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Environmental Assessment of Veterinary Medicinal Products in Denmark
This report presents the amount of both therapeutically and non-therapeutically
veterinary medicinal products used in Denmark. On the basis of the information collected
on use, fate and effects of veterinary medicinal products is it possible to draw a number
of overall conclusions
 | No public available database exists on the therapeutically use of veterinary medicines
in Denmark. Based on data from Danish Medicines Agency, this report present the amount
used in 1996 and 1997. |
| The Danish Plant Directorate calculates annually the total consumption of growth
promoters and medicines for feed additives on single active substance level. Data from the
period 1986-1998 is presented in this report. |
| Data for selected A and B labelled therapeutically used veterinary medicines is included
in this report. The sale of V and H labelled substances, such as antiparasitic drugs and,
and H labelled compounds, such as acetylicaceticacid, are not registered |
| Data showed the following use of VMPs in 1997:
- 14 tons for the alimentary tract and metabolism
- 29 kg of hormones
- 230 kg of substances for CNS-active products
- 236 kg of antiparasitic drugs
- 48.5 tons of antibiotics used for therapeutic applications |
| The quantity of antiparasitic drugs sold as V-labelled products is most likely
significant. |
| More than 105 tons of antibiotics were used in 1997 non-therapeutically as growth
promoters. |
| 17 tons of active substance was used as coccidiostatic in the production of poultry. |
| The main environmental release of veterinary medicines is through the faeces and urine
of treated animals. Very little information is available about the fate of veterinary
medicinal products when stored in manure and slurry tanks. It has, however, been shown
that certain excretion metabolites can be reactivated and converted into the parent
compounds in samples of liquid manure. |
| Biodegradation data showed that half-lives varies from a few days to years depending on
characteristics of the substance, the matrix (e.g. soil, water or manure) and on
environmental conditions such as temperature, humidity and pH. |
| Although submitted to a number of uncertainties, PECsoil calculations was
made for a number of substances. Worst case PECsoil estimation was made for
hormones (0.01-0.05 µg kg-1), antibiotics (0.2 to 9 mg kg-1) and
substances used for treatment of diseases associated with the alimentary tract and the
metabolism, (0.04 - 5.7 mg kg -1). |
| Very few field measurements are available to verify PEC calculations. Oxytetracycline
reach concentrations between 0.1 and 11 µg/kg in sediments located in the vicinity of
fish farms For cattle, dung concentrations of 1.6 mg / kg ivermectin was measured one week
after injection with 0.2 mg ivermectin/kg body weight. After 17 days a reduction in dung
concentration to 0.3 mg / kg dung was found. |
| Antibiotics are shown toxic to algae, crustaceans and fish. Especially blue-green algaes
seem very sensitive to some antibiotics |
| No information is available on effects of VMPs on soil living organisms or soil
functions |
| Many studies have shown that antiparasitic drugs may be lethal for beneficial insects
living in dung voided several weeks after treatment of cattle. |
| Information is lacking on the ecological consequences of a continuous environmental
exposure, e.g. in the cases of boli slowly releasing antiparasitic drugs during an
entire grazing season, and on the fact that the environment often will be exposed to many
drugs and/or other hazardous chemicals simultaneous. |
| A Guidance Document on how to assess environmental risk of new (i.e. post 1.1.1997)
veterinary medicinal products have been published by the EMEA. A guidance on how to assess
the environmental risk of already existing VMPs. Apparently there is currently no national
or international regulatory strategy on how to deal with environmental risk of existing
VMPs. |
| A number of deviations exist between the risk assessment procedure of veterinary drugs
and the procedure used for new and existing chemicals and plant protection products. |
| The procedure of environmental risk assessment (ERA) of drugs may stop further
assessment on the basis of arbitrary cut-off values for the environmental concentration,
i.e. a risk characterisation for drugs found in concentrations below 10 µg/kg in dung or
soil can be left out. A half-life shorter than 30 days in soil of the parent compound may
also stop the need for further assessment. |
| The required assessment factors used for deriving PNEC for VMPs in the terrestrial
environment is at least a factor of 10 lower than the assessment factors prescribed for
assessing chemicals. |
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