Background and importance Drug shortages are a major public health threat worldwide, occurring across all therapeutic classes. We focussed our study on the trends in reported causes of drug shortages in our country.
Aim and objectives The aim of the study was to propose a classification and trends in reported causes of drug shortages.
Material and methods Data from the national reporting system from a health product agency were analysed. This database contains information regarding the causes of shortages of major therapeutics of interest (MTI) (ie, drugs where a shortage represents loss of a treatment opportunity for patients with a severe disease) which are mandatory reported by marketing authorisation holders to the agency. Data are presented as numbers or percentages of pharmaceutical products (ie, the product name and its formulation) reported as shortages between 2015 and 2018.
Results The classification work identified two major categories of causes of drug shortages: causes related to the manufacturing process and those related to the drug distribution system. Causes related to manufacturing dysfunction were divided into five subclasses: 83 types of causes allowed the building of a systematic classification related to the manufacturing circuit. Material issues use ranked first (31%), followed by manufacturing issues, pharmaceutical market and regulatory issues, and inventory and stockage practice (30.4%, 23.5% and 9.89%, respectively). The number of reported pharmaceutical market causes of shortages showed a 3.5-fold increase between 2015 and 2018. In 78% of reported shortages, only one dysfunction caused the shortage. The number of multiple causes of shortages increased by 2.4 during the study period.
Conclusion and relevance To our knowledge, there are no studies with the same results. Drug shortages are increasingly reported in this country. Precise knowledge of the causes of the shortages can identify short term solutions to reduce their severity and long term solutions to reduce their numbers.
References and/or acknowledgements The authors thank the drug shortages team and the pharmacosurveillance division. They also thank the professor team of Strasbourg Faculty of Pharmacy.
No conflict of interest.
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