U.S. patent application number 13/563138 was filed with the patent office on 2013-01-03 for personalized healthcare management system.
This patent application is currently assigned to Bilcare Limited. Invention is credited to Mohan Harakchand Bhandari, Praful Ramachandra Naik.
Application Number | 20130006660 13/563138 |
Document ID | / |
Family ID | 39710605 |
Filed Date | 2013-01-03 |
United States Patent
Application |
20130006660 |
Kind Code |
A1 |
Naik; Praful Ramachandra ;
et al. |
January 3, 2013 |
PERSONALIZED HEALTHCARE MANAGEMENT SYSTEM
Abstract
Personalized healthcare management system. The personalized
integrated healthcare anti-counterfeit management system provides
pack authentication, user (5) feedback and compliance,
documentation of the dosage uptake by the users (5), maintenance of
user (5) related data and displaying compliance and feedback
information, and liasing with healthcare agencies, user's nominated
persons and/or medical practitioners (6). It further provides
real-time and authentic data in raw and analysed form to diverse
agencies in the healthcare chain. Moreover, a method for delivering
pharmacovigilance related information in clinical trials is
disclosed. Authentication of diverse healthcare agencies in the
healthcare value chain such as medical practitioners (6), users
(5), pharmacists (7), pharmaceutical companies (9), and clinical
researchers is taken care of.
Inventors: |
Naik; Praful Ramachandra;
(Honavar, IN) ; Bhandari; Mohan Harakchand; (Pune,
IN) |
Assignee: |
Bilcare Limited
Pune
IN
|
Family ID: |
39710605 |
Appl. No.: |
13/563138 |
Filed: |
July 31, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12528058 |
Oct 19, 2009 |
8234127 |
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PCT/IN2007/000590 |
Dec 13, 2007 |
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13563138 |
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Current U.S.
Class: |
705/2 |
Current CPC
Class: |
G06Q 10/10 20130101;
G16H 10/60 20180101; G06Q 40/08 20130101; G06Q 10/00 20130101; G16H
20/13 20180101 |
Class at
Publication: |
705/2 |
International
Class: |
G06Q 50/22 20120101
G06Q050/22 |
Foreign Application Data
Date |
Code |
Application Number |
Feb 21, 2007 |
IN |
350/MUM/2007 |
Claims
1-57. (canceled)
58. An integrated healthcare management system relating to a
patient which is interactive between a first healthcare agency and
at least one other party, the said other party being selected from
the patient and at least one other healthcare agency, the system
comprising: i) a remote system for storing a defined healthcare
regime for the patient and optionally other data relating directly
or indirectly to the healthcare regime; ii) a patient medication
system for use by the patient providing medication to be taken by
the patient and comprising: a. a package comprising a product for
dispensing, information relating to the identity of the package;
and b. an associated device with which the package is engagable so
as to be readable by the associated device; iii) the patient
medication system being communicably linked to the remote system
through the associated device; iv) a communication port for at
least one healthcare agency to communicate interactively with the
remote system; wherein; v) the remote system and the patient
medication system are linked and interactively communicable whereby
information relating to the healthcare regime is transmissible to
the patient medication system and accessible by the patient and
information relating to the patient medication system is
transmissible to the remote system and comparable with the defined
healthcare regime stored in the system; and vi) the communication
port is adapted for the at least one healthcare agency to input
information and/or to receive information relating to the
healthcare regime of the patient by transmission of information
between the communication port and to the remote system; the
arrangement being such that the first healthcare agency and at
least one other party, the said other party being selected from the
patient and at least one other healthcare agency transmit and/or
receive via the remote system information relating directly or
indirectly to the healthcare regime of the patient wherein at least
one healthcare agency is selected from the patient's medical
practitioner, a hospital or other health institution attended by
the patient, a pharmacy supplying the patient medication system,
clinical researcher, a pharmaceutical company or distributor
providing the patient medication system, a healthcare regulator and
an insurance company providing insurance to the patient wherein
information from at least one of the healthcare agencies is
transmissible to the remote system and information is retrievable
by the healthcare agency from the remote system
59. A system according to claim 58 wherein the patient medication
system comprises a package and associated device comprising a smart
package for carrying a product and which package is adapted to
communicate with an associated device, the package comprising a
plurality of containments adapted to receive a product, each
containment being closed or optionally with closure means, the said
plurality of containment(s) and/or closure(s) being
non-electrically interconnected; signal generating means adapted to
convey to an associated device information relating to one or more
of the containments; a chip, said being optional when signal
generating means itself is a chip and optionally transmitter and/or
receiver means; the said associated device comprising a housing
adapted to communicate with the smart package; signal sensing for
detecting a signal from the signal generating means said signal
sensing optionally comprising acquiring means configured with data
input, storing, output, decoding and processing and communicating
means adapted to communicate with an external data record; wherein
said signal generating means is disposed in the said package such
that, on communication with the device, the signal generating means
provides information relating to one or more of the containments to
the signal sensing means in the said associated device and
optionally the information is communicated externally of the said
system for the purpose of comparison of the information with the
external data record.
60. A system according to claim 58 wherein the associated device
comprises a housing with package holding provision adapted to
receive the package containing a product; a signal generator
adapted to determine information relating to the presence or
absence of the product in the package and signal sensing means
provided in the said device to detect signals generated by the said
signal generator providing information relating to the product; a
patient interface whereby the patient may input information or
receive information relating to the healthcare regime from the
remote system the arrangement being such that the device is
registrable to the patient; the package is registrable to the
device; and the identity and/or status of the package and device
are comparable to the healthcare regime for the patient so as to
enable authentication of the identity and/or status of the package
to determine compliance or otherwise of the patient with the
healthcare regime.
61. A system according to claim 58 wherein the patient medication
system comprises: a dispensing system with an optional product
outlet provision; an operating system comprising data logging and
storing means comprising optionally a data processing means,
communication/interaction means; a power source built-in or
optionally induced; non-accessible compartment for the said
operating system; a separate non-accessible product containment; a
means for authentication such as an encoded chip or a pattern or a
random pattern or a marker or combinations thereof; optional
display/interactive means; a sensing means that
activates/deactivates upon dispensing of the product from the
package; means to establish connection of the power source with the
said operating system; wherein the said operating system is
configured with the sensing means and optionally with
authentication means and is housed in the said compartment wherein
the said compartment is operably connected with the said
containment; wherein the said package is authenticated by the
remote system; optionally prompting product consumption; the said
sensing means senses the product dispense, the said operating
system records and transmits/communicates real time product
dispense data via said interaction/communication means to the
remote device, rendering the package un-authentic in case of
compromise/tampering.
Description
FIELD OF THE INVENTION
[0001] The present invention relates to a personalized integrated
healthcare anticounterfeit management system providing pack
authentication, user feedback and compliance, documentation of the
dosage uptake by the users, maintenance of user related data and
displaying compliance and feedback information, liaising with the
healthcare agencies, users' nominated persons/medical practitioner,
providing real-time and authentic data in raw and analysed form to
diverse agencies in the healthcare chain.
