WO2009156832A1

WO2009156832A1 - A risk management system

Info

Publication number: WO2009156832A1
Application number: PCT/IB2009/006048
Authority: WO
Inventors: Johannes Marthinus Albertus Kotze; Jacques De Vos; Eugene Pretorius; Eduard Kriegler
Original assignee: GEO-ICT HEALTH Pty Ltd
Current assignee: GEO-ICT HEALTH Pty Ltd
Priority date: 2008-06-24
Filing date: 2009-06-24
Publication date: 2009-12-30
Anticipated expiration: 2010-12-24

Abstract

A risk management system (1 ) is provided which includes a disposable sensor (2) to monitor access to a drug container (7) and record information relating to such access. The sensor is configured to communicate with a portable information retrieval unit (10) which forms part of the system and whereby information recorded by the sensor (2) may be retrieved when the unit (10) is proximate the sensor (2). The system also includes a reminder device (3) associated with the sensor (2) which may be pre-programmed with a specific drug usage regimen for the patient and which provides prompts to the patient when a drug needs to be taken in accordance with the regimen. A processor (15) is configured to receive the information recorded by the sensor (2), to process it into a user determined format and to supply data to a life - or health insurance related system (17) to be used to monitor compliance to adherence clauses in insurance contracts and determine risk profiles of patients undergoing chronic medical treatment.

Description

A RISK MANAGEMENT SYSTEM

FIELD OF THE INVENTION

This invention relates to a system for monitoring patient compliance with a prescribed drug regime.

BACKGROUND TO THE INVENTION

With many diseases it is vitally important for patients being treated with drugs to fully comply with the prescribed regime. A high level of adherence to complex regimens is critical for virological efficiency because resistance develops rapidly when drug levels are not maintained within therapeutic ranges. This is particularly true of chronic diseases such as HIV/AIDS (Human immunodeficiency virus/ Acquired immune deficiency syndrome), Tuberculosis (TB), diabetes, hypertension and cardio vascular illnesses, among others. Non-compliance with drug regimens arises from a number of factors including side effects experienced by patients from the drugs and a false sense of recovery by the patient.

In the health sector, non-compliance is a concern due to the arising of resistant disease strains which are no longer treatable by known drugs, for the wasting of resources especially drugs, for the extended second-line treatment that is subsequently required to enable patients to recover and for a potential increase in viral load in the patient which may result in an increased probability for the development of other opportunistic infectious diseases which might result in poor health (which requires additional treatment) and, ultimately, death of the patient.

Non-compliance is also a concern in the insurance industry where premiums and policy payouts are predicated on full compliance by patients. In cases of non-compliance, patients often experience premature mortality or earlier prognosis than expected, thus placing undue burden on the insurance industry. Patients may also develop drug resistance which requires the use of a more advanced, and hence expensive, regimen. The terms of compliance as specified by medical and life insurance companies often includes compliance to a prescribed action intake (adherence monitoring policy).

Although drug dispensers are available which may be configured to dispense drugs at predetermined times there is no way of checking at present whether dispensing in fact took place. There is thus no effective way at present in which compliance can be monitored other than requiring a patient to take medication in the presence of a health professional. This is clearly labour intensive and impractical for widespread use or complicated regimens. Available dispensers are also generally bulky, require regular maintenance including re-filling at a healthcare facility, and frequently contain communication mechanisms requiring the dispensers to have sophisticated built-in electronics allowing them to communicate over long distances with monitoring facilities.

OBJECT OF THE INVENTION

It is an object of this invention to provide a system which will at least partially alleviate some of the abovementioned problems.

