FiMVO Newsletter 2-2019

It works!

We have a month of official medicines verification behind us. Our first experience is that the system has worked well.

Patients have received their medication from pharmacies and the supply of medicine has not been compromised. This is thanks to all the Finnish supply chain stakeholders!

By working hard together for a common goal, we have been very successful in putting the system into operation.

The verification system is a huge project both in IT and administration both in Finland and in Europe. It’s like building a house, there’s always something to repair and develop.

We’ve had some challenges in the first few weeks, but together we’ve managed to solve them.

The supply chain, FiMVO included, gets to learn new procedures and ways of working. In this newsletter we’ve compiled some experiences for you and give tips on how to deal with different situations.

The FiMVO team is also happy to receive comments and feedback, so please be in touch.

 

A positive start and future system updates

Over the past four weeks, the EU Hub has been updated a few times. In doing this, EMVO’s purpose has been to ensure that all retrieval messages concerning the downloading of data by the OBP (On-boarding partner) pass back to the OBP without error. The OBP receives an acknowledgment for each download, whether the operation was successful or failed.

Arvato (= Finnish FiMVS system vendor) has also updated its software based on the first week's experience. All pharmacy software used was tested prior to implementation and all user organizations in the system are technically connected to the system.

The next major update from Arvato to the Finnish medicines verification system will be in June. Initially, it will only include a variety of non-urgent fixes to problems that have been detected either after implementation or in tests before implementation. The last software update of the year will be available in November 2019.
 

There are likely to be some updates that also require changes to either the pharmacy software or at least the interface with which the pharmacy system is connected to the Finnish system.

 

Findings and feedback on the use and operation of the FiMVS system

The number of system alerts is still quite high, which is why we do not automatically forward these alerts to Fimea. When the number has gone down to an acceptable level, we still start to forward them to Fimea as well.

The following alerts do not require attention from pharmacies during the soft launch unless there is reason to doubt a counterfeit medicine:

• Alerts from unknown product codes caused by non-EU serialized batches that look like serialized items but are not. In general, the product code (GTIN) for these items starts with 0890 or 1890, but not always.
• The batch data for some individual serialized batches have not yet been uploaded into the FiMVS system, which triggers an alert due to missing batch data.
• Alerts arising from batches where the 2D data matrix expiry date on the package differs from the information uploaded in the FiMVS system.

Alerts other than those mentioned above have so far been caused by either different technical malfunctions or user errors. The most common reason for user-based alerts has most probably been incorrect configuration of scanners. Typically, the scanner changes the uppercase letters in the serial number or batch number to lowercase letters or vice versa. There is a more detailed description further on in the newsletter.

 

Advice to users on possible problems

• When should a pack be verified?

A serialized pack has a 2D data matrix and the same information (product code, serial number, batch, expiry date) printed also in human readable form. If the pack does not have a 2D data matrix (or a serial number or anti-tampering device), it probably belongs to an older, non-serialized batch. A pharmacy may have older non-serialized packages in stock, even if the pharmaceutical company has already made a serialization notification for the product and there is already a new serialized batch in wholesaler’s stock. Non-serialized packs should not be manually verified, but should be dispensed “in the old way” without verification. With non-serialized packs the use of a manual verification causes unnecessary system alerts and also complicates the dispensing process.

• When should I use the manual verification function?

If a pack has a 2D data matrix, you should always scan it. Only if you cannot scan the 2D data matrix printed on the package, should you use the manual verification transaction, if necessary. If the reason for the scanning failure is poor printing quality or a smudged 2D data matrix and not, for example, a scanner malfunction, we also recommend reporting this to the marketing authorization holder.

• What causes the alert “Batch number does not match the serial number”?

If the serial number of the pack is found in the FiMVS system, but the batch number is incorrect, the system will raise the above alarm. The most common reason for this alarm is that the scanner used is not configured correctly and the batch number contains either uppercase or lowercase letters. An incorrectly configured scanner can change the uppercase letters of the batch number to lowercase and vice versa, causing an alert. Instructions for configuring scanners can be obtained from your pharmacy system provider. If no clear reason for the alert is found, we recommend contacting the distributor or the marketing authorization holder.

• What causes the alert ”Unknown serial number”?

There are several reasons for this. If the user attempts to manually verify a non-serialized pack and enters the correct product code but, for example, the batch number instead of the serial number, the system gives an alert for unknown serial number. In some cases, this may be due to incorrect configuration of the scanner (letters in the serial number) or another malfunction, for example it does not read the serial number completely or it also reads the first part of the linear barcode (EAN) after the serial number. In addition to the above, it is possible that batch data uploading to FiMVS has not been successful, and only some serial numbers have been successfully uploaded. If no clear reason for the alarm is found, we recommend contacting the distributor or the marketing authorization holder.

• If the system alerts as a result of a dispense transaction, should the transaction be undone?

Generally speaking no. If the system alerts when you dispense a pack, the state of the pack will not change in the system. It is therefore still active in the system. Also, undoing a transaction will not prevent or cancel the alert in the system. If you try to undo the transaction you will receive the alert ”Actual pack status doesn't match the undo transaction”, because the pack is still active in the system. However, this does not result in a system alarm. If you need to check the pack status in FiMVS, you should always use the Verify function.

• Why does the system report ”Re-setting of the property via double scan is registered”?

The same user has already dispensed the pack in the FiMVS system. This error does not result in a system alert. Only if the user attempts to dispense the same pack for a fourth time is an alert generated "Pack is already inactive". In this context, it is good to note that the user means the entire unit (pharmacy, hospital pharmacy etc.) so the pack may have been previously dispensed by another pharmacist in the same unit.

• I tried to undo a previous dispense transaction, why is there an alert?

There may be several reasons for this. If the original transaction was performed more than 10 days earlier, it can no longer be undone, and the system will announce "Defined timeframe between setting this property and the undo was exceeded". However, this does not trigger an alert if it is a pack intended for the Finnish market. It is also good to note that the undo transaction can only be performed by the same user (unit) that performed the original transaction. Therefore, if the pack has been dispensed at for example the main pharmacy, and an attempt is made to undo the transaction at the main pharmacy’s side pharmacy, the system will provide a notification "Undo can only be executed by the same user who previously set the attribute". This will not trigger an alert if it is a pack intended for the Finnish market. If the user inadvertently tries to undo the dispense transaction of a pack that has not been dispensed in the FiMVS system (i.e. the pack is active in the system), the system will issue the notification "Actual pack status doesn't match the undo transaction". You can always check the pack status in the FiMVS system by using the Verify transaction.

 

End users – expect email from us, a new contract round for end users!

The transition to the operating phase of our system requires an update of the agreement with FiMVO for end users. Even if you recently signed a contract with us, this new contract must be signed.

This time the contract will be signed electronically. End users will receive a link by email. This link will come to you in the next few days. If your organization doesn't receive any mail from us, please contact us!

This new contract is replacing our current contract, therefore in cases of a pharmacy change of ownership, the new owner must send FiMVO their Access Request Form, a copy of their Pharmacy License, and request the link to sign our operations phase contract.

 

MAH invoicing – ramp up fee invoice

Many of you have inquired after the invoice for the ramp up fee. This will be decided in the next few days and invoices will follow. Please inform us ASAP if you need a PO number on your invoice.