AMK Received Over 8,800 Reports on Drug Quality Issues and Side Effects in 2014

The German Association of Pharmacists' Commission (AMK) reported a total of 8,832 spontaneous reports concerning quality deficiencies and adverse effects of pharmaceuticals in 2014. This figure exceeded the previous record from 2012 by 373 reports.

The reports primarily concerned medicinal products, with 6,251 relating to prescription drugs and 1,824 to over-the-counter (OTC) medications. Additionally, 399 reports involved medical devices, and others pertained to product categories like dietetics and food supplements.

The proportion of reports on adverse effects increased to 30 percent compared to the previous year. Among these, 300 reports were related to severe adverse drug reactions (ADRs), and 229 were linked to drug substitutions. Reports concerning medication errors significantly decreased to 107, down from 235 in the prior year.

The most frequent quality deficiencies reported were packaging errors, followed by formulation defects, mechanical issues, and declaration errors. Reports of drug tampering or counterfeiting saw a decline.

In 2014, AMK processed 192 batch recalls and 44 other product recalls. Only 7 percent of AMK's total submissions underwent analysis at the Central Laboratory of German Pharmacists, with 26.5 percent of those analyses confirming the reported issues.