Pharmacies (covering hospital pharmacies and dispensaries) are gate keepers of the Medicines Verification System. Pharmacies are the last part of the supply chain before dispensing safe medicines to the patient. They effectively safeguard the public health medicine distribution.
How do pharmacies prevent falsifications from ending up with patients?
- They connect to the verification system through their existing software
- They verify the safety features on the medicine pack by scanning the 2D code – the unique identifier and tamper evidence – at the point of dispensing the medicine to the patient. The pack may be verified at any point, but the unique identifier may not be decommissioned from the verification system before the pack is being dispensed
The aim is that the unique identifier is always decommissioned from the repository system as close to the end user, the patient, as possible. Thus, the possibility of falsified medicines entering the legal supply chain can be minimized.
EU legislation enables hospital pharmacies to decommission the unique identifier already at the point of the medicine arriving 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 the medicine.
Alerts in the system
Alerts or error messages may occur in the drug verification system. These may be due, for example, to possible cases of falsified medicines or incomplete/incorrect information on medicinal products.
The cause of the alert must always be investigated before the pack is dispensed to the patient.
If the investigations shows that it was a false alert and there is no other reason to suspect a falsification, the pack may be dispensed to the customer.
Please note: The pack should not be returned to the wholesaler until the cause of the alert has been determined and/or the return has been agreed with the marketing authorisation holder.
FiMVO has established guidelines for dealing with the alerts. The guideline is available in Finnish, Swedish and English.
Technical issues and problems
Technical failures may occur in the operation of the verification system which impede or significantly slow down the operation of the system.
The disruption may occur as error messages from the pharmacy/hospital pharmacy/dispensary IT system.
In the event of disturbances
- Check if FiMVO or your IT system supplier has issued a bulletin about the incident.
- FiMVO provides information on possible large-scale and/or long-term incidents on its own website. IT system providers have their own information channels agreed with their clients
- If there is no information on the incident, primarily contact your IT system vendor's user support.
- In most pharmacy and wholesaler IT systems verification functions are buffered. This means that if there is a technical problem with the system, the medicine pack can still be verified and dispensed. The user's own IT system ensures that the information on the medicine pack is transferred as soon as the technical failure is over.
- The unique identifier information on the medicine pack is also marked in human readable format. To ensure the necessary medical treatment in the event of a disruption, it is possible to supply the medicines without verification. In this case the unique identifier information on the pack (product code, serial number, batch number, duration) must be recorded (in addition, it is a good idea to take a photograph of the packaging) and to verify the information on the medicine package as soon as possible