FR2787317A1 - ASSISTANCE PROCESS FOR THE ADMINISTRATION OF MEDICINES IN ACCORDANCE WITH A MEDICAL PRESCRIPTION AND DEVICE FOR IMPLEMENTING THIS PROCESS - Google Patents

Abstract

Assistance method for the administration of medicaments in accordance with a medical prescription, not requiring the intervention of the patient, 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 steps: - Step I .. Prior preparation of one or more medicinal doses, and. Programming and storage on computer (1) of identification parameters. - Step II .. Individually inserting each of the doses into a packaging element (2), then sealed, and. Transcription of said parameters on any recording medium (3) applied to the conditioning element (2). - Step III. . Integration of the packaging into a dispensing unit (4), the operation of which is programmable and comprising means for reading the parameters.

Description

ASSISTANCE PROCESS FOR THE ADMINISTRATION OF

  DRUGS IN ACCORDANCE WITH A MEDICAL PRESCRIPTION

  AND DEVICE FOR IMPLEMENTING THIS PROCESS

  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 execution treatment at home, without risk of error. There are currently surveillance networks, in particular for the elderly, which include a local central unit that can generate a call to qualified personnel or a family member, in response to an alarm issued by the elderly person in question from their home. . For this, it is sufficient for the latter to actuate a button mounted on a box which it carries on it, for example, as a pendant or on the wrist. In a known manner, this box contains a signal generator, which, thanks to a wireless link, acts on the central unit which transmits the signal to a

1s base station.

  Using such a monitoring network, it is also possible to remotely monitor various parameters of a patient such as, for example, his temperature, the number of heartbeats, etc. In this context, the applicant describes in its French patent application No. FR / 97 05547 a device for monitoring the activity of a person making it possible to detect a possible fall with a view to helping him. All these systems provide real assistance to the elderly, the disabled, or simply a patient in recovery, but they had to be complemented by a system of assistance for the administration of drugs allowing '' help those concerned to take their medication in the right quantity and at the right time according to the doctor's prescriptions. In fact, the method and the device according to the invention are intended to reduce the possibility of errors in the manner of taking these drugs, and also to avoid the risks of errors during the preparation of the doses of

these drugs.

  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 - Stage I. f Prior preparation of a drug dose (s), carried out in pharmacies by a pharmacist, with reference at

  a prescription from a doctor.

  f Programming and storing on computer the identification parameters concerning the patient (name, address, social security code) and the preparation corresponding to the prescribed medication

  (name of medication, dosage, 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

patient or medical staff.

- Stage III.

  f Integration of the packaging in 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 of 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 possible technical combinations.

  This description, given by way of nonlimiting example, will do better

  understand how the invention can be implemented with reference to the accompanying drawings in which: - Figure 1 is a block diagram of a device

  assistance in taking drugs according to the invention.

  - Figure 2 is an exploded perspective view of an element of

  packaging of drugs and an associated dispensing unit.

  The assistance procedure for the administration of medicaments in accordance with a medical prescription is schematically illustrated in

Figure 1.

  The invention also relates to a device for implementing the aforementioned 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 itself in pharmacies with reference to a prescription drawn up by a doctor, said packaging 2 then being hermetically sealed for delivery to the patient or to a

medical staff.

  - a recording medium 3 linked to the packaging element 2, and into 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 element of

conditioning 2.

  means of identification and of reading 5 of 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 packaging element 2 and the dispensing 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 packaging element 2 consists of a container subdivided into a plurality of compartments 6, in each of which are previously arranged the tablet (s), corresponding to a given medication intake, to be ingested by the patient according to a dosage, starting at one hour and during a predetermined interval. 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 of course be 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 cm3.

  One can also provide a disposable single-use dispensing assembly, but it is not excluded either to reuse the dispenser by bringing it back to the pharmacist for a new use, for example.

  example, for further processing.

  According to another characteristic of the invention, the compartmentalized drawer, 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 compartmented drawer has no bottom, the plastic film 7 surrounding it completely to form upper and lower closing and protective walls which can be destroyed at the time of setting, by means

localized pullout 8.