SUMMARY OF THE INVENTION

In accordance with this invention there is provided a risk management system which includes a disposable sensor to monitor access to a drug container and record information relating to such access and which is configured to communicate with a portable information retrieval unit; and a processor configured to receive the information recorded by the sensor and to process such information into a user determined format. Further features of the invention provide for the risk management system to include a portable information retrieval unit whereby the information recorded by the sensor may be retrieved from the sensor when the unit is proximate the sensor and whereby the recorded information may be communicated to the processor; for a reminder device to be associated with the sensor to provide prompts to a patient when a drug needs to be taken in accordance with a drug usage regimen which is pre-programmed onto a memory associated with the sensor; for the reminder device to be wearable on the person of the patient; for the portable information retrieval unit to communicate with the sensor in wired or wireless fashion; and for the portable information retrieval unit to communicate with the sensor by means of a 2.4GHz short distance wireless link.

Still further features of the invention provide for the processor to supply data to an insurance related system to be used to monitor compliance to adherence clauses in insurance contracts and determine risk profiles of patients undergoing chronic medical treatment; for the insurance related system to be a life- or health insurance system; for the pre-programmed drug usage regimen and information relating to the access to the drug container as recorded by the sensor to be used to determine a patient's adherence to the prescribed drug regimen and, in turn, to determine a change in a patient's risk profile over a predetermined usage period; for the change in a patient's risk profile to be used to adjust the patient's insurance premium; and for the patient's adherence to the prescribed drug regimen to be verified by at least one analytical test.

Yet further features of the invention provide for the portable information retrieval unit to communicate the stored information to a central information storage facility; for the processor to retrieve information from the sensor directly, via a wireless communications link, and supply data to an insurance related system to monitor compliance to adherence clauses in insurance contracts and determine risk profiles of patients undergoing chronic medical treatment; and for the wireless communication link to preferably be a cellular GSM network.

Yet further features of the invention provide for the reminder device to be a mobile or cellular telephone handset; for the sensor to communicate information to the cellular telephone handset which, in turn communicates the information to the processor via a wireless communications link, preferably a GSM cellular network; for the portable information retrieval unit to be a mobile or cellular telephone handset configured with an appropriate software application to enable retrieval of the recorded access information from the sensor and subsequent communication of the recorded access information to the processor; and for the sensor to be securable in the lid of a drug container.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be described, by way of example only, with reference to the drawings in which:

Figure 1 is a diagrammatic illustration of one embodiment of a risk management system;

Figure 2 is a graphic illustration of the risk profile of a patient undergoing chronic medical treatment; and

Figure 3 is a diagrammatic illustration of a second embodiment of a risk management system. DETAILED DESCRIPTION WITH REFERENCE TO THE DRAWINGS

One embodiment of a system (1 ) is shown in Figure 1 and includes a sensor

(2) and reminder device (3). The sensor (2) is secured within the lid (5) of a drug container (7) and monitors and records each time the lid (5) is removed and replaced on the container (7). The sensor (2) includes a memory (not shown) to record information relating to the access to the container, and a power source (not shown) in the form of a battery. The sensor (2) and lid (5) are manufactured as an integral unit so that the battery is not replaceable. The sensor (2) therefore has a lifetime of approximately 24 months, depending on the lifetime of the battery, after which it may be disposed of.

The reminder device (3) provides an audible and text prompt to the user (not shown) each time a drug or drugs need to be taken. It is preferred that the reminder device (3) is incorporated into an item that can be worn on the person of the user, in this embodiment a wristwatch, so as to be inconspicuous and to prevent other people in the vicinity from being alerted to the fact that the user is on a drug regimen.

The sensor (2) can communicate with portable information retrieval unit (10), in this embodiment a mobile telephone handset, in wireless fashion. The unit (10) is loaded and configured with a software application allowing it to communicate with the sensor (2) so as to receive and store information from it. A wired link between the sensor and portable unit may, however, be provided. Any suitable protocols can be used for communication including, for example, USB, serial (RS232), Bluetooth and Wibree. It is also foreseeable that a separate protocol may be developed specifically for the purpose of this invention; such protocol to potentially become a standard for medical devices in future. When wireless communication between the sensor (2) and portable unit (10) is used, it is done at a frequency of 2.4 GHz. In this embodiment, the portable unit (10) may, however, only retrieve information from the sensor (2) when it is in relatively close proximity thereto. This, in the case of communication by, for example, Bluetooth would imply a range of approximately 10 meters (32 feet).

