DISPENSING MEDICINES

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Application No. 61/471 ,560, filed on April 4, 201 1 and U.S. Provisional Application No. 61/533,463, filed on September 1 1 , 201 1 , the disclosures of which are hereby incorporated by reference in their entireties.

FIELD OF INVENTION

[0002] The present invention generally relates to a method and apparatus to dispense medications.

BACKGROUND

[0003] Patient non-adherence to medications costs the United States healthcare system $300 billion in spending. The issues that lead to medication non-adherence are complex. Medications are not taken correctly or adequately for a host of reasons. Beyond the growing cost of pharmaceuticals, patients often times simply forget. With the average Medicare patients on 10 or more prescriptions, it is increasingly difficult to ensure proper medication adherence. Some patients have trouble understanding the proper dosing. Errors of this nature can lead to acute toxic ity or under-treatment of a condition. Others have difficulty understanding warning labels such as "avoid alcohol" or "take with food" for select medications. Finally, patients themselves, physicians and pharmacists all need a straightforward way to track proper adherence.

[0004] Thus, there remains a need in the art to provide cost-efficient manner to improve patient medication compliance.

SUMMARY OF THE INVENTION

[0005] The present invention addresses this need in the art by providing an adaptable vial cap technology that offers adaptable reminders and instructions directly at the point of dosing. Reminders, instructions and encouragement provided by the adaptable vial cap technology of

l the present invention are cycled to drive engagement and deliver improved behavioral change, which can immediately improve medication adherence.

[0006] In certain embodiments, the present invention is directed to an apparatus for improving patient medication compliance comprising: a housing having a side, a top surface and a bottom surface, the bottom surface adapted to be in contact with a vial cap; a projection in contact with the side of the housing, the projection extending downwards from the bottom surface of the housing and adapted to be in proximity to a vial when the vial cap is affixed to the vial in a closed position, the projection having a sensor which is activated in response to a change in the projection's location in relation to the vial; a control panel positioned inside the housing and in communication with the sensor; and a message delivery component coupled to the housing and in communication with the control panel, wherein the message delivery component provides a message in response to receiving instructions from the control panel.

[0007] In other embodiments, the present invention is directed to a method for providing a message to a patient in connection with a medication vial comprising: detecting, through a sensor located on a cap of a medication vial, a change the cap's position relative to the medication vial: selecting, through a programmable processor communicatively connected to the sensor, a message to be provided, wherein the message selection is based upon temporal input received through the processor, behavioral input received through the processor, or a combination of both; and providing the selected message to the patient.

[0008] In yet other embodiments, the present invention is directed to a method for improving patient medication compliance comprising providing a patient with the adaptable vial cap device described herein.

BRIEF DESCRIPTION OF THE DRAWINGS

[0009] For a more complete understanding of the present invention, reference is now made to the following descriptions taken in conjunction with the accompanying drawing, in which:

[0010] FIG. 1 illustrates an embodiment of the adaptable vial cap device of the present invention. [0011] FIG. 2 illustrates an exploded side view of an embodiment of the adaptable vial cap device of the present invention.

[0012] FIG. 3 illustrates an exploded isometric schematic diagram of an embodiment of the adaptable vial cap device of the present invention.

[0013] FIG. 4 illustrates a flow diagram for the basic software operation used in particular embodiments of the adaptable vial cap device of the present invention.

[0014] FIG. 5 illustrates a flow diagram of the electronics used in particular embodiments of the adaptable vial cap device of the present invention.

[0015] FIG. 6 illustrates an algorithm for generating specific messages used in particular embodiments of the adaptable vial cap device of the present invention.

[0016] FIG. 7 illustrates a top view of multiple adaptable vial cap device of the present invention working together

[0017] FIG. 8 illustrates an isometric view of multiple adaptable vial cap devices of the present invention attached together for multiple medication programs

[0018] FIG. 9 illustrates another embodiment of the adaptable vial cap device of the present invention.

