The European Medicines Verification System is functional and offers full guarantees to patients who are supplied exclusively from authorized sources. Although performing well, the system can still be improved, especially in terms of educating authorized users, to reduce the number of false alerts.
Casper Ernest
“I would like all patients to know that there is a functional system that protects them throughout the chain, from the factory to the pharmacy. Of course improvements are constantly being made, but the system is more secure than ever”explained Kasper Ernest, Secretary General of Affordable Medicines Europe and board member of the European Medicines Monitoring Organization (EMVO), for the parallel distribution sector.
He pointed out that if all users of the system become better trained in its use, then the number of incidents will also decrease.
At the same time, Kasper Ernest also spoke about the importance of educating patients to understand the importance of purchasing medicines exclusively from authorized sources, drawing attention to the fact that safety guarantees only apply to the legal supply framework.
“The number of counterfeit packages in the supply chain has dropped to almost zero,” Kasper Ernest also said.
Referring to the potential use of the system for other purposes than the original one, Kasper Ernest explained that the legislation allows certain operations – for example related to settlements – but not monitoring to cover the lack of certain medicines. “So we have a system that really helps with settlement matters. On the other hand, it cannot track medicine boxes, so it cannot be used for shortages”said Kasper Ernest.
Regarding the operation of the National Medicines Verification System in Romania, he appreciated that it is performing. Incidentally, Kasper Ernest participated, in Bucharest, in the fifth edition of the conference with the theme “Patient safety, through the safety of medicines”, held on April 9.
In a speech delivered on this occasion, he noted the uniqueness of the European system. “I would like to see any other public authority able to manage 10 billion shares per year, in almost 30 countries. The system we have built successfully does this”, said Kasper Ernest, who also emphasized during the conference that there are still aspects to improve.
“We have to educate people. It is a task that we undertake, although it is not necessarily mentioned in the legislation. There is a lot we can do in terms of education and I think the educational institutions that train pharmacists need to be involved because imagine how many false alarms could be avoided if pharmacists became familiar with the system from the bench the school”he said.
Reference event, held in Bucharest
The implementation of Directive 2011/62 and Delegated Regulation 2016/161 in Romania is a success, 5 years after the operationalization of drug verification systems in the EU, pharmacies, hospitals and drug distributors being enrolled in the system and fulfilling their obligations to checking each medicine box. At the same time, the number of incidents remains well below the target set at the European level, of 0.05%. These were the main topics discussed during the conference with the theme “Patient safety, through the safety of medicines” (5th edition), organized, on Tuesday, at the Palace of the Parliament, by OSMR (Organization for the Serialization of Medicines from Romania) and the National Agency of Medicines and Medical Devices in Romania (ANMDMR).
Top decision-making actors in the field of health, such as: Presidential Adviser on Public Health – Diana Loreta Păun, President of the National Agency for Medicines and Medical Devices in Romania (ANMDMR) – Răzvan Mihai Prisada, President of the Senate Health Committee – Adrian Streinu Cercel OSMR President – Dan Zaharescu. They discussed the importance of the system, how it works and the role of the various institutions involved, but also about the future prospects, given the new challenges regarding medicines.
“OSMR has stood out in its five years of operation as a serious discussion partner within the EMVO (European Medicines Verification Organization). SNVM is performing in line with the high expectations we initially set, and as a recognition of its good performance, we note that we have twice been a pilot country for the implementation of new, more powerful versions of the platform. At the same time, we issued two Guides: the Guide for Pharmacies and the Guide for Distributors with the transactions available in the National Drug Verification System”said Laurentiu Mihai, OSMR General Director.
SNVM has 100% registered users and an alert level of 0.02% of the total of over 850 million transactions registered in 2023, below the 0.05% target set at European level by the Directive. In January 2024, a total of 9,612 pharmacies, 592 hospitals and 392 wholesale distributors were registered in SNVM.
“Ever since 2017, we have been actively involved in the national implementation process of the European Medicines Verification System, with the main objective being the safety of the Romanian patient. We currently have an efficient, viable and continuously adapting drug verification system to market realities, and the success of the project is due to transparent communication, involvement and sustained effort by all parties involved. As before, ANMDMR will continue to monitor compliance with the provisions of the regulation, allocating resources, time and effort to prevent counterfeit medicines from entering the legal supply chain, thus guaranteeing patients' access to authentic medicines”declared, for his part, Răzvan Mihai Prisada, President of ANMDMR.
Article supported by OSMR
