New study claims drug authentication protects customers

Published: 23-Sep-2008

A professor involved in an independent audit on authenticating drugs at the point they are dispensed, has called on other European countries to introduce tougher legislation to protect customers.


A professor involved in an independent audit on authenticating drugs at the point they are dispensed, has called on other European countries to introduce tougher legislation to protect customers.

Professor Dr Steven Simoens of Katholieke Universiteit Leuven, Belgium has called on policy makers in Europe and on the global scale to consider results from a recent study at his university that supports the reliability of authentication system Aegate in removing counterfeit and sub-standard drugs from the market place.

According to the study, Aegate's system was found to be 100% reliable1 and an effective method to identify authentic, recalled, expired and suspicious drugs at the point of dispense.

"The full impact of authentication processes will only be realised if such systems are applied fully within and across countries," said Simoens whose university conducted an audit of Aegate's AegatePROTECT initiative in Belgium and Greece. "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."

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."

Simoens said: "Our findings verify that Aegate's patient safety communications service is 100% effective in ensuring that the drugs pharmacists dispense to patients are fit for purpose and safe."

Aegate has so far this year scanned more than 24.5 million packs of drugs across Europe with operations in Belgium, Greece and Italy.

Aegate ceo Gary Noon, 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."

References

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

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