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Why we need mass serialization — now!
Gary Noon argues the case for mass serialization and explains why point of dispensing drug authentication is not only a guarantee of medicine integrity, but also a beneficial and cost-effective solution for the pharmaceutical industry.


Pharmaceutical Technology Europe
Volume 22, Issue 6

Today, approximately 1.5 million counterfeit medicine packs enter the legal supply chain each year — in other words, one pack in every 20000 is counterfeit. What is more worrying, however, is the rate at which this is increasing. Between now and 2020, the spread of counterfeit drugs is estimated to rise to either an 'optimistic' 19.5 million or a pessimistic 192 million packs in the legal supply chain.


We have the technology...
What happens when a product has to be removed from the market? Experience from a range of industries shows that a more effective method of recalling products is needed. In 2005, for example, 2500 packets of fake Lipitor, Pfizer's widely used anticholesterol medicine, were believed to have entered the UK market. Research by Frost & Sullivan estimates that fewer than 15% of the packs were recovered. Aside from the potential danger to patients this inability to effectively recall drugs poses, the damage to the reputations of individual manufacturers and to the industry as a whole is vast.

According to the EU Commission consultation on combating counterfeiting medicines for human use, released in December 2008, the annual direct and indirect societal costs of counterfeiting are approximately €950 million. The overall costs of inaction will reach €9.5 billion–€116 billion by 2020, and this does not take into account the intangible yet significant damage to brand reputation and trust. The proposal also highlighted the worrying change in the type of medicines that are now being counterfeited: there has been a distinct shift during the last few years from lifestyle medicines to prescription medicines such as oncology treatments and antidepressants; even generic and overthecounter (OTC) products are no longer immune.

So, we clearly need an urgent solution — but which one?

Mass serialization

Mass serialization is the method of adding machinereadable codes containing a serial number to individual packs of medicines. Unlike all other methods for verifying drugs, it enables product authentication at the point of dispense (POD) and provides the ultimate barrier between potentially harmful drugs and the patient, while offering the pharmaceutical industry a myriad of benefits.


Rules for optimal secure coding
Serialization is only effective, however, as long as an authentication check takes place. For optimal results, the authentication check is conducted in real time at the POD in pharmacy, using the professionalism of the final healthcare worker in the patient's care pathway to confirm the suitability of the medicine for dispensing. Verification at other points in the supply chain is not authentication and will not sufficiently protect patients. At retail level, mass serialization allows for the detection of fake products across every single product dispensed, ensuring that none are missed.


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