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Sci Total Environ. 2017 Dec 31;609:1023-1040. doi: 10.1016/j.scitotenv.2017.05.269. Epub 2017 Aug 2.

Risks associated with the environmental release of pharmaceuticals on the U.S. Food and Drug Administration "flush list".

Author information

1
Oak Ridge Institute for Science and Education, Oak Ridge, TN 37830, USA.
2
Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
3
Department of Civil Engineering & Applied Mechanics, McGill University, 817 Sherbrooke Street West, Montreal, Quebec, Canada, H3A 0C3.
4
Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA. Electronic address: james.laurenson@fda.hhs.gov.

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.

KEYWORDS:

Disposal; Environmental impact; Flush list; Opioids; Pharmaceuticals; Wastewater

PMID:
28787777
DOI:
10.1016/j.scitotenv.2017.05.269
[Indexed for MEDLINE]

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