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Unused pharmaceuticals: where do they end up?

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Health Care Without Harn: Vision & Mission, Goal on Pharmaceuticals.
How do pharmaceuticals get in the Environment?
Therapeutic Classes That Can Have Harmful Effects on Unintended Organisms
How Can Pharmaceuticals in the Environment Affect Wildlife?
What Is Currently Being Done at the EU Level to Address Pharmaceutical Pollution?

Published in: Environment
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Unused pharmaceuticals: where do they end up?

  1. 1. Unused Pharmaceuticals - Where Do They End Up? Adela Maghear Pharmaceuticals Policy Officer Health Care Without Harm Europe www.noharm-europe.org Minsk, 27 April 2016
  2. 2. Slide Title Minsk, 27 April 2016
  3. 3. HCWH Vision & Mission Healthcare mobilizes its ethical, economic and political influence to create an ecologically sustainable, equitable and healthy world. Transform healthcare worldwide so that it reduces its environmental footprint, becomes a community anchor for sustainability and a leader in the global movement for environmental health and justice. Minsk, 27 April 2016
  4. 4. HCWH Goal on Pharmaceuticals Minsk, 27 April 2016 Support the safe production, management and disposal of pharmaceuticals, reducing their environmental and health impact throughout the entire life cycle and fostering innovations for green products.
  5. 5. How Do Pharmaceuticals Get in the Environment? Minsk, 27 April 2016 2ndmajorpathwayintheenvironment!!!
  6. 6. How Do Pharmaceuticals Get in the Environment? Residues can reenter the water supply and spread to other environmental compartments (e.g., surface waters, agricultural lands) Wastewater treatment plants unable to completely filter the improperly disposed pharmaceuticals Minsk, 27 April 2016
  7. 7. How Do Pharmaceuticals Get in the Environment? Minsk, 27 April 2016 (1) BIO Intelligence Service. 2013. (2) Kummerer K. 2009. (3) York Health Economics Consort. 2010.
  8. 8. Therapeutic Classes That Can Have Harmful Effects on Unintended Organisms => cytotoxic by design => risk of promoting antimicrobial resistance => endocrine disruptors => consumed in large quantities Minsk, 27 April 2016
  9. 9. There Is a Large Number of Pharmaceuticals on the Market and Consumption Is Increasing Minsk, 27 April 2016 (1) BIO Intelligence Service. 2013.
  10. 10. How Are Humans Exposed to Pharmaceuticals in the Environment? Minsk, 27 April 2016 Pharmaceutical residues that re- enter the water supply and spread to surface waters and agricultural lands can end up in drinking water and accumulate in vegetables and fish. Low concentrations of pharmaceuticals in the environment can have adverse effects on animals and other organisms. ? How humans can be affected by continuous, long term exposure to low concentrations of pharmaceuticals ?
  11. 11. How Are Humans Exposed To Pharmaceuticals in the Environment? Minsk, 27 April 2016 (4) WHO. 2012. (5) Heberer T et al. 1997. (6) Huerta-Fontela et al. 2011. (7) Mons M et al. 2003.
  12. 12. Minsk, 27 April 2016 But Isn’t Water Filtered? 80% • Sewage treatment plants generally remove only 80% of pharmaceuticals and their metabolites (8). 10% • Even using the most advanced treatment methods, 10% of pharmaceuticals remain after water has been treated (8). 600+ • More than 600 pharmaceuticals have been detected in sewage treatment effluents, sludge, groundwater, surface waters and biota across the globe(9). (8) EurEau. 2014. (9) Kuester A, Adler N. 2014.
  13. 13. How Can Pharmaceuticals in the Environment Affect Wildlife? Minsk, 27 April 2016 (14) Larsson DGJ. 2007. Antibiotics in the environment can promote the development of antibiotic-resistant pathogens. Though traces of pharmaceuticals in the environment are well below therapeutic doses, they can still have effects on unintended targets.
  14. 14. How Can Pharmaceuticals in the Environment Affect Wildlife? Minsk, 27 April 2016 (14) Larsson DGJ. 2007. (16) Arnold KE et al. 2014. (17) Cuthbert R et al. 2007. (18) Kidd KA et al. 2007.
  15. 15. How Can Pharmaceuticals in the Environment Affect Wildlife? Minsk, 27 April 2016 (15) Jobling S et al. 1998. (19) Lazarus RS et al. 2014. (20) Oaks JL et al. 2004.
  16. 16. What Is Currently Being Done at the EU Level to Address Pharmaceutical Pollution? Collection systems for unused medicinal products • Directive 2004/27/EC (relating to medicinal products for human use) introduces an obligation for Member States to implement appropriate collection schemes for unused pharmaceutical products. Collection systems for unused medicinal products • It does not provide any guidelines on implementation of schemes and a number of studies have pointed to significant differences between Member States. Collection systems for unused medicinal products • Detailed information regarding the implementation and efficiency of collection schemes for unused pharmaceuticals throughout Europe is highly scattered and deficient, preventing comparisons between countries and type of scheme implemented. • It is not clear that all EU countries have implemented their obligations. Minsk, 27 April 2016
  17. 17. Environmental Risks of Medicines in European Legislation Minsk, 27 April 2016 In practice, this means that environmental risks are not part of the risk- benefit analysis for human medicines. “In any event this impact should not constitute a criterion for refusal of a marketing authorisation” (Directive 2004/27/EC ). The application must contain “an indication of any potential risks presented by the medicinal product for the environment”, and “specific arrangements to limit it [the environmental impact] shall be envisaged” (Directives 2001/83/EC and 2004/27/EC). Before being placed on the European market, pharmaceuticals have to undergo an authorization process.
  18. 18. Collection Schemes for Unused Pharmaceuticals The Waste Framework Directive (Directive 2008/98/EC) establishes the basic principles and provisions on re-use, recycling, recovery and disposal of waste to avoid dangers to human health and harm to the environment. Collection schemes for medicines from household waste are not to be subject to registration, as the schemes present a low risk and contribute to the separate collection of waste. Diclofenac and two synthetic oestrogens are included on the Watch List of substances subject to EU-wide monitoring under the Water Framework Directive (Directive 2013/39/EU). Minsk, 27 April 2016
  19. 19. Strategic Approach Minsk, 27 April 2016 The European Commission will develop a strategic approach to the pollution of water by pharmaceuticals. In autumn 2016, the Commission will propose a Roadmap on PiEs.
  20. 20. Challenges HCWH is advocating for upstream, preventative solutions to address pharmaceutical pollution: • raising public awareness • improving the implementation and enforcement of pharmaceutical collection systems • optimising use of the environmental risk assessment for pharmaceuticals • promoting the development of green and sustainable pharmaceuticals Minsk, 27 April 2016 Copenhagen 19-21 October 2016
  21. 21. Minsk, 27 April 2016

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