Now things are getting serious: before the end of the year, authorities want to start checking false alarms in the Securpharm system themselves. ABDA has now updated its Securpharm website and FAQ catalog.Since February 2019, pharmacies have had to scan the data matrix code printed on an Rx package before dispensing it. Because this still results in too many false alarms, the authorities now want to crack down harder.
In the meantime, the alarm rate in the counterfeit protection system for pharmaceuticals has decreased, but it is still too high. According to the latest Securpharm status report, the rate for pharmacies and wholesalers in 2021 was 0.14 percent, with an average of 39 million transactions per week. That compares to 0.28 percent on 34 million transactions the previous year. However, the target for the pan-European alert rate is 0.05 percent, which equates to around 3500 alerts per day in this country. According to the ABDA, however, there are currently still just under 8000 alarms per day.
The cause of many alarms is often due to handling errors, incorrectly set scanners or incompletely uploaded package data. The PZ had already reported several times on the frequent sources of error. In the past two years, the authorities have been busy with other issues. But in the future, they will take a closer look at the responsible market participants. The fundamental right to do so is already enshrined in the Delegated Regulation of the EU Commission from 2015. Currently, it is already possible for the authorities to obtain information on alerts upon request at the Securpharm office. However, this query is still a multi-step process.
That will change this year: „It is expected that in 2022, along with the agreement on system use and legitimation, the other access requirements will also be completed,“ the status report now states quite specifically. In other words, the authorities themselves will get access to the system to query audit trails on their own. Last year, they had already asked the office for information in 445 cases.
In addition, the authorities will in future also be able to view reports on the monitoring of market participants and on pharmacovigilance and pharmacoepidemiology. These reports also exist in the other EU countries to track down violations of the anti-counterfeiting directive, among other things. This makes it possible to trace the actions of individual players. Securpharm is also currently working on linking the national alert systems via a standardized interface in order to standardize the processes internationally.
As a reminder, since February 9, 2019, pharmacies have been obliged to scan the data matrix code on the box before dispensing Rx preparations in order to check them for authenticity. The Europe-wide monitoring mechanism, which in this country is backed by the Securpharm organization, is intended to safeguard security in the legal trade in medicines.