U.S. patent application number 12/777992 was filed with the patent office on 2010-09-02 for unified ingestion package and process for patient compliance with prescribed medication regimen.
Invention is credited to Narayanan Ramasubramanian, Anand Subra.
Application Number | 20100219097 12/777992 |
Document ID | / |
Family ID | 35426302 |
Filed Date | 2010-09-02 |
United States Patent
Application |
20100219097 |
Kind Code |
A1 |
Ramasubramanian; Narayanan ;
et al. |
September 2, 2010 |
UNIFIED INGESTION PACKAGE AND PROCESS FOR PATIENT COMPLIANCE WITH
PRESCRIBED MEDICATION REGIMEN
Abstract
Techniques for reducing non-compliance of medication use are
described. The techniques involve generating and storing an
identifier for a specific dosage instance of a specific patient,
and creating a package that includes a mechanism for conveying the
identifier. Once the package is created, a set of one or more
medications that are prescribed to be taken by the specific patient
at the specific dosage instance are placed in the package. The set
of medications within the package in a manner that prevents the
identifier from being perceived from the mechanism until the
package is opened. Once opened, the identifier is perceived and
communicated back to an automated compliance system.
Inventors: |
Ramasubramanian; Narayanan;
(Fremont, CA) ; Subra; Anand; (Plymouth,
MN) |
Correspondence
Address: |
HICKMAN PALERMO TRUONG & BECKER, LLP
2055 GATEWAY PLACE, SUITE 550
SAN JOSE
CA
95110
US
|
Family ID: |
35426302 |
Appl. No.: |
12/777992 |
Filed: |
May 11, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11140012 |
May 27, 2005 |
7712288 |
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12777992 |
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60575488 |
May 28, 2004 |
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60577319 |
Jun 3, 2004 |
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Current U.S.
Class: |
206/534 ;
455/466; 53/410 |
Current CPC
Class: |
A61J 1/03 20130101; G16H
20/13 20180101 |
Class at
Publication: |
206/534 ; 53/410;
455/466 |
International
Class: |
B65D 83/04 20060101
B65D083/04; B65B 61/20 20060101 B65B061/20; H04W 4/12 20090101
H04W004/12 |
Claims
1. A method for reducing non-compliance of medication use, the
method comprising: generating and storing an instance-specific
identifier for each dosage instance of a plurality of dosage
instances that are associated with a specific patient, wherein
generating an instance-specific identifier for each dosage instance
includes generating a first instance-specific identifier for a
first dosage instance; creating a package that includes a mechanism
for conveying the first instance-specific identifier for the first
dosage instance; placing in the package a set of one or more
medications for the first dosage instance for the specific patient;
and sealing the set of medications within the package in a manner
that prevents the first instance-specific identifier from being
perceived from the mechanism until the package is opened.
2. The method of claim 1 wherein: each dosage instance of the
plurality of dosage instances is an instance in which the specific
patient is prescribed to take medications; the instance-specific
identifier generated for each dosage instance of the plurality of
dosage instances is unique relative to instance-specific
identifiers provided to the specific patient for any other dosage
instance of the plurality of dosage instances.
3. The method of claim 2 further comprising: capturing
instance-specific identifiers associated with dosage instances of
the specific patient, and analyzing a set of captured
instance-specific identifiers to characterize a specific patient's
compliance behavior.
4. The method of claim 3 further comprising predicting probable
medical outcomes based on characterization of the specific
patient's compliance behavior.
5. The method of claim 1 wherein: the steps of generating,
creating, placing and sealing are performed for each patient of a
plurality of patients; and the instance-specific identifier
generated for each specific dosage instance for each specific
patient is unique relative to all other identifiers generated for
other patients.
6. The method of claim 1 wherein: the steps of generating,
creating, placing and sealing are performed for each patient of a
plurality of patients; the instance-specific identifier generated
for each specific dosage instance for each specific patient is not
unique relative to all other instance-specific identifiers
generated for other patients; and the instance-specific identifier
generated for each specific dosage instance for each specific
patient is combined with another number associated with the
specific patient to create a composite identifier that is unique
relative to all other identifiers generated for other patients.
7. The method of claim 6 further comprising: the receiving an
indication of the first instance-specific identifier through a
communication; and capturing the number associated with the
specific patient from the communication.
8. The method of claim 7 wherein: the step of receiving an
indication of the first instance-specific identifier through a
communication includes receiving an indication of the first
instance-specific identifier by a telephone communication; and the
step of capturing the number associated with the specific patient
from the communication includes capturing caller identifier
information associated with the telephone communication.
9. The method of claim 1 further comprising: communicating a
reminder to the specific patient, wherein the reminder is
associated with the first dosage instance; and determining whether
the specific patient has complied with taking the set of
medications at the first dosage instance based on whether the first
instance-specific identifier is received in response to the
reminder.
10. The method of claim 9 wherein: the step of communicating a
reminder includes using an automated compliance system to send a
text message to cell phone of the specific patient; and the step of
determining whether the specific patient has complied with taking
the set of medications at the first dosage instance is based on
whether the automated compliance system receives a response, to the
text message, that includes the first instance-specific
identifier.
11. The method of claim 1 further comprising an automated
compliance system determining whether the specific patient has
complied with taking the set of medications at the first dosage
instance based on whether the automated compliance system receives
a communication that includes the first instance-specific
identifier prior to a predetermined deadline.
12. The method of claim 1 further comprising an automated
compliance system determining whether the specific patient has
complied with taking the set of medications at the first dosage
instance based on whether the automated compliance system receives
a communication that includes the first instance-specific
identifier within a predetermined window of time before and after
the prescribed time of the first dosage instance.
13. The method of claim 1 wherein: the mechanism is an RFID Tag,
and the step of sealing the set of medications within the package
in a manner that prevents the first instance-specific identifier
from being perceived from the mechanism until the package is opened
includes sealing the package in a manner that shields the RFID
Tag.
14. The method of claim 13 wherein the step of sealing the package
in a manner that shields the RFID Tag includes covering the RFID
Tag with a material that shields the RFID Tag.
15. The method of claim 1 wherein: the mechanism is printed
material from which the first instance-specific identifier may be
visually perceived, and the step of sealing the set of medications
within the package in a manner that prevents the first
instance-specific identifier from being perceived from the
mechanism until the package is opened includes sealing the package
in a manner that prevents the printed material from being visually
perceived.
16. The method of claim 15 wherein the first instance-specific
identifier is printed on the printed material using human-readable
symbols.
17. The method of claim 15 wherein the first instance-specific
identifier is printed on the printed material using a bar code.
18. The method of claim 1 wherein: the mechanism is a magnetic
strip on a card material, and the step of sealing the set of
medications within the package in a manner that prevents the first
instance-specific identifier from being perceived from the
mechanism until the package is opened includes sealing the package
in a manner using a material that shields the magnetic strip.
19. The method of claim 1 wherein: the set of medications includes
tablets and/or capsules, each representing a specific dosage of a
specific medication.
