History of Authentication

The journey of drug authentication to ensure patient safety 2003-2008: From Pilot to Practice

Over the last five years, there have been at least 12 pilot studies to test different approaches to drug authentication in Europe and the USA. Over time a commonality of views have grown which indicates that the pilot stage is over.

• An authentication approach remains the most effective way to secure patient safety. This is endorsed by EFPIA as "The single most promising solution to fight counterfeiting and diversion threats in Europe and globally"
  
• Security at point of dispensing is an important first step in attempting to secure each point of the supply chain, leading to a full track and trace solution. The combined effect of a variety of approaches including tamper evidence would substantially decrease the risk of patient safety being compromised.

Securing the supply of drugs between manufacturer and patients to ensure they receive the highest quality medicines is in the interest of all industry stakeholders. A complex supply chain, particularly in Europe, that may involve products changing hands more than 20 times before they reach the patient, combined with the proliferation of Internet pharmacies, means there are increasingly more opportunities for harmful, substandard and counterfeit drugs to reach consumers.

It is in this context that Governments and industry are seeking to find practical solutions to secure the supply chain. Yet, while awareness and concern over patient safety is on the increase, no consensus has yet been reached as to how best to secure the pharmaceutical supply chain.

17 September 2008, is a significant milestone as it marks a real break-through in drug authentication with the first audit of a fully operating "real world" point of dispense authentication solution. Aegate, who has been operating its authentication system for more than a year in Belgium and Greece, offered its authentication process for public scrutiny. The audit was carried out independently by the University of Leuven.

The findings from the world's first independent study of a working drug authentication system conclude that the AegatePROTECT^TM system is:

• 100% reliable
  
• An effective method to identify authentic, recalled, expired and suspicious drugs at the point of dispense
  
• Able to protect consumers from receiving counterfeit or substandard medicines