The wristwatch (3) has five alarms (not shown) which are user initiated or pre-set by a healthcare facility supplying the device. The alarms are set up to conform to the patient's treatment regimen.

The portable unit (10) will typically be carried by a healthcare or insurance provider employee and used during visits to patients. The configuration of the portable unit (10) enables the healthcare provider employee to view the information received from the sensor, which is then compared to the patient's drug regimen on the unit (10). This enables the employee to provide further advice to the patient based on the comparison. The comparison will preferably be done electronically and automatically and will highlight anomalies. The information recorded by the sensor will therefore only be retrievable when the healthcare provider is at or near the sensor. The container access information stored by the sensor (2), together with the patient's prescribed drug regimen may then be used to determine a patient risk profile on the portable unit (10). The portable unit (10) may display information relating to the change in the patient's risk profile since the last visit by the healthcare or insurance provider employee which allows the employee to advise the patient accordingly. A patient's risk profile will be described in more detail below.

Each sensor (2) and reminder device (3) includes a unique identifier associated with the patient. In the embodiment described the identifier is a unique bar-code (4) which is applied to the drug container (7) and uniquely associated to the patient, preferably at the time of dispensing. When a healthcare or insurance provider employee visits the patient the bar-code (4) may be scanned with the portable unit (10) which may potentially identify the patient, pull up the patient's prescribed regimen and other personal information, as well as verify that the visit did in fact take place. The portable unit (10) can also communicate with a processor (15) located at, in this embodiment, a healthcare facility (17), alternatively a life- or health insurance provider (17). Communication between the portable unit (10) and the processor (15) may also be in either wired or wireless fashion using any suitable communications protocol. In the present embodiment the communication is wireless by means of a 2.4 GHz communications protocol. It is, however, foreseeable that standard, wired protocols such as UART and USB may be used. The information received from the sensor (2) and stored on the portable unit (10) can thus be downloaded to the processor (15) for further analysis and further drug regimens for specific patients may also be uploaded from the processor (15) to the portable unit (10) for downloading to patient reminder devices (3) at a later stage.

It should be appreciated that the information relating to the access to the container provides adherence information which may assist insurance companies to determine a risk profile of a patient and thereby determine whether or not a patient is complying with adherence clauses stipulated in a life- or health insurance contract of the patient. It may also assist risk management companies to draw up a risk profile of a patient and advise insurance companies, as well as the patient, accordingly. The information may also be used by employers of patients on chronic illness treatment, to determine the risk such employees pose to the company, as well as to fellow employees.

Figure 2 shows the risk curve used in a typical risk analysis of a patient on chronic medical treatment, in this case an HIV positive patient on antiretroviral treatment, in accordance with a prescribed regimen. The graph shows the risk the patient represents to the life- or health insurer on the y- axis and time (in years) on the x-axis. The risk increases on the y-axis from bottom to top with "R-T representing a low risk patient, and "R₅" a high risk patient. The three different graphs represent the risk a patient infected at t₀ would pose to the insurer if it did not receive any antiretroviral treatment at all ("No ART"), if it does receive treatment but does not adhere to the prescribed regimen ("Non-adherence ART") and if it receives treatment and adheres to the prescribed regimen ("100% adherence ART").

When the graphs are, for example, evaluated at time t.₃, it can be seen that the patient represents a significantly higher risk ("R₅") to the insurer when it does not adhere to its prescribed dosage regimen than when it does ("R2"). It should be appreciated that the change in a patient's risk profile ("ΔR") from one visit by the healthcare provider employee to the next may be used by the life- or health insurer to adjust the patient's insurance premium and or payout amount as appropriate.

It is also foreseeable that the adherence information retrieved from the sensor (2) may be verified by at least one analytical test. For example, an HIV positive patient may be required to undergo CD4 or viral load tests at regular intervals. These tests may confirm whether the actual intake of medication did in fact take place as indicated by the access information recorded on the sensor (2) and may include, but is not limited to, blood, urine, saliva or other body tissue tests, as well as pchychological and psychometric assessments. This will, for example, prevent a patient experiencing uncomfortable side-effects from the medication to simply open and close the drug container without actually taking the medication.

