EP1016399A2 - Method for assisting the dispensing of drugs according to a medical prescription and device for performing this method - Google Patents

Abstract

Medicine e.g. tablets is placed into compartments (6) of package (2), covered by a film (7) and parameters of patient and use are computer printed on the side (3). The package (2) is placed inside a distributor (4) with a data viewing window (5) and doors (8) which allow the film (7) to be removed and the medicine accessed. Door operation is monitored remotely and may set off a local audible alarm

Description

The present invention relates to an assistance method, for administration of medication according to a prescription medical, not requiring the intervention of the patient and avoiding any false manipulation on the part of the latter, so as to allow the execution of his treatment at his home, without risk of error.

Surveillance networks currently exist, particularly for elderly people, who include a local power plant that can generate a call to qualified personnel or a family member, in particular response to an alarm issued by the elderly person in question from his home. For this, it is sufficient for the latter to actuate a mounted button on a case that she wears on her, for example, as a pendant or wrist.

In known manner, this box contains a signal generator, which thanks to a wireless link, acts on the control unit which transmits the signal to a base station.

Using such a monitoring network, it is also possible remotely monitor different parameters of a patient such as example, temperature, number of heartbeats, etc.

In this context, the plaintiff described in her request for French patent n ° FR / 97 05 547 an activity monitoring device a person to detect a possible fall in view of him rescue. All these systems provide real assistance to the elderly person, disabled person, or simply a patient recovering, but needed to be supplemented by a assistance system for drug administration allowing to help those concerned to take their medication properly quantity and at the right time as prescribed by the doctor. In fact, the method and device according to the invention are intended to reduce the possible errors in how to take these medicines, and also to avoid the risk of errors during the preparation of doses of these drugs.

• Etape I. f Préparation préalable d'une/des doses médicamenteuses, effectuée en officine par un pharmacien, en référence à une ordonnance établie par un médecin.f Programmation et mise en mémoire sur ordinateur des paramètres d'identification concernant le patient (nom, adresse, code sécurité sociale) et la préparation correspondant à la médication prescrite (nom des médicaments, posologie, horaire des prises).
• Etape II. f Insertion des doses dans un élément de conditionnement, scellé ensuite.f Transcription desdits paramètres sur un support d'enregistrement intégré à l'élément de conditionnement avant remise au patient ou au personnel médical.
• Etape III. f Intégration du conditionnement dans une unité distributrice programmable, initialement verrouillée et déverrouillable, manuellement ou automatiquement, pour la délivrance des doses médicamenteuses en fonction des paramètres qui sont stockés en mémoire dans le support d'enregistrement du conditionnement et identifiés par l'unité distributrice par tout moyen de lecture, au moment de leur association.

To this end, the present invention relates to a method of assistance for the administration of drugs in accordance with a medical prescription, not requiring the intervention of the patient and avoiding any false manipulation on the part of the latter, so as to allow the execution of his treatment at his home, without risk of error, characterized in that it comprises the following stages:

• Step I. f Prior preparation of a drug dose (s), carried out in pharmacies by a pharmacist, with reference to a prescription drawn up by a doctor. f Programming and storing on the computer of the identification parameters concerning the patient (name, address, social security code) and the preparation corresponding to the prescribed medication (name of the drugs, dosage, dosing schedule).
• Stage II. f Inserting the doses into a packaging element, then sealed. f Transcription of said parameters on a recording medium integrated into the packaging element before delivery to the patient or medical staff.
• Stage III. f Integration of the packaging into a programmable dispensing unit, initially locked and unlockable, manually or automatically, for the delivery of drug doses according to the parameters which are stored in memory in the recording medium for the packaging and identified by the dispensing unit by any means of reading, at the time of their association.

The invention also relates to a device for setting work of this process.

The present invention also relates to the features which will emerge during the description which follows and which should be considered in isolation or in all their technical combinations possible.

