Iwona McManus, PLMVO General Manager
In 2019 the Polish Medicines Verification Organization (PLMVO) have implemented a robust verification system, which is a part of European Medicines Verification System (EMVS) in European Union. The Polish Medicines Verification System (PLMVS) plays a crucial role in ensuring the safety and authenticity of medicines in the supply chain in Poland. Day by day information regarding statistics on users, transactions and alerts provide valuable insights into the effectiveness of these systems. Today, I would like to introduce the key statistics and efforts made in Poland to fight against falsified medicines.
The PLMVS has garnered significant recognition in Poland, with approximately 15,000 end users actively participating in the verification system, including over 400 wholesalers, over 1,500 hospitals and nearly 13,000 pharmacists. This high number of users demonstrates the commitment of stakeholders to ensuring patient safety. On average, there are approximately 44 million transactions weekly, showcasing the extensive use of the system in Poland's pharmaceutical supply chain. One of the fundamental pillars of the verification system is scanning of each medicine pack to verify its authenticity by pharmacist before providing it to the patient. In Poland, over 16 million packs are scanned weekly, emphasizing the widespread adoption of this crucial practice.
Despite the high volume of transactions and scans, the rate of alerts remains impressively low, standing below 0.015%. This low alert rate is a testament to the effectiveness of the PLMVS in detecting and preventing the circulation of falsified medicines. It is worth noting that Poland boasts one of the lowest alert rates among big countries such as France, Spain and Germany.
To ensure optimal response to alerts and to enhance overall system effectiveness, substantial efforts have been invested in communication and education initiatives. Pharmacists play a pivotal role in combating falsified medicines, and educating them about how to react to alerts is vital. Through comprehensive trainings and informative materials, pharmacists are equipped with knowledge on identifying and handling alerts promptly. Additionally, PLMVO have introduce new National Alert Management System (NAMS), a web application which provides pharmacists with even more detailed information about potential root cause of the alert, as well as provides quicker communication path with the Marketing Authorization Holder of the pack. This proactive approach empowers pharmacists to take immediate action, further fortifying the supply chain against falsified medicines.
A strong collaboration between the PLMVO and the local National Competent Authority (NCA) has significantly contributed to the success of the verification system in Poland. The NCA plays a crucial role in oversight and ensuring compliance with regulations. Regular communication and close cooperation enable swift responses to any emerging challenges or threats. This collaborative approach fosters a proactive and dynamic environment, continually improving the system's efficiency and efficacy.