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

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A Commentary to this article was published on 28 December 2017

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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Authors and Affiliations

  1. Division of Epidemiology, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA

    Steven T. Bird, Kate Gelperin, Lockwood Taylor, Mohamed A. Mohamoud & Christian Hampp

  2. Division of Pediatric and Maternal Health, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA

    Leyla Sahin

  3. Weill Cornell Medicine, Division of Biostatistics and Epidemiology, New York, NY, USA

    Hoda Hammad

  4. Meyers Primary Care Institute (Fallon Health, Reliant Medical Group), University of Massachusetts Medical School, Worcester, MA, USA

    Susan E. Andrade

  5. Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA

    Sengwee Toh

Authors
  1. Steven T. Bird
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  2. Kate Gelperin
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  3. Lockwood Taylor
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  4. Leyla Sahin
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  5. Hoda Hammad
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  6. Susan E. Andrade
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  7. Mohamed A. Mohamoud
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  8. Sengwee Toh
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  9. Christian Hampp
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Corresponding author

Correspondence to Steven T. Bird.

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Conflict of interest

Steven Bird, Kate Gelperin, Lockwood Taylor, Leyla Sahin, Hoda Hammad, Susan Andrade, Mohamed Mohamoud, Sengwee Toh, and Christian Hampp have no conflicts of interest to declare that are directly relevant to the content of this study. This study represents the opinions of the authors and not necessarily those of the FDA. Susan Andrade received a grant from Pfizer Inc. unrelated to this study or any drugs evaluated in our study. No other conflicts are present.

Funding

Sentinel is funded by the US FDA. No other funding was received for this study.

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Bird, S.T., Gelperin, K., Taylor, L. et al. Enrollment and Retention in 34 United States Pregnancy Registries Contrasted with the Manufacturer’s Capture of Spontaneous Reports for Exposed Pregnancies. Drug Saf 41, 87–94 (2018). https://doi.org/10.1007/s40264-017-0591-5

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  • DOI: https://doi.org/10.1007/s40264-017-0591-5

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