Melrose Pain Solutions Method and Algorithm: Managing Pain in Opioid Dependent Patients

Abstract

The present invention provides a novel, comprehensive approach for the effective, safe and compassionate management of pain and opioid dependency, both in inpatient and outpatient settings, through the various stages of patient contact with the current healthcare system (e.g. initial encounter, treatment initiation, inpatient care, discharge, and post-discharge/chronic management) via innovative methods and treatment algorithms that provide consistent, repeatable and material advances in potential and high-risk, opioid-dependent patient management.

Claims

1. An algorithm-based system by which potential and current high-risk, opioid dependent patients are assessed and evaluated via a predetermined set of objective and subjective criteria to determine a safe, effective and consistent mode of treatment that creates a protocol for complex opioid utilizing and opioid dependent patients in both inpatient and outpatient settings.

2. The algorithm-based system of claim 1, wherein patients are treated uniformly, by all system participating healthcare providers, based on a set number of predetermined measurements where each patient is classified according to need and capability and special attention is paid, in the Initial Encounter to determine under Initial Presentation Diagnosis, Differential Diagnosis, and Early Treatment Factors a patient’s designation according the following: Initial Presentation Diagnostics and Tests s) Locus or Loci and source of pain (e.g. chronic pain, trauma, post-operation pain, cancer pain, trip and fall, abscess from cellulitis, etc.) Differential Diagnosis (Establishing Low v. High Risk Patients) a) History of pain (duration and origin) Or History of pain relief: (non-opioid analgesics, opioid analgesics -high and low dose) b) Patient claiming multiple drug allergies/specific requests e.g. specific drugs and routes of administration) c) Objective evidence of withdrawal d) Leaving the floor frequently e) History of controlled substance (e.g. opioid) use f) History of controlled substance (e.g. opioid) abase g) Frequent/multiple hospital admissions h) History of illicit drug use i) Evidence of drug use i. Abscess/cellulitis from IVDA ii. Claim of spider bite/MRSA j) Recordation of attempts at detoxifying k) Evidence of drug (illicit- and non-illicit) use through: Drug/Toxicity screen for drugs and/or alcohol PIMP (Prescription Drug Monitoring Programs) Patient requesting a certain route of administration Patient stating several drug allergies to lower schedule drugs (e.g. tramadol) or non-scheduled drugs (e.g. NSAIDs) Demanding/Difficult patients Patient asking for Benadryl®, benzodiazepines (i.e. Valium®, Xanax®, Ativan®), or muscle relaxants (e.g. Soma®) in addition to opioid Medical Record Review Oral History of drug and alcohol consumption History of certain or particular opioid use (e.g. OxyContin®) Methadone use History of large quantity of short acting opioids Previous DUIs Early Treatment Factors a) Contraband search as needed b) Restriction of visitors as needed c) Checking PDMP d) Confirming what narcotic medications patient has at home e) Call methadone clinic and conform last appointment f) History of paying cash for medications g) Accessing whether or not patient has insurance (as this may affect treatment options and substance abuse therapy prospectively).

3. The algorithm-based system of claim 1, wherein patients are treated uniformly, by all system-participating healthcare providers, based on a set number of predetermined measurements and whereas each patient is classified according to need and capability, where special attention is paid, in the Treatment Initiation Phase, to determine under Additional Test and Data, Treatment Efficacy, and. Treatment Decisions a patient’s designation according to, and in light of the following; Additional Test and Data Points a) Urine Toxicology Screen b) PDMP (Prescription Drug Monitoring Program(s)) c) ER work-up d) Self-reported opioid use Treatment Efficacy a) Measurement of Pain Scores (via hospital protocol) b) Recording, of vitals c) Documenting sleep patterns d) Monitoring disruptive behavior (aggressiveness, demanding behavior, hostile, threatening or intimidating behavior) e) Moni Wring calls to nursing staff and doctor (via nursing staff) Treatment Decisions (based on Initial Presentation and Differentia Diagnosis) LOW RISK PATIENTS a) Opioids/Opiates for low-risk patients (oral, transdermal or PCA); or HIGH RISK PATIENTS b) Short time opioid PCA or Buprenorphine (Belbuca®, Bunavail®, Buprenex®, Butrans®) and/or buprenorphine/naloxone (Subutex®, Suboxone®).

4. The algorithm-based system of claim 1, wherein patients are treated uniformly, by all system-participating healthcare providers, based on a set number of determined measurements and whereas each patient is classified according to need and capability, where special attention is paid, in the Inpatient Care Phase, to determine, wider Additional Test and Data, Treatment Efficacy, and Treatment Decisions a patient’s designation according to and, in light off, the following: Additional Data Tests and Data Points a) Good pain control - continue therapy b) Inadequate pain control --- modify therapy c) Improved NPO status (Nothing by Mouth) - introduce oral (PO) medications including opioids or buprenorphine and/or buprenorphine/naloxone Treatment Efficacy a) Assess pain score b) Assess vital signs for withdrawal c) Continue monitoring drug screens for possible inconsistency d) Monitor behaviors and truthfulness of patient Treatment Decisions a) Patient well controlled - continue treatment b) Patient poorly controlled - adjust treatment and consider adjuvant of buprenorphine and/or buprenorphine/naloxone or single buprenorphine and/or buprenorphine/naloxone therapy c) Identify inconsistences on therapy d) Continue to monitor pain control.

5. The algorithm-based system of claim 1, wherein patients are treated uniformly, by all system-participating healthcare providers, based on a set number of predetermined measurements and whereas each patient is classified according to need and capability, where special attention is paid, in the Discharge Phase, to determine under Additional Test and Data, Risk of Recurrence Mitigation, and Treatment Decisions a patient’s designation according to, and in light of, the following! Additional Tests and Data Points a) Review PDMP to determine the appropriateness of discharge medications b) Determine presence or absence of insurance coverage to lessen the hurdles to patient access to (1) affordable medication per insurance formulary; (2) affordable treatment post discharge, and (3) substance abuse treatment Risk of Reoccurrence Mitigation a) 7-day supply of pain medication is provided at time of discharge with a guaranteed appointment within that 7-day period b) Referral to substance abuse treatment where appropriate via social services or private concern Treatment Decisions a) 7-day supply of medication and guaranteed appoint within that 7-day period b) Referral to substance abuse treatment facility or private practice (where applicable).