20. The method of claim 1 wherein: the set of medications is
comprised of multiple subsets of micro-spheres, granules or
pellets, each subset comprised of a specific number or weight of
micro-spheres, granules or pellets that are customized to represent
a specific dosage of a specific medication for a specific patient,
for a specific dosage ingestion time.
21. The method of claim 20 wherein: each subset of micro-spheres,
granules or pellets comprising a specific dosage of a specific
medication, is treated with a time-release coating that delays the
release, in the patient's body, of the specific medication for a
specific time after ingestion.
22. A package sealed with medications, the package created by steps
recited in claim 1.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS; BENEFIT CLAIM
[0001] This application claims benefit as a continuation of U.S.
patent application Ser. No. 11/140,012 filed May 27, 2005 the
entire contents of which is hereby incorporated by reference as if
fully set forth herein, under 35 U.S.C. .sctn.120, which claims
priority to the following provisional applications, the entire
contents of which are incorporated herein by this reference:
[0002] U.S. Provisional Patent Application No. 60/575,488, filed by
Narayanan Ramasubramanian on May 28, 2004, entitled
"Patient-Specific Medication Preparation"; and
[0003] U.S. Provisional Patent Application No. 60/577,319, filed by
Narayanan Ramasubramanian on Jun. 3, 2004, entitled
"Patient-Specific Medication Preparation".
[0004] The applicants hereby rescind any disclaimer of claim scope
in the parent applications or the prosecution history thereof and
advise the USPTO that the claims in this application may be broader
than any claim in the parent applications.
FIELD OF THE INVENTION
[0005] The present invention relates to medication regimes and,
more specifically, to techniques and systems to assist compliance
with those regimes.
BACKGROUND
[0006] In many oral medication regimes, patients or experimental
subjects are required to take multiple oral medications and/or
doses at specified intervals during the day. There are several
reasons why such patients do not comply with their regimens, but a
large percentage (1) simply forget, (2) cannot get prescriptions
filled or delivered, or (3) do not like the side effects. It is
common for such patients to forget to take the medications at the
proper time or even to take multiple doses because of difficulties
in remembering what they have already taken. The risks of not
complying with the prescribed regimens and suffering the symptoms
of under-dosing or over-dosing are well documented. The costs of
treating the resulting medical problems have been estimated at over
$100 billion per year in the US alone.
[0007] A large factor in the lack of compliance is inconvenience.
While bottles are ideal as a delivery system for tablets or
capsules from the pharmacy to the patient, they are not conducive
to patient compliance. The inconvenience for a given patient
increases dramatically with: (1) the number of medications in
separate containers that the patient has to take, (2) the number of
daily repetitions of each medication, (3) the complexity of the
rules governing the how and when to take the medications,
especially if some have to be taken during normal sleeping times,
or with food, or on an empty stomach, and (4) under-dosing or the
side-effects that arise out of the slight overdosing because the
medications can only be roughly titrated to the specific patient's
metabolism (in order to balance efficacy and side-effects). This is
because medications are available only in certain dosages in
relatively large increments.
[0008] Products and services have been introduced to the market in
an attempt to improve compliance. There are online services that
offer free or fee-based automated reminders on a daily or other
user-selected basis, via email or cell phone, to remind patients to
take their medicines (such as services offered by Freeminder.com
and Iping.com). Over time, some patients begin to ignore the
reminders, while others dislike the `automated` nature of the
reminders and prefer a `human touch`.
[0009] Some existing solutions also provide a multi-dose package
containing all the medications to be taken by a particular patient
at a particular time of day. These take the form of cups containing
pills and capsules such as in the MD2 product from E-Pill.com, and
rely on caregivers to fill the containers with the appropriate
medications, leaving open the possibility of errors, especially for
complex regimens. In some cases, reminders may be programmed into a
device by the patient or caregiver. Some solutions automate the
process of dispensing the appropriate pills and capsules, such as a
system described in U.S. Pat. No. 5,839,257, and rely on a nurse or
other licensed practitioner to administer the multi-dose to the
patient and record the compliance event, typically in a hospital or
managed facility setting. Due to cost and other factors, these may
not be suited for patient self-administration. Yet other solutions
use specially constructed blister packaging incorporating
specialized electronics to detect compliance events. Some even
provide remote dispensing of medications of different dosage
strengths. These solutions are expensive since they rely on
proprietary packaging and do not provide the convenience of a
single package. There are also combinations of multiple drugs into
a single pill or capsule, referred to as `cocktail` therapy, but
due to size limitations, these are usually for a single
disease.
[0010] More recently, electronics-enabled blister packs have become
available--these provide multiple medications and automated
compliance recording, but are either expensive or have size
limitations and thus may not be able to handle complex regimens.
Other solutions such as a `Smart Tray` with embedded RFID enabled
medication containers, record which medication vials are removed
from the tray and the time of removal; the data are transmitted to
an online database as compliance events. In yet another solution,
each medication vial is fitted with an RFID enabled detector that
records the opening of the vial as a compliance event. The drawback
in recording the opening of each container is that the patient
still has to open each individual vial and manually assemble the
requisite pills or capsules before taking them. In addition, the
amount of data recorded is dependent on the number of containers
rather that just the act of opening a single package. In many of
the above cases, a special device or computer interface hardware
and software must also be provided to patients, posing limits on
scalability and speed of adoption.
[0011] In general, the above solutions address specific parts of
the overall problem and have thus far failed to make a significant
impact on patient compliance. The system described hereafter builds
on some of these existing solutions, or parts thereof, to provide a
more comprehensive solution.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] The present invention is illustrated by way of example, and
not by way of limitation, in the figures of the accompanying
drawings and in which like reference numerals refer to similar
elements and in which:
[0013] FIG. 1 illustrates a unified ingestion package, according to
an embodiment of the invention;
[0014] FIG. 2 illustrates two medication compartments of a unified
injection package, according to an embodiment of the invention;
[0015] FIG. 3 illustrates a unified injection package that houses
multiple sets of coated micro-spheres, according to an embodiment
of the invention;
[0016] FIG. 4 illustrates steps of a method for using a unified
ingestion package, according to an embodiment of the invention;
[0017] FIG. 5 shows a schematic view of a Compliance Tracking and
Management System, according to an embodiment of the invention;
and
[0018] FIG. 6 shows a schematic view of a package production
system, according to an embodiment of the invention.
DETAILED DESCRIPTION OVERVIEW
[0019] Techniques and systems are described hereafter for reducing
non-compliance by (1) reminding patients to take their medicines at
the appropriate times, (2) simplifying the taking of medicines
through personalized and convenient multi-dose packaging, (3)
incorporating features in the packaging to enable the monitoring of
patient compliance events, (4) monitoring and recording patient
compliance events in a database, (5) analyzing the database to
guide interventions to improve patient compliance, (6) analyzing
the actual consumption of the medications to (a) automatically
refill and deliver a labeled multi-day (15, 30 or 90 days) supply
of medication packages to patients, and (b) more accurately
forecast future drug production requirements, and (7) personalizing
the dosage strengths to minimize side effects while maximizing the
therapeutic effects.
