WO2011058194A1

WO2011058194A1 - Dispensing medicaments

Info

Publication number: WO2011058194A1
Application number: PCT/EP2010/067605
Authority: WO
Inventors: Arthur Alexander Calbo
Original assignee: Systimed Bv
Priority date: 2009-11-16
Filing date: 2010-11-16
Publication date: 2011-05-19

Abstract

A method for dispensing medicaments using a dispensing unit is described. The dispensing unit is configured for communicating with a network server and comprises cartridges comprising medical units associated with medicaments. The method comprises: receiving medicament profiles associated with said cartridges, wherein each medicament profile comprising information regarding the weight of a medicament unit and the amount of medicament in a medicament unit; receiving from said network server at least part of a medical record associated with a user of said dispensing unit, said medical record comprising a medicament prescription comprising dosage information associated with said first and second medicament; calculating on the basis of medicament profiles and said medical record, a number of medicament units; releasing said medicament units in a dispenser container wherein during said releasing the weight increase of said dispenser container is monitored; and, providing access to said dispensed medicament units if said monitored weight increase of said dispenser container substantially matches the weight associated said medicament units in said dispenser container.

Description

Dispensing medicaments

Field of the invention

The invention relates to dispensing medicaments and, in particular, though not necessarily, to a method for

dispensing a combination of different medicaments into a cartridge, a medical dispensing unit using such method, a medicament cartridge for use in such medical dispensing unit and a computer product program.

Background of the invention

With the increase in life expectancy and aging population in the western world, the number of people

requiring long-term medicament is rapidly increasing. The people concerned are often elder people typically having mental and/or physical limitations. These people are often affected by multiple, chronic pathological processes and therefore the medicament involved comprises a number and often a large number of different medicaments (e.g. pills, capsules, tablets, etc.) per day. These patients are referred to as "poly-pharmacy patients". Due to the mental and/or physical limitations of these patients, compliance or adherence to various prescribed medicament regimes may be largely impaired and may cause serious problems.

Incorrect adherence may cause the medical treatment to be less effective or even counterproductive. Moreover, patients dealing on a daily basis with varying combinations of different pills or capsules may easily make mistakes in the dosages. These mistakes may cause medicament under- or over dosages, often which may result in serious health threatening or even fatal consequences. Similar problems exist with healthcare workers assisting patients in a nursing home or a hospital. Moreover, healthcare workers deal with large numbers of patients so that prescriptions may be easily mixed-up thereby resulting in unfortunate events wherein one patient is provided with medicaments which are meant for another patient.

In order to improve adherence to a medicament regime semi-automated medicament dispensing devices for use by a patient have been developed. WO02/081015 describes for example a medicament dispenser for use at a patient's home location, which is connected to a central server of a health care provider or the like. Similarly, US200/0259336 describes a medicament dispenser for use at a patient's home location comprising a build in pill dispensing assembly. A conveyor mechanism and photoelectric sensors are implemented to ensure that the correct amount of medicament is dispensed. Although such dispensers may help the patient in the administration of a medicament to some extent, such types of dispensers also have significant problems and shortcomings.

One problem may relate to the fact that although the highest risk group in medicament compliance are poly-pharmacy patients, known dispensers do not allow automatic dispensing of prescribed combinations of different medicaments. In particular, dispensers are not configured for poly-pharmacy patients requiring automatic and safe dispensing of multiple medicament and flexible adjustment of the dosages of

prescribed combinations of different medicaments. Dosage variations and/or variations in the combinations of

medicaments may be required on a regular or even daily basis, like for instance with anti-coagulation therapy. In these cases the daily dosage may vary strongly and may depend on patho-physiological parameters such as weight, blood pressure, blood sugar level, INR, etc. of a patient.

A further problem may relate to the safety of known dispensing systems. A dispensing system should be suitable for poly-pharmacy patients at heir home's location without or with only minimal interference of the patient or medical personal such that the risk of human errors may be eliminated or at least largely reduced. US2007/0043469 and US2009/0012818 describe dispensing systems for use in a medical service environment, e.g. a pharmacy or a hospital. These documents describe various measures to verify correct dispensing of a single medicament. Hence, these systems do not take into account problems related to the verification of dispensing combinations of medicaments in the home environment of a patient. Furthermore, these systems do not provide a solution for a safe dispensing system which is suitable for use in the environment of a patient's home, wherein a dispensing device should be small, portable and relatively simple to construct while at same time ensuring a dispensing process which meets very stringent safety requirements.

Hence, there is a need in the art for new and improved methods and systems for dispensing medicaments, in particular methods and systems for dispensing medicaments for dispensing dose varying combinations of medicaments in a safe and controllable way.

Summary of the invention

It is an object of the invention to reduce or eliminate at least one of the drawbacks of known service provisioning systems. In a first aspect the invention may relate to method for dispensing medicaments using a dispensing unit, preferably a portable dispensing unit, configured for communicating with a network server, said dispending unit comprising at least a first cartridge comprising first medical units associated with a first medicament and a second

cartridge comprising second medical units associated with a second medicament and an electronic weight balance for detecting the release of said medical units, said method comprising: receiving at least a first and second medicament profile associated with said first and second cartridge respectively, each medicament profile comprising information regarding the weight of a medicament unit and the amount of medicament in a medicament unit; receiving from said network server at least part of a medical record associated with a user of said dispensing unit, said medical record comprising a medicament prescription comprising dosage information

associated with said first and second medicament; calculating on the basis of said first and second medicament profile and said at least part of a medical record, a first number of first medicament units and a second number of second

medicament units; releasing said first and second number of medicament units in a dispenser container wherein during said releasing the weight increase of said dispenser container is monitored; and, providing access to medicament units dispensed in said dispenser container if said monitored weight increase of said dispenser container substantially matches the weight associated with said medicament units in said dispenser container .