6. The algorithm-based system of claim 1, wherein patients are treated uniformly, by all system-participating healthcare providers, based on a set number of predetermined measurements in the Chronic Management Phase to provide the patient sufficient medication to treat the patient’s pain for 1 week and allowing the patient sufficient time of 1 week to follow up with either the Melrose Pain Solutions® team, via a guaranteed appoint, or other qualified healthcare providers, or to coordinate with hospital staff prior to discharge to attain the proper social services.

7. The algorithm-based system of claim 1, wherein each phase (Initial Encounter, Admission, Inpatient Care, and Discharge) have tied to them time, location and staff components that better utilizes limited resources, further enhances the systems’ goals of timely and adequate pain control, and facilitates overall better healthcare to patients as follows: Initial Encounter a) PCA placement and use initiates faster pain control with less need for nursing intervention b) Buprenorphine and/or buprenorphine/naloxone delivers pain control for longer periods with less need for nurse intervention c) Greater communication, a concerted group approach, and single system utilization between and among healthcare providers provides less redundancy and duplicative action in. the Melrose Pain Solution® system Admission a) Time location and staff component carries with it the benefit of knowing which steps were taken and at what time in an effort to optimize timely pain control (e.g. within the optimal time of 30 minutes to 6 hours) Inpatient Care a) Time location and staff components lead to optimum pain control, increased patient compliance, higher staff satisfaction rates, and higher HCAP scores, Discharge a) With a temporal emphasis, the. Melrose Pain Solution® system seeks to i. provide prescription(s) well in advance of patient leaving the facility ii. recommends filling prescription on-site when possible (beds-to-meds) iii. deliver substance abuse referrals as appropriate.

8. The algorithm-based, system of claim 1, which allows for gathering, tracking, sharing, analyzing, utilizing, storing and retrieving of patient information, in a real time and confidential., password secured database, among a health worker peer network to better to a€ k and trace potential and current opioid-dependent patients via an computer program or computer application running on a computer system, further ‘herein the application may be operated using computer hardware, including a computer processor capable of securely safeguarding protected patient information (PPI).

9. The algorithm-based system if claim 1, which allows for tracking and sharing of patient information, in a real time and confidential, password-secured database, among a health worker peer network to better track and trace potential and current opioid-dependent patients via a mobile device (e.g. a mobile application or software application) running on a mobile computer system, further wherein the application may be operated using computer hardware, including a computer processor capable of securely safeguarding protected patient information (PPI).

10. The algorithm-based system of claim I that incorporates a means of transmitting and providing password-secured or otherwise selectively available and authorization verifiable access via an internet website Where the primary system is parsed into several “subsystems” that allow for a more specific, honed and tailored treatment protocol for each individual patient.

11. The algorithm-based system of claim 1 that incorporates a means of transmitting and providing password-secured or otherwise selectively available and authorization verifiable access via a computer or mobile device and via interact website in use as a tool in providing telemedicine to rural areas.

12. A method for managing and tracking potential and active opioid-dependent patient data for the maintenance and management of treatment of an opioid-utilizing or opioid-dependent pain treatment patient., said method comprising: establishing clinical criteria and protocol for the assessment, evaluation and placement of patients into categories and sub-categories based on patient presentation, patient history, diagnostic questioning and tests, and a differential diagnosis by a trained healthcare professional upon the initial encounter, in emergency department or urgent care settings, and determining (a) level of pain control, (b) level of opioid use, (c) level of opioid dependency, and (d) clinical stability placing patient into one of two categories (a) outpatient or (b) inpatient (hospital admitted); treating outpatient individuals with (a) 3 to 7-day supply of opioids with pain physician referral for continued care or (2), after verifying opioid abuse through a state controlled substances monitoring program (e.g. PUMP -Prescription Drug Monitoring Program) and integration of additional considerations as to opioid usage, dispensing non-opioid medications or (3) dispensing buprenorphine and/or buprenorphine naloxone with referral to a detoxification center or dependency drug authorized dispenser; treating inpatient (hospitalized) patients, through additional testing, varying data points determinations, and treatment decisions, with (1) continued patient controlled analgesia pump, oral or transdermal opioid with or without a non-opioid analgesic, (2) acute buprenorphine and/or buprenorphine/naloxone with a transition to a maintenance buprenorphine and/or buprenorphine/naloxone, or (3) short-acting opioids, with a transition to maintenance buprenorphine and/or buprenorphine/naloxone; discharging patients after observation and subsequent stabilization with an establishment of risk/likelihood of reoccurrence and outpatient treatment plan (taking into consideration possible suboptimal pain therapy regimen, ineffective therapies, inability to take certain formulations, long-acting versus short-acting opioids and history of substance abuse) tip to and including modification of current drug treatment and possible inclusion of buprenorphine and/or buprenorphine/naloxone.

13. The method according to claim, 12 wherein a plurality of program possibilities are established, and one direction of treatment best suiting the patient’s needs and abilities is selected based on a set protocol for complex opioid utilizing and opioid dependent patients in both inpatient and outpatient settings.

14. The method described in claim 12 wherein a plurality of program possibilities ate established, and one direction of a treatment best suiting the patient’s needs and abilities is selected, at time of initial assessment, based on a set protocol for complex, opioid utilizing and opioid dependent patients (n bode inpatient and outpatient settings) where reevaluation and reassessment, at some time after initial assessment reveals the necessity to restructure and reimplement an evolved and revised treatment plan resulting in a new treatment direction.

15. The method of claim 12, further compromising: providing a means to track, trace, store, analyze, retrieve and electronically display the number of prescriptions (and number of individual dosages) received by a specific patient, providing a means to track, trace, store, analyze, retrieve and electronically display the number of emergency department or urgent care settings visited by a specific patient a given period of time, providing a means to track, trace, store analyze, retrieve and electronically display the number of prescribers prescribing for a specific patient in a set or variable period of time; displaying, in a graphical display, via a computer interface, application or mobile application, a graphic representation of prescriptions and unit dosage received, the number of prescribers prescribing, and the number of urgent care and ER visits of a specific patient.

