Community pharmacists have been required to practice drug serialization since February 9, 2019. However, French pharmacies have fallen behind in implementing this system. The Ministry of Health set the goal of having 100% of pharmacies connected to serialization by the end of 2022. Status update.
Drug serialization is part of security measures aimed at fighting the introduction of falsified medicines in the European Union. It was implemented by European Directive 2011/62/EU and has been mandatory since February 9, 2019. Serialization is also part of Good Dispensing Practices in pharmacies (decree of February 26, 2021). It concerns all medicines subject to mandatory medical prescription and some medicines with optional medical prescription.
Despite a delay in applying the system, all French pharmacies must be connected to serialization by the end of 2022. The situation reveals significant progress to comply with Ministry of Health requirements.
France Behind Its European Neighbors
In September 2021, only 800 pharmacies practiced serialization. In comparison, in other European Union countries, 99 to 100% of pharmacies were already connected on the same date. France therefore has a significant delay compared to its neighbors.
This situation led the Ministry of Health, as well as the National Council of the Order of Pharmacists (CNOP), pharmaceutical unions and France MVO, to repeatedly remind pharmacists of this obligation. On May 7, 2021, they set the goal of 100% of pharmacies connected to the national medicines verification directory, managed by France MVO, by the end of 2021.
A 100% Goal Difficult to Achieve
Despite efforts by profession representatives to encourage pharmacists to adopt drug serialization, few are getting started. They often consider the process too time-consuming. As of May 1, 2022, only 33% of pharmacies in France had implemented medicine authentication!
Facing this situation, on June 21, 2022, CNOP, pharmaceutical unions and France MVO alert pharmacies again. They send them an open letter to encourage them to adopt serialization. However, in September 2022, the ambitious goal of connecting 100% of French pharmacies is finally postponed to December 31, 2022.
Nearly 100% of Pharmacies Connected to Serialization in Early 2023
This time, efforts by CNOP and pharmaceutical unions are paying off. On January 2, 2023, according to the General Directorate of Health, 78.6% of community pharmacies (i.e., 16,333 pharmacies) decommission, i.e., authenticate medicine boxes.
About half of pharmacies that do not yet practice serialization have undertaken steps to connect. On January 11, this percentage rises to 81%, according to France MVO.
The ambitious goal of connecting 100% of French pharmacies by December 31, 2022 is not completely achieved. However, the strong progress recorded in a few months has allowed catching up with the French delay in medicine authentication.
Despite a difficult start, France has therefore made significant progress to implement drug serialization in pharmacies. However, to guarantee patient safety and fight the introduction of falsified medicines, it is essential to have 100% of pharmacies connected to serialization.
Read also: “Discover PharmaliZr V1.0.0: The New Version of the Drug Serialization Application is Now Available”
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