• La figure 1 est un schéma synoptique d'un dispositif d'assistance à la prise de médicaments selon l'invention.
• La figure 2 est une vue en perspective éclatée d'un élément de conditionnement des médicaments et d'une unité distributrice associée.

This description, given by way of nonlimiting example, will make it easier to understand how the invention can be produced with reference to the attached drawings in which:

• FIG. 1 is a block diagram of a device for assisting in taking medication according to the invention.
• Figure 2 is an exploded perspective view of a drug packaging element and an associated dispensing unit.

The assistance process for the administration of drugs according to a medical prescription is schematically illustrated in Figure 1.

• un élément de conditionnement 2 dans lequel un pharmacien dispose au moins une dose médicamenteuse ayant fait l'objet d'une préparation préalable effectuée par lui-même en officine en référence à une ordonnance établie par un médecin, ledit conditionnement 2 étant ensuite hermétiquement scellé en vue de sa remise au patient ou à un personnel médical.
• un support d'enregistrement 3 lié à l'élément de conditionnement 2, et dans lequel sont transcrits tous les paramètres d'identification concernant le patient : nom, adresse, code sécurité sociale, etc. et la préparation correspondant à la médication prescrite : nom des médicaments, posologie, horaire des prises, etc.
• une unité de distribution 4 programmable, initialement verrouillée et déverrouillable, manuellement ou automatiquement, pour la délivrance d'une/des doses médicamenteuses en fonction des paramètres en mémoire dans le support d'enregistrement 3 de l'élément de conditionnement 2.
• des moyens d'identification et de lecture 5 desdits paramètres liés à l'unité de distribution 4 et activés au moment de son association avec l'élément de conditionnement 2 des doses médicamenteuses à administrer.

The invention also relates to a device for implementing the above-mentioned method which consists (see FIG. 2) of the following elements:

• a packaging element 2 in which a pharmacist has at least one medicinal dose which has been the subject of a prior preparation carried out by himself in pharmacies with reference to a prescription drawn up by a doctor, said packaging 2 then being hermetically sealed in view of its delivery to the patient or medical personnel.
• a recording medium 3 linked to the packaging element 2, and in which all the identification parameters relating to the patient are transcribed: name, address, social security code, etc. and the preparation corresponding to the prescribed medication: name of the medication, dosage, schedule, etc.
• a programmable distribution unit 4, initially locked and unlockable, manually or automatically, for the delivery of one or more medicinal doses as a function of the parameters stored in the recording medium 3 of the packaging element 2.
• means for identifying and reading 5 said parameters linked to the distribution unit 4 and activated at the time of its association with the conditioning element 2 of the drug doses to be administered.

According to a nonlimiting exemplary embodiment, the element of packaging 2 and the distribution unit 4, shown in FIG. 2, are more particularly intended to contain medicinal doses in the form of tablets.

Of course, these elements could be adapted to contain liquid, powdered or other medicines.

According to this example therefore, the conditioning element 2 is consisting of a container subdivided into a plurality of compartments 6, in each of which are previously placed the tablet (s), corresponding to a given medication intake, to be ingested by the patient according to a dosage, from one hour and during an interval predetermined.

In fact, the container constituting the packaging element 2 may be a compartmentalized drawer of generally parallelepiped shape.

This is preferably made of plastic. The number of compartments and their size can be clearly understood very variable, depending on the number of drugs corresponding to the prescribed medication, and the duration of treatment.

As an indication, the volume of the assembly can be, for example, 2 cm ³ .

One can also provide a disposable distribution assembly to single use but it is not excluded either a reuse of the distributor by bringing it back to the pharmacist for a new use, by example, for further processing.

According to another characteristic of the invention, the drawer compartmentalized, constituting the packaging element 2, is covered by a hermetically sealed plastic film 7, possibly transparent at least on top.

According to a particular embodiment, the compartmentalized drawer has no bottom, the plastic film 7 completely surrounding it for constitute upper and lower walls for closure and protection can be destroyed at the time of taking, by means localized pullout 8.

