FiMVO Newsletter 4-2019

Welcome to our latest Newsletter!

We are pleased to announce that Mirka Koski will be joining our team as Service Manager starting 25th September. Mirka has an extensive background in IT systems and project management and development.

Mirka will be in charge of managing the Finnish Medicines Verification System. She will be working closely with end users to continuously improve our operations. Mirka will also be heavily involved in alert analysis.

We look forward to welcoming her to FiMVO!

This newsletter focuses on ending the soft launch period in Finland. We have a very low alert rate that gives us a  great opportunity to finalise the implementation of the medicines verification system. Read more about our approach after some announcements.

Save the date!

We will be hosting our next workshops at our offices in Helsinki in November. Please save the date!

MAHs: Tuesday 5th November, 1pm-4pm.

End Users: Wednesday 6th November, 1pm-4pm

The dates are set but the times are approximate and will be fixed when we send our invitations and agendas.

Change of contact details?

Please remember to inform us of any change in your contact details!

Alert queries

Please send all queries regarding alerts to our email address: nmvs@fimvo.fi

We all have access to this inbox which will ensure you get a speedier reply in the case of any of us being out of office.

 

The soft launch of the medicines verification system will end by January 31, 2020

Actors in the pharmaceutical distribution chain have jointly decided to continue the soft launch of the medicines verification system until January 31st 2020. The number of alerts has already fallen to a low level (on average, one alert per 1000 verified packages). End users have gained experience with the operation of the system and the resolution of various alerts and error situations. Over the next five months, IT systems will be further developed. In addition, the FiMVS system will receive new features with the next system upgrade, which will further reduce the number of alerts which are currently covered by the soft launch.

Re-cap of the soft launch

Prior to when the Falsified Medicines Directive (FMD) came into force, there were many batches of medicines in packs that contained 2D barcodes and human readable information, but 1) had not been serialized, or 2) data for all serialized batches had not been uploaded to the system or (3) there were various errors in the information printed on the packaging or uploaded to the verification system. These packages and batches would have caused a large number of alerts during the deployment phase of the system.

In order to safeguard the functioning of the pharmaceutical supply chain and the availability of medicines, the supply chain stakeholders (pharmacies, pharmaceutical wholesalers, FiMVO) agreed on specific procedures for the implementation of the medicines verification system and committed to them for the time being. In practice, the wholesalers committed to verify at least one pack of each new batch with “safety features” (“serialized”) by 9th February 2019. With this approach, products or whole batches can be prevented from alerting at later stages of the distribution chain for the following alerts:

• Unknown product code
• The batch ID does not match the serial number in the NMVS
• Expiry date does not match the date held in the NMVS

Because these three alerts can be prevented for batches released on or after February 9th 2019, and medicines verification legislation does not obligate pharmaceutical companies to add safety features to batches released before February 9th 2019; these alerts can be ignored in pharmacies, hospital pharmacies, as long as there is no reason to suspect counterfeiting for any other reason.

All other alerts must be resolved in accordance with legislation and the stakeholder’s own approved practices for counterfeit medicines. These alerts include:

• Unknown serial number
• The batch ID does not match the serial number
• Pack is inactive
• Property is already set on pack
• Pack is already inactive

In practice, the soft launch means that pharmacies, hospital pharmacies, and dispensaries do not need to respond to an alert from the medicines verification system if:

1. The batch has been released before February 9th 2019, AND
2. The cause of the alert is unknown product code OR missing batch information OR expiry date mismatch

However, with some exceptions, wholesalers must solve all alerts before these packs and batches can be moved to the warehouse.

In this context, it is particularly important for pharmaceutical companies to note that batches released after February 9th 2019 are not covered by the soft launch. All batches released after this date must include the safety features required by the Delegated Regulation 2016/161 and must be uploaded to the medicines verification system before release for distribution. Likewise, any alerts caused must be resolved.

End of the soft launch

The end of the soft launch is unlikely to cause a major increase of verification alerts for pharmacies, hospital pharmacies, or dispensaries. There are several reasons for this:

1. Pharmaceutical wholesalers, according to current information, will continue to voluntarily verify the new batches they receive.
2. Many batches covered by the soft launch will be sold out before the end of the soft launch.
3. In addition, alerts caused by non-serialized and / or products out of scope will be prevented in future by technical modifications to the FiMVS system.

The most significant change is in principle. That is, after January 31st 2020, all alerts in the medicines verification system must be resolved before the alerting pack can be dispensed to the patient. This requires that the end user's IT system clearly notifies if the pack alerts.

Currently, more than 60% of all alerts are due to the fact that the information content of the verification query sent by the end user IT system does not match the information encoded in the 2D barcode of the pack. The reason for the alert is either 1) Unknown serial number or 2) Serial number does not match batch number (batch number is invalid). Both alerts are such that the pack must not be dispensed until the cause of the alert has been determined. These alerts are not currently covered by the soft launch.

These alerts may be due to incorrect reading of the 2D barcode by the barcode scanner or accidental change of the serial number or batch number by the user after reading the barcode. The most common error is that the serial number or batch number is split and / or missing one or more characters. Another common error is that extra characters are added to the serial number or batch number, usually the EAN code or its prefix.

In many cases, the situation is corrected by re-reading the 2D barcode on the pack. If the system still gives the same alert, it is also possible to enter the pack information manually. If the information is correct and the system still alerts, the package should be put aside and the distributor / pharmaceutical company should be involved to clarify the situation.

Approximately 7.5% of the alerts are due to the fact that the pack has already been decommissioned. Often this is a case where the pack is decommissioned by the pharmacy at the time of purchase, but the customer does not take it after all and the process is not undone. The next time the pack is decommissioned, it will alert. In these situations, the process should first be undone. If the original process was performed in the same pharmacy less than 10 days ago, the pack will return to an active state in the FiMVS system and can be decommissioned again. If this does not work, the pack should be put aside. FiMVO should be contacted to determine the pack’s audit trail. If the report indicates a suspected falsification or product defect, FiMVO will notify the system user, the pharmaceutical company and Fimea.