Shortage of breast cancer drug in Czechia triggers emergency measures
Amid a continuing shortage of a key breast cancer drug, the Czech Republic is temporarily relaxing its drug rules. Pharmacies will be allowed to dispense tamoxifen products that are not registered in the Czech Republic, but authorised in other European Union member states.
Around 7,900 women are diagnosed with breast cancer in the Czech Republic each year, and tamoxifen is one of the most commonly prescribed medicines used after surgery or radiotherapy to reduce the risk of the disease returning. It is also prescribed to treat advanced breast cancer.
Supplies of this vitally important medicine have been disrupted since last year, and since June even the replacement product that was introduced has been unavailable.
The shortage now affects pharmacies across the country. As of Wednesday morning, only 81 packs of Tamoxifen remained available nation-wide. The situation is most critical at pharmacies near oncology centres, where demand is highest. Patients are panicking and sharing tips on social media where the drug is still available or where they can get it in neighbouring states.
In an interview for Czech Radio, Health Minister Adam Vojtěch expressed regret over the situation, saying the ministry was working intensively to resolve the problem.
"We found a replacement for the medicine that was in short supply, but unfortunately that replacement also became unavailable in July, as the manufacturer informed us. We are working intensively to resolve the problem. Unfortunately, we are dependent on supplies from abroad. The medicine is not manufactured in the Czech Republic, and everyone is doing their utmost to restore deliveries."
To bridge the shortage, the Health Ministry has now introduced emergency measures that allow pharmacies to dispense tamoxifen medicines that are not registered in the Czech Republic, provided they are authorised in another European Union member state.
The head of the State Institute for Drug Control, Tomáš Boráň, said there is no reason to be concerned about the safety of the replacement medicines, stressing that they still comply with strict European standards and will be sourced only from verified suppliers.
“These are medicines containing the same active ingredient and they are as safe as those that are registered in the Czech Republic. The deliveries should arrive in the course of Thursday and Friday though it may take a bit longer for them to reach pharmacies around the country.“
The ministry has also temporarily allowed pharmacies to repackage intact blister strips into new packs corresponding to the prescribed dosage and strength. They will also provide patients with detailed instructions on how to take the medicine.
This move should allow for available medicines to be distributed among a larger number of patients and will give the Health Ministry more time to secure fresh deliveries.
Health Minister Adam Vojtěch said the ministry is aware of the gravity of the problem and is preparing legislative changes that will bind the state and pharmacies to create more robust reserve stocks of critical medicines in the future.
