Earlier this year, the European Medicines Verification Organization (EMVO) released its new Alert Management System (AMS) portal to improve the exchange of information between stakeholders in the event of suspected counterfeiting. In addition, the initiated investigations can be tracked and logged more easily with the help of this portal. Due to the pan-European approach of this endeavor, a standardization of warning statuses and notifications, as well as an anonymous communication between the different actors is expected to be achieved.
In our last article, we already described business process outsourcing and presented its advantages and disadvantages. We would like to illustrate how tracekey can take over this area of the serialization process in your company with the concrete example of alert management. For this purpose, we present the process as it could look like in case of an alert, calculate how much the operation of such a system could cost and show how tracekey can support in such a process.
The Alert Management Process
In the event of an alert, the person responsible for it must become active first. Usually, this person is a member of the quality management team of the respective manufacturer. EMVO has published a guideline for this, whose steps should be followed. First, the source of the alarm must be identified and documented. This can be viewed in the AMS portal for example. Depending on the type of alert, different actions must be taken here. [The different types of alerts can be found here]. If alerts of the types A7, A24 or A68 are reported, no investigation takes place and the investigation ends here. This also applies to alerts of types A2, A3 and A52, but only if manufacturers are sure that the alert was caused by an end user.
For all other alert types, the guidance requires an internal investigation by MAHs, which must also notify and request assistance from National Medicines Verification Organizations (NMVOs). To get to the bottom of potential counterfeiting, MAHs request a photograph to analyze the package. If the suspicion of counterfeiting persists, they also receive the package itself. If the suspicion is confirmed, MAHs must notify the country’s NMVO and national competent authority (NCA).
Cost example: Alert Management Processes
An Alert Management System can involve a lot of work. Depending on the size of the manufacturer, the number of daily notifications may be particularly high. Even though they are not usually actual counterfeits, they still need to be processed. Depending on the type of alert, processing can take between five and 20 minutes. To illustrate this, we have prepared an estimate showing the costs of in-house alert management.
We assume that the activity is performed by a person from quality management, where the average salary is 50,000€ per year. For employers, this results in expenses of approximately 62,000€, or an hourly wage of 31€. As an average processing time for an alert, we assume 7 minutes, since serious suspicions are rather rare.
|Number of alerts||Time in hours||Personnel costs in Euro|
Furthermore, it must be considered that other tasks are neglected due to the processing of the alerts. If the number of alerts is particularly high, it may even be necessary to create a new position for this purpose, along with the associated costs. Especially for small and medium sized enterprises there is often not enough financial capacity for this.
How tracekey can offer support
In view of the current changes regarding the Alert Management System, it is obvious that EMVO will pay more attention to this in the future. After all, it is an important means of preventing counterfeit medicines and making the supply chain safer. In terms of the costs involved, business process outsourcing is not out of the ordinary here. Especially we at tracekey, have the possibility to take care of the complete alert management process for manufacturers. Thanks to our years of experience, we have the necessary know-how to proceed efficiently and make life easier for our customers. Especially financially, this can be a relief.
With the help of our tracekey Serialization Manager (TKSM), we can take over all tasks of the serialization process. The extent of this is individually customizable and is not limited to alert management alone. If you are interested or would like more information, please contact us.