Only Ofloxacin mibe eye drops has marketing authorisation in Sweden, but the medinal product is not currently available according to Fass.se (2022-11-16). There is no environmental information on Fass.se.
Ofloxacin is included on the watch list of substances for Union-wide monitoring in the field of water policy pursuant to Directive 2008/105/EC of the European Parliament and of the Council.
Ofloxacin is a racemate. One of the enantiomers is levofloxacin (S-enantiomer). Therefore, see also environmental information for levofloxacin.
Ofloxacin is a racemate. One of the enantiomers is levofloxacin (S-enantiomer). Therefore, see also environmental information for levofloxacin. In analyzes of ofloxacin in water both ofloxacin and levofloxacin are measured.
Pharmaceuticals residues in the aquatic environment in Region Stockholm
Previously, there was some risk for the selection of antibiotic resistant bacteria in wastewater treatment plants, but sales in Region Stockholm (Sweden) have fallen sharply in recent years, and so the levels in wastewater have also decreased. At present only a medicinal product (eye drops) with ofloxacin has marketing authorisation.
Studies have shown that even low concentrations of antibiotics in the environment may trigger antibiotic resistance and should therefore be taken to ensure that as little as possible end up in our environment.
EU water legislation
"During 2021, the Commission gathered data on a range of other substances that could be included in the watch list. It took into account the different types of relevant information referred to in Article 8b(1) of Directive 2008/105/EC, and consulted experts from Member States and stakeholder groups. Substances for which doubt exists about their toxicity, or for which the sensitivity, reliability or comparability of the available monitoring methods are not adequate, should not be included in the watch list. The fungicide azoxystrobin, the herbicide diflufenican, the insecticide and veterinary pharmaceutical fipronil, the antibiotics clindamycin and ofloxacin, the human pharmaceutical metformin and its metabolite guanylurea, and a group of three sunscreen agents (butyl methoxydibenzoylmethane, also known as avobenzone; octocrylene; and benzophenone-3, also known as oxybenzone) were identified as suitable candidates. The addition of the pharmaceuticals is consistent with the EU Strategic Approach to Pharmaceuticals in the Environment (6), and the inclusion of the two antibiotics is also consistent with the European One Health Action Plan against Antimicrobial Resistance (AMR) (7), which supports the use of the watch list to ‘improve knowledge of the occurrence and spread of antimicrobials in the environment’."
- Goodpoint. Prioritering av läkemedel med miljörisk inom SLL. Stockholm: Goodpoint; 2016. Rapport LS 2016–0634.
- IVL Swedish Environmental Research Institute Ltd. Fick J, Lindberg RH, Kaj L, Brorström-Lundén E. Results from the Swedish National Screening Programme 2010. Subreport 3, B 2014 Pharmaceuticals.
- IVL Swedish Environmental Research Institute Ltd Fick J, Lindberg RH, Fång J, Magnér J, Kaj L, Brorström-Lundén E. Screening 2014. Analysis of pharmaceuticals and hormones in samples from WWTPs and receiving waters. Rapport C 135.
- Official Journal of the European Union. Commission implementing decision (EU) 2022/1307 of 22 July 2022.
Author: Health and Medical Care Administration, Region Stockholm