Utility of a New Database to Study Drug Safety during Pregnancy

描述（由申请人提供）：产前接触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。通常用于孕妇安全性研究的数据来源和设计存在一些局限性，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小规模（队列研究）。这些数据源的生成成本也很高，而且往往仅限于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妊娠期间药物的安全性。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，这些数据可进一步链接到有关出生和生殖史的临床信息。这些以人口为基础的卫生保健利用数据与可链接的出生数据有可能加强对怀孕期间药物使用和安全性的研究。我们建议建立一个识别孕妇及其后代的研究数据库，以研究孕妇处方药的使用和安全性。为了检验新研究数据库的有效性和有用性，我们将评估妊娠期间选择性血清素再摄取抑制剂的使用与后代临床结果（包括新生儿持续性肺动脉高压（PPHN）和心血管缺陷）之间的关系。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。项目简介：我们将开发和测试一个研究数据库的实用性，该数据库使用基于人口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。该数据库基于大量以人群为基础的随访数据和可链接的临床出生数据，有可能提高孕妇及其儿童使用处方药的安全性。

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.