Pharmaceutical Technology Europe - July 2010 - (Page 2)

Can pharma keep pace with the counterfeiters? This month, PTE speaks with experts to reveal the true extent of the threat that counterfeiting presents to the pharmaceutical industry as well as some of the new regulations and innovations that are on the horizon that aim to hamper this criminal activity and prevent the situation from escalating further. T he problem of counterfeit medicines was first addressed at an international level in 1985, when a conference of experts recommended that the World Health Organisation (WHO), together with other international and nongovernmental organisations, should study the feasibility of setting up a clearing house to collect data and to inform governments about the nature and extent of counterfeiting. Since then, however, the problem has only escalated. According to the WHO, the magnitude of the issue is difficult to assess because of the variety of information sources available.1 Additionally, the WHO stresses that counterfeiters are extremely flexible and can change their methods from day to day, so the results of a study may already be out of date the day they are released. However, the statistics that are available show unsettling results. For example, compared with 2005, seizures of counterfeit medicines at the EU border increased by 380% in 2007. 2 Meanwhile, research commissioned by Aegate revealed that 5% of consumers across five European countries suspect they may have received a Figure 1: PTE survey results, June 2010. Q: Which anti-counterfeiting solution is your company currently using? RFID 11% Barcoding 24% None 27% Other 11% On dose technologies 7% Tamper-evident packaging 20% Source: www.pharmtech.com/counterfeitpoll counterfeit prescription drug.3 The research adds that the majority of consumers believe that the trade in counterfeit medicines is largely the responsibility of the manufacturer. Fortunately, the threat of counterfeits has prompted the development of a number of anti-counterfeiting solutions, from simple holograms and watermarks, to sophisticated barcodes that enable track and trace, tagged packages, and even technologies that can be applied directly to individual tablets. But which solution is most widely used by the pharma industry? To get a better idea, PTE conducted a survey4 of industry executives and found that, although barcoding and tamper-evident packaging was the most popular solution in use amongst those surveyed, astonishingly, the majority of respondents (27%) admitted that their company had yet to instate an anti-counterfeiting solution (Figure 1). Products can never be made completely secure against counterfeiting; however, counterfeiters will always target medicines that are easiest to copy. In the EU, companies that have yet to implement a solution are going to have to move quickly in light of the significant threat that counterfeiting presents as well as amendments that are being made to the current EU anti-counterfeiting directive; one of which mandates safety features, such as seals or serial numbers, for certain medicines.5 Speaking to a variety of industry leaders, PTE examines some of the trends in anti-counterfeiting technologies, as well as the innovative solutions being used by the industry. PTE References 1. www.who.int 2. http://ec.europa.eu 3. www.aegate.com 4. www.pharmtech.com/counterfeitpoll 5.www.europarl.europa.eu 1 CONTENTS 8 EDIBLE MICROTAGS 3 OVERCOMING OBSTACLES 9 X-RAY ANALYSIS 4 EU LEGISLATION 11 RAMAN SPECTROSCOPY 6 DATA MATRIX CODES 14 TOP TECHNOLOGIES http://www.pharmtech.com/counterfeitpoll http://www.who.int http://ec.europa.eu http://www.aegate.com http://www.pharmtech.com/counterfeitpoll http://www.europarl.europa.eu

Table of Contents for the Digital Edition of Pharmaceutical Technology Europe - July 2010

Pharmaceutical Technology Europe - July 2010
Can Pharma Keep Pace with the Counterfeiters?
Obstacles to Implementing an Effective Anti-Counterfeit Strategy: Can They Be Overcome?
EU Anti-Counterfeiting Legislation on its Way
You Can't Control What You Can't Measure
Data Matrix Barcodes: Points to Consider
Authenticating Drugs with Edible Microtags
The Power of X-Ray Analysis
NIR Chemical Imaging Could Hold Key Data
How Raman Spectroscopy is Benefitting Developing and Developed Countries
Overt Versus Convert Technologies
Serialisation is Here to Stay
Eight Latest Technologies Showcased

Pharmaceutical Technology Europe - July 2010

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