The French reporting system for drug shortages: description and trends from 2012 to 2018: an observational retrospective study.

OBJECTIVES: The aim was to provide figures for drug shortages in France and describe their characteristics, causes and trends between 2012 and 2018. METHODS: Data from the national reporting system from the Agency of Medicine and Health Product Safety (ANSM) was analysed. This database contains information regarding effective and predicted shortages of major therapeutic of interest drugs (ie, drugs whose shortage would be life-threatening or representing a loss of treatment opportunity for patients with a severe disease) which are mandatory reported by marketing authorisation holders to the ANSM. Data are presented as numbers or percentages of pharmaceutical products (ie, the product name and its formulation) reported on shortage between 2012 and 2018. RESULTS: There were 3530 pharmaceutical products reported on shortage during the period, including 1833 different active substances. Drugs on shortage were mostly old products (63.4%) with national marketing authorisation procedures (62.8%), as well as injectable and oral forms (47.5% and 43.3%, respectively). Anti-infectives for systemic use ranked first (18%), followed by nervous and cardiovascular system drugs and by antineoplastic and immunomodulating agents (17.4%, 12.5% and 10.4%, respectively). The number of reported shortages presented a fourfold increase between 2012 and 2018 and a sharp rise in 2017 and 2018, along with a rise in the number of active substances on shortage. The therapeutic classes concerned remained similar over time. Manufacturing and material supply issues were the main reported reasons for the shortage each year (30%) and there was an overall rise of pharmaceutical market reasons. CONCLUSION: Drug shortages were increasingly reported in France. Preventive measures should specifically target the products most on shortage, in particular old drugs, injectable, anti-infective, nervous system and cardiovascular system drugs as well as antineoplastic and immunomodulating agents.

[Supply disruptions and drug shortages: the example of benzathine benzylpenicillin]. / Tensions d'approvisionnement et ruptures de stock des médicaments : l'exemple de la benzathine benzylpénicilline.

Supply disruptions and drug shortages : the example of benzathine benzylpenicillin. Despite collective mobilisation, drug shortages have increased in recent years, creating a strong impact on public health. Anti-infective drugs, mainly injectable antibiotics, are particularly affected by these shortages. Although the causes of these ruptures are multiple, they are mainly related to the effects of globalisation and industrial strategies of rationalisation of production costs. The shortage of benzathine benzylpenicillin illustrates the action of the French Medicines Agency (ANSM), and the various actors to guarantee access to care and limit the consequences for the patient. Beyond measures taken at national level by the regulatory authorities in connection with the pharmaceutical companies, it is necessary to set up a concerted action at European level to fight effectively against drug shortages.

Tensions d'approvisionnement et ruptures de stock des médicaments : l'exemple de la benzathine benzylpénicilline. Malgré une mobilisation collective, les ruptures de stock des médicaments se sont multipliées ces dernières années, créant un fort retentissement en matière de santé publique. Les médicaments anti-infectieux, principalement les antibiotiques injectables, sont particulièrement impactés par ces pénuries. Bien que les causes de ces ruptures soient multiples, elles sont principalement liées aux effets de la mondialisation et des stratégies industrielles de rationalisation des coûts de production. La rupture de la benzathine benzylpénicilline illustre l'action de l'Agence nationale de sécurité du médicament et des produits de santé et des différents acteurs pour garantir l'accès aux soins et limiter les conséquences pour le patient. Au-delà des mesures prises au plan national par les autorités sanitaires en lien avec les laboratoires pharmaceutiques, il est nécessaire de mettre en place une action concertée au niveau européen pour lutter efficacement contre les pénuries de médicaments.