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Drugs and the Environment: Stewardship & Sustainability

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Drugs and the Environment: Stewardship & Sustainability Drugs and the Environment: Stewardship & Sustainability APM 200 R E S E A R C H A N D D E V E L O P M E N T EPA/600/R-10/106 September 2010 www.epa.gov Drugs and the Environment: Stewardship & Sustainability APM 200 Christian G. Daughton, PhD U.S. Environmental Protection Agency Office of Research and Development National Exposure Research Laboratory Environmental Sciences Division Environmental Chemistry Branch 944 E. Harmon Ave. Las Vegas, NV 89119 Although this work was reviewed by EPA and approved for publication, it may not necessarily reflect official Agency policy. Mention of trade names and commercial products does not constitute endorsement or recommendation for use. U.S. Environmental Protection Agency Office of Research and Development Washington, DC 20460 12 September 2010 Drugs and the Environment: page <2> of 196 CG Daughton Stewardship & Sustainability US EPA/ORD, Las Vegas, NV TABLE OF CONTENTS Table of Contents .......................................................................................................................................... 3 ABSTRACT ................................................................................................................................................. 7 INTRODUCTION ........................................................................................................................................ 8 Terminology and What Exactly Is Drug Wastage? .................................................................. 14 MAJOR FINDINGS and INSIGHTS ......................................................................................................... 15 Overview................................................................................................................................... 16 (1) The need for prudent drug disposal is not a new issue .................................................... 16 (2) Drug disposal is a deceptively complex issue and one refractory to simple solutions ... 16 CAUSES of LEFTOVER MEDICATIONS ............................................................................. 16 (3) The causes of accumulation of leftover drugs are numerous, complex, and not amenable to simple solutions ................................................................................................................ 16 (4) A comprehensive approach for reducing the incidence of leftovers will require a full and accurate understanding of the entire cradle-to-grave life cycles of medications .................. 17 DISPOSAL: SCIENCE ISSUES & CONCERNS .................................................................... 17 (5) Evidence for drug disposal acting as a major origin of ambient aquatic residues of APIs does not exist, except for some select cases.......................................................................... 17 (6) Drug disposal may serve as the major source of APIs in landfills (even when not receiving biosolids)............................................................................................................... 18 (7) Disposal to trash poses unknowns with regard to the environmental fate of APIs ......... 19 (8) Disposal to trash poses additional hazards ...................................................................... 19 (9) Concerns regarding individual privacy during disposal can increase the risks for poisoning or injury................................................................................................................ 19 UNDER-RECOGNIZED CONCERNS or DRUG-USE PRACTICES ................................... 19 (10) Graywater and septic systems are under-recognized potential problems with regard to drug disposal ......................................................................................................................... 19 (11) Disposal of certain select delivery devices to sewers may serve as a major source of particular API residues in the environment .......................................................................... 20 (12) Pharmacokinetics, dosage form, and patient compliance are the main factors dictating whether disposal can be a significant contributor to ambient environmental levels of APIs 20 (13) Certain drug-use practices can essentially serve as indirect, unintended, hidden forms of disposal ............................................................................................................................. 20 (14) Biologics pose little concern with regard to disposal to sewers, but do pose some concern with regard to disposal to trash................................................................................ 21 (15) Drug donations are a major problem for humanitarian relief efforts ............................ 21 DISPOSAL GUIDANCE.......................................................................................................... 22 (16) Guidelines for prudent disposal need to avoid a singular focus on protecting the environment .......................................................................................................................... 22 (17) Current drug disposal guidance may be flawed and increase risks for humans ............ 22 (18) Drugs possessing the potential for single-dose lethality require special consideration in disposal guidance .................................................................................................................. 23 (19) Protecting the environment with optimal disposal guidelines can conflict with ensuring human safety ......................................................................................................................... 23 12 September 2010 Drugs and the Environment: page <3> of 196 CG Daughton Stewardship & Sustainability US EPA/ORD, Las Vegas, NV (20) Prudent drug disposal requires balancing the protection of the environment with ensuring access to timely medical care ................................................................................. 24 FORMAL COLLECTION PROGRAMS ................................................................................. 24 (21) The potential effectiveness of drug-collection programs for curbing imprudent disposal is unknown ............................................................................................................................ 24 (22) Formal collection programs for unwanted drugs may have significant hidden costs ... 24 (23) The statistical representativeness of data from drug collection or take-back programs is unknown................................................................................................................................ 24 (24) Data from drug collection programs cannot be inter-compared; standardization is needed ................................................................................................................................... 25 (25) Prudent drug disposal requires attention not just to the API, but also to the packaging 27 (26) Drug collection programs (e.g., take-backs) may not be an effective approach for reducing the diversion of the primary drugs of concern - controlled substances ................. 27 (27) Patchwork of take-backs in the US adds to the existing confusion regarding drug disposal ................................................................................................................................. 27 (28) Sustainable approaches to drug disposal require clear and useful measures of success 28 DRIVERS for ASSESSING MEDICATION WASTE ............................................................ 28 (29) Connection to Healthcare: Viewing leftover drugs as measures of success or opportunities for improvement, rather than simply as waste ................................................ 28 (30) Focus on Source Reduction: An overwrought focus on drug disposal may distract from a sustainable solution yielding a wide range of collateral benefits ....................................... 29 (31) Adopting Healthier Lifestyles: Reducing the incidence of leftover drugs may in some instances also serve to reduce the entry of APIs to sewers via excretion and bathing ......... 30 (32) Counter to current perception, excretion of APIs can be reduced – without jeopardizing the quality of healthcare........................................................................................................ 30 (33) Several trends hold potential for exacerbating the need for prudent drug disposal ...... 30 (34) Manufacturer promotions such as Direct-to-Consumer (DTC) advertising and drug sampling increase the incidence of leftovers ........................................................................ 32 (35) Certain trends such as large-scale drug diversion may be exacerbating the need for drug disposal ................................................................................................................................. 33 MESSAGING & COMMUNICATION ................................................................................... 33 (36) Current science can only justify a focus on drug disposal on the basis of the collateral benefits for healthcare and protecting human safety - not for protecting the environment .. 33 (37) Possible unexpected paradox: Drug take-back events may potentially worsen the drug disposal problem, as well as diversion and poisonings, by encouraging stockpiling ........... 34 (38) Public outreach efforts designed to promote prudent disposal should try to ensure that certain, select groups are reached ........................................................................................
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