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The risks of environmental effects of pharmaceutical and medicinal products

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Context - The pollution of the various compartments of the environment (water, soil and air) with pharmaceutical residues is an environmental concern

This is a faithful summary of the leading report produced in 2013 by the DG Health and Consumers: " Study on the environmental risks of medicinal products, BIO Intelligence Service (déc. 2013) " 

Latest update: 26 March 2015

Context and importance of the issue

The pollution of the various compartments of the environment (water, soil and air) with pharmaceutical residues is an environmental concern. Consumption of human medicines is between 50 to 150 g per person per year in the EU. Veterinary drugs are used in smaller quantities, but pets are a growing segment of the veterinary products market. In the majority of EU Member States, of unused human medicinal products (3 to 8% of the total amounts sold), about 50% is not collected.

The issue is that we lack a global view of what happens when these medicinal products are discharged into the environment, and further characterisation of possible exposure routes for humans is necessary. Residues of various types of medicinal products (hormones, anti-cancer, antidepressants, antibiotics, etc.) have been detected in the various compartments of the environment, which raises the question whether this represents a risk for exposed plants, animals and microbes, or for humans.

This study characterises the scale of the environmental effects of medicinal products, personal care products being excluded. The objective was to identify non-legislative and legislative causes of their presence in the environment, and suggest ways to adapt the legislation in order to address it.

How do medicinal products enter and behave in the environment?

Between 30 and 90% of the orally administered dose of a drug is generally excreted as active substance in the urine of animals and humans. A notable portion of medicinal products is disposed of in sinks and toilets, and ends up in the environment. Inappropriate and excessive consumption might also be at the origin of unnecessary emissions.

In the EU, the contribution of manufacturing facilities to emissions of medicinal products and/or their residues is generally considered as negligible.

Once in the environment, medicinal products are transformed and transferred between the different compartments of the environment (surface and ground water, soil, air). Highly lipid-soluble medicinal products also have the ability to accumulate in the fat tissues of animals and can be thus introduced into the food chain. These products can degrade either by being digested and metabolized by organisms, or through physico-chemical processes in soils and water. Some degradation products can be persistent even after wastewater treatment, and be of concern.

What kind of hazards and risks do they represent for ecosystems?

For a range of pharmaceuticals, environmental risks can be rather negligible as they do not stay for long in the environment and are not very toxic. It is becoming increasingly clear however that some medicinal products, in particular anti-parasiticides, anti-mycotics, antibiotics and (xeno)estrogens, which can all have ecotoxicological effects, pose environmental risks in specific cases. For example, vulture populations on the Indian sub-continent declined due to poisoning with Diclofenac, a painkiller, which was present in the carcasses that the vultures were feeding on.

What are the potential impacts on human beings?

For humans, the possible impacts are less clear than for the environment. The levels of residues in drinking water, or in food are very low and considered not to be a concern for humans, but long-term low-level exposure can occur through those pathways.

To date no legal limit exists for human medicinal products potentially present in animal products since this pathway of exposure is assumed to be negligible, although it is currently not well characterised. For example, in Europe only very low concentrations of veterinary antibiotics are found in dairy products.

What are the limits of the present EU legislative framework regarding the presence of medicinal products in the environment?

Before 2005, the process of authorization for medicinal products did not include an environmental risk assessment (ERA), and therefore there is a lot of relevant information lacking. Even for more recent products, ERA was often incomplete. A number of regulatory frameworks for chemicals marketed and used in Europe now include an assessment for Persistence, Bioaccumulation and Toxicity (PBT) potential but, regarding veterinary and human medicinal products, no specific guidance is available.

There is at present no EU regulation that covers the risk assessment of contaminated soil, and of the product residues transferred to food animals, including fish, or present in sewage sludge originating from water treatment plants.

What can be done to limit the presence of pharmaceuticals in the environment?

The key steps of legislative actions to solve these limitations concern – but are not limited to – the strengthening of the environmental risk assessments that could also target «old» pharmaceuticals. The Water Framework Directive could explicitly take into consideration ERA results for active pharmaceutical ingredients. Tailored legislative tools could also establish a specific label for green pharmacy.

Major non-legislative solutions focus on consumption and waste management, through better knowledge of the ecotoxicity of medicinal products, and by encouraging the recruitment in regulatory agencies of personnel with an eco-toxicology background. In parallel, training sections could be organised for medical doctors, a better match between consumer needs and packaging sizes could be considered, all the while valorising the role of pharmacists in the collection of unused medicinal products and organising public information campaigns.

Major improvements in waste management could be focused on the more effective collection schemes for unused human and veterinary medicines, as well as on tracking their efficiency.

Disclaimer: The views expressed in this study are those of the authors alone and do not necessarily represent those of the European Commission Directorate-General for Health and Consumers or the EAHC. The authors are fully responsible for any errors.

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