BACKGROUND ART
[0002] The health care sector is becoming increasingly demanding.
The ultimate end user/drug consumer that is patient is the focal
point/hub in the healthcare system. At the same time related
entities such as doctors, pharmacies, insurance agency,
pharmaceutical company, distributor etc. form important
links/stakeholders and are integral part of the healthcare circle
and their cognitive effort plays vital role in maintaining
patient's healthcare and providing value added services to him/her.
Conventionally, these links are isolated and not integrated with
the patient to understand his/her usage pattern of drug and related
feedback. Further patient compliance and feedback plays a
significant role in clinical research/trials as they provide
insight by way of pharmacovigilance into the drug/medicine under
development.
[0003] If these entities appropriately and authentically liaison
with patient and work in tandem with the information generated by
and from the patient's end using means to link the patient and
his/her compliance process such as his compliance with drug
schedule, feedback about symptoms etc., synergistic effect could be
produced resulting in patient compliance thereby enhancing quality
of health care and providing value addition to all the links in
this healthcare system. Various healthcare management systems are
reported in the literature. They are as follows:
[0004] U.S. Pat. No. 6,961,285 discloses a system and process for
assisting patients in taking medication and assisting third parties
in accumulating information regarding patient medication intake.
The instrumented medication package along with a portable
medication package is communicably connected to the third parties
via computer network. However, the process is restricted to only
accumulating and transmitting data related to patient medication
intake. However the system is not capable of integrated value added
functionalities of product authentication, patient feedback,
pharmacovigilance, etc.
[0005] U.S. Pat. No. 5,781,442 discloses patient management system
capable of monitoring, controlling and tracking the administration
of care in a health care institution. The invention provides a
modular management system that processes the functional information
from the hospital and its administration such as patient list and
their data, ongoing procedures. This system is restricted to
management of health care within an institution/hospital. Further
the management system does not facilitate product authentication,
online feedback of the patients with doctor, pharmacies, insurance
agency, pharmaceutical company etc.
[0006] U.S. Pat. No. 6,021,392 discloses a system and method for
drug and health cam supply distribution and replenishment wherein a
Health care provider/hospital having a, drug dispensing
machine/hand held drug dispensing unit and second computer located
at a drug supplier facility are in electronic communication with
each other providing records of drugs received by the health care
provider, drugs dispensed to patients at the health care provider,
and an ongoing inventory of drugs stored at the health care
provider. This inventory system is not capable of authenticating
the drugs, or online record patient feedback, or network with value
added services to doctors, pharmacies, insurance agency,
pharmaceutical company etc at it is merely manages the drug
inventory control.
[0007] The U.S. Pat. No. 5,390,238 discloses health care support
method and system for health care support. The system comprises of
health support unit for monitoring and supporting a patient,
monitoring terminal, and a network server coupled between the
health support unit and monitoring terminal for exchanging
information between health support units and monitoring terminal.
The method comprises the steps of [0008] inputting a medication
delivery schedule to the health support unit, [0009] synthesizing
speech in the health support unit to inquire a wellness status of
the patient at predetermined intervals and to remind the patient to
take medication as scheduled, [0010] recognizing patient speech in
the health support unit, [0011] recording patient data concerning
the patient's compliance with the medication delivery schedule and
the patient's wellness check results, [0012] transmitting patient
data to a central network server for access by the patient's health
care provider.
[0013] However the system and the method disclosed is limited to
monitoring the patient's compliance with medication delivery
schedule. Further it does not provide facility and method of
liaison/interaction with the other entities in the health care
circle such as doctors, pharmacies, insurance agency,
pharmaceutical company, distributor etc.
[0014] U.S. Pat. No. 5,558,638 discloses a system for monitoring
the health and medical requirements of plurality of patients at
remote sites and providing these requirements to a care center. The
system comprises a sensor for monitoring the patient's medical
state, the sensor generating a parameter indicative of the
patient's medical state; a data base located at a remote location
from the sensor for storing the patient's medical state; a means
for communicating the parameter to the data base; a means for
retrieving the parameter from the data base; and a means for
providing medical procedure to the patient in response to the
retrieved parameter. It may be noted that this system allows for
the collection of information from the patient through sensors on
the patients and does not procure personal feedback from the
patient nor does the system authenticate the drug being taken by
the patient. Further this is not a system capable of
comprehensively managing a distributed healthcare system by
integrating several of all the stake holders of a healthcare
system.
[0015] U.S. Pat. No. 7,251,609 discloses a method for conducting
clinical trials over the internet. The invention encompasses a
method of conducting a clinical trial of a test substance from a
primary site, via the internet. The internet is used in various
phases of a clinical trial, including: recruiting and screening for
candidates who are eligible to participate in a clinical trial of a
test substance using the internet obtaining, directly from a
participant at a remote site, personal information as well as
information allowing a determination of any effect(s) of the test
substance on the participant after use (e.g., by evaluation forms
completed and transmitted over the internet); compiling data from
multiple participants. This system does not procure personal
feedback from the patient when he has consumed the medicine nor
does the system authenticate the pack with the protocol being taken
by the patient during a clinical trial. Further this is not a
system capable of comprehensively managing a distributed healthcare
system by integrating several of all the stakeholders of a
healthcare system.
[0016] U.S. Pat. No. 5,778,882 discloses a health monitoring system
which tracks the state of health of a patient and compiles a
chronological health history of the patient uses a multiparametric
monitor which periodically and automatically measures and records a
plurality of physiological data from sensors in contact with the
patient's body. The data provides the information necessary to
derive patterns, which are characteristic of healthy patients as
well as those who are ill. The data collected is periodically
uploaded to a database in which it is stored along with similar
health histories for other patients. The, monitor is preferably
self-contained in a chest strap, which is located on the patient's
torso, and makes use of a controller, which controls sampling of
the desired data and storage of the data to a local memory device
pending uploading to the database. Such a system allows for the
collection, storage and retrieval of information from the patient
via a chest strap on the patients. It does not procure online
personal feedback from the patient nor does the system authenticate
the pack with the protocol being taken by the patient in a normal
course of treatment of during a clinical trial. Further this is not
a system capable of comprehensively managing a distributed
healthcare system by integrating several of all the stakeholders of
a healthcare system.
[0017] U.S. Pat. No. 6,440,069 discloses Health monitoring system
that monitors the health of a patient includes an ingestible
capsule containing a medication to be consumed by a subject. A
signal generator located within the capsule outputs an electrical
signal having a predetermined characteristic indicative of said
medication, said capsule and said medication being liberated by
dissolution of the capsule in the stomach acid of a subject. A
signal detector, preferably having an input in electrical contact
with a portion of the subject's skin, is used to detect the
electrical signal. This allows the ingestion of the medication to
be tracked. As in the case of other prior art, it does not procure
personal feedback from the patient nor does the system authenticate
the pack with the protocol being taken by the patient in a normal
course of treatment of during a clinical trial. Further this is not
a system capable of comprehensively managing a distributed
healthcare system by integrating several of all the stakeholders of
a healthcare system.
