Pharmaceutical serialization, a global effort to combat counterfeit medicines

Pharmaceutical serialization

  • Georgiana Andreea Pascu Regulatory Affairs Department, Gedeon Richter Romania
  • Gabriel Hancu University of Medicine, Pharmacy, Science and Technology of Tîrgu Mureș, Faculty of Pharmacy, Department of Pharmaceutical Chemistry
  • Aura Rusu University of Medicine, Pharmacy, Science and Technology of Tîrgu Mureș, Faculty of Pharmacy, Department of Pharmaceutical Chemistry
Keywords: serialization, counterfeit medicines, fake medicines, quality assurance, pharmaceutical industry

Abstract

Objective. Pharmaceutical serialization is a process in the pharmaceutical industry that offers a secure solution to track and authenticate drugs in the distribution chain. The unique recognition number for every drug unit helps to identify and combat counterfeit products. This paper aims to highlight the advantages of serialization implementation as an innovative tool to combat globally the counterfeiting drugs phenomenon.

Methods. Worldwide a considerable effort was focused on enhancing medicines identification. Analytical methods, development of the new lab equipment, digital solutions, and blockchain technology are the new directions for the future. Also, legislation needs to be correlated at the international level between the pharmaceutical industry, distribution, and pharmacies.

Results. A good collaboration between responsible entities should be implemented to protect public health and to promote patients’ access to safe medicines. A directive implemented on European Union focused on fake drugs, Global Monitoring and Surveillance System launched by the World Health Organization, or the international campaign “Fight the Fakes” are remarkable examples.

Conclusions. An efficient joint effort between the pharmaceutical industry and law enforcement is required. Counterfeit medicines are a worldwide threat to public health and demand a unitary pharmaceutical serialization system to be implemented as an ideal solution.

Published
2020-11-03
How to Cite
1.
Pascu G, Hancu G, Rusu A. Pharmaceutical serialization, a global effort to combat counterfeit medicines. amm [Internet]. 3Nov.2020 [cited 24Feb.2021];66(4):132-9. Available from: https://ojs.actamedicamarisiensis.ro/index.php/amm/article/view/28