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OBJECTIVE: To describe, for the 2016-2018 period, the adequacy of care provided to women who died of maternal death in France, as well as the possible preventability of these deaths. METHOD: National data from the Enquête Nationale Confidentielle sur les Morts Maternelles for 2016-2018. For each maternal death identified, the National Expert Committee on Maternal Mortality (CNEMM) assesses the adequacy of the care provided and whether the death was probably, possibly or not preventable. RESULTS: For 2016-2018, 272 maternal deaths (considered up to 1 year after the end of pregnancy) occurred in France. Of these, 265 had sufficient information collected by the confidential survey and could be assessed by the CNEMM. In total, care was judged to be "sub-optimal" for 66% of deaths assessed for all causes, a proportion similar to that for previous periods. In addition to the obstetric and anaesthetic care provided at the time of the acute complication, which was judged to be sub-optimal for 45% (obstetric care) and 38% (anaesthetic care) of maternal deaths, this report highlights the scope for improvement in other types of care, more related to prevention and screening: "sub-optimal" preconception care for 51% of the women who died for whom it was justified, particularly notable for deaths linked to a preexisting condition (52%) and for suicides (67%); prenatal surveillance judged to be "sub-optimal" in 30% of cases, a sub-optimality also more frequent among deaths linked to a preexisting condition (35%) and suicides (34%). In all, 59.7% of maternal deaths assessed were judged to be "probably" (17%) or "possibly" (42.7%) preventable, a profile that remained stable. Suicide and other psychiatric causes, the leading cause of maternal death, were considered to be potentially preventable in 79% of cases. Deaths from haemorrhage remained largely preventable (95%, the highest proportion by cause). The factor most often implicated was inadequate care, and preventability linked to this factor was identified in 53% of deaths, all causes combined. Gap in organization of care was a preventability factor identified in 24% of deaths, and poor interaction between the woman and the healthcare system in 22% of deaths. CONCLUSION: This proportion of more than half of potentially preventable maternal deaths shows that a reduction in maternal mortality in France is still possible and must be achieved, the objective being to prevent all preventable deaths. Analysis of the factors involved, overall and by cause of death, suggests areas for improvement.
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Anestésicos , Muerte Materna , Suicidio , Embarazo , Humanos , Femenino , Mortalidad Materna , Muerte Materna/etiología , Francia/epidemiologíaRESUMEN
OBJECTIVE: To describe, for the 2013-2015 period, the frequency, causes, risk factors, adequacy of care and preventability of maternal deaths in France. METHOD: Data from the National Confidential Enquiry into Maternal Deaths for 2013-2015. RESULTS: For the period 2013-2015, 262 maternal deaths occurred in France, one every four days, i.e a maternal mortality ratio of 10.8 per 100,000 live births (95 % CI 9.5-12.1), stable compared to 2010-2012. Compared to women aged 25-29, the risk is multiplied by 1.9 for women aged 30-34, by 3 for women aged 35-39 and by 4 for women aged 40 and over. Obese women are twice as frequent among maternal deaths (24 %) than in the general population of parturients (11 %). There are territorial disparities - the maternal mortality ratio in the French overseas departments is 4 times higher than in metropolitan France -, and social disparities - the mortality of migrant women remains higher than that of women born in France, particularly for women born in sub-Saharan Africa whose risk is 2.5 times higher than that native women. A striking result of the 2013-2015 period is the preponderance of suicides and cardiovascular diseases, the two leading causes of maternal mortality, each responsible for approximately one death per month. These two etiologies are not only the most frequent, but also among those with the highest proportion of preventable deaths, 91.3 % and 65.7 % respectively. Another important result is the continued decrease in mortality from obstetric haemorrhage, halved in 15 years, particularly the decrease n hemorrhages due to uterine atony. Overall, 57.8 % of maternal deaths are considered probably or possibly preventable and in 66 % of cases, the care provided was not optimal. CONCLUSION: While the overall maternal mortality ratio remains stable overall, and territorial and social inequalities unchanged, the profile of the causes of maternal mortality is changing. Some developments are a success, such as the continued decrease in maternal mortality due to haemorrhage, the result of the general mobilisation of health actors on this issue. Others point to new priorities for mobilisation, in particular on the mental and cardiovascular health of women during pregnancy or in the year following childbirth. In order to go further in understanding the mechanisms involved, and to identify precise avenues for prevention, it is necessary to analyse in detail the stories of each maternal death in order to identify the opportunities for improvement repeatedly found in the series of deaths. This is what the following articles in this issue propose, with an analysis by cause of death.