16. The method of claim 12, further compromising: providing a means for determining the risk or level of opioid use or activity of an individual during set or variable periods of time and storing said information regarding the risk or level of opioid use; calculating and analyzing the cumulative opioid intake or morphine equivalent intake the period of time; storing, retrieving, and displaying, in a graphical display, via a computer interface, application or mobile application or mobile application, a comparison of the opioid usage and intake for the period of time.

17. The method according to claim 12, wherein a plurality of programs are established and one best suiting the patient’s needs or capabilities is selected and possibly reselected based on changing patient variables and reevaluations and reassessments based on such variables in progression to a new treatment plan.

18. The method of claim 12, further compromising: an interactive system that may optionally include one or more audio inputs (e.g. microphones) and outputs (e.g. speakers) and/or video capabilities, and accompanying hardware and software components that allow a user to listen to audible components from a file (on a computer, web interface, mobile application, or a combination of the three) and/or watch recorded content, where the interactive system may also optionally include a microphone and accompanying hardware and/or software audio visual components that allow a user to record his or her own audio and idea input which, for instance, can be transcribed and stored allowing a healthcare practitioner to contribute additional information, e.g. regarding a patient’s status.

19. The method of claim 12, further compromising: the capability to mathematically sort, store categorize, classify, and present information in the aggregate, without referral to a specific patient, to further the understanding of opioid dependency and to allow for greater insight and understanding of opioid abuse, resulting in more effective, adaptive future treatment choices and decisions, the ability to display cumulative data numerically, graphically, or in such a manner when the statistical data accumulated can be better interpreted or understood by clinicians, practitioners, and statistician.

Description

BRIEF DESCRIPTION OF THE FIGURES

[0013] FIG. 1, depicts a Venn diagram representing the relationship between and among patients using opioid medications to treat pain and those that continue to use opioid medications for recreational, non-medical use.

[0014] FIG. 2A depicts a representative decision flowchart for Melrose Pain Solutions in which certain types of information is gathered, stored, analyzed and processed in accordance with the present invention.

[0015] FIG. 2B depicts additional information which is incorporated into the decision-nuking process as an adjunct to the information in FIG. 2A which is gathered, stored, analyzed and processed in accordance with the present invention.

[0016] Still other objects and advantages of preferred embodiments of the present invention will become readily apparent to those skilled in this art from the following detail: description, wherein they is described certain preferred embodiments of the invention, and examples for illustrative purposes.

DESCRIPTION OF PREFERRED EMBODIMENTS

[0017] Advantages of the present invention will become readily apparent to those skilled in the art from the following detailed description, wherein there is described certain preferred embodiments of the invention, and examples for illustrative purposes. Although the following detailed description contains many specific details or the purposes of illustration, one of ordinary skill in the art will appreciate that many variations and alterations to the following details are within the scope of the invention. Accordingly, the following embodiments of the invention are set forth: without any loss of generality to, and without imposing limitations upon, the claimed invention. While embodiments are described in connection with the description herein, there is no intent to limit the scope to the embodiments disclosed herein. On the contrary, the intent is to cover all alternatives, modifications, and equivalents.

[0018] As used herein, the terms “comprising,” “having,” and “including” are synonymous, unless the context dictates otherwise.

[0019] According to one preferred embodiment, the present invention provides well-tested methods or managing and treating pain patients, creates a lattice and framework for consistent, repeatable techniques and methods for effective pain control, and addresses the public health care crisis of pain management and opioid dependence. The system and methods of the present invention have numerous benefits. For example, the present invention will fill a significant void for patients suffering with pain in need of acute medical care (including those patients who are and are not also patients with substance abuse issues), patients on high dose opiates with unrelieved and persistent severe pain, patients with frequent admissions of uncontrolled pain, and patients experiencing drug overdose. The present invention will also improve patient satisfaction and quality of life (thereby enhancing MAPS scores), decrease the burden on an already strained healthcare system, enhance recognition and appreciation of the interrelation of pain and addiction, and, ultimately, help to generate significant healthcare savings (in the millions of dollars); moreover, the present invention will also improve healthcare worker satisfaction through increased reliance upon a uniform, established protocol, lessen after-hour phone calls (e.g., to doctors, charge nurses, and administration), reduce frequent hospital admissions and readmissions, improve remission rates, and reduce untoward harm events.

[0020] The present invention also provides methods for healthcare professionals to address both pain control and opioid addiction in a consistent, reliable, safe and effective way. Upon observing that opioid addicts can be pain patients and, conversely, pain patients can be opioid addicts, implementation of the present invention provides the surprising and unexpected benefits of providing safe, effective, reliable and consistent pain control to everyone who needs it, without enabling opioid addiction. The present invention provides significant benefits to high-risk individuals and offers real-world pragmatic solutions to our ongoing public and healthcare crisis.

[0021] As used herein, a potential “high-risk individual” is classified by the Melrose Pain Solutions, system as a patient who meets identifying criteria according to the table below:

TABLE-US-00001 Any One of the Following Any Two or More of the Following Acknowledges substance abuse History of incarceration IV Drug abuse History of high dose opiate, history illicit substance use, history of DUI Alcoholism Doctor shopping, drug diversion Reasons for admission drug overdose Family reporting of drag use Reason for admission altered mental state, lethargy Disruptive behavior, non-compliance Transfer from drug treatment center History of drug treatment, discrepancies in story. Positive urine toxicology screen for illicit substance Asking for opioid drugs by me, and by specific route of administration Frequent hospital admissions Ante-cubital spider bite Cellulitis, infective endocarditis, osteomyelitis of the spine. Hepatitis C

[0022] In a preferred - embodiment, the methods and system of the present invention significantly help to manage and treat patients who seek pain relief. One such preferred approach contemplated by the present invention is called the “Melrose Pain Solutions®” system which is used to manage and treat patients who seek pain relief. The “Melrose Pain Solutions®” system can be effectively utilized in many settings, including, but not limited to, an acute-care hospital, emergency department, king-team care residence, clinic, and/or physician’s office. It is preferred that the “Melrose Pain Solutions” system is taught and practiced by all members of a healthcare community, broadly, and a healthcare team, specifically, for maximum efficacy and impact.