System Overview
[0020] A comprehensive system is provided for reducing
non-compliance. The system includes: (1) a patient-centric package
of medications with a built-in compliance feature, and methods of
using the said package, (2) a compliance tracking and management
system comprised of: (a) a reminder service, (b) methods to capture
patient compliance events, (c) a portal to receive compliance event
data and to provide secured user access, (d) a secured database to
hold the patient compliance records, (e) methods for handling
non-compliance, and (f) a set of control programs and decision
support programs that operate on the compliance records, and (4)
specialized equipment produce the patient-centric packages. The
system and its elements are described below.
OVERVIEW OF FIGURES
[0021] FIG. 1 shows one embodiment of the `unified ingestion
package`. The package is constructed out of two rectangular sheets
of flexible plastic film that are fastened together by means of a
permanent heat-seal (a). The package also has peel-able heat-seal
lines that seal in the contents but allow the two sheets to be
separated along the said lines (b), and medication compartments (c)
formed by multiple adjacent peel-able heat-seal lines. At least one
of the compartments (d) is lined with opaque or shielding material
in order to prevent the information embedded in the compliance
feature (e) from being perceived without separating the sheets,
i.e., opening the package. The compliance feature (e) may be in the
form of a card with information printed on it, either as text or
barcode that is glued to one of the sheets, or encoded on a
magnetic strip or an RFID Tag.
[0022] FIG. 2 shows a section of the unified ingestion package,
specifically two of the medication compartments, each containing
micro-spheres (a) of different medications. There may be multiple
sets of micro-spheres in a compartment comprising multiple dosages
of a medication, each set with a coating designed to provide
different time release profiles (b).
[0023] FIG. 3 shows a specific embodiment of the unified ingestion
package that houses multiple sets of coated micro-spheres. A
permanent heat-seal (a) serves to fasten the two plastic sheets
together to form the package and also to provide a maximum fill
height (b) for the different medication micro-spheres (g) in the
different compartments (d). As in FIG. 1, peel-able heat seal lines
(c) form the compartments and seal in the contents, and at least
one of the compartments (e) is lined with opaque or shielding
material in order to prevent the information embedded in the
compliance feature (f) from being perceived without separating the
sheets, i.e., opening the package. The compliance feature (e) may
be in the form of a card with information printed on it, either as
text or barcode that is glued to one of the sheets, or encoded on a
magnetic strip or an RFID Tag.
[0024] FIG. 4 shows the method of use of the unified ingestion
package. At the appointed unified ingestion time, the patient opens
the package by peeling back the two sheets of plastic (a) along the
peel-able heat seal lines, up to the point of the permanent heat
seal line. At this point, all the medications are ready to be
removed (b) by inverting the package into an ingestion medium or
vessel. The compliance feature is also exposed (c) at this point,
so that it can be perceived by reading the symbols, or using a
barcode scanner or a magnetic strip reader, or an RFID reader.
[0025] FIG. 5 shows a schematic view of one embodiment of the
`Compliance Tracking and Management System`, which uses an RFID Tag
as the compliance feature, and which enables the patient (a) to
open the medication package (b) as described above, and to use a
cell-phone equipped with an RFID reader (c) to record a compliance
event. The compliance event information is transmitted via one of
several telecom providers (d) to a system portal (e) which
communicates to a database (f) and a server with software programs
(g). The portal also provides secured access via user access
terminals (h). There are system setup elements (1) that represent
prerequisites for the proper functioning of the system. The system
provides compliance functions (2) and facilities for handling
non-compliance (3).
[0026] FIG. 6 shows a schematic view of the package production
system comprised of: (a) prescription receipt, consolidation and
storage software, (b) prescription order preparation and sequencing
software, (c) control instruction generator software, (d) label
data preparation software, (e) an equipment control apparatus, (f)
a compliance feature preparation apparatus, (g) a drug dispensing
and staging apparatus, (h) a custom coating apparatus, (i) a
filling and labeling apparatus, (j) a raw stock transport and
sealing apparatus, and (k) verification logging and alerting
software.
Patient-Centric Medication Package
[0027] The techniques described herein seek to simplify the taking
of medications by combining all the medications that are to be
taken by a particular patient, at a particular time of day, into a
single "unified ingestion package". The techniques seek to further
simplify the taking of medications through a `one-a-day` unified
ingestion package which combines all the medications that are
readily available in `one-a-day` formulations, and needs to be
taken only once a day.
[0028] Accordingly, a technique and system are provided in which
multiple medications are packaged in patient-specific multi-dose
packages. For example, assume that a particular patient's
prescribed regimen requires three, three and four different
medications to be taken in the morning, late afternoon and before
bedtime, respectively, on a daily basis. The regimen may be a
combination of different medications, or repetitive doses of the
same medication, or both, and the regimen may further require some
pills to be split or contents of some capsules to be divided. The
difficulties in adhering to this type of regimen are obvious. This
aspect of the present invention simplifies the taking of these
medicines by packaging the three, three and four medications, in
the appropriate dose strengths, in three separate multi-dose packs,
to be taken in the morning, late afternoon and before bedtime,
respectively. Medications that are readily available in `one-a-day`
(extended release or sustained release) formulations may be
combined into one of the above multi-dose packs, based on the
patient's convenience. As shown in FIG. 1, the package may be
constructed in a manner that allows multiple medications to be
placed in compartments within the package.
[0029] The set of medications that are to be included in the
unified ingestion package are referred to herein as the
"constituent medications" of the unified ingestion package. If the
physical size of the constituent medications is small enough, the
unified ingestion package may be a single pill or capsule.
Alternatively, the unified ingestion package may be two or more
pills or capsules containing the same contents.
[0030] A technique and system are provided in which multiple
medications are packaged into a multi-dose package in
patient-specific, or personalized, time release treatments.
According to this embodiment, the unified ingestion package may
contain globules or micro-spheres, as shown in FIG. 2, which may be
swallowed directly, mixed into an `ingestion medium` such as a
liquid that the patient may then drink, or a semi-solid food such
as apple sauce, that the patient may then find easier to swallow.
Taste-masking or protective coatings may also be applied to the
globules to prevent their dissolution in the ingesting medium.
[0031] The coatings enable the medications to be absorbed in the
stomach, or to survive the environment in the stomach and then be
released in the small intestine, or to further survive the small
intestine and later be released in the large intestine. The
different time release treatments allow for (1) repeated dosing at
regular intervals after ingestion, or (2) dosing at appropriate
times of day to improve drug absorption or bio-availability, or (3)
introducing appropriate time delays between different interacting
medications to minimize the interactions. There may also be
requirements to take some of the medications either with or without
food. According to one aspect of the invention, a system is
provided for treating the medications so that all medications may
be taken simultaneously at the same time every day ("unified
ingestion time"). With reference to the above example, because each
of the ten medications has been treated for time release based on
the prescriptions applicable to the specific patient, i.e., the
regimen, three of the medications will be released within the
patient in the morning, three in the late afternoon and the
remaining four at bed-time. Because the patient needs only to
remember to take the unified ingestion package at the unified
ingestion time every day, the patient is more likely to become
habituated and thus adhere to the regimen over an extended period
of time.
