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Background: Spontaneous reporting of adverse drug reactions (ADR) is fundamental to drug safety surveillance (pharmacovigilance) and assessment of benefit/risk ratio. However, under-reporting remains the limit of the system., Objective: The aim of this study was to assess the effect of regular visits of an Assistant in Clinical Research (CRA) on the improvement of ADR reporting in non-university hospitals., Methods: We set up an ADR report collecting system that involved regular visits in non-university hospitals, We began the visits in 2006 in 2 areas (Haute Garonne and Gers), extended to 4 other areas in 2009. We compared the reporting rate (number of reports/number of beds) of total ADRs reported by non-university hospitals in these areas before (one year) and after the start of CRA visits., Results: A total 2831 of reports were collected by the CRA: 40% were "serious" including two deaths. The results suggest an increase of 100% of the rate of reporting of ADRs., Conclusion: This study shows that regular visits increases the number of ADRs reported by non-university hospitals. Further assessment of this procedure is necessary for long term evaluation of its effectiveness., (© 2012 Société Française de Pharmacologie et de Thérapeutique.)

Objective: The purpose of this study was to describe the care level, legal status and size of the maternity units where deliveries take place in France according to risk level for mother and infant. We analyzed the 1997-1998 data to better implement the network's perinatal policy., Material: and methods. Our standardized sample included 4200 single births in 1997 and 3650 in 1998 collected by the French Sentinel Network after applying a sample rectification technique to offset the methodological problems created by the volunteer nature of the sample population. Distribution of care level, legal status and size of the maternity unit where deliveries took place were recorded according to the risk level of the patients., Results: In 1997-1998, 22% of pregnant women delivered in level III maternity units and 33% in level II units. Twenty percent of the deliveries took place in level II maternity units with less than 1500 deliveries per year. During this period, women with diabetes or hypertension delivered more often in level III units (31% and 27% respectively) than women in the general population. This was not true for women with a previous perinatal death (23%). Inversely, births of infants before 33 weeks gestation or weighing less than 1500 g occurred more often in level III maternity units (55% and 59% respectively) than in the general population. Twenty-seven percent of the infants requiring neonatal transportation were born in level I maternity units. For 'low risk' mothers, delivery occurred more often in level I maternity units (more than 50%) or in small maternity units with less than 1000 deliveries per year (45%) than for the general population (45% and 36% respectively)., Conclusion: These data obtained from the Sentinel Network provide precise information on where deliveries occur in France. These data will be useful for implementing the network's perinatal policy. They will also provide a means of following referral practices in the future.