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Ethinylestradiol

Hazard 9 P 3 B 3 T 3 Risk See below

Information

Ethinylestradiol is on the EU list of substances whose concentrations in surface waters should be monitored in the Member States for environmental reasons. Estimated levels in Swedish waters are in some cases sufficiently high to affect reproduction and gender development in fish.

Ethinylestradiol is included in the Stockholm County Council's table of pharmaceuticals with a negative environmental impact according to the environmental programme 2017–2021 based on lowest effect concentration, LOEC = 0.32 nanog/L, and concentrations found in treated wastewater.

The environmental risk of ethinyl estradiol is higher than for estradiol. Compared with estradiol, ethinyl estradiol is less degraded in the body, in wastewater treatmentplants and in the environment, and ethinyl estradiol is also more potent in fish.

Ethinylestradiol 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.

When using combination preparations with estrogen and gestagen, the gestagen component must also be considered. In particular, levonogestrel stands out as a drug with increased environmental risk. Environmental risk assessment is therefore relevant for both the gestagen and the estrogenic component.

In total, levonorgestrel + ethinylestradiol and etonogestrel + ethinylestradiol are considered to be the highest environmental risk, drospirenone + ethinylestradiol lower risk (based on gestagen component) and nomegestrol and estradiol lowest risk (based primarily on the gestagen component but also the estrogen component).

Suggestions on how to reduce the release of ethinylestradiol

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 advice. 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 ethinylestradiol

  • Ethinylestradiol (combined contraceptives) is recommended in the Wise list.
  • Individual adjustment of  contraceptives is important  in order to optimize treatment and avoid side effects.
  • Ensure that you, in your own business, discard leftover pharmaceuticals and used rings and patches correctly.
  • Inform the patient about the importance of discarding leftover pharmaceuticals, as well as used P-rings and patches, correctly.
  • Order the folder for patients "Protect the Environment – Throw in the Right Way".

The risk classification high, according to Fass.se, is based on total sold amount (kg) of the substance in Sweden during the year 2011 and the toxicity of the substance.

References

  1. Europeiska unionens officiella tidning. Kommissionens genomförandebeslut (EU) 2018/840 av den 5 juni 2018.
  2. Goodpoint. Prioritering av läkemedel med miljörisk inom SLL. Stockholm: Goodpoint; 2016. Rapport LS 2016–0634.
  3. Parrott JL, Blunt BR. Life-cycle exposure of fathead minnows (Pimephales promelas) to an ethinylestradiol concentration below 1 ng/L reduces egg fertilization success and demasculinizes males. Environ Toxicol. 2005;20:131-41.
  4. D.G.J Larsson, M Adolfsson-Erici, J Parkkonen, M Pettersson, A.H Berg, P.-E Olsson et al. Ethinyloestradiol — an undesired fish contraceptive? Aquatic Toxicology 1999; 45 (2-3): 91-97.
  5. Kidd KA, Blanchfield PJ, Mills KH, Palace VP, Evans RE, Lazorchak JM et al. Collapse of a fish population after exposure to a synthetic estrogen. Proc Natl Acad Sci U S A. 2007;104:8897-901.
  6. Zeilinger J, Steger-Hartmann T, Maser E, Goller S, Vonk R, Länge R. Effects of synthetic gestagens on fish reproduction. Environ Toxicol Chem. 2009;28:2663-70.
  7. Friel PN, Hinchcliffe C, Wright JV. Hormone replacement with estradiol: conventional oral doses result in excessive exposure to estrone. Altern Med Rev. 2005;10:36-41.
  8. Runnalls TJ, Beresford N, Kugathas S, Margiotta-Casaluci L, Scholze M, Scott AP et al. From single chemicals to mixtures--reproductive effects of levonorgestrel and ethinylestradiol on the fathead minnow. Aquat Toxicol. 2015;169:152-67.
  9. Fick J, Lindberg RH, Tysklind M, Larsson DG. Predicted critical environmental concentrations for 500 pharmaceuticals. Regul Toxicol Pharmacol. 2010;58:516-23.
  10. Stockholms läns landsting. Förteckning över miljöbelastande läkemedel med åtgärdsförslag framtagen inom ramen för SLL:s miljöprogram 2017–2021.
  11. Fass.se för vårdpersonal
  12. Stockholms läns landsting. Kloka listan (Wise list).
  13. Stockholm County Council. The Wise List 2015.

Author: The Pharmaceutical unit of Region Stockholm