Serialization, seriously

Iiro Jantunen, D.Sc. (Tech.), is the Chief Technology Officer at Servicepoint. His blog examines current themes and events in serialization. Follow his blog to find out what's going on in the industry. You can comment on the article in LinkedIn Pulse.



 

Securing pharma supply chain for the patients

08.06.2017



recent simulation pilot — by St. James's Hospital (Dublin, Ireland), Systech International, and Sharp Packaging Solutions — tested the logistics of medicines from the manufacturer to a hospital with test "fake" products mixed in. The simulation consisted of three batches of cancer medicines each secured by different means: one using the European Stakeholder Model (ESM), another using the US Drug Supply Chain Security Act (DSCSA) model e-Pedigree, and the third using the proprietary Systech UniSecure solution. 50 "fake" products with unique identifiers copied from the authentic ones were randomly mixed into batches of 500 products each, simulating a breach of logistics security. It was found out that of 50 "fake" products, 18 got dispensed to the patient before warning signs in the ESM model, and 10 in the e-Pedigree model. This was because in a case the counterfeiters have genuine codes to copy, either because of an information system breach or by copying the codes from authentic products (e.g. in a warehouse), the first product with an authentic serial number will get passed to the patient, even if it is fake.
 

A fake drug with a copied unique identifier reaches the patient, if it passes the logistics chain before the authentic drug.

 

Systech UniSecure adds a very efficient layer of security by detecting specific measurable characteristic patterns within the printing noise, harnessing these variations to generate an electronic signature. This electronic signature is unique to a given instance of a product and can be utilized on either a serialized or non-serialized product. These variations are both random and unique, producing e-Fingerprint that is impossible to replicate. As UniSecure does not interfere with the serialization track and trace regulations, it can be readily applied whenever the industry has the need. The logistics partners, pharmacists or even the patient can then authenticate the product with a phone app, which uses the camera existing in virtually all smartphones.

This brings us to another example of problems with the ESM or e-Pedigree: the internet pharmacies. Authentication at the point-of-dispense is all well in traditional pharmacies as the patient can see the verification to happen. In internet pharmacies this is not the case. The patients should, thus, have a means to authenticate the products themselves, but the government-regulated systems do not allow that, the incoming Russian drug traceability system as an exception. One must remember, that an unscrupulous villain can fake the point-of-dispense application, too, to sell fake products at a criminal-run pharmacy. Systech UniSecure provides for these cases, too, as the industry can opt for extra protection: enter a "pharma brand app". This functionality can readily be a part of mobile health app providing also other functions, such as assistance for medication adherence.

Another group that is not yet covered by the government-regulated anti-counterfeiting method nor have a system of reliable pharmacy network are people of the undeveloped countries. A prime example are antimalarial medications: a recent study found 1/3 of antimalarials in sale in Africa were fake. Another survey by WHO in Nigeria in 2011 found that 64 % of the antimalarials were fake (Bad Medicine, The Economist, 2012). Mobile phones have been tested as a simple tool for authenticating drugs already, with scratch labels containing a serial number one can authenticate by texting it to a service provider (see mPedigree). Smartphones are becoming ubiquitous in undeveloped countries. The pharma manufacturers could, then, provide protection for the poor patients, too.

For the pharmaceutical industry, we offer services of an experienced full-service packaging, device assembly, and serialization and track & trace automation integration company. With experience from 30 years in the pharmaceutical industry, and of 800 production & packaging line upgrades or new installations, Servicepoint can help you throughout the whole serialization projects. Call us for professional help!

Iiro Jantunen, D.Sc.
Chief Technology Officer
Servicepoint Oy

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