[0018] Thus review of the prior art reveals following drawbacks:
[0019] The systems and methods do not address patient centric,
interactive, authenticated integration of the complete cross
section right from the medication package, insurance agency to
pharmacists of the health care system wherein the interaction
between them brings value to each of the entities and produces
synergistic effect to ensure patient compliance including
appropriate patient feedback from clinical trials and/or collection
of pharmacovigilance data and in the process enhancing the value of
the total healthcare system. [0020] Methods and systems restricted
to hospitals/health care institutions only [0021] The information
generated by the patient at his/her end regarding drug consumption,
its symptoms etc. is not been accessed/used/transmitted as a
primary source to various links of the health care system. [0022]
The methods and systems do not provide the facility for patient
registration and identification with the system, authentication
& registration of the medication package and authentication of
the facilitators such as medical practitioners, pharmacist etc. are
not reported in the prior art
[0023] There is a need to develop a personalized integrated
healthcare anticounterfeit management method and a system thereof
wherein patient is at the focal point (patient centric method) and
stakeholders/healthcare agencies such as medical practitioners,
health insurance agency, healthcare regulators, pharmaceutical
companies, clinical researchers, pharmacies and medication package
are integrated with the patient and also are in
interaction/communication/liaison with each other via authenticated
and registered process to provide the technical effect of user
compliance to doctors prescription, recording user compliance to
medication and acquiring patient feedback on the effects of the
medication, maintaining data and displaying compliance and feedback
information, liaising with users' nominated persons and medical
practitioner, providing real-time and authentic data to insurance
agencies, creating statistical and other reports which can be
accessed by the healthcare agencies by means including websites/ftp
sites. The present invention is also especially useful in clinical
trials/research and pharmacovigilance in providing an effective and
reliable way of monitoring patient compliance with a specified
healthcare regime.
SUMMARY OF THE INVENTION
[0024] The main object of the invention is to provide a
personalized integrated healthcare anticounterfeit management
method and a system capable of pack authentication, user feedback
and compliance, documentation of the dosage uptake by the users,
maintenance of user related data and displaying compliance and
feedback information, liaising with various healthcare agencies,
users' nominated persons/medical practitioner, providing real-time
and authentic data in raw and analysed form to diverse agencies in
the healthcare chain. A further object is to provide a method of
providing pharmacovigilance related information in clinical
trials.
[0025] Yet another object of the invention is to provide an
integrated healthcare management system relating to a patient which
is interactive between a first healthcare agency and at least one
other party, the said other party being selected from the patient
and at least one other healthcare agency.
[0026] Another object of the invention is to provide a method for
authentication of medical package against counterfeit.
[0027] Yet another object of the invention is to provide a patient
medication system that is communicably linkable to the healthcare
agencies.
[0028] Yet another object of the invention is to provide
authentication of diverse healthcare agencies in the healthcare
value chain such as medical practitioners, users, pharmacists,
pharmaceutical companies and clinical researchers.
[0029] Yet another object of the invention is to provide a method
for user compliance of medication intake as prescribed by medical
practitioner and/or clinical researcher and feed back regarding the
same from/to the user.
[0030] Yet another object of the invention is to provide a method
for creating a database of maintenance of user related health
records/feedback and clinical trials information.
[0031] Yet another object of the invention is to provide a method
for maintaining secure databases and interactions between user, the
package containing the dosage, and diverse agencies in the
healthcare value chain.
[0032] Thus in accordance with the invention a method of providing
an integrated healthcare management system relating to a patient
which is interactive between a first healthcare agency and at least
one other party, the said other party being selected from the
patient and at least one other healthcare agency, the system
comprising: [0033] a. registering a defined healthcare regime for
the patient in a remote system and optionally other data relating
directly or indirectly to the healthcare regime; [0034] b.
providing to the patient a patient medication system comprising a
package comprising a product for dispensing, information relating
to the identity of the package and the patient medication system
being communicably linked to the remote system; [0035] c. recording
information relating to the identity of the package in the patient
medication system or remote system and whereby upon dispensing of
the product the said recorded information is comparable with the
information of the package to determine whether or not the
information of the said product dispensing system corresponds with
the said recorded information; [0036] d. providing to the at least
one healthcare agency a communication port communicably linked to
the remote system; [0037] e. periodically providing information
relating to the identity of the patient and/or the status of the
package from the patient medication system to the remote
system;
[0038] f. comparing the information periodically transmitted to the
remote system with the healthcare regime recorded for the patient
in the remote system to ascertain whether the information
corresponds with the recorded healthcare regime; [0039] g.
optionally providing information from the remote system to the
patient medication system to indicate whether the status of the
patient medication system and/or identity of the patient
corresponds with the information relating to the healthcare regime
and/or the identity of patient; [0040] h. providing information
from the remote system to the at least one healthcare agency
indicating that a periodic transmission of information has been
received by the remote system;
[0041] whereby the first healthcare agency and at least one other
party, the said other party being selected from the patient and at
least one other healthcare agency transmit and/or receive via the
remote system information relating directly or indirectly to the
healthcare regime of the patient
[0042] wherein
[0043] the said integrated healthcare management system comprises
of: [0044] i) a remote system for storing a defined healthcare
regime for the patient and optionally other data relating directly
or indirectly to the healthcare regime; [0045] ii) a patient
medication system for use by the patient providing medication to be
taken by the patient; [0046] iii) a communication port for at least
one healthcare agency to communicate interactively with the remote
system; [0047] wherein; [0048] iv) the remote system and the
patient medication system are linked and interactively communicable
whereby information relating to the healthcare regime is
transmissible to the patient medication system and accessible by
the patient and information relating to the patient medication
system is transmissible to the remote system and comparable with
the defined healthcare regime stored in the system; and [0049] v)
the communication port is adapted for the at least one healthcare
agency to input information and/or to receive information relating
to the healthcare regime of the patient by transmission of
information between the communication port and to the remote
system; [0050] the arrangement being such that the first healthcare
agency and at least one other party, the said other party being
selected from the patient and at least one other healthcare agency
transmit and/or receive via the remote system information relating
directly or indirectly to the healthcare regime of the patient
including the information obtained in clinical research and
pharmacovigilance;
[0051] wherein
[0052] the patient medication system comprises: [0053] a) a package
containing medication and which has information relating to the
identity of the package; and [0054] b) an associated device with
which the package is engagable, the associated device being
communicably linked to the remote system and registrable with the
remote system;
[0055] and recording information relating to the identity of the
package in the associated device or remote system whereby upon
engagement of the package and associated device the said recorded
information is comparable with the information of the package to
determine whether or not the information of the engaged package
corresponds with the said recorded information; and optionally
providing information from the remote system to the associated
device to indicate whether the status of the package and/or
identity of the patient corresponds with the information relating
to the healthcare regime and/or the identity of patient;
[0056] to facilitate authentication, compliance optionally
including appropriate patient feedback from clinical trials and/or
collection of pharmacovigilance data, liaising and integration of
the patient with various stake holders/healthcare agencies such as
medical practitioner, pharmacists, distributor, pharma company,
health insurance agency, clinical researchers and their liaising
with each other.
