Many families are currently experiencing shortages of penicillin and other medications
Source: Andrea Warnecke/dpa-tmn
Because antibiotics are lacking in many places, more and more federal states are clearing the way for the import of preparations that are not approved in Germany. A pharmacist explains what parents should know about this – and why the deliveries do not solve the real problem.
Dhe child has scarlet fever – and penicillin is hard to come by. Many families are currently experiencing this due to the supply bottlenecks for medicines. More and more federal states are therefore temporarily allowing the import of antibiotic juices from abroad that are not permitted in Germany. They could soon be over the counter in pharmacies.
But parents already have questions: What does it mean if such a drug is not approved in Germany? Does that mean these antibiotic juices are automatically less safe?
No, says Alexander Schmitz, who runs five pharmacies in Dannenberg (Lower Saxony) and the surrounding area. There can be various reasons why a medicinal product is not approved in Germany.
A lack of approval does not have to be due to defects
“The main reason will be that the respective manufacturer has no interest in the German market,” says Schmitz. If a company does not intend to sell a specific drug in Germany, it does not seek approval here. However, that does not have to mean that the drug does not meet the requirements in this country.
The Federal Institute for Drugs and Medical Devices (BfArM) is responsible for the approval of medicines in Germany. “The fact that the BfArM actually had concerns – that is the most unlikely reason why a drug is not approved in Germany,” is the assessment of pharmacist Schmitz.
Requirements for medicinal products are similar across the EU
According to Schmitz, if an antibiotic juice is approved in another EU country, the risk of it being unsafe is low. “One can assume that the approval requirements, the manufacturing conditions and the test standards in terms of quality will be close to those in Germany,” he says. Because requirements for medicinal products are similar across the EU – even if they are not identical.
Schmitz, himself a father of five children, comes to the conclusion: “I would give my children antibiotic juices approved in the EU, with a very clear conscience.”
What parents should know: The liability issues that can arise should the drug cause damage – they are not clarified in detail. But: “It is extremely rare for medicines that are approved in the EU to actually harm people. Unless they are applied incorrectly or incorrectly.”
Doctor and pharmacy give assessment
In the best case, parents are not left alone with their worries. “The doctor and pharmacy should then work together,” says Schmitz. For example, when the pharmacy consults the doctor if they want to issue an import from another EU country for a prescribed active substance. “And then it’s in the hands of the doctor to carry out a risk assessment,” says Schmitz.
Incidentally, the pharmacist does not expect that too many antibiotic juices from abroad will be sold over the counter in this country. For example, there is a lack of penicillin not only in Germany, but throughout Europe. “It’s a band-aid that’s far too small on a widening wound.”
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