This summary information about persistence, bioaccumulation and toxicity comes from Fass. The information on risk comes from the report by Goodpoint.
Persistence. No data available, hence the potential for persistence of roxithromycin cannot be excluded due to lack of data.
Bioaccumulation. Roxithromycin has low potential for bioaccumulation.
Toxicity. Roxithromycin has very high acute toxicity.
Risk. See the report from Goodpoint.
Fass environmental information
Fass environmental information for Surlid (roxitromycin) from Sanofi AB (downloaded 2020-11-13).
Persistence: No data.
Bioaccumulation: "Log Kow = 2.75 at neutral pH (estimated with unknown method)."
Acute toxicity: There are data for 3 trophic levels, most sensitive Blue green algae (Anabaena flos-aquae) EC50 72h (growth rate) = 211 microg/L.
PEC/PNEC is based on sales data in Sweden in year 2018. PEC/PNEC = 0.0038 which gives the risk insignificant, i.e. consideration has not been given to measured levels in the environment.
Concentrations of roxithromycin in swedish wastewater treatment plants is likely to select for bacterial resistance. Can cooperate in the environment with other macrolide antibiotics, e.g. azithromycin, erythromycin and clarithromycin.
Roxithromycin is included in Region Stockholm's table of pharmaceuticals with risk for negative environmental impact according to the environmental program 2017–2021.
Low concentrations of antibiotics
Studies have shown that even low concentrations of antibiotics in the environment may trigger antibiotic resistance and therefore measures should be taken to ensure that as little as possible ends up in our environment.
Suggestions on how to reduce the emissions of roxithromycin
Concrete proposals on how to work to reduce emissions of environmentally harmful pharmaceuticals on the list have been developed in close cooperation with the Stockholm Drug and Therapeutics Committee's expert groups. The action proposals were developed from an environmental perspective. The patient's best always goes first and several pharmaceuticals on the list are also included in the Wise list. (The Wise list is the drug formulary of essential medicines for common diseases in Region Stockholm from the Drug and Therapeutics Committee.) However, for such pharmaceuticals, there may be measures that could reduce the environmental impact.
Concrete proposal for roxithromycin
- Roxithromycin is not recommended in the Wise list.
- For antibiotics, the general rule is as restrictive use as possible without risking the patient's health. Relevant cultivation is important in order to choose antibiotics that have a good effect with as narrow spectrum as possible.
- Fass.se för vårdpersonal
- 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. 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.
- Yang LH, Ying GG, Su HC, Stauber JL, Adams MS, Binet MT. Growth-inhibiting effects of 12 antibacterial agents and their mixtures on the freshwater microalga Pseudokirchneriella subcapitata. Environ Toxicol Chem. 2008;27:1201-8.
- Bengtsson-Palme J, Larsson DG. Concentrations of antibiotics predicted to select for resistant bacteria: Proposed limits for environmental regulation. Environ Int. 2016;86:140-9.
- Gullberg E, Cao S, Berg OG, Ilbäck C, Sandegren L, Hughes D et al. Selection of resistant bacteria at very low antibiotic concentrations. PLoS Pathog. 2011;7:e1002158.
- Provtagningar av läkemedelsrester i vatten, sediment och fisk för Region Stockholm.
- Region Stockholm. Förteckning över miljöbelastande läkemedel med åtgärdsförslag framtagen inom ramen för Region Stockholms miljöprogram 2017–2021.
Author: Health and Medical Care Administration, Region Stockholm