In every year, doctors in Germany diagnose around 200,000 people with an ischemic stroke, a blocked blood vessel in the brain that can lead to permanent damage and even death. If the condition is recognized quickly enough, it is possible to treat the life-threatening condition. The doctors in the hospital’s emergency room often resort to a biological drug that dissolves the blood clot – lysis therapy has been standard for decades.
The drug alteplase helped doctors save thousands of lives. “It was a revolution,” says Peter Berlit, Secretary General of the German Society for Neurology. “Blocked vessels could not be reopened before.” Doctors and patients have gotten used to the fact that strokes can be treated quite well today. And that’s where the problem begins.
Only one manufacturer worldwide
Because there is only one manufacturer worldwide who produces Alteplase. The German pharmaceutical company Boehringer Ingelheim sells it under the name Actilyse, and the drug is extremely successful. Experts were all the more alarmed when the company sent out a letter in the spring about Actilyse, among other things. Subject: “Information about delivery bottlenecks through to temporary interruptions in delivery”.
The company expects a bottleneck for Actilyse until December, although deliveries could even be completely interrupted at the end of the year. It could become a problem for patients if, in the worst case, the hospitals run out of the drug in the winter. “In the case of larger clots, there is the option of removing them mechanically using a catheter,” says neurologist Berlit.
In many cases, however, lysis is recommended even in parallel with thrombectomy, which significantly improves the chance of recovery. “A thrombectomy alone has a poorer prognosis than combined therapy,” says Berlit. “But it’s still much better than doing nothing.” The German Stroke Society describes the bottleneck as “unusual and worrying”.
Smaller packs for more patients?
The Actilyse bottleneck is not an isolated case. It often happens that individual medicines are only available to a limited extent in Germany. The industry has currently reported restrictions on 271 preparations to the Federal Institute for Drugs and Medical Devices (BfArM) in Bonn. Sometimes there is a lack of active ingredients, sometimes certain pack sizes are scarce, sometimes individual dosage forms. A total of around 100,000 funds are approved, so the shortage rate is not particularly high. However, it is not always possible for pharmacists to find alternatives to the prescribed medicines. In the spring, for example, the active ingredient tamoxifen, which is used to treat breast cancer, was scarce.