Alert Management & EMVO AMS | Alerts keep the industry busy – ever since the start of the active commissioning of the serialization activity. The system, which is supposed to protect patients from counterfeit medicines, produces many error messages from the very beginning when verifying medicines in the pharmacy. These are almost exclusively false positive alerts. Most of the time those are caused by handling errors in the pharmacies or misconfigured systems – both, on the pharmacy and the manufacturers’ side.
The mass of alerts poses a major hurdle for all stakeholders involved: The authorities have difficulties filtering out genuine counterfeits, the pharmacies cannot sell medicines, and the manufacturers have to take care of the assessment and management of the alerts in addition to their daily business. Depending on the batch size and number of medicines, 10,000 false-positive alerts per week can quickly accumulate.
How do you manage your alerts?
But what do you do with the alerts? With large quantities, the manual processing of each error message is hardly manageable. However, the manufacturers are obliged to deal with their alerts and accept the loss of sales if their medicines are withdrawn from circulation due to false-positive alerts. Additionally, the possibility of an audit, which will also examine the quality of alert management, becomes more likely the longer the FMD is in force.
Sensitivity to the issue is very heterogeneous among pharmaceutical companies. Some companies conscientiously process large numbers of alerts, others have hardly dealt with the issue at all.
No wonder, for a long time there were no suitable possibilities from the authorities to manage the alerts in a meaningful way. However, the new AMS portal of the EMVO comes with some functions that will make it easier to handle alerts. This, however, also increases the expectations for pharmaceutical companies to actively dedicate themselves to alert management.
The EMVO AMS portal
Advantages:
- Own EU portal for alert management
- Alert Management to become more efficient
- End-to-end communication between all stakeholders for root cause analysis
- Mass processing of alerts is made possible
Disadvantages:
No root cause analysis in the system itself
EMVO’s AMS portal does open up new possibilities for pharmaceutical companies and will also improve the management of alerts. However, it is not a fully comprehensive solution; companies still have to manually take care of the root cause investigation, and thus the main part of the work is to clean up alerts.
Our solution: mytracekey ALERTS
Through a direct connection to the AMS, we are expanding our system and the possibilities for our customers to categorize and process their alerts quickly and easily.
The new functions available to us through the AMS portal are a useful addition to our solution. Especially the point of mass processing of error messages simplifies the process and brings more efficiency.
An alert management concept is also indispensable for good quality management. Through our audit trail and our validated system, you work fully GxP-compliant.
What happens next?
As soon as the EMVO AMS portal is fully established, the announced authority audits will come. Qualitative alert management is, therefore, a must for all pharmaceutical manufacturers. With mytracekey ALERTS you are prepared for the upcoming audits.
More about alert management
[Update]
Since this text was published, EMVO’s Alert Management Portal has been fully running. You can read the corresponding article here.