Cradle-to-cradle stewardship of drugs for minimizing their environmental disposition while promoting human health. I. Rationale for and Avenues toward a Green Pharmacy - Green Pharmacy Mini-Monograph

Environmental Health Perspectives, May, 2003 by Christian G. Daughton

Since the 1980s, the occurrence of pharmaceuticals and personal care products (PPCPs) as trace environmental pollutants, originating primarily from consumer use and actions rather than manufacturer effluents, continues to become more firmly established. Although PPCPs typically have been identified in surface and ground waters, some are also undoubtedly associated with solid phases such as suspended particulates, sediments, and sewage sludges, despite their relatively high affinity for water. Often amenable to degradation, their continual introduction to waste-receiving waters results from their widespread, continuous, combined use by individuals and domestic animals, giving PPCPs a "pseudo-persistence" in the environment. Little is known about the environmental or human health hazards that might be posed by chronic, subtherapeutic levels of these bioactive substances or their transformation products. The continually growing, worldwide importance of freshwater resources, however, underscores the need for ensuring that any aggregate or cumulative impacts on (or from) water supplies ate minimized. Despite the paucity of effects data from long-term, simultaneous exposure at low doses to multiple xenobiotics (particularly non-target-organism exposure to PPCPs), a wide range of proactive actions could be implemented to reduce or minimize the introduction of PPCPs to the environment. Most of these actions rail under what could be envisioned as a holistic stewardship program--overseen by the health care industry and consumers alike. Significantly, such a stewardship program would benefit not just the environment; additional, collateral benefits could automatically accrue, including reducing consumers' medication expenses and improving patient health and consumer safety. In this article, the first of a two-part mini-monograph describing the "green pharmacy," I focus initially on the background behind the imperative for an ecologically oriented stewardship program for PPCPs. I then present a broad spectrum of possible source control/reduction actions, controlled largely by the health care industry, that could minimize the disposition of PPCPs to the environment. This two-part mini-monograph attempts to capture cohesively for the first time the wide spectrum of actions available for minimizing the release of PPCPs to the environment. A major objective is to generate an active dialog or debate across the many disciplines that must become actively involved to design and implement a successful approach to life-cycle stewardship of PPCPs. Key words: cradle-to-cradle stewardship, drugs, environmental pollution, green pharmacy, pollution prevention. Environ Health Perspect 111:757-774 (2003). doi:10.1289/ehp.5947 available via http://dx.doi.org/[Online 12 December 2002]

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The occurrence of pharmaceuticals and personal care products (PPCPs) in the environment has received growing attention since the 1980s. The major issues associated with the origins and occurrence of these chemicals in surface, subsurface, and drinking waters (as well as what little is known about the potential effects on nontarget species) have been captured in a number of reviews, books, and proceedings, examples of some recent ones of which include Daughton (2001a), Daughton and Jones-Lepp (2001), Daughton and Ternes (1999), Heberer (2002); see also Kummerer (2001), Servos et al. (2002), and the entire special issue of Toxicology Letters (2002). The most comprehensive target-monitoring study ever performed was completed by the U.S. Geological Survey (USGS) (Kolpin et al. 2002). Many of these materials (and more) are accessible from the U.S. Environmental Protection Agency (U.S. EPA) website devoted to the topic of PPCPs in the environment (Daughton/U.S. EPA 2002a).

This article is the first of a two-part examination of the many facets of a little-discussed but very important aspect of the overall issue of PPCPs as environmental pollutants: pollution prevention. In light of the fact that trace residues from this large, diverse galaxy of sometimes highly bioactive chemicals gain entry to the environment simply through their use and disposal, and regardless of what little is known regarding the consequences for ecologic or human health (Daughton 2001a; Daughton and Ternes 1999), a wide spectrum of actions could be taken to minimize or eliminate the continued environmental disposition of PPCPs. Significantly, these actions toward pollution prevention (e.g., source reduction/control) hold the potential at the same time for beneficial human health consequences unrelated to the occurrence of PPCPs as pollutants. In this article I focus on those aspects of source control/reduction that reside under the control of the health care industry (further up the chain of events involved with a drug's cradle-to-grave disposition). In part II (Daughton 2003), I address those activities tied more closely to the end user (e.g., the patient) and issues associated with drug disposal/recycling. In this article I also present some of the background and context for why pollution prevention is a topic worth considering for PPCPs; in part II, I make specific suggestions and recommendations centering more on end use, present recommendations for further research, and pose some considerations regarding the future.