Blog #26: Fake medicines with side effects

By Natascha de Raad

Over the last two weeks, there has been a lot of coverage about a counterfeit medicine, an as yet unknown number of which has entered the legal supply chain. This reminded me of the entry into force of the EU Falsified Medicines Directive, a very specific topic, but one that is an immensely important factor in patient safety and can therefore be relevant to us all. I thought of a few things that, for me, reflect the current case. 

The many discussions in the run-up to the Falsified Medicines Directive, which has been in force since 2019, are still very much on my mind. It felt like mountains of unanswered questions. Little by little, the details crystallized. The anti-counterfeiting protection is organized by Securpharm, an organization largely supported by associations from the pharmaceutical industry and pharmacists. "The German protective shield against counterfeit medicines" was the claim at the time. Today it is called "the German organization for the authentication of medicines".  Securpharm operates the system for authenticating medicines, in short: data management. 

How counterfeit protection works 

I'm sure not everyone is familiar with the subject, so let me briefly explain how the counterfeit protection of medicines works. Every prescription medicine has an individual code printed on it, which is uploaded to a central hub.  As a second security feature, each pack of medicine has a tamper-evident seal that makes it visually apparent whether the box has been opened. The features are checked at every stage of the supply chain so that complete documentation is available.  

How counterfeit protection works at Med-X-Press 

At Med-X-Press, we formed a project group at an early stage, which dealt intensively with the consequences of the new EU regulations and, above all, with possible to-dos for us as a pharmaceutical logistics company. In many conversations and discussions, we explored and examined various options and finally decided to establish serialization as a new, sophisticated service. In recent years, we have invested in two machines with which we can prepare medicines with the described safety features for unhindered transportation to the patient. A scale integrated into the system ensures 100% control of the individual medicine pack. We offer our customers a range of value-added services, such as data documentation or booking out of the system. We wouldn't be business people if we hadn't asked ourselves the question of amortization of the investment. However, despite all business considerations, we are always aware of the responsibility we have within the pharmaceutical supply chain to ensure safe patient care. 

Difficult start - successful progress 

Back to the Falsified Medicines Directive. The directive was scheduled to go live in February 2019, the deadline was met and the system was up and running, despite many prophecies of doom. Problems that arose, for example with the software, were resolved - but the cries of Cassandra were slow to fade. Now, four years later, we know that the system works. Why am I describing all this in such detail? Because a recent case shows that the directive is working.

It concerns Omzempic, a drug manufactured by Novo Nordisk, which is prescribed for type 2 diabetes. Copies of the illegal preparation have now entered the legal supply chain, but have not been dispensed to patients in Germany according to current knowledge. The responsible authorities are warning against the counterfeit medicine, as there is a high probability that considerable health risks could occur during use. The counterfeits were discovered in the wholesale trade, which for me, without knowing the specific details, is proof of the successful use of the control mechanisms. It gives me a reassuring feeling that medicines are protected against tampering in the best possible way and that we at Med-X-Press can make a significant contribution to this in serialization.  

As a side note at the end: the diabetes drug contains the active ingredient semaglutide, which has triggered a worldwide hype under the brand name Wegovy.  The drug is approved for weight reduction in obesity patients. There is even talk of a game changer in the treatment of obese or severely overweight people. The "slimming product" naturally aroused the interest of many dieters or people who had been plagued by other weight loss methods. The conspicuous weight loss in the celebrity world - from Adele to Kim Kardashian to Elon Musk - aroused desires, so that delivery problems were reported within a short time. And sorry, I have to exaggerate a little and be sarcastic: Not all supply bottlenecks are life-threatening! 

Have you ever been confronted with counterfeit medicines or are you involved in the anti-counterfeiting control processes? I look forward to your feedback! Write to me at: blog@med-x-press.de