Caroline Hurault-Delarue

Healthcare databases in Europe for studying medicine use and safety during pregnancy

The aim of this study was to describe a number of electronic healthcare databases in Europe in terms of the population covered, the source of the data captured and the availability of data on key variables required for evaluating medicine use and medicine safety during pregnancy.

Non-adjuvanted 2009 influenza A (H1N1)v vaccine in pregnant women: the results of a French prospective descriptive study.

UNLABELLED In 2009, during the influenza A (H1N1)v pandemic, the French Health authorities recommended influenza immunisation for pregnant women because of the higher risk of serious influenza outcomes in that population. Thus, the non-adjuvanted inactivated influenza vaccine Panenza(®) was administered to French women from the second trimester of pregnancy. Several studies suggest that inactivated seasonal influenza vaccines are safe during pregnancy but there are few data about the effects of new A (H1N1)vaccines (new antigen) on pregnant women. OBJECTIVE The aim of the present prospective study was to describe pregnancy outcomes among women vaccinated with non-adjuvanted influenza vaccines in South Western France. METHODS the study ran from November 2009 to February 2010 and included, on a voluntary basis, pregnant women who were vaccinated against A (H1N1) influenza in vaccination clinics or maternity wards. RESULTS 569 pregnant women were monitored until delivery. Compared with the general population, the risks of maternal conditions, malformations and neonatal conditions were not statistically different. CONCLUSION This study does not reveal any sign of safety concerns regarding the effects of the vaccine on pregnancy outcomes.

Pandemic A/H1N1 influenza vaccination during pregnancy: A comparative study using the EFEMERIS database

OBJECTIVE To evaluate the risk of adverse pregnancy outcomes following A/H1N1 vaccination in pregnant women. METHODS This observational cohort study compared vaccinated and non-vaccinated pregnant women in EFEMERIS, a French prescription database including pregnant women. Women who ended their pregnancy in South Western France between October 21, 2009 and November 30, 2010 (the period of the French vaccination campaign) were included. Two non-vaccinated women were individually matched to each vaccinated woman by month and year of pregnancy onset. Conditional logistic regression and Cox proportional hazards regression were used to evaluate associations between each outcome (all-cause pregnancy loss, preterm delivery, small for gestational age (SGA) and neonatal pathology) and A/H1N1 vaccination during pregnancy. RESULTS 1645 women of the 12,120 (13.6%) in the database who were administered A/H1N1 vaccine during pregnancy were compared to 3290 non-vaccinated women. Most were vaccinated in December 2009 (61%) with a non-adjuvanted vaccine (93%). The risks of pregnancy loss (adjusted HR=0.56; 95% CI=0.31-1.01), of preterm birth (adjusted HR=0.82; 95% CI=0.64-1.06), and of neonatal pathology (adjusted OR=0.70; 95% CI=0.49-1.02) did not differ between the vaccinated and the non-vaccinated groups. The rate of SGA was lower in the vaccinated group than in the non-vaccinated group (0.5% vs. 1.4%; adjusted OR=0.36; 95% CI=0.17-0.78). CONCLUSION There was no significant association between adverse pregnancy outcomes and vaccination with a non-adjuvanted A/H1N1 vaccine during pregnancy.

Drug Prescribing Before and During Pregnancy in South West France

AbstractBackground: Several drugs that are known to exhibit teratogenic or fetotoxic risks when used during pregnancy should not be prescribed to pregnant women. However, most women of childbearing age use medications, and drug use cannot always be avoided during pregnancy, especially for women with chronic diseases for whom the benefit of treatment outweighs the potential risk of the drug for the fetus. Nevertheless, it is often possible to replace a drug with another one that has been better evaluated. Objective: The aim of the present study was to describe the prescribing of drugs to pregnant women before and during pregnancy in order to examine whether the occurrence of pregnancy modifies drug prescribing and dispensing to women. In particular, drugs that are contraindicated or must be avoided during pregnancy, such as retinoids, ACE inhibitors, angiotensin II receptor blockers, NSAIDs and valproic acid, will be analysed. Methods: This retrolective study used data already prospectively recorded in the database of the French Health Insurance Service. It analysed pharmacy records of women who gave birth between 1 January 2007 and 31 December 2007 in Midi-Pyrenees. Pharmacy data were analysed from 9 months before pregnancy until delivery. Drugs were classified according to the Anatomical Therapeutic Chemical code. Results: The study included 23 898 women. Approximately 77% and 96% of the women received at least one prescription before and during pregnancy, respectively. The number of women who were prescribed contraindicated drugs significantly decreased with pregnancy (p< 0.0001). Most of the drugs were stopped during the 3 months before pregnancy without alternative treatment, even for chronic diseases. However, for some women, potentially dangerous prescriptions were maintained during pregnancy, and for others these drugs were dispensed for the first time during critical periods of pregnancy. Conclusion: Despite recommendations, some teratogenic and/or fetotoxic drugs are still prescribed and dispensed to pregnant women in France. There is a need to repeat information to sensitize health professionals and women to the harmful potential of drugs. Moreover, discontinuation of a needed treatment must be avoided. Therefore, attention must be given to ensuring that younger females and women of childbearing potential who are likely to need continued treatment in adolescence and adulthood are aware of the potential risks that some drugs may pose during pregnancy.

