Title

DRUG MANAGEMENT SYSTEM AND METHOD WITH REMOTE PROGRAMMER

Field of the Invention

The present invention relates to drug management systems. More importantly, the invention relates to a wireless drug management system for use by a patient and their health care providers.

Background to the Invention

Approximately one third of all independent living elderly people are not compliant with their drug therapy. This lack of medication management results in either under medication or overmedication. It will be appreciated that this can in turn cause unnecessary and often serious health risks.

So far, care schemes and retrospective assessment procedures have been the only applicable solution to deal with this problem. However, with the increasing aging of the population and cost constraints in the health sector, it is desirable to find an alternative, more cost effective drug management system for patients and their health care providers.

Summary of the Invention

The present invention provides a drug management system comprising: at least one medication dispenser programmable to provide notification of when medication containable therein should be removed for use by a patient associated with the dispenser; at least one processing means for remotely programming and receiving status information from the dispenser with which it is associated; and an authentication means for authenticating the data exchange between the at least one dispenser and the at least one processing means.

By providing a system which notifies a patient of when their medication is due, it provides peace of mind to patients, who no longer need to recall when their medication should be taken.

The authentication means ensures that messages not coming from a trusted source can not compromise the integrity of the drug management system, and thus results in a secure and a tamper-proof drug management system.

Preferably, the authentication means receives all data from the processing means which is destined for the dispenser and all data from the dispenser which is destined for the processing means, but only allows data which has been authenticated to be transmitted to their target destination.

The authentication means may further comprise a database on which all data pertaining to the system and all data which is received at the authentication means is stored, regardless of the authenticity of the data.

The provision of a database ensure that a full paper trail is provided of all the actions and events which take place in the drug management system.

Preferably, the dispenser, the processing means and the authentication means communicate over a wireless network.

By the use of a wireless network, this enables the system to be dispatched in any location, and does not require the use of internet or a landline connection.

At least one tray on which the medication can be placed may be associated with the dispenser by the programming means, wherein the tray is adapted for insertion in the dispenser.

The tray may comprise a plurality of compartments, wherein the programming means programs each compartment with a day and a time at which medication locatable in the compartment should be removed for use by a patient.

The programming means may further program each compartment with information as to how medication locatable in the compartment should be taken by a patient.

This enables a patient to be easily informed as to how their medication should be consumed.

The dispenser may be adapted to detect whether a tray associated with the dispenser is correctly inserted in the dispenser.

This prevents the possibility of a patient taking the incorrect medication from the dispenser.

The dispenser may further comprise a sensor to detect whether medication has been removed from a compartment at the correct time.

This enables alarms to be generated in the event that a patient is not complying with the medication intakes.

The status information may comprise information as to whether medication has been removed from a compartment at the correct time.

Accordingly, non-compliance by a patient can be detected immediately by their health care provider.

The system may comprise a plurality of processing means and a plurality of dispensers, wherein each processing means is associated with a particular health care provider, and each dispenser is associated with the processing means corresponding to the health care provider of the patient with whom the dispenser is associated.

The present invention also provides a method for providing notification of when medication locatable in a dispenser should be removed for use by a patient associated with the dispenser, the method comprising the following steps: inputting programming data at a remote processing means for programming the dispenser to provide notification of when the medication containable therein should be dispensed; transmitting the programming data from the processing means; verifying the authenticity of the programming data transmitted from the processing means at an authentication means; and transmitting only verified programming data to the dispenser for programming the dispenser.

Preferably, the step of inputting programming data comprises the steps of: associating one or more trays containing medication with the dispenser, each tray comprising a plurality of compartments; wherein the trays are adapted for insertion in the dispenser; and for each compartment which contains medication, assigning a date and a time during which medication contained on that compartment should be removed from the dispenser for use by a patient.

The step of inputting programming data may further comprise the step of providing information as to how the medication in each compartment should be taken by a patient.

The method may further comprise the steps of : inserting the trays associated with the dispenser into the dispenser, and providing notification as to whether each tray is correctly inserted in the dispenser.