[0019] It should be understood that the drawings are not necessarily to scale and that the disclosed embodiments are sometimes illustrated diagrammatically and in partial views. In certain instances, details which are not necessary for an understanding of the disclosed methods and apparatuses or which render other details difficult to perceive may have been omitted. It should be understood, of course, that this disclosure is not limited to the particular embodiments illustrated herein.

DETAILED DESCRIPTION

[0020] The adaptable vial cap device of the present invention combines such things as time reminders, instructions triggered by the patient, and feedback on dosing history using software encoded in each device. [0021 ] The adaptable vial cap device may be configured to fit any size or shape medicine vial cap used to dispense medications. The device may be affixed to the vial cap using any type of adhesive known in the art. such as double stick tape, glue, rubber cement, etc., and may be affixed by the patient himself on any existing medication vial/bottle. Once affixed, a sensor connected to the device will detect when the vial cap has been removed from and/or replaced onto the vial. The programmable software within the device will then deliver messages to the patient, based upon the feedback from the sensor in order to assist in improving patient adherence compliance.

[0022] In certain embodiments, algorithms may be used to dynamically deliver a range of messages that include instructions, encouragement and/or general education facts to promote adherence. In such embodiments, the decision algorithm selects the optimal stored message to play during each medication event based on prior adherence patterns and other variables.

[0023] In preferred embodiments, the device of the present invention activates an audio beep, or message when the patient is timed to take their medication dose, or alternatively, the device may display a flashing LED notification and/or a LCD message, or a combination of both audio and visual notifications. These notifications can be modified for once a day, twice a day or more depending on the medication dosing schedule.

[0024] Additionally, the device may also provide an informational message to the patient. In such and embodiment, the device may dynamically change the message delivered based on whether a patient is adherent in the recent past and the stage of a patient's prescription. For example, if the patient has missed doses over the past week, then the device will repeat more dosing instructions. Patients who have been adherent over a period of time may receive more general information or encouragements to promote adherent behavior. The device may also timestamp when the cap is placed back onto the vial, as a further measurement of adherence.

[0025] Further, the device may also provide over-dosing warning notifications. If a patient opens the cap too soon after an earlier cap opening event, the device will provide an audio and visual notification of this. Hardware

[0026] Referring now to Figures 1 through 3, the device of the present invention [000] is affixed to a vial cap [003] of a vial [007]. The device [000] has a housing with an upper portion [020], which preferably contains apertures to access portions of the control panel [009]. and a bottom portion [017], which is affixed to the vial cap [003]. In preferred embodiments, the control panel has a speaker [016], a graphic display [001], user buttons

[002] and [005], a visual display, such as an LED [028], a microcontroller [015], digital memory (removable or integrated) [018], a power source (e.g., a battery (replaceable or integrated)) [032], and a proximity sensor [023].

[0027] In certain embodiments, the proximity sensor [023] may be, e.g., a laser rangefinder, an LED Photodiode pair, a light sensor, a physical switch, an electrical contact switch, a Hall effect sensor, a reed switch, or any other proximity sensor known in the art. In a preferred embodiment, the proximity sensor [023] is a reed switch, which is activated in the presence of a magnetic field. In such an embodiment, the magnetic field may be produced by a small thin strip of flexible, adhesive backed magnetic material [004] that is wrapped around the top of the vial [007]. When the vial [007] is opened, removing the cap [003] from the vial [007] separates the reed switch [023] from the vicinity of the magnetic strip [004], thereby activating the reed switch [023] and indicating that the vial [007] has been opened. The detection of this change in position of the sensor [023] may trigger any number of events, including but not limited to communicating information to the user through the activation of the visual display [028], speaker [016], and/or graphic display [001].

