Number of reported Counterfeits on the Rise

Recommendation

4/5 October 2023

The GDP Compliance Manager - Live Online Training

The Drug Commission of German Pharmacists ("Arzneimittelkommission der Deutschen Apotheker", AMK) has published data from the year 2017 on notifications on quality deficiencies and adverse (drug) reactions on the AMK website.

The AMK received more notifications from pharmacies in 2017 than ever before. The Berlin based office received a total of 9084 reports from 4816 different pharmacies (for comparison: in 2016, there were 8891 reports and in 2015, there were 8409 reports on quality deficiencies and adverse reactions in total).

About 96% of all notifications were related to medicinal products. The most common cause for complaint was suspected cases of quality deficiencies (70%), followed by galenic deficiencies, mechanical defects and declaration errors. There was a significant rise in reported suspicions of manipulation and counterfeits: the number rose to overall 57 notifications in 2017 (from 14 in the year before). This doesn't necessarily mean an increasing number of counterfeits. It does also show a greater awareness for the issue, however.

The AMK doesn't only receive notifications from pharmacies; it also informs them about measures for the prevention of drug risks. However, incidents concerning medical devices are no longer recorded by the AMK. The complete AMK figures as well as a fact report can be found on the AMK website (in German language).