REKS alert handling
REKS exceptions list
If MAH knows a batch that is genuine, but is giving a confirmed alert (troubles with uploading data, known problem with the batch etc.) then with the official confirmation from MAH/manufacturer REKS can add the product to its exceptions list. With the exceptions list, the end user can get an instant answer from REKS’s alert management system (please see more information below) that the product is an exception and can be dispensed. This helps to reduce the number of alerts that needs to be manually investigated by REKS and MAH/manufacturer. Additionally, it helps to reduce the number of genuine packs with known alert reasoning in quarantine, allowing a quicker dispense for the end user.
If MAH/manufacturer knows a batch that should be added to the exceptions list, please contact help(at)reks.ee, with the following information:
- Product name
- Reason for adding to the exceptions list
In Estonia, the end user is required to inform REKS and the wholesaler if an alert appears. The end user can inform REKS through REK-IS alert management system via the software suppliers interface or through REK-IS online form. As an alternative, end user can also use e-mail to inform.
REKS is monitoring system alerts regularly and if needed makes inquires. If it is necessary to perform supervision activities, REKS will involve the Estonian State Agency of Medicine, who has been appointed as national competent authority (NCA) in Estonia.
REK-IS alert management system
REKS has developed a software for alert management called REK-IS, which is connected to nearly 80% of the end users via their software suppliers. The system is a free of charge for all end users who can connect via the software suppliers interface or use an online form. REKS strongly suggests interface the software directly, which will allow the end users to send alerts automatically to REK-IS and receive a prompt feedback. The ones that are not connected yet can use online version to send in the alert.
How the system works is that once the end user is decommissioning the product, the alert will be sent to REK-IS (automatically if connected via software suppliers or sent in manually by the end user). If it is an exception the end user will get automatic response it’s okay to dispense. However, if alert is raised it will notify the end user and stay in REK-IS for a member of REKS team to investigate.
MAH/OBP and alerts
REKS does not expect the MAH/OBP to report alerts and/or the results of their investigation on a regular basis, unless REKS has been a part of the alert investigation. REKS will contact the MAH/OBP directly if it needs any additional information or help regarding the alert investigation. REKS also kindly asks the MAH/OBP to assess the alert before sending it to REKS. If the MAH/OBP can see that the alert could be possibly triggered by human error (such as in SN 0 is replaced by O or SN contains ??), we kindly ask not to send these in by MAH/OBP. However, if MAH/OBP sees that the SN does not belong to their system at all (no similar SN’s could be traced) or there is a serious suspicion of falsified medicine, we kindly ask the MAH/OBP to contact REKS in order to start an investigation.
REKS is not allowed to provide the end user contact information to MAH/OBP, as decided by the Supervisory Board of REKS. REKS will contact the end user directly if there is a reason suggesting a possible falsification.
Since the implementation of FMD REKS has tried different approaches how to manage the alerts in the most effective way. Over the time REKS has found that this kind of approach of REKS directly contacting MAH/OBP is the most effective in the sense that more alerts will be investigated in quicker time span.
If there are any additional questions about alert handling, please do not hesitate to contact help(at)reks.ee.