Now is the time to establish a global vision in the path to a harmonious approach to product security that provides close-term benefits for patient safety. While the US centers on how to achieve an e-pedigree system and the pharma industry in Europe incorporates a 2D datamatrix-based “bookend” system, patient safety is in possible danger due to the split approaches and expensive implementation strategies.
The drugs supply chain is becoming more and more complex due to the increase in the globalization of the pharma trade. Manufacturers, distributors, re-packagers, and retailers may be all located in different countries or even continents. Given the complexity of the supply process, drugs have become a profitable target for illegal distribution and forgery.
Many methods have been proposed to protect patients, however, the answer may be very simple: an approach in phases, which initially focuses on the point of dispensing and avoids the significant difficulties and costs that a full supply chain pedigree system encompasses.
Currently, there are two main initiatives that are fragmenting the resources of the industry: The European Federation of Pharmaceutical Industries and Associations (EFPIA) initiative, and the California ePedigree network. Not long ago, the pharma industry overcame many years of irrational enthusiasm in regards to the near-term potential of RFID technology. It is time to learn from mistakes and select an approach that leads to improvements in patient safety that are achievable instead of considering a large-scale solution focused on the supply chain. In this regard, the European initiative is better.
Key organizations and agencies have to become aligned in regards to a global approach that can be launched in any region and using the available technologies. This global approach should have a main goal: checking drugs at the most critical transaction in the supply chain, when they are delivered to patients. The EFPIA follows this route, however it requires two important and costly developments: all products must be serialized at the unit level, and an industry-wide data routing and data management system has to be established. These developments will allow for significant short-term improvements to patient safety through point-of-dispensing verification, will offer important knowledge, and will enable other developments of supply chain pedigree programs that can build on this foundation.
Like bank ATM’s and credit cards, this system would permit global use with universal results: the approval or denial to sell a drug. Along with serialization as an aspect of an authentication program, authentication technologies are also needed. Explicit and secret product authentication characteristics used by the manufacturer in the product’s packaging or in the product itself, give the manufacturer the capacity to detect abnormalities fast.
In order to make this a reality, the EFPIA, EMEA, FDA, PhRMA, and WHO will have to join forces to define an industry standard with a data exchange infrastructure that could strengthen the broad implementation of unit-level serialization. Eventually, this system will evolve into a more extensive track and trace system, forming the supreme supply chain management tool.
It is everyone’s responsibility to work towards a solution for patient safety in view of the growing global danger of distribution of illegal and forged drugs. As pharmaceutical consultants will agree, global problems beg for global solutions.
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