DETAILED DESCRIPTION OF THE INVENTION
[0057] The features and advantages of the present invention will
become apparent in the following detailed description and the
preferred embodiment with reference to the accompanying
figures.
Definitions
[0058] Compliance: a patient's (or doctor's) adherence to a
recommended course of treatment [0059] Pharmacovigilance is the
pharmacological science relating to the detection, assessment,
understanding and prevention of adverse effects, particularly long
term and short term side effect of medicines. Generally speaking
pharmacovigilance is the science of collecting monitoring,
researching, assessing and evaluating information from healthcare
providers and patients on the adverse effects of medications.
[0060] comprehensive personalized healthcare anti-counterfeit
management system is a personalized integrated healthcare
anticounterfeit management method and a system [0061] Healthcare
agencies include diverse stakeholders and facilitators such as
medical practitioners, pharmacists, clinical researchers, insurance
agencies, distributors and others in the healthcare system. [0062]
remote system includes devices such as servers, central processing
units, communication devices. [0063] healthcare regime means
medication schedule, prescription, medication protocol including
those administered in clinical trials. [0064] patient medication
system includes packages provided with package identifiers such as
a blister pack with a smart chip, bottle with chip, randomized
pattern etc and optionally with an associated device described
herein [0065] Associated device means a devices that is capable of
uniquely identifying a package, sensing presence/absence of product
in the package and interacting with the patient, remote system and
other external devices. [0066] Information related to identity of
the package and status of the package includes information related
to authentication of the medication package identify and confirm
the source of the package including production batch details, and
access information such as manufacturing date, expiry date, place
of manufacture, geographical validation in that area; [0067] a
communication port includes Web based portals, communication
means
[0068] This invention also facilitates user compliance including
appropriate patient feedback which may be provided manually or
automatically and is especially useful in clinical trials and/or
collection of pharmacovigilance data.
[0069] The present invention is particularly useful in monitoring
pharmacovigilance, providing pharmacovigilance data and may be used
to monitor participant compliance with the research protocol and
goals to determine preferred actions to be performed. Optionally,
the invention may provide a spectrum of noncompliance, from minor
noncompliance needing only corrective feedback, to significant
noncompliance requiring participant removal from the clinical trial
or from future clinical trials. The decision rules can also be
domain-specific, such as detecting non-compliance or fraud among
subjects in a drug trial, for example a cardiovascular drug trial,
or demographically specific, such as taking into account gender,
age or location, which provides for algorithms and decision rules
to be optimized for the specific sample of participants being
studied.
[0070] FIG. 1 Schematic of the system (Sheet 1)
[0071] FIG. 2 Steps of system operation (Sheet 2)
[0072] FIG. 2a Steps of interaction of the patient with the
associated device (Sheet 3)
[0073] FIG. 2b Steps of interaction of the patient medication
system including associated device with the remote system (Sheet
4)
[0074] FIG. 2c Steps of Interaction of the patient with the
registered doctor/medical practitioner (Sheet 5)
[0075] FIG. 2d Steps of Interaction of the remote system with the
registered medical practitioner/doctor (Sheet 6)
[0076] FIG. 2e Steps of interaction of the patient with the
registered pharmacist (Sheet 7)
[0077] FIG. 2f Source of the associated device to the patient
(Sheet 8)
[0078] FIG. 1a illustrates conventional healthcare system wherein
patient 5 interacts with various healthcare agencies such as
medical practitioner 6, pharmacists 7, distributor 8,
pharmaceutical company 9 and health insurance agency 10. The said
healthcare agencies are isolated and there is one way interaction
with the patient. The patient is not liked with all the healthcare
agencies and the healthcare agencies are also, not liked with each
other in the conventional system/process.
[0079] FIG. 1b illustrates comprehensive integrated healthcare
system of the present invention to integrate patient 5 with
healthcare agencies such as medical practitioner 6, pharmacists 7,
distributor 8, pharmaceutical company 9 and health insurance agency
10, clinical researcher (not shown) but not limited to it. The
patient 5 along with the medication system 2 is integrated with
various healthcare agencies via remote system 4 and communication
ports 6p-10p wherein the patient medication system in one of the
embodiments comprises medication in a package and an associated
device 1, the package being adapted to communicate with the
associated device and the associated device being communicably
linkable to the remote system.
[0080] The said comprehensive integrated healthcare system relating
to a patient is interactive between a first healthcare agency and
at least one other party, the said other party being selected from
the patient and at least one other healthcare agency. The system
comprises of a remote system 4 for storing a defined healthcare
regime for the patient and optionally other data relating directly
or indirectly to the healthcare regime; a patient medication system
2 for use by the patient providing medication to be taken by the
patient; a communication port 3 for at least one healthcare agency
to communicate interactively with the remote system 4;
[0081] wherein;
[0082] the remote system 4 and the patient medication system 2 are
linked and interactively communicable whereby information relating
to the healthcare regime is transmissible to the patient medication
system 2 and accessible by the patient 5 and information relating
to the patient medication system 2 is transmissible to the remote
system 3 and comparable with the defined healthcare regime stored
in the system; and
[0083] the communication port 3 is adapted for the at least one
healthcare agency to input information and/or to receive
information relating to the healthcare regime of the patient by
transmission of information between the communication port 3 and to
the remote system 4; the arrangement being such that the first
healthcare agency and at least one other party, the said other
party being selected from the patient and at least one other
healthcare agency transmit and/or receive via the remote system 4
information relating directly or indirectly to the healthcare
regime of the patient
[0084] The system operates in steps of: [0085] i. registering a
defined healthcare regime for the patient in a remote system and
optionally other data relating directly or indirectly to the
healthcare regime; [0086] j. providing to the patient a patient
medication system comprising a package comprising a product for
dispensing, information relating to the identity of the package and
the patient medication system being communicably linked to the
remote system; [0087] k. recording information relating to the
identity of the package in the patient medication system or remote
system and whereby upon dispensing of the product the said recorded
information is comparable with the information of the package to
determine whether or not the information of the said product
dispensing system corresponds with the said recorded information;
[0088] l. providing to the at, least one healthcare agency a
communication port communicably linked to the remote system; [0089]
m. periodically providing information relating to the identity of
the patient and/or the status of the package from the patient
medication system to the remote system; [0090] n. comparing the
information periodically transmitted to the remote system with the
healthcare regime recorded for the patient in the remote system to
ascertain whether the information corresponds with the recorded
healthcare regime; [0091] o. optionally providing information from
the remote system to the patient medication system to indicate
whether the status of the patient medication system and/or identity
of the patient corresponds with the information relating to the
healthcare regime and/or the identity of patient; [0092] p.
providing information from the remote system to the at least one
healthcare agency indicating that a periodic transmission of
information has been received by the remote system;
[0093] whereby the first healthcare agency and at least one other
party, the said other party being selected from the patient and at
least one other healthcare agency transmit and/or receive via the
remote system information relating directly or indirectly to the
healthcare regime of the patient. Further, the said health care
agencies may also be in liaison with each other through the said
remote system 4.