[0023] It is also contemplated that the “Melrose Pain Solutions.” system can be made available to healthcare practitioners, for instance, via a “mobile app” or other type of software application, or via any other electronic or digital means, which can be implemented on one or more hardware devices such as computer, smartphone, tablet, or any other suitable electronic or computerized device. In one embodiment, the “Melrose Pain Solutions®” system is implemented as a secure, confidential, interactive, computerized system which has an easy-to-use interface, that utilizes one or more decision-assisting algorithms, Which may be implemented as an application (e.g. a mobile application or software application) running on a computer system, further wherein the application may be operated using computer hardware, including a computer processor. The interactive, computerized system gathers and processes information regarding a patient, and uses this information to assist a healthcare professional with identifying and determining optimized management and treatment protocols for individual patients. The Melrose Pain Solutions® system can also be used for rural tele-medicine in under-served areas. The “Melrose Pain Solutions®” system can be operated using any computer platform, wireless platform or other electronic platform (such as a smartphone, tablet, laptop, robot, or other similar device), thus allowing the healthcare practitioner to gather, analyze, utilize, store and retrieve information, for instance, about the status of a particular patient or other at-risk individual, and assist in identifying and determining optimized management and treatment protocols for individual patients. The secure, confidential, interactive system can preferably contain data and information about several individual patients and can be implemented in any hospital, clinic, doctor’s office or other healthcare facility. Access to the secure, confidential, interactive system can also be made available after payment of a fee, for instance, a foe paid by the hospital, clinic, doctor’s office, other healthcare facility, or insurance company.

[0024] In a preferred embodiment, a healthcare practitioner can preferably access the “Melrose Pain Solutions®” interactive system of the present invention, for example, may be accessed by a secure website (which is password and/or encryption protected) via a personal computer or PC, or via access to any other type of computer terminal, network terminal, and/or other electronic device, including but not limited to a laptop, tablet, robot, or smartphone. The computer or other electronic device can be operated using any type of operating system including but not limited to, for example, any type of Linux®, Apple®, Android® or Windows® brand operating system. In preferred embodiments, the computer or other electronic device has a screen and a keyboard and the keyboard can, for example, be a physical keyboard, an onscreen virtual keyboard, or a “touch screen keyboard” (e.g. a keyboard that is accessed via touching the screen). The screen can also be a “touch screen” which allows the user to use the interactive system by touching the screen with either their lingo’s, a stylus, or by other means, The user can also preferably zoom in or zoom out to change the size of the content when they are viewing the content via the interactive system.

[0025] By way of non-limiting example, the interactive system can include any number of hardware and software components that together provides a secure and reliable system which is operable for providing users with access to the “Melrose Pain Solution” system. By way of non-limiting example, hardware components can include, but are not limited to, a monitor, keyboard, hard disk drive, sound card, graphic cards, memory (RAM), motherboard, and computer data storage. The interactive system can also optionally include one or more speakers, and accompanying hardware and software components that allow a user to listen to audible components from a file. The interactive system can also optionally include a microphone and accompanying hardware and software components that allow a user to record his or her own audio input which, for instance, can be transcribed and allow a healthcare practitioner to contribute additional information, e.g., regarding a patient’s status.

[0026] More preferably, a user of the “Melrose Pain Solution” system can securely and confidentially store data and files, via mammal and/or encryption protection, including for instance files regarding a patient’s status, on one or more remote data servers that can accessed by other healthcare professionals confidentially and securely user of system can also preferably use one or more secure and customized web-based applications, for instance any suitable SaaS or “Software as a Service” application, to organize the data and files. A “cloud server” can also be utilized to store the files available on the interactive system, such as video files, patient records, graphics, images, etc., using any suitable cloud computing server architecture. These and other data-backup, server and storage technologies can be utilized in accordance with the present invention suet) that healthcare professionals and authorized users of the interactive system can safely and reliably upload any type of audio and video content, and other data and files to a server, such as a network server or cloud-tease server.

[0027] According to preferred embodiments of the present invention, the “Melrose Pain Solutions®” system of the present invention, as described herein including any mobile application, software application, and/or customized interactive system, and which c be utilized by healthcare professionals and authorized users, is preferably comprised of several components or “subsystems” which together reliably enables a healthcare professional to make informed clinical decisions about how best to treat a particular individual. These “subsystems together semi to gather a great deal of information, e, g. shout a particular patient, so that the best management and treatment decisions can be made, in such a manner, the “Melrose Pain Solutions®” system of the present invention allows for reliable, effective and efficient methods for identification of patients, methods for managing patients, and method: for treating patients. Collection of data from different patients (e.g. including patients of different age, gender, ethnicity, prescription records, health histories, etc.) can also be compiled into a large, confidential, secure database, in such a manner that healthcare professionals can then acquire a larger data set, thus providing a very valuable database of information of analysis that will allow for an even better understanding of the patient population and provide for even better methods of identifying, managing and mating patients.

[0028] In accordance with a preferred embodiment of the present invention, a representative approach is depicted schematically in FIGS. 24 and 213, in which opioid-dependent pain patients are identified and evaluated, and recommendations are made for management of the patients. Referring to FIG. 2A, a representative decision algorithm flowchart is shown in which certain types of information can be gathered, stored, analyzed and processed in accordance with the present invention. This information can, for instance, be stored in an interactive system and made assessable via a mobile application or other software application, as described herein, and then used by healthcare professionals in a password protected, confidential and secure manner for better identification, management and treatment of patients.

[0029] Referring again to FIG. 2A, a potential opioid-dependent pain patient is initially identified by a healthcare professional, e.g. after being seen by the healthcare professional in an urgent care center, a hospital emergency room (ER), intensive care unit (ICU), skilled care rehabilitation center, or other healthcare setting. The patient is then categorized as falling within the guidelines of opioid dependency or outside of the guidelines of opioid dependency. If a patient is designated as falling under the guidelines of opioid dependency, the patient is then accessed on clinical stability, e.g., as an outpatient if not meeting criteria for hospital admission, or as a patient meeting the criteria for hospitalization. Referring to both FIGS. 2A and 2B, multiple types of information can be gathered based on an initial encounter with a patient. Various types of “Diagnostics and Tests” can be performed during the “Initial Encounter” with the patient. Examples of certain diagnostics and tests that can performed dung the “Initial Encounter” are shown in FIGS. 2 and 2B. The results of these Diagnostics and Tests can be entered into an interactive, dynamic system, for instance the “Melrose Pain Solutions t” interactive system, as described herein. During the “Initial Footnote” with the patient, “Differential Diagnoses for Low vs. High Risk Patients” can then be performed, and the information gathered from this “multiple Diagnoses for Low vs’. High Risk Patients″ s also entered into the same interactive, dynamic system. One or more “early treatment factors” can then also be analyzed and the information obtained can also be entered into the same interactive, dynamic system.

