Alerts and Exceptions
When pharmacies, wholesalers or other end users check a pack against EMVS, the database always sends a response back to the end user. Some warnings also generate alerts which are sent to the pharmaceutical company.
e-VIS has published recommendations for how warnings and alerts should be handled in the EMVS. The recommendations are a supplement to the EMVO Best Practice on Alert Handling.
When pharmacies, wholesalers or other end users check a pack against the EMVS, the database always sends a response back to the end user. The response can either be information that decommissioning of the pack was successful or a warning from the system. Some exceptions also generate alerts, which means that e-VIS and the pharmaceutical company are notified of the warning.
Recommendations for handling of exceptions and alerts
e-VIS has published recommendations for how exceptions and alerts should be handled in the e-verification system. e-VIS recommendations for handling of alerts and exceptions from SMVS (e-VIS rekommendationer för hantering av varningar och alerts från SMVS) are developed together with pharmacies, wholesalers, and pharmaceutical companies. The recommendations are a supplement to the EMVO Best Practice on Alert Handling.
EMVO’s Best Practice on Alert Handling is developed by EU representatives of the pharmaceutical industry, wholesalers, pharmacies, and health care and describes how alerts should be investigated jointly by the actors in the pharmaceutical supply chain.
- MAH has to investigate alerts generated for its products
- Packs creating exceptions, with or without alerts, where the cause is unknown to the end user should be reported to the pharmaceutical company (MAH or MAH’s local representative) as a possible falsification.
- If the end user has caused an alert due to incorrect handling or technical error, the cause must be documented by the end user. End-users in Sweden document the cause for the alerts in e-VIS alert portal NMVS Alerts.
Reporting of pack through the complaint channels
Packs that can be suspected of being possible counterfeits or that cannot be verified or decommissioned against the EMVS must be reported to the pharmaceutical company, i.e. MAH or MAH’s local representative.
Most pharmacies use reklameralakemedel.se
If reporting takes place via e-mail or another reporting tool, firstname.lastname@example.org should be set as a copy.
When MAH replies with results of the investigation to the end user, email@example.com should be added on copy.
- Always put firstname.lastname@example.org on copy for feedback and correspondence regarding reports for exceptions and alerts.
- The investigation must be done by MAH and the end user together. e-VIS can always be contacted for support if no reason for the warning can be found at the pharmacy or wholesaler.
- Note that alerts are not created for all types of exceptions in the e-verification system and that a warning can be equally serious regardless of whether an alert has been generated or not.
- e-VIS recommends all MAHs to be connected to the collaboration for reklameraläkemedel.se
If the exception is caused by the end user’s own handling
Exceptions and alerts can easily arise from the end user’s own handling, for example if the same pack is decommissioned several times, if the scanner reads values incorrectly or if incorrect data have been entered manually.
Document the reason for the alert
If an alert has been generated by the pharmacy’s or wholesaler’s own handling, it is especially important that the pharmacy/wholesaler document the cause of the alert. The documentation must take place in the e-VIS alert portal NMVS Alerts.
Documentation of the cause of the alert is important since:
- The pharmaceutical company is responsible for investigating alerts that are generated for their products, for this reason e-VIS or the pharmaceutical company may need to be informed of the reasons for the alert.
- e-VIS has an obligation to ensure that alerts that are generated are investigated by end users and/or the pharmaceutical company.
MAH’s investigation of alerts
All alerts generated by end users are sent to the MAH via EMVO’s hub. EMVO’s best practice on alert handling describes that MAH must investigate and inform NMVO/e-VIS about its investigation.
For A2, A3 and A52 alerts
MAH should inform e-VIS about its investigation of an alert that has been generated on the Swedish market and whether the cause of the alert is due to MAH or not.
MAH may request e-VIS to contact the end user if MAH believes that the error may be due to mishandling by the end user.
For A7, A24 and A68 alerts
MAH does not need to carry out any investigation of the alert at all as it is likely that the cause is due to the end user. Exceptions apply, however, if the end user were to request an investigation from MAH, for example if the pack is reported by the end user via the complaint channels.