[0032] In another aspect of this invention, if required by a
patient's regimen, the contents of the unified ingestion package
may include time-release coated globules containing substances that
may be considered as `food`, timed to be released at the same time
as certain medications that must be taken with food. The food
substances may also be timed to be released just before medications
that must not be taken on an empty stomach. Alternatively, flavored
excipients may be included in the package for taste-masking and
improving palatability.
[0033] Yet another aspect of this invention serves to more finely
titrate the dosages to a specific patient's metabolism and thus
personalize the package even further in order to balance the side
effects with the therapeutic effects. This is achieved by providing
medications in the form of globules that contain a small but
standardized amount of the medications, and counting the globules
to provide the desired, more precise dosages for a specific
patient. Each standardized globule contains the same amount of the
medication, within practical limits, which enables the prescribed
medication dosages to be metered by counting a specific number of
the standardized microscopic globules to add up to the prescribed
dosages, or by weighing the standardized globules to provide the
requisite dosages. The small standardized amount of medication in
each globule permits much finer dosage increments to be prescribed
based on titration for specific patients in order to minimize side
effects. For example, a patient may require and be able to tolerate
somewhere between 50 mg (milligram) and 100 mg of a medication that
is currently available only in these increments. The 50 mg dose
would be insufficient to address the medical conditions and the 100
mg dose would result in intolerable side effects. However, if the
medication were provided so that each globule contained a
standardized 1 mg of the medication, then to provide 75 mg (half
way between 50 mg and 100 mg) of the medication, we only need to
count 75 globules. Alternatively, the requisite 75 mg dosage could
be metered by weight of the standardized globules. The dosages can
be successively titrated even more finely, say to 65 mg, by
monitoring the patient's response and side effects, and adjusting
the dosage accordingly.
[0034] As shown in FIG. 3, the unified ingestion package may be
constructed with multiple compartments, each containing a set of
standardized microscopic globules, granules or powder, encapsulated
in time-release coatings representing specific medication dosages
that are to be released either continuously or in time-spaced
intervals. The package may be produced in different shapes and
sizes, and may have some or all of the following elements: (1)
compartments for medications, food, chemical markers and excipients
(2) a specially shielded compartment to house a compliance feature,
and (3) other features to help the patient (a) open the package,
(b) retrieve the medications and (c) expose the compliance feature.
The package is designed to handle different types of medication
formulations (pills, capsules, liquids, globules, micro-spheres,
etc.) over time, with the same form factor, providing scalability
between multiple generations. The package may be produced in a
standard ten-compartment version or a version with a customized
number of compartments, depending on the need. In the standard
version, not all the compartment would necessarily have to be
filled; only as many as the number of medications would be, and the
rest would be empty.
[0035] Individual medications are dispensed in their mass-produced
dosage forms such as liquids, pills or capsules into multiple
compartments in order to keep interacting medications separated
until the package is opened for consumption. For example, capsules
may all be placed in a single compartment because the gelatin
covering keeps the medications from even touching each other, but
pills may be placed in individual compartments to avoid mutual
contact, and liquids would be dispensed into individual
compartments. Medications for which chemical reactions are not of
concern may be placed in the same compartment. Medications in
powder, granule or micro-sphere form may also be placed in
compartments in a similar manner. In the case where all the
medications are coated whether in micro-sphere, granule or powder
form, there is little risk of interaction, and all of the
medications may be placed in a single compartment, greatly
simplifying the design of the package.
[0036] The package may be constructed of a water-proof polymer
material to keep the medications dry. The material may also have
anti-static properties in order to keep drug globules or
micro-spheres from sticking to the sides of the package due to
electrostatic charge and preventing their complete removal. The
material may also have ultraviolet radiation reflecting or
absorbing properties to keep the medications from deteriorating.
The interiors of the compartments may optionally be coated with
gelatin or a similar substance in order to mimic the protective
characteristics of a gelatin capsule for drug micro-spheres that
are readily available in such capsule form.
[0037] The package may be constructed of a heat-sealable polymer in
order to provide heat-induced separators between the compartments
and to provide tear-off or peel-off heat-seals that allow patients
to open the packages. For example, the well-known `chevron pack`
design may be used to facilitate easy opening of the package.
[0038] In another embodiment, the package maybe constructed out of
gelatin or similar material that dissolves in water, releasing the
medication micro-spheres directly into the fluid in the mixing cup.
In this case, selected micro-spheres would be coated with a
taste-masking material that does not dissolve in water (or the
ingestion medium) but dissolves rapidly in the stomach.
[0039] The FDA requires that labels clearly indicate several items,
such as patient's name, doctor's name, pharmacy's address and phone
number, prescription number, and so on. In addition, warning labels
and instructions such as `Do not Take with Alcohol` or `Take with
Food`, etc. are also required. In addition, each individual
medication name and dosage must be legible on the label. Barcodes
of the National Drug Code are also required foe each medication.
While much of this information can be printed on the package, the
sheer volume of information will require an additional insert or
folded label on each package. Alternatively, a label may be
attached to the container of the individual packs with all the
information and a subset of the information may be printed on each
pack. In another embodiment, the entire package may be constructed
of gelatin or similar material, and the labeling may be printed
using edible inks that are non-toxic and non-allergenic. In this
case, the entire package may be dropped into a cup containing an
ingestion medium, dissolved in the medium and ingested. The
compliance feature may be detached prior to this or retrieved from
the ingestion medium. Alternatively, a printed label may be peeled
off after ensuring that it is the correct package and before
immersing in the ingestion medium. The act of peeling off the label
may be used to generate a compliance signal by simultaneously
uncovering a compliance feature.
[0040] Packages may be color coded to identify when they should be
taken. For example a `white` colored package would identify a
morning package, a `black` colored package would identify a night
package and a `yellow` colored package would identify an afternoon
package. Packages may be additionally color-coded or otherwise
marked with a clearly visible specific geometric shape specific to
an individual patient in a household or facility with multiple
patients. Alternatively, the package may have a printed photograph
of the patient on the label, subject to applicable regulations. In
cases where some medications are optional or have to be taken just
before or with meals, supplemental packs may be attached to one of
the standard packs.
[0041] The unified ingestion time may also be personalized for
individual patients based on their preferences and known circadian
rhythms. Sometimes medications work better if they are absorbed in
the morning versus the evening and vice versa. By providing
different time release coatings based on patient convenience or per
physician directions, different medications can be timed for
release at different times of the day. Excipients, dyes, flavors
and additives may also be personalized to patient preferences or to
avoid allergic reactions, or additionally, as a way, particularly
for pediatric or geriatric patients, to remember which package to
take when. For example, strawberry in the morning and chocolate in
the evening may serve as an inducement for pediatric patients to
take their medicines.
