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e-VIS recommendations for handling warnings and alerts from SMVS

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This is a translation of the basic principles Swedish recommendations for handling exceptions and alerts. Translation for information purposes only, the Swedish version prevails

Target group and purpose

Target group

These recommendations are intended for end users of the system (pharmacies, hospital pharmacies, wholesalers and healthcare providers) as well as MAHs, so that each organization in the supply chain can build procedures, instructions and training materials based on these recommendations.

The recommendations have been developed by e-VIS, in cooperation with the Swedish industry associations for pharmacies, wholesalers and pharmaceutical companies.

Purpose of the recommendations

The recommendations are a basis for each organization in the supply chain to use when developing its processes and procedures, instructions and training materials.

The recommendations have been developed to:

  • Ensure that possible falsifications are investigated as quickly as possible so that falsified medicines cannot enter the legal supply chain or reach patients.
  • Ensure that pharmacies and distributors handle and communicate alerts in the same way.
  • Ensure that local representatives in Sweden (pharmaceutical companies) are quickly informed about problems with packs, can take action and provide feedback on why an alert occurred.
  • Avoid different interpretations that lead to uncertainty, extra administration and long lead times.
  • Reduce the risk of medicine shortages.
  • Prevent patients from being affected by long waiting times when pharmacies are unable to meet their supply obligations.

Conditions for the recommendations

  • Warnings and alerts from SMVS must be displayed to the end user and must clearly prevent packs that cannot be found or cannot be decommissioned in SMVS from being supplied to patients or distributed further.
  • Packs with complete 2D code must be uploaded to SMVS in order to be supplied.[AL1] [LM2] 
    All stakeholders are responsible for balancing the risk of shortages and patient risks against their own interests and priorities.
  • If the MAH delays communication and upload, pharmacies may be left without saleable stock, which may ultimately lead to entire batches being returned and may cause shortages.
  • The MAH should work proactively to ensure that packs are uploaded to the EU-Hub.
  • Alerts and warnings caused by handling errors at the end user should be prevented and corrected by the end user.
  • Even if a medicine is not considered to be falsified, it is a quality defect in the pack if the information in the 2D code, the information printed on the pack and the information in SMVS do not match. If a pack has quality defects that create alerts in SMVS, the pack may be distributed further provided that an approved exemption from the Swedish Medical Products Agency exists for the defect and that pharmacies and other affected parties are informed about the exemption.
  • The joint work with SMVS is based on openness and understanding between the parties. If deviations occur in another party’s handling, we all understand the importance of informing other parties in the supply chain about the deviations that have occurred, to prevent errors and deviations from recurring.

Scanning and verification of the 2D code must be performed correctly

For the recommendations to work, the end user must ensure that the 2D code is read correctly and that requests to SMVS are made in accordance with applicable specifications and requirements. This means, for example, that:

  • The scanner and system support can correctly separate the four (or more) elements in the 2D code.
  • The scanner and system support read and send the information in the 2D code exactly as stated, without changing special characters, and report lower-case and upper-case letters correctly.
  • The system support indicates in the request to SMVS whether the 2D code was read by scanner or whether the check was performed by manually entering the values printed on the pack.

e-VIS provides test codes that can be used to check that the end user’s scanner equipment can read the 2D code correctly.

Basic principles for investigating and handling packs that generate warnings and alerts from SMVS

  • If a pack cannot be verified as active and cannot be decommissioned at the time of supply, the pack must not be supplied and must be placed in quarantine and investigated.
  • The purpose of investigating warnings and alerts is to ensure that a technical or process-related cause can be identified at the end user or at the pharmaceutical company, and thereby to ensure that the case does not concern a possible falsification.

An error in EMVS can be:

  • That the pack does not have complete or correct safety features
  • That a pack cannot be found in EMVS
  • That a pack in available stock in the medicines supply chain has already been decommissioned.

1. End user investigation and handling of the pack

1.1 Keep the pack in quarantine in a protected manner together with any alert ID or other case information.

  • Packs that cause alerts or have an incorrect status must not be supplied. The pack must be treated as non-saleable (unfit for supply) until the error has been corrected.
  • Protected manner: if there is a possible falsification, the pack is evidence. For example, store the pack in a plastic bag and label the bag with the alert ID or a description of the warning caused by the pack.

1.1.1 Packs that cause warnings and alerts in SMVS may only be supplied after:
  • Scanner errors have been identified and corrected. If a scanner error is the cause, decommissioning may be performed by entering the serial number, batch number and product code manually before the scanner error has been corrected.
  • Data errors have been corrected by the MAH, or an exemption has been approved by the Swedish Medical Products Agency.
  • It has been confirmed that the incorrect status is due to the end user’s own handling and that the medicine has been reactivated, provided that the end user has confirmed that the medicine is otherwise fit for supply.

Packs that do not meet the requirements of the Delegated Regulation on safety features must not remain in the supply chain.

1.2 The end user checks whether the warning is due to the end user’s own handling

  • Warnings in SMVS may occur due to the end user’s own handling. Such warnings or alerts do not need to be reported to the MAH, but they must be documented by the end user.
  • If the warning has generated an alert, e-VIS must be informed of the cause of the alert. The documentation is completed by the end user in the e-VIS alert portal, NMVS Alerts.
  • If the error is not due to the end user’s handling, the pack must be reported to the MAH or the MAH’s local representative.

1.2.1 If the cause is due to the end user’s own handling

If the warning is due to the end user’s own handling, the pack does not need to be reported through the complaint reporting channels.

Inform e-VIS of the cause of the warning when an alert has been generated

If the warning has generated an alert, e-VIS must be informed of the cause of the alert. The documentation is completed by the end user in the e-VIS alert portal, NMVS Alerts.

