Kommersiellt obunden läkemedelsinformation riktad till läkare och sjukvårdspersonal

Clarithromycin

Information

The information on persistence, bioaccumulation and toxicity in this summary information is based on previous environmental information on fass.se. Environmental information is missing (2020-11-04). 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.

Detailed information

Fass environmental information

Fass environmental information for Nexium HP (amoxicillin, esomeprazole, clarithromycin ) from AstraZeneca (downloaded 2015-09-07).

Hazard

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.

Risk

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.

Report Goodpoint

Clarithromycin is on the EU list of substances whose concentrations in surface water should be monitored in the Member States for environmental reasons.

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.

EU's groundwater monitoring and candidate list

Clarithromycin is on the EU's watchlist of substances whose concentrations in groundwater should be monitored in the Member States for environmental reasons.

Low concentrations of antibiotics

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.

The Wise list

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.

Suggestions on how to reduce the emissions of clarithromycin

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

  • Clarithromycin is recommended in the Wise list. Eradication of Helicobacter pylori only on strict indication.
  • For antibiotics, the general rule is as restrictive use as possible without risking the patient's health. Relevant diagnostics are important in order to choose antibiotics that have a good effect with as narrow spectrum as possible.

References

  1. Goodpoint. Prioritering av läkemedel med miljörisk inom SLL. Stockholm: Goodpoint; 2016. Rapport LS 2016–0634.
  2. Europeiska unionens officiella tidning. Kommissionens genomförandebeslut (EU) 2018/840 av den 5 juni 2018.
  3. 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.
  4. 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.
  5. Isidori M, Lavorgna M, Nardelli A, Pascarella L, Parrella A. Toxic and genotoxic evaluation of six antibiotics on non-target organisms. Sci Total Environ. 2005;346:87-98.
  6. 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.
  7. Sveriges geologiska undersökning (SGU). Nya ämnen att leta efter i grundvattnet. 15 januari 2020.
  8. 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.
  9. Provtagningar av läkemedelsrester i vatten, sediment och fisk för Region Stockholm.
  10. Region Stockholm. Förteckning över miljöbelastande läkemedel med åtgärdsförslag framtagen inom ramen för Region Stockholms miljöprogram 2017–2021.
  11. Fass.se för vårdpersonal
  12. Region Stockholms läkemedelskommitté. Kloka listan (the Wise list).
  13. Region Stockholm's Drug and Therapeutics Committee. The Wise list 2015.

Author: Health and Medical Care Administration, Region Stockholm