[0028] The device [000] is designed so that it can be attached to any medication vial, regardless of size or shape in such a way as to not substantially obstruct the normal opening and closing of the vial. Similarly, the sensor [023] is designed to detect opening/closing of the bottle regardless of vial size, shape, or material. In the desired embodiment, a flexible magnetic strip [004] coupled with a reed switch [023] was chosen for the reed switch's sensitivity and the low likelihood of false positives. A flexible, adhesive backed magnetic strip [004] is wrapped around the vial [007] to ensure the triggering of the reed switch [023] regardless of the rotational orientation of the cap [003] with respect to the vial [007]. [0029] In preferred embodiments, the control panel [009] is comprised of two printed circuit boards [027]. The upper [020] and lower [017] parts of the housing may be held together, e.g.. by a series of screws [024], which also act to locate the printed circuit boards [027]. Alternatively, the upper [020] and lower [017] parts may be held together using, e.g., snap hooks, and the printed circuit board [027] may be located using internal features of the housing. Apertures in the upper part of the enclosure [020] allow the user to view the graphic display [001], actuate the user buttons [002] and [005], and view the indicator visual display

[028].

Electronics

[0030] The control panel [009] functions to implement the device [000]. An activation switch on the control panel (not shown) indicates that the container has been opened, signaling the control panel [009] to turn on and begin to display dosing instructions on the graphic display [001]. Preferably, at the same time, the control panel [009] signals an audio record and playback unit to play an audio recording of the dosing instructions or to play other audio messages through the speakers [016] as required. At dosing time, the control panel plays an audible alert through the speakers [016] or an LED (visual alert) on the visual display [028] to signal that it is dosing time. It may also display a suitable message on the graphic display [001]. \Mien the activation switch indicates that the vial [007] has been opened, the control panel [009] may write a record of the date and time to a memory storage unit. e.g.. a Micro SD Memory card [018] for later retrieval. The control panel may be a portion of a multifunction microcontroller integrated circuit including various peripheral devices such as timers, analog-to-digital converters, power management functions, etc.

[0031] The memory storage [018] contains the text and graphics to be displayed on the graphic display [001] for each medication of interest. The memory storage [018] may also be used to store the audio alerts and messages, or to record actual dosing times detected by the activation switch. In certain embodiments, built-in internal storage via, e.g., RAM or EEPROM on the circuit board [027] may be used to store recorded force values. In such embodiments, the values generated can be used, e.g., to create a patient summary sheet for integration with health information systems or printed out to be placed in a patient chart. This may occur directly on the circuit board [027] or sent via the communication module (not shown) to a third party computer at a remote location for further analysis. Communication modules may utilize any type of remote communication methods known in the art, such as, e.g.. Bluetooth technology.

[0032] The graphic display [001] is preferably an LCD or "electronic ink" graphical display, and can be used to display dosing instructions and other messages.

[0033] An audio record and playback component may also be incorporated into the device, which is capable of recording and playing back several different audio alerts or messages. Individual messages and alerts are selected and activated by control signals from the control panel [009]. A small loudspeaker [016] may be used to reproduce the audio messages and alerts. In certain embodiment, the speaker [016] may also function as a microphone.

[0034] In preferred embodiments, the power component [015] utilizes a battery. The power component [015] can maximize battery life by shutting down most of the device functionality between dosing times and activations. The device will contain an internal timer, and preferably, the timer is part of the power component. When the timer indicates that a dosing time has arrived, the power component will power up the control panel to sound an alert and display a dosing message. After a predetermined amount of time has passed, if the activation switch has not detected a container opening, the alert and dosing message will repeat. The dosing message and alert will repeat a number of times, until the activation switch detects a container opening. If no container opening is detected, the power component unit will power down the control panel, including the graphic display and audio components for a predetermined time interval or until the next dosing time.

