040824_miljouppdraget-rapport

associated with negative effects on the aquatic environment. These are the sex hormones oestradiol and
ethinyloestradiol, both previously known to have effects on the environment. For another two sex hormones
and three other active substances environmental risk assessments could not be done due to incomplete
data. The remaining 20 substances were considered not to constitute any acute risk to the aquatic environment.
The results indicate that today’s use of pharmaceuticals does not involve any acute environmental
risks, but do not exclude the possibility for long-term environmental risks.
Acute toxic effects in the aquatic environment of substances used in pharmaceutical products, if they occur,
generally appear at concentrations in the magnitude of milligrams per litre. As the hitherto determined concentrations
of pharmaceutical substances in the environment are at least one thousand times lower, it is
doubtful whether these acute toxic effects are of ecotoxicological relevance.
Long-term toxic effects of pharmaceutical substances occur in some cases at concentrations that have actually
been determined in the environment. For most pharmaceutical substances there are no data on longterm
environmental toxicity and, thus, there is a need for further long-term studies in order to be able to
predict with greater certainty a substance’s potential long-term environmental risk. Often there is also a
lack of information on how the substances are affected by and distributed in the environment, i.e., biodegradation
data, partitioning coefficients, and data on bioaccumulation.
It is important to emphasize that the ecotoxicity tests that are used today to conduct environmental risk
assessments do not take into account the biological activity that is characteristic of active pharmaceutical
substances. There is, thus, also a need to examine the combined biological effects, so called “class effects”,
of active substances in the environment.
Environmental risk assessments of veterinary pharmaceuticals are based on the dosage of the substance to
different animal species together with effects on local ecosystems. Consequently, it is not necessary to
perform risk assessments on the basis of the total usage of the substance in the same way as for substances
used in human medicine. The Medical Products Agency has therefore chosen to summarise identified problem
areas on the basis of environmental risk assessments of individual products submitted with marketing
approval applications. Veterinary substance groups that may be suspected of affecting the environment are
those with antiparasitic and antimicrobial properties, but no such substance was assessed to involve any
major environmental risk.
Environmental risk assessments were also made for a number of excipients. No particular risks to the environment
could be identified. Many of the excipients are also used in other products, e.g., foodstuffs. Their
use in pharmaceutical products makes up a minor part of their total usage.
Information on qualitative and quantitative composition
Knowledge of the amounts of pharmaceutical products that are used and the routes by which they are released
into the environment (mass flows) is important for the identification of potential environmental problems.
Data from the registers kept by the Medical Products Agency and Apoteket AB have been combined
to obtain information on the flows. The intention was to review mass flows starting with the retail distribution
phase via the user/patient phase to dispersion routes entering the environment. However, the databases
were not primarily designed to be able to deliver information on mass flows, and consequently it was not
possible to obtain fully reliable figures. The work with combining existing registers has provided valuable
information on the difficulties that must be solved in order to be able to make better use of the databases in
the future.
Even if existing registers are adapted for mass flow calculations, there is still a flow that is difficult to quantify,
i.e. the amounts of the retailed pharmaceutical products that are discarded in relation to the amounts
that are consumed.
Environmental classification
The Medical Products Agency has studied the legal conditions for a possible introduction of environmental
classification of pharmaceutical products. Regulation of pharmaceutical products is largely based on EU
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