The method may further comprise the step of the dispenser generating a notification on the day and at the time at which the medication in each compartment should be removed for use by a patient.

The notification may be an aural or a visual indicator.

The method may further comprise the step of sensing whether medication has been removed from a compartment at the correct time.

The method may further comprise the steps of: transmitting status information from the dispenser; verifying the authenticity of the status information at the authentication means; and passing only the verified status information to the processing means.

The status information may comprise information as to whether medication has been removed from a compartment at the correct time.

The method may further comprise the step of the processing means generating an sms messages containing the status information.

Preferably, the dispenser, the processing means and the authentication means communicate over a wireless network.

The present invention also provides a method of dispensing a patient with medication at their due intake times from a dispenser, the method comprising the steps of: remotely programming a dispenser to provide notification of when medication contained therein should be removed for use by a patient associated with the dispenser; notifying the patient of when the medication contained in the dispenser should be removed for use by the patient; and removing the medication from the dispenser for use by the patient upon receipt of the notification.

The method may further comprise the step of generating an alarm if the patient does not remove the medication upon receipt of the notification.

Brief Description of the Drawings

Figure 1 illustrates diagrammatical Iy the drug management system of the present invention;

Figure 2 illustrates a typical top level process flow of the drug management scheme of the present invention;

Figure 3 illustrates the graphical user interface by means of which the dispenser is programmed; and Figure 4 illustrates the dispenser of the present invention.

Detailed Description of the Drawings

Figure 1 illustrates diagrammatically the drug management system of the present invention. In its simplest form, it comprises a dispenser 1, a base station 2 or processing means, and a management station 3 or authentication means, all of which are in wireless communication with each other.

The dispenser 1 is a portable device adapted to contain trays for storing drugs or medication assigned to a particular patient for dispensing to that patient. Each dispenser 1 is therefore associated with a particular patient and thus located where they reside. It is remotely programmed to notify a patient of the due times of their medication intakes. If a patient does not take their medication from their dispenser 1 at the notified times, it sends alarm messages back to the particular base station 2 associated with the dispenser 1.

The base station 2 is located on the premises of each pharmacist participating in the drug management scheme. At the base station 2, the dispensers associated with the patients (customers) of the pharmacy are remotely programmed with the required data in order for the dispensers to carry out their functionality, as will be explained in more detail below. This includes providing notification to patients of when their next intake of medication is due, and the monitoring of patient compliance with their medication intake, by receiving alarm information generated from the dispensers.

The management station 3 is the gateway between the dispenser 1 and the base station 2. It is responsible for ensuring that all data passing between the dispenser 1 and the base station 2 is authentic. It also comprises a database, on which all of the data pertaining to the drug management system is stored.

While Figure 1 describes the invention with reference to a single base station 2 and a single dispenser 1, it will be appreciated that a typical drug management system comprises a plurality of base stations, with each base station being associated with a particular pharmacy, and a plurality of dispensers associated with each base station, each dispenser 1 being associated with a particular patient of the pharmacy.

Figure 2 illustrates a typical top level process flow of the drug management scheme of the present invention. It beings by a GP writing a prescription for a patient, and the patient bringing the prescription to their local pharmacy or health care provider (step 1). Once at the pharmacy, the prescription is filled by the pharmacist, and the medication is assigned to the patient (step 2). The medication is then placed on the compartments of one or more trays designed for insertion in the dispenser 1 associated with the patient. The pharmacist places the medication in the compartments of the trays in the order required so that when the patient inserts the trays in their dispenser 1 it can be dispensed from their dispenser 1 by the patient at the appropriate intake times. The pharmacist then proceeds to remotely program the patient's dispenser 1 via the base station 2 located at the pharmacy with information relating to how and when the medication on the trays should be taken from the dispenser l(step 3). Only programming data authenticated by the management station 3 is transmitted to the patient's dispenser 1.