Hence, by monitoring different parameters, in particular the weight increase during the release of the different medicament units, errors - especially human errors - in the administration of a plurality of medicaments may be eliminated or at least greatly reduced. The process may easily and safely deal with variations of the dosage and/or

variations in different medicament units. Moreover, the simple press-release mechanism may substantially reduce the

involvement of the patient or health care workers in preparing the medicament combinations. Combining a sensor signal and the correct weight increase provides a very reliable verification process of the individual medicament dispensing steps of the dispensing process. Moreover, the use of multiple cartridges comprising strips of medicament units and an electronic miniature scales allows compact design of the dispensing unit, which is required for portable dispensing units which are used by the patient at home.

In one embodiment at least of one of said first or second cartridges comprises an identifying unit, preferably an electromagnetic identifying unit, for providing at least a medicament identifier associated with said first or second cartridge or at least one medicament profile associated with said first or second cartridge to said dispenser unit. In this embodiment when inserting the cartridge into the dispensing unit, an identifying unit is read by the controller so that information for identifying the medicament in the cartridge is readily available.

In another embodiment said method may further comprise: authenticating a user to said dispending unit using an authentication process, preferably a challenge-response authentication process; starting said release of said medicaments units if said authentication process is successfully executed.

In a further embodiment said first and second cartridges are located in a lockable container compartment in said dispending unit, said cartridges being accessible by providing an input terminal of said dispensing unit with an authorization code.

In yet another embodiment said method may further comprise: receiving a medicament identifier from said identifying unit; associating said a medicament identifier with a medicament profile stored in a memory of said

dispensing unit, said medicament profile comprising

information regarding a medicament contained in a cartridge; checking whether medicaments identified in said prescription are contained in said at least first and second cartridges.

In one variant said first and second cartridge comprise a strip comprising pockets containing at least one medicament unit, wherein said method may further comprise: releasing a medicament unit associated with said first or second cartridge from said pocket by applying a press force on at least part of said pocket.

In another variant said method may further comprise: one or more sensors, preferably a movement sensor, sensing the release of a medicament unit into said dispenser container; and, storing the one or more sensor signals produced by said sensors in a memory.

In yet another variant the method may further comprise: after a release, preferably each release, of a first or second medicament unit, measuring the weight increase of said cartridge; determining whether said weight increase is substantially equal to the weight of said released medicament unit .

In yet a further variant said method may further comprise: correlating said one or more sensing signals with said weight increase of the dispenser container.

In one embodiment said dispensing unit may further comprise at least one input for receiving at least one patho- physiological parameter associated with said user; wherein said method may further comprisge determining on the basis of said parameter the dosage information of each medicament in the medicament prescription associated with said user;

inserting said dosage information into the medical record of said user.

In one embodiment said identifying unit may comprise an electromagnetic identifier or a microchip.

In another embodiment said dispensing unit may comprise a radio card for providing a connection, preferably a wireless connection, to said network server.

In a further aspect, the invention may relate to a dispensing unit, preferably a portable dispensing unit, for dispensing a medicament, comprising: at least a first

cartridge comprising a first medicament strip, said first medicament strip comprising pockets comprising first

medicament units associated with a first medicament and a second cartridge comprising a second medicament strip, said second medicament strip comprising pockets comprising second medicament units associated with a second medicament; a network interface for communicating with a network server; at least one release mechanism, preferably comprising an

actuating member, for releasing a medicament unit from said at least first and second cartridge into a dispenser container; at least one weight balance for monitoring the weight of said cartridge during the process of releasing said calculated number of medicament units; and, a controller configured for: receiving at least a first and second medicament profile associated with said first and second cartridge respectively, each medicament profile comprising information regarding the weight of a medicament unit and the amount of medicament in a medicament unit; receiving from said network server at least one medical record associated with a user of said dispensing unit, said medical record comprising a medicament prescription comprising dosage information associated with said first and second medicament; calculating on the basis of said first and second medicament profile and said medical record, a first number of first medicament units and a second number of second medicament units; releasing said first and second number of medicament units in a dispenser container wherein during said releasing the weight increase of said dispenser container is monitored; and, providing access to medicament units dispensed in said dispenser container if said monitored weight increase of said dispenser container substantially matches the weight associated said medicament units in said dispenser container.

In a further aspect, the invention may relate to a cartridge for use in a dispensing unit as described above, wherein said cartridge may comprise: a storage part for housing a wound medicament strip, said medicament strip comprising pockets comprising at least one medicament unit; a guiding part comprising guiding members for guiding said medicament strip out of said cartridge, said guiding part further comprising a release mechanism comprising a movable press head configured to move downwards and to exert a force onto a pocked such that at least one medicament unit is released from said pocket; wherein when inserted in said dispensing unit said release mechanism is configured to engage with the actuating member of said dispending unit.

