendadas en el paciente anciano. La prevalencia de alteraciones en el metabolismo de la glucosa, el colesterol y los triglicéridos en el grupo de estudio es del 23,96, el 34,83 y el 26,29%, respectivamente, no encontrándose diferencias estadísticamente significativas con respecto al grupo control. El análisis por tipo de fármaco no muestra diferencias significativas. Conclusiones Los resultados obtenidos muestran que la utilización de antipsicóticos atípicos en el paciente anciano sigue en líneas generales las recomendaciones establecidas. Las dosis utilizadas en el paciente anciano con alteraciones de conducta asociadas a la demencia, mayoritariamente tratado con risperidona, no tienen un impacto significativo sobre el aumento de la prevalencia de alteraciones metabólicas (AU)

Objectives Describe and evaluate atypical antipsychotics utilisation on the institutionalized elderly population of the Valencian Community and prevalence of associated metabolic alterations. Material and methods Multicentre transversal descriptive study on medication utilisation and prevalence case-control of alterations of glycaemia, cholesterol and triglycerides. The statistical analysis of metabolic alterations is performed from the difference in prevalence and its statistical signification between the control group and the study group.Results681 patients were included (study group, 344; control group, 337) from 20 social-health-care centres. 18.5% of the institutionalised patients are being treated with atypical antipsychotics. The most frequent diagnoses are: behavioural alterations associated with dementia (63.6%) and schizophrenia (18.4%). Risperidone is the most frequently used antipsychotic (66.0%). For all the drugs in general the doses used adjust to those recommended for elderly patients. The prevalence of alterations in glycaemia, cholesterol and triglycerides metabolism in the group under study is 23.96%, 34.83%, and 26.29%, respectively, with no statistically significant differences against the control group. The analysis by type of drug did not show significant differences. Conclusions The results obtained show that utilisation of atypical antipsychotics in elderly patients complies with the established general recommendations. The doses used in elderly patients with behavioural alterations associated with dementia, mostly treated with risperidone, do not have a significant impact over prevalence increase of metabolic alterations (AU)

[Utilisation of atypical antipsychotic drugs in institutionalised elderly persons and prevalence of metabolic alterations]. / Utilización de fármacos antipsicóticos atípicos en ancianos institucionalizados y prevalencia de alteraciones metabólicas.

OBJECTIVES: Describe and evaluate atypical antipsychotics utilisation on the institutionalized elderly population of the Valencian Community and prevalence of associated metabolic alterations. MATERIAL AND METHODS: Multicentre transversal descriptive study on medication utilisation and prevalence case-control of alterations of glycaemia, cholesterol and triglycerides. The statistical analysis of metabolic alterations is performed from the difference in prevalence and its statistical signification between the control group and the study group. RESULTS: 681 patients were included (study group, 344; control group, 337) from 20 social-health-care centres. 18.5% of the institutionalised patients are being treated with atypical antipsychotics. The most frequent diagnoses are: behavioural alterations associated with dementia (63.6%) and schizophrenia (18.4%). Risperidone is the most frequently used antipsychotic (66.0%). For all the drugs in general the doses used adjust to those recommended for elderly patients. The prevalence of alterations in glycaemia, cholesterol and triglycerides metabolism in the group under study is 23.96%, 34.83%, and 26.29%, respectively, with no statistically significant differences against the control group. The analysis by type of drug did not show significant differences. CONCLUSIONS: The results obtained show that utilisation of atypical antipsychotics in elderly patients complies with the established general recommendations. The doses used in elderly patients with behavioural alterations associated with dementia, mostly treated with risperidone, do not have a significant impact over prevalence increase of metabolic alterations.

[Presence of sulfites in minced meat and meat products prepared in industries of the Valencia Community]. / Presencia de sulfitos en carne picada y preparados de carne elaborados en industrias de la Comunidad Valenciana.

BACKGROUND: In view of the development of harmonization provisions for food legislation with regard to additives, the aim of this study is to find out the use of sulfites in minced meats and meat products prepared in establishments located in the Valencia Region. METHODS: Following planning of the types of products and number of samples to be researched, the results obtained were evaluated qualitatively and quantitatively for the presence of sulfites, expressed in mg/kg of SO2. RESULTS: The presence of sulfites was found in 65.38% of the samples of beef and pork burgers and in 64.18% of chicken burgers. Minced meat, fresh chorizo (highly-seasoned pork sausage) and raw sausages were more in line with legislation. CONCLUSIONS: The extensive use of sulfites in prepared meat products was observed. The imminent application of Community legislation will bring lead to a modification in the practices when preparing these products.