David Schiller served 30 years as a Special Agent in Charge with the federal Drug Enforcement Administration. By the end of his career, he rose to the level of Vice Chairman of the field advisory committee for the DEA's national Diversion Control Program. In that role, he supervised 1.7 million registrants, including drug manufacturers, distributors, prescribers, and retailers, to enforce what he calls the "closed circle of distribution" of controlled substances. Though most people assume DEA agents spend their careers battling heroin and cocaine gangs, Schiller led the team that oversaw legal drugs, mostly prescription opioids.
Schiller rose to national prominence, never a goal for DEA agents, following a three-year investigation into the illegal distribution practices of one otherwise legitimate pharmaceutical distribution company with a familiar name. He and his team exposed the role McKesson Corporation played in exacerbating the national opioid addiction crisis.
According to the Washington Post, "The team, based out of the DEA's Denver field division, had been examining the operations of the nation's largest drug company, McKesson Corp. By 2014, investigators said they could show that the company had failed to report suspicious orders involving millions of highly addictive painkillers sent to drugstores from Sacramento, California to Lakeland, Fla. Some of those went to corrupt pharmacies that supplied drug rings."
To Schiller's chagrin, McKesson and government lawyers reached a settlement agreement that left the drug company's operations intact. He had expected his efforts would have resulted in the company being decertified as a distributor. "It was insulting," Schiller said at the time. "Morale [at the DEA] has been broken because of it."
We met Mr. Schiller at a recent home care telehealth conference and asked him about his history with the DEA and about his December, 2017 "60 Minutes" appearance that gave him a chance to tell the nation the entire story of how a team of high-paid lawyers helped the nation's fifth largest corporation escape the consequences of its actions.
Schiller came to Las Vegas to deliver an important — some might say life or death — message to hospices and their clinicians. When a person dies under their care, residential hospices are now authorized to dispose of leftover controlled substances (see references in footnote one about the 9/9/14 DEA final rule and in footnote two regarding the 2/22/19 EPA ruling). In-home hospice service providers are "encouraged" to do the same. This is the result of a bill that was signed into law on October 24, 2018 after its three-year journey through Congress. The pertinent section of the 600-page law known as HR6, section 3222, was written by NAHC President Bill Dombi.
The problem the law was intended to solve is that disposal into the sewer system is illegal because it contaminates water systems. You cannot simply flush controlled substances. In addition, transporting opioids to EPA incineration centers is both expensive and potentially vulnerable to hijacking while in transit. Some hospices may have been doing the right thing, carefully disposing of morphine, oxycontin, and other opioids before, but they were not permitted to do so, nor did they have access to proper methods.
Schiller had several messages for in-home care providers at the Telehealth 2019 conference, put on by Connected Home Living:
The ideal disposal method is to "drown" dangerous pharmaceuticals in a solution that neutralizes them and makes it impossible for addicts to reconstitute them. This is what brought David Schiller to a healthcare conference. He was introducing hospice and other providers to "NarcX™, a chemical solution that meets both needs and induces vomiting in anyone who attempts to consume the pills by consuming the solution.
NarcX is available in a container as small as a soda can and as large as 55-gallon drums, with up to 330 gallon containers available for industrial destruction centers. A hospice nurse attending the passing of a patient can drop hundreds of leftover pills into the smaller container. She can safely transport it from one home to the next, for months if necessary, until it has reached its capacity.
Diverting controlled substances is defined as transferring them from the one to whom they were prescribed to someone else. Pills deposited in a NarcX solution are immediately rendered non-divertable. Within moments, never longer than two hours, they also become completely non-retrievable -- defined as showing 0.00% detectable opioid content. Pills can be added to a single container for six to twelve months before it is recommended that the canister be disposed. A full container remains environmentally safe and can be discarded with normal home or office trash.
"Our disposal method is safer than transporting dangerous controlled substances to incineration facilities, and it saves hospices thousands and hospitals millions of dollars annually," he told us. "Plus, the solution is all natural, which means it is environmentally friendly when discarded." NarcX, he added, is the only DEA/CFR-compliant liquid solution disposal method.
Pricing for all sizes of NarcX containers and a list of frequently asked questions are available on the company web site. narcx.com
1 Disposal of Controlled Substances: https://www.deadiversion.usdoj.gov/fed_regs/rules/2014/2014-20926.pdf
21 CFR Parts 1300, 1301, 1304, 1305, 1307, and 1317 [Docket No. DEA–316] RIN 1117–AB18 Disposal of Controlled Substances
Federal Register 9/9/14
"If a person dies while lawfully in possession of a controlled substance for personal use, any person lawfully entitled to dispose of the decedent’s property may deliver the controlled substance to another person for the purpose of disposal under the same conditions as provided for ultimate users." This rule provides a number of options for ultimate users and persons lawfully entitled to dispose of a deceased ultimate user’s property to safely and securely dispose of pharmaceutical controlled substances, yet the DEA does not require ultimate users to utilize these options. However, it is unlawful for ultimate users to transfer pharmaceutical controlled substances to unauthorized persons, and it is unlawful for unauthorized persons to receive such substances. It is also unlawful for any person to possess a controlled substance unless authorized to do so under the CSA (i.e., an ultimate user, an entity registered with the DEA, or an entity exempt from registration with the DEA). 21 U.S.C. 844(a). Home hospice and other homecare providers are encouraged to assist their patients, and their patients’ families, in disposing of pharmaceutical controlled substances in accordance with the CSA and its implementing regulations. While education is paramount, home healthcare agencies are also encouraged to partner with authorized collectors to promote or jointly conduct mail-back programs.
2 Management Standards for Hazardous Waste Pharmaceuticals: https://www.federalregister.gov/documents/2019/02/22/2019-01298/management-standards-for-hazardous-waste-pharmaceuticals-and-amendment-to-the-p075-listing-for
©2019 by Rowan Consulting Associates, Inc., Colorado Springs, CO. All rights reserved. This article originally appeared in Tim Rowan's Home Care Technology Report. homecaretechreport.com One copy may be printed for personal use; further reproduction by permission only. firstname.lastname@example.org