The use of multiple re-chargeable medicament

cartridges which may be inserted in the dispensing unit allows a compact design for a dispending unit which is suitable for dispensing multiple different medicaments. Further by using a cartridge with medicament strips, a simple mechanical pressrelease may be used for releasing the medicament units out of the pocket. Such design allows a simple and controllable dispensing process. Moreover, the use of cartridges comprising strips allows easy standardization.

The invention may also relate to a computer program product, the computer program product comprising software code portions configured for, when run by a computer, executing the method as described above. The invention will be further illustrated with reference to the attached drawings, which schematically show embodiments according to the invention. It will be understood that the invention is not in any way restricted to these specific embodiments. Brief description of the drawings

Fig. 1 depicts a schematic of at least part of a medical dispensing system according to one embodiment of the invention .

Fig. 2 depicts a schematic of a cross section of a cartridgecartridge according to one embodiment of the

invention .

Fig. 3A-3D depict schematic of a dispensing unit according to one embodiment of the invention.

Fig. 4 depicts a process of dispensing a medicament according to one embodiment of the invention.

Detailed description

Fig. 1 depicts a schematic of at least part of a medical dispenser system 100 according to one embodiment of the invention. The system may comprise a portable medical dispensing unit 102, which may be configured for use at the patient's location, e.g. at home, the hospital or nursing home. The dispensing unit is configured for dispensing combinations of different medicaments. To that end, the medical dispenser may comprise a storage compartment for receiving a number of cartridges 104, e.g. cartridges, wherein each cartridge is filled with units of one particular

medicament. The medicament unit may have the form of a capsule, a tablet or a pill or the like and each medicament unit may comprise a predetermined amount of medicine, i.e. a pharmacologic active substance. The medicament units may be further packaged in strips, which are inserted in the

cartridge. The cartridge may be provided with an identifying device allowing the dispensing unit to identify the medicament units contained in a particular cartridge.

The dispensing unit further comprises a computer- controlled release mechanism, which may comprise an actuating mechanism controlled by an electromotor for releasing a medicament unit out of a strip into a dispenser container 106. A controller may control and validate the release of the correct number of different medicament units into the

dispenser container. Validation is realized by using one or more sensors, e.g. light or movement sensors which are capable of sensing the release of a medicament unit out of the

cartridge. Further, a weight balance, in particular a

miniature electronic scale, is configured to measure the increase of the dispenser container when a sensor signal signals the release of a medicament unit or a predetermined number of medicament units. The validation process may be executed by the controller, e.g. through the execution of one or more software programs stored in the memory of the

dispensing unit, and is designed to eliminate or at least minimize erroneous and/or incorrect dispensing of combinations of medicaments wherein the dosage of each medicament may vary in time.

The cartridge, the dispensing unit comprising one or more cartridges, the process of dispensing a medicament using such dispensing unit and the advantageous thereof will be described in more detail hereunder with reference to Fig. 2-4.

The controller may comprise an Operating System (OS) comprising a kernel, which manages the resources of the hardware resources associated with the controller e.g. one or more Central Processing Units (CPUs), Input/Output (I/O) devices, a memory (RAM, ROM, (E)EPROM) for storing data associated with the user, the cartridges and program

instructions associated with software applications for

executing the dispensing and validation processes of the dispensing unit and. Further, the OS comprises Application Programming Interfaces (APIs) through which application programs may access a wireless or wired network. The OS of the dispensing unit may execute client software, which uses web sessions based on HTTP and XML type protocols. In

particular, in order to provide secure data exchange between the dispensing unit and the network server the secure socket layer (SSL) protocol and/or Security Assertion Mark-up

Language (SAML) may be used.

The controller may be configured to identify insertion of cartridges into the dispensing unit, to control the release mechanism for releasing medicament units from the cartridges into a dispenser container and to control and process the validation process executed by the validation unit. For example, in one embodiment, if the result of the validation process is positive access to the dispensed

medicament units by means of release of the dispenser

container (a cup or a chalice) is granted. If the validation process is negative, no access to the medicament granted and a warning signal is issued to the network server and/or an authorized healthcare worker.

Further, for executing the processes in the dispensing unit the controller may use medicament profiles associated with the cartridges and medical records associated with the user of the dispensing unit. A medicament profile may comprise a unique medicament identifier associated with a particular medicament, the chemical and pharmacological characteristics and/or composition of a medicament unit, the weight and strength of a medicament unit, the legally required medicament instructions, the date of manufacturing and the perishable date of the medicament, etc.

Similarly, a medical record may comprise a medicament prescription comprising one or more medicament identifiers, the dosage per medicament, the frequency and time schedule with which the medicament needs to be administered by the dispensing unit, the issue date of the prescription, the one or more persons authorized to access and/or modify the data in the medical record, a date at which the medicament

prescription was last modified, one or more medicament

identifiers for identifying medicaments which may not be taken by the user because of medical and/or health reasons e.g.

allergies, and medical and/or physical data associated with the user, e.g. weight, blood type and pressure, cholesterol, etc .

In one embodiment the medicament profile may comprise one or more identifiers associated with contra-indications (e.g. medicaments with which medicaments identified in the prescription may not be combined and/or one or more

identifiers of medicaments with which the medicaments identified in the prescription may only combined within a certain dosage range), side effects, allergies, etc. The dispensing unit or the medicament management server may use this information in the medicament profile and check these medicaments with the prescribed medicaments and/or the prescribed medicament dosages. If the check indicates that an non-allowable combination of medicaments may occur, in

particular that a non-allowable pharmacological cross- interference may occur, the dispensing unit may send a warning message to an authorized person in order to verify the identified problem.

