Kommersiellt obunden läkemedelsinformation riktad till läkare och sjukvårdspersonal

Azithromycin

Information

Environmental information for azithromycin is missing on fass.se (2020-10-12). It is voluntary for manufacturers to provide information about environmental impact on fass.se. This summary information on persistence, bioaccumulation and toxicity is based on previous environmental information in Fass from 2011. For risk, see the environmental assessment from Goodpoint.

Persistence. Azithromycin is slowly degraded in the environment.
Bioaccumulation. Azithromycin has no potential to bioaccumulate.
Toxicity. Azithromycin has a very high acute toxicity.
Risk. See the environmental assessment from Goodpoint below.

Detailed information

Fass environmental information

Fass environmental information for Azitromax (azithromycin) from Pfizer (downloaded 2011-03-09).

Hazard

Persistence: "Ready Biodegradation: None after 28 days (OECD 301D). Sediment binding: 74,2–96,3 % sediment bound azithromycin was solvent non-extractable in an OECD 308 study. This means that a minimum of 74,2 % of the substance volume cannot be stripped from sediment using solvent, it will not release in water, and hence not be bioavailable."

Bioaccumulation: Log Kow at pH 7.0 = 0.534 (FDA TAD 3.02).

Toxicity: There are data for 3 trophic levels, most sensitive blue-green algae EC50 0.94 microg/L.

Risk

PEC/PNEC is based on sales data in Sweden in year 2008.
PEC/PNEC = 0.28 which gives the risk low.

Report Goodpoint 2016 and pharmaceuticals residues in the aquatic environment

Azithromycin is on the EU list of substances whose concentrations in surface water should be monitored in the Member States for environmental reasons. May interact in the environment with other macrolide antiobiotics, such as clarithromycin, erythromycin and roxithromycin.

Has been found in Swedish waste water treatment plants in concentrations that might select for antibiotic resistance.

Azithromycin is included in Region Stockholm's table of pharmaceuticals with risk for negative environmental impact according to the environmental programme 2017–2021.

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.

The Wise list

Azithromycin is recommended in the Wise list. 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 emissions of azithromycin

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 azithromycin

  • Azithromycin is recommended in the Wise list for the treatment of Mycoplasma genitalium.
  • 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.

References

  1. Europeiska unionens officiella tidning. Kommissionens genomförandebeslut (EU) 2018/840 av den 5 juni 2018.
  2. European Medicines Agency, EMA: Committee for Medicinal Products for Human Use (CHMP). Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use. 1 June 2006.
  3. Goodpoint. Prioritering av läkemedel med miljörisk inom SLL. Stockholm: Goodpoint; 2016. Rapport LS 2016–0634.
  4. 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.
  5. 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.
  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. 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.
  8. Region Stockholm. Förteckning över miljöbelastande läkemedel med åtgärdsförslag framtagen inom ramen för Region Stockholms miljöprogram 2017–2021.
  9. Fass.se för vårdpersonal
  10. Stockholm Drug and Therapeutics committee. Kloka listan (Wise list).
  11. Stockholm Drug and Therapeutics committee. The Wise List 2015.

Author: Health and Medical Care Administration, Region Stockholm