[0030] After the initial Encounter with the patient, treatment initiation begins, e.g., depending in part on whether the patient is deemed an opioid-dependent outpatient or a more ideal opioid dependent hospitalized patient this stage is referred to as the “Admission” stage (as shown in FIG. 2A) or “Treatment initiation” stage (as shown in FIG. 2B) During this treatment initiation stage, additional information is gathered :from additional tests (e.g. wine toxicology screen, P: MP (Prescription Drug Monitoring Program), etc.). This additional information is also entered into the interactive system, for instance the “Melrose Pain Solutions®” interactive system, as described herein, it moreover, information regarding “Measures of Treatment Efficacy” (examples of these measures are shown in FIG. 2B) is also gathered and this additional information is also entered into the same interactive, dynamic system, for instance the “Melrose Pain Solutions.sup.∗” interactive system, as described herein. Significantly, daring the “Admission” stage (as shown in FIG. 2A) or “Treatment initiation” stage (as shown in FIG. 2B), information regarding a patient; “Treatment Decisions” is also entered into the same interactive system.

[0031] Referring again to FIGS. 2A and 2B, additional information can be gathered about a patient during the “Inpatient Care” stage, including information from additional tests, measures of treatment efficacy, and information regarding treatment decisions. Referring to FIG. 2A, information that has been collected about a specific patient can be utilized to make very specific recommendations or decisions about acute management or chronic management of a patient. Representative examples of steps that may be taken for acute management or chronic management of a patient are shown in FIG. 2A. Treatment with Suboxone®) for instance, using a Suboxone® film or tablet (or a similar buprenorphine and naloxone combination), is one example of a step that may be taken for acute management or chronic management of a patient in like manner, referring again to FIGS. 2A and 2B, additional information can be gathered about a patient during the “Discharge” stage and “Chronic Management” stage. One representative and preferred implementation of the system, as depicted schematically in FIGS. 2A and 2B, and as described in more detail herein, is a “Melrose Pain Solutions” system. All additional information can likewise be entered into the interactive system, for instance the “Melrose Pain Solutions®” interactive system, as described herein. As further described herein, the “Melrose pain Solution®” system can be made available to healthcare practitioners, for instance, via a “mobile app” or other type of software application, or via any other electronic or digital means, and implemented on one or more hardware devices such as computer, smartphone, tablet, robot, or any other suitable electronic or computerized device.

[0032] In one embodiment, the “Melrose Pain Solution®” system is implemented as a cure confidential, interactive, computerized system which has an easy-to-use interface, that utilizes one or more certain decision making algorithms, and which may be implemented as an application (e.g. a mobile application or software application) running on a computer system, further wherein the application may be operated using computer hardware, including a computer processor capable of securely safeguarding protected patient information (PPI). The interactive, computerized system gathers and processes information regarding a patient, and uses this information to assist a healthcare professional with identifying and determining optimized and customized management and treatment protocols for individual patients.

[0033] The interactive, computerized system of the present invention has a number of additional and significant advantages, with regard to assisting a healthcare professional with identifying and determining optimized and customized management and treatment protocols for individual patients, e.g. optimized methods for managing and treating wide range of pain patients. As further described herein, the interactive system of the present invention can significantly help healthcare professionals with the process of effectively managing and treating a wide variety of patients in a customized and consistent way.

Identifying Potential Opioid Dependent Patients

[0034] Patients enter the hospital or other portal into the healthcare system ostensibly seeking pain relief Yet, at times, the situation is more complicated because there may be an additional motivation: a genuine need for analgesia, opioid seeking behavior, or seeking relief from withdrawal symptoms. Addressing these complicated situations requires a reliable, consistent, and structured method. In accordance with the present invention, the “Melrose Pain Solution®” system helps insure that all the pain patients receive appropriate pain management, while not necessarily acquiescing to their demands. While the treatment of pain does not discriminate depending on history or behavior, identifying potential high-risk patients can be useful in helping to predict and proactively address behaviors and drug-seeking tactics. This stratification shapes how the physician and health-care team may, in combination with sound professional judgment, handle inpatient and aftercare.

[0035] High risk patients may reveal themselves in any numbers of behaviors, questions they ask, and requests they make. They may frequently request specific drugs by name or exhibit detain knowledge about pain medication such as dosing regimens and specific route of administration. Sometimes they already have prescription opioids but request higher doses or different agents. They frequently offer reasons as to why they want a specific drug and why other pain relievers are not appropriate for them (it doesn’t work for me″ or “I’m allergic”), Patients at risk frequently want specific opiate drugs plus benzodiazepines, IV Benadryl and deflect attempts to control their pain with other agents or treatments.

[0036] The “Melrose Pain Solutions®” system of the present invention can be used to obtain more relevant insights faster (a material benefit under the conditions of limited time and resources). Using the “Melrose Pain Solutions®”, approach, the patients are asked a series of structured questions that seek to access relevant, consistent, and necessary information from the patient in different rays. (The intent is to identify the nature, location, and cause of the patient’s pain and to ascertain if the patient is currently taking prescribed, non-prescribed, or illicit drugs.) The potential high-risk patient often tries to conceal his/her addiction, but repetitive questions that approach the same topics from various angles can often break through the facade. The healthcare professional should ask structured screening questions designed to reveal prior drug use, alcohol use, family life dysfunction, arrests for drug use, previous rehabilitation efforts, and family history of substance abuse ( among other questions). A subset of opioid addicts may be considered high functioning, that is, they may hold down jobs, maintain a household, and have intact personal relationships. Often the burden of addiction takes its toll to the pointy that they are unable to function normally for protracted periods of time, if at all. The intent of the structured Melrose Pain Solutions® system is not to intimidate or shame the patient or make the patient defensive, but rather to get a more holistic picture of the patient and to avoid mating assumptions. Certainly, a poor work history and chronic pain does not mean a person is an addict. The clinician needs to get a true picture of the patient’s life, true nature of the pain, and a complete history of opioid use. This stage is for let finding and correct stratification of the patient, while seeking to decrease the number of false positive patients. See Table 1.

