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DEA-Compliant Drug Detection and Deactivation Technology to Deter Opioid Theft in Hospitals for Next Generation Controlled Substance Diversion Prevention Program (CSDPP)

Description:

 

DEA-Compliant Drug Detection and Deactivation Technology to Deter Opioid Theft in Hospitals for Next Generation Controlled Substance Diversion Prevention Program (CSDPP)

Fast-Track proposals will be accepted.

Number of Anticipated Awards: 3-4

Budget (total costs, per award): Phase I: up to $225,000 for up to 6 months; Phase II: up to $1,500,000 for up to 2 years

PROPOSALS THAT EXCEED THE BUDGET OR PROJECT DURATION LISTED ABOVE MAY NOT BE FUNDED.

In addition, NIDA strongly encourages the offerors submitting a proposal to this Topic to include potential participation in the I-Corps™ at NIH program within its Phase I proposal. For details about the I-Corps™ at NIH program see Section 2.5.

Background:

With an increasing number of opioid prescriptions and related opioid misuse and abuse, health care facilities have become sites for diversion of controlled substances. Unfortunately, the diversion of opioids in hospitals is common and can lead to serious patient safety issues, harm to the diverter, and significant liability risk to the organization. The lack of efficient security regarding opioid access has led to its increased diversion and/or abuse. It is estimated that 10-15% of healthcare workers (HCWs) have experience addiction at some point in their careers. The likelihood of deliberate misuse of prescription drugs in hospitals, when compared to street drugs, may rise because prescription drugs are often available and can be readily accessed. There also seems to be a misconception that misuse of drugs for stress alleviation by HCWs may be manageable because of their familiarity with the drugs that may help them to "control" its use. However, the diversion of controlled opioid substances and the associated addiction puts both HCWs and patients at high risk of harm. Issues range from inadequate pain relief to longer-term pain sequelae, and also include inaccurate documentation of patient care in the medical record, exposure to infectious diseases from contaminated needles and drugs, and impaired HCW performance.

When offerors develop their proposals, they should use the existing guidelines, for example current guidelines from American Society of Health-System Pharmacists (ASHP), that support a safe patient-care environment, protect co-workers, and discourage controlled the diversion of substances. These guidelines provide a detailed and comprehensive framework to support health care organizations in developing their controlled substances diversion programs (CSDPPs) and to protect patients, employees, the organization, and the community at-large. Ultimately, each health care organization is responsible for developing a CSDPP that complies with applicable federal and state laws and regulations and also incorporates technology and diligent surveillance to review process compliance and effectiveness, strengthen controls, and proactively prevent diversion.

The current guidelines highlight that substances returns and waste streams remain among the key sources of opioid diversion in the hospitals. Thus, there is an urgent need to develop improved technologies / surveillance systems. An improved surveillance system technology are expected to reduce waste-handling practices and to maintain chain of custody to minimize the risk of diversion. Opioid waste may include expired-date medications, medication products appropriately prepared but not administrated to the patient, and the product remaining after a partly used medication is removed from its prepared or originally packaged unit. All items should be time stamped as close to the time of preparation and administration as feasible.

Currently, there is little continuity or generally adhere to standard practices for opioid waste disposal across various health facility systems. DEA compliance is partly addressed by having two healthcare providers licensed to dispense drugs and to timely documenting the disposal of the controlled substances. The recommended procedure includes definitions of key issues, including verification of the drug label, and volume or quantity being wasted. This documentation process is time

 

consuming and not proactive. The limited tools and strategies for effective opioid waste deactivation or disposal is a key issue that may benefit from the development of more efficient and pro-active disposal systems.

There is a need for modern technologies with the integrated systems to monitor medication dispensing and disposal, provide effective diversion prevention efforts, proactively prevent diversion, and effectively confirm compliance regarding opioid waste control.

Project Goals:

The primary goal of this funding opportunity is to incentivize small businesses to develop a new commercially viable devices, tools, technologies or integrated systems for drug detection and deactivation to deter opioid theft in hospitals. NIDA envisions that a new technologically advanced system shall combine a device with analytical approaches that 1) accurately measure waste volume and/or quantities, 2) efficiently synchronize waste information with pre-existing data records, 3) deactivate the opioid waste, and 3) continuously monitor disposal of controlled substances, while securing unused portions and simplifying the process. The purpose of deactivation is to render the controlled substances to a non-retrievable state and to prevent diversion of any portion of such substance to illicit purposes.