The processor (15) also receives information relating to other patients on the portable information retrieval unit (10) as well as information from other portable units (not shown). The processor (15) is configured through software to be able to access and analyse individual patient information as well as information from any user determinable group of patients. Compliance with drug regimens can thus be determined on an individual basis or for a group which could be selected on gender, location, occupation or age. These details will be recorded against each patient at the time of registering them on the processor (15) in conventional fashion.

The processor (15) in turn communicates with a further processor (20), in this embodiment an offsite server, through a communication link (25) in this embodiment the worldwide web of the Internet. The server (20) communicates in similar fashion with other processors (20) located at other healthcare facilities (not shown).

The server (20) may be located at a central storage facility (27), from where it may be accessed by numerous interested parties (29) whom may use the information collected from the various healthcare facilities to determine the adherence to prescribed treatment regimes of specific patients as well as user defined groups of patients.

An alternative embodiment of the invention is shown in Figure 3. In the figure, items corresponding to those of the embodiment described with reference to Figure 1 are indicated by like numerals.

The system (1 ) again includes a sensor (2) and a reminder device (3), in this embodiment a mobile telephone (30). The sensor (2) operates similarly to that of the previous embodiment and records each time the lid (5) of the drug container (7) is removed and replaced.

The mobile phone (30) is configured with a mobile phone software application (not shown) capable of being programmed to remind the patient at set times to take medication. For this purpose, the software sets up a number of electronic alarms which can be programmed by the user, or preprogrammed by a healthcare provider according to the patient's prescribed drug regimen. The software will be supplied by the healthcare provider and will be installed on the patient's mobile phone (30).

The mobile phone (30) with the installed software therefore provides an audible and visual prompt (not shown) each time a drug or drugs need to be taken. When an alarm is activated, the user is prompted to indicate on the mobile phone whether medication has been taken as prescribed. A compliance log of when medication was used is kept and updated in a log file on the mobile phone (30). The log file can be downloaded directly to the processor (15) for adherence monitoring purposes. It should be appreciated that, as is the case in the previous embodiment, the use of a mobile phone as a reminder device is inconspicuous to other people in the vicinity. It therefore still provides the patient with a degree of privacy.

The sensor (2) in this embodiment can also communicate with the mobile phone reminder device (3) in either wired or wireless fashion. Information stored by the sensor (2) can then be communicated to the mobile phone (30) where it may be stored on a mobile phone memory or further communicated from the mobile phone (30) to a remote storage facility (31 ) or a healthcare facility (17) or life- or health insurance facility, by means of a cellular GSM network (32). The mobile phone reminder device (30) may communicate with the cellular network (32) by means of text or multimedia messaging, Wi- Fi, or by means of any of the standard Internet communications protocols such as GPRS, Edge, 3G, HSDPA, ETL or the like, depending on which of these is supported by the mobile phone (30) and network (32). Alternatively, the sensor (2) may include a communications module which will allow it to transmit information via the network (32) directly, without having to first transmit it to the mobile phone (30).

It should, however, be appreciated that the mobile phone may also be configured to communicate with a portable information retrieval unit as described in the previous embodiment, but that the use of a mobile phone as a reminder device may alleviate the need for such a unit. If a mobile phone is, however, used as a reminder device and a portable information retrieval unit is still used, the information retrieval unit may be a second mobile telephone handset programmed with appropriate software. In this configuration it should be appreciated that the adherence information contained on the mobile telephone reminder device of a patient may be communicated to the mobile telephone information retrieval device of a healthcare provider employee during intermitted visits, or spot check visits, by the healthcare provider employee to the patient. The information may then be transmitted between the patient's mobile phone and the portable unit by any suitable communications protocol such as Bluetooth, infra red, Wi-Fi, USB or any other suitable protocol.