[0094] The said system results in the useful, tangible and concrete
technical effect of authentication of the medication package 2
against counterfeit, authentication of the said health care
agencies; compliance of medication intake at prescribed times by
the medical practitioner; maintaining health diary that includes
health indicators such as maintenance of health records/feedback of
a user including indications like blood pressure, heart rate, blood
sugar level, headache, nausea, dizziness etc.; data and Information
including those obtained in clinical research and pharmacovigilance
wherein secured database is maintained at various terminals
including said associated device 1, local machine of the medical
practitioner, the said web portals and the said remote system 4;
liaising with the said healthcare agencies including medical
practitioners, users, persons nominated by the user, clinical
researchers, pharmacists, pharmaceutical companies, insurance
agencies etc.
[0095] FIG. 2 and subsequent figures from FIG. 2a to FIG. 2f depict
the steps of the system operation. FIG. 2 indicates the
interactions of the patient with various healthcare agencies such
as doctor, pharmacist, insurance agency, clinical researchers,
distributor etc. in the healthcare chain. The subroutines indicated
as A, B, C etc. corresponding to each of the step are separately
elaborated in sub FIGS. 2a to 2f. It is implied that all the said
healthcare agencies are registered with the remote system 4 of the
system illustrated in FIG. 1. As shown in the FIG. 2 the associated
device of the patient medication system 1 is registered with the
said remote system 4. In the further step, the registration is
confirmed from the remote system 4. Further, the system operates in
various steps as shown in the figure from steps 101 to 107 in terms
of
[0096] interactions of the patient with the said healthcare
agencies via said remote system 4 and corresponding said web
portals 6p-10p.
[0097] FIG. 2a depicts steps of interaction of the patient with the
associated device of the medication system. The patient can access
the associated device 1 only if his/her registration is carried out
with the medication system. The method comprises of: [0098] i)
providing a unique identifier for the associated device 1 of the
patient and recording the identifier with the healthcare regime of
the patient in the remote system 4 to register the associated
device 1; [0099] ii) optionally receiving a confirmation signal of
the registration from the remote system 4; [0100] iii) registering
the patient with the associated device 1 in the remote system 4;
[0101] iv) registering the healthcare regime of the patient in the
remote system 4; [0102] v) engaging the package of the patient
medication system into the associated device 1; [0103] vi)
comparing the recorded information which relates to the identity of
the package and which is stored in the associated device 1 or
remote system 4 with the information of the package engaged with
the associated device 1 to determine whether or not the information
of the engaged package corresponds with the said recorded
information; and; [0104] vii) provided the information of the
package corresponds to the stored information relating to the
identity of the package, registering the package with the
associated device in the remote system;
[0105] whereby information is provided to the remote system 4
linking the package and associated device 1 with the healthcare
regime of the patient so as to enable authentication and
registration of the medication package identity.
[0106] After registration of the patient with the said associated
device, as indicated by step 201 in the figure, the patient inputs
medication schedule and sets alarm times in predetermined range
with reference to the prescription in the associated device 1.
Further, patient inserts medication package 2 into the said
associated device 1 as indicated in step 202. In the further step,
204, registration of the said package 2 with the said associated
device 1 is carried out and further authentication of the said
package 2 is checked in the associated device 1. The process
continues only if the package authentication is confirmed by the
said associated device. In the next step 205, the compliance with
the medication schedule is monitored by sensing presence/absence of
the medication in the said package by the said associated device.
Further, the device also provides reminders at the medication
timing to the patient The process concludes with the step 206
wherein post medication feed back by is entered in the said
associated device by the patient.
[0107] The medication system interacts with the remote system 4 to
detect compliance of the patient with the, healthcare regime. The
healthcare regime is stored in the remote device 4 by inputting the
healthcare regime/schedule or clinical trial protocol in the
associated device 1 of the patient medication system and
communicating the healthcare regime from the patient medication
system to the remote system 4 and storing the regime in the remote
system 4 as indicated in FIG. 2b in step 301. The method for
detecting compliance of the patient with the healthcare regime
comprises of: [0108] i. storing the healthcare regime of the
patient in the remote device; [0109] ii. periodically checking that
the patient medication system is communicably linked to the remote
system 4; [0110] iii. where the patient medication system has not
been communicably linked to the remote system after a predetermined
time to validate adherence to the healthcare regime, generating and
transmitting a message to the patient to link the patient
medication system to the remote system 4; [0111] iv. where the
patient medication system is not communicably linked to the remote
system 4 after a pre-set delay from the time of transmission of the
message in step iii), generating and transmitting a message to at
least one of the medical practitioner of the patient or a nominated
individual indicating non-compliance of the patient with the
healthcare regime; and [0112] v. where the patient medication
system is communicably linked to the remote system, recording
information in the remote system relating to the time of the link
and the identity and status of the package and providing access to
the said information to the medical practitioner.
[0113] The particulars are indicated in FIG. 2b. The system
operates in steps of transmission of the regime/schedules set by
the patient mentioned in the previous step from the associated
device 1 of the medication system to the remote system 4 as shown
in step 301; pinging the device intermittently to check whether the
associated device 1 is online in step 302; SMS generation and
transmission to the patient if the associated device 1 is not found
to be online at the time of medication in step 303; sending SMS to
the medical practitioner/doctor and persons nominated by the
patient if the associated device 1 is not found online even after
stipulated time of dose time in step 304; receipt of the time
stamped user feedback data from the associated device 1; making the
feedback data available to the authenticated medical practitioner
in real time as shown in step 305; making the feedback data
available to the authenticated medical practitioner in real time as
shown in step 306; sending list of pharmacists with contact details
including name, phone number, address and the map in the area where
the device is located to the associated device upon request from
the user as shown in step 307.
[0114] FIG. 2c illustrates process steps in the Interaction of the
patient with the registered doctor/medical practitioner. If the
doctor is registered with the remote system 4, he enters
prescription on prescription interface provided at his local
machine/computer as indicated in step 401. Further, Generation of
the patients name and the prescription identifier number takes
place at the medical practitioner/doctor's end as indicated in step
402. The said prescription is logged in the said remote system 4 in
step 403. The prescription is also saved in the local machine of
the doctor as shown in step 404. As shown in step 405, insurance
form is generation and printed at the doctor's machine/computer.
