The information on persistence, bioaccumulation and toxicity in this summary information is based on previous environmental information on fass.se. Environmental information is missing (2021-08-16). It is voluntary for manufacturers to provide information on environmental impact on fass.se. The risk comes from the report by Goodpoint.
Persistence. Clarithromycin is potentially persistent.
Bioaccumulation. Clarithromycin has low potential for bioaccumulation.
Toxicity. Clarithromycin has very high acute toxicity.
Risk. See the report by Goodpoint.
Fass environmental information for Nexium HP (amoxicillin, esomeprazole, clarithromycin ) from AstraZeneca (downloaded 2015-09-07).
Persistence: Percentage Biodegradation OECD 301D test substance concentration 0.003 mg/L, time 28 days and resultat 0 % ThOD (Theoretical oxygen demand). Test substance concentration 2.43 mg/L, time 28 days and resultat 0 % ThOD. "Based on the data above (considering that no other data is available), the phrase ‘Clarithromycin is potentially persistent ’ is chosen."
Bioaccumulation: Log P = 3.16. "Clarithromycin has low potential for bioaccumulation."
Toxicity: There are data for 3 trophic levels, most sensitive green algae (Pseudokirchne riella subcapitata) EC50 = 0.002 mg/L. However, studies on blue-green algae according to CHMP guidelines are lacking.
PEC/PNEC is based on sales data in Sweden in year 2011. PEC/PNEC = 0.75 which gives the risk low.
In selection of algae for toxicity testing of antimicrobials the European Medicines Agency, EMA, recommends test on blue-green algae (cyanobacteria). No information on toxicity on blue-green algae has been found, which means that a calculation of environmental risk becomes uncertain.
Clarithromycin has previously been monitored within the framework of EU water legislation. There is now enough data to assess whether clarithromycin is to be proposed as a priority substance when the European parliament and the Council next time proposes a revised directive regarding priority substances in the field of water policy.
Clarithromycin is on the EU's watchlist of substances whose concentrations in groundwater should be monitored in the Member States for environmental reasons.
Studies have shown that even low concentrations of antibiotics in the environment may contribute to antibiotic resistance and therefore measures should be taken to ensure that as little as possible ends up in our environment.
Concentrations in Swedish wastewater treatment plants are at risk of selecting antibiotic resistance. May interact in the environment with other macrolide antiobiotics, such as azithromycin, erythromycin and roxithromycin.
Clarithromycin is included in Region Stockholm's table of pharmaceuticals with risk for negative environmental impact according to the environmental program 2017–2021. This also takes into account the risk of antibiotic resistance selection and environmental interaction between other macrolide antibiotics. Clarithromycin has been detected in treated wastewater in Region Stockholm.
Clarithromycin is recommended 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.) Environmental classification of pharmaceuticals is taken into consideration, sometimes with other environmental aspects, when selecting pharmaceuticals for the Wise list. When comparable pharmaceuticals are equivalent to medical effects, safety and pharmaceutical efficacy, environmental impact and price are considered.
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. However, for such pharmaceuticals, there may be measures that could reduce the environmental impact.
Concrete proposal for clarithromycin
Author: Health and Medical Care Administration, Region Stockholm