Incident types for this category:
– The end user scans the 2D code on the pack;
– The software sends the data for verification to the verification system – SK-NMVS;
– The verification system checks all 2D code parameters (Product Code, Serial Number, Batch, Expiration) and pack status;
– If parameters are correct (all 4 parameters) but pack status is inactive, the system returns a negative response;
– The end-user software displays a warning message;
– If the pharmacist is not aware of his own mistake during verify the pack, he must not dispense the pack to the patient and must quarantine the pack and wait for investigation. If the deactivation is itself caused by mistake (attempts to deactivate the same pack twice, the first attempt was successful, the second failed attempt generates an incident of this category), the pack can be delivered to the patient.
– The verification system automatically generates the incident and assigns it a unique identification number = Alert ID;
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SUBSEQUENTLY
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– The verification system sends information about the incident to the Incident Management System – IMSin the Pharmacy or Distributor application – lekaren.e-vuc.sk / distributori.e-vuc.sk;
– The end user who created the incident will see the incident in the list of incidents in the section: ” Waiting for Your Action “, and the MAH to which the product belongs will see the incident on IMS in the list as:” Watting for End User “;
– The end user is informed of the incident by email;
– In this type of incident, it is essential that the end user actively intervenes in the incident first. Because only the end-user knows whether this incident was caused only by a user error or is a seriously suspected counterfeit;
– The end user must open the incident detail and select one of the three predefined options:
-> 1. Accidentally scans the same package.
-> 2. Human error when dispensing medicine.
-> 3. I am not aware about human error or technical problem with dispensing of the medicine to the patient. It is necessary to investigate.
– In the event that the incident occurred by mistake and the end user marks option 1 or 2, the SOOL automatically closes the incident after checking. The MAH is informed of the closure of the incident on the IMS;
– If the end-user is not aware of any human / technical error in verifying the pack, the end-user marks option number 3. The incident moves to SOOL and the SOOL is starting an investigation. In this case, the MAH may be asked to cooperate in the investigation.
> In case the incident is not confirmed. The incident closes as unfounded. All parties concerned are informed (MAH, End User, SOOL).
> If the suspicion is confirmed. The incident is reported to NCA. NCA is starting an internal investigation. All parties concerned are informed (MAH, End User, SOOL). Incident is closed by official statement from NCA.
* Each procedure may vary and may not always be the same as above.