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Muerte Materna , Suicidio , Inercia Uterina , Adulto , Femenino , Francia/epidemiología , Humanos , Muerte Materna/prevención & control , Mortalidad Materna , Persona de Mediana Edad , EmbarazoRESUMEN
Resumen Objetivo: Caracterizar las reacciones adversas graves evitables por antivirales presentes en el Sistema Cubano de Farmacovigilancia durante los años 2008 al 2017. Material y métodos: Investigación cuantitativa, observacional y descriptiva; enmarcada dentro de los estudios de farmacovigilancia, con un diseño de serie de casos. El universo conformado por las notificaciones de reacciones adversas graves evitables provocadas estos fármacos. Se utilizaron variables como: reacción adversa identificada, grupo de edad, sexo, fármaco antiviral, frecuencia y causas de evitabilidad. Resultados: Las reacciones adversas evitables graves a los antivirales se comportaron a ritmo irregular que muestra tendencia al incremento. Predominaron en hombres (77.8%) y en adultos (94.4%). Zidovudina (44.4%) y nevirapina (38.9%) muestraron la mayor cantidad de reportes, relacionados con la aparición de anemia y síndrome de Stevens Johnson. Los médicos reportaron el 72.2% de los casos. Las reacciones encontradas se describen como frecuentes. Las interacciones medicamentosas (61.1%) fue la principal causa de evitabilidad. Conclusiones: La caracterización de las reacciones adversas graves evitables a los antivirales permitió identificar que las mismas fueron frecuentes, producidas por antirretrovirales y presentadas hombres adultos; siendo la anemia y síndrome de Stevens Johnson las más frecuentes. Las causas de evitabilidad identificadas con mayor frecuencia responden a errores de la prescripción.
Abstract Object: To characterize the serious adverse reactions avoidable by antivirals present in the Cuban Pharmacovigilance System during the years 2008 to 2017. Materials and methods: Quantitative, observational and descriptive research; framed within the pharmacovigilance studies, with a case series design. The sample conformed by the reports of avoidable serious adverse reactions caused by these drugs. Variables were: identified adverse reaction, age group, sex, antiviral drug, frequency and causes of preventability. Results: Severe avoidable adverse reactions to antivirals were presented at an irregular level that shows a tendency to increase. They predominated in men (77.8%) and in adults (94.4%). Zidovudine (44.4%) and nevirapine (38.9%) showed the highest number of reports, related to the appearance of anemia and Stevens-Johnson syndrome. The doctors reported 72.2% of the cases. The reactions found are described as frequent. Drug interactions (61.1%) was the main cause of preventability. Conclusions: The characterization of the serious adverse reactions avoidable to the antivirals allowed to identify that they were in their majority produced by antiretroviral and occurred mainly in adult men; anemia and Stevens-Johnson syndrome were the most frequent. The causes of preventability identified with greater frequency correspond to errors of the prescription.
Resumo Objetivo: Saracterizar as reações adversas graves evitáveis por antivirais presentes no Sistema Cubano de Farmacovigiláncia durante os anos de 2008 a 2017. Materiais e métodos: Pesquisa quantitativa, observacional e descritiva; enquadrada no ámbito de estudos de farmacovigiláncia, com um desenho de estudos de casos. O universo foi constituido pelos relatórios das notificações de reações adversas graves causadas por esses medicamentos. Foram utilizadas variáveis, tais como: reacjao adversa identificada, grupo etário, sexo, fármaco antiviral, frequência e causas de prevenjao. Resultados: Reações adversas severas preveníveis por antivirais surgem a um ritmo irregular mostrando um aumento crescente. Predominaram em homens (77,8%) e em adultos (94,4%). Zidovudina (44,4%) e nevirapina (38,9%) apresentaram o maior número de relatos, relacionados ao aparecimento de anemia e síndrome de Stevens Johnson. Os médicos relataram 72,2% dos casos. As reações encontradas são descritas como frequentes. As interajoes medicamentosas (61,1%) foram a principal causa da prevenção. Conclusões: A caracterização de reações adversas graves, preveniveis por antivirais permitiram identificar que eram frequentes, produzidos por anti-retrovirais e apresentados em homens adultos; sendo a anemia e a síndrome de Stevens Johnson as mais frequentes. As causas mais frequentemente identificadas de prevenção demonstram erros de prescrição.
