A population analysis of prescriptions for asthma medications during pregnancy

<p>Background: It is important to control asthma during pregnancy. However, some studies indicate that women stop or change their asthma medications when they become pregnant. Objective: We used a population database to analyze changes in prescriptions for asthma medications to patients before, during, and after pregnancy.</p><p>Methods: We collected information from a pregnancy database that is part of the population-based pharmacy prescription InterAction Database from the northern Netherlands. Our study cohort comprised 25,709 pregnancies for which prescription data were available. We collected data over a study period of 1 year before pregnancy until 6 months after birth and analyzed data from pregnant women who received at least 1 prescription for asthma medication during the study period (n = 2072), identifying all prescriptions for asthma medication and oral corticosteroids.</p><p>Results: Prescriptions for asthma medications did not change during pregnancies from 1994-2003. However, during the 2004-2009 period, there was a significant decrease (P = .017) in prescriptions for asthma medications during the first months of pregnancy compared with the months before pregnancy, especially prescriptions of long-acting bronchodilators. Although most asthma prescriptions continued throughout pregnancy, prescriptions for controller therapies were reduced by 30% during the first months of pregnancy.</p><p>Conclusions: Many women stop or reduce their use of asthma medications when they become pregnant. Strategies to safely control asthma during pregnancy are needed. (J Allergy Clin Immunol 2013;131:711-7.)</p>

Direct-from-Patient Information on Medication Use: PROTECT Pregnancy Study Results

Background: The PROTECT Pregnancy Study is a non-interventional, prospective study of pregnant women who provide information about medication use and key lifestyle factors at set intervals throughout their pregnancy, and pregnancy outcome. Objectives: This study was designed to pilot new methods of collecting pharmacovigilance data in natural language directly from reporters, whoever they are. Methods: Pregnant volunteers were sought mainly via the internet and leaflets in pharmacies. They were provided with study information and could choose to participate on-line or by phone using an interactive voice response system (IVRS). Internet participants could choose to provide data every 2 or 4weeks during pregnancy. In Denmark and the UK we also sought individual permission to link with electronic healthcare records to compare the reports of prescribed medication use, and where possible, birth outcomes. Results: Following informed consent, 2521 pregnant women from Denmark, the Netherlands, Poland, and the United Kingdom were recruited. Of these, only 14 (0.5%) chose to provide data via IVRS. After study entry, 82% of “internet” women and 1 (7%) “IVRS” woman went on to complete a detailed baseline questionnaire. The choice of follow up period varied between country, but overall 43% (range 28-49%) chose every two weeks and 58%, (range 49-72%) every 4 weeks. To date, 38% have provided followup data, despite all receiving reminders at each follow- up time point. Limited information was available as to why participants stopped participating as few subjects completed the discontinuation forms, which inquired about reasons. Conclusions: Pregnant women can be recruited directly to provide information for research via the internet but recruitment for data provision by IVRS was poor. Our research suggests additional tools are needed to enhance retention of recruited volunteers. These results should help guide future study designs using direct-to-patient enrolment and follow-up. Additional research from this project will examine self-reported medication use

Maternal high-dose folic acid during pregnancy and asthma medication in the offspring

Purpose Low-dose folic acid supplementation (0.5 mg) taken during pregnancy has been associated with an increased risk for childhood asthma. The effect of high-dose folic acid (5 mg) advised to women at risk for having a child with neural tube defect has not been assessed so far. Our aim was to investigate the effect of dispensed high-dose folic acid during pregnancy and asthma medication in the offspring. Methods We used data from the pregnancy database IADB.nl, which contains pharmacy-dispensing data of mothers and children from community pharmacies in the Netherlands from 1994 until 2011. The dispension of asthma medication in children exposed in utero to high-dose folic acid was compared with children who were not exposed to this high dose. Incidence rate ratios (IRRs) with 95% confidence intervals (CIs) were calculated. Results In 2.9% (N=913) of the 39 602 pregnancies in the database, the mother was dispensed high-dose folic acid. Maternal high-dose folic acid was associated with an increased rate of asthma medication among children: recurrent asthma medication IRR = 1.14 (95%CI: 1.04-1.30) and recurrent inhaled corticosteroids IRR = 1.26 (95%CI: 1.07-1.47). Associations were clustered on the mother and adjusted for maternal age, maternal asthma medication, and dispension of benzodiazepines during pregnancy. Conclusion Almost 3% of the children were prenatally exposed to high-dose folic acid. This study suggests that supplementation of high-dose folic acid during pregnancy might increase the risk of childhood asthma. Copyright (C) 2014 John Wiley & Sons, Ltd

Identifying Associations between Maternal Medication Use and Birth Defects Using a Case-Population Approach:An Exploratory Study on Signal Detection

<p>Background The effects of many drugs on the unborn child are unknown. In a case-population design, drug exposure of cases is compared with that of a source population; this kind of study can be useful for generating signals.</p><p>Objective To see whether a comparison of drug use rates from the birth defect registry EUROCAT NNL (cases) with prescription rates from a population-based prescription database, the IADB (population), could be used to detect signals of teratogenic risk of drugs.</p><p>Methods We defined 3,212 cases from the EUROCAT NNL database, a population-based birth defect registry in the Northern Netherlands and 29,223 population controls from the IADB, a prescription database with data from community pharmacies in the same geographical area, born between 1998 and 2008. We classified the malformations of the 3,212 cases into several malformation groups according to organ system (based on the International Classification of Diseases codes and the EUROCAT guidelines). If a child had multiple malformations in several organ systems (n = 253, 7.9 %), he/she was counted in all the categories represented. For several groups of malformations we calculated rate ratios (RR) and 95 % confidence intervals for drugs acting on the central nervous system and for drugs considered to be safe for use in pregnancy. The RRs were based on first-trimester drug use rates from the cases in the EUROCAT NNL database and prescription rates from the population controls in the IADB.</p><p>Results For drugs acting on the central nervous system we found significantly increased RRs for the anti-epileptic drug valproic acid and for some selective serotonin reuptake inhibitors. For drugs considered to be safe only the anti-hypertensive methyldopa showed significantly increased RRs.</p><p>Conclusion We show that a case-population study is a suitable method for detecting signals of possible teratogenicity, provided that the teratogenic effects and the drugs under study are as specific as possible and the drugs are widely used.</p>