[0035] In certain embodiments, the messaging components of the device can be activated by a physical push button. When pushed by the user, the signal produced can be acted on by the control panel. In some embodiments, wireless technologies (e.g. Bluetooth, ZigBee, etc.) can be used to be to communicate with the device, providing a channel for the transmission and or receipt of data and commands for their device. An intermediary such as a smartphone may be used in this process to receive and transmit data or commands. Alternatively, a wired transfer technology such as USB could be used to communicate with the device.

[0036] Figure 5 depicts a flow chart of how the electronics may work together in the control panel of the present invention. Alternate Embodiments

[0037] Referring now to Figures 7 and 8, the device of the present invention can also be adapted to be connected, so as to provide for a multiple device configuration. Such a configuration may be beneficial for patients having numerous medications.

[0038] Alternatively, referring to Figure 9. the device of the present invention can be configured into a pill dispenser, e.g.. a weekly divided dose pill dispenser as shown in Figure 10. or adapted to fit such a pill dispenser.

Dynamic Messaging Algorithm

[0039] The type of message that the adaptable vial cap device of the present invention delivers when the patient opens the cap is dynamic. These messages vary from educational messages regarding the patient ^' s underlying condition, information about the medication itself ( e.g. name, color, shape and purpose), warnings about potential signs of deterioration of health that w arrants interaction w ith the medical establishment (e.g. swelling in the ankles, shortness of breath or a red rash on the hands), instructions on the proper dosing of the medication (tw ice per day by mouth), instructions on what to avoid when taking the medication that may lead to deleterious interactions (e.g. avoid alcohol or dairy products) and w arnings about potentialh dangerous drug-drug interactions. The type of message displayed and given to the patient may be triggered by the length of time elapsed from the first activation of the device. For example, the first 30 days of a prescription, the device will preferably tend to focus more on instructions and basic information. As the length of time from the initial activation increases, for example on day 35, the device may begin to incorporate more general educational statements about the patient's condition or even more lighthearted facts about their medication ^' s history of development and other interesting facts. In addition, pre-installed encouragement messages or custom recorded encouragement messages ( e.g. recorded from a patient ^' s loved one) can be delivered by the device if the patient is non-adherent for a certain period of days. These messages can also be randomly generated to reinforce proper dosing behavior.

[0040] The device preferably incorporates an element of random message generation to promote patient engagement and to prevent de-sensitization. The mix of encouragement, educational and coaxing (e.g. this medication can cause itching, but it is protecting your heart) messages will allow patients to slowly gain a deeper understanding of their medication and conditions without repetition of the same information. The delivery of this message can be mixed between audio message or visual notifications through the visual and or graphic displays.

[0041] Patient compliance can be relayed back to the patient in an audio message as well. For instance, if the patient opens and closes the medication vial at the right period of time for 7 days in a row. the device can replay ^" congratulations for taking your medication correctly for 7 days in a row ^" . This tracking function can also be displayed on the graphic display as, e.g.. a simple number or dots filling up the shape of a star or happy face. The device allows the patient and their medical caretakers to track progress. This creates momentum to track and promote medication adherence.

[0042] Each of the auditory messages takes the form of a prerecorded spoken message stored in the device ^' s memory. The auditory message can either be a single stored messaged or a series of multiple prerecorded messages played one after another depending on the circumstance. The ty pes of content that can be delivered in these messages include (but are not limited to ): instruction, education, safety, feedback, and encouragement. The number of messages delivered can also vary.

[0043] The barriers to medication adherence that the device of the present invention can overcome and the types of messages that patients will find useful varies based on a number of factors. The length of time the patient has been on the medication, the patients other medications, the patient ^' s comorbid conditions, and the patient's performance during previous dosing events are all examples of factors that can useful for selecting optimal message content for a specific patient at a specific time.

