GB2483221A - Mobile phone and camera for dose recognition - Google Patents

Abstract

Monitoring patient compliance using a camera on a telecommunication device to record the individual pill opening of a blister pack. The automated system detects whether an individual pill seal within the blister pack has been broken using image recognition software. The system collates the data issued by individual telecommunication devices by updating a database and queries it against preset parameters set by an individual patient's relevant health care professional. The system issues reminders, delivers video instructions and information to patients through the application on the telecommunication device. This is triggered by the data uploaded from the telecommunication devices. The system issues reminders and information to health care professionals through the web based platform provided by the service. This is triggered by the data uploaded from the telecommunication devices. The database of patients held on the server can be downloaded by relevant healthcare practitioners using a web based platform.

Description

Summary

Overview -General background Information

Pharmaceutical companies create and manufacture drugs to alleviate and treat patients. A vast number of these patients begin to take medication which is supplied by their GP but, for various reasons, do not complete the course of treatment or miss tablets, do not follow the instructions, take them at incorrect different times or change medication at any time throughout the prescribed course. During the clinical trial phase (i.e. the development of a new compound) this action leads to inconsistent and inaccurate data, which can extend the clinical trial, evaluation process. The pressure for new product launches is intense and the competition between different companies to be first to market is highly lucrative.As an example, a successful product launch in the USA (for a new compound) could have a projected sales value of $ Ibillion USD.

Background Information

To date there are a number of "novel" types of dispensing systems or packaging concepts which have all been designed to monitor the date, time & sequence in which patients take there medication.

Reference U520061089542 Al Pub April 27th 2006 -Application no 60/ 622,337 filed on October 25th 2004 Many of the systems available require either the core blister pack (which holds the tablets) to be adapted or for the blister pack to be "housed" into special patient wallets or bespoke plastic cradles.Bottles which are also in use, would also need to adapted to accommodate compliance monitoring.

The technology used to transmit the data varies for each application, but in general it would be incorporated into the cap,added to the blister pack or held within the card. The methodology used is either printed circuit (blister) or solid circuit (wallet) within each offering. The data is transmitted using either Blue tooth or NFC (near field communication). Other features required for this process to work would be RFID, memory, battery, mobile phone and software which is capable of transmitting the data-from the patient action, to a dedicated web based (receiving) platform.

Companies currently in this field usually take on full responsibility for the whole data compliance process and management in conjunction with the pharmaceutical companies. To date, the technology has proved to be both costly to introduce and maintain as well as a long development, production timeline that is, typically, in the region of three to four months.Further implications may relate to the stability of the tablets.

Alongside the compliance products described, new technology is also available for smart pills.Smart pills are a embedded ingestible sensor, within the tablet,which disperse in your stomach At this point a signal is sent to a microelectronic receiver worn either as a skin patch or implanted under the skin. The system is currently under evaluation & exclusive terms with Novartis.

Our field of invention is straightforward to define and explain. However, we do not believe that this in anyway devalues the idea because, more importantly, it demonstrates our knowledge of the subject matter and our overriding desire to offer a compliance technique/device which is easy to understand and introduce.

Drawings

Brief Description of the Drawings

FIG. 1: Flow diagram illustrating a preferred method of use of the present system.

FIG. 2: Illustrates the relationship of the patient, care provider, and system

Original Idea -Specification

The intention is to use the patient's personal Mobile Phone/ cell phone that is enabled with access to the Internet and includes a camera. compliance software is installed on to the device either at the point of sale or after the initial purchase of the phone.

When the patient enrolls in a new clinical study they would be advised that are taking part in a compliance-monitoring program. Upon initiation they would be advised concerning what they are expected to do and how to do it. Unlike all other technologies, which are available, the participation of the patient is minimal, quick and unobtrusive. Briefly, in line with their dosage instructions, which are issued via the clinician, the patient would be asked to photograph each and every time when they take their tablets. The software which is contained within the phone would record the date, time and sequence which are the important reference points for all clinical data.

The means of delivering the data would be via the cellular network. The means of receiving the information would be via a dedicated, bespoke web base platform.

The advantages of this system are clear to see as each clinical trial and patient who is enrolled in the clinical trial can be accurately monitored, advised and supported. With a higher retention rate of patients (mid9O%) the clinical studies/trials can progress more quickly to market submission than studies/trials without a compliance aid which have a high fall out rate and poor data (mid 60%).

The idea is to create an electronic data device for (pharmaceutical) blister packs. Data capture is a fundamental and key aspect of all clinical trials. The quality of the data received determines the longevity and accuracy of the patient program by monitoring patient compliance. The intention will be to speed up and improve the discovery to market process.

New tablet combinations are tested and approved via global clinical trials and can take in the region of seven years. During this period, many different patient groups will be brought in and evaluated. The tests may involve comparisons with other drugs on the market. blind, or double blind, placebos will also be used as part of the monitoring analysis.

Specification

Detailed Explanation of the invention -Process A. Preferred Implementation of the System Configuring the System The EDC system will be run either for or by the pharmaceutical company.

Each patient who is chosen to participate in the study! program will be issued with applications to their mobile phone (also called telecommunication device, cellular phone, cell phone or handphone) which is an electronic device used for full duplex two-way radio telecommunications over a cellular network of base stations known as cell sites. Here in, this device will be collectively known as a telecommunication device. This software will be available to download though mobile application stores.

