What are ‘falsified medicines’?
Falsified medicines are medicines that are presented as genuine and authorised medicines. The term “falsified” includes all forms of falsifications, including infringement of intellectual property rights.
Falsified medicines can contain ingredients, including active ingredients of poor quality or in the wrong dose – either too high or too low. For the reason, as they are not properly evaluated for the quality, safety and efficacy (as strict EU procedures require it), they can be detrimental to the patients who use them. The distinction between falsified medicines and genuine medicines is becoming increasingly complex, increasing the risk of falsified medicines reaching EU patients.
Cases of falsified medicines have occurred all over the world, including in Europe, and there is a risk that falsified medicines may reach Estonia. In order to avoid the latter, Estonia, together with other European countries, has a duty to implement a unified system for checking security features to ensure patient safety.
Prevention falsified medicines from reaching the legal supply chain?
Pharmaceutical companies must apply two safety features to their packaging:
- A unique identifier (which includes the drug product code (GTIN), the unique serial number, the expiration date and batch number), both in 2D code and in human-readable form
- An anti-tampering device on the packaging, such as a sticker that identifies the packaging has not previously been opened
When a medicine is dispensed, the security feature on the packaging is scanned and authenticated against the data in the database of the country of origin or supranational. If the unique identifier matches the information in the database, the packaging is deactivated and delivered to the next link in the supply chain or to the end user (patient).
If an alert is triggered when a package is scanned, they system will display it as an emergency case and the package will not be delivered to the patient. The relevant procedure must clarify whether the packaging is falsified or not. In Estonia, the procedure is conducted by the State Agency of Medicines.
Due to high volume of alerts and the aim of ensuring the availability of medicines, a transitional period is currently in place in Estonia. This means that the end user must, in certain cases, quarantine the medicine package if the alert occurs (if the package is in the status of “inactive). Instructions are available on the State Agency of Medicine’s website.
The European Medicines Verification System (EMVS) consist of a central database and national medicines authentication databases.
The information systems of the Marketing Authorisation Holders and parallel distributors are connected to a central database for the purpose of uploading unique identifiers. These stakeholders are responsible for aligning their production lines and for building and maintaining European and respective country-specific systems.
End users, such as wholesalers (responsible for risk-based prescription medicine control), pharmacies and hospital pharmacies (responsible for controlling and prescribing all prescription medicines dispensed to patients), are connected to the Estonian Medicines Verification System (EtMVS). End users are responsible for customising their IT system and interfacing with the system.