Method of Using the Package
[0042] As shown in FIG. 4, a method is provided, through the
construction of the package, to: (1) release the medications so
they may be removed from their individual compartments and
ingested, and (2) expose the compliance feature so a compliance
event may be detected or recorded. With reference to the figure,
the covers are peeled back to the permanent heat-seal line, at
which point, all the peelable heat-seal lines are unsealed up to
the level of the permanent heat-seal line. This opens all the
compartments. The compliance feature may be read, or removed and
activated, and the medications may be removed by emptying the
package into a cup for mixing and ingestion.
Compliance Events
[0043] Recording patient compliance events--whether patients
actually took their medications and at what time of day, is of
great interest. Using the compliance event data, physicians would
be able to verify that their patients were indeed following their
prescriptions properly, insurance companies would be able to verify
whether patients were adhering to their regimens and offer
incentives to improve adherence (if needed), pharmacies would be
able to automatically process and deliver refills based on actual
consumption, and so on.
[0044] A compliance event can be detected in different stages,
namely, (1) opening of the package and emptying of the contents,
(2) preparation of the contents before ingestion, for example using
a cup to mix the contents with an ingesting medium, and (3) actual
ingestion by the patient. The compliance event itself may be
captured using manual or automated methods. The package may
additionally incorporate features that enable compliance event
detection, and methods are also provided to monitor and record
compliance events using different types of information such as
text, pictures or video.
[0045] The compliance number (Unique Package Identifier) would be a
sequence of digits with no inherent meaning or association with any
patient, and would be transmitted to a patient or caregiver, or
incorporated into a compliance feature on a specific package. Prior
to transmission or incorporation into a compliance feature, the
compliance number would be mapped to a specific package, its
intended ingestion time and the respective patient. This
association could only be accessed within a secured database.
During a compliance event, the compliance number would be received
and recorded in a secured database. Subsequently, the compliance
number would be mapped back to the respective patient and the
intended compliance event, and stored in a secured database. The
telephone number from which the compliance number is transmitted,
may be used to validate that the package was indeed opened by the
intended patient, thus providing a way to immediately detect errors
or fraud.
[0046] In order to provide incentives for patients to participate,
the compliance number may be linked to a rewards system that offers
instant prizes, rebates, discount coupons, etc., as well as options
for patients to earn compliance points that can be accumulated and
redeemed for goods or future medications. The compliance number
must be entered within the ingestion window to be eligible for
rewards, but may earn points in a six hour window on either side of
the ingestion window.
[0047] Compliance events are captured in a number of ways: in one
embodiment, the `compliance number` may be transmitted within the
cell phone reminder prompt, and the patient prompted to key in the
number to confirm compliance. Upon taking the medication, the
patient would key in this number either on a website on a cell
phone. This would work with conventional medications as well.
[0048] In another (visual) method, a camera-phone would be used by
the patient to record a still digital picture of the opened
package, with the label, including the barcodes, clearly captured
so as to indicate without ambiguity, the identity of the opened
package, making sure that no false compliance images are sent. The
picture would be transmitted to a secured database where the
mapping to the patient would occur and the compliance event would
be recorded.
[0049] Patients may also record images of the prepared contents
prior to ingestion, or video clips showing patients in the actual
act of ingestion. The images would clearly record the label on the
package which would show the patient's name, data and time of
ingestion. A time stamp would also be included. These images and
data would be encrypted, for privacy reasons and HIPAA compliance,
prior to transmission.
[0050] In another key aspect of this invention, the unified
ingestion package may be constructed to assist in confirming
patient compliance to varying degrees of automation. In one
embodiment, the package may be constructed to assist in confirming
compliance by incorporating a compliance feature that is invisible
or hidden in a compartment until it is opened. For example, the
compliance number may be printed on the interior surface but
shielded from external view by means of an opaque coating or
peel-off tab in the compartment. The number would be revealed only
after the package has been opened and the contents have been
removed in order to read the number or remove the peel-off
covering.
[0051] The compliance feature may be placed in a compartment with a
tear-off covering or a peel-off covering accessible from the
interior of the package. For example a barcode may be printed on a
small label that is inserted into one of the compartments in a
manner that obscures the barcode and prevents it from being scanned
until its compartment is uncovered. In another embodiment, a card
with a magnetic stripe containing the compliance number would take
the place of the printed barcode label. These embodiments make it
easier for the patient to enter the compliance number, by merely
requiring the patient to scan the barcode or swipe a card with a
magnetic stripe instead of manually entering the number.
[0052] In yet another embodiment, an RFID tag may be placed in a
compartment that is opaque to radio frequencies. Opening the
compartment in the package would unshield the tag and allow it to
respond to an RFID reader, and this signal would be recorded as a
compliance event by a remote compliance monitoring service.
[0053] In other embodiments, an RFID sensor, mounted inside a cup
would sense changes in resistance when the contents of a package
are mixed in the cup with water or other ingestion medium. When
interrogated by an RFID reader, the sensor would transmit the
changed signal signifying that the contents have been prepared.
[0054] In yet another embodiment, a non-toxic marker chemical may
be included in the unified ingestion package which would, after
ingestion, would produce a color change on the surface of the
patient's tongue, or a detectable marker metabolite level in the
patient's breath or serum. Changes in tongue color may be recorded
and transmitted using a camera-phone or digital camera, along with
a time-stamp. Metabolite levels in the breath may be recorded using
a breath analyzer enabled cell phone (such as those available from
Samsung). Metabolite levels in the serum may be recorded using
instruments that may be integrated with a more comprehensive remote
patient monitoring system (such as those available from
Siemens).
[0055] Other package embodiments may include the following:
[0056] Titration Packs, Drug or Dose Selector Packs, in which each
medication compartment is fitted with a set of breakable internal
membranes spaced at set intervals, say at 25 percent increments,
along the length of each compartment. Thus these membranes separate
the total medication dose into four parts. For example, if the
total dose is 100 mg, each increment holds 25 mg. By breaking none,
one, two, three or all four membranes, the patient can select a
dose of 0, 25, 50, 75 or 100 mg, respectively, of the particular
medication. Other compartments may be also fitted in a similar
manner, thus providing a way for the patient to select which
medication to take and the dosage of each medication individually.
Under the guidance of a physician, a patient can thus titrate the
dosages of each medication until the proper balance between
therapeutic and side effects has been found. Further, the physician
can specify a plastic template that can be aligned over the package
and pressed to break the appropriate membranes in order to release
the desired medications and dosages. The templates may be changed
on a daily, weekly or monthly basis by the physician or pharmacist
and thus provides a way to change drug regimens even while using
the same ingestion package. This pack may also be helpful in cases
where the physician wants the patient to skip some medications for
a period of time, in which case, the patient would simply not break
any of the membranes in the compartments containing the particular
medications to be skipped.