[0044] The device uses a number of features to deliver optimal auditory messaging content. Preferably, all of the prerecorded messages are sorted into separate categories based on their content type. The duration of a prescription may then be divided up into discrete phases. Each phase may be coded to only include messaging content from a relevant subset of the message categories, which results in each phase having a unique breakdown of message content. An algorithm may then be implemented to determine which phase the patient is at a particular time so that the optimal content will be delivered. [0045] The algorithms used in the present invention are able to determine the patient's adherence phase for any given dosing event based on a set of rules that take into account past patient behavior and/or the point in the duration of the prescriptions. Then, each of these possible adherence phases is coded to randomly include messaging content from specific message categories in specific ratios. Thus, the final outputs, the messages contained in each category, are a product of feedback loop selection and are relevant to the patient's observed adherence.

[0046] This creates modular components that can be changed in order to adapt the feedback loop control system for different medication applications. Changing the messages within each message category, adding or subtracting message categories, defining different intervention phases, changing the message categories that correspond to each phase, and/or changing how the controller assigns patients to an adherence phase are all means of adapting the basic feedback loop control system for a specific application.

[0047] In the following sections the different message categories, the different adherence phases, the breakdown of categories included in each phase, and the controller algorithm decision rules are described in greater detail.

[0048] Dosing instructions: time of day, number of pills, number of times per day, how to take pills, what to take them with, what to avoid. (Examples: "Take this medicine by mouth with a drink of water. ^" or "You may take this medicine with or without food.")

[0049] Safety: important side effects and signs and symptoms to watch out for and notify doctor about. This bin would also repeat some messages with the dosing instruction bin such as the substances to avoid taking with the medication and what the patient should be taking the medication with (food/water/etc). Examples: "Some patients do have headaches or dizziness on this medication. Alcohol can make this worse." or "Contact your doctor immediately if you have purple patches under your skin, black or bloody stool or vomit."

[0050] Education: information regarding the disease, its processes, and its trend with time if untreated or information about the drug, its method of action, and how it intervenes in the disease process. Examples: "This medication helps prevent clots from forming that can cause heart artack. stroke, or other vascular events in people who are at high risk" or "Patients sometimes bleed for longer when taking this medication." [0051] Feedback: messages reporting on the recent and/or overall frequency and/or amount of successful and/or missed dosing events. Examples: "Great job on taking your medication once a day for the last _ days! ^" or "Your last missed dose was _ days ago, keep up the good work. ^"

[0052] Encouragement: messages about the known benefits of the drug, clinical statements supporting the medications use, and clinical/case vignettes highlighting reasons for taking the drug. Examples: "This medication was shown to be superior to aspirin in presenting ischemic stroke and myocardial infarction in a study of +19,000 patients." or "Even if you don't feel any different, this medication is working to protect your heart."

[0053] Rewards: can include fun facts, jokes, or user stored messages from children or grandchildren for example. Examples: "The average heart pumps roughly 2,000 gallons of blood a day. ^" or "The F.D.A. approved this medication in 1997."

[0054] End of prescription or refill information: guidance on how to complete the prescriptions any impacts of coming off the medication if prescription is concluding. If the patient requires a refill, information on how to refill will be provided and importance of not having a gap in treatment will be given. Examples: "You should have 5 pills left, be sure to call your pharmacy for a refill." or "Contact your physician if you are having trouble obtaining your next prescription."

[0055] The algorithms can also incorporate a particular phase in the patient's medication therapy. For example:

[0056] Startup: A defined period of time. Starts with the first dosing event and continues for a predefined number of dosing events.

[0057] Reinforcement: Starts at the conclusion of the startup phase. Participants will remain in this phase until they successfully follow the dosing regimen for a predetermined number of dosing events.

[0058] Transition: Starts at the conclusion of the reinforcement phase or either of the remediation phases. This phase continues until participants successfully complete a predetermined number of dosing events. [0059) Maintenance: Participants enter this phase after completing the transition phase. Participants remain in this phase until another phase supersedes it (remediation, feedback, or refill ).

[0060) Basic remediation: Triggered if a certain (defined) number of doses are missed at any time after the reinforcement phase concludes and before feedback phase begins.