The printout is handed over to the patient (step 406). If the
doctor is not registered with the remote system 4, he/she provides
hand written prescription to the patient wherein the prescription
number is generated at the pharmacist end when he enters the
information in his local machine/computer (step 407). The method of
generation of the prescription identifier for a patient to whom a
medical prescription has been issued by a health care agency,
preferably a medical practitioner, comprising: [0115] i) either.
[0116] a) generation by a pharmacist of a prescription identifier
on presentation of the prescription the identifier comprising the
healthcare regime and information relating to the patient; or
[0117] b) generation by the medical practitioner of a prescription
identifier comprising the healthcare regime and information
relating to the patient; [0118] ii) communicating the prescription
identifier to the remote system via a communication port to which
the pharmacist or medical practitioner has access.
[0119] FIG. 2d indicates interaction of the remote system 4 with
the registered medical practitioner/doctor/clinical researcher. The
steps comprises of the following:
[0120] provision of the information regarding various dates and
times for the medication taken by the patient, received from the
said associated device 1 with the help of the GSM/GPRS service to
the local machine of the medical practitioner/doctor by the said
remote system 4 (step 501); generation and transmission of the
customized and pre-programmed reports to the medical
practitioners/doctor local machine through the internet in a pre
determined format by the remote system 4 as shown in step 502 and
transmission of the compliance and feedback of the patient to the
medical practitioner/doctor/clinical researcher on his local
machine as shown in step 503.
[0121] FIG. 2e illustrates steps in the interaction of the patient
with the registered pharmacist. The prescription identifier is
retrieved by the pharmacist from the remote system optionally he
can enter the prescription identifier (that is generated at the
medical practitioner's end) in the pharmacists machine/computer on
the web-based interface as shown in step 601; access to the
pharmacists to the data related to the medicine and dosages entered
by the doctor for the said patient along with information such as
medical practitioners name, patient's name, insurance company
information etc. on his local machine (step 602); generation and
printing of bill, form-and relevant documents that are signed by
the patient (step 603).
[0122] FIG. 2f depicts the source of the associated device 1 to the
patient. The associated device 1 may be subscribed to the patient
by the insurance agency. In this case, patient registers the
associated device 1 with the remote system 4 (step 701); the
patient visits pharmacists, purchases the medication package (step
702-705) and the process continues as illustrated in FIG. 2a. The
case wherein the associated device 1 is not subscribed by the
insurance agency, the patient visits doctor, collects prescription
and purchases the said associated device 1 from the pharmacists end
(step 710) followed by registration of the patient with the said
associated device 1 (step 709); the patient can also purchase the
associated device from doctor (step 706, 707); patient registers
with the associated device 1 (step 711); the patient inserts the
medication package in the said associated device 1 and the process
continues as illustrated in FIG. 2a.
[0123] In one of the embodiments the patient medication system
comprises: a package containing medication and which has
information relating to the identity of the package; and an
associated device 1 with which the package is engagable, the
associated device 1 being communicably linked to the remote system
4 and registrable with the remote system 4;and recording
information relating to the identity of the package in the
associated device 1 or remote system 4 whereby upon engagement of
the package and associated device 1 the said recorded information
is comparable with the information of the package to determine
whether or not the information of the engaged package corresponds
with the said recorded information; and optionally providing
information from the remote system 4 to the associated device 1 to
indicate whether the status of the package and/or identity of the
patient corresponds with the information relating to the healthcare
regime and/or the identity of patient. The associated device
comprises of:
[0124] interactive and/or user input means; powered time tracking
means; data decoding means, data processing, data storage means;
analog to digital converter, data sampling and organizing means so
configured to communicate with an external data source so as to one
or more of register the product user, authenticate, register
product package when housed/located in the said housing and
optionally carry out transient data collection or communicate with
and/or through a remote or integrated data system optionally for
the collection, transmission, collation, archival or dissipation of
transient data or information provided by the user or combinations
thereof.
[0125] In yet another embodiment the patient medication system
comprises of an interactive smart package--associated device
comprising a smart package for carrying a product and which is
adapted to communicate with an associated device, the package
comprising a plurality of containments adapted to receive a
product, each containment being closed or optionally with closure
means, the said plurality of containment/s and/or closure/s being
non-electrically interconnected; signal generating means adapted to
convey to an associated device information relating to one or more
of the containments; a chip, the said chip being optional when
signal generating means itself is a chip and optionally transmitter
and/or receiver means; the said associated device comprising a
housing adapted to communicate with the smart package; signal
sensing for detecting a signal from the signal generating means
said signal sensing optionally comprising acquiring means
configured with data input, storing, output, decoding and
processing and communicating means adapted to communicate with an
external data record;
[0126] wherein
[0127] said signal generating means is disposed in the said package
such that, on communication with the device, the signal generating
means provides information relating to one or more of the
containments to the signal sensing means in the said associated
device and optionally the information is communicated externally of
the said system for the purpose of comparison of the information
with the external data record.
[0128] In one of the variants of this interactive-smart package
medication system embodiment the associated device comprises a
housing with package holding provision adapted to receive the
package containing-a product; a signal generator adapted to
determine information relating to the presence or absence of the
product in the package and signal sensing means provided in the
said device to detect signals generated by the said signal
generator providing information relating to the product; a patient
interface whereby the patient may input information or receive
information relating to the healthcare regime from the remote
system the arrangement being such that the device is registrable to
the patient; the package is registrable to the device; and the
identity and/or status of the package and device are comparable to
the healthcare regime for the patient so as to enable
authentication of the identity and/or status of the package to
determine compliance or otherwise of the patient with the
healthcare regime.
[0129] In one of the variants of this embodiment the smart package
comprises a plurality of containment/s adapted to receive a
product, each containment being closed or optionally with closure
means wherein the containment/s and/or closure/s are
non-electrically-interconnected; chip and optionally transmitter
and/or receiver means; signal generating means provided in or
optionally on the containment/s, or in or optionally on the said
closure/s such that removal of product/s from the said
containment/s generate signal and/or alter the signal detected by
the signal sensing means in the said associated device.
[0130] In yet another variant the smart package comprises
containment/s in the form of one or plurality of enclosed spaces
formed in a first lamina to contain the product closed with second
rupturable lamina attached to the first lamina to form a closure so
as to seal the product in the said enclosed spaces; the said
containment/s and/or closure/s being non-electrically
interconnected; chip and optionally transmitter and/or receiver
means.
[0131] In yet another variant one or a plurality of magnets are
disposed on or in the smart package and adapted to provide
information relating to the location, portion or zone of one or
more of the products in the said enclosed space/s of the
containment/s.