  According to another exemplary embodiment, the bottom of the compartments (possibly, their upper and lower parts) is constituted by a door, which is actuated by an opening mechanism, thus releasing the medicaments from below, and which returns to its position starting after

drug release.

  As regards the dispensing unit 4, this is constituted by a receptacle of shape corresponding to that of the conditioning element 2 forming a drawer so as to allow, once filled with predetermined medicinal doses and wrapped in the protective film 7, the housing thereof by sliding, said receptacle 4 comprising at least 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 withdrawal in a predetermined compartment 6 of a dose of drug to be taken, this by tearing the protective film 7 located opposite both of the opening 9 considered of receptacle 4 and of

corresponding compartment 6.

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

  automatic or manual unlocking.

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

conditioning 2.

  According to a preferred embodiment, the means 8 for tearing off the protective film 7 of the receptacle constituting the distribution unit 4 are constituted by doors, which can be operated manually or automatically, disposed in the openings 9 of said receptacle 4 and which can be articulated relative to one of the sides thereof so that by pushing them selectively inwards, they cause the tearing of the upper and / or lower faces of the film 7 surrounding the compartments 6 of the drawer 2, thereby releasing the dose of drug contained

in a compartment 6 considered.

  In fact, the doors 8 of the distribution unit 4 can be actuated, according to a pre-established computer procedure so as to ensure the locking or unlocking of said doors 8 according to 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 lower and upper doors, the lower and upper doors corresponding to the same compartment can be mechanically coupled. According to another characteristic of the invention, the doors 8 include automatic return means towards their initial position, having the effect of reactivating the closing function ensuring their

conviction.

  We can also imagine a system where a single control button allows to exert an action on all doors 8, a

  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.

  The computer programming includes an unlocking function, at a predetermined instant 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 acoustic and / or luminous and / or radio alarm signal is emitted with the aim of attracting the attention of the patient or of medical personnel being at a distance, in the case of a mistake made or in the case of forgetting to take medication. 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 set of packaging element 2 - distribution unit 4; the doors 8, capable of being articulated inside the compartments 6, being represented by switches

10.

  The position of the switches 10 testify to the opening or closing of 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 whether the operation of opening the corresponding door has been carried out or not. This recognition is ensured by the processing unit 11, on the basis of the information recorded in the recording medium 3, of the information of the position of the doors (information given by the switches 10) and of the real time provided by a clock. internal forming, for example, part of said processing unit 11. If the door opening operation has not been carried out, an alarm signal is generated by the alarm generator 17 and is transmitted to a central local (for example, apartment) 19 via a transmission circuit 18 and a radio link. The central apartment unit then calls on an external service provider who contacts the patient. The external worker has the option of reporting to the patient, by telephone or any other means, that he has forgotten to do so, or even of intervening, remotely, to unlock, by radio information 20, the doors that should have been opened, thus allowing the patient taking his medicine. The system could allow other operating sequences such as, for example, automatic unlocking after a certain period of time. However, preference will be given to the safety of taking medication and to monitoring it by an external party. 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 at destination a transducer 14, which may be, depending on the case, of the 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 s15 will control the circuit 16. This possibility therefore allows the patient to alert the external worker in view of '' telephone contact or any other subsequent action. The assistance device which has just been described can be produced using discrete or modular circuits or components but, preferably, it will be based on the use of a microprocessor

suitably programmed.

  The operation of the system which has just been described, for use at home, is as follows: - The medical personnel, or possibly the user himself if he has sufficient autonomy, introduces the conditioning element 2 in the distributor 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 recorded program as seen above

above.

  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 base for control.

  - The information synthesized in the medium 3 is processed by means 5 for reading the parameters of the recording medium of the unit

secure distribution 4.

