MEDICINE DISPOSAL PRODUCTS an Overview of Products & Performance Questions

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MEDICINE DISPOSAL PRODUCTS an Overview of Products & Performance Questions MEDICINE DISPOSAL PRODUCTS an overview of products & performance questions Community Environmental Health Strategies LLC March Produced for San Francisco Department of the Environment 2019 Table of Contents Executive Summary .............................................................................................................................................. 2 Glossary of Abbreviations ..................................................................................................................................................... 4 I. Overview of Products and Questions Examined ..................................................................................... 5 II. Medicine Disposal Background ................................................................................................................... 8 A. Medicine Disposal Guidelines and Regulations............................................................................................... 8 B. DEA’s non-retrievable standard for controlled substances .................................................................... 10 C. Disposal of waste pharmaceuticals from households................................................................................ 11 D. Disposal of waste pharmaceuticals by the healthcare sector and regulated generators ........... 17 III. Medicine Disposal Products: Performance Questions & Available Product Testing ............ 23 A. Performance Questions .......................................................................................................................................... 23 B. Summary of Available Analytical Testing ....................................................................................................... 23 C. Active Ingredients and Mechanisms of Action ............................................................................................. 26 D. Types of Pharmaceuticals and Dosage Forms .............................................................................................. 32 E. Deterrence and Non-Retrievability ................................................................................................................... 34 F. Environmental Performance ................................................................................................................................ 37 G. Safety, Ease of Use, Product Costs, and Consumer Preferences ............................................................ 42 IV. Research Needs & Other Recommendations ...................................................................................... 48 V. Medicine Disposal Product Profiles ......................................................................................................... 55 Products for Consumers, Healthcare Facilities, and Others Deterra ....................................................................................................................................................................... 56 DisposeRx.................................................................................................................................................................. 65 Drug Buster .............................................................................................................................................................. 69 Element MDS ........................................................................................................................................................... 72 NarcX ........................................................................................................................................................................... 75 Pill Catcher ................................................................................................................................................................ 79 Pill Terminator ........................................................................................................................................................ 82 Rx Destroyer and Narc Gone HD ..................................................................................................................... 85 Products for Healthcare Facilities Only Cactus Smart Sink .................................................................................................................................................. 89 CsRx System ............................................................................................................................................................. 91 VI. End Notes .......................................................................................................................................................... 93 Medicine Disposal Products. March 2019. Page 1 of 93 Executive Summary Secure disposal of leftover and expired medicines is a key prevention strategy in reducing misuse and diversion of medicines to combat drug abuse and prevent overdoses. Safe disposal of medicines also helps prevent accidental ingestion by children, seniors, and pets. Proper disposal of the significant amounts of leftover and expired pharmaceutical waste generated in our homes and healthcare system also prevents those medicines from contributing to pharmaceutical pollution in waterways and water supplies. Disposing of unwanted medicines in the household trash creates risks of unintended exposures, drug diversion, and environmental pollution. This recognition has increased interest in and implementation of secure medicine take-back programs throughout the United States. It has also sparked a new market sector of products for in-home disposal of waste medicines intended to alter pharmaceuticals so that they are not available for abuse and are safe for trash disposal. Medicine disposal products are also marketed to hospitals, pharmacies, physician’s offices, law enforcement, and other facilities as a treatment method to made pharmaceuticals safe for solid waste disposal or as a pre-treatment to prevent diversion prior to disposal at a permitted facility. This report, which updates a version produced in April 2017, profiles ten medicine disposal products based on promotional materials, product labels, and product testing results available from the manufacturers. Eight products marketed to both consumers and the healthcare sector were reviewed: Deterra, DisposeRx, Drug Buster, Element MDS, NarcX, Pill Catcher, Pill Terminator, and Rx Destroyer (also sold as Narc Gone HD). Cactus Smart Sink and CsRx System were also reviewed as related products that are marketed for use solely by healthcare facilities, prior to final disposal by incineration at permitted facilities. None of the medicine disposal products are approved by any federal agency; no federal agency endorses such products, and none appear to be actively evaluating these products at this time. For disposal of home-generated medicines, federal guidelines from the DEA, EPA, and FDA recommend secure medicine take-back programs as the best disposal option, and preferable to disposing of medicines in the household garbage. Marketing of the medicine disposal products focuses on trash disposal of medicines and does not fully explain these federal disposal guidelines. For healthcare facilities and other regulated generators of waste pharmaceuticals, appropriate use of medicine disposal products depends on the type of pharmaceutical waste treated, as well as applicable federal, tribal, state, and local disposal regulations. In many jurisdictions, regulated generators of pharmaceutical wastes are prohibited from disposing waste medicines in the solid waste system even with this pre-treatment by a medicine disposal product. Verifying performance claims of these medicine disposal products is challenging because four manufacturers do not disclose any product testing and available testing for the other six products does not thoroughly examine key performance questions. Active ingredients are disclosed for only six of the ten products. Available test results do not convincingly demonstrate that any product meets the DEA’s stringent non-retrievable standard for disposal of medicines that are controlled substances. The limited data available for several products shows that some of the tested drugs are not fully “treated” and can be extracted from the disposal product by simple washes with water at room temperature. Complete waste determinations have not been conducted to assess whether the product-drug mixtures are non-hazardous and thus appropriate for solid waste disposal. Overall, the product testing examined treatment of only a small number of pharmaceuticals. In almost all Medicine Disposal Products. March 2019. Page 2 of 93 cases the product was tested for treatment of a single drug at a time, rather than in a real-world scenario where a combination of different pharmaceuticals would be mixed with the product. In hospitals and facilities that are regulated for management of controlled substances and pharmaceutical wastes, these products may be appropriate for deterring diversion of pharmaceutical wastage of controlled substances before final disposal at an appropriate permitted facility. For residents with no access to a medicine take-back program, in an area where trash disposal of pharmaceuticals is allowed by local authorities, these products could be used as alternatives to mixing medicines with dirt, kitty litter, or coffee grounds. By physically immobilizing most of the drugs, even reversibly, or making the drug mixture noxious,
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