[0057] Titration for specific patients in order to minimize side
effects may be based on techniques such as: (a) Design of
Experiments, or (b) Simulated Annealing. The titration method
involves: (1) providing the starting dosage strengths of each
medication in the form of micro-spheres, (2) monitoring the
therapeutic and side effects using a self-referent scale, (3)
adjusting the dosages in a predetermined manner and sequence, using
micro-spheres, (4) developing a response map for the particular
patient, (5) computing the optimum dosages of each medication for
the particular patient, and (6) providing the optimum dosages in a
package containing the appropriate number or weight of
micro-spheres of each medication. Throughout this process, the
patient, physician and pharmacist are kept involved, in order to
provide clinical oversight.
[0058] In clinical trials, study subjects are required to comply
with the experimental protocols and take the drugs or placebos as
directed. The quality of the trial data is highly dependent on the
extent to which the subjects are in compliance with the directions.
The system described herein seeks to simplify compliance by
providing multiple doses of the medication under study in the form
of a unified ingestion package to be taken once a day, at the
unified ingestion time. In addition, the exact ingestion time of
the package is captured, rather than relying on the reports of the
study subjects. The system described herein also enables
dose-response studies as well as adaptive trials by providing means
to alter the study drug dosage strength or substitution with
placebos in an ongoing manner using drug/dose selector packs and
templates, or reissuing new trial packs.
[0059] Disease-specific Packs (Diabetes pack, Hypertension pack,
Cholesterol pack, Polypill pack): in many cases, poly-pharmacy, or
the use of multiple medications, is necessary to bring specific
conditions such as serum glucose level or blood pressure under
control. As another example, the National Health Service of the UK
is considering a `polypill` that includes of several medications as
a prophylactic for people over 55. This invention provides a way to
package multiple medications together into disease-specific packs
or such `polypill` packs.
[0060] Private Label, Antibiotic Compliance Pack: in this
embodiment, the multi-dose packs would contain only the medications
manufactured by a specific pharmaceutical manufacturer and its
partners, and would carry the manufacturer's label. For example,
some antibiotic courses that include one or more medications must
be taken for a set period of time in order to prevent the emergence
of drug-resistance. Frequently, patients only take partial courses,
and discontinue the antibiotics as soon as they start feeling
better, resulting in bacteria that develop resistance to the
antibiotics. This is a serious concern in the healthcare industry.
This system described herein, by providing the entire course in
multi-dose packs, by recording compliance events, and by providing
reminders, can mitigate this concern.
[0061] Travel multi-pack/purse pack: in this embodiment, a number
of multi-dose packs would be placed inside a larger pack fitted
with an RFID enabled detector that would transmit a signal whenever
the pack is opened, thus recording a compliance event. In one
embodiment, the individual multi-dose packs would not contain any
of the compliance features mentioned above, thus reducing the size
of the packs and providing a convenience for travelers, or highly
mobile patients. The RFID detector, in this case would be enabled
for WiFi transmission.
[0062] Alternatively, a cell phone based RFID reader (such as those
available from Nokia) would be used to pick up and transmit the
compliance events. In a different embodiment, this invention would
take the form of a `Compliance Box` into which conventional
medications in bottles would be placed in a box, whose lid would be
enabled with a compliance event detection feature similar to the
above travel pack.
[0063] In yet other embodiments of this invention, the packages may
be in different shapes and sizes for different applications. For
example, a titration pack may be larger than or of a different
shape from a standard pack, not only to house the additional
membranes, but also to differentiate it from a regular pack. In
further embodiments, the compliance features may be hidden in
compartments that can be opened using a tear-off stub rather than
having to reach inside the pack to retrieve them. Compliance
features may also be hidden in one of the cups in a blister
pack.
Reminder System
[0064] Reminders improve patient compliance with regimens.
Accordingly, techniques are described herein that remind patients
automatically to take their medications just before their
individual ingestion times on a daily basis. The reminders may be
based on voice, text or visual cues and transmitted via telephone,
including cell-phone, or the internet. The system may also be
customized by the patient to provide different levels of reminding,
as some patients may want to be reminded every day, while others
may not. The system can also be set to not remind patients when
they have been asked to suspend their regular regimen for various
reasons such as hospitalization, infection or illness.
[0065] The reminder system may use printed material or barcodes or
magnetically encoded cards to capture unique compliance events. In
one embodiment, the reminder system transmits a `compliance number`
within the reminder message and requires the patient or caregiver
to enter the `compliance number` in the response as a means to
confirm that the medications have been taken. This embodiment
requires no special packaging and can work with existing medication
delivery vehicles such as bottles. In other embodiments, the
`compliance number` is in the form of a unique `package identifier`
that is encoded in other forms such as bar-codes, magnetic strips
or RFID Tags, and is captured using the appropriate techniques. A
compliance number that identifies a specific dosage instance may be
called an instance-specific identifier.
Online "Buddy System"
[0066] Without a human touch, reminders tend to become less
effective over time. Many patients, especially those who are
home-bound, appreciate and respond better when an actual person,
particularly a peer, does the reminding. Accordingly, a key aspect
of this system provides an automated reminder service that is
coupled with an online `buddy system` for patients to team up and
remind each other by phone, with self-selected levels of anonymity,
in order to provide a human touch. The levels of anonymity may be
adjusted by the patient or buddies at any time. The buddy system
could expand to include multiple members who would participate in
an online peer group and discuss their experiences. The online peer
group would also provide a vehicle to record patient
quality-of-life related comments, as well as side-effect
information, and the information may be shared with the service,
subject to members' permissions.
Compliance Tracking and Management System
[0067] As shown in FIG. 5, in one embodiment, the compliance
tracking and management system uses RFID Tags, and the different
parts of the system perform their respective functions, as
described below.
Patient-Related Functions
[0068] In order to enable the system to work, there are some
prerequisites that must be set up before hand. These include: A00
Order & Receive Medication Packages: (1) get prescription(s)
from physician(s), (2) agree to daily ingestion time(s) and/or
window(s) as prescribed, (3) register with and order prescribed
medications from a certified pharmacy, and (4) receive the
medication packages.
[0069] Business Rules will be provided as configurable options per
the requirements of the service provider, for example: (1) the size
of ingestion window may be set at 1 hour or a maximum of 24 hours,
as prescribed, and per patient convenience, (2) the start of the
ingestion window maybe 5 minutes before the start, (3) the contact
attempts at different time intervals and the total number of
attempts before escalation, (4) primary, secondary and authorized
caregiver telephone numbers, and (5) specific escalation
procedures.
[0070] Compliance functions are as follows: A01 Respond to Reminder
Call: (1) patient receives an automated reminder call before
ingestion window, (2) patient answers the call, and (3) patient
retrieves the package labeled with the specific ingestion date
& time.
[0071] A02 Open Package and Un-shield Compliance Feature (RFID
Tag): (1) patient opens the pack, which action removes the RFID Tag
shielding, and (2) patient uses the RFID reader in the cell phone
to read the tag.
[0072] A03 Ingest Contents: (1) patient swallows contents of the
package along with an appropriate ingestion medium such as water or
apple sauce.
