EEA Technical report No 1/2010, 34 http://www.eea.europa.eu/publications/pharmaceuticals-in-the-environment-result-of-an-eea-workshop
The highlights prepared by GreenFacts are those from the executive summary and from the conclusions chapter of the report  Pharmaceuticals in the environment.
The five key facts of the report :
1. All over Europe wastewater and rivers contain a broad variety of pharmaceutical substances and their metabolites. Not all of them are known.:
2. Research results have confirmed that both human and veterinary medicines pose environmental risks, and some eco-toxicity data indicate that the concentrations found in the environment have detrimental effects.
3. To date, two cases have been identified of pharmaceuticals affecting wildlife.
4. A project financed by the European Commission’s Research Directorate-General reveal however no evidence that current concentrations of pharmaceutical products in the environment will result in significant environmental impact or human harm .
5. There is considerable need for greener pharmacy innovations that are ‘benign by design’ and extending the patent duration for such pharmaceuticals that are ‘benign by design’ could boost incentives to develop substances with less environmental impact.
1. Context : the increasing presence of pharmaceutical in waste water and rivers
A decade ago, the EEA (European Environmental Agency) and others first drew attention to the environmental impact of pharmaceuticals. The situation looks worse than a decade ago. Compared to 1999, there are grounds for increased concern. We now understand better the potential eco-toxicity of many pharmaceuticals and mixtures of medicines that enter the environment during their production, consumption and disposal, albeit in very small quantities.
All overEuropewastewater and rivers contain a broad variety of pharmaceutical substances and their metabolites. Not all of them are known. As the substances occur mainly as the result of medical treatments and can hardly be replaced, pollution is unavoidable and must be addressed through.
According to the report summary, “research results have confirmed that both human and veterinary medicines pose environmental risks, and some eco-toxicity data indicate that the concentrations found in the environment have detrimental effects.”The situation is likely to deteriorate further, adds the report, as ageing populations demand ever more medicines, and persistent or bioaccumulative compounds build up.
2. Are adverse environmental effects of pharmaceuticals established today ?
To date, two cases have been identified of pharmaceuticals affecting wildlife:
• many countries report that the oestrogen derivate ethinyl estradiol (used in the contraceptive pill) is responsible for the feminisation of male fish, most likely in combination with other hormones or hormone‑mimicking substances;
• the anti-inflammatory drug diclofenac, used as a veterinary drug, has killed tens of millions of vultures inAsia.
These cases are well documented. But other pharmaceuticals, including antibiotics, endocrines, antiparasitics, antidepressants and anticancer medications, give reason for concern. Various factors can amplify risks or disguise their impact. For example, effects on small organisms and microorganisms may be less obvious due to their size and therefore not reported. Furthermore, pharmaceuticals are often used as mixtures of several active ingredients. In Germany, results of data obtained from the Environmental Risk Assessment of pharmaceuticals showed that 95 % of the applied pharmaceuticals were not readily biodegradable according to OECD Test 301. Of the human pharmaceuticals assessed, 15 % were persistent in water and 50 % in sediment (OECD 308, persistence criteria according to EU-TGD). About 50 % of the applied veterinary pharmaceuticals fulfilled persistence criteria for soil (OECD 307).
Whereas single substances are mostly found in the environment in modest quantities, mixtures may be sufficient to have an environmental impact. Assessments of individual substances may therefore be misleading. Although the concentrations of individual pharmaceuticals found in European environments are often too low to provoke direct ecotoxicological effects, a whole range of different pharmaceuticals are present in a given environmental compartment at any given time. Hence the typical exposure situation in the environment is normally a multi-component mixture of low-effect concentrations of individual pharmaceuticals
Two classical mixture toxicity concepts, (Concentration Addition’ and ‘Independent Action), have been successfully applied to a range of pharmaceutical mixtures . Their power for predicting the joint action of pharmaceuticals is usually good to excellent. Cases of synergistic or antagonistic mixture toxicities (a higher or lower toxicity than expected) are rare.
In this respect, the Knowledge and Need Assessment on Pharmaceutical Products in Environmental Waters (KNAPPE) project financed by the European Commission’s Research Directorate-General reveal no evidence that current concentrations of pharmaceutical products in the environment will result in significant environmental impact or human harm .
As a matter of facts, states one of the workshop speaker, a lot more research, and often better research, is required before it will be possible tojudge how serious a threat pharmaceuticals pose to wildlife.
3. Reducing the environmental footprint of pharmaceuticals
We need to move from environmental risk assessment of a few drugs to far more comprehensive, holistic environmental stewardship of pharmaceuticals across their full life cycles, states the report. A life-cycle approach means looking at pre‑production issues (including raw materials and energy), secondary manufacturing, and the impact of drugs and their breakdown products when they enter the environment. This should imply , underlines one contributor, to further investigate the fate of pharmaceutical products in sewage treatment plants. One important amendment in the present regulations would be to extend the pharmacovigilance concept to include not only public health and patient health but also the environment.
There is anyway considerable need for greener pharmacy innovations that are ‘benign by design’ and, says the report, extending the patent duration for pharmaceuticals that are ‘benign by design’ could boost incentives to develop substances with less environmental impact.
The environmental footprint of pharmaceuticals can be reduced by various means. Green pharmacy is the design of pharmaceutical products and processes that eliminate or reduce the use and generation of hazardous substances. Following these principles, pharmaceuticals can be generated with reduced impact on the environment during production or after use. The introduction of such processes and pharmaceuticals is currently not a high priority for the pharmaceutical industry, underlines the report.
As a result of the workshop the participants drew up proposals for action among which:
- environmental risk assessment of human pharmaceuticals should be part of the risk‑benefit analysis within the authorisation process;
- all pharmaceuticals should be classified according to their environmental hazardousness;
- research in the EU should be initiated including better methods for eco-efficient synthesis, developing new ‘greener’ pharmaceuticals that break down after use.
- take back scheme rules for unused pharmaceuticals should be harmonised in the EU and pharmaceutical waste should always be incinerated;
- to destroy unavoidable remnants of active substances and metabolites (mainly from treatment), improved wastewater treatment should be considered, for example using activated carbon, advanced oxidation or UV.
- prioritization should be given to evaluating pharmaceuticals with potentially severe environmental effects (e.g. antibiotics ivermectins, steroid hormones );
Regarding more specifically practical experience on removing and degrading pharmaceuticals at wastewater treatment plants at present, knowledge is rather weak. The pharmaceuticals can, in some cases, be biologically degraded if the process conditions are favourable in the plant. They can also be moved from the water phase to sewage sludge due to sorption or to the air by stripping. By improved treatments the pharmaceutical potency should be lost and become more easily biodegradable.
Reference : European Environment Agency. Pharmaceuticals in the environment. Results of an EEA workshop 2010 — 34 pp. — 21 x 29.7 cm ISBN 978-92-9213-063-3 ISSN EEA Technical report series 1725-2237 DOI 10.2800/31181
note : these “highlights” are not subjected to a peer review by the Scientific Committee of GreenFacts