Everyone has without doubt heard of it by now – the so-called “miracle drug” for losing weight quickly, Ozempic® from the Danish company Novo Nordisk. This drug contains the active ingredient “Semaglutide” and is indicated for patients with type II diabetes. However, the drug is now regularly in the news because of its impending shortages on the market due to its misuse and the many exhortations to doctors and pharmacists to provide only genuine patients with it.
Very recently, counterfeits were spotted 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 boxes had the same serial number. The packaging looked very similar and the other lot-specific data such as lot number and expiration date were also correct. There are very many things to remark, e.g., the importance of good distribution practices and adequate performance of supplier qualification, but today we focus on the concept of serialization.
Serialization: what is it?
Since February 9, 2019, it is mandatory in the EU to include on most drugs and some OTC products (mostly with reimbursement) a unique 2D barcode as well as a physical barrier to the drug by sticking the box with glue or with a seal (a so-called tamper-evident seal).
In simple terms, serialization is providing each individual box of a drug with a unique number. This number is printed along with its product code, batch number and expiration date and is additionally also contained in a data matrix code. At the end of the Supply Chain, this code is scanned at the pharmacist to check for its authenticity.
Of course, each individual package with its unique number undergoes a long way before it can be scanned and purchased at the pharmacy. First of all, all these numbers, linked to one specific product (with its in turn unique product code), must be retrieved in a software. This software is directly or indirectly linked to the devices that eventually print all the lot-specific data on the cartons.
n principle, a surplus of numbers will always be provided because there will always be losses (e.g. emissions when not readable, legal samples and damage). Therefore, “reconciliation” is also a very important term here. After all, you want as many serial numbers to be on “active” at the end of the run as there are finished boxes on the pallet ready to be shipped for commercial sale. If this is not the case, there is a chance that medicines will end up in the pharmacy that are set to “inactive” and therefore may not be sold, or that “active” packages end up in the company’s garbage bin, which can then be misused, for example, by reselling them through illegal channels.
How does serialization avoid potential dramas?
When the reconciliation of a given lot is successfully completed, the order is closed in the software and the used numbers are sent to a central collection point after which it is sent to a kind of cloud, where both wholesalers and pharmacists can verify that the product in front of them is indeed an authentic drug whose origin is known. When sold at the pharmacy, the serial number listed on the box is given the status “used up” so that it cannot be sold a second time under the same number.
Serialization has been a robust exercise in most pharmaceutical companies, requiring, among other things, the purchase of new software and devices and the writing, training and implementation of new procedures.
However, with the recent coverage like this one on Ozempic®, it should be clear that this exercise has not been in vain and that the additional measures against counterfeit drugs are having their effect in detecting malpractices early.