In step 4, the patient is provided with their trays of medication by the pharmacist for insertion into the their dispenser 1 when they return home. Once the patient is home, they should insert the trays into their dispenser 1 in accordance with the programmed instructions displayed on the dispenser 1. The insertion of the trays into the dispenser 1 completes the set up of the drug management system. The dispenser 1 is now ready to provide notification to the patient at those times at which they should take their medication, and how the medication should be taken. Information on the status of the

intakes from the dispenser 1 is also communicated back to the base station 2 by the dispenser 1 (step 6). This information is communicated to the base station 2 via the management station 3, which ensures that only authenticated information is passed from the dispenser 1 to the base station 2. In the event that an alarm is raised due to a patient not having complied with their intakes, the base station 2 notifies the pharmacist of the alarm by sms message.

More detail on each of the steps described above is set out in the paragraphs below.

The remote programming at the base station 2 of a particular dispenser 1 requires a number of steps to be performed by the pharmacist or health care professional responsible for filling the prescription of a patient. In the described embodiment of the invention, the base station 2 comprises a software application running on a pc which can wirelessly communicate with all of the dispensers belonging to patients of the pharmacy via the management station 3. The software application provides a graphical user interface (GUI) by means of which the pharmacist can view and enter information, as illustrated in Figure 3. In the first step in the programming of a particular dispenser associated with a patient of the pharmacy, the pharmacist must commence the programming session by selecting the patient and their associated dispenser they wish to program from the list of available patients associated with the base station 2 in question. Once this information is input into the base station 2, the base station 2 proceeds to the main programming screen, which enables the dispenser 1 to be remotely programmed with the necessary data to correctly dispense the selected patient's medication from the one of more trays to be inserted in their dispenser 1.

In the described embodiment of the invention, each tray used by the dispenser 1 represents one week, and consists of 28 compartments, with four different compartments being provided for each day of the week, to cover four different time slots. Figure 4 illustrates such a tray contained in a dispenser 1. Each tray which the pharmacist has filled with medication for a patient is provided with an electronic tag or identifier and an identifier in the form of a label. The compartments are transparent, and are sealed once they are filled with medication by the pharmacist. Therefore, a tray is both tamper proof and provides moisture-protection for hydroscopic drugs.

The software application provides a graphical representation of these trays and their compartments, mirroring the structure of the physical trays. The identifier on the physical trays is thus used to associate the physical trays with the image of the trays displayed on screen. It will be appreciated that any other suitable means of displaying the trays and compartments could also be used to provide the same functionality.

In order to remotely program the dispenser 1, the pharmacist must first select a particular tray, and a compartment of this tray which corresponds to both a day on which the pharmacist wishes the patient to take a particular medication and the time slot on which the medication should be taken. This is achieved by the pharmacist reading the identifier on the physical tray, and then selecting on the GUI the tray having the matching identifier. A compartment of this particular tray should then be selected. This means that there should be some medication present in the corresponding compartment of the physical tray which was earlier filled by the pharmacist, for later insertion by the patient in their dispenser 1. The pharmacist must then enter data related to the medication which they have placed in this particular compartment of the tray. This data should include the actual time at which the medication in this compartment is to be taken. It should also include how the medication is to be consumed, such as for example by itself, with food or with water. The pharmacist should also enter in an alarm relating to the medication in this compartment, which corresponds to the time interval which may be allowed to elapse before an intake is considered to be missed (such as for example one intake, two intakes etc) . The alarm information may also detail as to what the patient should do if an intake is missed. In the described embodiment, this data is entered by selecting values from drop down boxes provided on the GUI. However, it will be appreciated that any other means of entering the required information could be used. The dispenser will then generate status information when an alarm condition is satisfied and transmit it back to the base station.

Once all of the required data fields are complete for the selected compartment, the pharmacist should then select a further compartment of a tray displayed on the GUI, which corresponds to another compartment of a physical tray which the pharmacist has filled with medication for the patient. The pharmacist should then complete the data

fields associated with this particular compartment in the same manner as described above.

