The American Generic Pharmaceutical Association (GPhA) proposed in March 2012 its own model for the traceability of medicinal products.
According to the GPhA, the drug pedigree model - which would require implementation of a full electronic "track and trace" solution - set to take effect in 2015 under California law, is very demanding and pretty expensive. These high-cost measures would raise the costs for prescription medicines but also for generics - which are usually less expensive. The GPhA thinks that, technically, implementing the respective FDA provisions is not achievable with yearly up to 4 billions prescriptions.
The GPhA has therefore elaborated another proposal - in collaboration with further partners from the pharmaceutical supply chain - to meet FDA's requirements and achieve better patients' safety.
The PDSA model (PDSA = Pharmaceutical Distribution Security Alliance) which applies to the whole American distribution system has been developed for the American market. The GPhA supports the electronic traceability system called RxTEC (Pharmaceutical Traceability Enhancement Code).
As part of the RxTEC system, pharmaceutical manufacturers have committed to serializing individual saleable units of medicine with RxTEC labels, and maintaining and managing RxTEC data (serialisation number, batch number, number of saleable units sold) in their systems. The system would enable to visualize the way of each single drug through the supply chain. Moreover, tests can already be made on the packaging. The GPhA believes in the feasibility and the scalability of this model which should be operational with large data volumes too.
Learn more about the situation in Europe at the Anti-Counterfeit Conference organised by the University of Würzburg. During the conference, EDQM's eTACT system will be presented by Dr Hans-Joachim Bigalke. In addition, the German "securPharm" model will be introduced by Dr Stephan Schwarze from Bayer AG. For further information please visit the Anti-Counterfeit Conference Website.
Additional background information is available in the GPhA press release "GPhA Pledges Support to the RxTEC Supply Chain Security Model".
Dr Günter Brendelberger
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)