[0132] In another variant the said containment or closure means is
provided with magnetic ink which encodes information relating to
the location, portion or zone of one or more of the products in the
said enclosed space/s of the containment/s optionally by having
specific strength on areas corresponding to the location, portion
or zone of the product in the said enclosed space/s of the
containment/s.
[0133] In another variant the smart package comprises a
carded/walletized package system which comprises:
[0134] carding comprising a first lamina provided with openings
corresponding to the said formed enclosed spaces of the said
package such that the said formed enclosed spaces pass through the
said openings; a second lamina provided with perforated peelable
portions provided corresponding to or aligned with the locations of
the said rupturable lamina of the package such that when the
product in the package is removed, the said perforated portion
corresponding to that product is also removed; the package
comprising a plurality of containments in the form of a first
package lamina in which one or a plurality of enclosed spaces are
formed to contain the product(s) closed with a second package
rupturable lamina attached to the unformed portion of the first
package lamina to seal the product(s) in the said enclosed spaces;
the said containment/s and/or closure/6 being non-electrically
interconnected; chip and optionally transmitter and/or receiver
means; wherein the said package is placed between the first and the
second lamina of the said carding; signal generating means in or
optionally on the containment/s, or in or optionally on the said
closure/s.
[0135] In yet another variant the smart package comprises of
product containment in the form of a flexible material wherein part
of the same material is sealed to form a pouch and a closure means
in the form of a product entrapment and dispensing provision;
signal generating means provided in the said product entrapment and
dispensing provision means such that removal of the product from
the said containment portion results in generation of signal and/or
alteration of the signal; chip and optionally transmitter and/or
receiver means.
[0136] In one of the variants the signal generating means of the
smart package generates a signal in the form of magnetic field or
modifies a magnetic field. In yet another variant, the signal
generated from the signal generating means is generated from the
smart package resulting from a change in the physical, electrical,
thermal, optical, visual property, characteristics or signal of the
smart package.
[0137] In yet another variant the package comprises of a multipolar
or unipolar sheet capable of being pre-magnetized and which is
disposed so as to be disturbed by the removal of a product from a
containment in the smart package.
[0138] In another variant, the smart package is provided with a
customized pattern representing information relating to the
location, portion or zone of product in the containment/s to
generate a signal and/or alter a signal generated and/or detected
by the signal sensing means in the said associated device caused by
removal of product/s from the said containment/s.
[0139] In one of the embodiments of the package of the medication
system the smart package comprises a first sheet having multiple
containment capsules upstanding from a first surface thereof and
dimensioned to receive individual product items and multiple
corresponding openings in a second surface of the sheet to the
upstanding capsules; a second sheet secured to the second surface
of the first sheet so as to provide closures over the multiple
openings in the first sheet and components having individual
signatures and being disposed adjacent corresponding closures such
that respective signatures are substantially detectable only if
their corresponding closures are intact. In one of the variants of
this embodiment the respective components include respective
discrete magnets respectively secured to the second sheet opposite
openings to corresponding upstanding containment capsules; and
wherein the substantially detectable signatures comprise respective
magnetic fields. In another variant of this embodiment the
respective components include respective magnetic layers disposed
upon the second sheet opposite openings to corresponding upstanding
containment capsules; and wherein the substantially detectable
signatures comprise respective magnetic fields. In another variant
of this embodiment the respective components include respective
light reflecting surface regions integral with the second sheet
opposite openings to corresponding upstanding, containment
capsules; and wherein the substantially detectable signatures
comprise reflection of light. In another variant of this embodiment
the respective components include respective, light absorptive
surface regions integral with the second sheet opposite openings to
corresponding upstanding containment capsules; and wherein the
substantially detectable signatures comprise absorption of light.
In yet another variant the respective components include respective
electrical components disposed upon the second sheet opposite
openings to corresponding upstanding containment capsules; and
wherein the substantially detectable signatures comprise an
electrical characteristic of the respective electrical
components.
[0140] In another embodiment the smart package of the medication
system comprises:
[0141] a product package that includes; an entrapment region to
contain a product; a removable closure that encloses the product
within the entrapment region prior to its removal and that allows
passage of the product from the entrapment region upon its
removal;
[0142] a component having signatures and being disposed adjacent
the closure such that the signatures is substantially detectable
only if the closures is intact; a reader that includes, a sensor to
sense signature when a product is disposed within the entrapment
region; and a receptor region contoured to receive at least a
portion of the product package that includes the entrapment region
and to align the sensor with the entrapment region to permit
sensing of the signature prior to removal of the closure while the
product is disposed within the entrapment region. One of the
variants of this embodiment comprises of first data storage
circuitry secured to the package and encoded with first
information; second data storage circuitry secured to the reader
and encoded with second information; processing circuitry
associated with the reader to process the first information and the
second information to authenticate the package; and a communication
interface to communicate information between the first data storage
circuitry and the second data storage circuitry and the processing
circuitry.
[0143] In yet another variant the processing circuitry is coupled
to receive a sensor signal indicative of receipt of a signal
imparted by the signal generator; and a communication interface to
communicate information externally to the reader that is indicative
of the imparting of a signal generated by the signal generator
through a free space in the entrapment region to the sensor in the
absence of the product within the entrapment region. In another
variant the processing circuitry is coupled to receive a sensor
signal indicative of detection of the signature; and a
communication interface to communicate information externally to
the reader that is indicative of whether the signature has been
detected.
[0144] In another embodiment the smart package of the medication
system includes an entrapment region to contain a product; a reader
that includes, a signal generator to impart a signal across a free
space; a sensor to sense the signal generated by the signal
generator across the free space; a receptor region sized to receive
at least a portion of the product package that includes the
entrapment region and contoured to align the signal generator and
the sensor with the entrapment region to permit the signal
generator to impart a signal through a free space in the entrapment
region to the sensor in the absence of the product within the
entrapment region.
[0145] In one of the variants, the smart package further comprises
first data storage circuitry secured to the package and encoded
with first information; second data storage circuitry secured to
the reader and encoded with second information; processing
circuitry associated with the reader to process the first
information and the second information to authenticate the package;
a firsts communication interface to communicate information between
the first data storage circuitry and the second data storage
circuitry and the processing circuitry; processing circuitry
coupled to receive a sensor signal indicative of receipt of a
signal imparted by the signal generator; and
[0146] a second communication interface to communicate information
externally to the reader that is indicative of the imparting of a
signal generated by the signal generator through a free space in
the entrapment region to the sensor in the absence of the product
within the entrapment region.
