The wholesalers, pharmacies and hospital professionals, play a vital role in ensuring that falsified medicines do not reach patients in Denmark. One of the most effective ways to prevent falsifications is by verifying medicine and handling system-generated alerts according to the established guidelines.

Together with wholesalers, pharmacies and hospitals, DMVO supports valuable work in protecting medication safety across Europe.

How do wholesalers prevent falsifications from ending up with patients?

A wholesaler must verify the authenticity of medicines using a risk-based approach. This means the wholesaler must verify the unique identifier of at least:

• Products that are returned to them  by pharmacies, hospitals or other wholesalers
• Prescription medicines that are not received directly from either the manufacturer, the marketing authorisation holder or a designated wholesaler. As a wholesaler you must, therefore, have access to the Danish medicine verification system, DMVS.

In addition, DMVO recommends verifying at least one pack per  batch received before distribution. This  significantly reduces the risk of false alerts in pharmacies and hospitals across the country.

More information on wholesaler responsibilities  can be found in the European regulation on falsified medicines here.

How do Pharmacies and Hospitals prevent falsifications from ending up with patients?

Pharmacies and hospital pharmacies must verify each pack before it is dispensed.

• System Connection: Pharmacies and hospitals connect to the medicine verification system through their existing software.
• Verification Process: At the point of dispensing, the 2D barcode on the medicine pack is scanned and the anti-tampering device is checked. While verification can occur at any time, the unique identifier must not be decommissioned until the medicine is dispensed.
• EU legislation allows hospital pharmacies to decommission the unique identifier at the point of receipt at the hospital pharmacy. Best practices regarding the time of decommissioning will depend largely on the hospital pharmacy’s stock management and the also the type of medicine.
• Best Practice: The aim is to decommission the unique identifier, in the verification system, as close to the patient as possible. This minimizes the risk of falsified medicines reaching patients.

Alerts

Alerts or error messages may appear in the verification system due to suspected falsifications or incorrect product data.

• Before Dispensing: Always investigate the cause of an alert before giving the medicine to the patient or distributing to the wards medication rooms.
• False Alerts: If the alert is confirmed to be false and there is no suspicion of falsification, the investigation findings are documented and the medicine may be dispensed.
• Returns: Do not return the pack to the wholesaler until the alert cause is clarified or the return is approved by the marketing authorisation holder.