Drug delivery bottlenecks: Is it what it says on the tin?

Anyone who goes to a pharmacy in Germany and… medicine If you buy something, it would not occur to you that the packaging does not contain what is written on the box. You swallow a pill, perhaps thinking about the potential side effects, but not thinking about the fact that it might be wrongly dosed, contaminated, or even counterfeit. Our pharmaceutical market is considered safe.

But since the beginning of October, this no longer seems so obvious. The Friborg regional council has warned: counterfeit packets of the diabetes drug Ozempic could be in circulation; Corresponding batches were found at a wholesaler. For a while, it was unclear exactly how big the problem was. If patients had already purchased the drug at the pharmacy and perhaps had already injected themselves. The regional council warned of “significant health risks”. The investigation into this case is still ongoing and raises many questions about how drugs are actually controlled in this country.

This is the first incident in which counterfeit products were apparently intended to be introduced on a large scale into the legal pharmaceutical trade, explains pharmacology expert Ulrike Holzgrabe from the University of Würzburg. But she also says the incentives to do so are growing. For one simple reason: there is a global shortage of basic medicines. Also in Germany there are repeated bottlenecks in the supply of important antibiotics, anti-fever juices for children or anti-cancer drugs such as the breast cancer drug tamoxifen. The Federal Institute for Drugs and Medical Devices currently lists just over 500 such problems – often there are other treatment options or only certain presentations are not available.

Still, doctors have long warned that they cannot provide optimal care to some patients because of shortages. Ozempic is also on the list. “Whenever the need for a medicine greatly exceeds what exists on the market, counterfeits appear,” explains Holzgrabe. Ozempic is just one example. Its Danish manufacturer Novo Nordisk has become Europe’s most valuable company thanks to the drug, but cannot keep pace with its production due to a global weight loss hype around the active ingredient semaglutide . The company opens Counterfeits attention in several countries. In Austria, some syringes were delivered to end customers, but to the great relief of all concerned, none were delivered to end customers in Germany – it appears that the counterfeits are relabeled insulin pens.

If certain medications are not available here, this constitutes a possible entry point for drug counterfeiters.

Lutz Heath

Could counterfeiters also exploit the shortage of other medicines? Experts believe that this is entirely conceivable: “If certain drugs are not available here, this constitutes a possible entry point for drug counterfeiters,” explains Lutz Heide, director of the Pharmaceutical Institute of the University of Tübingen. The president of the Pharmaceutical Commission of German Pharmacists, Martin Schulz, also considers it “plausible” that the risk of counterfeiting increases with the shortage. Holzgrabe cites examples from the past: At the time of the bird flu, a good 15 years ago, the flu drug Tamiflu was popular, and counterfeits immediately appeared. When letters containing anthrax pathogens appeared in the United States after the terrorist attacks of September 11, 2001, word quickly spread that the antibiotic ciprofloxacin was effective against the disease. Fake products appeared just as quickly. So, to what extent is the pharmaceutical trade protected against this today?

Ordered illegally from abroad

Anyone who approaches this question will initially find something reassuring. The Federal Association of German Pharmacists’ Associations (ABDA) assures on its website: “Fortunately, the supply of medicines in Germany is one of the safest in the world. In the past, counterfeit medicines only appeared in very isolated cases in pharmacies.”

The main gateway for counterfeits is the Internet and especially illegal trade. In any case, individuals are only allowed to order medicines from pharmacies in other EU countries under certain conditions or to buy them for their own use on vacation. Customs at Frankfurt airport sometimes confiscate illegal sexual stimulants, antibiotics, sleeping pills or ivermectin, a dewormer that some wrongly thought was also effective against Covid-19.

The normal distribution channel, on the other hand, is much safer. The approximately 20,000 established pharmacies are supposed to test counterfeit drugs randomly, at a rate of one packet per day. These are what we call identity checks, prescribed in the operating regulations of the pharmacy with a goal of common interest. In 2021, suspicions of counterfeiting arose in exactly 16 cases. It seems that everything is safe in pharmacies.

The problem is that no one checks whether pharmacies are doing their job. There is no scientific evaluation on this subject. There is a reason for this: “In fact, controls are almost impossible for pharmacies because they involve a lot of equipment and economic losses,” reports Martin Hug, head of hospital pharmacy at the University Hospital of Freiburg. Pharmacies receive no financial compensation for testing; they are in fact a cost factor: each prescription drug is sealed.

If the pharmacy breaks the seal to check the contents, the package is not for sale. Test methods are described in a comprehensive compendium, the European Pharmacopoeia, and vary depending on the active ingredient. However, most pharmacies do not have the expensive equipment needed to perform all of these tests. According to operating regulations for pharmacies, they must only have a relatively limited selection of equipment, explains Hug.

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