Drug shortages continue to affect new groups of patients

Drug shortages continue to affect new groups of patients

Supplies of children’s antibiotics, certain ADHD medications, painkillers or asthma spray are stalling. Data shows: The bottlenecks often have a long history.

The “Notice according to Section 79 Paragraph 5 of the Medicines Act” is a good example. In it, the Ministry of Health notes a lack of supply of “medicines containing salbutamol in pulmonary dosage form”. This refers to inhalers such as those used by patients with asthma or chronic bronchitis.

Salbutamol relaxes the lung muscles – such a spray can be a real lifesaver in severe attacks of shortness of breath. But because the demand for it has increased worldwide, such funds are sometimes difficult to obtain in Germany. Several manufacturers assume that delivery difficulties will continue into next year.

The shortage of medication in German pharmacies and doctor’s offices goes far beyond asthma spray. Around 500 open delivery bottleneck reports with more than 850 affected individual products. This means that the number of affected medications at the beginning of autumn is roughly at the same level as last year. However, this can change quickly, as the database is updated daily. The number of individual products registered as part of an initial report has been increasing since the end of August.

Pharmacists’ Association assumes thousands of medications will be affected

The BfArM data only shows the tip of the iceberg. “Every pharmacy has hundreds of orders that cannot be fulfilled,” reports the chairman of the North Rhine Pharmacists’ Association, Thomas Preis. With more and more medications, the shortage is practically a permanent condition. “Even if the drug is available from a retailer in between, it can be gone again in the next second.”

In total, several thousand medicines are affected by supply bottlenecks, Preis estimates. Many of them do not even appear in the BfArM database – for example because they are not considered relevant to supply or because the manufacturer does not report the defect on its own initiative. “No manufacturer wants to admit that they can’t deliver,” says Preis.

However, the publicly available data at least provides an insight into how comprehensive and complex the problems on the German pharmaceutical market are. The composition of the list changes almost daily. “As a result, new groups of patients are constantly being affected,” observes the pharmacist from Cologne.

Failure symptoms often last for months

Delivery bottlenecks often last longer than expected, as a comparison of the database entries shows. In their first communication to the BfArM, many manufacturers initially seem to assume that the situation will soon ease again. The majority of initial reports indicate an expected bottleneck of at least three months. But almost every fifth initial report puts the estimated duration of the delivery problems at less than eight weeks.

In retrospect, this initial assessment often turns out to be too optimistic: the expected end of the delivery problems is then gradually pushed back in several change notifications. Production of over 60 percent of currently registered medicines has not been kept up for more than six months. A good third have been experiencing delivery problems for over a year. In addition, there are several medications for which supply bottlenecks have already been declared over several times – closely followed by a new initial report.

Manufacturers are ditching “bread-and-butter” medicine

It is not just Germany that is struggling with recurring problems in the pharmaceutical supply chains. “Many important active ingredients are only manufactured by a few large production facilities in China or India,” says Preis. “If their deliveries fail, we will have a big problem here in Europe.” A lack of packaging material also repeatedly leads to production bottlenecks, especially for injection solutions, juices or sprays. Most recently, two manufacturers referred to an insufficient supply of glass bottles and ampoules in their report to the BfArM.

However, one of the most commonly cited reasons why pharmaceutical companies cannot provide enough medicines has to do with demand. On the one hand, this can increase due to unexpected outbreaks of disease. Much more often, however, the shortage symptoms occur as a result of a chain reaction: If a large manufacturer fails, for example due to quality problems, the competitors are usually unable to immediately close the resulting supply gap.

The company Infectopharm, which specializes in pediatric and adolescent medicine, is not reporting failures at competitors for the first time. The company from Heppenheim in Hesse is currently faced with a sharp increase in demand for penicillin juices. The company recommends switching to higher-dose granules that can be mixed into the juice if necessary.

Domino effect primarily affects “bread and butter” medicine

It is often only a matter of time before delivery bottlenecks arise with alternative products. This was most recently observed with painkillers containing hydromorphone, which are used, among other things, in cancer therapy. The delivery bottlenecks have been going on for some time now across different manufacturers and dosages.

Such domino effects are becoming more and more noticeable. The situation is particularly difficult when it comes to tried-and-tested “bread-and-butter medications,” as Preis calls them: fever syrups for children, antibiotics and so-called generics, i.e. off-patent medications. Because the business promises less and less profit, more and more corporations are withdrawing from production and turning to lucrative areas of business – such as the development of weight loss injections. “In the end there is no money left to make fever suppositories for the children,” criticizes Preis. “I don’t think that’s okay. There is a supply mandate and both the pharmaceutical industry and politicians are responsible for ensuring that the supply chains remain stable.”

The BfArM is already authorized to take certain measures in the event of impending supply bottlenecks. It can issue special permits and thereby enable additional imports of medicines from abroad. At the same time, appeals are often made to the medical profession and pharmacies to dispense the affected medications sparingly.

Lauterbach’s drug reform is not having the desired effect

The “Law to combat supply bottlenecks for off-patent medicines and to improve the supply of children’s medicines” (), which came into force in July 2023, also relies on financial incentives for manufacturers, more flexibility in issuing medicines and larger stocks. Despite the drug reform, there can be no talk of a noticeable improvement in the situation, says the association’s head Preis. “The law uses tools that are too lenient,” he said.

However, a sustainable solution that not only combats the symptoms of medication shortages would have to start with global supply chains. Health Minister Karl Lauterbach is also pushing for a joint approach by the EU states to bring the production of supply-critical medicines back to Europe – a plan that is unlikely to be implemented quickly.

The good news is: So far, the reported delivery bottlenecks have rarely resulted in tangible supply problems. In fact, patients often don’t even notice if a certain medication is not immediately available. Doctors and pharmacies are working in the background to make up for the shortage. But dissatisfaction is growing: more than ten percent of working hours in many pharmacies are spent on managing bottlenecks.

With a bit of luck, you will quickly find an alternative for the missing funds. Sometimes it is possible to switch to other active ingredients, a different dosage or dosage form. And sometimes necessity is the mother of invention: If the children’s antibiotic is not available as juice, there is always the option of mixing crushed tablets into the baby’s porridge. Such a solution is likely to leave parents with an uneasy feeling.

Note: This article first appeared at ntv.de

Source: Stern

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