The Spanish Agency for Medicines and Health Products (AEMPS) has announced an important rearrangement of the formats of antibiotics available on the market with the aim of promoting a more responsible use and reduce the risk of self-medication and bacterial resistance.
Over the next year, Spain will withdraw seven presentations of large antibioticsincluding some of amoxicillin, amoxicillin with clavulanic acid, fosfomycin or cefuroxime, which include more units than necessary for most common treatments. At the same time, they will incorporate four new smaller formats adapted to current clinical guidelines.
Specifically, amoxicillin presentations of 30 units of 1000, 750, 500 and 250 mg will be eliminated; amoxicillin clavulanate of 30 units of 875/125, 500/125 and 250/62.5 mg and 100-12.5 mg/mL; phenoxymethylpenicillin 40 units of 500 mg; cloxacillin 40 units of 500 mg; cefuroxime 20 units of 500 and 250 mg; cefixime, 21 units of 200 mg; and fosfomycin, 2 units of 3 g and 12 units of 500 mg.
For its part, new, tighter formats will be incorporated: 20 units of amoxicillin 250; phenoxymethylpenicillin 160 mL; and 20 units of amoxicillin clavulanate 500/125 mg and 250/62.5 mg.
According to the AEMPS, between 35% and 40% of prescriptions currently include more doses than requireds, which makes it easier for patients to keep leftover tablets and reuse them without medical supervision, thus increasing the risk of bacterial resistance.
3,000 deaths a year in Spain due to bacterial resistance
The National Plan against Antibiotic Resistance (PRAN) highlights that this change responds mainly to public health criteria. Every year, infections due to resistant bacteria cause around 33,000 deaths in Europe, about 3,000 in Spain.
In addition to the health impact, the measure also has a environmental component, as it will prevent these surpluses from ending up in the trash or the drain.
The transition will be carried out progressively over a year and will not affect treatments already available in pharmacies. The AEMPS is also working on updating prescription systems to automatically adjust packaging to the duration of treatments.
Health authorities insist that the objective is to maintain the effectiveness of treatments and guarantee patient safety, while promoting a more rational use of antibiotics.