Pharmaceutical Counterfeiting, the Threats Posed and the Countermeasures Available

Paul Osborne

Performance PharmaTech Ltd.
United Kingdom
Tel: +44. 1487 832023   Fax:

Email: paul.osborne@pptech.eu

 

  

 

  
 

Biography

Paul Osborne IEng MIIE – Managing Director, Performance PharmaTech Ltd.

Paul has 25 years’ experience in pharmaceutical packaging, having worked in the sector since joining Laetus in 1984.

Paul’s career development included the design of an
award-winning vision system in 1990. He then spent
five years in Germany at Laetus GmbH as head of
vision design, while simultaneously acting as pharmaceutical regulatory advisor for international processing and packaging machinery group Romaco.  Paul was subsequently appointed International Projects Director, with overall responsibility for all engineering and regulatory aspects of international projects.

After his return to the UK in 2005, Paul was appointed controlling director of Hapa-Laetus UK. He was also instrumental in developing Laetus’ portfolio of strategic anti-counterfeiting solutions for pharmaceutical packaging.

In January 2009 Paul founded Performance PharmaTech to provide a range of services to the pharmaceutical and other industries:

  • Validation and regulatory issues – strategy development, documentation creation and execution
  • Training – fully structured program development and performance
  • Project management -  program planning, development and follow through to successful completion
By working directly with pharmaceutical manufacturers and the companies supplying equipment into this highly regulated environment, Performance PharmaTech seeks to assure that projects are not only completed on time and within budget but fully achieve their intended purpose.

Paul has qualifications in electronics, machine vision, pharmaceutical regulatory issues, machine control and computer systems and is a regular speaker for bodies including the ISPE and David Begg Associates on subjects such as computer system validation, trends in packaging and packaging security, anti-counterfeiting and mass serialisation.

 

 

   
 

Abstract

Counterfeiting of pharmaceutical products is not often discussed, for obvious reasons, but currently it is:

  • Increasing at an alarming rate
  • Very lucrative, with low penalties 
  • A significant danger to patients worldwide

Two factors significantly increase the opportunities introducing counterfeiting pharmaceuticals into the supply chain:

  • Internet trading
  • Parallel importing and repackaging

Counterfeiting is difficult to control and is growing increasingly sophisticated. The biggest issue of counterfeit medicines is consumer safety.  Linked to the patient safety issue are the significant threats to the company's brand protection, and potential product liability actions.

Therefore all companies are actively pursuing anti-counterfeiting technology in a variety of forms.
Besides overt and covert countermeasures to counterfeiting, employing both active and passive technologies, a complementary technique is also evolving. This is using unique serial identification, placed on the pharmaceutical packs themselves. 

A unique and non-predictive serial code (USC) is placed on every carton pack, along with complementary information, such as the expiry date, the product identification (GTIN) code and the batch number of the product.

As a first step towards securing the supply chain, a ‘bookend’ strategy will be employed where drug product is serialised at the point of manufacture and checked at the point of dispensing.