securPharm false alarm reports occupy Federal Ministry of Health
In a few days, securPharm, the German organisation implementing the Falsified Medicines Directive (FMD), will be officially launched. False alarms are still expected, especially in the initial phase, but securPharm is nevertheless confident about the start.
A few days before the start date of securPharm, there are more and more reports about possible problems. Bündnis90/Die Grünen also joined in last week and asked the Federal Ministry of Health for a report. Kordula Schulz-Asche (Die Grünen), Spokeswoman for Nursing Policy, told tracekey: “We were concerned to hear the reports about frequent false reports from the securPharm system. Even though the supporting organisation of the system has now given the all-clear signal, we would like to ensure more transparency in the implementation of securPharm with the request for reports from the Federal Ministry of Health in the Health Committee.”
What happens in the event of an error message?
Current information is now available on the question of what happens if a drug cannot be verified in a pharmacy. If an error message is issued, this does not necessarily mean that you are holding a counterfeit in your hand. Just in the initial phase, it can still come to error messages, which have other backgrounds. Possible are, for example, operating errors such as a double write-off or a technical problem on the part of the manufacturer.
In addition, pharmacies were made aware that there are finished pharmaceutical packages in stock which carry precursors of the current safety features. They meet the FMD requirements only in part or not at all. They cannot therefore be verified using the securPharm system but may be issued to the patient if the pharmacy is satisfied that they are genuine and undamaged. In principle, stock goods without security features remain deliverable until their expiration date.
Medicine packs must be separated
If a drug carries the new security features, it is scanned and cannot be verified, this packaging may not be issued. The securPharm system then first searches for errors itself. In the event of an operating error, the pharmacy receives a message directly from the system so that it can correct the error itself. The medication must first be secured and stored separately from the dispensable medication, see also § 21 paragraph 5 of the Apothekenbetriebsordnung (ApBetrO).
In case of problems with the serial numbers, the pharmaceutical manufacturers receive an error message from the system. According to the current regulations, they then have seven days to clarify and solve the problem. If there is no all-clear within this period, securPharm reports the suspicion of forgery to the relevant authority (BfArM).