Mistakes around FMD can happen. Among those are critical alerts that will call authorities upon the scene and may disrupt your work processes tremendously. With medAspis Alert Guard, Lean FMD supports you in reacting correctly and efficiently to any alert from trivial to critical. This is especially true for cases of suspected counterfeiting, where the authorities automatically get involved.
This is especially true for cases of suspected counterfeit that will automatically involve authorities. medAspis’s sophisticated FMD process ensures that you will get a handle on all FMD alert cases with minimal additional effort and can document them in a way that is officially secure.
Just a quick refresher: the handling of error messages has been laid down by law. In principle, the Falsified Medicine Directive 2011/62/EU (FMD) applies throughout Europe. Laws of the European countries regulate further measures:
With medAspis Alert Guard you can rest assured that not a single alert is forgotten. All alert cases are processed. Lean FMD and Alert Guard will support you in a way that even in the case of an alert your daily workflow will hardly get out of step. Quarantine times are reduced as much as possible.
At the same time, it is ensured that you always have the right answers for the authorities in every case:
Each case that is solved and documented will no longer be a problem for the authorities.
But what happens if there really is counterfeit? Then action must be taken quickly. The medAspis Alert Team is ready to help you and will take care of the process.
Patient safety comes first, of course – and so does the implementation of all necessary measures if there is an alert. But even so, your processes and workflows should be disrupted as little as possible.
Whenever counterfeit is suspected, the corresponding pack must be quarantined. This will stop and interrupt the workflow. From this point on, the faster the alert is identified and processed, the faster everything will return to normal.
With procedural instructions or SOPs (Standard Operation Procedures), alert situations can be remedied. For optimal error management, your SOPs must offer solutions for all potential FMD alert cases.
Are you prepared for all cases? You probably already have SOPs for the most common alert situations. In order to supplement or complete your existing measures, we will be happy to provide you with our SOP sample formulations.
Together with you, we derive instructions for action for all cases of error from the completed SOPs. Valid for the person responsible and the scanning staff. Everything is summarised in a simple and easily comprehensible FMD rulebook.
The instructions for the scanning staff are kept very simple. There is not much to read. One look is enough, and you will know what to do:
As soon as an alert occurs in the operational process, the operator will know what to do – after all, he has the FMD rulebook. If a critical alert occurs, cautious and prudent action is called for. The authorities have already been notified of this alert automatically. There is a solution in the rulebook. Ideally, the pack will not go into quarantine, and the work process will continue without interruption.
What’s crucial is that this decision is well justifiable with regard to the authorities.
However watertight internal procedures may be: The report to the authorities has already gone out – automatically and immediately.
It is indispensable to document all alert situations comprehensively and comprehensibly. This is the only way to ensure that information can still be provided years later if the supervisory authority asks about a specific case in a spot check.
The medAspis Alert Guard automatically collects all alert cases that have occurred in the Control Panel. Each individual alert can be processed with little effort:
Some cases can be solved automatically in advance. For example, double deactivations caused by the user are found and automatically processed. All together, this increases efficiency and helps to respond correctly to requests from authorities.
With medAspis Alert Guard, contacts with the authorities in matters of FMD run more smoothly.
Now your top priority will be quarantining affected packs. Report the cases to your NMVS and contact medAspis immediately.
If, after examination by the manufacturer, the pack is indeed found to be counterfeit, you must inform the authorities. We will guide you through each of these steps. Because in everything you do now, we are at your side.
Curious about it? Please feel free to contact our support team. We are at your disposal for all questions concerning FMD.