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Utility of a New Database to Study Drug Safety during Pregnancy

新数据库在妊娠期药物安全研究中的应用

基本信息

批准号：
7442322
负责人：
Soko Setoguchi Iwata
金额：
$ 25.61万
依托单位：
BRIGHAM AND WOMEN'S HOSPITAL
依托单位国家：
美国
项目类别：
财政年份：
2007
资助国家：
美国
起止时间：
2007-06-15 至 2010-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7442322
关键词：
Address Adverse effects Adverse event Algorithms Apgar Score Birth Birth Weight British Columbia Cardiovascular system Case-Control Studies Child Chronic Disease Clinical Code Cohort Studies Congenital Heart Defects Data Data Sources Databases Defect Diagnosis Drug Exposure Drug Prescriptions Drug Utilization Drug usage Elderly Exposure to Future Gestational Age Grant Health Maintenance Organizations Health Services Hospitalization Hospitals Interview Life Link Malignant Childhood Neoplasm Medicaid Medical Methodology Minerals Monitor Mother-Child Relations Mothers Newborn Infant Observational Study Outcome Persistent Fetal Circulation Syndrome Pharmaceutical Preparations Pharmacy facility Physicians Population Pregnancy Pregnancy Outcome Pregnant Women Principal Investigator Province Randomized Records Regulation Reporting Reproductive History Research Research Design Research Personnel Risk Safety Selective Serotonin Reuptake Inhibitor Services Solutions Source Specific qualifier value Stable Populations Standards of Weights and Measures Testing Validation Vital Statistics Vital Status Vitamin, Other administrative database base case control design follow-up health care service utilization neonatal pulmonary hypertension post-market prenatal exposure programs reproductive size

项目摘要

DESCRIPTION (provided by applicant): Prenatal exposure to prescription drugs has been linked to teratogenicity and chronic diseases of the offspring in the later life. While many pregnant women take prescription drugs, the safety of most drugs during pregnancy is not well understood. Commonly used data sources and designs for safety studies in pregnant women have several limitations including recall bias of drug exposure (case-control studies), and small size to detect rare adverse events (cohort studies). These data sources are also expensive to generate, and are often limited to a few pre-specified outcomes assessed shortly after birth. Although, large health care utilization databases have become the standard source of information for pharmacoepidemiologic studies on the safety of drugs, few studies used these data sources in studying the safety of drugs during pregnancy. We have identified administrative data with pharmacy dispensing from the entire province of British Columbia that are further linkable to clinical information on birth and reproductive history. These population-based health care utilization data with linkable birth data have the potential to enhance the research of drug utilization and safety during pregnancy. We propose to develop a research database that identifies pregnant women and their offspring to study drug utilization and safety of prescription drugs in pregnant women. To test the validity and usefulness of the new research database, we will assess the association between selective serotonin reuptake inhibitor use during pregnancy and clinical outcomes in the offspring, including persistent pulmonary hypertension of the newborns (PPHN), and cardiovascular defects. To enhance the validity of the research database, we will further assess the accuracy of coded diagnosis of PPHN and cardiovascular defects and develop the most specific algorithm to define these outcomes. Upon completion of this study (R21), we will have developed the research database and tested relevant hypotheses that will help inform the usefulness and validity of the database in studying drug safety during pregnancy. Project Narrative: We will develop and test the utility of a research database that identifies pregnant women and their children using population-based claims databases to study safety of prescribed drugs during pregnancy. This database based on large population-based follow-up data with linkable clinical birth data has the potential to enhance the safety of prescription drug use in pregnant women and their children.

描述(申请人提供)：产前接触处方药与后代在晚年的致畸性和慢性病有关。虽然许多孕妇服用处方药，但大多数药物在怀孕期间的安全性尚不清楚。孕妇安全性研究常用的数据来源和设计有几个局限性，包括药物暴露的回忆偏差(病例对照研究)，以及用于检测罕见不良事件的规模较小(队列研究)。这些数据来源的生成成本也很高，而且往往仅限于在出生后不久评估的几个预先指定的结果。虽然大型卫生保健利用数据库已经成为药物安全性药物流行病学研究的标准信息来源，但很少有研究使用这些数据来源来研究孕期药物的安全性。我们已经确定了来自不列颠哥伦比亚省整个省的药房配药的管理数据，这些数据可以进一步链接到有关出生和生育史的临床信息。这些以人群为基础的卫生保健利用数据与出生数据相关联，有可能加强孕期药物利用和安全性的研究。我们建议开发一个识别孕妇及其后代的研究数据库，以研究孕妇的药物利用和处方药的安全性。为了测试新研究数据库的有效性和有用性，我们将评估怀孕期间选择性使用5-羟色胺再摄取抑制剂与后代临床结局之间的关系，包括新生儿持续性肺动脉高压(PPHN)和心血管缺陷。为了提高研究数据库的有效性，我们将进一步评估PPHN和心血管缺陷编码诊断的准确性，并开发最具体的算法来定义这些结果。在这项研究(R21)完成后，我们将开发研究数据库并测试相关假设，这将有助于了解数据库在研究怀孕期间药物安全性方面的有用性和有效性。项目简介：我们将开发和测试一个研究数据库的效用，该数据库使用基于人口的索赔数据库来识别孕妇和她们的孩子，以研究怀孕期间处方药物的安全性。这个数据库以大量基于人群的跟踪数据和可链接的临床分娩数据为基础，有可能提高孕妇及其子女使用处方药的安全性。

项目成果

期刊论文数量（3）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

Use of disease-modifying antirheumatic drugs during pregnancy and risk of preeclampsia.

DOI：
10.1002/acr.21807
发表时间：
2012-11
期刊：
ARTHRITIS CARE & RESEARCH
影响因子：
4.7
作者：
Palmsten, Kristin;Hernandez-Diaz, Sonia;Kuriya, Bindee;Solomon, Daniel H.;Setoguchi, Soko
通讯作者：
Setoguchi, Soko

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