In a further embodiment, the medical record may comprise one or more measuring device identifiers for

identifying measuring devices for measuring one or more pathophysiological parameters, e.g. weight, INR, blood pressure, etc. Further, the medical record may comprise one or more dosage functions associated with said patho-physiological parameters, allowing the controller to determine the dosage of a medicament using the measured parameter as an input

variable .

The measuring device identifier may be used by the controller in order to check whether the measuring device may be connected to the dispensing unit and to provide the

dispensing unit with measured patho-physiological parameters associated with the user in order to determine the correct dosages of medicaments to be dispensed.

The medicament dispenser may be further connected to a user interface 110, comprising e.g. a display allowing displaying of information associated with the medicament processes provided by the dispensing unit and an input device for providing user input to the dispensing unit. Further, a network card 112 may connect the dispensing unit via a network 114 to a medicament management system 116 using a wired or wireless connection. The medicament management system

comprises one or more network servers configured to manage the medicament profiles and the medical records used by the dispensing units, control the authentication procedure for centrally storing data associated with the dispensing process of a dispensing unit in a database. Further, the dispensing unit may be connected via the network card to one or more measuring devices and/or sensors 126 which are configured to measure one or more patho-physiological and/or biological parameters associated with the user of the dispensing unit. Alternatively or in addition, the dispensing unit may be connected to a system for controlling and registering

parenteral medication.

Registration and authentication of a dispensing unit and/or a measuring device to the medicament management system may involve a subscriber identity module (SIM) comprising a private key and a secret encryption algorithm. The SIM may be installed in the dispensing unit as a smart card and may use a private key and a public key to securely encrypt and/or electronically sign data, which are transmitted between the medicament dispensing unit and the network server. This way secure exchange of personal data such as a medical record may be ensured.

The medicament management system may be connected to one or more databases 120,122 for storing medical records, medication profiles and data associated with a dispensing process as executed and monitored by a dispensing unit. The medicament management system may be administered and/or accessed by one or more authorized persons 124, e.g. a physician, a pharmacist or other authorized medical personal. Such authorized person may access the medical record and monitor and change the medicament administration provided by the dispensing unit.

Fig. 2 depicts a cartridge 200 according to one embodiment of the invention in more detail. In particular, Fig. 2 depicts a cartridge comprise a housing 202 for housing medicament units 204 arranged in a medicament strip 206. Each cartridge may comprise a storage part 208 for storing the medicament strip, which may be wound around an axis 210. The medicament strip may comprise pockets 212 comprising

medicament units and guiding members 214 located between the pockets. One end of the medicament strip may lead towards a guiding part 216 for guiding the medicament strip out of the container. When inserting the cartridge into the dispensing unit a driving mechanism (not shown) in the dispensing unit may mechanically engage with the spool axis and/or one or more guiding wheels 218 of the cartridge so that the strip may controllably moved through the guiding area.

The guiding part of the cartridge may further comprise a spring-press mechanism comprising a press-head 220 and positioning members 222. In order to dispense a medicament unit into a dispenser container, a pocket of the medicament unit is positioned underneath the press-head. The press head and positioning members are configured to move downwards towards the pocket and the guiding members respectively. The press head and the positioning members may be configured to move relative to each other such that when pressed down by an actuator, the positioning members will be pressed onto the guiding members thereby setting the medicament strip in a fixed position and so that thereafter the press-head may securely release the medicament unit out of the pocket by a pressing action. After release of the medicament unit, the actuator retracts and the press-head and the positioning members are moved back to their original position by means of a spring mechanism.

Information about the medicament cartridge and/or the medicament units stored in the medicament cartridge may be provided by an identifying unit 224 attached to the medicament cartridge. The identifying unit may be an electro-magnetical (EM) identifier. In one embodiment, the EM identifier may comprise an electrical component such as resistor wherein the resistance value may be associated with medicament profile. In another embodiment, the EM identifier may comprise a memory comprising medicament information associated with the

cartridge .

Once the medicament strip is finished, authorized personal may remove the cartridge from the dispensing unit and refill the cartridge with a new strip.

Fig. 3A-3D depict schematics cross-sections and a front- and back view of at least part of a dispensing unit according to one embodiment of the invention. Fig. 3A depicts a schematic of a cross-section of a dispensing unit comprising cartridges 304 inserted into a compartment formed in the housing 302 of the dispensing unit. The insertion of

cartridges into the dispensing unit is further depicted in

Fig . 3B (cross section) and Fig . 3C (back side) . A storage compartment 301 for housing multiple cartridges 304i_₄ is designed such that the cartridge tightly fits into the storage compartment. Hence, the use of multiple re-chargeable

medicament cartridges which may be inserted in the dispensing unit allows a compact design for a dispending unit which is suitable for dispensing multiple different medicaments.

As shown in Fig . 3A, when inserted into the storage compartment, the release mechanism 320,322 of a cartridge engages with an actuating member 328, which may be moved by an actuator 330. In one embodiment, the release mechanism

comprises a spring-press mechanism, comprising a press-head 320 and positioning members 322 as described with reference to Fig . 2.

