Aegate News

In the fight against fake medicines, Aegate calls for improved bar-coding standards

2nd August 2005

Following last week's discovery of fake Lipitor in the UK regulated supply chain, the third incident in the last 12 months, Ian Rhodes, CEO of Aegate Ltd, the leading drug authentication company, has stated that it is clearly time to tighten up on anti-counterfeiting measures. In rapid response to the MHRA's recall notice, Aegate's authentication alert solution relayed the information to participating pharmacists within a matter of minutes.

In a statement released by the Director General of the ABPI, Richard Baker calls for existing systems to be examined to see where they can be further tightened . Rhodes suggests the starting place is to treat medicines like any other FMCG item and make use of the existing barcodes. For pharmaceuticals, bar-coding standards will need tightening but if the FMCG industry can do this - why not medicines?

In one of the largest patient safety pilots of its kind, Aegate's results highlighted many inadequacies in the bar-coding of medicines. During the pilot, 50 authentication devices were provided to pharmacists who used these to scan the barcodes of more than 180,000 items over a three month period. 14% of these, representing 1600 different product lines, were not recognized or were inaccurate.

Working with the National Pharmaceutical Association and Chemist and Druggist, Aegate has notified those companies with product lines involved and steps are being taken to correct these. The issue is that, unlike the US, there is no regulatory requirement for pharmaceutical companies to centrally record which barcode relates to which product. This is one reason why today, 8% of UK medicines still do not contain a barcode .

What is needed in the UK, Rhodes states, is stronger collaboration between the regulatory authorities, pharmaceutical companies and Government to look at what is being adopted in the USA under guidance from the FDA.

The FDA's approach of uniquely identifying medicine packages, known as mass serialisation, is a more secure and proactive approach to anti-counterfeiting. Aegate's system, authentication at the point of dispensing^TM, makes use of this approach to improve patient safety by identifying counterfeits and other types of fraudulent medicines to the pharmacist as well as supporting them with real time recall notices and special safety alerts that are given at the most effective time i.e. before handing the medicine to a patient.

The majority of ethical and generics manufacturers within the UK are stating publicly that "Patient safety is our top concern". Rhodes of Aegate believes that with this in mind, industry, regulators and Government should work towards tightening barcode accuracy and uniformly mass serialising medicines.

Graham Satchwell, author of the Stockholm Network report, A Sick Business --Counterfeit Medicines and Organised Crime concurs, "We need much tighter controls around the ability to identify good product at the point of delivery to the customer. The U.S. is using the E.U. as a model in the belief that we have it safe here. We don't have it safe."

Red Herring Magazine, the California-based "Bible of Technology", writes that "Mr. Satchwell has suggested that a system of unique identifiers, such as those developed and piloted by the authentication firm Aegate, should be incorporated into pharmaceutical products at the point of manufacture and then validated before being dispensed to the customer."

Aegate's system will be rolled out in the UK in 2006 and as mass serialisation becomes commonplace it will grow in its effectiveness. In trials so far there have already been demonstrable results that both pharmacists and pharmaceutical companies are able to take better care of the patients they are treating as a result of such an authentication service.