Risks associated with the environmental release of pharmaceuticals on the U.S. Food and Drug Administration "flush
Usman Khan1, Raanan A Bloom2, James A Nicell3
1Oak Ridge Institute for Science and Education, Oak Ridge, TN 37830, USA.
Abstract:
A select few prescription drugs can be especially harmful and, in some cases, fatal with just one dose when not used as prescribed. Therefore, the U. S. Food and Drug Administration (FDA) recommends that expired, unwanted, or otherwise unused portions of most of these drugs be disposed of quickly through a take-back program. If such an option is not readily available, FDA recommends that they be flushed down the sink or toilet. The goal of the current investigation was to evaluate the ecological and human-health risks associated with the environmental release of the 15 active pharmaceutical ingredients (APIs) currently on the FDA "flush list". The evaluation suggests that even when highly conservative assumptions are used-including that the entire API mass supplied for clinical use is flushed, all relevant sources in addition to clinical use of the API are considered, and no metabolic loss, environmental degradation, or dilution of wastewater effluents are used in estimating environmental concentrations-most of these APIs present a negligible eco-toxicological risk, both as individual compounds and as a mixture. For a few of these APIs, additional eco-toxicological data will need to be developed. Using similar conservative assumptions for human-health risks, all 15 APIs present negligible risk through ingestion of water and fish.
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