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POMME: The New Cohort to Evaluate Long-Term Effects After Prenatal Medicine Exposure

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Abstract

Introduction

The POMME (PrescriptiOn Médicaments Mères Enfants) cohort has been implemented for the evaluation of the long-term consequences of medicine prenatal exposure. It holds anonymous medical information as well as information on medicine and healthcare reimbursement to the children, from the first day of intra-uterine life until childhood.

Objective

This article provides a description of the cohort regarding its structure and content and presents an outlook of the studies that could be performed with this new data source.

Methods

Data sources include (1) the French Health Insurance Database (medicines and medical care prescriptions and reimbursements to children and mothers during pregnancy) and (2) the Mother and Child Protection Centre Database (child health certificates at birth, 9 months of age and 24 months of age). Children born in Haute-Garonne (south-west France), over a period of 1 year (from 1 July to 30 June), are registered in POMME every 5 years. The cohort began on 1 July, 2010.

Results

To date, 8372 children have been recorded in POMME. They have reached 7 years of age now. Among them, 4249 (50.8%) are boys, 286 (3.4%) were from multiple pregnancies and 519 (6.2%) were born prematurely. They were prenatally exposed to 9.8 ± 6.1 medications. After birth, drug exposure was greatest in children aged 0–2 years. Children were mostly exposed to paracetamol, anti-infective agents and respiratory system drugs; 908 (10.8%) children presented with at least two signs of psychomotor development disorders.

Conclusions

POMME provides an observatory study on drug exposure and medical care use in children. This innovative cohort would make it possible to assess the risk of the long-term consequences of prenatal medicine exposure.

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Notes

  1. Mothers’ and children’s drug prescriptions.

  2. Information Systems Security Unit.

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Acknowledgements

The authors acknowledge the data providers, who made anonymised data available for their research institution: the French Health Insurance System of Haute-Garonne and the Mother and Child Protection Center of Haute-Garonne. The authors are grateful to the POMME collaborators: Protection Maternelle et Infantile de Haute-Garonne and Caisse Primaire d’assurance Maladie de Haute-Garonne.

Author information

Authors and Affiliations

  1. Laboratoire de Pharmacologie Médicale et Clinique, Faculté de Médecine de Toulouse, Toulouse, France

    Justine Benevent, Jean-Louis Montastruc & Christine Damase-Michel

  2. Service de Pharmacologie Médicale et Clinique, Centre Midi-Pyrénées de PharmacoVigilance, Pharmacoépidémiologie et d’Informations sur le Médicament, Pharmacopôle, Centre Hospitalier Universitaire de Toulouse, Toulouse, France

    Justine Benevent, Caroline Hurault-Delarue, Mélanie Araujo, Jean-Louis Montastruc, Isabelle Lacroix & Christine Damase-Michel

  3. INSERM, UMR 1027, Faculté de Médecine de Toulouse, Toulouse, France

    Justine Benevent, Jean-Louis Montastruc & Christine Damase-Michel

  4. CIC 1436, Centre Hospitalier Universitaire de Toulouse, Toulouse, France

    Jean-Louis Montastruc

Authors
  1. Justine Benevent
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  2. Caroline Hurault-Delarue
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  4. Jean-Louis Montastruc
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Corresponding author

Correspondence to Justine Benevent.

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Funding

No sources of funding were used to assist in the preparation of this study.

Conflict of interest

Justine Benevent, Caroline Hurault-Delarue, Mélanie Araujo, Jean-Louis Montastruc, Isabelle Lacroix and Christine Damase-Michel have no conflicts of interest that are directly relevant to the content of this study.

Ethics approval

This study was performed on anonymised patient data. For this type of study, formal consent is not required.

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Benevent, J., Hurault-Delarue, C., Araujo, M. et al. POMME: The New Cohort to Evaluate Long-Term Effects After Prenatal Medicine Exposure. Drug Saf 42, 45–54 (2019). https://doi.org/10.1007/s40264-018-0712-9

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