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01-01-2018 | Original Research Article

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

Authors: Steven T. Bird, Kate Gelperin, Lockwood Taylor, Leyla Sahin, Hoda Hammad, Susan E. Andrade, Mohamed A. Mohamoud, Sengwee Toh, Christian Hampp

Published in: Drug Safety | Issue 1/2018

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 pregnancies (5–258) and median spontaneous report capture was 450 pregnancies (89–1192). Products used in >20/100,000 live births had a median registry enrollment of 490 pregnancies and median capture of 1061 spontaneously reported exposed pregnancies. Lower median registry enrollment and spontaneous report capture was observed for products used in 0.5–20/100,000 live births (36 from registries, 541 spontaneous reports) and <0.5/100,000 live births (3 from registries, 41 spontaneous reports). Among 24 registries enrolling ≥10 pregnancies, median capture of pregnancy outcomes (e.g. live birth, spontaneous abortion) was 83.9%. For 19 registries enrolling ≥10 infants, the median proportion of infants achieving protocol-specified follow-up was 89.9% for up to 4 weeks post-birth, 75.0% for 1–5 months, and 57.1% for ≥6 months.

Conclusions

Relatively higher product utilization among pregnant women predicted greater pregnancy registry enrollment. For products rarely used during pregnancy, registry enrollment was low and differences in registry enrollment compared with worldwide spontaneous report receipt were most pronounced. Products with very low utilization levels during pregnancy may require a combination of worldwide pharmacovigilance, pregnancy registries, and additional study methods to achieve adequate surveillance.

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Title: Enrollment and Retention in 34 United States Pregnancy Registries Contrasted with the Manufacturer’s Capture of Spontaneous Reports for Exposed Pregnancies
Authors: Steven T. Bird
Kate Gelperin
Lockwood Taylor
Leyla Sahin
Hoda Hammad
Susan E. Andrade
Mohamed A. Mohamoud
Sengwee Toh
Christian Hampp
Publication date: 01-01-2018
Publisher: Springer International Publishing
Published in: Drug Safety / Issue 1/2018
Print ISSN: 0114-5916
Electronic ISSN: 1179-1942
DOI: https://doi.org/10.1007/s40264-017-0591-5

Keynote webinar | Spotlight on medication adherence

Springer Medicine

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

Abstract

Introduction

Objectives

Methods

Results

Conclusions

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Introduction

Objectives

Methods

Results

Conclusions

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