Anti Counterfeiting, the USA and European Perspective

Paul Osborne

Laetus, Romaco Pharmatechnik GmbH

Sandwiesenstr. 27, DE 64625 Alsbach Hähnlein, Germany

Tel: +49 6257 5009   Fax: +49 6257 5009 0
Email: Paul.Osborne@romaco.com

Biography 
 

Paul Osborne has worked in the pharmaceutical industry for more than 22 years, developing and supplying product security equipment solutions for packaging machines.  Trained in electronics and computer systems he is a regular speaker for such bodies as the ISPE, Brighton University and David Begg associates.

Currently employed as the Director of Hapa-Laetus UK, he works as a consultant engineer developing new product security applications and equipment for the Pharmaceutical industry worldwide. Additionally he is a consultant for the Hapa-Laetus companies on pharmaceutical regulatory issues.

Laetus was founded in Germany over thirty years ago.  When it produced the first ARGUS Pharmacode reading system.  In 1987 it produced the first POLYPHEM Blister Inspection system In 1996 new ARGUS and POLYPHEM technology was released and 2002 saw the launch of the new wt-technology based on web technology and industrial computers.

Since the introduction of its first overprinting machine more than five decades ago, Hapa has delivered a constant stream of innovative, state-of-the-art technologies for the pharmaceutical, cosmetic and healthcare industries. Working in close partnership with its global customer base, Hapa’s team of highly-skilled professionals translates in-line printing innovations into system solutions tailored to the individual needs of the customer.

Abstract

The threat of counterfeit Pharmaceuticals entering the supply chain is ever increasing. Besides increasing the policing efforts needed to overcome this problem, Pharmaceutical companies are using a variety of counterfeit resistant technologies on drug packaging and labelling to help protect the integrity of the drug supply chain. These include both overt and covert packaging and labelling features. These technologies provide layers of security that make pharmaceuticals more difficult for counterfeiters to reproduce. They are also useful for assessing the authenticity of products already identified as "questionable."
As an anti-counterfeiting control and for improving the supply chain security to the end user, the Italian government has recently made law a modification to this vignette label. How will this affect pharmaceutical packaging?
 

This paper sets out to detail some of the evolving approaches to anti-counterfeiting being used today in pharmaceutical companies.  Besides marking the packs and even the individual unit dose with Covert and Overt marking, there is also a growth in ‘track and trace’ methods.  The use of a track and trace system protects the integrity of the drug supply chain throughout the distribution system and prevents the entry of counterfeit drugs.

The USA Prescription Drug Marketing Act (PDMA) Final rule took effect on December 1, 2006, this included: Paper or e-pedigree, starting with the distributor , the requirement to trace all prior sales back to manufacturer Includes licensing, storage, handling and recordkeeping requirements. 

Within Europe there is no common industry standard for the identification and coding of pharmaceutical products. Consequently, there are an increasing number of different and costly local country solutions being implemented by Governments (Italy, Belgium), each with its own objectives and motivation. The EFPIA recommends the adoption of a 2D matrix Bar Code system to be introduced across Europe, as the solution that would meet industry safety, tracking and logistic needs. Encrypted information of the products can be confirmed at each step within the channel of distribution by comparing the encrypted information of the scan with that already in the database.

Certain anti-counterfeit security features that provide track and trace capability will also offer additional functionality.  The use of a 2D barcode or other symbology like a datamatrix code gives data capability to not only provide authentication of the protected items, but also to contain the inventory control information now carried by the existing barcode.  Using the latest in marking technologies, or RFID tags, information such as manufacturer’s identification, as well as the batch and lot information can be encoded when marking the carton, label or other component.   

Most importantly, information relating to the intended destination, potentially to the detail of the customer and location, can be included. This provides identification of each item and enables a detailed track and trace system to be developed.