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Observational Study
. 2019 Sep 19;14(9):e0222667.
doi: 10.1371/journal.pone.0222667. eCollection 2019.

Characteristics of prescription in 29 Level 3 Neonatal Wards over a 2-year period (2017-2018). An inventory for future research

Béatrice Gouyon  1 , Séverine Martin-Mons  1 , Silvia Iacobelli  1 , Hasinirina Razafimahefa  2 , Elsa Kermorvant-Duchemin  3 , Roselyne Brat  4 , Laurence Caeymaex  5 , Yvan Couringa  6 , Ceneric Alexandre  7 , Catherine Lafon  8 , Duksha Ramful  9 , Francesco Bonsante  1 , Guillaume Binson  10 , Florence Flamein  11 , Amélie Moussy-Durandy  12 , Massimo Di Maio  13 , Gaël Mazeiras  14 , Olivier Girard  15 , Cécile Desbruyeres  16 , Julien Mourdie  17 , Guillaume Escourrou  18 , Olivier Flechelles  19 , Soumeth Abasse  20 , Jean-Marc Rosenthal  21 , Anne-Sophie Pages  22 , Marine Dorsi  23 , Léila Karaoui  24 , Abdellah ElGellab  25 , Florence Le Bail Dantec  26 , Mohamed-Amine Yangui  27 , Karine Norbert  28 , Yaovi Kugbe  29 , Simon Lorrain  1 , Anaelle Pignolet  1 , Elodie Marie Garnier  1 , Alexandre Lapillonne  3 , Delphine Mitanchez  30 , Evelyne Jacqz-Aigrain  31 , Jean-Bernard Gouyon  1
Affiliations
Observational Study

Characteristics of prescription in 29 Level 3 Neonatal Wards over a 2-year period (2017-2018). An inventory for future research

Béatrice Gouyon et al. PLoS One. .

Abstract

Objectives: The primary objective of this study is to determine the current level of patient medication exposure in Level 3 Neonatal Wards (L3NW). The secondary objective is to evaluate in the first month of life the rate of medication prescription not cited in the Summary of Product Characteristics (SmPC). A database containing all the medication prescriptions is collected as part of a prescription benchmarking program in the L3NW.

Material and methods: The research is a two-year observational cohort study (2017-2018) with retrospective analysis of medications prescribed in 29 French L3NW. Seventeen L3NW are present since the beginning of the study and 12 have been progressively included. All neonatal units used the same computerized system of prescription, and all prescription data were completely de-identified within each hospital before being stored in a common data warehouse.

Results: The study population includes 27,382 newborns. Two hundred and sixty-one different medications (International Nonproprietary Names, INN) were prescribed. Twelve INN (including paracetamol) were prescribed for at least 10% of patients, 55 for less than 10% but at least 1% and 194 to less than 1%. The lowest gestational ages (GA) were exposed to the greatest number of medications (18.0 below 28 weeks of gestation (WG) to 4.1 above 36 WG) (p<0.0001). In addition, 69.2% of the 351 different combinations of an medication INN and a route of administration have no indication for the first month of life according to the French SmPC. Ninety-five percent of premature infants with GA less than 32 weeks received at least one medication not cited in SmPC.

Conclusion: Neonates remain therapeutic orphans. The consequences of polypharmacy in L3NW should be quickly assessed, especially in the most immature infants.

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Conflict of interest statement

Dr Beatrice Gouyon (1st author) was in charge of the B-PEN program (Benchmarking of Prescription in Neonatology) in the research center (CEPOI) from 2012 to 2016. Her employer was the University Hospital of La Reunion. Then Dr B. Gouyon left the CEPOI to take the lead of a new start-up (LogipremF comp.) responsible for the development of the prescription software Logipren and its implementation in the NICUs of the B-PEN network. This change of affiliation has been contracted with the University Hospital of La Réunion, after authorization from the “Commission de Déontologie de la Fonction Publique” was obtained. Dr B. Gouyon remained closely involved in the research project issued from the B-PEN database particularly in setting of the data warehouse, treatment of data and writing of this manuscript. Pr J-B. Gouyon (the corresponding author) has no function, no shares, no role, nor any financial relationship in and with the LogipremF company. Additionally, he has no other competing interests. As a corresponding author and to the best of my knowledge, other authors have no potential conflicts of interest. This does not alter our adherence to all PLOS ONE policies on sharing data and materials.

Figures

Fig 1
Fig 1. Flow chart diagram from the entire B-PEN program population to the population allowing the study on medication prescriptions in 29 Level 3 Neonatal Wards.
Fig 2
Fig 2. Part of the French extremely and very preterm infants (PMSI data) cared for in the Level 3 Neonatal Wards of the B-PEN network (2017–2018).
See this image and copyright information in PMC

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