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

• 批准号: 7242389
• 负责人: Soko Setoguchi Iwata
• 金额: $ 21.76万
• 依托单位: BRIGHAM AND WOMEN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-06-15 至 2009-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7242389
• 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

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（由申请方提供）：产前暴露于处方药与后代日后的致畸性和慢性疾病有关。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倚（病例对照研究），以及检测罕见不良事件的样本量小（队列研究）。这些数据来源的生成成本也很高，而且往往仅限于出生后不久评估的一些预先指定的结果。尽管大型医疗保健利用数据库已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源研究妊娠期间药物的安全性。我们已经确定了行政数据与药房配药从整个不列颠哥伦比亚省，是进一步的出生和生殖史的临床信息。这些以人群为基础的卫生保健利用数据与重复出生数据有可能加强妊娠期药物利用和安全性的研究。我们建议开发一个研究数据库，识别孕妇及其后代，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实用性，我们将评估妊娠期间使用选择性5-羟色胺再摄取抑制剂与后代临床结局之间的关联，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。完成本研究（R21）后，我们将开发研究数据库并测试相关假设，这将有助于告知数据库在研究妊娠期间药物安全性方面的有用性和有效性。项目叙述：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群的索赔数据库来识别孕妇及其子女，以研究怀孕期间处方药的安全性。该数据库基于大量基于人群的随访数据和大量临床出生数据，有可能提高孕妇及其子女使用处方药的安全性。