How to know if a pharmaceutical product is authentic (in the EU)?

It is typical for the Big Pharma to undergo certain regulatory updates aiming the betterment of the pharmacovigilance and quality processes. It's all for the sake of respecting and protecting the end-user. Serialisation is a big part of the whole grand scheme of things and is to know further developments this coming 9th of February 2019. This is the day the European Union will put into place two levels of requirements that will help verify the authenticity of a product, by 1) demanding all marketed pharmaceuticals to contain a unique identifier, thus enabling the verification of its authenticity and the authenticity of its associated parts; 2)  demanding an anti-tampering physical system to make sure the product has never been compromised.

But what is this Serialisation everyone is talking about these days? Serialisation is a sort of tracking system to assure pharmaceutical companies, healthcare professionals and patients that the products in their hands can be trusted. For that matter a series of unique identifiers (almost like a person's national citizen card) are produced, recorded and tracked so authenticity can always be checked and verified. Serialisation protects not only the end-customer, but also the profile of the pharmaceutical company as it shows that the company is in control of the different stages of the manufacturing and distribution processes, authenticity-wise.

How does serialisation work? In very simplistic terms, all pharmaceutical products contain a coding that work as their identification details. The product code is an assigned number that identifies a specific strength, dosage form, and formulation for a particular product/company. These codes are made of unique identifiers (code numbers) that can be found affixed on the saleable unit of any pharmaceutical product, and also at any underlying levels of packaging (cases, pallets, pouches, etc). The numbers and the way they are displayed can differ slightly from place to place (geographically speaking) due to different regulations. However, for some areas there is standardised referencing, e.g., the Global Trade Item Number (GTIN) standard. The GTIN standard, when properly assigned, is globally unique and assigned to a product at the stock keeping unit level, meaning NO OTHER PRODUCT ANYWHERE IN THE WORLD CAN EVER BE ASSIGNED THAT SAME GTIN. 

Is serialisation coding always the same? Some companies have chosen additional nomenclatures or reference numbers. For example, some use what is known as National Trade Item Number (NTIN). In addition, the National Healthcare Reimbursement Number (NHRN or NN for short) is used in a number  of countries to facilitate the reimbursement process. In the packaging and in the subsequent levels of product, any displayed Serial Number (SN) must relate to the particular unit (GTIN/NTIN) and also to a particular lot. In that sense, the serial number is a very specific identifier, related to all four components that make of serialisation a very useful scheme for one to be always sure that the product is reliable in its authenticity.

In summary, typically, units can have the human readable serialised code, the 2D bar code and an anti-tampering tape to ensure the product is fully controlled. The requirements now for the EU market is that hospitals, pharmacies and other medicines dispensers are responsible for scanning the data matrix on the pack and waiting for a confirmation of its authenticity before releasing the product to a patient. So pharmaceutical companies must check the components mentioned above and if they don't match up this will trigger what is known as a Level 5 alert, also known as Potential Falsification Alert. In case a compromised and/or non-authentic product is discovered, the information must be transferred to the National Competent Authorities for a serious investigation to be carried on, and the product must be immediately quarantined.

Let me know if this post was clear in helping you understand what serialisation is and how it does help protect you as a patient/end-user.

Cheers

Image 1 kindly taken from CrestSolutions, [http://www.crestsolutions.ie/serialisation-pharma-turkey].

Image 2 kindly taken from The Pharmaceutical Journal, [https://www.pharmaceutical-journal.com/news-and-analysis/news/mhra-says-falsified-medicines-directive-could-cost-500m-over-ten-years/20205213.article?firstPass=false].