[0037] Table 1 shows representative questions and techniques for the “Melrose Pain Solutions ®” methods and systems of the present invention as described herein. These questions listed herein in Table 1 are representative samples and may be modified to meet the needs of the healthcare professional and the patient.

TABLE-US-00002 Techniques for the Healthcare Professional Ask questions politely but firmly, and be persistent; Approaching the subject from different angles helps overcome obfuscation. Be systematic in the interview; don’t abandon the line of questioning even if, after the initial questions, the patient appears irritated or uncooperative. If active drug use is suspected, a contraband search should be conducted. Ask questions in a methodical consistent manner, rephrasing a question if a discrepancy is identified. If possible or appropriate, continue probing questions after the initial interview. Sample Questions that a Healthcare Professional can Ask a Patient Do you normally take pain medicines at home? How do you take it? Crush it? Snort it? Inject it? Have you ever used drugs in the past? When you were younger? Do you use marijuana? Do you drink alcohol? How much? How Often? Have you ever had a DUI? Have you ever been in rehab? Have you ever been arrested for anything drug related? Do you work? What kind of work do you do? Who do you live with? Do you have any children? Do they live with you? What surgeries have you had in the past? Has anyone in your family been in rehab before? Have you ever been arrested for drugs before? Do you drink? Have you ever been arrested? Do you smoke? Have any medications worked better for you than others? Have you ever tried on Suboxone® or methadone or the like? Why are you asking for this specific opioid? Have you had it before? Do you drive to work?

[0038] In a preferred embodiment, there is a method to manage and treat patients who seek pain relief. This method comprises identifying the patient, asking questions of the patient, prescribing the appropriate and safe pain treatment (i.e. not necessarily the drug of choice), offering a realistic plan with the ultimate goal of arriving as early as possible in the course of treatment at a treatment plan that can be continued in an outpatient setting. In another embodiment, high risk patients are identified through a series of structured questions and as the hospital treatment progresses more actionable information becomes available.

[0039] High ride patients are often very skillful in denying or at least minimizing their addiction, possibly believing they are exceptional and “can handle it” while others cannot. Despite the persuasiveness, the healthcare professional should ask questions systematically and address any inconsistencies. When the patient contradicts himself/herself, the clinician should realize this was information that should be clarified. If the patient becomes hostile or defensive a good approach, is to softly explain that the questions help in identifying the best treatment path. If necessary, step away and return with a clinical colleague.

Confronting the Addict

[0040] High risk patients may demand specific medications, formulations, or doses, and may resort to disruptive tactics (outbursts, tantrums, negotiations, arguments, rage, threats, flirtation, or persuasion) to try to convince the prescriber to do what they want. Addicts who realize they are not going to get the drugs they want may walk out. It is interesting to note that in no other area of medicine are prescribers faced with such persistent “patient negotiations”. For example, in infectious medicine, the physician will discuss the patient’s condition, may offer a few treatment options, and then prescribes the appropriate pharmacological regimen without having the patient demand or insist can antibiotic X instead of antibiotic Y or get angry if oral antibiotics are administered instead of IV antibiotics. Yet the healthcare system has come to expect and accommodate such demands from patients seeking pain control.

[0041] In yet another embodiment, the step of confronting the high-risk patient comprises discussing the patient’s medical condition causing the pain and describing the pain control regimen, if appropriate. In some cases, the patient’s pain may be maned with a non-opioid pain reliever, but if an opioid is required, the healthcare provider may prescribe buprenorphine or buprenorphine/naloxone. This is the same approach for a patient who is opioid naive or opioid dependent. Many experienced drug users will decline Suboxone® (buprenorphine/naloxone), for example, claiming allergy or a “bad” experience. This step is important because it highlights their ambivalence to change and refusal of alternatives. Many will leave against medical advice (AMA). While this step might interfere with treatment of their medical condition, the Melrose Pain Solution® system has the distinct advantage that it does not enable addictive behaviors, in fact, MPS creates an opportunity for the drug addict to begin medication assisted treatment with Suboxone® which has been shown to help not only with their disease of addiction but with their pain as well.

[0042] High risk patients who are hospitalized or in long-term care settings may try to find enablers to bring or sell them drugs. In this scenario, the “Melrose Pain Solutions®” methods and systems of the present invention advocates restricting visitors. Contraband search may be warranted. In this situation, some addict patients will attempt to get around the regulations, persuade clinicians to give them special treatment, or attempt to leave the facility (which may not always be possible), in the event a patient does leave the facility even against medical advice, this is not necessarily a bad outcome as the patient was offered appropriate treatment by healthcare professionals which he/she refused, yet in the end the healthcare team did not enable the addiction.

[0043] Sometimes patients who already have prescriptions for opioid medications will see a physician or visit the emergency room demanding more or different opioids. Mere are two main motivations for this patient. First, either the patient is frustrated over inadequate pain control or the patient is an addict seeking more and/or better drugs. The prescriber should first confirm the patient’s current opioid regimen, who prescribed it, and how tong the patient has taken it. The patient should be asked when the medication was last taken and what the dosing schedule.

[0044] Then the prescriber should assess the pain, using a 10 point scale where 0 is no pain at all and 10 is the worst possible pain imaginable. Many addicted patients will report very severe pain (10/10 is not unusual). At this point, the prescriber should use this information as a “teachable moment,” If the, patient is taking prescription opioids in moderate to large doses as directed and his or her pain is virtually unaffected by the rug, then clearly the opioids are not working. The patient will scramble to explain that the pain is getting worse or some new condition has intervened. The prescriber should then explain to the patient that the medication appears not to be working likely due to tolerance and to excessive high dose prior to admission. In accordance with the “Melrose Pain Solutions®” Y methods and systems of the present invention, the prescriber should take the opportunity to contact the patient’s original physician and report the incident, that is, that the patient is soliciting more opioid analgesics from another physician. One notable shortfall of the healthcare system is that high risk patients are able to consistently exploit is the fact that prescribers and other healthcare professionals do not usually make that phone call. Improved communications among prescribers in a community can help to prevent such patients from abusing the system.

