Researchers Submit Patent Application, “System and Method for Monitoring Drug Delivery”, for Approval (USPTO 20230123761): Patent Application

2023 MAY 09 (NewsRx) -- By a News Reporter-Staff News Editor at Insurance Daily News -- From Washington, D.C., NewsRx journalists report that a patent application by the inventors Giles, Michael (Dallas, TX, US); Jayaraman, Avinash Prasanna (Chicago, IL, US); Macris, Dimitri (Dallas, TX, US); Menchaca, John Thomas (San Antonio, TX, US), filed on November 9, 2022, was made available online on April 20, 2023.

No assignee for this patent application has been made.

News editors obtained the following quote from the background information supplied by the inventors: “Opioids are used for a variety of purposes such as treating pain, mental disorders, and physical disorders, among others. Opioids are powerful and in many cases addictive. As such, regulating adherence to opioid regimes is important not only to patients but their families and medical workers.

“Opioid use disorder (“OUD”) and addiction remain prevalent in the U.S. and worldwide. Over three (3) million Americans and sixteen (16) million individuals worldwide have had or currently suffer from OUD. Roughly 21-29% of patients prescribed opioids for chronic pain misuse them, and between 8-12% develop an OUD. The use of opioids to treat OUD is subject to federal regulations beyond those that apply to the same medications used for other purposes (e.g., treating pain).

“Federally certified opioid treatment programs (“OTPs”)-often called methadone clinics-offer these medications alongside counseling and other services for OUD patients. With few exceptions, the use of methadone to treat opioid addiction is limited to OTPs certified by the Substance Abuse and Mental Health Services Administration (“SAMHSA”). A patchwork of state and local regulations often mandates further regulatory burdens, which limit the number and distribution of OTP locations.

“OUD and opioid addiction affect individuals from all socioeconomic and educational backgrounds. The consequences are devastating, including the rising incidence of neonatal abstinence syndrome due to opioid misuse during pregnancy, and the spread of infectious diseases such as HIV and hepatitis C due to the increase in injection drug use.

“The treatment for OUD can be a sensitive topic which individuals may wish to keep private. Accordingly, anonymity and autotomy are highly valued by both patients and care providers. A telehealth medication monitoring system satisfies the need for anonymity and autotomy however such known systems suffer from a lack of security, versatility to use different forms of medication, incentives for adherence to dosage regimes, and workflow automation for clinicians. Known systems fail to find a balance between patient privacy and autonomy against regulation and monitoring medication dosage, especially highly regulated and addictive substances, while also providing clinical workflow automation and clinic incentives. Furthermore, telehealth systems have the added difficulty of compliance with Health Insurance Portability and Accountability Act (“HIPAA”) where sensitive information is being transferred to/stored in remote locations.

“Medication-assisted treatment (“MAT”) with methadone, buprenorphine, or naltrexone is central to the treatment of OUD. Although all three medications are effective, they are not equivalent or interchangeable. Methadone is a proven and effective opioid medication used to treat OUD, shown to extend retention in treatment programs, reduce overdose death rates and further illicit drug use. Methadone is a full opioid agonist that binds to and activates opioid receptors in the brain. It suppresses withdrawal symptoms in detoxification treatment and controls the craving for opioids in maintenance treatment. Naltrexone requires detoxification prior to initiation, which can be challenging and painful. The risk of relapse during this process is substantial and is a significant barrier to antagonist medications. Buprenorphine, a partial opioid agonist, is less addictive than methadone but less effective in detoxification and maintenance treatment, and utilization remains low (around 20% of OUD sufferers). Accordingly, strict adherence to medication dosage regimes is highly important.

“According to SAMHSA, the greatest barriers that keep individuals with OUD from receiving treatment are as follows: 1) accessibility, to be compliant with federal laws concerning methadone overdose and diversion risk, OUD patients must visit a specialized clinic daily for directly observed dosing. This prevents many patients from receiving methadone due to a variety of reasons including geography, personal and work obligations, travel, and access to transportation; 2) acceptability, all non-methadone medications require some form of highly uncomfortable opioid detox prior to treatment initiation. Many OUD sufferers are unwilling to undergo detox and instead continue to use opioids illicitly; 3) availability, opioid treatment programs do not exist in 39% of counties nationally. Individuals living in rural areas report higher rates of prescription opioid misuse than urban residents, yet only about 3% of all opioid treatment programs are located in rural areas; 4) privacy, individuals, especially those living in rural locations, commonly cite privacy as a barrier to starting OUD treatment. Concerns include being the subject of gossip or marginalization.

“Medication monitoring systems known in the art include the etectRx ID-Cap, the SMRxT NOMI vial system, AiCure, Welldoc, Medisafe, DynamiCare Health, Kaden, Ophelia, Boulder, Workit, and Emocha.

“The etectRx ID-Cap system uses a consumable microchip to monitor drug delivery. This system notably requires the ingestion of a microchip. Patients have expressed that ingesting a microchip is overly invasive. The use of a microchip adds substantial cost.