A new technology could provide a quantitative assurance against opioid waste theft, as well as saving valuable time for auditing substance disposal data. Implementation can reduce liability risks for the hospitals, improve patient safety, and improve HCW performance. Achieving these goals are expected to contribute to the overarching goal of reducing opioid theft by bringing medical facilities into compliance and establishing next generation CSDPPs.

It is highly encouraged that offerors refer to the current guidelines, for example AHSP guidelines, for discouraging controlled substances diversion and to work with potential purchasers in order to establish a clear regulatory and acquisition/commercialization strategies.

The potential features of new device or system may include, but are not limited to:

• Hospital’s level of compliance with the current guidelines, for example AHSP guidelines;

Compliance with DEA regulations and definition of non-retrievable;

• Identification of staff disposing the opioid waste and time of disposing;

• Detection and identification of substance waste;

• Deactivation of substances with lock & key to deter diversion;

• Integration into a hospital’s data continuum (electronic medical record, internal inventory system and purchasing systems).

Phase I Activities and Deliverables

The goal of Phase I is to develop a proof-of-concept or prototype technology for opioid detection, deactivation and disposal. Offerors must clearly demonstrate the understanding of the key elements of effective CSDPP and needs for the new generation of drug detection and deactivation technologies. It is expected that the technology developed does not interfere in any way with healthcare provision. Activities and deliverables should include:

• Identify and justify the development of a technology for opioids detection, deactivation and disposal in hospitals.

• Identify the key features of a technology to be compatible with existing hospital systems. Design the core structure and process architecture that further optimize the detection and minimize the occurrence of controlled substance diversion.

• Describe the current state of the art technologies and approaches controlled substance detection, deactivation and disposal and outline the advantages that new approaches will provide for CSDPP.

• Describe how a technology is compliant with DEA, EPA, and ASHP regulations and guidelines.

• Specify and justify quantitative milestones that can be used to evaluate the success of a technology being developed.

• Develop an assay or system for testing and benchmarking the specificity and sensitivity of a technology. Develop milestones to compare it to existing approaches.

• Demonstrate utility and technical validly of a technology in a laboratory study.

Develop a device or system prototype and describe the architecture of its integration to the modeled CSDPP. Provide an example of a proof-of-concept standard operation procedure (SOP) for incorporation of the innovative approach to CSDPP.

Phase II Activities and Deliverables

The goal of Phase II is to develop and test the technology to deter opioid theft in clinical setting and optimize for CSDPPs in hospitals. These activities should support commercialization of the product with varying complexity.

Decisions for continued product development into Phase II will be based on:

• Successful proof-of-concept data demonstrating adaptively of the product to the key elements of the best practice of CSDPPs.

• Evidence that the technology can be scaled up and compatible with the general hospital’s procedures and DEA/ EPA/ ASHP regulations.

• Evidence for commercialization feasibility by providing feedback from potential purchasers and end-users.

Activities and deliverables in Phase II include:

• Demonstrate high accuracy and reliability of the device or technology.

• Demonstrate superiority over currently available tools and procedures.

• Enhance and validate the technology in the pilot study. Demonstrate utility and capability of the technology in clinical setting.

• Provide a report that synthesizes feedback from all relevant categories of end-users (such as physicians, nurses, pharmacists, administration of pharmacy service and hospital) and summarizes the modifications made the technology after usability testing.

• Further enhance and refine the systems for deployment in diverse software environments and provider network. Provide a report detailing the communication systems architecture and capability for data reporting to hospital’s administration.

• Refine SOPs to allow friendly implementation of the tool by the target market.

• Provide a report detailing plans for obtaining DEA regulatory approval and implementation to the market.

References:

ASHP Guidelines on Preventing Diversion of Controlled Substances:

http://www.ajhp.org/content/ajhp/early/2016/12/22/ajhp160919.full.pdf?sso-checked=true

Drug Enforcement Administration, 21 CFR Parts 1300, 13001, 1304, 1307, and 1317. Disposal of Controlled Substances. Federal Register, v.79, No174 /Tuesday, September 9, 2014/Rules and Regulations


 
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