Prescribe a Pain Management Plan (Not Simply the Drug of Choice)

[0045] The “Melrose Pain Solutions®” (or “MPS”) approach of the present invention recognizes that physicians treat pain. Many severe patients have painful conditions for which opioids might appropriately be prescribed. However, it is not up to the patient to select the drugs he or she wants; it is a physician’s choice to prescribe responsibly. Healthcare providers should prescribe like the healthcare professionals they are, and not acquiesce to the patient’s demands.

[0046] The “MPS” model of the present invention recognizes that buprenorphine (Belbuca®, Bunavail®, and Butrans®), is an outstanding, analgesic product for a wide range of patients, particularly but not exclusively for addicts with pain indications. While buprenorphine can still be abused, its abuse potential is lower than other opioids. Buprenorphine is well known for its ceiling effect on respiratory depression. It has been shown in numerous clinical trials to safe and effective against many types of pain. It is available in many formulations, including a transdermal patch, which allows for dosing and administration versatility.

[0047] Of course, not all patients in pain require opioid analgesics. In some cases, it is appropriate to prescribe non-opioid agents, such as acetaminophen or nonsteroidal anti-inflammatory drugs (NSAIDs). These agents may be supplemented by muscle: relaxants, antidepressants, anticonvulsants to address other components of the patient’s pain. No pharmacological options may be appropriate or some patients such as physical therapy, hot or cold therapy, TENS (Transcutaneous Electrical Nerve Stimulation) units, or massage therapy. Combination approaches may also provide greater relief.

[0048] The urgency to avoid withdrawal symptoms (dope sickness”) can be particularly intense and, may be the driver behind the patient’s insistence on getting more opioids fast. Buprenorphine will prevent withdrawal symptoms as well as provide pain relief. In fact, buprenorphine can turn off withdrawal symptoms for the patient which can interrupt the drug-seeking behaviors.

Offer a Realistic Alternative

[0049] In accordance with the “MPS” methods and systems of the present invention, it is recognized that some addicted patients will leave the hospital setting if they do not get the drugs they want. This can be upsetting to some clinicians, but it is not necessarily a negative outcome: Far Worse would it be if addicts came to a clinic and not exactly what they wanted.

[0050] While society finds it preferable that all addicts gets treatment it is not realistic to expect every addict to agree to the recommended intervention. Some will balk, and with varying degrees of intensity and anger. Others will enthusiastically embrace the treatment. Some will leave one emergency room and head for another. Yet if all hospitals across the nation embraced the MPS treatment model, and methods and systems of the present invention, there would be no other more “helpful” emergency room to visit. While the MPS treatment model, and methods and systems of the present invention, can work in an individual hospital or clinical setting, it has the potential to change the face of addiction across the nation if it was to be embraced as a comprehensive national program.

[0051] The Melrose Pain Solutions® model requires that the entire healthcare team be trained and educated in this treatment paradigm. Some patients can be particularly adept in figuring out who is the “weak link in a system and might take advantage of the healthcare systems propensity to achieve patient satisfaction. Melrose Pain Solutions system and method requires all healthcare providers in the system to not only be knowledgeable and follow the same protocol, they must also be professional, kind, patient, approachable, and compassionate. The patient should not be allowed to dictate his/her own care.

[0052] Many high risk patients are characteristically unable to appreciate the depth or extent of their own problems. They may deny their drug use or trivialize it as a minor quirk. For that reason, many patients do not want treatment for their addiction, even when it is offered to them, or at best---care ambivalent: about beginning treatment, putting it off to some vague point in the future. The interview format works well in this setting.

[0053] At this phase of the treatment algorithm MPS system and method utilizes well established and previously described motivational interviewing techniques. The Clinician should ask the patient; On a scale of 0 to 10 where 0 is not at all and 10 is the most likely, how willing are you to make a change? Most patients will answer with a rating of 3 or 4; they most likely will not say 0, but they may make a point to let the healthcare team know that they are not seriously looking for rehabilitation. At this point, the clinician should answer by saying, “Why so high? I would have thought you were going to say zero, Why a 3 or 4 and not a 0?” This strategy forces the patient to argue in favor of making a change. In this setting, the patient may reveal to the physician some genuine concerns that can help give the prescriber greater insight into the patient. For example, some patients may report that they want to get custody of their children, hold down a job, save some money, or find a better place to live. Some will say simply they just want to have a “nonnal life”. The clinician should use these answers to encourage the patient to agree to better alternatives.

Continue to Treat the Patient

[0054] For patients treated with buprenorphine, a transition in attitude occurs after a few days. These patients describe effective pain control and no withdrawal symptoms. Formerly difficult and demanding patients often regain their equilibrium and report to the healthcare team that they are feeling well. They are likely now to agree to remain on buprenorphine as an outpatient.

[0055] This work takes proper training, resources, and consistency within the healthcare system.

The Role of Buprenorphine in the Methods and Systems of the Present Invention

[0056] In accordance with the Melrose Pain Solutions® system and methods of the present invention, it is recommended that clinicians prescribe buprenorphine, when an opioid is indicated, to treat pain in both pain patients and drug- seeking patients with painful conditions.

[0057] Buprenorphine is a potent opioid, effective analgesic, and has a low abuse liability. It owes some of these characteristics to its unique pharmacology. Various forms of buprenorphine are available on the market in various delivery systems and can be used fix pain. Numerous’ clinical studies have found buprenorphine to be an effective pain reliever and it treats neuropathic pain and a broader array of pain phenotypes than do certain other opioids. Buprenorphine is associated with fewer side effects, notably less constipation, less cognitive impairment, and it does not prolong the QT-interval of the heart. Buprenorphine is not immunosuppressive (as are morphine and fentanyl) and does not cause hypogonadism or adverse effects on the hypothalamic-pituitary-adrenal axis. It is recognized as one of the safest opioids to use for patients with compromised renal function. Finally, as mentioned earlier, it has a ceiling effect on respiratory depression, a potentially fatal adverse event associated with other, strong opioids.