  • Confirm that the cause of the alert is on the end user’s side (Root Cause On My Side).
  • Briefly describe the cause of the alert.
  • Handle the pack according to current procedures.

Feedback on the cause in NMVS Alerts must be provided as soon as possible, and no later than within 2 working days.

Correct and address errors in processes and end user systems

If there are deficiencies in the end user’s system support, for example incorrect reading of the 2D code, this must be handled as a deviation in the end user’s quality system/self-inspection program so that the errors can be followed up and corrected.

1.2.2 Packs with errors in EMVS must be reported to the MAH or the MAH’s local representative

If the end user cannot see that the alert is due to their own handling, the pack is a possible falsification and must be reported to the MAH or the MAH’s local representative.

Reporting must follow the agreed process through the existing complaint reporting channels. e-VIS recommends using reklameraläkemedel.se for reporting possible falsifications.

Copy alerts@e-vis.se if a channel other than the complaint forms is used. e-VIS needs to be informed that the warning does not concern a possible falsification.

Reporting to the MAH must be done as soon as possible, and no later than within 2 working days.

A report to the MAH should include at least the following information:
  • Product code and which medicine the report concerns.
  • Alert ID – must always be provided when reporting if one has been created.
  • Serial number if no alert ID is available or if no alert has been generated. If both the alert ID and serial number are missing, the investigation cannot be performed.
  • Which warning was generated from the e-verification database and what happened. Please also describe whether the patient’s need could be met with another pack.

The end user needs to respond to any questions or requests for clarification from the MAH or the MAH’s local representative.

2 MAH investigation of alerts and reported packs

The MAH investigates and provides feedback on the investigation through two processes:

  • Investigation of alerts from EMVS
  • Investigation of reported packs together with the end user

2.1 MAH investigation of alerts from EMVS

2.1.1 According to EMVO Best Practice on Alert Handling, the MAH must investigate:
  • All A2 and A3 alerts for their products.
  • A7, A24, A52 and A68 alerts if:
    • The alerts were caused by MAH’s transactions in EMVS.
    • The end user or e-VIS has requested support from the MAH in the investigation, i.e. if the end user has reported the pack that generated the alert through the complaint channels.

When the alerts have been generated by Swedish end users, feedback on the investigation must be provided to e-VIS within 2 working days.

  • e-VIS recommends that MAHs provide feedback on their investigation through eAMS.
  • The priority information in the MAH’s alert investigation is whether a cause can be found on the MAH’s side or not.
  • Investigation of A2 and A3 alerts as described above must be carried out regardless of whether the end user has reported the pack or not.

2.2 MAH investigates reported packs together with the end user

  • When end users and MAHs provide feedback and communicate about reported packs with errors in EMVS, e-VIS asks that alerts@e-vis.se is copied. e-VIS needs to be informed that the cause of the warning/alert has been identified so that falsification can be ruled out.
  • When providing feedback to the end user, the language and wording should be easy for the end user to understand.

Feedback to the end user, with e-VIS copied, must be provided within 2 working days. If the MAH cannot confirm whether a cause exists on its side after two days, the MAH must send a status update to the end user within 2 working days.

2.2.1 Internal investigation at the MAH

The MAH must investigate whether the alert was caused by a data error or a process error on its side. Since MAHs use different systems and processes, each MAH will need to develop its own procedure for how this step should be carried out. Examples of errors that may be identified at this stage include:

  • Incorrect product master data uploaded for a product
  • A batch has been placed on the market before the packs in the batch were uploaded
  • Packs have been placed on the market where an incorrect batch ID or expiry date has been uploaded.
  • An individual serial number that was rejected on the production line has mistakenly been returned to the batch.
  • Repeated decommissioning of a pack or batch while it is still under the MAH’s control.
  • Two or more packs have been manufactured with the same serial number/unique identifier.

2.2.2 Request support from e-VIS

If the MAH cannot find a cause on its side or does not know how the investigation should continue, the MAH needs to request support from e-VIS.

This is especially important if the report concerns a pack that has already been decommissioned, as e-VIS usually needs to support the end user and the MAH in investigating where the serial number was previously decommissioned.

2.2.3 Request a photo of the pack

The MAH may ask the end user for a photo of the pack in order to quickly:

  • Check whether falsification can be ruled out based on the photos.
  • Check whether the 2D code is correctly printed and formatted.

2.2.4 Request the pack for analysis

If falsification cannot be ruled out after the internal investigation and after checking the photos, the pack must be requested for analysis by the MAH.

2.2.5 Information when providing feedback to the end user and e-VIS

When the MAH responds to a pharmacy, wholesaler or healthcare provider that has reported a pack as a possible falsification, the following information is prioritized and must be provided as soon as possible, and no later than within 2 working days.

1. Whether a cause of the error/warning can be found on the MAH’s side

  • If a cause can be found on the MAH’s side, the warning no longer indicates a possible falsification.
  • The actual cause and corrective actions only need to be sent to the reporter if the reporter explicitly requests this. Feedback must be provided as soon as the MAH has identified that a cause can be found on the MAH’s side.

2. If the cause can be found on the MAH’s side, state whether the error can be corrected or not.

3 If the error cannot be corrected, inform the reporter how the non-saleable pack should be handled. Instruct the reporter to either:

  • Discard the pack
  • Return the pack to the supplying wholesaler
  • Send the pack to the MAH

Please note that a pharmacy, wholesaler or healthcare provider may only supply medicines or distribute them further if they can decommission them in the e-verification database. If the error cannot be corrected, the pack may only be supplied if an excemption has been approved by the Swedish Medical Products Agency for the specific batch and the specific defect.