The actuator is controlled by the controller 326 and may move the actuating member downwards onto the release mechanism so that a medicament unit may be released from the pocket of the medicament strip into the dispenser container 332. Further, the actuating member may comprise a cutting member 334 for cutting the end of strip. The pieces of the medicament strip may be assembled by a waste container 336.

When moving downwards the cutting member extends a downwards force onto the medicament strip (without actually cutting the strip) such that the strip is pulled downwards over the guiding wheel. Due to this downwards pulling action the strip will be pulled over some length out of the cartridge such that a pocket comprising a medicament unit is positioned underneath the press-release mechanism. At the moment the pocket is correctly located underneath the press-release mechanism, the positioning member will make contact with the guiding members of the medicament strip such that the position of the strip is fixed and such that the press head, which is pressed down by the actuator member, may release the

medicament unit from the pocket. Due to the fixation of the strip by the guiding members, the cutting member associated with the actuator member may cut a piece from the end of the strip .

In other embodiment, the positioning of a pocket comprising a medicament unit underneath the spring-release mechanism, the release of the medicament unit and the cutting of the end of the strip may be realized in separate phases.

Hence, by using a cartridge with medicament strips, ; simple mechanical press-release may be used for releasing the medicament units out of the pocket. Such design allows a simple and controllable dispensing process. Moreover, the use of cartridges comprising strips allows easy standardization.

When inserting the medicament cartridge into the dispensing unit, the identifying unit of the medicament cartridge may contact an interface 338 allowing the controller of the dispensing unit to read the information from the identifying unit. For example, the interface may contact the identifying unit for reading the impedance of a passive electrical circuit, e.g. a resistor. Other ways of reading information from the cartridges may include a bar code reader or other known types of electromagnetic readers such as an RFID tag. The controller may associate the resistance value with a medicament profile stored in the memory of the

dispensing unit. A resistive medicament identifier is simple and cheap and may be advantageously used when the cartridge is designed as a disposable cartridge.

Alternatively, the interface may contact the memory in the identifying unit, e.g. an RFID tag, and directly read a medicament profile from it. An authorized health care worker may store the medicament profile into the identifying unit during the filling of the cartridge. This way a medicament profile may be unambiguously associated with medicament units in the medicament cartridge. The use of a memory comprising a medicament profile also allows information like the

preparation date of the medicament units in the cartridges to be incorporated into the medicament profile or the number of medicament units in the container such that the dispensing unit may determine when a container needs to be replaced. An identifying unit with a memory comprising the medicament profile may be advantageously used when the cartridge is designed to allow refill and reuse.

Hence, when inserting the medicament cartridges into the storage compartment, the controller may identify the associated medicament profiles, which may be viewed by a user through a user interface 305, e.g. a touch screen or the like, as depicted in Fig. 3D (schematic front view of the dispensing unit) . In one embodiment, the entrance to the storage

compartment comprising the cartridges may be locked and only accessible for authorized persons, e.g. a pharmacist and/or physician. The storage compartment may be locked through a suitable entrance code or the like. If an unauthorized person is trying to gain access to the storage compartment, the dispensing unit may disable itself and/or may send a warning message to the medicament management system monitoring the medicament administration process.

The dispensing unit further comprises one or more sensors 340 for detecting the release of a medicament from the pocket of a medicament strip and a weight balance 342, in particular a miniature digital balance, for monitoring the release of the different medicament units from the different cartridges into the dispenser container 336. The sensor may be a light sensor or a movement sensor for generating a sensor signal if a released medicament unit passes the sensor. Such sensor signal should be necessarily followed by a

predetermined weight increase of the cartridge, which may be detected by the weight balance. Typical oral medicament units have a weight within the rang of approximately 50-500 mg, typically 100-500 mg, so that the weight balance should be capable of measuring weights within a range of between 5 and 10 grams with a precision of around 50-10 mg or less,

preferably around 2-1 mg. Electronic miniature scales with such specifications are readily available and allowing compact design of the dispensing unit, which is required for portable dispensing units which are used by the patient at home.

During the dispensing process, the controller may correlate the actuator control, the sensor signals and the weight information in order to accurately determine whether the correct medicament units are dispensed. In particular, when the movement of the actuator has resulted in the release of medicament unit out of the pocked of the medicament strip, a sensor signal, e.g. a movement sensor signal, should be signaled and a weight increase of the medicament cup

substantially equal to the weight of the medicament unit should be sensed by the electronic weight balance. Combining a sensor signal and the correct weight increase provides a very reliable verification process of the individual medicament dispensing steps of the dispensing process. Further, the filling of the cartridge may be monitored by a camera in order to acquire visual images which may be stored and used for insurance or other controlling purposes.

In a further embodiment, the dispensing unit also comprises a clock for timing the dispensing process. The clock allows the controller to associate a time to the various actions in the dispensing process (e.g. the controller signal to the actuator to initiate the release of a medicament unit, the sensor signal and the weight signal) . If the controller initiates a dispensing action, the sensor signal and the weight increase measured by weight balance should appear within predetermined time windows, which are stored in a memory of the dispensing unit. If these actions do not appear within the predetermined time windows, the controller may decide that the dispensing process is not correctly executed so that access to the dispenser container may be denied and an authorized person may be warned. The use of the clock for timing the actions in the dispensing process thus further improves the safety of the dispensing process.