[0058] In accordance with the “Melrose Pain Solutions®” methods and systems of the present invention, buprenorphine can be administered as a parenteral injection, a sublingual tablet, sublingual/buccal film, and a transdermal delivery system. These, various formulations and doses allow for prescribing versatility. Furthermore, buprenorphine is an established treatment for opioid addiction with considerable evidence in the literature for its safety and efficacy in this setting.

The Status Quo Versus the “Melrose Pain Solutions®” Method of the Present Invention

[0059] Chronic pain remains under-treated, opioid addiction has reached epidemic proportions, and most healthcare professionals are left in a quandary as to how to treat pairs without fueling the opioid epidemic,. Prescribers are expected to treat legitimate painful conditions in patients with active substance abuse. Patients have a right to expect appropriate pain management even under high risk circumstances.

[0060] Opioid addiction has become so prevalent that legal arid political forces have become involved. The problem is vast and growing, and Melrose Pain Solutions®, system offers a safe., effective, reliable, and consistent solution. If implemented broadly Melrose Pain Solutions® system has the potential to manage and solve the opioid epidemic by treating the high-risk patient each time they interface with the healthcare system.

[0061] The “Melrose Pain Solutions “approach of the present invention places the focus on fighting addiction where it belong& in the healthcare setting. Addicts frequently interface with the healthcare system-in fact, over time, it is almost impossible for a long-term drug addict to avoid hospitalization and frequent doctor appointments. The “Melrose Pain Solutions®” method and approach does not require some sort of outreach campaign, or outer efforts to find addicts, nor does it expect addicts to knock on the doors of treatment centers. It is the nature of opioid dependency that the patients-sooner or later and usually repeatedly — enter the healthcare system. It is the healthcare system that must be prepared to treat them. The “Melrose Pain Solutions” approach systematizes this care and renders it safe, effective, reliable and consistent.

[0062] If all hospitals and clinics and healthcare providers across America embraced the “Melrose Pain Solutions®” system and approach, addicts would not be able to demand their drug of choice from the healthcare system. They would get appropriate pain treatment and an opioid product that would prevent them from going into withdrawal and they would get a frank discussion about their condition alone with long term options for treatment These are potential victories in of r public health wars on two fronts a victory for pain patient in that they get pain control and a victory for reducing opioid abuse in that opioids are not so freely dispensed thereby supporting continued addictive behavior.

[0063] Many people with addiction issues would like to overcome their dependence but just do not know where to turf. The “Melrose Pain Solutions®” model of the present: invention cognizes that in the real-world clinical setting, many people with dependence issues may deny their addiction (at least at first) and, even if they begrudgingly admit some degree of drug dependence, often refuse help or approach options presented by caregivers with great skepticism. Most active addicts do not seek treatment on their own and may reject treatment when called Overburdened hospitals and clinics end up providing addicted patients with the drugs they seek in an effort to placate patients and move them quickly through the system. In other words, addressing the real issue of addiction is trumped by the immediate goal of rapid patient throughput and limited. Resources. More are even some healthcare professionals who misplace their system and think it is helpful to at least ease the temporary suffering of an addict in pain by giving in to a request for a Taken opioid. Still other healthcare professionals think like the addict that it is not such a big deal to provide an addicted patient with a few extra pills. The status quo is a system that d muds a quick fix for pain, i.e. more Tapir>ids. The opioid epidemic has been fueled by a system that demands it.

[0064] There is therefore a significant and urgent need for better solutions and tools vis-A-vis the status quo. The Melrose Pain Solutions system is the effective, safe, reliable, and consistent method and tool to treat pain in difficult patients. The present invention also accomplishes numerous objects are including but not limited to the following: [0065] Helps healthcare professionals to better understand and evaluate the current continuum of care of opioid dependent patients with. pain in the hospital: setting (From Initial Evaluation to Discharge) [0066] Helps healthcare professionals to better understand and evaluate the current alternative decision pathways for the treatment of the opioid dependent patient with pain [0067] Helps healthcare professionals to develop a workable to address a broader public health care crisis [0068] The present invention will fill a void for patients suffering with pain., including but not limited to these types of patients: [0069] 1. Patients with substance abuse in need of acute medical care [0070] 2. Patients on high dose opiates with unrelieved and persistent severe pain [0071] 3. Patients with frequent admissions for uncontrolled pain [0072] 4. Patients with drug overdose [0073] The present invention will improve the Mowing: [0074] 1 . Patient satisfaction [0075] 2. HCAPS scores, [0076] 3. Significant costs savings, [0077] 4. Improve healthcare professionals employment satisfaction, [0078] 5. Reduction in after-hours phone calls (to doctors, charge nurses, administration) [0079] 6. Reduction in frequent readmissions, [0080] 7. Reduction in harm events, and [0081] 8. Leveraging the acute treatment incidence in the hospital setting as the first step of addressing the Opioid Use Disorder (OUD)

Example: Representative Inclusion C T R

[0082] A. patient’s data may be collected for analysis if they meet the diagnosis and main criteria of the analysis as well as any of the following criteria: [0083] Uncontrolled pain on high doses of opioids [0084] PDMP reveals large quantities of opioids or doctor shopping [0085] Evidence of substance abuse (track marks, ET OH intoxication, AMS, frequent. Ms. prior documentation of “drag seeking” [0086] Requesting/demanding specific mediation, specific route of administration (MP), specific dose [0087] Allergic to alternative medications other than their drug of choice [0088] Refusal to provide prior medical records [0089] Threatening to leave AMA, sue, call administration if not given what they want

[0090] The foregoing descriptions of the embodiments of the present invention have been presented for purposes of illustration and description. They are not intended to be exhaustive or to limit the present invention to the precise forms disclosed. The exemplary embodiments were chosen and described in order to best explain the principles of the present invention and. its practical application, to thereby enable others skilled in the art to best utilize the present invention. Although specific embodiments have been illustrated and described herein, a variety of alternate and or equivalent implementations may be substituted for the specific embodiments show. and described without departing from the scope of the present invention. This application is intended to cover any adaptations or variations of the embodiments discussed heroin.