“The SMRxT NOMI vial system tracks contents removed or added to a smart vial. This system notably lacks the ability to verify what is added to the vial, or that whatever is removed from the vial is consumed.

“The AiCure applies machine learned algorithms to video data to track adherence to pill-based regimes. By recording a patient’s facial expressivity, verbal acoustics, speech characteristics, and patterns of movement in conjunction with visually confirming the taking of medication, AiCure attempts to report clinical trial results remotely. This system notably does not employ tamper-evident packaging, or tamper-evident bar code or near field communication (NFC) labels.

“Welldoc system uses tablet-based adherence tracking and is unable to track liquid medication. The Welldoc system also uses generic workflow management which limits efficiency. The Medisafe system suffers from similar problems.

“DynamiCare Health is a contingency management system that does not implement medication tracking and dosage regime adherence.

“The Kaden system is unable to track liquid medication while the Emocha system has insecure medication tracking, and no workflow automation for clinicians.

“The Ophelia, Boulder, and Workit systems are not suitable for use with all types of medication, including specifically methadone, and these systems lack workflow automation for clinicians.

“Furthermore, known systems work only with pill-based medication. The present invention works with any type of medication, including pill-based, liquid-based, and aerosol medication.

“Other deficiencies of known systems include a lack of patient engagement to adhere to dosage regimes, providing support though addiction and OUD treatment.”

As a supplement to the background information on this patent application, NewsRx correspondents also obtained the inventors’ summary information for this patent application: “When asked: “instead of going to the clinic daily, would you be willing to send your doctor brief daily videos of yourself taking methadone?”, 88% of survey participants responded “yes”. For these and other reasons known to a person of an ordinary skill in the art, what is needed is a secure telehealth system for monitoring drug delivery.

“The present teachings are designed to address the aforementioned hurdles while mitigating safety and diversion risks beyond what is possible with currently available technologies. By offering an OTP-specific telemedicine solution that supports methadone, the present invention has the potential to significantly expand access to this life-saving therapy.

“A goal of the present teachings is to provide a unique telehealth platform that aligns incentives and brings value to each of the “three P’s” of healthcare: patients, providers, and payors.

“For patients, the present teachings address the four main barriers to treatment: accessibility, acceptability, availability, and privacy. Patients commonly cite privacy as a barrier to treatment-especially those living in rural locations. For example, patients often need to publicly line up outside a clinic daily for hours. Access to treatment via telehealth will not only protect privacy but also reduce travel time, saving patients on average 13 hours per month.

“For providers, the present teachings may 1) enhance clinical decision-making by providing previously unknown medication handling and adherence data, 2) save time (e.g., AI-enhanced workflow allows batch processing of multiple dosing sessions at once), and 3) lead to improved treatment initiation and retention rates, therefore increasing providers’ revenue over time (e.g., up to 40% more revenue per patient/month compared to in-person workflows).

“For payors, the enhanced access to quality care provided by the presently disclosed system may lead to reduced healthcare resource utilization by OUD patients (for instance, less visits to the ER).

“Another goal of the present teachings is to provide a system to track medication dosing adherence remotely and reliably and provide patient autotomy. Patients cite the burden associated with daily visits, such as long drives and the cost of gas. The present invention seeks to provide a solution that will not only address common barriers to receiving treatment, but also alleviate the stigma and inconvenience associated with treatments for opioid addiction.

“Another goal of the present teachings is to streamline generic workflow through remote assessments and automatic billing increasing clinic revenue. Through the present invention providers may receive the data needed to identify the medical indication required for billing new telemedicine billing codes for Medicare patients (e.g., missed dose, exemption take-home doses) or remote evaluation codes for Medicaid patients.

“Another goal of the present teachings is to create patient accountability and provider trust needed for take-home dosage regimes, especially those for at risk patients and for potentially dangerous medications.

“Another goal of the present teachings is to monitor and guide patient consumption of dangerous, heavily regulated, expensive, or epidemiologically consequential medication regimes. For example, methadone for opioid addiction, opioid-based therapy for chronic pain, and antibiotic therapy for tuberculosis.

“Another goal of the present teachings is to provide secure medication dosing though the use of multifactor authentication and/or tamper-evident codes. In addition to providing secure medication dosing the present invention also seeks to provide HIPAA compliant privacy and security measures.

“Another goal of the present teachings is to provide real time feedback on patient adherence to medication regimes to caregivers, guardians, prescribers, payors, or other stakeholders.

“Another goal of the present teachings is to provide medication adherence or non-adherence behaviors for contextually guided interventions.

“In one embodiment the system for monitoring drug delivery may include a container having a medicine disposed inside, the medicine associated with a patient and a machine-readable code on an outside of the container. The system may also include a user device having a camera and software executing on a computer readable medium for initiating recording of a video with the camera, prompting the patient to show the machine-readable code in the video, and prompting the patient to show the taking of the medicine in the video. The system may further include a computer receiving the video, the computer having a datastore with a plurality of profiles, one of the plurality of profiles being a patient profile associated with the patient and software executing on a computer readable medium for storing the video and associating the video with the patient profile, verifying the association of the medicine and the patient using the code, identifying movement of the patient in the video, and generating a score based on the verifying and the identifying, the score indicative of the likelihood the medicine was taken by the patient.

