Pharmaceutical companies are paying an annual subscription for registration and maintenance of their unique product codes into the Aegate database to protect the consumers against counterfeit or substandard pharmaceuticals according to Aegate sources.
The pharmaceutical companies have access to add additional safety or security information into the database about their products at any time. Pharmacies are provided with Aegate's authentication service free of charge to ensure that for patient safety reasons cost is not a barrier to use, added Aegate.
The system was brought into focus with the presentation of an independent report at the European Parliament premises recently by Françoise Grossetête, MEP.
The report corroborated that Aegate's drug authentication service is 100 percent reliable and effective and keeps consumers fully protected against counterfeit or substandard pharmaceuticals when their pharmacist authenticates their medicines at the point of dispensing.
Speaking at the occasion, Professor Dr. Steven Simoens, Katholieke Universiteit Leuven, Belgium, confirmed: "Our findings verify that Aegate's patient safety communications service is 100 percent effective in ensuring that the drugs pharmacists dispense to patients are fit for purpose and safe."
The independent market analysis of "The reliability and impact of drug authentication at the point of dispensing" was carried out by Professor Simoens, The Research Centre for Pharmaceutical Care and Pharmaco-economics at the Katholieke Universiteit Leuven, Belgium.
According to the study details provided, the retrospective analysis included 114 pharmacies in Greece and 658 in Belgium. In day to day operation approximately 20 percent of pharmacies in Belgium and Greece are using the system with another 20 percent waiting to receive the technical upgrade to their software.
On the question of conflict of interest, the University of Leuven said in comments on the commercial contract, "the authors have no conflicts on interest that are directly relevant to the content of this manuscript." Moreover, the study carried out under a non disclosable commercial agreement with the University of Athens took two months to complete, the statement added.
SUPPLY CHAIN SECURITY
According to experts present at the presentation there are two approaches to supply chain security:
- authentication (such as Aegate system)
- track and trace
There are many companies in the US preparing to develop a track and trace system but the US does not yet have unique bar-coding so it is impossible to install. A decision on this approach by the FDA is being continually put back and is now expected by 2011 but it was confirmed by Aegate that with regards to authentication approach, "there is no other operating authentication system in the world today."
Dr. Guido Hoogewijs, General Manager of The Association of Belgium Pharmacists (APB), said: "The Aegate system is allowing us to strengthen our efforts by providing additional tools to filter out packs that are not authentic, that have just been recalled, just expired or are about to expire."
Hoogewils reiterated the concern of the Belgian pharmacists to only deliver pharmaceuticals of impeccable quality to their patients saying, "They have been financing and operating a Medicines Control Laboratory for the past 50 years in order to filter out substandard products from the market,"
Asked to comment on why the study was conducted only in Belgium and Greece, while Pharmaceutical Group of the European Union (PGEU) has 30 European members, PGEU in a statement explained, "Belgium, Greece and Italy (the three countries in which Aegate is operating) are the only three EU countries where by law all reimbursable pharmaceutical prescription items must contain a unique number on the individual drug package. (Similar to a passport number but on medicines). It is this number that creates the security."
John Chave, Secretary General, PGEU said: "Pharmaceutical safety is of fundamental importance for PGEU members and is a critical issue on the EU health agenda. Initiatives that have the potential to reduce the risk of counterfeits and promote patient safety are welcome."
HOW IT WORKS
Aegate explained that it provides drug manufacturers, pharmacists and their patients with a real time communication system that operates at an individual item level. Each pack of medicine is given a unique machine-readable identification number, known as unique serialisation. Using one of a number of technologies, including RFID, 1D or 2D barcodes, items are scanned as they are dispensed.
Allowing the pharmacist to check expiry dates and recall information, and provide updated patient care advice, the system ensures pharmacists receive product safety information more rapidly added Aegate. Currently, communications are achieved by fax or post and can reach pharmacies after drugs have been dispensed. The system also allows the authentication of the origins of medicines, thereby protecting against stolen and fake drugs.
With patient safety becoming an increasingly important issue and counterfeit drug sales forecast to hit USD 75 billion by 2010, Professor Simoens concluded: "The full impact of authentication processes will only be realised if such systems are applied fully within and across countries. We believe policy makers on a European and global scale should consider these findings and enact the necessary legislation to introduce drug authentication processes based on mass serialisation technology in community pharmacies."
Aegate has commenced roll-out in a new country every eight months since the technology completed development in 2006 and the next country will be announced shortly Aegate said. Currently in operation in Belgium, Greece and Italy, the system has so far this year scanned more than 24.5 million packs of drugs across Europe according to Aegate.
Urging others to follow the role of Belgium and Greece, Gary Noon, CEO of Aegate, said: "Industry and Governmental organisations now need to step up and demonstrate a similar level of commitment to patient safety."
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