It has been a year and a half since the Medicines Verification System became operational in Latvia. In order to learn about the current events, look back at what has been achieved and look at the future challenges, we had a conversation with Inese Erdmane, Executive Director of the Latvian Medicines Verification Organisation (LZVO).
The Medicines Verification System has been operating in Latvia since 9 February 2019, which is more than a year and a half. What has this time been like for you?
This year and a half has been interesting, intensive and creative. The work on maintenance, improvement and supervision of the system has not stopped for one moment. The Medicines Verification System was introduced according to plan, and we managed to implement the system in due time. The system’s operation is currently stable, and it is applied by users. Within the last eight months, 44 new users have joined the system. This means that there are still users who have not connected to the system, or who have not had the need to connect to it. In close cooperation with the Health Inspectorate, the LZVO reviews each system user and checks whether this user has connected to the system or not. The system currently has 1,248 users. On average, 5-6 new users join the Medicines Verification System every month.
One of the system’s tasks is to generate alert notifications in accordance with the requirements. On average, 322 units are generated monthly, which affect end-users. In terms of percentage, if we compare alert notifications against the total number of transactions, then at the beginning of the year these were 0.4%, and now this indicator is 0.06%. In view of the overall data of Europe, the LZVS (Latvian Medicines Verification System) is showing very good results. The most common causes for the notifications are of a technical nature, for example, capital letters are mixed with small letters, and there are some programme or scanner errors. Such errors are resolved very quickly. Alert notifications are also selected by their origin, i.e., who gives these notifications. At present, the majority of alerts come from manufacturers (59%), pharmacies (14%), healthcare institutions (5%), wholesalers (8%), IMT (transactions that are intended for markets of various countries) (9%) and others (5%).
What is currently on your agenda — current work, challenges, plans?
This year, active work is taking place on the development of system updates or releases. The development of each release takes six to eight months. This means that for about six to eight months, we have been working to develop new features that we want to introduce in the system. In the case of the LZVO, this year these are two main releases and four reporting releases. The reporting system releases are mainly related to the access of national competent authorities to the system and options to analyse data, access to which is permitted in the delegated regulation. The main releases are related to system improvements and the integration of new requirements, if necessary. We are currently actively working on the 1.08 release, where the LZVS is involved both in overall tests and in quality assessment.
We have also commenced work on improving the client portal. The existing client portal has been serving its functions, yet over time we realised that it needed to be expanded both in relation to manufacturers and users. In the new client portal, data bases will be synchronised with the Register of Enterprises, the State Agency of Medicines and the Health Inspectorate. Therefore, for example, we can more quickly keep track of which users need to renew their medicine purchase permits. In this way, the data available on the client portal will be updated and legitimate. At present, we have finished the development of the client portal for manufacturers where it is possible to register information about the company and contact the LZVO, as well as receive the latest data from the European Medicines Verification Organisation.
And one of the main challenges we still have is to ensure continuous operation of the LZVS, its stability and accessibility to all users.
How was the LZVS and LZVO affected by the Covid-19 pandemic and its consequences?
From the point of view of the Medicines Verification System, during this time we simply needed to ensure the continuous operation of the system. There was absolutely no reason to have doubts about the system’s operation and capability of verifying medicines. No problems were found in the system’s operation either – as before, pharmacies and other users continued scanning and checking whether medicines were falsified.
On the level of Europe, a working group was created, which works on and plans how the Medicines Verification System might be affected by the new Covid-19 vaccines and medications. Of course, as soon as these vaccines and medicines are available, the demand will be extremely high, and it will be necessary to ensure very high-volume delivery in a very short time. At present, talks are taking place on how to make this stage quick, convenient, and successful in order to avoid any errors. Of course, we also understand that forgers will take advantage of this situation, which is why it is essential that these medicines are verified in Latvia through the Medicines Verification System.
The same as the majority of Europe, we are also working remotely from our homes. The office was available, and if someone did not have the chance to work from home, they could go there. All this time we could be reached by phone and by e-mail; we also used postal services to receive or send items.
Did the LZVO undergo any training during this time and are they planning to take any in their future work?
In my opinion, this new Medicines Verification System and the related processes is something new for the entire of Europe, and we learn every day. Of course, it is a huge success that we, 30 countries, are able to cooperate without any hitches and improve at the same time. Our IT manager and quality manager participate in the joint system quality development processes of Europe. Participation in the system’s 1.08 release tests will also be one of the experiences we will take with us – what it is like to work in an international environment, in a united team.
What challenges are ahead of the LZVO and LZVS in the near future?
One of the challenges is BREXIT. At present, there are many unanswered questions as to how Great Britain will leave the EU, and what will happen with those medicines that are intended for the British market as well as other markets, as multimarket packages. This will not only have an impact on Latvia but also on other countries, such as Ireland, Cyprus and Malta, where it will be much higher. It will also affect Belgium and Germany where these multimarket packages are sold. It is very important to understand what the technical and legal solution will be for BREXIT. This is a process where both system developers and the state and European level institutions work alongside each other.
Along with BREXIT, Europe is giving thought to how to optimise different processes, such as automated testing. Another subject of consideration is the outsourcing of various professional services, which would alleviate work for all member states. Not only with developing an IT system, but also in IT qualification and testing.
One of the current projects is a joint alert notification investigation system in Europe. Work is already being done on this project, and it is planned that the end-users, national organisations and competent public authorities will all be able to connect to a unified system and obtain the data that each needs to investigate. Therefore, if there is one alert notification in Latvia, it will be accessible to the pharmacy or the medical treatment facility that made it, the LZVO and national competent authorities. In this way, all together and at the same time, we will be able to investigate this alert case, by exchanging information and closing the specific case.
One of the local activities that we continue to perform is regular face-to-face or online meetings with the largest clients. During these meetings, we inform them about the latest matters concerning the system, talk through any problems, as well as tell them about any challenges that might come up within the next months. One of the biggest challenges at the moment is system authentication certificates that need to be renewed every two years and, in this particular case, will expire at the end of December this year. The current system authentication certificates must be replaced with new ones. It is nothing complicated, yet if it is not done in a timely manner, then at some point we can no longer connect to the system. For this reason, we inform the end-users in good time to avoid any unpleasant surprises.