Critical Success Factors and Traceability Technologies for Establishing a Safe Pharmaceutical Supply Chain

Abstract

Drug counterfeits have been an international issue for almost two decades, and the latest statistics show that fake medications will continue to penetrate legitimate pharmaceutical supply chains (PSCs). Therefore, identifying the issues faced by PSCs is essential to combat the counterfeit drug problem, which will require the implementation of technologies in various phases of the PSC to gain better visibility. In this regard, a literature review was conducted to fulfill the following objectives: (i) review the application of traceability technologies in various PSC phases to detect counterfeits; (ii) analyze the various barriers affecting the establishment of a safe PSC and the critical success factors used to overcome those barriers; and (iii) develop a conceptual framework and guidelines to demonstrate the influence of traceability technologies and success factors on overcoming the various barriers in different phases of the PSC. The major finding of this review was that traceability technologies and the critical success factors have a significant influence on overcoming the barriers to establishing a safe PSC.

A Blockchain and Fingerprinting Traceability Method for Digital Product Lifecycle Management

“…Specifically, GPS technology provides accurate outdoor location tracking and it can be utilized for asset traceability over large service coverage areas. On the other hand, WSN and IoT sensors are useful to continuously sense, collect and transmit physical properties of the product of interest, such as temperature and humidity in drug management [ 33 ] and food supply chains [ 34 , 35 ].…”

Dynamics of Pharmaceutical Drugs Serialization

“…Any error or adverse events in manufacturing, supply chain process, material sourcing, ideal storage and temperature can affect to drugs potency which can cause to people health. [2] Pharmaceutical business always attracts to criminals and drug trafficker to produce mass quantities of fake medicine and distribute them through illicit network and online selling through dark web. Covid-19 also played a crucial role for illicit drug trade which increased counterfeit drug production due to the disruption lack of skilled resources, low business resilience, and the rapid misuse of technologies.…”

Legal Responsibility for Illicit Trade in Pharmaceuticals under Conditions of the Covid-19 Pandemic

“…As a result, there are side effects, diseases spread more rapidly, and the mortality rate increases (Haji et al, 2021). However, the illegal circulation of medicines has an extremely negative impact not only on the health of the population but also on the economic situation.…”

“…Thus, under the COVID-19 pandemic, a super-profitable type of transnational organized criminal activity was formed. This determines the mainstreaming of the issues of countering it with measures of legal liability, which allow influencing the behaviour of interested persons (Haji et al, 2021).…”

“…But to this day, there is no general understanding of the seriousness of the problem. In particular, pharmaceutical companies are trying to independently counter the counterfeiting of medicinal products through the introduction of potential protection measures (Haji et al, 2021). In many countries, regulations do not contain adequate definitions, provide for inadequate penalties, or do not include crimes related to the circulation of falsified medical products as predicates for anti-money laundering.…”