Pharmaceuticals

various colorful tablets and pills from the topClick to enlarge
Drugs have many different entry pathways to the environment.
Source: CC Vision

Since the mid-1980s scientists have increasingly reported about traces of pharmaceuticals in the environment. When endocrine substances drew special attention in the 1990s, public debate also focused on contraceptive hormones and the environmental impact of pharmaceutical residues. There was also concern that antimicrobial feed additives was increasing resistance to antibiotics and that contamination of drinking water was having a negative impact on human health. Scientists have in the meantime traced some 150 pharmaceutical active ingredients in surface waters, sediments, groundwater and soil (Bergmann et al. 2011). The different entry pathways to the environment account for the discrepancies in the presence of human and veterinary drugs in the environment. Human drugs enter surface waters through sewage systems and sewage treatment plants. Most veterinary drugs are spread onto agricultural land in the slurry and manure from mass livestock production.

The measured concentrations of the active ingredients in the environment are mostly below the therapeutic doses of pharmaceutical products and below the maximum allowable amount of residues in foodstuffs which have been established for them. However, this does not give an all clear sign for the environment: whereas pharmaceuticals are among the most thoroughly researched substances as concerns human toxicology, the ecotoxicological effects of the relatively low, yet permanent, exposure of bodies of water and soil to pharmaceutical residues are largely unknown.

The drug authorisation procedure requires the Federal Environment Agency to carry out an environmental assessment of new human and veterinary drugs. The assessment investigates the fate of the drug’s active ingredient and its ecotoxicity based on a catalogue of standardised testing guidelines. The applicant conducts the tests and submits the results to UBA for review. The German Drug Act provides the statutory basis and makes provisions for the protection of the environment if risk from the use of the drug is proven.

The reform to European pharmaceuticals law has raised the standards of environmental safety of new drugs. New assessment schemes were introduced in 2006 which make it possible to carry out a detailed analysis of the behaviour and effects of human and veterinary drugs in the environment.

In the case of risk-associated veterinary drugs, it appears that environmental requirements to reduce risk and thus ensure safe marketing are applicable in most cases. In the case of human drugs, it is far more difficult to ensure risk reduction through restriction of the drug's use on grounds of regional and continuous input to the environment or because of its special benefits. The Federal Environment Agency is exploring new avenues to sustainable pharmacy in an intensive dialogue with pharmaceutical manufacturers.