According to another exemplary embodiment, the bottom of the compartments (possibly their upper and lower parts) consists of a door, which is actuated by an opening mechanism, thereby releasing drugs from below, and which returns to its starting position after drug release.

With regard to the distribution unit 4, this is made up by a receptacle of shape corresponding to that of the element of packaging 2 forming a drawer so as to allow, once filled with predetermined drug doses and wrapped in protective film 7, housing thereof by sliding, said receptacle 4 comprising at less on its upper or lower face as many openings 9 as there are compartments in the packaging element 2; said openings being arranged opposite the compartments, so as to allow the taking from a predetermined compartment 6 of a dose of medication to be taken, this by tearing off the protective film 7 finding opposite both the opening 9 considered of the receptacle 4 and the corresponding compartment 6.

According to another variant, the distribution unit 4 can be provided, in its lower part, a recovery / distribution element (not shown), whose function is to recover the doses from compartments and allow easy distribution to the patient. This recovery / distribution element can be fitted with a door automatic or manual unlocking.

The distributor 4 has a front door, possibly having a key which is closed after introduction of the element conditioning 2.

According to a preferred embodiment, the means tearing 8 of the protective film 7 of the receptacle constituting the unit of distribution 4 consist of doors, which can be operated manually or automatically, arranged in the openings 9 of said receptacle 4 and capable of being articulated with respect to one of the sides thereof so that in selectively pushing them inwards, they cause tearing of the upper and / or lower faces of the film 7 surrounding the compartments 6 of drawer 2, thus releasing the dose of medicine contained in a compartment 6 considered.

In fact, the doors 8 of the distribution unit 4 can be actuated, according to a pre-established IT procedure so as to ensure the locking or unlocking of said doors 8 in a chosen order and according to pre-established time periods recorded in said recording medium 3, and managed by an electronic clock.

In the case of a distribution unit 4 provided with doors lower and upper, lower and upper doors corresponding to the same compartment can be coupled mechanically.

According to another characteristic of the invention, the doors 8 include automatic return means to their initial position, having the effect of reactivating the closing function ensuring their conviction.

We can also imagine a system where a button single command enables action on all doors 8, one only one, the good one, then opens to release the drugs. We can also imagine one button per door, only the button on the good door that can activate it.

Also, computer programming includes a function recognition of a single user.

Computer programming includes a function of unlocking, at a predetermined time T, of one of the doors 8 of the dispenser 4 corresponding to a compartment 6 containing the dose to take this instant T, the other compartments 6 remaining locked.

According to another characteristic of the invention, an alarm signal acoustic and / or luminous and / or radio is emitted in order to attract the attention of the patient or distant medical personnel, in the case of an error made or in the case of forgetting to take drug.

Figure 1 shows, in a block diagram, the method of the invention and the means for its implementation.

This is how we see in this figure 1 a whole element of packaging 2 - distribution unit 4; doors 8, able to articulate inside compartments 6, being represented by switches 10.

The position of the switches 10 testify to the opening or closing a door 8; they can optionally be ordered from distance by radio according to a preset schedule.

At the end of the time window during which the drug must be taken, the system is able to recognize if the operation the corresponding door has been opened or not. This recognition is ensured by the processing unit 11, from the information recorded in the recording medium 3, information on the position of the doors (information given by the switches 10) and real time provided by an internal clock making, for example, part of said processing unit 11. If the operation door opening was not carried out, an alarm signal is generated by the alarm generator 17 and is transmitted to a local central (by apartment) 19 via a transmission circuit 18 and a link radio. The central apartment unit then calls on an external service provider who gets in touch with the patient. The external speaker has the right to report to the patient, by telephone or any other means, his forgetfulness or to intervene, remotely, to unlock, by radio information 20, the doors that should have been opened, allowing the patient to take his medicine. The system could allow other sequences such as, for example, automatic unlocking after a certain period of time. However, preference will be given to the safety of drug intake and its control by a external speaker. It can also be provided that, prior to the transmission to the outside of an alarm signal, the processing unit 11 sends a control signal to a generator 13, which then generates a warning signal intended for a transducer 14, which can be, depending on the case, optical or acoustic type. This warning signal has to attract the patient's attention and allow him to repair his forgetfulness.

