Laurențiu Mihai, OSMR General Manager
The main mission of the Romanian Medicines Serialisation Organisation (OSMR) is to manage the National Medicines Verification System (NMVS), through which we ensure that every medicine put into circulation on the national market is authentic. As General Manager, I have had the privilege of overseeing the implementation and operation of Romania’s NMVS, a cornerstone in the fight against falsified medicines.
In practice, our activity involves continuous coordination with medicines’ manufacturers, wholesalers, pharmacies, hospitals, software solution providers to implement and maintain an electronic system that is unique and a model for all other areas of the world in combating falsified medicines.
We are also working closely with competent national authorities and international partners to ensure interoperability at the European level.
Implementing the NMVS in Romania was an ambitious undertaking. The main issues faced by our organization were related to the complexity of managing and monitoring a national medicines verification system involving multiple stakeholders, each with specific requirements and expectations.
The danger of using falsified medicines is a real one that the general public may not fully understand. The risk is related to therapeutic ineffectiveness, as a result of ingredients of poor quality, or the lack of the active substance, but above all to possible harmful effects on health.
Since its Go-Live, on February 9th, 2019, the NMVS has demonstrated its value again and again. The system processes millions of scans each day and its robust architecture ensures high availability, with minimal to zero downtime, allowing stakeholders to rely on its functionality seamlessly.
Over the years, we have celebrated several milestones, out of which we mention a few, such as:
- The scanning of the first medicine pack in the NMVS PROD environment by an authorized wholesaler, on November 5th, 2018;
- Reaching the 0.05% target of alerts’ percentage out of the total transactions in the system during week 45 of 2020. 0.05% is the agreed target at the European level for the medicines verification system to be considered fully functional and mature;
- Signing of the Cooperation Agreement between the National Agency for Medicines and Medical Devices of Romania (ANMDMR) and the Romanian Organization for Serializing Medicines (OSMR) on July 7th, 2022;
- Developing an Alerts’ Guide for the End-Users which provides more details on the entire process of alert handling and most importantly, offers some recommendations on managing the alerts in December 2022;
- The first in-person meeting with the software providers, on September 26th, 2024. The gathering marked a significant step forward in fostering a strong partnership and increased transparency within the software providers’ community.
This success is not just measured in numbers but in the growing confidence of our stakeholders in the system’s reliability.
We are extremely grateful for the feedback from the End-Users which has been overwhelmingly positive, as everyone understood the importance of this system in protecting patients’ safety.
Some of the most important lessons learnt whilst reflecting on our journey up until now are:
- stakeholder engagement is essential – building and maintaining trust with stakeholders is a key element. From the very beginning, we prioritized open communication and transparency, which proved helpful in navigating challenges effectively.
- flexibility and adaptability are critical – as we all know every implementation has its unique challenges. Thus, I believe it is very important to remain flexible. This helped in adjusting our strategies and timelines when it was needed to address unforeseen issues.
One of our main concerns remains the continuous optimization and improvement of the National Medicines Verification System (NMVS), to ensure that it continues to operate at the highest standards of efficiency and security. The continuous development of the NMVS is essential to face emerging challenges and to ensure the authenticity of medicines on the Romanian market.
The journey of implementing and operating Romania’s NMVS has been both challenging and rewarding. It stands as a testament to what can be achieved when stakeholders unite around a common goal.
As we take time to reflect on what has been achieved, we remain focused on the future. Our priorities are closely linked to the use of technology for patient safety and the medicine verification system is a fundamental basis for a safe and reliable pharmaceutical environment.
Also, the use of the European verification system for other purposes about which there are already discussions, such as measures for improving the control of expenses with compensated medicines, are the directions to follow in the future.