The Fight Against Counterfeit Medicines

Very recently, counterfeit products were detected in a warehouse in the United Kingdom that could be traced back to a pseudo-pharmaceutical company in Turkey. The counterfeiting was detected because all the boxes had the same serial number. The packaging looked very similar, and the other lot-specific details, such as the lot number and expiration date, were also correct. There are many important points to note here, such as the importance of good distribution practices and conducting supplier qualification, but today we’re focusing on the concept of “serialization.”

Serialization: What Is It?

Since February 9, 2019, it has been mandatory in the EU to provide most prescription drugs and some OTC products (usually reimbursable) must be provided with a unique 2D barcode and a physical barrier to the medication by sealing the box with adhesive or a tamper-evident seal.

Simply put, serialization involves assigning a unique number to each individual medication package. This number is printed alongside the product code, batch number, and expiration date, and is also encoded in a data matrix code. At the end of the supply chain, this code is then scanned at the pharmacy to verify its authenticity.

Of course, every individual package with its unique number travels quite a distance before it can be scanned and purchased at the pharmacy. First, all these numbers—linked to a specific product (which in turn has a unique product code)—must be retrieved by software. This software is directly or indirectly linked to the devices that ultimately print all the lot-specific data onto the cardboard boxes.

In principle, a surplus of numbers will always be provided because there are inevitably losses (such as rejects due to illegibility, legally required samples, and damage). That is why “reconciliation” is such an important term here. After all, you want the number of “active” serial numbers at the end of the process to match the number of finished boxes ready on the pallet to be shipped for commercial sale. If this is not the case, there is a risk that medications will end up in pharmacies that are marked as “inactive” status and therefore should not—or cannot—be sold, or that “active” packages end up in the company’s trash, where they could be misused—for example, by reselling them through illegal channels.

How does serialization prevent potential disasters?

Once the reconciliation of a specific batch has been successfully completed, the order is closed in the software, and the used serial numbers are sent to a central collection point, after which they are transmitted to a cloud-based system where both wholesalers and pharmacists can verify that the product is indeed an authentic medication with a known origin. When sold at the pharmacy, the serial number printed on the box is marked as “used” to prevent it from being sold a second time under the same number.

Serialization has been a major undertaking for most pharmaceutical companies, requiring, among other things, the purchase of new software and equipment, as well as the development, training, and implementation of new procedures.

However, given recent reports such as this one regarding Ozempic®, it should be clear that this effort was not in vain and that the additional measures against drug counterfeiting are effective in detecting fraudulent practices at an early stage.