With a new regulation, the Spanish Medicines Agency (AEMPS) is aligning the package sizes of antibiotics with current treatment guidelines. The aim is to prevent resistance caused by self-medication with leftover antibiotics from previous prescriptions.
The Spanish Agency for Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios; AEMPS) has introduced a comprehensive resolution to adjust the package sizes of systemic antibiotics. The new regulation requires pharmaceutical companies to remove large packages of specific drugs, such as amoxicillin, cefuroxime, or fosfomycin, from the market and replace them with smaller package sizes tailored to the actual duration of treatment. The goal of the measure is to curb the development of antibiotic resistance and protect the environment from pharmaceutical residues.
The regulatory decision is based on recent scientific findings. Clinical studies increasingly show that a shorter course of treatment for many bacterial infections is just as effective as a longer course, while carrying a lower risk of developing antibiotic resistance. Many of the approved package sizes do not yet reflect these shortened dosing regimens. As a result, tablets regularly remain in patients’ households after treatment is completed. If these leftover medications are used for a subsequent infection without a doctor’s prescription, this promotes the development of resistant bacteria.
Smaller package sizes mean fewer antibiotic residues in households and in wastewater
“This measure by the Spanish authorities is a logical step,” explains Professor Thomas Gutsmann, spokesperson for the Leibniz INFECTIONS research network. “Unused antibiotics in private households pose two major risks: First, they encourage uncontrolled self-medication for subsequent illnesses or within the family, which accelerates the selection of resistant pathogens. Second, improper disposal leads to a direct burden on the environment.”
Antimicrobial resistance (AMR) is considered one of the greatest global threats to health. When active ingredients enter our ecosystems via wastewater, they exert selective pressure on environmental bacteria. Resistance genes can thus spread in nature and ultimately be transmitted back to humans or livestock through the food chain or direct contact.
The AEMPS resolution, developed in close collaboration with the Spanish National Plan Against Antibiotic Resistance (PRAN) and various scientific societies, addresses precisely this issue. By precisely controlling dispensing volumes, the goal is to minimize excess production at the source.
Further information
AEMPS-Resolution dated April 28, 2026 (in Spanisch)