Safety of oseltamivir during pregnancy: a comparative study using the EFEMERIS database.

To compare pregnancy outcome between women exposed and unexposed to oseltamivir during pregnancy.

Prescription of asthma medications before and during pregnancy in France: an observational drug study using the EFEMERIS database.

ABSTRACT Objective: Asthma affects between 3% to 8% of pregnant women. Previous studies have suggested that womens prescriptions for asthma medications change during pregnancy. The aim was to describe the prescription of asthma medications before and during pregnancy in France. Methods: Women from the EFEMERIS, a French database assessing the drugs prescribed, dispensed and reimbursed during pregnancy, delivering between July 2004 and December 2012, were included. Women, who were dispensed asthma medications on at least two dates from 3 months prior to pregnancy through delivery, were considered. Results: 2,977 women out of 69,205 (4%) were selected. They were prescribed 2.4 ± 1.2 different anti-asthmatic drugs with 3.5 ± 2.7 different dispensing dates. Almost 62% of the women were dispensed at least one prescription for short-acting β2-agonist (SABA), 63% at least one inhaled corticosteroid (IC), 42% a fixed-combination of an IC and a long-acting β2-agonist (LABA) and 8% a LABA. An increase in SABA and IC prescriptions and a decrease in fixed-combination prescriptions were observed during pregnancy compared to pre-pregnancy period. A rapid drop in prescriptions for montelukast was observed. Among the 1,507 women who were prescribed asthma medication before pregnancy, one third had a drop in dispensed asthma medications from the beginning of pregnancy. Conclusions: The prevalence of dispensed asthma medications varies during pregnancy. There is a decrease in the prescriptions of fixed-combinations during pregnancy and an increase in the prescriptions of ICs. It appears important to study the potential impact of such changes on fetuses and newborns.

How to take into account exposure to drugs over time in pharmacoepidemiology studies of pregnant women

The aim of this study was to develop a new pharmacoepidemiological method to take into account intensity and evolution of drug exposure, applied to pregnant women.

Psychomotor developmental effects of prenatal exposure to psychotropic drugs: a study in EFEMERIS database.

Little is known about neurodevelopment of children exposed to psychotropic drugs during pregnancy. The purpose of this study was to evaluate the effects of prenatal exposure to psychotropic drugs on psychomotor development in children. This observational study used the EFEMERIS database. The database records the drugs prescribed and delivered during pregnancy and the resulting outcomes. Neurodevelopment at nine and 24 months of children born to women exposed to psychotropic drugs (anxiolytics, antidepressants, neuroleptics and anti‐epileptics) during the second and/or third trimesters of pregnancy was compared to children who were not exposed to these drugs. Psychomotor development of 493 children (1.5%) exposed to psychotropic drugs during pregnancy was compared to 32 303 unexposed children. Exposure to psychotropic drugs during pregnancy was associated with an increased risk of abnormal motor development at 9 months (OR = 1.3 [1.1–2.2]) and abnormal motor and mental development at 24 months (OR = 4.8 [2.1–11.0] and OR = 2.3 [1.05–4.9]). Increased risk was observed in children born to women exposed to anti‐epileptic drugs, neuroleptics or antidepressants during pregnancy. This study found a higher rate of deviation from the normal developmental milestones in children born to women exposed to psychotropic drugs during pregnancy and more particularly antidepressants, neuroleptics and anti‐epileptics.

Interest of the trajectory method for the evaluation of outcomes after in utero drug exposure: example of anxiolytics and hypnotics

The aim of this study was to examine the potential benefit to take into account duration and intensity of drug exposure using the recently published method based on individual drug trajectories. This approach was used to define profiles of exposure to anxiolytics/hypnotics during pregnancy and to evaluate the potential effect on newborn health.

Patterns of antidepressant use during pregnancy: a nationwide population‐based cohort study

We explored the patterns of antidepressant use during pregnancy.