Enrollment and Retention in 34 United States Pregnancy Registries Contrasted with the Manufacturer's Capture of Spontaneous Reports for Exposed Pregnancies.

ABSTRACT:

Introduction

Pregnancy registries and spontaneous reports are essential pharmacovigilance tools to evaluate drug safety during pregnancy.

Objectives

The aim of this study was to evaluate postmarket capture of exposed pregnancies.

Methods

Pregnancy registries for drugs and biologics were identified in a systematic review. Through a standardized questionnaire, manufacturers provided information on (1) pregnancy registry enrollment and retention, and (2) worldwide receipt of spontaneous reports for exposed pregnancies. A validated algorithm for live-birth pregnancies allowed calculation of exposure rates per 100,000 live births using claims data.

Results

Among 34 products with a pregnancy registry, median (interquartile range) registry enrollment was 36 pregnancie

SUBMITTER: Bird ST 

PROVIDER: S-EPMC8979755 | biostudies-literature | 2018 Jan

REPOSITORIES: biostudies-literature