In the nine months of this year, 20.5 million medicine packages were checked against falsification from the medicines purchased by citizens in pharmacies or used by patients in healthcare institutions. This is 8% more than in the same period of last year, according to data from the Latvian Medicines Verification Organization (LZVO). LZVO in Latvia is responsible for the verification system where the safety and authenticity of prescription medicines are checked.
In general, 77.4 million transactions were carried out in the verification system in Latvia from January to September, which shows a similar trend to last year when 76 million transactions were made in the corresponding period. There are two types of transactions – one type is verification of the medicinal product, the other is decommissioning of the medicine package from the system, when the product reaches the patient.
“The responsible authorities of Latvia, such as Customs and Patent Office, regularly summarizes information about counterfeits in Latvia, and pharmaceuticals are unfortunately in the first place in terms of the volume of counterfeits. This once again confirms that consumers need to be vigilant and cautious when purchasing prescription, non-prescription medicines, or food supplements online or outside of licensed pharmacy networks. Reviewing the results of the system’s operation in the nine months of this year, we can conclude that the verification system continues to fulfil its basic task and ensures the safe distribution of medicines, thus protecting patients from falsified medicines. So far, no case of falsification of prescription medicine or omeprazole has been recorded in Latvia. The system is constantly being improved to ensure that verified and safe prescription medicines are available to patients in Latvia,” says Inese Erdmane, chairwoman of the board of LZVO.
In case the system does not recognize the unique identifier during the verification, an alert is generated, which is received and investigated by the Health Inspectorate. According to the information at the disposal of LZVO, all alerts in Latvia so far have been of technical origin, not because of the falsified medicines. In the 3rd quarter of 2022, the share of the alerts affecting Latvian end-users was only 0.03% on average – this is significantly less than the target set by the European Medicines Verification Organization (0.05%).
Medicines verification system operates across Europe, covering 29 countries and interconnecting 2.500 pharmaceutical companies, 4.000 wholesalers, 100.000 pharmacies, and 6.000 hospital pharmacies in one ecosystem. During the year, 10 billion transactions are carried out in the European medicines verification system. The operation of the system, which is regulated by the EU Falsified Medicines Directive, guarantees that patients throughout Europe, including Latvia, receive only safe and authentic prescription medicines.
The basic principle of the system is that manufacturers provide each package of medicines with a unique code or identifier, which is verified several times on the way to the consumer and finally decommissioned when handing over or using the medicine to the patient in a pharmacy or healthcare institution. This procedure ensures that the same code can’t be used to bring falsified medicinal products into the legal supply chain.
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 works in 29 European countries since 9 February 2019. All prescription medicines and one over-the-counter medicine – omeprazole – are checked by the system.