Using their brand of telecommunication devices respective application stores to download and install the application to their respective phones, the user then runs the application. The user configures the application by typing in their pre defined ID number and setting a 4-digit security access code.

The database of the patient and medication records can be uplifted to the server by the healthcare provider using an online form within the web based platform provided by the service. From this point, the healthcare provider and

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the patients insurance company are then able to gain access to the users' information that is stored on the server's database.

When in use, the application works real time using the best available network connection that the telecommunication device has access to at the specific moment in question.

To simplify the introduction and gain patient confidence in this technology, a short video explaining how the application will start the process will be provided. Once this is finished, the user agrees that they fully understand. At any time should the patient have any questions / concerns then these can be flagged up and actioned.

B. Preferred Implementation of the System Start of EDC (patient compliance) After video introduction, the application informs the patient about when they need to take the next dose of their course of treatment / medication. When the patient is about to take a tablet / capsule, they open the application. The application asks the patient to take a photo image of the blister pack.

[0003] Patient takes prescribed medicine dose from (blister pack or packs).

[0003] Patient takes photograph of the front the [0008] blister packs that they have taken doses from at that particular point in their medical program. The photograph is taken, using the [0001] camera on their already enabled [0002] telecommunication device.

The Image recorded with the date, (Ideally) Location, and time stored using software installed on the [0002] telecommunication device.

The [0002] telecommunication device transmits this data to the [0009] server through available networks or postpones the transmission until a network connection is available.

Once the [0009] Server has received the data for the particular patients [0002] telecommunication device it updates patient's record with this new data.

[0005] Image recognition software uploaded on the [0009] server analyses the image to determine that the [0008] particular backing foil is broken and the tablet dispensed according to the pre -determined sequence devised by the [0006] healthcare provider. The date time, sequence and location is recorded.

The results are analysed against predetermined parameters for inconsistencies by the server [0005], which have been previously set up by the healthcare provider. (These parameters can be changed at any time by the [0006] healthcare provider through the [0009] web based platform).

The [0009] server sends a receipt to the telecommunication device noting the patient of the results or any problem. One possible problem may be that the [0003] patient needs to take a clearer image of the blister pack.

A progress report is sent to [0006] care providers and [0007] insurance companies database updating patient's progress.

A transmitted alert is sent to [0006] care provider if the [0003] patient has deviated from pre-set parameters.

The [0006] care provider are then able to access whether an intervention is required.

The process is then repeated when the next does is due to be taken and until the completion of the prescribed medicinal course.

The [00031 patient follows the above events until all the tablets / capsules are removed, the last photo / image is when the final tablet is pushed out / taken.

SMS messages and reminders can also be included to enhance the communication flow, between the patient, clinician, GP.

Benefits of this system All batches of medicine can be fully tracked and traced. This gives the pharmaceutical company full compliance and patient monitoring, either for clinical studies or commercial use. There is an option for feedback loops and questions & answers, depending on the specific treatment.

Patients, doctors and clinicians can work closely together to improve patient care and support and impart changes to the medication because of side effects etc. The system is simple to administer and easy to introduce as there will be no change to the primary or secondary packaging components such as the blister pack or the carton / patient wallet.This feature is particularly important as pharmaceutical companies operate highly efficient production facilities.

Unique Proposition Within the pharmaceutical industry, there is a realisation that patient non-compliance places a significant strain upon the financial budget of all global heathcare providers heath authorites, as well as the pharmaceutical companies' resources.As much as $290 billion USD -13% of total healthcare expenditures is added to the cost of healthcare bills annually by patients deviating from prescribed course of treatment-source New England Institute, USA.

How is it different? Whilst the concept of EDC electronic data capture is not new, companies such as Cypak who are based in Sweden and DSM (TCG) based in the The Netherlands are both offering different forms of this technology. However, all of these companies, which we are aware of, are providing packaging related solutions or placing something, within the tablet itself. These products require process changes and additional features to the core' packaging components.

The unique feature of our invention is the field of use and the ability to introduce this technology with no packaging adaption or noticeable change for the pharmaceutical company or the patient.

Key features the invention We are not changing any components which have already be specified by the pharmaceutical companies. The number of global blister packs shapes, sizes and types of materials used is infinitely variable and dependent upon the tablet/capsule configuration compound.

We are not adding anything to the primary blister pack. Typical blister packs are manufactured on high speed dedicated lines running @ speeds between 35Oper mm and 500per mm. Many of the existing technologies which we are aware of would have to be added at speed on to the blister packs either inline( as part of the normal blister packing process) or offline (which would require a dedicated pick & place, application piece of equipment) .Our solution removes this additional process from the equation.

We are proposing to use various parts of existing technology. However, our field of invention is that we are redefining the use to suit the requirement for compliance monitoring and accurate data capture.

Our technology should be capable of use across of a minimum of at least two packaging formats, for example, blister packs or patient wallet cards Within the EU approx 80% of all tablets in circulation are presented to the patient in a blister pack or wallet. in the USA traditionally the use of plastic bottles has been prominent. However, during recent times there has been a marked shift towards the blister pack as the preferred tablet presentation for prescription, over the counter or general sales licenses.This move is supported by the HCPC healthcare compliance packaging council both in the USA & the EU.