Description:
Objective: This topic addresses the need to fund research and development activities to promote the commercial development and testing of an inexpensive prescription medicine disposal system that would provide a simple means for patients (prescription drug “end-users” defined by the Drug Enforcement Administration) or members of their household to safely render prescription drugs unusable and effectively contained in order to minimize the potential for diversion or accidental exposure to children or pets. Methods proposed may include approaches or agents that mechanically destroy or chemically neutralize prescription drugs for either safe home disposal or safe transit for disposal by another facility. For example, such a product or agent could be distributed by practitioners and pharmacies along with scheduled medications. As an ancillary benefit, such a product holds the potential to minimize drugs entering the watershed and other adverse environmental effects.
Background
Last year in America, 210 million prescriptions for opioids were written- enough medication for every American to have a 30-day supply. Nearly every American household will at some time be in possession of controlled substances. A large percentage of prescription medicines are never used or are used in much smaller quantities than prescribed. For example, a recent study showed that among upper extremity surgery patients, who were prescribed an average dose of 30 narcotic pills, approximately half only used 2 days worth of pills or fewer Rodgers et al 2012). This illustrates how leftover medicine is a large problem. Death of an elderly family member or medication changes can also result in surplus controlled substances in the home.
Results from the most recent (2010) National Survey on Drug Use and Health (NSDUH) show prescription drug misuse is generally initiated via “diversion”- when people are given psychoactive pills (or steal) from friends or relatives. Accordingly, safe drug disposal is a pillar of the President’s Prescription Drug Strategy http://www.whitehouse.gov/sites/default/files/ondcp/issues-content/prescription-drugs/rx_abuse_plan_0.pdf (page 7) and Drug Enforcement Administration (DEA) is in the process of rulemaking on the Secure and Responsible Drug Disposal Act of 2010. This rulemaking likely will involve a combination of take-back and other means to return medication to facilities with incinerators.
Aside from cost, one problem with all such programs is the drug remains available to use/misuse/abuse until incineration or other final disposal. Currently, DEA provides labor-intensive prescription drug disposal “takeback” programs that visit sites to collect unused medications from households (e.g. http://www.deadiversion.usdoj.gov/drug_disposal/non_registrant/transcript_diposalmtg_011911.pdf). Federal sponsorship of this program underscores the high interest in this problem.
Although there are products like drug shredding machines that are deployed in nursing homes and other care-giving venues www.ultimateproducts.us/DrugShredder.htm#features, there are few alternatives for safe medication removal by patients in the home. For most scheduled medicines, the Food and Drug Administration (FDA) recommends mixing the medicines with coffee grounds or kitty litter and then throwing these medicines in the trash. This process presumes availability of such material in the household. Notably, in addition to risk of diversion, household disposal of some medications in solid waste (especially in transdermal patches) http://www.fda.gov/Drugs/DrugSafety/ucm300747.htm can create hazards to children and pets.
FDA has recommended that only a subset of medications be flushed - http://www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm. Flushing some types of unused medications into the water supply can create environmental hazards and is only recommended for medications that pose the most imminent risk if accidentally ingested.
An in-home prescription medicine deactivation or disposal system would meet the goal of having an immediate method to render unused medicine harmless. Recent advances in technology offer the opportunity for companies to add technology-based features such as mobile phone applications that could include medication expiration dates and disposal reminders.
Families with small children and pets are likely audiences for this product in terms of prevention of poisoning. As such, sales of this product may benefit from positioning by child-proofing and pet-proofing products. Parents of teenagers (particularly teens who are known to have experimented with alcohol or marijuana) are likely consumers of this product as well. At home drug test kits are routinely sold in pharmacies, and positioning this product near opioid test-kits is a natural marketing strategy. Finally, “green” consumers, interested in reducing their environmental impact may consider such a product for its environmental benefits.
Phase I Activities and Expected Deliverables
This SBIR topic will help address the need for safe, at-home deactivation of divertible medications for home disposal in solid or liquid waste or before transit for third-party disposal. It is expected that potential offerors can demonstrate with preliminary data that agents or devices in their proposals (such as chemical-based drug-deactivating agents, nanomaterials or mechanical processes) will inactivate the proposed chemical class of psychoactive medication and its medium of delivery (e.g. tablet, capsule, or patch) in direct application (not embedded in a device or product). It is not expected that a single agent or device would be suitable or capable of deactivating all classes of medication or deactivating across all forms of medication delivery.
Specifically, the contractor will be provided with funding to develop this agent or device into a consumer-friendly, low-cost, and simple-to-use product for home use that contains the drug-deactivating device or agent, into which medication may be dropped, inserted, mixed or adhered for inactivation and disposal.
Phase I testing should include testing the product for ease of portability, storage, and use. The device or product should be able to be handled and transported by an elderly or physically-challenged consumer. Because repeat use of this type of product hinges on the user experience being at minimum not unpleasant, focus groups may address ease of use and aesthetic factors for the “disposal system”. Phase I may also include development and testing of materials such as instruction sets, educational materials, calendars, and mobile applications to facilitate use the product.
Deliverables will include:
1. Product usability testing to establish that the product can be easily used by the targeted users, including elderly patients and their caregivers, families with young and teenage children (particularly women). For example, testing should assess the degree to which having to open the medication container for inactivation of its contents paradoxically introduces exposure and toxicity risk. Additionally, tests should ensure the product provides an optimized aesthetic experience (i.e., does not emit unpleasant or noticeable odors) and is amenable to cleaning, if the product is a reusable device.
2. Market research to determine how the proposed product could either compete with, compliment, or assist existing drug-disposal schemes, like in-person drop-off boxes at participating pharmacies or programs that provide mailers to consumers to mail unused medications to an incineration service. This research should be geared toward determining whether the product would have a market for direct sales to families, or would be best distributed by pharmacies as part of the costs of scheduled drug dispensing. Notably, the product should have a unit cost low enough to be either sold readily directly to consumers or distributed routinely with medications and prescriptions along with patient information sheets.
3. Risk-assessment and solutions for product liability issues with regard to incompletely-deactivated medications, such as from misuse of the product. 4. Toxicology assessment to demonstrate that the agent or product itself (or as an amalgam with a medication), is non-toxic and either directly disposable or eligible for transport by the postal service or other commercial carriers.
Phase II Activities and Expected Deliverables
Projects that demonstrate feasibility, safety, and marketability of the product/device in Phase I may be extended into Phase II. In Phase II, the offeror will be expected to have packaged the deactivating agent or device in a deployable form for mass-distribution. In addition, in Phase II the offeror will be expected to conduct assays, tests or surveys to assess:
1. Degree of adherence by prescribers, pharmacies, and/or home users
2. Whether use under normal household conditions improves outcomes (e.g., reduces calls to poison centers, changes total medication reported used or total medication reported destroyed). Such a test should include random or quasi-random assignment of patients and families typically prescribed narcotics and likely to have leftover medicine (e.g., acute injury patients or patients undergoing orthopedic surgery.) Because certain individuals are at high risk for substance misuse it is recommended investigators stratify assignment based on whether people have a history of a substance use disorder, chronic pain, or mental illness.
3. The classes of chemical compositions or delivery systems of medicines (transdermal patch, tablets, capsules) for which the device or agent is most effective or exclusively effective. This might be specific individual medicines.
4. Adverse events from use of the product
5. The durability or shelf-life of the product, so as to establish and provide expiration dates of products that use chemical or nano-particle based inactivating agents.
6. Development of ancillary materials to ensure adoption and consistent use- such as educational and public-awareness materials, a programmable adherence application for a mobile phone, or paper reminder calendars.