Of course, the patient can trigger the alarm himself by the alarm generator 17 by actuating a control button 15 which will control circuit 16. This possibility therefore allows the patient to alert the external speaker for a telephone contact or any other action later.

The assistance device which has just been described can be produced at using discrete or modular circuits or components, but preferably it will be based on the use of a microprocessor suitably programmed.

• Le personnel médical, ou éventuellement l'utilisateur lui-même s'il dispose d'une autonomie suffisante, introduit l'élément de conditionnement 2 dans le distributeur 4, et ferme la porte frontale éventuellement à clé. De cette manière, chaque compartiment 6 se trouve en vis-à-vis d'une porte 8, dont l'ouverture peut être faite à l'aide d'un doigt, mais sous le contrôle du programme enregistré comme il a été vu ci-dessus.

The operation of the system which has just been described, for use at home, is as follows:

• The medical staff, or possibly the user himself if he has sufficient autonomy, introduces the packaging element 2 into the dispenser 4, and closes the front door possibly with a key. In this way, each compartment 6 is located opposite a door 8, the opening of which can be made using a finger, but under the control of the program recorded as has been seen below. -above.

• L'information synthétisée dans le support 3 est traitée par des moyens 5 de lecture des paramètres du support d'enregistrement de l'unité de distribution sécurisée 4.

After this introduction, the medium 3 for recording the parameters is read by the distributor, and the contact details of the user are verified. If an error occurs, an acoustic message is emitted and the system is blocked. In the case of the radio link option, a message is sent to the base for checking.

• The information synthesized in the medium 3 is processed by means 5 for reading the parameters of the recording medium of the secure distribution unit 4.

• Lorsque l'élément de conditionnement 2 est introduit dans le distributeur 4, toutes les portes 8 des compartiments 6 sont fermées.
• Le plan de médication indique pour chaque période de prise, le numéro du compartiment contenant les médicaments qui doivent être pris durant cette période (par exemple le médicament contenu dans le compartiment X doit être pris entre 11 heures du matin et 1 heure de l'après-midi).
• Pour chaque période de prise, un signal acoustique est émis dans le but d'attirer l'attention de l'utilisateur sur la nécessité de prendre son médicament. Pour la version avec le lien radio, ce signal est relayé par la centrale d'alarme externe. De plus, la fermeture de la porte 8 correspondant au compartiment désigné est relâchée, donc ladite porte peut être ouverte, et un indicateur visuel est activé (par exemple un indicateur lumineux sur le devant de la porte clignote).
• L'utilisateur est donc apte à pousser la porte 8, le film plastique de protection 7 est percé, et/ou la porte du fond des compartiments est actionnée, et les médicaments tombent dans l'autre main du patient, prêts à être absorbés.
• La porte de dessus (et celle du fond, si elle existe) est ensuite repoussée et revient automatiquement dans sa position initiale, par exemple à l'aide d'un ressort, la fermeture est ensuite réactivée et la porte 8 bloquée.
• Entre les temps de prise des médicaments, toutes les portes sont fermées; ce qui a pour effet que les médicaments sont bien protégés contre les fausses manipulations. A l'intérieur d'une période de prise, la seule porte qui peut être ouverte est celle correspondant à la bonne posologie. Ceci permet à l'utilisateur, s'il a des problèmes de vue, de procéder par tri et d'éviter une erreur.
• Si une personne a oublié de prendre son médicament à l'intérieur du temps de prise prévu, elle ne peut, normalement, plus ouvrir la porte et accéder au médicament. Si le temps n'est pas critique, le temps de prise correspondant peut être aussi long que souhaité.
• Dans le cas de l'option du lien par radio, si nécessaire, une personne intervenante compétente peut rouvrir la porte à distance, éventuellement, après avoir discuté avec l'utilisateur concerné.
• Les éléments de conditionnement 2 peuvent être retirés lorsqu'ils sont vides et retournés au pharmacien.

