The problem of pharmaceutical pollution

Over 100,000 tonnes of pharmaceutical products are consumed globally every year (24% in Europe). During their manufacture, use and disposal, Active Pharmaceutical Ingredients (APIs) as well as other chemical ingredients are released into the environment.

A very substantial share of pharmaceutical production now takes place overseas. This is particularly the case for antibiotics and other generic medicines. China produces 80-90% of antibiotic APIs and Indian companies lead the production of finished dose products. There have been numerous high-profile pollution scandals at antibiotics production sites in both China and India, resulting in the spread of drug-resistant bacteria.  Possible downstream pollution from manufacturing plants has been observed in the EU and other parts of the world.

APIs are released in high amounts to the environment during human and veterinary consumption of drugs, as between 30 and 90% of an oral dose is excreted in urine as an active substance. A global review shows that over 600 different APIs have been detected in the environment, in some cases at levels that pose a high risk to the environment. Pharmaceuticals have also been detected in drinking water, waste-water, sewage sludge and soils.

3000 APIs are marketed in the EU as human or veterinary drugs. Although the environmental impact of most of these substances is widely unknown, several API are known to persist and to accumulate in the environment. Examples of ecotoxicological effects of APIs include impairment of  the reproduction of exposed fish populations; the effects of various antibiotics on environmental bacteria and algae or the decline of vulture populations due to poisoning with diclofenac when feeding on animals carcases.

The presence of antibiotics in the environment contributes to the development of antimicrobial resistance (AMR), one of the major emerging threats to human health today. AMR burden in terms of lives lost, morbidity, and healthcare expenses and productivity losses is much greater than currently available statistics suggest – 25,000 deaths in 2007 –  and projections estimate a 15 fold increase in morbidity in Europe due to AMR by 2050 with 390,000 deaths .

Despite the high concerns on the threats posed by pharmaceuticals, their releases into the environment are almost unregulated:

• Information on environmental impacts of APIs is not available to the public or authorities.
• The assessment of the environmental risks  covers only a minority of pharmaceuticals.
• There are insufficient monitoring requirements and no specific emission limits in place for releases of API  from manufacturing plants.
• There are no limits in place for the content of pharmaceuticals in drinking water, in surface water, or waste water, not even from hospitals’ effluents.
• There are no specific regulations for the management of most medicinal products waste.
• There is no obligation to monitor or regulate medicinal pharmaceuticals present in sewage sludge or in manure used in agriculture.

As well as other chemical pollutants such as pesticides, biocides or industrial chemicals, the emission of pharmaceuticals into the environment needs to be regulated to ensure adequate information and transparency on the environmental impacts of pharmaceuticals; adequate and reliable evaluation of environmental risks of pharmaceuticals; to prevent environmental releases of pharmaceuticals throughout their life-cycle; and to control emissions of pharmaceuticals to the environment when prevention is not feasible.