Pharmacies across Germany have reported an unprecedented number of medication-related incidents to the Drug Commission of German Pharmacists (AMK) in the past year, reflecting a significant increase in vigilance and reporting activity within the sector.

According to recent data, 4,978 community and hospital pharmacies submitted reports to the AMK. Of the 11,154 spontaneous notifications compiled, approximately two-thirds were related to quality defects in medicinal products, while one-third documented adverse drug reactions. Around 7% of the side effect notifications were associated with drug substitutions, indicating challenges that arise when switching between equivalent pharmaceuticals.

Rise in Medication Error Reports

The volume of medication error reports saw a marked increase compared to the previous year, rising from 348 to 624 cases. Notably, 535 of these reports involved actual or potential usage errors with the Mounjaro^® KwikPen^®. In contrast, notifications concerning suspected drug misuse saw a slight decline, dropping from 50 to 41 cases over the same period.

Most Common Quality Concerns

As in prior years, packaging errors remained the most frequently reported type of quality issue, followed by mechanical faults, formulation defects, and labeling inaccuracies. These findings underscore the persistent challenges in ensuring product integrity across the pharmaceutical supply chain.

Increased Reporting, Not Increased Risk

The AMK attributes the record number of incident reports primarily to an increase in reporting willingness among pharmacies rather than a surge in actual medication problems. Both the number of reported cases and participating pharmacies rose, with an additional 272 cases and 21 more pharmacies compared to the previous year.

Since a low point in 2022, reports to the AMK have shown a steady upward trend, growing from 8,320 in 2023 to 10,882 in 2024, and reaching 11,154 most recently.

Continuous Communication and Safety Efforts

The AMK plays a central role in evaluating and disseminating risk information to pharmacies. In the past year, the commission issued 263 risk communications, including 23 prominent warning and information letters, as well as over 150 batch-specific recalls and investigations. This ongoing exchange ensures that pharmacists are kept informed of emerging risks and can promptly respond to safety concerns.

Pharmacists are recognized for their expertise in identifying quality issues, detecting potential usage errors, and advising on the tolerability of medication therapies. Their active participation in the reporting system is considered essential for safeguarding patient health.

The AMK encourages all pharmacy professionals to continue reporting suspected side effects and quality defects, preferably through the official online portal, to maintain and enhance medication safety standards across the country.