[0147] In another embodiment the smart package includes;
[0148] an entrapment region to contain a product; a removable
closure that encloses the product within the entrapment region
prior to its removal and that allows passage of the product from
the entrapment region upon its removal; a magnetic material
associated with the closure; a reader that includes, a sensor to
sense a magnetic signal imparted by the magnetic material when the
product is disposed within the entrapment region; and
[0149] a receptor region contoured to receive at least a portion of
the product package that includes the entrapment region and to
align the sensor with the entrapment region to permit the magnetic
material to impart a magnetic signal to the sensor prior to removal
of the closure while the product is disposed within the entrapment
region; first data storage circuitry secured to the package and
encoded with first information; second data storage circuitry
secured to the reader and encoded with second information;
processing circuitry associated with the reader to process the
first information and the second information to authenticate the
package; a first communication interface to communicate information
between the first data storage circuitry and the second data
storage circuitry and the processing circuitry; processing
circuitry coupled to receive a sensor signal indicative of receipt
of a signal imparted by the magnetic material; and a second
communication interface to communicate information externally to
the reader that is indicative of the imparting of a signal by the
magnetic material to the sensor in the absence of the product
within the entrapment region.
[0150] In another embodiment the patient medication system
comprises a package system comprising:
[0151] an embedded system comprising data logging and storing means
comprising optionally a data processing means,
communication/interaction means;
[0152] a power source built-in or optionally induced;
[0153] non-accessible compartment for the said embedded system;
[0154] a separate non-accessible product containment;
[0155] a means for authentication such as an encoded chip or a
pattern or a random pattern or a marker or combinations
thereof;
[0156] optional display/interactive means;
[0157] a sensing means that activates/deactivates upon dispensing
of the product from the package;
[0158] means to establish connection of the power source with the
said operating system;
[0159] wherein
[0160] the said embedded system is configured with the sensing
means and optionally with authentication means and is housed in the
said compartment wherein the said compartment is operably connected
with the said containment;
[0161] wherein
[0162] the said package is authenticated by the remote system;
[0163] optionally prompting product consumption;
[0164] the said sensing means senses the product dispense, the said
operating system records and transmits/communicates real time
product dispense data via said interaction/communication means to
the remote device,
[0165] rendering the package un-authentic in case of
compromise/tampering.
[0166] In a specific embodiment of this invention when used in
clinical trials, it provides a method for interactively collecting
pharmacovigilance data relating to a patient by: [0167] providing
to the patient means to provide feedback of information from the
patient to the remote system said information relating to the
condition of the patient and/or response to medication taken during
the clinical trails; [0168] periodically providing information
relating to the condition of the patient and/or response to
medication taken during the clinical trial to the remote
system.
[0169] Further it provides a method wherein the system may
comprises a device to monitor or measure one or aspects of the
medical condition of the patient such as his temperature, blood
pressure, etc, and the information is periodically communicated to
the remote system either automatically or manually.
[0170] Thus in clinical trials this integrated healthcare
management system provides an interactive means between at least
one patient in the clinical trial and a party carrying out a
clinical trial for collection of collection of pharmacovigilance
data wherein the system comprises: [0171] i) registering a defined
healthcare regime (i.e. protocol) for the patient in a remote
system and optionally other data relating directly or indirectly to
the healthcare regime (protocol); [0172] ii) providing to the
patient a patient medication system comprising a package comprising
a product for dispensing, information relating to the identity of
the package and the patient medication system being communicably
linked to the remote system; [0173] iii) optionally recording
information relating to the identity of the package in the patient
medication system or remote system and whereby upon dispensing of
the product the said recorded information is comparable with the
information of the package to determine whether or not the
information of the said product dispensing system corresponds with
the said recorded information; [0174] iv) providing to the party
carrying out the clinical trial a communication port communicably
linked to the remote system; [0175] v) periodically providing
information relating to the identity of the patient and/or the
status of the package from the patient medication system to the
remote system; [0176] vi) comparing the information periodically
transmitted to the remote system with the healthcare regime
recorded for the patient in the remote system to ascertain whether
the information corresponds with the recorded healthcare regime;
[0177] vii) optionally providing information from the remote system
to the patient medication system to indicate whether the status of
the patient medication system and/or identity of the patient
corresponds with the information relating to the healthcare regime
and/or the identity of patient; [0178] viii) optionally providing
information from the remote system to the party carrying out the
clinical trial indicating that a periodic transmission of
information has been received by the remote system;
[0179] whereby the party carrying out the clinical trial may
determine whether the patient has complied with the healthcare
regime.
[0180] Thus it is evident that the present invention provides a
method and an integrated healthcare anti-counterfeit management
system relating to a patient which is interactive between a first
healthcare agency and at least one other party, the said other
party being selected from the patient and at least one other
healthcare agency wherein patient is at the focal point (patient
centric method) and healthcare agencies such as medical
practitioners, health insurance agency, healthcare regulators,
pharmaceutical companies, clinical researcher, pharmacies and
medication package are integrated with the patient and also are in
liaison with each other via authenticated and registered process to
provide the useful technical effect of: [0181] authentication of
the medication package against counterfeit wherein the system
identifies and confirms the source of the medication package and
accesses information such as manufacturing date, expiry date, place
of manufacture, geographical validation in that area etc.; [0182]
registration and authentication of the associated device and
various stakeholders including medical practitioners, pharmacists
and users to the remote system; [0183] user compliance to doctors
prescription wherein SMS is generated and sent to the patient if
the associated device is not found to be online at the time of
medication; SMS is sent to the medical practitioner and people
nominated by the patient at the time of registration if the
associated device is found not to be online even after substantial
time lapse after dose time; [0184] recording user compliance to
medication and acquiring patient feedback on the effects of the
medication including during clinical trials/research and
pharmacovigilance [0185] patient feedback wherein user enters post
medication feedback in the medication system that is time stamped
and transferred to the server wherein the said data is available
for a authenticated practitioner in real time; [0186] generation of
the prescription at the doctors end and further storage of the same
at the remote system level and doctors end; [0187] generation and
transmission of customized and pre-programmed reports for the
medical practitioners at his/her local machine through the internet
in a pre determined format; [0188] maintaining secured data and
Information for various stake holders at including said associated
device; [0189] providing real-time and authentic data in raw and
analysed form to diverse agencies in the healthcare chain; creating
statistical and other reports that can be accessed by healthcare
agencies groups by means including websites/ftp sites; [0190]
creating documentation of the dosage uptake by the users; [0191]
facility at the pharmacists end to see the medicine and dosages
entered by the medical practitioner/doctor for the patient along
with information such as medical practitioner's name, patient's
name, insurance company information etc.; [0192] reminder/alert
provision to distributor on his local machine/computer through
desktop cookie information about "low stock" at particular pharmacy
for particular brand; [0193] access to the distributor to the
database on the said remote system about the sell pattern of
particular brand of medicine and volumes of the same; [0194]
provision for pharma company to track stocks available with all
distributors and replenish stock through the database; [0195]
liaisoning with the said healthcare agencies including medical
practitioners, users, persons nominated by the user, pharmacists,
clinical researchers, pharmaceutical companies, insurance agencies
etc.; [0196] registered pharma company can track stocks available
with all distributors and replenish stock through the database;
[0197] interaction of insurance agency directly with the patient
and through the remote system as well;
[0198] to the patient.
* * * * *