This process continues until the pharmacist has selected and completed the data fields pertaining to all of the compartments shown on the graphical display which correspond to the compartments of the physical trays which the pharmacist has filled with medication for the patient in question.

After the required compartments of all of the necessary trays are completed, the pharmacist should proceed to the confirmation screen. This screen displays a textual representation of the alarm settings and tray details for the current programming session. Upon confirmation that all of the data entered is correct, the base station 2 transmits this programming information as message data over the wireless network for reception at the dispenser 1 of the patient which the pharmacist specified in the first step of the programming procedure. In the preferred embodiment of the invention, this is carried out over the GSM network. To ensure a secure transmission, the message data is transmitted in encrypted format. This involves assigning a shared private key to both the base station 2 and the management station 3 for use in the encryption and decryption process.

The pharmacist should then print the details of the prescriptions which have been remotely programmed at the base station 2 for a particular patient's dispenser 1.

It will be appreciated from the above that more than one tray can be programmed at once. This means that a number of weeks worth of medication can be added to a number of trays and programmed. This has the advantage of a patient not having to worry about having to come back to the pharmacist every week to obtain a new tray.

The programmed information transmitted from the base station 2 is not directly sent to the dispenser 1 of the patient for which it is intended. Instead, as previously explained, the data is first passed to the management station 3 for authentication, with only authenticated data being transmitted to the patient's dispenser 1.

In the preferred embodiment of the invention, the authentication process comprises a number of steps. In the first step, each message data is checked to see if the base station 2 from which it originates is considered a trusted source. In the described embodiment of the invention, a trusted source is considered to be a recognised mobile phone number. If they are established to be from a trusted source, the messages are then decoded, by the use of the shared key which has been previously assigned to the particular base station 2 and the management station 3. Once the messages are decoded, they are checked to confirm that they comply with their expected format. This involves checking that the message header is correct. If they do comply to their expected format, the data checksum is compared against the checksum which is calculated over the decoded data. If the checksum is intact, a verification is then carried out to ensure that the data messages have a new index value. Where the data messages have a new index value rather than an old index value, it confirms that the data is not a replay attack, whereby an unauthorised user resends messages that have previously been sent. If the messages are verified to have a new index value, the messages are deemed authenticated, and are passed onto the dispenser 1 of the patient to which they are addressed. However, where the message data fails to be authenticated, it is not passed to the dispenser 1 in question.

Regardless of whether the message data is authenticated or not, all of the message data is nonetheless stored in the database of the management station 3. This database therefore incorporates of all of the tables containing the required data fields for the functionality of the drug management system. These may include an alarm table, a patient table, a healthcare providers table, a dispensers table, a tray table, a log table, and a patient table among others. This is so that the management station 3 provides a paper-trail of the entire process flow of the drug management system.

It will be appreciated therefore that the management station 3 ensures that only data which is originated from a trusted source, which is properly encrypted and which has a pre-specified format is passed onto the dispenser for which it was intended. This feature is an important aspect of the drug management system of the present invention, as it minimises the possibility of the system being hacked. It therefore ensures that messages not coming from a trusted source can not compromise the integrity of either the data stored in the database, or the state of the dispensers.

In one embodiment, the management station 3 comprises a standalone GSM Module that is connected to a server. However, it will be appreciated that this functionality could equally well be implemented through the use of different components.

Once the pharmacist has filled the physical trays with the medication and remotely programmed the patient's dispenser 1 with the information relating to the medication on each tray, the patient should take the trays home and place each tray in their dispenser 1. Each tray is provided with seven sliding lids, one for each day of the week, which provides access to the four compartments beneath them, corresponding to four different time intervals during each day. As the dispenser 1 has been already programmed, the dispenser 1 will advise the patient which tray is to be inserted into which section of the dispenser 1. In the described embodiment, this advice is provided by means of a visual display. Once a tray is inserted into a section, the dispenser 1 reads its electronic identifier to verify if the correct tray has been inserted. Once the correct tray is inserted, the dispenser 1 will display the time the next intake of the medication in the tray is due to be taken. If the inserted tray does not correspond with the tray which has been associated with the section when the dispenser 1 was programmed at the base station 2, the dispenser 1 will notify the patient by means of the visual display.