The system proceeds as follows:

• When the packaging element 2 is introduced into the dispenser 4, all the doors 8 of the compartments 6 are closed.
• The medication plan indicates for each period of intake, the number of the compartment containing the drugs which must be taken during this period (for example the drug contained in compartment X must be taken between 11 am and 1 hour after -midday).
• For each period of taking, an acoustic signal is emitted in order to draw the user's attention to the need to take his medication. For the version with the radio link, this signal is relayed by the external alarm center. In addition, the closing of the door 8 corresponding to the designated compartment is released, therefore said door can be opened, and a visual indicator is activated (for example a light indicator on the front of the door flashes).
• The user is therefore able to push the door 8, the protective plastic film 7 is pierced, and / or the door at the bottom of the compartments is actuated, and the drugs fall into the other hand of the patient, ready to be absorbed.
• The top door (and the bottom door, if it exists) is then pushed back and automatically returns to its initial position, for example using a spring, the closure is then reactivated and the door 8 blocked.
• Between the times of taking the drugs, all the doors are closed; which has the effect that the drugs are well protected against mishandling. Within a period of intake, the only door that can be opened is the one corresponding to the correct dosage. This allows the user, if he has vision problems, to sort and avoid an error.
• If a person has forgotten to take their medication within the scheduled intake time, they cannot normally open the door and access the medication. If the time is not critical, the corresponding setting time can be as long as desired.
• In the case of the radio link option, if necessary, a competent intervener can reopen the door remotely, possibly, after having discussed with the user concerned.
• The packaging elements 2 can be removed when empty and returned to the pharmacist.

According to another advantage of the invention, the system is created in the goal of whether or not patients are taking their medication. For the simple systems, i.e. without radio link, this is possible when the container is removed and replaced by a competent person. For the option with radio link, the statistics are made in time real, and any intervention can be made if necessary (call urgent, etc.). This point is of great interest to the industry pharmaceutical or for research, which needs to know the impact drugs prescribed on the behavior of people and their therapy. In this sense, the link with other monitoring devices is valuable because it allows direct and real-time assessment of the causes and the effects.

A system according to the invention also makes it possible to rationalize the drug distribution in the sense that drugs are distributed in exact quantity (preparation of exact dosage) and, if need is in the case of very expensive drugs, to recover the unused drugs). Recovery of expensive drugs, which have not been taken by the patient, may be considered because their conditioning by the method and the device according to the invention makes it possible to guarantee their cleanliness and good condition. This is all the more important since the wasted medication is an important factor in increasing current health care costs.

Claims (15)