Numerous changes and modifications may be made to the above described embodiments of the invention without departing from the scope of the invention. In particular, it may be possible to use a variety of alternative reminder devices and portable information retrieval devices. It is also foreseeable that the recorded adherence information may be useful in other applications, for example, medical field trial research to name but one.

It is also foreseeable that the gathered information may be stored and/or processed at a variety of locations and for specific purposes. All gathered data may, for example, also be processed by a central information management institution, from where it may be distributed to interested parties.

The portable information retrieval units may also be operated by life- or health insurance provider employees in which case the spot visits to patients may be conducted by such employees instead of by healthcare providers.

Claims

CLAIMS:

1. A risk management system (1) which includes a disposable sensor (2) to monitor access to a drug container (7) and record information relating to such access and which is configured to communicate with a portable information retrieval unit (10); and a processor (15) configured to receive the information recorded by the sensor (2) and to process such information into a user determined format.

2. A risk management system (1 ) as claimed in claim 1 which includes a portable information retrieval unit (10) whereby the information recorded by the sensor (2) is retrieved from the sensor (2) when the portable unit (10) is proximate the sensor (2) and whereby the recorded information is communicated to the processor (15).

3. A risk management system (1) as claimed in claim 1 or claim 2 which includes a reminder device (3) associated with the sensor (2) to provide prompts to a patient when a drug needs to be taken in accordance with a drug usage regimen which is programmed onto a memory associated with the sensor (2).

4. A risk management system (1 ) as claimed in claim 3 in which the reminder device (3) is wearable on the person of the patient.

5. A risk management system (1 ) as claimed in any one of the preceding claims in which the portable information retrieval unit (10) communicates with the sensor (2) in wired or wireless fashion.

6. A risk management system (1 ) as claimed in claim 5 in which the portable information retrieval unit (10) communicates with the sensor

(2) by means of a 2.4GHz short distance wireless link.

7. A risk management system (1 ) as claimed in any one of the preceding claims in which the processor (15) supplies data to an insurance related system (17) to be used to monitor compliance with adherence clauses in insurance contracts and determine risk profiles of patients undergoing chronic medical treatment.

8. A risk management system (1 ) as claimed in claim 7 in which the insurance related system is a life insurance system.

9. A risk management system (1 ) as claimed in claim 8 in which the drug usage regimen and information relating to the access to the drug container as recorded by the sensor (2) are used to determine a patient's adherence to the prescribed drug regimen and, in turn, to determine a change in a patient's risk profile over a determined usage period.

10. A risk management system (1) as claimed in claim 9 in which a change in a patient's risk profile is used to adjust the patient's insurance premium.

11. A risk management system (1) as claimed in claim 10 in which the patient's adherence to the prescribed drug regimen is verified by at least one physiological test.

12. A risk management system (1) as claimed in any one of the preceding claims in which the portable information retrieval unit (10) communicates the stored information to a central information storage facility (27).

13. A risk management system (1) as claimed in claim 1 in which the processor (15) retrieves information from the sensor (2) directly, via a wireless communications link (32), and supplies data to an insurance related system (17) to monitor compliance to adherence clauses in insurance contracts and determine risk profiles of patients undergoing chronic medical treatment.

14. A risk management system (1) as claimed in claim 13 in which the wireless communication link (32) is a cellular GSM network.

15. A risk management system (1 ) as claimed in any one of claims 3 to 14 in which the reminder device (3) is a mobile cellular telephone handset (30).

16. A risk management system (1) as claimed in claim 15 in which the sensor (2) communicates information to the cellular telephone handset (30) which, in turn communicates the information to the processor (15) via a wireless communications link (32), preferably a GSM cellular network.

17. A risk management system (1 ) as claimed in any one of the preceding claims in which the portable information retrieval unit (10) is a mobile telephone handset (33) configured with an appropriate software application to enable retrieval of the recorded access information from the sensor (2) and subsequent communication of the recorded access information to the processor (15).

18. A risk management system (1 ) as claimed in any one of the preceding claims in which the sensor (2) is securable in the lid (5) of a drug container (7).