The list has now grown to more than 300 medicinal products. There are delivery bottlenecks that pharmacies and health insurance companies complain about. It affects common medications such as antihypertensives, fever syrups for children and many cancer therapies.
“It’s not available right now” – patients hear this sentence again and again in the pharmacy when they stand there with their prescription. More than 300 medicines are in short supply (as of September 16, 2022). For Germany, these are on the list of the Federal Institute for Drugs and Medical Devices (BfArM). It stocks medicines with supply bottlenecks based on the reports from the manufacturers and the data from the federal medicines and application database (AmAnDa).
The problem: How big the shortage of medicines actually is is not yet apparent. Because the list is not complete. The industry does not have to report, but only obliges itself to do it. This is reported by the specialist magazine “Medscape”. “In addition, only prescription drugs are listed that are considered to be particularly relevant to supply,” explains Christian Splett, deputy press spokesman for the Federal Union of German Pharmacists’ Associations (ABDA) to the portal. “And the list is unweighted. It can include medicines that are prescribed three times a year or three million times a year.” In short: the list is only “an indication of the problem”.
This is confirmed by Daniela Hänel, pharmacist and chairwoman of the Freie Apothekerschaft when asked by FOCUS online: “Medicines that ‘make’ it onto the BfArM list, i.e. that are not available, are just the tip of the iceberg, or active ingredients for which the Pharmacy, despite efforts, cannot offer any goods or alternatives.” One example is the months of non-delivery of drugs containing the active ingredient tamoxifen. “Thousands of women have not been able to continue their breast cancer treatment as prescribed.”
A wide range is affected by the delivery bottlenecks. Generics, i.e. so-called “copycat products”, are often becoming scarce. They contain the same active ingredient as an original preparation whose patent protection has expired.
Antibiotics, asthma sprays, certain eye drops, some insulins, medicines to lower blood sugar levels, ibuprofen and paracetamol juices and suppositories for children, antihypertensives, neuroleptics and many cancer therapies are currently affected. Hänel adds to the dimension: “Some medicines have not been available for more than a year. The result is that patients have to be switched over.” This causes higher costs in the healthcare system due to the additional medical consultation and care of the new therapy. In addition, the patient also has to get involved with and accept a change.
“There are always delivery bottlenecks because a producer fails, but the amount and length of the failure has become much more dramatic,” said Hans-Peter Hubmann, Vice Chairman of the German Association of Pharmacists, the German Press Agency. Five years ago, less than half as many products were affected.
Helmut Renz, chief pharmacist at the University Hospital Rechts der Isar, also reports in a press release that it affects drugs for all indication groups. The situation is explosive, especially in the hospital, because he and his team have to ensure that patients are supplied with vital medicines.
Reasons for the shortage include the corona pandemic and the Ukraine war. Renz explains: “There were supply bottlenecks for medicines before that, but they became very clear during the corona pandemic. This has been a problem for pharmacies for a long time and is a major burden for us. You are faced with new surprises almost every day, which is currently not available or only available to a limited extent.”
According to colleague Hänel, this leads to the unavailability of medicines
In addition: “Since the manufacturers also do not keep stocks, due to cost minimization and the motto ‘just in time’, supply bottlenecks can no longer be compensated for,” explains Hänel.
According to her, the situation, which has been critical for years, has been exacerbated by another factor: during the pandemic, in the lockdown, drug sales and sales plummeted. Due to the lack of contact, people were less sick, but rather stayed healthy. The pharmaceutical industry then reduced its production. Because they measure the production volume based on the sales of the previous year and order the raw materials accordingly. “That’s why many large pharmaceutical manufacturers can’t double or triple production all at once because the increased demand is suddenly there,” says the pharmacist. “In addition, there are the increased energy and transport costs.”
In the BfArM list, the “Type of reason” column contains either “Production problem” or mostly “Other” quite vaguely. At the request of “Medscape”, the BfArM explains: Manufacturing changes could be the reason or quality problems that prevent the release of the drugs, or logistics problems if the active ingredients were manufactured in the Far East.
Renz also points out this risk. The supply bottleneck arises in particular when certain active ingredients are only manufactured in a single plant worldwide. “If there are problems in production, this active ingredient is then no longer available anywhere in the world – and with it all the medicines that are made from it,” says the pharmacist.
If certain medicines are not available, ABDA spokesman Splett explains that alternative medicines from other manufacturers are available in pharmacies. When filling the prescription, the pharmacies could check whether another preparation that is available could be considered for an exchange. However, the basis for this is the “Sars-CoV-2 Drug Supply Ordinance”. It gives pharmacies more leeway to issue replacement drugs with the same active ingredient.
As an example of everyday hospital life, pharmacist Renz reports that they have always been able to ensure the supply of the hospital.
It is possible to one
All of this represents a considerable amount of additional work. Comprehensive documentation is required to prevent dangerous mix-ups or incorrect dosing. “If we have to replace an unavailable product with another one, we take a picture of the old and the new pack and create a document that all stations receive: ‘Attention, the medicine previously delivered will now be replaced by a new one’. It’s work, but we maximize drug therapy safety when changing the preparation,” explains Renz. “This conversion will then only take place for the duration of the supply bottleneck. Such preparation changes, forced by supply bottlenecks, take place up to 280 times a year.”
With medicines in short supply, some are calling for a “national reserve” for them. Hänel thinks this makes sense, especially for antibiotics. “In addition, the manufacturers should keep a certain reserve and be obliged to report a bottleneck in good time,” the pharmacist suggests. According to Medscape, a permanent regulation could solve the problem in the short term.
As mentioned, medicines can be substituted by pharmacists. You currently have more options thanks to the “Sars-CoV-2 Drug Supply Ordinance”. This ordinance runs until November of this year and was recently extended by the Bundestag until April 7, 2023.
“Our demand is to make them completely unlimited so that pharmacists continue to have the patient-friendly option of dispensing replacement drugs,” says Splett. “This would be an important short-term step ahead of any long-term effort to move API manufacturing back to Europe.”
The role this aspect plays is shown in Renz’s explanations of how he decides which medicines to buy. Many active ingredients, including antibiotics, are now exclusively manufactured in India or China.
Renz therefore considers it positive if the production of the active ingredient and the drug takes place in the EU: “Then the likelihood of such interruptions is lower,” says Renz, while at the same time raising concerns: “But that doesn’t mean that drugs manufactured in the EU are always 100 percent available.” For example, there is currently a bottleneck with Actilyse from Boehringer Ingelheim, an emergency drug for acute ischemic strokes. According to him, Actilyse is manufactured in a single plant in Germany. “Its capacity is currently no longer sufficient to cover the increased global demand.”
Hubmann also underscores the association’s demand that active ingredient production must take place in Europe again. Politicians urgently need to create the conditions for this. But even if the approval procedures went through faster, the cost pressure was reduced and production in Europe became more profitable again – “that doesn’t happen overnight”. It takes at least five to ten years for the appropriate structures to be set up.
