Cracking the code for safer drug dispensing

 

Simeon Goldstein, Packaging News, 04 July 2008

 

In May, the European Federation of Pharmaceutical Industries and Associations (EFPIA) revealed that pharmaceutical firms are to pilot a bar code system to monitor the authenticity of drugs as they are dispensed. The scheme was set up in response to a European Commission consultation on tackling fake products, but with pharmaceutical counterfeiting a $70bn business (see box), beating the criminals is likely to take more than one approach.

 

A Californian scheme appears to have provided the main model for tackling counterfeiting. In 2004, the state passed a law requiring pharmaceuticals manufacturers to provide individual ‘electronic pedigrees’ for all their products, showing all transactions from manufacturing to dispensing. The system is designed to highlight fraudulent products when they are sold by registering repeated items.

 

We talk about breaking the counterfeiters’ business model. They can copy a single pack, but they would have problems copying more if they are all different, says EFPIA director of legal affairs Ann Robins.

 

Pack problems

Although 2D bar codes and RFID tags have received the most attention, the Californian regulations do not specify a tracking technology. The question over where the code should be placed remains unanswered, but EFPIA would like to ensure that the integrity of the pack is assured from manufacturer through to patient.

 

It’s a waste of time for manufacturers to use security labelling if the packaging is changed and the label is discarded, says Robins.

 

Part of the problem is that the EU permits parallel trade of goods and the repackaging of products, and drugs move freely across borders. The UK’s medicines watchdog, the Medicines and Healthcare products Regulatory Agency (MHRA), has expressed concerns that a unique seal on pharmaceutical packaging would restrict importers from complying with UK-specific regulations on medical leaflets and labelling.

 

Contract packer Brecon Pharmaceuticals, based in Hay-on-Wye, believes late-stage customisation is the best approach, as a counterfeit product is more likely to enter the system between leaving the packer and reaching the dispenser.

 

If you put a label over the end of the box it can act as a tamper-evident feature as well as carry the individual product code, says business development director Steve Kemp.

 

Akan Oton, global marketing director for packaging services at US-based Catalent Pharma Solutions, agrees that most counterfeiters go after the secondary packaging.

 

Oton recommends a combination of overt and covert tracking elements, but admits cost is the key factor.

 

Bar codes are obviously less expensive than RFID tags, but they have to be scanned individually, whereas an RFID system can scan a whole case. On the other hand, RFID will require additional equipment and procedures to be put in place, he says.

 

There are more cost-effective alternatives, such as holograms, micro-print – so small it can’t be read by the naked eye – or using specific papers or inks. It’s down to how manufacturers want to audit their products.

 

Tesa, the German self-adhesive product manufacturer, last year launched Holospot, a system that contains four secure identification devices, including a hologram and an encrypted code. The system, which can be as small as 5mm2, can be applied to all types of pharmaceutical packaging, such as vials or blister packs.

 

Viable technologies

Domino Control, a division of Cambridge-based Domino Printing Sciences, has been working with Dutch firm Tjoapack to develop a system to print data matrix codes onto individual cells of blister packs, meaning that the ability to trace the product is not lost even if you cut up the pack.

 

Not only is it now possible to use mobile or internet technology and high-speed printing and data transfer systems to develop coding for pharmaceutical products, it is practical with cost-effective, tried-and-tested technology, says Tony Walsh, European business development manager for Domino Control.

 

The details of the authenticated products would be kept on a central electronic database that could be accessed by hospitals and chemists as drugs are delivered and dispensed.

 

If you link a pack to a patient’s prescription, you can achieve a more robust real-time system that answers a number of issues in terms of counterfeiting and fraud, says Walsh.

 

However, he adds that the security of database software needs to be improved before such a system could be considered safe.

 

Whatever the system, the ease of implementation – the Californian law won’t be fully introduced until 2011 – and data security will be important factors to consider. Shaun Gallagher, MHRA director of policy, says: We are keen to see changes that help keep counterfeits out of the medicines supply chain without putting in place requirements that would be unduly burdensome or impractical.

 

The most secure place for an itemised tag could be on a tablet, but there are limitations. Catalent’s Oton says: There are techniques available, perhaps putting a specific pattern on a pill, but you have to ask when it becomes cost-effective and how much information could actually be added.

 

FAKE DRUGS: A $70BN INDUSTRY

• The World Health Organisation (WHO) estimates that around 10% of medicines sold in the world are counterfeit, ranging from less than 1% in developed countries, such as the US and in Europe, to over 30% in some parts of Africa. In the former Soviet republics, WHO estimates around 20% of medicines are fake.

• According to US-based health industry consultancy IMS, global pharmaceutical sales in 2007 were worth $712bn (£364bn), which would suggest around $70bn was paid for counterfeit products. The US’s Center for Medicines in the Public Interest has predicted this will rise to $75bn by 2010.