Once all of the requested trays have been inserted into the dispenser 1, the dispenser 1 is in its active state. In this state, it is ready to notify the patient when there is medication to be consumed. When the dispenser 1 establishes that the due time for an intake of a particular medication in a compartment of a tray has been reached, which is determined from the data which was associated with the compartment when the dispenser 1 was programmed, a notification is displayed to the patient. In the described embodiment of the invention, this is shown by the illumination of the compartment containing the medication to be consumed, and the sounding of an audible alarm. It will also display how the medication in the compartment should be consumed. The dispenser 1 then monitors for this compartment to be opened by the patient. The monitoring is carried out by means of a sensor, which senses the electronic identifier on the tray to determine if the lid of the compartment has been opened for more than 5 seconds when the intake becomes due. The dispenser 1 also presents a warning to the patient if it senses that the

wrong lid is opened, or if the tray is kept opened after the medication has been removed. Once the tray has been opened, the dispenser 1 will display the next intake time.

If the indicated compartment is not opened within the time interval of the alarm value programmed by the base station 2, the dispenser 1 will notify the patient that their intake has been missed, and warn the patient not to take the medication.

The dispenser will also generate status information when an alarm condition is satisfied and transmit it for reception at the base station 2. As is the case with all data exchanged between the base station 2 and the dispenser 1, it is passed first to the management station 3 for authentication. The management station 3 authenticates the message data using the same process as described previously in relation to the authentication of the data messages sent from the base station 2 to the dispenser 1. Provided the data is authenticated, it is passed to the base station 2. Where a pharmacist associated with the base station 2 is provided with a mobile phone associated with the drug management system, the base station 2 can provide an SMS message to the pharmacist that contains the alarm details. These details may include information as to which patient did not comply with their intake, and in what manner, and when the alarm occurred. Alternatively, the information relating to the alarm can be simply stored at the base station 2 in machine readable format, and displayed when requested by the pharmacist, in the event that the pharmacist is not provided with a mobile phone associated with the drug management scheme. The management station 3 keeps track on how the alarm information should be dealt with, and thus determines whether the alarm is sent as an SMS message and to whom the SMS messages should be sent, or whether the alarm should be simply stored at the base station 2. _^

In addition to the dispenser 1 sending alarm information to the base station 2, the dispenser 1 is also adapted to transmit status information to the base station 2 upon request. This may include information such as whether the trays have been opened and/or closed for example. This status information is again only passed to the base station 2 once it is authenticated by the management station 3.

The present invention also enables the pharmacists to access their base station 2 at any time and review historical programming information on any of the dispensers associated with their pharmacy. They also have the option of generating and printing reports on these dispensers, including alarm events.

In one embodiment of the invention, the dispenser 1 is additionally provided with user authentication. This could include for example biometric authentication means. Biometric authentication could be carried out by the patient being asked to provide a fingerprint to the dispenser 1 when a tray is to be opened. Alternatively, a built-in CCD camera could take an image while the dispenser 1 is opened. In all cases, the biometric information is sent for storage to the management station 3 to complete the paper trail.

The management station 3 is also responsible for adding new patient and base station 2 details. Once a new patient is entered at the management station 3, the patient details are sent to the base station 2 located at the pharmacy associated with the patient. The management station 3 is also responsible for creating new trays to be associated with a particular dispenser 1. The new tray information is then forwarded to the base station 2 associated with the dispenser 1 to which the new tray was assigned. In the event that a patient moves from one pharmacy to another, the management station 3 stores this change at its database and sends a request to the base stations located at both the old and new pharmacies to update their records.

The words "comprises/comprising" and the words "having/including" when used herein with reference to the present invention are used to specify the presence of stated features, integers, steps or components but does not preclude the presence or addition of one or more other features, integers, steps, components or groups thereof.

It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable sub-combination.