Aegate's drug authentication service is 100 per cent reliable and effective, corroborates report

Aegate, Brussels, September 17, 2008

Consumers can be protected from receiving counterfeit or substandard pharmaceuticals when their pharmacist is able to authenticate their medicines at the point of dispensing, concludes the world’s first audit of a working drug authentication system. Results prove the Aegate authentication process is 100 per cent reliable1 and an effective method to identify authentic, recalled, expired and suspicious drugs at the point of dispense.  

Conducted independently by the Katholieke Universiteit Leuven, Belgium, the audit of Aegate’s AegatePROTECT™ initiative in Belgium and Greece, which authenticates drugs when being dispensed by the pharmacist in order to filter out counterfeit medicines, is highly significant. Whilst awareness and concern over patient safety in relation to counterfeit pharmaceuticals is on the increase, no consensus has yet been reached either at an industry or governmental level as to how best to secure the pharmaceutical supply chain. 2

Dr Guido Hoogewijs, General Manager of The Association of Belgium Pharmacists (APB), said: “We congratulate Aegate for opening up their system for public scrutiny, and for creating the tangible proof that there are methods achievable today to protect patient safety. The findings from the Katholieke Universiteit Leuven are a pivotal milestone in the journey to eradicate harmful drugs reaching consumers. “In their concern to only deliver pharmaceuticals of impeccable quality to their patients, Belgian pharmacists have been financing and operating a Medicines Control Laboratory for the past 50 years in order to filter out substandard products from the market. 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.”

1 99.8% statistical significance using 95% confidence interval
2 Working Together on Mass Serialisation: Whose Responsibility is Ensuring Patient Safety, Frost and Sullivan white paper April 2008

Professor Dr. Steven Simoens, Katholieke Universiteit Leuven, Belgium, confirmed: “Our findings verify that Aegate’s patient safety communications service is 100 per cent effective in ensuring that the drugs pharmacists dispense to patients are fit for purpose and safe.” Dimitris Karageorgiou, Secretary General from the Panhellenic Pharmacists Association, Greece, commented: “Patient safety and the best effectiveness of medicines are the drivers for pharmacists, and these results will be welcomed by pharmacists who are looking for effective easy to use tools to protect themselves and their patients against the risk of substandard medicines.”

John Chave, Secretary General, Pharmaceutical Group of the European Union (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.” In Aegate’s commitment to patient safety and its fight to assure the quality and safety of medicines that are dispensed to patients across Europe, Aegate has commenced roll-out in a new country every eight months since the technology completed development in 2006. Currently in operation in Belgium, Greece and Italy, Aegate has so far this year scanned more than 24.5 million packs of drugs across Europe.

Gary Noon, CEO of Aegate, said: “Belgium was the first country in the world to pioneer our patient safety communications service and this study validates the commitment by pharmacists and their professional membership associations to put patient care at the heart of their business. Industry and Governmental organisations now need to step up and demonstrate a similar level of commitment to patient safety. Aegate is proud to be part of this significant step in Europe towards ensuring patients receive the best quality medicines as prescribed.”

Professor Dr. Steven Simoens, Katholieke Universiteit Leuven, Belgium, 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.”

EndsNotes

Aegate’s authentication system utilises a unique barcode in place on every prescription medicine package. The product manufacturer provides the unique barcodes to the Aegate database before distribution. When the product has reached the pharmacy and is being dispensed, the package code is validated in real time by the pharmacist through an on-line scanning process, integrated inside the pharmacy software. This supports and enhances existing safety systems such as the recall procedures in use in most countries. The real time nature of the authentication process means that safety information can be disseminated more rapidly and that substandard and counterfeit medicines are proactively prevented from reaching patients.

About The Katholieke Universiteit Leuven, Belgium
The independent market analysis of “The reliability and impact of drug authentication at the point of dispensing” was carried out by Professor Dr. Steven Simoens, The Research Centre for Pharmaceutical Care and Pharmaco-economics at the Katholieke Universiteit Leuven, Belgium.

About The Association of the Pharmacists of Belgium (APB)
L'Association Pharmaceutique Belge (APB) is the professional pharmacy association representing more than 90% of independent pharmacies in Belgium. www.apb.be

About Pharmaceutical Group of the European Union (PGEU)
The Pharmaceutical Group of the European Union (PGEU) is the European Association representing community pharmacists in 30 European countries including EU Member States, EEA countries and EU applicant countries. Within the enlarged EU, over 400,000 community pharmacists provide services throughout a network of more than 160,000 pharmacies, to an estimated 46 million European citizens daily. www.pgeu.org

About the Panhellenic Pharmacists Association
The Pan-Hellenic Pharmacy association is the professional pharmacy association representing 54 local Pharmacy associations (100% of pharmacies) all over Greece.