[0061 j Intense remediation: Triggered if more doses are missed than the amount needed to trigger the basic remediation phase.

[0062J Prescription conclusion and refill: The final dosing event and a defined number of preceding dosing events depending on the necessity and complexity of obtaining a prescription refill.

[0063J Each phase is preferably assigned to cycle messages from an appropriate set of message categories. For example, the startup phase will focus primarily on messages from the dosing instruction category. Side effect information will only be incorporated after the startup phase, ( to correspond with when the effects begin to emerge) and will taper off when side effects are no longer expected to present. Messages from the maintained phase will be less frequent and will include rewards such as jokes or fun facts about the medication or disease. And messages pertaining to refill instructions will make up the majority of messages during the final phase of the prescription.

[0064J The length and number of messages can also be adjusted for each phase. For example, the startup phase might feature multiple messages one after another in order to convey the necessary information needed at the start of a prescription, while the maintenance phase could feature a single short message to avoid overburdening patients.

[0065J The algorithm, or controller, has three main functions: observation, feedback, and determining the patient ^' s phase of adherence. The observation and feedback elements require the controller to detect which day in the course of the prescription it is (temporal input) and w hether or not the patient has opened the device at an appropriate dosing event (behavioral input ). The last function requires the algorithm to assign the patient to one of the predefined patient adherence phases based on the observed patient outcomes and the predefined algorithm assignment rules (the rules for using the observed feedback for determining the adherence phase). A flow chart depicting how the algorithm may be used to provide a message is shown in Figure 4.

[0066] Rules for determining which adherence phase the patient may be determined with the following variables:

[0067] (X - day in the prescription course, Xo = first dosing event, X A ⁼ last day of startup phase. X _\ c = first day of conclusion/refill day, X _z = last dosing event; Y - nonadherent days since Xo or last Z event, Y _A = # of missed or over dosing events separating basic and intense remediation; Z - number of adherent events in a row since X ₀ or last Y, Z _\ = number of adherent doses needed to exit reinforcement phase, Z ₂ = number of adherent dosing events needed to exit transition phase, Z ₃ = number of adherent dosing events needed to exit basic remediation phase, Z ₄ = number of adherent dosing events needed to exit intense remediation phase)

[0068] Phase 1 - Startup: Temporal: X ₀ to X _NA ; Behavioral: no rules

[0069] Phase 2-Reinforcement: Temporal: X > XNA, < XNB _; Behavioral: Z < Z _\ not following phase 3. 5 or 6

[0070] Phase 3 - Transition: Temporal: X > X _NA , X < X B; Behavioral: Z < Z ₂ not following phase 5 or 6

[0071 ] Phase 4 - Maintenance: Temporal: X > Χ _\Α , X < X B; Behavioral: Z < Z ₂

[0072] Phase 5 - Basic remediation: Temporal: X > XNA, X < XNB; Behavioral: Y < Y _A dosing events missed until Z < Z ₃ dosing events not following phase 2, 3 or 6

[0073] Phase 6 - Intense remediation: Temporal: X > X _N A, X < XNB _; Behavioral: Y >/= Y _A dosing events missed until Z < Z ₄ dosing events not following phase 2, 3 or 5

[0074] Phase 7 - Prescription conclusion and refill: Temporal: Day Xz to XNB _;

Behavioral: no rules

[0075] Figure 6 depicts a chart of possible algorithm messages according to an embodiment of the present invention. EXAMPLES

[0076] The following examples are prophetic in nature and are set forth to assist in understanding the invention and should not be construed as specifically limiting the invention described and claimed herein. Such variations of the invention, including the substitution of all equivalents now known or later developed, which would be within the purview of those skilled in the art, and changes in formulation or minor changes in experimental graphic, are to be considered to fall within the scope of the invention incorporated herein.

