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Erythromycin

Information

This summary information comes from Fass 2015 and the risk is from the report from Goodpoint.

Persistence. Erythromycin is potentially persistent.
Bioaccumulation. Erythromycin has low potential for bioaccumulation.
Toxicity. Erythromycin has very high acute toxicity. However, studies on blue-green algae (Cyanophyta) according to CHMP guidelines are lacking.
Risk. See below.

Detailed information

Fass environmental information 2020-10-20

Fass environmental information for Abboticin Novum (erythromycin) from Amdipharm (downloaded 2020-10-20).

Hazard

Persistence: No data.

Bioaccumulation: No data.

Toxicity: No data.

Risk

PEC = 0.055558 microg/L. The environmental risk could not be calculated since ecotoxicity data are missing.

The manufacturer, Amdipharm, has on fass.se (2020-10-20) stated that data about the environmental impact is missing for the substance so that the environmental risk cannot be calculated. It is voluntary for manufacturers to provide information on the environmental impact on fass.se.

Fass environmental information 2015-09-07

Fass environmental information for Ery-Max (erythromycin) from Meda (downloaded 2015-09-07).

Hazard

Persistence: "Erythromycin did not pass the criteria for readily biodegradability. Closed Bottle Test (OECD 301D) resulted in <60% degradation in 28 days. Erythromycin did not pass the criteria for ready biodegradability, which justifies the phrase “Erythromycin is potentially persistent”."

Bioaccumulation: "Log Kow of 3.06 (unknown method)."

Toxicity: There are data for 3 trophic levels, most sensitive green algae (Selenastrum capricornutum) "NOEC 72h (growth inhibition): 0.0103 mg/L (OECD 201)". However, studies on blue-green algae (Cyanophyta) according to CHMP guidelines are lacking.

Risk

PEC/PNEC is based on sales data in Sweden during 2018 (Fass environmental information above from Amdipharm. PEC = 0.055558 microg/L). "PNEC is calculated as lowest NOEC (Algae)/AF = 0.0103 (mg/L)/100" which gives the value 0,103 microg/L. "Chronic NOEC data for the most sensitive species justifies an assessment factor (AF) of 100 according to ECHA guideline." According to ECHA guidelines, AF 100 can be used if there are long-term EC10 or NOEC values ​​for either fish or crustaceans. Such data have not been found. Based on AF 100, PEC/PNEC = 0.539, which gives the risk low.

If AF 1000 is used (at least one value for L(E)C50 from the three trophic levels: algae, crustaceans and fish), PEC/PNEC = 5.39, which gives the risk moderate.

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

Erythromycin is on the EU's list of substances for which concentrations in surface water should be monitored in the Member States for environmental reasons. There is a risk of selection for antibiotic resistance with the concentrations measured in Swedish wastewater treatment plants.

Erythromycin is included in Region Stockholm's table of pharmaceuticals with risk for negative environmental impact according to the environmental programme 2017–2021. Erythromycin has been detected in treated wastewater in Region Stockholm.

EU's groundwater monitoring and candidate list

Erythromycin 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 trigger antibiotic resistance and therefore, as little as possible should end up in our environment.

The Wise list

Erythromycin 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 the emissions of erythromycin

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 erythromycin

  • Eryhtromycin is 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.

References

  1. Fass för vårdpersonal.
  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. Europeiska unionens officiella tidning. Kommissionens genomförandebeslut (EU) 2018/840 av den 5 juni 2018.
  5. 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.
  6. 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.
  7. 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.
  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. Sveriges geologiska undersökning (SGU). Nya ämnen att leta efter i grundvattnet. 15 januari 2020.
  10. Provtagningar av läkemedelsrester i vatten, sediment och fisk för Region Stockholm.
  11. Region Stockholm. Förteckning över miljöbelastande läkemedel med åtgärdsförslag framtagen inom ramen för Region Stockholms miljöprogram 2017–2021.
  12. Region Stockholm's Drug and Therapeutics Committee. Kloka listan (Wise list).
  13. Region Stockholm's Drug and Therapeutics Committee. The Wise list 2015.

Author: Health and Medical Care Administration, Region Stockholm