The dispensing unit may be programmed to administer medicaments according to a predetermined formulation and time schedule associated with the medicament in the cartridges. To that end, at least part of a medical record associated with a patient may be stored in the memory of the dispensing unit. The medical record contains all information necessary for instructing the dispensing unit to dispense predetermined numbers of medicament units of each cartridge as required by the prescription associated with the user.

Fig. 4 depicts a dispensing process 400 according to one embodiment of the invention. In this example, an

authorized person, e.g. a health care worker, may access the network server comprising the medical records of the users of the dispensing units in order to retrieve the medical record associated with a user of a dispensing unit and to store the medical record into the memory of the dispensing unit.

Further, the authorized person may prepare a number of

medicament cartridges on the basis of the prescription in the medical file. For example, a prescription may instruct the authorized person to insert five cartridges comprising

medicament units A, B, C, D and E respectively into the lockable storage compartment of the dispensing unit (step

402) .

Using the identifying units associated with the cartridges and the prescription information in the medical record stored in the memory of the dispensing unit, the controller may check whether the correct cartridges are inserted into the dispensing unit (step 404) . If the

controller affirms installation of the correct cartridges, it allows the authorized person to activate the dispensing unit to dispense the medicament units according to the time table and the dosages as defined in the prescription. The user may then use the activated portable dispensing unit at home or wherever the location is, e.g. hospital, holiday address, nursing home, hospital, etc.

For example, the stored prescription may prescribe administration of a combination of medicaments every day at 9:00 AM comprising: 2 units of medicament A, 1 unit of

medicament B; no units of medicament C; no units of medicament D; and 3 units of medicament E. To that end, the controller of the dispensing unit may contact the network server at a predetermined time, e.g. 8:45 AM, to verify whether the prescription in the stored medical record is still up-to-date.

To that end, before dispensing the medicament units, the controller of the dispensing unit may send an update request to the medicament management system in order to retrieve the most recent medical record (step 406) so that changes in the dosage and/or other changes in the prescription may be taken into account when dispensing the prescribed medicaments. If the controller determines on the basis of the retrieved medical record that the prescription has been modified, it may check whether the correct cartridges have been inserted into the dispensing unit. Further, in one embodiment, it may calculate for each modified dosage, the number of medicament units to be released. In order to check authenticity of the adjusted prescription, the medical record may be digitally signed by an authorized health care worker using a digital certificate.

Then, at 9:00 AM the dispensing unit may start the dispensing process by warning the user, e.g. using a light indicator, a pager, buzzer or a text message for a mobile phone. Before initiating the process, the user is requested to identify himself to the dispensing unit (step 408) . The authentication may include the use of a biometrical

authentication process, e.g. fingerprint authentication and/or iris recognition. Alternatively and/or in addition

authentication may require a challenge-response authentication by using e.g. a smart card.

Successful authentication may initiate the dispensing process (step 410) . First the controller may check whether the initial weight of the dispenser container corresponds to the predetermined weight of a standard dispenser container for use with the dispensing unit (step 411) . If this is the case, it may initiate a release of a first medicament unit A. After activating the release mechanism of cartridge A, a medicament unit may be released from its pocket. The movement of the released medicament unit may be detected by movement sensor, in particular a light detector, which generates a sensor signal when the medicament unit passes through the sensing area of the sensor (step 412) . The sensor signal may trigger the monitoring of the weight increase of the dispenser

container by the electronic weight balance (step 414) . If the controller determines that the weight increase is substantially equal to the weight associated with medicament unit A as specified in the medicament profile or, at least within a predetermined range as defined in the medicament profile, the controller may confirm correct release of the first medicament unit A into the dispenser container (step 414). The controller may store the measured parameters (sensor signal, measured weight) into its memory.

In one embodiment (not shown) , the controller may use a clock in the dispensing unit in order to measure the time between the activation of the release mechanism, the

generation of the sensor signal and the weight signals

associated with detection of the weight increase. If these measured times are outside predetermined time windows, the controller may decide that the dispensing mechanism is not correctly executed. In that case it may send a warning message to the medicament management system.

The process may be repeated for the release of the second medicament unit A. When the controller confirms that two medicament units A are correctly dispensed, it may allow the user access to the dispenser container and instruct the user to take the medicament (step 416) . Thereafter the

dispensing unit monitors the medicine adherence. In one embodiment the weight balance may monitor whether the

cartridge is taken out of the dispensing unit and that an empty cartridge is placed back (step 418) . Alternatively, a separate sensor at the location of the cartridge may provide a sensor signal that the cartridge is taken out of the

dispensing unit.

Such monitoring may provide an indirect indication that the medicaments are taken by the user. Full medicine adherence monitoring may be realized by the use of a webcam coupled to the dispensing unit which actually films the user taking the medicaments. The adherence data generated by the webcam may be sent to the medicament management system for storage so that authorized persons are able to check the patient's medicine adherence. The steps 411-418 may be repeated for the release of the further medicament units B and E from cartridge in

accordance with the prescription.

Hence, by monitoring different parameters during the release of the different medicament units, errors - especially human errors - in the administration of a plurality of

medicaments may be eliminated or at least greatly reduced. The process may easily and safely deal with variations of the dosage and/or variations in different medicament units.

