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Prevention and management of health products shortages by the French national agency (ANSM), 10 years of experience

Shortages of drugs and medical devices have tended to increase in France and worldwide, with consequences for patients and healthcare professionals. Preventing shortages of health products has become a priority for regulatory authorities, including the French National Agency for Medicines and Health...

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Autores principales: Belgodère, Laëtitia, Emmerich, Joseph, Albin, Nicolas, Bacon, Trystan, Daynes, Pascale, Vignot, Stéphane, Vial, Thierry, Renaud, Guillaume, Le Saulnier, Carole, Maillard-Couvreur, Corine, Cachet, Mélanie, Veyries, Marie-Laure, Youdarene, Rym, Oualikene-Gonin, Wahiba, Ratignier-Carbonneil, Christelle, Maison, Patrick
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10690943/
https://www.ncbi.nlm.nih.gov/pubmed/38045969
http://dx.doi.org/10.3389/fpubh.2023.1293110
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author Belgodère, Laëtitia
Emmerich, Joseph
Albin, Nicolas
Bacon, Trystan
Daynes, Pascale
Vignot, Stéphane
Vial, Thierry
Renaud, Guillaume
Le Saulnier, Carole
Maillard-Couvreur, Corine
Cachet, Mélanie
Veyries, Marie-Laure
Youdarene, Rym
Oualikene-Gonin, Wahiba
Ratignier-Carbonneil, Christelle
Maison, Patrick
author_facet Belgodère, Laëtitia
Emmerich, Joseph
Albin, Nicolas
Bacon, Trystan
Daynes, Pascale
Vignot, Stéphane
Vial, Thierry
Renaud, Guillaume
Le Saulnier, Carole
Maillard-Couvreur, Corine
Cachet, Mélanie
Veyries, Marie-Laure
Youdarene, Rym
Oualikene-Gonin, Wahiba
Ratignier-Carbonneil, Christelle
Maison, Patrick
author_sort Belgodère, Laëtitia
collection PubMed
description Shortages of drugs and medical devices have tended to increase in France and worldwide, with consequences for patients and healthcare professionals. Preventing shortages of health products has become a priority for regulatory authorities, including the French National Agency for Medicines and Health Products Safety (ANSM). To highlight perspectives for a better prevention, we described and analyzed the management of shortages in the availability of health products in France over the last 10 years. The supply chain was mapped to identify the main causes of shortages and stakeholders involved in managing shortages throughout the supply chain. National and European initiatives and regulatory measures were reviewed. A retrospective nationwide data analysis from the French reporting system of health product shortage reports was conducted over 10 years for drugs (2013–2022) and over an 18-month period for medical devices, from 1st March 2022 to 31st August 2023. An increase in drug shortage reports was observed, rising from 404 in 2013 to 3,761 in 2022 for drugs, with a relatively constant distribution of affected therapeutic classes. In 2022, the main reported causes of drug shortage risk were insufficient production capacity (27.1%), increased sales volume (21.5%), or lack of supply (13.6%). Over half of the reports on medical devices (55.4%) were objectified as indispensable, and their causes were mainly due to a lack of supply (48.2%), discontinuation of marketing (14.9%), increased sales volume (13.2%), and regulatory reasons (9.6%). ANSM and French authorities have engaged a public health policy for prevention and management of health product shortages including financial penalties, minimum safety stocks for Major Therapeutic Interest drugs, and a shortage management plan. Based on 10 years of experience, four priority measures have been identified to anticipate the risk of heath products shortages based: the importance of a national coordination from raw materials to local market, the implementation of new prevention and management actions in the supply chain, strengthening European cooperation and regulation including the establishment of a list of critical drugs, and promoting transparency and information.
