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Adverse Drug Reaction Case Safety Practices in Large Biopharmaceutical Organizations from 2007 to 2017: An Industry Survey

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Abstract

Introduction

Drug safety remains a top global public health concern. An increase in the number of data sources available has increased the complexity of pharmacovigilance operations, so the US FDA has created draft guidance focusing on optimizing drug safety data for well-characterized medicines. However, to date, no data demonstrating changes in reports have been presented.

Objectives

This study provided data assessing changes in individual case safety reports (ICSRs) and aggregate reports (ARs) for large biopharmaceutical companies from 2007 to 2017. This study also evaluated current trends on the use of advanced machine and deep learning in order to process all data captured for ICSRs as well as opinions from industry thought leaders on creating a sustainable case-processing operation.

Methodology

Using data captured from Navitas Life Science’s annual pvnet® benchmark, we calculated workload indicators characterizing pharmacovigilance operations for large biopharmaceutical organizations. Workload indicators included the number of ICSRs by organization, the number of ARs, and the number and types of data sources used. We also conducted structured in-depth interviews with seven biopharmaceutical executives to discover the reasons for changes in workload indicators across time as well as current strategies for increasing efficiencies in drug safety reporting.

Results

The median number of ICSRs increased from 84,960 cases in 2007 to over 200,000 cases in 2017; this increase was largely attributable to an increase in both nonserious cases and follow-up cases. Member companies reported using 12 ± 3 data sources for case identification. The number of ARs also increased from a median of 70 reports in 2007 to 258 reports in 2017. To address these increases, 61% of the biopharmaceutical organizations we surveyed planned to adopt machine learning for full ICSR processing; however, as of 2018, none of the organizations surveyed had mechanisms in place.

Conclusion

This study demonstrated that pharmacovigilance departments are currently burdened by ever-increasing case volumes. With increased guidance from regulatory agencies, as well as improvements in artificial intelligence and natural language processing, biopharmaceutical organizations must determine the most resource-efficient and sustainable methods to process the growing volume of cases.

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Change history

  • 18 December 2019

    The correct name of the second author should be “Moritz Fehrle”, and not “Mortiz Fehrle” as given in the original publication of the article.

  • 18 December 2019

    The correct name of the second author should be ���Moritz Fehrle���, and not ���Mortiz Fehrle��� as given in the original publication of the article.

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Acknowledgements

The authors acknowledge Marie-Claire Wilson and Pete Boyd for their contributions to the study.

Author information

Authors and Affiliations

  1. Tufts Center for the Study of Drug Development, Tufts University School of Medicine, 75 Kneeland Street, Ste 1100, Boston, MA, 02111, USA

    Stella Stergiopoulos

  2. Bayer AG, 51368, Leverkusen, Germany

    Mortiz Fehrle

  3. Pfizer Inc, New York, NY, 10017, USA

    Patrick Caubel

  4. Pvnet®, Navitas Life Sciences GmbH, 60528, Frankfurt, Germany

    Louise Tan & Louise Jebson

Authors
  1. Stella Stergiopoulos
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  2. Mortiz Fehrle
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  3. Patrick Caubel
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  4. Louise Tan
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  5. Louise Jebson
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Corresponding author

Correspondence to Stella Stergiopoulos.

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Funding

No sources of funding were used to conduct this study or prepare this manuscript.

Conflict of interest

SS is a paid employee of Foundation Medicine, Inc. but was employed at the Tufts Center for the Study of Drug Development at the time the study was conducted. MF is a paid employee of Bayer AG. PC is a paid employee of Pfizer, Inc. LT and LJ are paid employees of Navitas Life Sciences. No companies contributed to or influenced the data analysis, study conduct, or writing of the manuscript. The manuscript reflects the authors’ personal opinions and contributions.

Ethical Approval

This article does not contain any studies with human or animal subjects performed by any of the authors.

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Supplement 1: Structured Interview Guide

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Stergiopoulos, S., Fehrle, M., Caubel, P. et al. Adverse Drug Reaction Case Safety Practices in Large Biopharmaceutical Organizations from 2007 to 2017: An Industry Survey. Pharm Med 33, 499–510 (2019). https://doi.org/10.1007/s40290-019-00307-x

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