Method of assistance for the administration of drugs in accordance with a medical prescription, not requiring the intervention of the patient and avoiding any false manipulation on the part of the latter, so as to allow the execution of his treatment at his home , without risk of error, characterized in that it comprises the following stages: Stage I.
f Prior preparation of one or more medicinal doses, carried out in pharmacies by a pharmacist, with reference to a prescription drawn up by a doctor.
f Programming and storing on computer (1) of the identification parameters concerning the patient (name, address, social security code) and the preparation corresponding to the prescribed medication (name of the drugs, dosage, dosing schedule). Stage II.
f Inserting the doses into a packaging element (2), then sealed.
f Transcription of said parameters on a recording medium (3) integrated into the packaging element (2) before delivery to the patient or to medical personnel. Stage III.
f Integration of the packaging into a programmable dispensing unit (4), initially locked and unlockable, manually or automatically, for the delivery of drug doses according to the parameters which are stored in memory in the recording medium (3) of the packaging (2 ) and identified by the dispensing unit (4) by any reading means (5), at the time of their association. Device for assisting with the administration of medicaments in accordance with a medical prescription, not requiring the intervention of the patient, characterized in that it consists of: a packaging element (2) in which a pharmacist has at least one medicinal dose which has been the subject of a prior preparation carried out by himself in a pharmacy with reference to a prescription established by a doctor, said packaging (2 ) then being hermetically sealed for delivery to the patient or medical personnel. a recording medium (3) linked to the packaging element (2), and onto which all the identification parameters relating to the patient are transcribed: name, address, social security code, etc. and the preparation corresponding to the prescribed medication: name of the medication, dosage, schedule, etc. a programmable distribution unit (4), initially locked and unlockable manually or automatically for the delivery of one or more medicinal doses as a function of the parameters stored on the recording medium (3) of the packaging element ( 2). means for identifying and reading (5) said parameters linked to the distribution unit (4) and activated at the time of its association with the conditioning element (2) of the drug doses to be administered. Device according to claim 2, characterized in that the drug dose (s) are in the form of tablets. Device according to claim 2, characterized in that the packaging element (2) consists of a subdivided container in a plurality of compartments (6), in each of which are previously placed the tablet (s), corresponding to taking given drugs, to be ingested by the patient at a dosage, one hour and at a predetermined interval. Device according to claim 4, characterized in that the container constituting the packaging element (2) is a drawer compartmentalized in a generally parallelepiped shape. Device according to claim 5, characterized in that the compartmentalized drawer, constituting the packaging element (2), is covered by a hermetically sealed plastic film (7), transparent to less on top. Device according to one of claims 5 or 6, characterized in that the compartmented drawer has no bottom, the plastic film (7) completely surrounding it to constitute upper walls and lower closure and protection can be destroyed at the time the grip by localized tearing means (8). Device according to one of claims 2 to 7, characterized in that the distribution unit (4) consists of a shaped receptacle corresponding to that of the packaging element (2) forming a drawer so as to allow the housing thereof by sliding, once filled with predetermined drug dose and wrapped in film protector (7), said receptacle (4) comprising at least on its face upper or lower as many openings (9) as there are compartments in the drawer packaging element (2), which are made of view of the latter, so as to allow removal from a determined compartment (6) of a dose of medication to be taken, this by tearing of the protective film (7) located opposite both the opening (9) considered of the receptacle (4) and the cubicle (6) corresponding. Device according to claim 7 or 8, characterized in that the means for tearing off (8) the protective film (7) from the receptacle constituting the distribution unit (4) are constituted by doors Maneuverable manually or automatically, arranged in the openings (9) of said receptacle (4) and capable of being articulated with respect to a sides of them so that by pushing them selectively towards inside, they cause the upper faces to tear and lower of the film (7) surrounding the compartments (6) of the drawer (2), releasing thus the dose of medicine contained in a compartment (6) considered. Device according to claim 9, characterized in that the doors (8) of the distribution unit (4) are connected together mechanically and actuable according to a pre-established IT procedure and managed remotely, so as to ensure locking or unlocking of said doors (8) in a chosen order and according to pre-established time periods managed by an electronic clock. Device according to claim 10, characterized in that the doors (8) have automatic return means to their initial position, which has the effect of reactivating the closing function ensuring their condemnation. Device according to claim 10, characterized in that the computer programming includes a recognition function of a single user. Device according to claim 10, characterized in that the computer programming includes an error detection function suitable for triggering the blocking of the distributor (4). Device according to claim 10, characterized in that the computer programming includes an unlocking function, at a predetermined instant T, of one of the doors (8) of the distributor (4) corresponding to a compartment (6) containing the dose to be taken there instant T, the other compartments (6) remaining locked. Device according to one of claims 10 to 14, characterized an acoustic and / or luminous and / or radio alarm signal is emitted in order to attract the attention of the patient or a medical staff finding at a distance, in the case of a mistake made or in the case of a forgetting to take medication.

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