“In another embodiment the system for monitoring drug delivery may include a container having a medicine disposed inside, the medicine associated with a patient and a machine-readable code on an outside of the container. The system may also include a user device having a camera and software executing on a computer readable medium for initiating recording of a video with the camera, prompting the patient to show the machine-readable code in the video, and prompting the patient to show the taking of the medicine in the video. The system may further include a computer receiving the video, the computer having a datastore with a plurality of profiles, one of the plurality of profiles being a patient profile associated with the patient. The system may have software executing on a computer readable medium for storing the video and associating the video with the patient profile, verifying the association of the medicine and the patient using the code, identifying movement of the patient in the video, and generating a score based on the verifying and the identifying. The score being indicative of the likelihood the medicine was taken by the patient. The system may additionally include a provider device having software executing on a computer readable medium for, receiving and displaying the score and the video, receiving a user input adjusting the score; and transmitting the user input to the datastore.”

The claims supplied by the inventors are:

“1. A system for monitoring drug delivery, comprising: a container having: a medicine disposed inside the container, the medicine associated with a patient; a machine-readable code viewable from an outside of the container; a second code in an interior of the container not accessible until the container is opened; a computer configured to receive from a user device a video showing the machine-readable code, the second code, and the patient take the medicine; the computer having software executing on a computer readable medium for: verifying association of the medicine and the patient using the machine-readable code; verifying association of the machine-readable code and the patient using the second code; identifying movement of the patient in the video using a machine learning algorithm; generating a score indicative of the likelihood the medicine was taken by the patient by weighing factors comprising verification that the medicine is associated with the patient, and the identified movements of the patient.

“2. The system of claim 1, wherein the software executing on a computer readable medium for identifying movement of the patient determines whether the patient took the medicine.

“3. The system of claim 1, the computer having software executing on a computer readable medium for identifying the medicine and generating the score based on the identity of the medicine.

“4. The system of claim 1, wherein the machine-readable code is encrypted.

“5. The system of claim 4, further comprising: the computer having software executing on a computer readable medium for decrypting the machine-readable code with the second code.

“6. The system of claim 1, wherein the machine-readable code is at least one of a bar-code, a QR code, an NFC tag, and an infrared tag.

“7. The system of claim 1, further comprising the computer sending a prompt to the patient to perform an action in the video.

“8. The system of claim 7, wherein the action is a physical move.

“9. The system of claim 7, the computer sending a prompt to the user device for sound synchronized with the video, and wherein the action is saying a phrase.

“10. The system of claim 1, further comprising a datastore in data communication with said computer for storing the video.

“11. The system of claim 1, the computer configured to receive feedback from the user device, the feedback being at least one of a notification, a sound, a vibration, or a flash.

“12. The system of claim 1, the computer further having software executing on a computer readable medium for sending a notification if the score exceeds a threshold.

“13. The system of claim 12, wherein the notification prompts the patient to input a reason for why the score exceeds a threshold.

“14. The system of claim 12, wherein the notification is sent to a provider device with the video.

“15. The system of claim 1, the computer further having software executing on a computer readable medium for providing a reward to the user device if the score exceeds a threshold.

“16. The system of claim 1, further comprising: a provider device having: software executing on a computer readable medium for: receiving and displaying the score and the video; receiving a user input adjusting the score; and transmitting the user input to the datastore.

“17. The system of claim 16, wherein at least one of the video, score, and the adjusted score is used to generate scores for future videos.

“18. The system of claim 1, further comprising software executing on said computer for storing the video and associating the video with the patient.

“19. A system for monitoring drug delivery, comprising: a container having: a medicine disposed inside the container, the medicine associated with a patient; a machine-readable code viewable from an outside of the container; a second code in an interior of the container not accessible until the container is opened; a computer configured to receive from a user device a video showing machine-readable code, the second code, and the patient take the medicine, the computer having: software executing on a computer readable medium for: storing the video and associating the video with the patient; verifying an association of the medicine and the patient using the machine-readable code; verifying association of the machine-readable code and the patient using the second code; identifying movement of the patient in the video using a machine learning algorithm; generating a score indicative of the likelihood the medicine was taken by the patient by weighing factors comprising the verification that the medicine is associated with the patient, and the identified movements of the patient.

“20. The system of claim 18, further comprising: a provider device having: software executing on a computer readable medium for: receiving and displaying the score and the video; receiving a user input adjusting the score; and transmitting the user input to the computer.”

For additional information on this patent application, see: Giles, Michael; Jayaraman, Avinash Prasanna; Macris, Dimitri; Menchaca, John Thomas. System and Method for Monitoring Drug Delivery. U.S. Patent Application Number 20230123761, filed November 9, 2022 and posted April 20, 2023. Patent URL (for desktop use only): https://ppubs.uspto.gov/pubwebapp/external.html?q=(20230123761)&db=US-PGPUB&type=ids

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