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spelling pubmed-106909432023-12-02 Prevention and management of health products shortages by the French national agency (ANSM), 10 years of experience Belgodère, Laëtitia Emmerich, Joseph Albin, Nicolas Bacon, Trystan Daynes, Pascale Vignot, Stéphane Vial, Thierry Renaud, Guillaume Le Saulnier, Carole Maillard-Couvreur, Corine Cachet, Mélanie Veyries, Marie-Laure Youdarene, Rym Oualikene-Gonin, Wahiba Ratignier-Carbonneil, Christelle Maison, Patrick Front Public Health Public Health Shortages of drugs and medical devices have tended to increase in France and worldwide, with consequences for patients and healthcare professionals. Preventing shortages of health products has become a priority for regulatory authorities, including the French National Agency for Medicines and Health Products Safety (ANSM). To highlight perspectives for a better prevention, we described and analyzed the management of shortages in the availability of health products in France over the last 10 years. The supply chain was mapped to identify the main causes of shortages and stakeholders involved in managing shortages throughout the supply chain. National and European initiatives and regulatory measures were reviewed. A retrospective nationwide data analysis from the French reporting system of health product shortage reports was conducted over 10 years for drugs (2013–2022) and over an 18-month period for medical devices, from 1st March 2022 to 31st August 2023. An increase in drug shortage reports was observed, rising from 404 in 2013 to 3,761 in 2022 for drugs, with a relatively constant distribution of affected therapeutic classes. In 2022, the main reported causes of drug shortage risk were insufficient production capacity (27.1%), increased sales volume (21.5%), or lack of supply (13.6%). Over half of the reports on medical devices (55.4%) were objectified as indispensable, and their causes were mainly due to a lack of supply (48.2%), discontinuation of marketing (14.9%), increased sales volume (13.2%), and regulatory reasons (9.6%). ANSM and French authorities have engaged a public health policy for prevention and management of health product shortages including financial penalties, minimum safety stocks for Major Therapeutic Interest drugs, and a shortage management plan. Based on 10 years of experience, four priority measures have been identified to anticipate the risk of heath products shortages based: the importance of a national coordination from raw materials to local market, the implementation of new prevention and management actions in the supply chain, strengthening European cooperation and regulation including the establishment of a list of critical drugs, and promoting transparency and information. Frontiers Media S.A. 2023-11-17 /pmc/articles/PMC10690943/ /pubmed/38045969 http://dx.doi.org/10.3389/fpubh.2023.1293110 Text en Copyright © 2023 Belgodère, Emmerich, Albin, Bacon, Daynes, Vignot, Vial, Renaud, Le Saulnier, Maillard-Couvreur, Cachet, Veyries, Youdarene, Oualikene-Gonin, Ratignier-Carbonneil and Maison. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Public Health
Belgodère, Laëtitia
Emmerich, Joseph
Albin, Nicolas
Bacon, Trystan
Daynes, Pascale
Vignot, Stéphane
Vial, Thierry
Renaud, Guillaume
Le Saulnier, Carole
Maillard-Couvreur, Corine
Cachet, Mélanie
Veyries, Marie-Laure
Youdarene, Rym
Oualikene-Gonin, Wahiba
Ratignier-Carbonneil, Christelle
Maison, Patrick
Prevention and management of health products shortages by the French national agency (ANSM), 10 years of experience
title Prevention and management of health products shortages by the French national agency (ANSM), 10 years of experience
title_full Prevention and management of health products shortages by the French national agency (ANSM), 10 years of experience
title_fullStr Prevention and management of health products shortages by the French national agency (ANSM), 10 years of experience
title_full_unstemmed Prevention and management of health products shortages by the French national agency (ANSM), 10 years of experience
title_short Prevention and management of health products shortages by the French national agency (ANSM), 10 years of experience
title_sort prevention and management of health products shortages by the french national agency (ansm), 10 years of experience
topic Public Health
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10690943/
https://www.ncbi.nlm.nih.gov/pubmed/38045969
http://dx.doi.org/10.3389/fpubh.2023.1293110
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