  The system proceeds as follows: - When the conditioning element 2 is introduced into the

  distributor 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 am afternoon). - 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

  indicator light 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 back 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 set period, the I (only door that can be opened is the one corresponding to the correct dosage. This allows the user, if he has vision problems, to

  proceed by sorting 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 time is not critical, time

  take may 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 with the aim of knowing whether or not the patients are taking their drugs. For 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 real time, and any intervention can be made if necessary (urgent call, etc.). This point is of great interest for the pharmaceutical industry or for research, which needs to know the impact of prescribed drugs on people's behavior and their therapy. In this sense, the link with other monitoring devices is precious, as 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 distribution of the drugs in the sense that the drugs are distributed in exact quantity (preparation of the exact dosage) and, if necessary is in the case of very expensive drugs, to recover the unused drugs ). The recovery of expensive drugs, which have not been taken by the patient, can be envisaged because their packaging 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 wastage of drugs is an important factor in the increase

current health care costs.

Claims (10)

  1. Method of assistance for the administration of medicaments 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: io Stage I. f Prior preparation of a drug dose (s), carried out in pharmacies by a pharmacist, with reference to   a prescription from a doctor.   f Programming and storing on computer (1) identification parameters concerning the patient (name, address, social security code) and the preparation corresponding to the prescribed medication   (name of drugs, dosage, times of intake). - 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 conditioning element (2) before   given to the patient or medical staff. - 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. 2. 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 itself in pharmacies with reference to a prescription drawn up by a doctor, said packaging (2) being   then 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 element of packaging (2).   means of identification and reading (5) of said parameters linked to the distribution unit (4) and activated at the time of its association with the conditioning element (2) of the medicinal doses to be administered. 3. Device according to claim 2, characterized in that   the drug dose (s) are in the form of tablets.   4. Device according to claim 2, characterized in that the packaging element (2) consists of a container subdivided into a plurality of compartments (6), in each of which are previously arranged the tablet (s), corresponding to a socket of given drugs, to be ingested by the patient according to a dosage, one hour   and at a predetermined interval.   5. Device according to claim 4, characterized in that the container constituting the packaging element (2) is a drawer   compartmentalized in a generally parallelepiped shape.   6. 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.   7. Device according to one of claims 5 or 6, characterized   in that the compartmented drawer has no bottom, the plastic film (7) surrounding it completely to form upper and lower closing and protective walls which can be destroyed at the time   the grip by localized tearing means (8).   8. Device according to one of claims 2 to 7, characterized in   that the distribution unit (4) is constituted by a receptacle of shape corresponding to that of the conditioning element (2) forming a drawer so as to allow the housing thereof by sliding, once filled with drug dose predetermined and wrapped in protective film (7), said receptacle (4) comprising at least on its upper or lower face as many openings (9) as there are compartments in the packaging element in the drawer (2), which are carried out opposite the latter, so as to allow the withdrawal in a determined compartment (6) of a dose of drug to be taken, this by tearing the protective film (7) located opposite the times of the opening (9) considered of the receptacle (4) and the corresponding cubicle (6). 9. Device according to claim 7 or 8, characterized in that the tearing means (8) of the protective film (7) of the receptacle constituting the distribution unit (4) are constituted by doors operable manually or automatically, arranged in the openings (9) of said receptacle (4) and capable of being articulated relative to one of the sides thereof so that by pushing them selectively inwards, they cause the tearing of the upper and lower faces of the film (7) surrounding the compartments (6) of the drawer (2), thus releasing the dose of medicament contained in a compartment (6) considered. 10. 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 computer procedure   established and managed remotely, so as to ensure the locking or unlocking of said doors (8) in a chosen order and according to   pre-established time periods managed by an electronic clock.   1il. Device according to claim 10, characterized in that the doors (8) include automatic return means to their initial position, having the effect of reactivating the closing function ensuring their condemnation.   12. Device according to claim 10, characterized in that the computer programming comprises a recognition function of a single user.   13. Device according to claim 10, characterized in that the computer programming comprises an error detection function   suitable for triggering the blocking of the distributor (4).   14. Device according to claim 10, characterized in that the computer programming comprises an unlocking function, at a predetermined instant T, of one of the doors (8) of the dispenser (4) corresponding to a compartment (6) containing the dose to be taken at this instant T, the other compartments (6) remaining locked.   15. Device according to one of claims 10 to 14, characterized   in that an acoustic and / or luminous and / or radio alarm signal is emitted in order to attract the attention of the patient or of medical personnel at a distance, in the event of an error made or in the case of a forgetting to take medication.