Résumé Objectif: Caractériser les effets indésirables graves évitables par les antiviraux présents dans le systéme cubain de pharmacovigilance pendant les années 2008 á 2017. Matériaux et méthodes: Recherche quantitative, observationnelle et descriptive; encadré dans les études de pharmacovigilance, avec une conception de série de cas. L'échantillon était conforme aux rapports d'effets indésirables graves évitables provoqués par ces médicaments. Les variables utilisées étaient réaction indésirable identifiée, groupe d'áge, sexe, médicament antiviral, fréquence et causes de prévention. Résultats: Les réactions indésirables évitables tombes aux antiviraux se sont comportées á un rythme irrégulier qui a tendance á augmenter. Ils prédominaient chez les hommes (77,8%) et chez les adultes (94,4%). La zidovudine (44,4%) et la névirapine (38,9%) présentaient le plus grand nombre de signalements, liés á l'apparition de l'anémie et au syndrome de Stevens-Johnson. Les médecins rapportent 72.2% des cas. Les réactions trouvées sont souvent déclinées. Les interactions médicamenteuses (61,1%) étaient la principale cause évitable. Conclusion: La caractérisation des effets indésirables graves évitables antiviraux a permis d'identifier qu'ils étaient produits principalement par les antirétroviraux et se produisaient principalement chez les hommes adultes; l'anémie et le syndrome de Stevens-Johnson étaient les plus fréquents. Les causes évitables identifiées généralement correspondent á des erreurs de prescription.
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OBJECTIVE: To describe, for the period 2010-2012, the frequency, the causes, the risk factors, the adequacy of care and the avoidability of maternal deaths in France. METHOD: Data from the National Confidential Enquiry into Maternal Deaths for 2010-2012. RESULTS: For the period 2010-2012, 256 maternal deaths occurred in France, a maternal mortality ratio of 10.3 per 100,000 live births (95% CI: 9.1-11.7), stable compared to 2007-2009. Compared to women aged 25-29, the risk is multiplied by 2.4 for women aged 35-39, and by 3 for women over 40 years. There are territorial disparities: 1 out of 7 maternal deaths occurs in the French overseas departments, and the maternal mortality ratio in those departments is 4 times that of metropolitan, France; and social disparities: the mortality of migrant women remains 2.5 times higher than that of women born in France, particularly for women born in sub-Saharan Africa whose RMM is 3.5 times that native women. A major finding is the 1/3 decrease in direct maternal mortality over the last 10 years, mainly due to for the first time the statistically significant decrease in mortality from obstetric hemorrhage, the frequency of which was divided by 2 in 10 years. However, almost all of the remaining deaths from hemorrhage are considered preventable and this is still the leading cause of maternal mortality in France (11% of deaths). Overall, 56% of these maternal deaths are considered "avoidable" or "possibly avoidable" and in 59% of cases the care provided was not optimal. CONCLUSION: Direct maternal mortality and in particular maternal mortality from hemorrhage has decreased significantly over the past 10 years, indicating improved obstetric care. However, territorial and social inequalities persist, and the majority of deaths remain preventable, which shows that the identification of opportunities for improvement must continue. To go even further in understanding the mechanisms involved, and to identify precise avenues of prevention, it is necessary to analyze in detail the stories of each maternal death in order to identify the repetitive elements in the series of deaths. This is what the following articles in this issue propose, with an analysis by cause of death, according to the idea that the same cause produces the same effects.
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Muerte Materna/etiología , Muerte Materna/estadística & datos numéricos , Adulto , África del Sur del Sahara/etnología , Factores de Edad , Causas de Muerte , Femenino , Francia/epidemiología , Humanos , Muerte Materna/prevención & control , Mortalidad Materna , Hemorragia Posparto/mortalidad , Embarazo , Complicaciones del Embarazo , Calidad de la Atención de Salud , Factores de Riesgo , Factores Socioeconómicos , MigrantesRESUMEN
AIM: To describe the serious adverse drug reactions (ADR) in elderly subjects aged over 65 years and assess their preventability. METHODS: A retrospective study was conducted at the Regional Pharmacovigilance Center of Champagne-Ardenne (northeast of France) between January and May 2013. Patients aged over 65 years who presented a serious ADR notified to the Regional Pharmacovigilance Center were included in the study. RESULTS: Over the study period, 100 subjects were included in the study. The sex ratio was 0.96. Twenty seven percent of serious ADR were preventable. Off-label use accounted for 20% and non-compliance for 5%. Bleeding events were the most common serious ADR (36%). The drugs most frequently involved in serious ADR were antithrombotic agents (31.4%). CONCLUSION: More than a quarter of serious ADR were preventable. Off-label use and non-compliance are the main causes identified in the occurrence of preventable serious ADR.
