OSMR is extremely honored to welcome to its virtual space Mrs. Inese Erdmane, Chairwoman of the Board of the Latvian Medicines Verification Organisation (LZVO), who shared the Latvian experience related to the implementation of the medicines verification system.
OSMR wanted to present to its public another view on the importance of the medicines verification system, part of a European eco-system, a unique project focused solely on safeguarding patients’ safety.
Inese Erdmane, Chairwoman of the Board at LZVO
“Medicines verification system: Latvia’s experience
Latvia is a relatively small country, which may sometimes be a disadvantage, but at other times – a great advantage. When it came to implementing the Falsified Medicines Directive (FMD), the small size of the Latvian market turned out to be advantageous, as we were able to introduce the medicines verification system without the need for a transition period. This means that from February 9, 2019, Latvia had a fully operational medicines verification system ensuring the provision of safe medicines for all the inhabitants of Latvia.
Latvia is one of the smallest European Union member states, with a population of 1.8 million. The capital city, Riga, serves as the country’s economic, cultural, and scientific centre. A third of the country’s population resides in Riga, making it the largest city in the Baltic States.
Latvian Medicines Verification System
The Latvian Medicines Verification Organization (LZVO) was founded in 2016 by five industry organizations representing pharmaceutical manufacturers, distributors, wholesalers, and pharmacies. The Latvian Medicines Verification System (LZVS) was developed by Arvato GmbH, and representatives from Latvia actively participate in the Arvato Customer Group working teams dedicated to IT Development and Quality Management issues. Since the introduction of LZVS at the beginning of February 2019, the system has been operating stably and without interruption.
There are 3 national competent authorities in Latvia. The Ministry of Health develops health policy and legislation, including the regulatory framework for the circulation of medicines and the operation of the medicines verification system in Latvia. The State Agency of Medicines of the Republic of Latvia registers medicinal products, coordinates the placement of safety markings on the packaging of medicinal products registered in Latvia as well as parallel import medicines. The Health Inspectorate monitors the circulation of medicinal products, investigates potential falsifications, and controls the procedure for distribution of medicinal products, including the fulfilment of the obligation to verify medicinal products.
System end users
Obligation of medicines verification in Latvia is determined directly in accordance with the FMD and the Delegated Regulation. All pharmacies (public and hospital), wholesalers, health care institutions licensed to purchase medicinal products, such as hospitals, polyclinics, health centres and doctors’ practices, must connect to the LZVS and verify medicinal products. This obligation also applies to dental clinics and doctors’ practices authorized to purchase medicinal products from wholesalers.
1043 end users in Latvia – pharmacies, wholesalers, and medical institutions – had joined the system when operations began in 2019. Currently, in Latvia, 100% of end users required by regulations have connected to the verification system. The total number of system end users is 1193, including 820 pharmacies, 58 wholesalers, and 315 healthcare institutions.
System performance indicators
The number of transactions made during the almost five years since the system’s operation began has increased consistently, stabilizing in recent years. In the first half of 2023, a total of 54.5 million transactions were carried out in LZVS, of which 14.3 million were decommissions, when medicines packs were issued to or used by citizens. Successful decommissioning of the unique identifier accounts for about a quarter of the total number of transactions. In the first months of 2023, the number of medicine packages issued to citizens increased by 4% – this corresponds to data on the rise of medicine use in Latvia.
Alerts that caused the most worry and questions to the end users in the early stages of the system have diminished considerably over time. Improving the quality of data uploaded by manufacturers and enhancing the skills and knowledge of end users has increased the effectiveness of the medicine verification system. The number of technical alerts has decreased, reducing resources spent on investigation. In the first half of 2023, the proportion of alerts affecting end users in Latvia was only 0.01% on average – significantly lower than the target set by the European Medicines Verification Organisation (0.05%). The low number of alerts indicates stable system operation, and the state institutions, users, manufacturers, and LZVO are capable of tracking and analysing these alerts.
In Latvia, the initial investigation of alerts is the responsibility of end users and manufacturers. LZVO monitors the system, offers support, training, and consultation to end users and manufacturers within its competence. LZVO gathers information about activities within the LZVS, as well as alerts and their causes, and regularly provides information to the competent state institutions.
Development and Challenges
Within the system, we proactively work on continuous improvements to ensure that safe and verified medications reach patients. Additionally, we aim to make the verification process as understandable, convenient, and effective as possible for all system users.
LZVO has established a closed Customer Portal with two modules – one for Marketing Authorization Holders (MAH) and another for end users. In addition, LZVO regularly organizes educational seminars for various partner groups – end users, manufacturers, and IT developers.
LZVO is also following along the development of a joint alert management system (Alert Management System – AMS), the implementation of which is intended to occur in the next few years.”