Example 1

[0077] An example of the algorithm for a generic patient is described as follows. A patient recently suffers a heart attack. This patient is promptly placed on a new medication. The device device is deployed to aid the patient in being adherent to his medication. The first instance of opening of the cap and activation of the device initiates the temporal tracking of the device. For the early part of a patient ^' s dosing, the device's algorithms will direct it to emphasize dosing instructions. As time elapses, the device's message content will change. If the patient is showing good adherence and a set number of days has elapsed in terms of time from the initial opening, the device will de-emphasize dosing instructions. Instead the device will provide more rewards (e.g. Great job! Keep it up!) or general education messages. However, if the patient shows poor adherence the device's message will be weighed towards more encouragement (e.g. This medication is very important to take every day) and dosing instructions (e.g. This is a once a day medication). If the patient begins to show initial adherence but has a period of poor adherence, the device can react by altering the message content. The probability that a specific type of message (safety, reward, encouragement or dosing) follows both the time from the initial activation of the device and the patient's past behavior. When the time from the initial activation of the device nears the length of the prescription, the device will begin to add reminder messages for the patient to refill their prescription (e.g. your prescription is likely running low, make sure to refill soon).

Examples 2-4

Examples 2-4 describe the various phases which may be used in the algorithms to determine the appropriate messages to be delivered by the device of the present invention. Example 2

[0078] Patient 1 : great adherer - The great adherer is the ideal patient who never misses a dose. In this example, the patient begins in the startup phase for the predetermined number of days. Following the startup phase, the patient will progress from the reinforcement phase to the transition phase to the maintenance phase as their cumulative consecutive dosing events crosses the threshold values. The patient will then persist in the maintenance phase because they are not missing any doses. Finally, at a set number of days before the prescription's conclusion, the patient will enter the refill phase until the prescription concludes and the next cycle begins with the next medication vial.

Example 3

[0079] Patient 2: typical adherer - The typical adherer will take a majority of their doses, but will miss some now and then. In this case, the patient begins in the startup phase for the predetermined number of days. Following the startup phase, the patient will progress from the reinforcement phase to the transition phase to the maintenance phase as their cumulative consecutive dosing events crosses the threshold values. When the patient misses a dose, this progression will be halted and the patient will enter the basic or intense remediation phase (depending on the number of doses the patient misses). The patient will then progress from the remediation phase to the maintenance phase as their cumulative consecutive dosing events crosses the threshold values. Each time the patient misses a dose, they will reenter the remediation phase and start this progression again. Finally, at a set number of days before the prescription ^' s conclusion, the patient will enter the refill phase until the prescription concludes and the next cycle begins with the next medication vial.

Example 4

[0080] Patient 3: poor adherer - The poor adherer misses numerous doses periodically throughout the course of the prescription. In this case, the patient begins in the startup phase for the predetermined number of days. Following the startup phase, the patient will enter the reinforcement phase. In this case, the patient misses a dose in the reinforcement phase and enters the remediation phase. This patient will persist in the basic or intense remediation phase (depending on the number of doses the patient is missing) because they continue to miss doses before they build up enough cumulative consecutive dosing events to exit the remediation phases. Finally, at a set number of days before the prescription's conclusion, the patient will enter the refill phase until the prescription concludes and the next cycle begins with the next medication vial.

[0081 ] Although the present invention and its advantages have been described in detail, it should be understood that various changes, substitutions and alterations can be made herein without departing from the spirit and scope of the invention as defined by the appended claims. Moreover, the scope of the present application is not intended to be limited to the particular embodiments of the process, machine, manufacture, composition of matter, means, methods and steps described in the specification. As one of ordinary skill in the art will readih appreciate from the disclosure of the present invention, processes, machines, manufacture, compositions of matter, means, methods, or steps, presently existing or later to be developed that perform substantially the same function or achieve substantially the same result as the corresponding embodiments described herein may be utilized according to the present invention. Accordingly, the appended claims are intended to include within their scope such processes, machines, manufacture, compositions of matter, means, methods, or steps.