Moreover, the simple press-release mechanism may substantially reduce the involvement of the patient or health care workers in preparing the medicament combinations.

In further embodiments, the dispensing process may include sequentially releasing all medicament units into the cartridge before access to the dispenser container is granted. Correct release of the different medicament units is validated using the senor signals, measuring the weight increase after each release (or after the release of a predetermined number of medicament units) and determining whether the weight increase is substantial similar to the weight of the released medicament unit. Alternatively and/or in addition, after the release of all medical units the total weight increase of the dispenser container may be weighted and checked with the total weight of the different medicament units associated with the prescription. In additional during the process also the time the time required for releasing a medicament unit into the dispenser container may be used to check correct release of the different medicament units.

Hence, monitoring the weight increase of the dispenser container during the dispensing process allows validation of a dispensed medicament unit by matching the weight increase with the (known) weight of the medicament unit. This way, errors in the dispensing process may be significantly reduced.

In yet a further embodiment, the dispensing unit as depicted in Fig. 3 may comprise at least one communication interface 344 for coupling one or more measuring devices and/or sensors 346 which are configured to measure one or more patho-physiological and/or biological parameters associated with the user of the dispensing unit. The interface may be configured to provide a wired or wireless connection. The measured patho-physiological and/or biological parameters may be used by the dispensing unit in order to determine the correct dosages to be dispensed.

For example, in one embodiment, one patho^¬ physiological parameter may relate to the International Normalized Ratio (INR) for measuring the clotting tendency (coagulation) of blood. The dosage associated with anticoagulation medicines, in particular Vitamin K antagonizing anticoagulation medicines, like acenocoumarol or fenprocoumon or warfarin, may be adjusted to on the basis of the INR. As the INR of a patient may vary strongly in time, it is very important to determine the dosage of such anti-coagulation medicines on the basis of recently determined INR values of the patent.

In yet a further embodiment, the interface 344 may also be configured connect to parenteral administration devices for monitor and/or control parenteral medicine intake of a user, e.g. injections, puffs, infusion fluids.

The INR may be determined near the patient location using an electrical measurement device coupled to the dispensing unit. One known measuring device configured for measuring coagulation of a blood sample is for example described in WO0006761. Such measuring device may be coupled to the interface 344 of the dispensing unit using for example a wireless connection, e.g. a Bluetooth or the like, or a wired connections, e.g. a USB connection.

In case the INR value is estimated in a hospital laboratory this value may be inserted by an authorized person into the medical record which can be retrieved by the

dispensing unit upon initiation of a dispensing process.

Before transmitting a measured parameter to the controller, the controller may request authentication of the measuring device and the user of the measuring device to both the controller and the medicament management system. The authentication may require transmission of a sensor identifier, which may be checked with one or more sensor identifiers in the medical record. The authentication process may be similar to the one used by the dispensing unit for registration and authentication to the medicament management system.

After successful authentication, the user may initiate the measuring device to measure the INR and to send the measured INR to the controller. Other patho-physiological parameters may also be provided to the dispensing unit using suitable measuring devices which may be used by the patient and coupled the dispensing unit in a similar way.

In one embodiment, the controller receiving the measured parameters, may check the medical record and/or medicament profile in order to verify whether the measured parameter is within a allowable range in which the dosages of the medicaments may be administered to the user. If the measured parameter falls outside the allowable range, then one or more dosages of the prescribed medicaments may require adj ustment .

To that end, in one embodiment, the controller may send the one or more measured parameters to medicament management server, which may comprise a dosage adjustment function. The dosage adjustment function may calculate on the basis of the measured parameter, e.g. the INR value, and the information in the medical record one or more adjusted dosages of the prescribed medicaments and the amounts of medicaments units associated with these adjusted dosages. The controller may then send the adjusted dosages via the medicament

management server to a terminal of an authorized person who may check the adjusted dosages and authorize the dispensing unit to dispense the medicaments on the basis of the adjusted dosages. Further, the adjusted dosages may be stored in the medical record of the user.

Alternatively, the controller may directly forward the one or more measured parameters to an authorized person who may determine the correct dosages associated with the measured parameters, store the adjusted dosages in the medical record of the user and authorize the dispensing unit to dispense medicaments on the basis of the adjusted dosages.

The use of patho-physological parameters obtained by measuring devices coupled to the dispensing unit may be incorporated in the dispensing process as described with reference to Fig. 4. In one embodiment, after having retrieved the most recent medical record of the user, the dispensing unit instructs the user to provide one or more current patho- physicolgical parameters obtained by a measuring device coupled to the dispensing unit. Thereafter, the controller may send the measured parameters to the medicament management server or to an authorized person and receive dosages which are adjusted according to the measured parameters.

It is to be understood that any feature described in relation to any one embodiment may be used alone, or in combination with other features described, and may also be used in combination with one or more features of any other of the embodiments, or any combination of any other of the embodiments. One embodiment of the invention may be

implemented as a program product for use with a computer system. The program(s) of the program product define (s) functions of the embodiments (including the methods described herein) and can be contained on a variety of computer-readable storage media. Illustrative computer-readable storage media include, but are not limited to: (i) non-writable storage media (e.g., read-only memory devices within a computer such as CD-ROM disks readable by a CD-ROM drive, flash memory, ROM chips or any type of solid-state non-volatile semiconductor memory) on which information is permanently stored; and (ii) writable storage media (e.g., floppy disks within a diskette drive or hard-disk drive or any type of solid-state random- access semiconductor memory) on which alterable information is stored. Moreover, the invention is not limited to the

embodiments described above, which may be varied within the scope of the accompanying claims.