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To monitor the maternal mortality which is an indicator of the quality of obstetric and intensive care, France has a specific approach since 1996. Recently linkages have been introduced to improve the inclusion of cases. Here are the results for the 2007 to 2009 period. The identification of the pregnancy associated deaths is lying on different data bases that are medical causes of death, birth register and hospital discharges. To document the cases, confidential enquiries are conducted by two assessors on the field; a committee of medical experts analyses the documents, select the underlying cause and assess the quality of health care. Two hundred and fifty-four obstetric deaths were identified from 2007 to 2009 giving the maternal mortality ratio (MMR) of 10.3 per 100,000 births. The maternal age and nationality, the region of deaths are associated to the MMR. The haemorrhages are the leading cause but their ratio is 1.9 versus 2.5 previously; this decrease results from the postpartum haemorrhage by uterine atony going down. The suboptimal care are still frequent (60%) but slightly less than before. The linkage method should be pursued. Maternal mortality is rather stable in France. We may reach more reduction as deaths due to atony decreased as suboptimal care did.
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Mortalidad Materna , Adulto , Femenino , Francia/epidemiología , Humanos , Edad Materna , Servicios de Salud Materna , Mortalidad Materna/etnología , Complicaciones del Trabajo de Parto/mortalidad , Hemorragia Posparto/epidemiología , Hemorragia Posparto/etiología , Hemorragia Posparto/mortalidad , Embarazo , Complicaciones del Embarazo/mortalidad , Atención Prenatal , Calidad de la Atención de Salud , Inercia Uterina/epidemiología , Inercia Uterina/mortalidadRESUMEN
OBJECTIVE: To assess the quality of intrapartum care in birth asphyxia cases. METHODS: Prospective analysis of all cases of birth asphyxia in nine maternity units during one year (2010). Birth asphyxia was defined as the combination of at least one clinical factor (Apgar≤7 at 5 minutes, signs of encephalopathy at birth) and at least one biological factor in cord (pH≤7, BD≥12 mmol/L, lactates>10 mmol/L). These cases were analyzed with a peer review from French guidelines 2007. RESULTS: Fifty cases of birth asphyxia were identified. After peer-review, they were defined as 46% non preventable, 27% possibly preventable, 24% definitely preventable and 3% not established. The main causes have been described as (i) misinterpretation of CTG during the first and second stages of labour, (ii) delayed response time to CTG anomalies and (iii) prolonged second stage. CONCLUSION: In half of the cases of birth asphyxia, this dreaded event was considered as preventable by a group of peers.
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Asfixia Neonatal/prevención & control , Revisión por Pares , Puntaje de Apgar , Asfixia Neonatal/diagnóstico , Asfixia Neonatal/terapia , Cardiotocografía , Femenino , Sangre Fetal/química , Francia , Humanos , Concentración de Iones de Hidrógeno , Recién Nacido , Trabajo de Parto , Lactatos/sangre , Embarazo , Estudios Prospectivos , Factores de RiesgoRESUMEN
AIMS: To investigate the characteristics of adverse drug events (ADE) causing emergency medical admissions in the elderly. METHODS: Data were obtained from two prospective cross sectional studies with similar experimental design which were carried out in seven French emergency departments in 1999 and 2003. The proportion of ADE leading to admission, their severity and preventability were assessed in patients aged ≥70 (group A) and compared to those of patients <70years (group B). RESULTS: Out of a total of 2907 patients, 1158 (39.8%) were ≥70years of age. Among these, 17.1% were admitted as a result of an ADE vs. 13.2% in group B (p=0.004). ADE appeared to be more severe in group A than in group B. The part of preventable ADE did not significantly differ between the two groups (48.9% vs. 43.7%, respectively). CONCLUSION: ADE are a common preventable cause of unplanned admissions, especially in the elderly.