[0073] Non-Compliance functions are as follows: A04 Non-Compliance
Alert: (1) patient ignores reminder call or makes error in taking
the reminder call, in which case, the call is repeated, (2)
ingestion window expires, in which case, issue a final reminder,
renew the window and generate an exception alert, or (3) in case of
continued non-compliance even after window has been renewed,
generate an escalation alert to inform the predetermined
caregiver.
[0074] Examples of other exceptions and remedial actions are as
follows: (a) patient does not verify correct pack or label is
unreadable, in which case, the RFID Tag needs to be re-read, or the
patient can enter using the keypad or call the hotline, (b) patient
spills contents while opening the package, or misplaces the
package, in which case a call to the hotline will reset the next
appropriate pack for the present ingestion window, (c) RFID Tag is
not read properly, in which case, a voice and/or text message, or a
visual, color cue is transmitted to instruct the patient to `please
read tag again`.
Cell Phone Related Functions
[0075] In order to enable the system to work, there are some
prerequisites that must be set up before hand. These include: B00
Presets--ring-tones, program downloads, and defaults, based on
specific patient preferences.
[0076] Compliance functions include: B01 Receive Reminder at
Ingestion Window: (1) receive call placed by server, based on
preset options, such as a special ring-tone for `it's time to take
your medication!` message.
[0077] B02 Activate/Deactivate RFID Reader: (1) receive `activate`
signal from server and activate RFID reader, (2) confirm `active`
status to server, (3) receive `deactivate` signal from server and
deactivate RFID reader, and (4) confirm `inactive` status to
server.
[0078] B03 Receive Signal from RFID Tag (Unique Package
Identifier): (1) read RFID Tag and store in memory, and (2) record
date & time of signal storage in memory.
[0079] B04 Generate & Transmit Compliance Message comprising:
Unique Package Identifier and Time Stamp.
[0080] Non-Compliance functions include: B05 Generate &
Transmit Exception Message comprising: Unique Package Identifier
and Expected Time.
Telecom Service Provider Related Functions
[0081] These are part of the providers' standard services: (1) COO
Service Contracts, Billing and Other Agreements, (2) C01 Transmit
Reminder Call, (3) C02 Transmit RFID Reader Activate/Deactivate
Signal, (4) C03 Direct Compliance Message to System Portal, and (5)
C04 Direct Non-Compliance Message to System Portal.
System Portal Functions
[0082] (1) D01 Receive/Register Compliance Message, (2) D02
Receive/Register Non-Compliance Message. Also, the system portal
provides interfaces to user access terminals.
Database Functions
[0083] In order to enable the system to work, there are some
prerequisites that must be set up before hand. These include: E00
HIPAA compliance, and use of encryption to (1) store patient
profiles and (2) map Unique Package Identifier to patient ID,
[0084] Compliance and Non-compliance functions include: (1) E01
record compliance message in database (Unique Package Identifier,
Time Stamp), (2) E02 record non-compliance message in database
(Expected Unique Package Identifier, Ingestion Window),
Server Functions
[0085] In order to enable the system to work, there are some
prerequisites that must be set up before hand. These include: (1)
F00 scan database & generate reminders based on (i) Patient
Profile, Patient-Specific Parameters, (ii) Ingestion Window &
Expected Unique Package Identifier.
[0086] Compliance functions include: (1) F01 place or close
reminder call at ingestion window, (2) F02 Include RFID Reader
Activate/Deactivate Message in F01, (3) F03 Map Compliance Messages
to Patient ID, (4) F04 Generate Patient Compliance Reports, (5) F05
Transmit Reports to Customers, reports such as: (i) Compliance
Trends, History, etc., (ii) Actual Drug Consumption &
Forecasting, (iii) Automated Reordering information.
[0087] Non-compliance functions include: (1) F06 Place Reminder
Call upon Exception, (2) F07 Generate Exception Alerts, and (3) F08
Generate Emergency/Escalation Alerts.
[0088] Business Rules: HIPAA regulations govern all System
functions; all data are secured, access to data is controlled,
transmissions do not contain any identifiable data. The compliance
database is secured to be compliant with HIPAA regulations. Subject
to HIPAA regulations, compliance data that is collected in the
database may be provided for examination by authorized parties.
Personal or patient data may also be scrubbed from the raw data in
order to maintain confidentiality, and then provided for similar
examination to yet others.
Decision Support Programs & Analytics
[0089] Techniques are also provided to detect whether patients are
in compliance on a daily basis. The remote compliance-monitoring
service records the date and time of the package-opening signal. If
patients have missed taking their medications within a
predetermined window after the ingestion time, the system provides
a means to automatically record an exception and alerts buddies and
designated caregivers so they might take appropriate intervention
action.
[0090] The system analyzes the database for compliance trends and
history for individual patients. Following the applicable
regulations, the trends and history may be provided to insurance
companies, payers or managed-care organizations. These
organizations may further use the information to structure
incentives, such as rebates or premium adjustments, to improve the
compliance performance of individual patients. Alternatively, the
data may be used to more accurately manage risk, as an enabler for
consumer-driven healthcare. This data may also be transmitted to
providers for use in managing `Pay-for-Performance` programs.
[0091] In another embodiment, the system provides analytics that
use patient compliance data as a leading indicator to improve
disease management programs. Patient compliance is treated as
another vital sign that is captured on a daily basis. When a
particular patient stops taking medicines it is only a matter of
time before health problems become serious enough to warrant
medical attention. Thus compliance data can be useful in
identifying which patients are likely to require medical attention
if left unattended and disease management programs can proactively
stratify risks. Additionally, such patients can be contacted and
asked to resume their medications in an attempt to stave of
unnecessary medical treatments.
[0092] Current supply chain management systems can only track drugs
to the pharmacy level. Once the prescriptions are filled and taken
from the pharmacy, it is difficult to ensure that the right drugs
get to the right patients, outside of a managed facility setting.
With the compliance number (keyed-in or uploaded from the
compliance feature) provided by the system, and its association
with pre-authorized phone numbers, there is a way to quickly detect
whether the drugs are being consumed in the intended patient's
facility or in a different location, possibly by a different
person. Errors and fraud are quickly detected. In further
embodiments, a bio-marker such as a fingerprint or iris-scan may be
used to authenticate the patient.
[0093] The system further reduces non-compliance by tracking the
actual consumption of the medications by patients and automatically
refilling and delivering them before the patients run out of their
medications. Actual consumption data is also fed to pharmaceutical
manufacturers, distributors and pharmacies to enable timely and
accurate supply replenishment and production forecasting.
[0094] In all of the above, as applicable, the patient may be a
human or an animal. In the case of animals, the regimen may either
be packaged into the food or additionally masked to reduce the
olfactory rejection response.
Package Production Equipment
[0095] According to another aspect of this invention, a system
receives the prescriptions and rules for any number of patients and
accordingly dispenses the appropriate medications into
patient-specific, labeled unified ingestion packages. In another
embodiment, the system receives a specific patient's prescriptions
and rules, and accordingly dispenses the appropriate medications
into the patient-specific, labeled unified ingestion packages.
