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
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
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
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
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
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
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
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
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.