According to the Mexican Association of Pharmaceutical Research Industries, the large volume of illegal drugs sold in Mexico places it as the sixth country in the world in this practice, below China, Russia, the United States, India and Brazil. Being the only country of the ones mentioned above, which does not yet have or is in the process of a national serialization and traceability of drugs regulation.
According to the AMIIF, six of every ten medicines that are offered in national territory are stolen, expired or falsified, affecting 8 million people victims of these sales. Added the risk that represents for pharmaceutical companies, who have recorded losses of up to 50 million pesos, according to the National Union of Pharmaceutical Entrepreneurs.
In line with this and driven by GS1 Mexico and important players in the industry, Verifarma has been very interesting to collaborate in conducting the first test concept of the traceability of serialized medicines, from its creation in the pharmaceutical manufacturer until it reaches the patient.
The members of the industry and participants of this test concept were: two large multinational pharmaceutical manufacturers; one of the largest distributors in the country and a renowned pharmacy firm.
The objective of the test was to demonstrate that, through the use of Global Data Standards with GS1 and the correct identification of the products, it is possible to trace a medicine or device along the supply chain, allowing to know the medicine’s journey from its origin until its dispensation to patient.
When the survey was made about the needs of the industry, it was detected that it is not only important to have traceability from the point of view of pharmacovigilance, but also to know the origin of medicines and medical devices. In this way, immediate notification can be made when it is detected that an illegal product has entered the market.
To implement traceability, the use of GS1 standards and the identification of medicines and medical devices with DataMatrix code was proposed. For the integration of the communication of all these transactions, Verifarma was chosen as the technological provider. Solution that allows the management of traceability of the different links of the supply chain.
For the realization of this project, two stages of evaluation were considered. The first consisted in the identification of the products, placing the labels with the DataMatrix codes. The second part consisted of capturing the information in Verifarma through scanning or “picking”, managing to record each of the movements that the drug has.
This test concept served to take the first steps with the traceability of medicines in Mexico and the authorities can have a first information of the processes involved.
By 2020 is estimated that 75% of medicines marketed in the world will be serialized and traceable. Currently, there are already regulations in Turkey (2009), Argentina (2011), China (2015), South Korea (2016), Pakistan (2017), Saudi Arabia (2017), Egypt (2018) and the European Union (2019).