The European Medicines Agency (EMA) has issued a warning that falsified diabetes medicine has been found in the European Union and the United Kingdom. Therefore, the Latvian Medicines Verification Organization (LZVO) urges residents to purchase medicine only at legal public and online pharmacies, and to avoid buying medicine from unknown websites or through social media advertisements.
EMA has been notified by relevant national competent authorities that pre-filled pens falsely labelled as the diabetes medicine Ozempic have been identified in Germany, Austria, and the UK. There is no evidence that any falsified pens have been dispensed to patients from legal pharmacies. The issue is currently being investigated by EU medicines regulatory authorities and the original marketing authorization holder. EMA information
According to the information available to the Latvian Medicines Verification Organization (LZVO), there is no evidence that these falsified Ozempic packs of specific batch have been on the Latvian market.
Ozempic is a prescription medicine, authorized for the treatment of type 2 diabetes in adults. Ozempic is an injectable solution administered with a pen. Its main ingredient is the same, which is also used in other medicine, which can be used to treat obesity. High demand for both medicines has led to a shortage, which most likely was the reason for the falsification, admits competent authorities in EU countries.
"The verification system is established to protect patients from falsified medicine. Therefore, I can say that in Latvian pharmacies and healthcare institutions, only safe medicines that have been verified by the verification system are available. I would like to remind that the system checks all prescription medicine and one non-prescription – omeprazole. Therefore, we invite all Latvian inhabitants to buy medicine in legal public and online pharmacies only, by avoiding using unknown and unverified websites for the purchase of any medicine and food supplements," says Inese Erdmane, Chairwoman of the Board of the LZVO.
The basic principle of the system is that manufacturers provide each package of medicine with a unique code or identifier, which is verified several times on the way to the consumer and finally decommissioned when handing over the medicine to be used by the patient in a pharmacy or healthcare institution. This procedure ensures that the same code cannot be used to bring falsified medicinal products into the legal supply chain. In case the system does not recognize the unique identifier during the verification, an alert is generated, recognizing a potential falsification and would be investigated by competent authorities.
Overall, the verification system is a European-level project that connects 2,800 pharmaceutical companies, 4,000 wholesalers, 110,000 pharmacies and 6,000 hospital pharmacies in 30 European countries online.
The basis for the establishment of the medicines verification system is the EU Falsified Medicines Directive (2011/62/EU) and the Delegated Regulation which defines detailed rules for the safety features appearing on the packaging of medicinal products for human use (EU 2016/161). The system has been working in 30 European countries since 9 February 2019.