Inese Erdmane, Chairwoman of the Board at LZVO share insights of the Latvian medicine’s verification process with Dansk Medicin Verifikation Organisation Newsletter.
The original article was published on the DMVO newsletter https://mailchi.mp/0e27bdd6a5ef/dmvo-newsletter-7084653#english
Latvia is a relatively small country, which is sometimes a disadvantage, but sometimes a great advantage. In the case of the implementation of the Falsified Medicines Directive (FMD), the small Latvian market was a privilege, as we were able to introduce a medicines verification system without a transition period. This means that on February 9, 2019, the medicines verification system in Latvia became fully operational to provide safe medicines to 2 million Latvian inhabitants.
Latvian Medicines Verification System
The Latvian Medicines Verification System (LZVS) has been developed by Arvato GmbH. Latvia, together with 16 other countries, whose national system has also been developed by Arvato, has developed its own management model, which consists of groups of management, quality, and technical experts. Each group has its own board. Two employees of the Latvian Medicines Verification Organisation (LZVO) – Quality Manager Andra Pučko and IT Manager Rihards Plivčs – work in the respective group councils.
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 the medicinal product. This obligation also applies to dental clinics and doctors' practices authorized to purchase medicinal products.
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 registers medicinal products, coordinates the placement of safety features on the packaging of medicinal products registered in Latvia as well as parallel imported. 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.
Statistics – users, transactions, alerts
1,043 end users in Latvia – pharmacies, wholesalers, and medical institutions – had joined the system at the beginning of 2019. This number increased by an average of 9 users per month in 2019 and 2020. At the end of 2020 there were 1,261 end users already using the system. LZVO works closely with the Health Inspectorate to ensure that only legitimate users are connected to the system. Since the beginning of this year, the number of users has been declining due to the closure of access to those users who do not use and do not plan to use the system. At the beginning of September, there were 804 pharmacies, 62 wholesalers and 321 medical institutions connected to LZVS.
On average 3 million transactions are performed in LZVS per week. Successful decommissioning of the unique identifier code from the total number of transactions makes up about 34%.
Alerts that caused the most worry and questions to the end users in the early stages of the system have diminished considerably over time. In 2019, the share of alerts from the total number of transactions was 0.1%, while in August 2021 the share of alerts was 0.07%. In addition, not all alerts apply to end users. Latvian end users receive only one alert in an average of 20 days or 0.05 alerts per day. This number of alerts indicates about stable operation of the system. All involved parties – national competent authorities, end users, Marketing Authorization Holders (MAH), and LZVO – can track and investigate these alerts.
Developments and challenges
This year LZVO has launched a customer portal, which has two modules – MAH portal and end user portal. Each LZVO customer has a profile on the portal where it is possible to update the data of own company, submit and receive documents, ask questions to LZVO, and receive answers. LZVO is publishing professional information on the operation of the verification system, system updates, European and Latvian operational guidelines, and other documents in portal. The current challenge is to get all customers connected to the portal and update their profile data.
So far, no special IT solution has been used in Latvia to investigate alerts. An Alert Management System (AMS) is currently being developed at European level and in cooperation with many stakeholders. This system will bring together end users, MAHs, national organizations, and competent authorities to jointly investigate, communicate and record alerts.
The Covid-19 pandemic also brought new challenges. At the end of 2020 and the beginning of 2021, strict trade and gathering restrictions were set in Latvia, which also affected the work of LZVO and end users, for example, it was not possible to hold face-to-face seminars, pharmacies were under enormous stress and had high workload, and there was a shortage of medicines. However, we look at things from a positive point of view and say that Covid-19 also had a positive side effect – discussions about vaccines have created unprecedented interest in medicines, their use, and their safety. It is good for people to keep track of the medicines they use: to know name of medicine, active substance and manufacturer who produce it. The safety of medicines and human health are common goals for all of us.