[0096] As shown in FIG. 6, one embodiment of the system includes:
(a) prescription receipt, consolidation and storage software, (b)
prescription order preparation and sequencing software, (c) control
instruction generator software, (d) label data preparation
software, (e) an equipment control apparatus, (f) a compliance
feature preparation apparatus, (g) a drug dispensing and staging
apparatus, (h) a custom coating apparatus, (i) a filling and
labeling apparatus, (j) a raw stock transport and sealing
apparatus, and (k) verification logging and alerting software.
[0097] The Prescription Receipt, Consolidation And Storage Software
electronically receives and stores prescriptions for any number of
patients, from any number of physicians or other authorized
prescribers, on a hard drive that is secured from access by
unauthorized parties. For individual patients, the software then
consolidates the prescriptions that are relevant to their
respective upcoming regimen periods (30, 60 or 90 days).
[0098] Next, the Prescription Order Preparation And Sequencing
Software prepares consolidated prescription orders, or `regimens`
for each patient specifying: (1) labeling elements such as (a)
patient name, (b) physicians' names and DEA numbers, and (c) other
legally required elements, (2) prescription identifiers such as (a)
drug names and respective dosages, (b) respective time release
delays after ingestion, (c) number of packages, (d) regimen start
and end dates and times, (e) other required elements such as drug
information sheets, (f) claims information for payers, and (g)
invoices. It then sequences individual patients' regimens (based on
delivery dates) and transmits individual patient regimens to the
control instruction generator software.
[0099] The Control Instruction Generator Software generates
specific instructions, per the consolidated prescription for a
particular patient, for: (1) label data preparation, (2) compliance
feature preparation, (3) drug dispensing and staging, (4) custom
coating, (5) filling and labeling and (6) raw stock transport and
sealing. The control instructions and transmitted to the `Equipment
Control Apparatus`.
[0100] The Custom Coating Apparatus provides a means for applying
time-release coatings on selected sets of micro-spheres, based on
specific instructions from the Control Instruction Generator
Software. The software may also check regimens for drug
interactions and generate instructions to treat selected
micro-spheres with time-delay coatings.
[0101] The Label Data Preparation Software receives labeling
information, including all the labeling elements described earlier,
for a particular patient, from the `equipment control unit` and
generates instructions for the labeling device that is part of the
`filling and labeling unit`.
[0102] The Compliance Feature Preparation Apparatus receives a set
of `compliance numbers`, for a particular patient, for a sequence
of planned compliance event (ingestion date and time). Each
compliance number is incorporated into a compliance feature that is
to be placed into the shielded compartment of a particular package.
This may be accomplished in multiple ways, as described above,
including: (1) printing the number on a card or label, (2) printing
a bar code on a card or label, (3) programming the number into a
magnetic strip on a card, or (4) programming the number into an
RFID tag. Depending on the method used, a corresponding device will
be incorporated into the system. This task is performed in
synchronization with the package label data preparation.
[0103] The Drug Dispensing and Staging Apparatus: based on a
particular patient's medications and dosages, this unit first
verifies that the correct medications and dosages are being
provided (by scanning the bar codes on the bulk drug containers),
then removes the appropriate tablets or capsules from the bulk
containers. This unit then dispenses and assembles all the tablets
and capsules that are to be placed in a particular package, in
synchronization with the label data preparation and compliance
feature preparation operations for the same package.
[0104] The Filling and Labeling Apparatus receives the labeling
information for a specific package and prints the information on
predetermined places on the package. It then receives the
pre-sorted tablets, capsules, or micro-spheres, for a particular
package, as well as the prepared compliance feature, and places
them in appropriate compartments in the empty package stock.
[0105] Equipment are available to dispense multiple medications in
standard tablet or capsule form into multi-dose packages and labels
the packages for specific patients and ingestion times. The system
described herein will augment the above available equipment with a
distinct dispensing unit that preassembles the different oral
medications, based on a specific patient's regimen, that are to be
placed in each multi-dose package. During preassembly, medications
that can be placed in the same compartment are sorted and placed in
separate funnels, one for each compartment in the package. In
addition, the system will modify the available equipment to prepare
and place the compliance feature in a shielded compartment of the
package.
[0106] Further, the modified equipment may be coupled with other
available robots that automatically fetch the appropriate
medications for a patient from an array of standard
medications.
[0107] Based on the particular regimen being prepared, the relevant
medications, in bulk form, are retrieved and staged (manually or
using a robot). The barcode on each bulk medication container is
scanned to verify that it is the right medication for the given
regimen, and the verification event is logged. If errors are found,
alerts are issued immediately which must be rectified before the
dispensing can proceed.
[0108] Drugs in micro-sphere form: in a different embodiment, the
medications may be provided in micro-sphere form (or coated
globules or powder form). The micro-spheres would be specified to
provide: (1) identical amounts of medication within a certain
tolerance, (2) coatings to release the medication in specified
times after ingestion, (3) coatings to prevent dissolution in
ingestion media, etc. Micro-spheres would be tested and certified
before acceptance for dispensing.
[0109] The system described herein provides a distinct dispensing
unit that meters appropriate medications, based on a patient's
prescriptions, by counting or weighing the micro-spheres, granules
or powders, and places each medication in a separate funnel, one
for each compartment in the package. By inserting each funnel into
a different compartment in the raw package and vibrating the
funnels, each medication is placed in the respective compartment.
The system then verifies and records that the drugs have been
dispensed as prescribed and the dispensing unit is clean, as
follows. When the medications have been placed in their respective
compartments, each funnel is weighed to make sure that there is no
residual medication in the funnel. The vibration is then continued
for a pre-determined period in an attempt to dislodge any residual
medication.
[0110] The Raw Stock Transport And Spooling Apparatus: this is
usually part of available packaging equipment and serves to feed
the raw (empty) package stock to the filling
[0111] Verification Log and Alerting Software: records and
maintains the prescription and verification records for (1)
dispensing, (2) compliance feature preparation, (3) labeling, (4)
package filling, and (5) equipment clean-up and reset for the next
prescription. The unit also alerts the operator in case of error,
and provides options for error recovery, such as when the weight of
a dispensing funnel indicates residual medication even after
vibration during filling.
[0112] According to another aspect of the invention, a system
receives prescription rules for any number of patients and applies
different time release treatments to the same base medications in
order to generate patient-specific, properly labeled unified
ingestion packages for each patient based on the prescription rules
(regimen) for the patient.
[0113] In the foregoing specification, embodiments of the invention
have been described with reference to numerous specific details
that may vary from implementation to implementation. Thus, the sole
and exclusive indicator of what is the invention, and is intended
by the applicants to be the invention, is the set of claims that
issue from this application, in the specific form in which such
claims issue, including any subsequent correction. Any definitions
expressly set forth herein for terms contained in such claims shall
govern the meaning of such terms as used in the claims. Hence, no
limitation, element, property, feature, advantage or attribute that
is not expressly recited in a claim should limit the scope of such
claim in any way. The specification and drawings are, accordingly,
to be regarded in an illustrative rather than a restrictive
sense.
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