The Pharmaceutical Journal
Vol 280 No 7494 p335-336, 341-342
22 March 2008

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Impact of waste pharmaceuticals: an environmental hazard or “greenwash”?

Do pharmaceutical products really present an environmental problem or is it just another case of “greenwash”? In this article, Colin Richman and Staffan Castensson aim to report the known issues, to identify what we do and do not yet know and to look at work taking place in Europe, with a focus on Sweden where considerable effort is being put into addressing the risk and acting on the evidence

What is meant by the environmental impact of pharmaceuticals? Medicines (including excipients and preservatives) are derived from many different sources, some natural and some synthetic. About 3,000 pharmaceuticals are licensed for human use in the UK.

Most drugs have some adaptation to resist biological degradation in the body and these same adaptations may lead to persistence in the environment when the drug is excreted via urine or faecal matter.

The presence of pharmaceutical micro- pollutants in various water environments has been extensively investigated within numerous studies for more than a decade. More than 170 references, relating to 181 compounds in samples from 23 countries, can be compiled to date.

Pharmaceuticals, whether human or veterinary, will find their way into waste water plants or watercourses and potentially the ground water as the active pharmaceutical, metabolite or other transformation product. Some drugs have been found in drinking water, which is a warning sign that the current handling of pharmaceuticals may lead to future health and environmental problems.

Reports indicate that pharmaceutical micropollutants are detected at parts per trillion or parts per billion levels, far below their acute toxic levels. There is, however, positive evidence of an endocrine disruption effect on aquatic life with reports on the feminisation of male fish, notably the freshwater roach (Rutilus rutilus), causing intersex species or development of ova in the testes, where oestrogens (from HRT, oral contraceptive and endogenous human production) are present at the level of one part per billion.

It has been postulated that, as the UK takes one third of its water from rivers, water with these oestrogen levels have the potential to enter the drinking supply. The effect of chronic exposure to these low levels of pollutants on humans remains unknown and arguments to apply the precautionary principle have been made as a reason for action into reducing the presence of pharmaceuticals in the environment.

For most chemical substances (eg, pesticides, agrochemicals and household chemicals) there is rigorous environmental hazard testing and guidance on disposal. The environmental safety of human medicines is defined by the EU Commission in directive 2004/27/EC (which amended directive 2001/83/EC).

In a report of a European Parliament session, Erkki Liikanen, member of the European Commission responsible for enterprise was quoted as saying: “The possible effects of the use of medicinal products on the environment are important. The question needed to be addressed carefully as, at the end of the day, the availability of certain medicines was at stake.

“The compromise amendments, which require an environmental impact assessment and possible mitigating measures, but leave the criteria for granting the marketing authorisation untouched is to be seen as a well balanced solution.”

The EU directive attempts to take into consideration two key elements — diminishing the risk to the environment while at the same time not restricting the availability of medicines.

For veterinary medicinal products a more straightforward approach is laid down in directive 2004/28/EC (which amended directive 2001/82/EC). This legislation forbids product authorisation when the environmental risk is unacceptable and the managing the risk is not possible.

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