Claims

1. Method for dispensing medicaments using a dispensing unit, preferably a portable dispensing unit, configured for communicating with a network server, said dispending unit comprising at least a first cartridge

comprising first medical units associated with a first

medicament and a second cartridge comprising second medical units associated with a second medicament and an electronic weight balance for detecting the release of said medical units, said method comprising:

receiving at least a first and second medicament profile associated with said first and second cartridge respectively, each medicament profile comprising information regarding the weight of a medicament unit and the amount of medicament in a medicament unit;

receiving from said network server at least part of a medical record associated with a user of said dispensing unit, said medical record comprising a medicament prescription comprising dosage information associated with said first and second medicament;

calculating on the basis of said first and second medicament profile and said at least part of a medical record, a first number of first medicament units and a second number of second medicament units;

releasing said first and second number of medicament units in a dispenser container wherein during said releasing the weight increase of said dispenser container is monitored; and,

providing access to medicament units dispensed in said dispenser container if said monitored weight increase of said dispenser container substantially matches the weight associated with said medicament units in said dispenser container .

2. Method according to claim 1, wherein at least of one of said first or second cartridges comprises an

identifying unit, preferably an electromagnetic identifying unit, for providing at least a medicament identifier

associated with said first or second cartridge or at least one medicament profile associated with said first or second cartridge to said dispenser unit.

3. Method according to claim 2, wherein said method further comprises:

authenticating a user to said dispending unit using an authentication process, preferably a challenge-response authentication process; starting said release of said

medicaments units if said authentication process is

successfully executed.

4. Method according to any of claims 1-3, wherein said first and second cartridges are located in a lockable container compartment in said dispending unit, said cartridges being accessible by providing an input terminal of said dispensing unit with an authorization code.

5. Method according to any of claims 2-4, wherein said method further comprises:

receiving a medicament identifier from said identifying unit;

associating said a medicament identifier with a medicament profile stored in a memory of said dispensing unit, said medicament profile comprising information regarding a medicament contained in a cartridge;

checking whether medicaments identified in said prescription are contained in said at least first and second cartridges .

6. Method according to any of claims 1-5, wherein said first and second cartridge comprise a strip comprising pockets containing at least one medicament unit, said method further comprising: releasing a medicament unit associated with said first or second cartridge from said pocket by applying a press force on at least part of said pocket.

7. Method according to any of claims 1-6, wherein said method further comprises:

one or more sensors, preferably a movement sensor, sensing the release of a medicament unit into said dispenser container; and' '

storing the one or more sensor signals produced by said sensors in a memory.

8. Method according to any of claims 1-7, the method further comprising:

after a release, preferably each release, of a first or second medicament unit, measuring the weight increase of said cartridge;

determining whether said weight increase is substantially equal to the weight of said released medicament unit .

9. Method according to claim 8, wherein said method further comprises:

correlating said one or more sensing signals with said weight increase of the dispenser container.

10. Method according to any of claims 1-9, wherein said dispensing unit further comprises at least one input for receiving at least one patho-physiological parameter

associated with said user;

determining on the basis of said parameter the dosage information of each medicament in the medicament prescription associated with said user;

inserting said dosage information into the medical record of said user.

11. Method according to any of claims 1-10, wherein said identifying unit comprises an electromagnetic identifier or a microchip.

12. Method according to any of claims 1-11, wherein said dispensing unit comprises a radio card for providing a connection, preferably a wireless connection, to said network server .

13. A dispensing unit, preferably a portable dispensing unit, for dispensing a medicament, comprising:

at least a first cartridge comprising a first medicament strip, said first medicament strip comprising pockets comprising first medicament units associated with a first medicament and a second cartridge comprising a second medicament strip, said second medicament strip comprising pockets comprising second medicament units associated with a second medicament;

a network interface for communicating with a network server;

at least one release mechanism, preferably comprising an actuating member, for releasing a medicament unit from said at least first and second cartridge into a dispenser

container;

at least one weight balance for monitoring the weight of said cartridge during the process of releasing said

calculated number of medicament units; and,

a controller configured for:

receiving from said network server at least one medical record associated with a user of said dispensing unit, said medical record comprising a medicament prescription comprising dosage information associated with said first and second medicament; calculating on the basis of said first and second medicament profile and said medical record, a first number of first medicament units and a second number of second

medicament units;

providing access to medicament units dispensed in said dispenser container if said monitored weight increase of said dispenser container substantially matches the weight associated said medicament units in said dispenser container.

14. A cartridge for use in a dispensing unit according to claim 13, said cartridge comprising:

a storage part for housing a wound medicament strip, said medicament strip comprising pockets comprising at least one medicament unit;

a guiding part comprising guiding members for guiding said medicament strip out of said cartridge, said guiding part further comprising a release mechanism comprising a movable press head configured to move downwards and to exert a force onto a pocked such that at least one medicament unit is released from said pocket;

wherein when inserted in said dispensing unit said release mechanism is configured to engage with the actuating member of said dispending unit.

15. A computer program product, the computer program product comprising software code portions configured for, when run by a computer, executing the method according to any of claims 1-13.