Pharmaceutical residues are ubiquitous chemical pollutants in surface waters of populated areas throughout the world. Although the problem was identified several decades ago, it was only recently that proper attention was given to this potential threat to human and environmental health. This article describes briefly what is done by research institutions, by national and international authorities, and by the health care system. New initiatives among all kinds of human activities – whether social, governmental or scientific – usually depend on actions taken by single fiery sprits. The first attempts to raise attention to the emerging potential problem of environmental pharmaceutical residues was indisputably derived from the US EPA official Christian Daughton.
In several informed articles in newspapers and scientific journals CD called for more research and an increased sense of responsibility from health care providers, pharma producers and patients to appreciate the fact that our surface waters are continuously being contaminated with residues of human medicines. Undoubtedly, this has led to increased focus on the problem, in particular among environmentalists and interested health care stakeholders. And today even ordinary well informed citiziens have come into contact with media information on the topic.
Research institutions and granting foundations have become progressively more active in this arena during the past 10-15 years. The European Union was early in supporting research on the appearance and possible elimination of pharma residues in sewage water, and has granted a handful of projects (e.g. Rempharmawater, ERAPharm and Knappe) in each of the latest framework programs. Such support has undoubtedly been instrumental to build up not only knowledge but also increased interest among other research groups and funders.
The most comprehensive current project (MistraPharma) is supported by a three-year grant of around 5 million euro by the Swedish governmental fund MISTRA. National grants for research on pharmaceuticals in the environment are also available in a number of other EU member states (Germany, France, Italy and others). National and international authorities (FDA, EMEA), who started regulating the use of pharmaceutical products in the mid 1990s, established acceptable upper limits of these products in surface water. They were, however, not particularly specific about the surveillance of the limits or what to do if they were exceeded.
Today more detailed analyses of possible environmental effects of new pharmaceutical products are required to be authorized before they are marketed. The European Medicines Agency (EMA) published the current guidelines (2005) for assessment of environmental risk of human medicines. These guidelines are mandatory in all member states. They probably represent the currently most far-reaching instructions to the producers on risk assessment. Yet, no outcome of this risk assessment would obstruct the marketing authorization of the product.
The European Commission is currently investigating the need for additional environmental preventive measures with respect to water pollution from medicines. With concerted information from media and research groups, several health care providers have started taking action to counteract the problem. Take-back systems for unused or expired human medicines are in use in several (but not all) EU member states. The idea is that if patients have left-over medicines they should not discard them via the toilet or the sewage system, inasmuch as this would yield a potential environmental pollution of pharmaceutical residues. Instead they should be taken to the pharmacy, to be destroyed in an environmentally safe way. Since 2004 such take-back systems are a legal requirement in all EU states. In the US several private initiatives have been taken to establish similar take-back systems. However, this has only been carried out in some regions in the US.
Improved environmental cautiousness amongst prescribers has been recommended in Sweden and Germany. The basic concept is that if there are two or more pharmaceutical alternatives with equal medical efficacy for curing a patient, the prescriber should recommend the alternative with the lowest environmental negative impact. This however requires that the prescriber has access to scientifically based information about the environmental impact of the different pharmaceutical alternatives. In order to provide this the health care stakeholders in Sweden have collaborated to establish an environmental classification system for all human medicines on the national market. The system was introduced in 2005 and is currently being upgraded to take into account experiences from the first period of use.
Åke Wennmalm, former environmental director for Stockholms County Council, Sweden.
The brochure Environmentally classified pharmaceuticals can be accessed at www.janusinfo.se/environment